Frequently Asked Questions

Everything you need to know about FlexiSEQ's two drug-free gels

FAQs

If you have a question relating to our two gels - FlexiSEQ (for Joint Wear & Tear) or FlexiSEQ Max Strength (for Osteoarthritis) - please see our answers below. For questions relating to FlexiSEQ CBD please, see here.


Product

What is FlexiSEQ?

FlexiSEQ is a topically applied, drug-free gel clinically proven to relieve the pain and improve the joint stiffness associated with osteoarthritis (OA).

There is extensive clinical data available from several randomised, double-blind clinical trials and FlexiSEQ is approved as a medical device for the treatment of all joints affected by OA.

The Intended Purpose of FlexiSEQ is: FlexiSEQ lubricates the cartilage in joints to relieve pain and stiffness and improve impaired joint function associated with all stages of osteoarthritis.

There are two different FlexiSEQ devices: FlexiSEQ Max Strength (for Osteoarthritis - the original product) and FlexiSEQ (for Joint Wear & Tear)

There are a number of different brand names:

• FlexiSEQ Osteoarthritis (OA), the original product in a 50g tube
• FlexiSEQ Osteo (OA), available in a 30g, 50g and 100g tube
• FlexiSEQ Active, available in 50g and 100g sizes
• FlexiSEQ Max Strength (for Osteoarthritis), the rebranded FlexiSEQ Osteoarthritis (OA) product in a 50g tube
• FlexiSEQ (for Joint Wear & Tear), the rebranded FlexiSEQ Active, available in 50g and 100g sizes

What is the difference between FlexiSEQ Max Strength (for Osteoarthritis) and FlexiSEQ (for Joint Wear & Tear)?

FlexiSEQ Max Strength (for Osteoarthritis) is intended for patients who need to treat the pain and stiffness associated with OA. Patients seeking maximum strength treatment for their symptoms should choose FlexiSEQ Max Strength. SEQ Tech inside FlexiSEQ Max Strength (for Osteoarthritis) delivers lubricating ingredients into joints to help reduce pain and improve mobility.

FlexiSEQ (for Joint Wear & Tear) contains a lighter formulation specially formulated to help restore joint function and relieve the pain associated with joint wear and tear. SEQ Tech inside FlexiSEQ delivers plant-based phospholipids into joints to help lubricate and protect damaged cartilage. All FlexiSEQ products contain Sequessome Technology – tiny lipid spheres that pass through the skin when the gel is applied topically. FlexiSEQ Max Strength (for Osteoarthritis) contains the maximum concentration of these vesicles. FlexiSEQ (for Joint Wear & Tear) contains a lower concentration of the vesicles, making it lighter and therefore suitable for less severe symptoms of joint wear and tear.

Which FlexiSEQ product should I choose?

All FlexiSEQ gels contain Sequessome vesicles (SEQ Tech) – the tiny lipid spheres that pass through the skin when the gel is applied topically. Fully concentrated FlexiSEQ Max Strength (for Osteoarthritis) is clinically proven to be as effective as a prescription oral painkiller (celecoxib) for the pain and stiffness associated with osteoarthritis and is the gold standard product we offer. Patients seeking maximum strength treatment for their condition should choose this formulation.

FlexiSEQ (for Joint Wear & Tear) contains a lower concentration of Sequessome vesicles (SEQ Tech), making it lighter and therefore suitable for the daily needs of active people whose joints suffer from wear and tear.

Both products offer a drug-free alternative for the treatment of joint pain and stiffness which means patients can avoid drug-based side effects that can be caused by traditional painkillers such as diclofenac and ibuprofen. In addition, FlexiSEQ products can be used alongside medications without interference, and by patients with other conditions (co-morbidities) without exacerbating their other conditions.

Do all FlexiSEQ products work in the same way?

All FlexiSEQ gels have exactly the same physical mode of action and work by lubricating the affected joint to reduce pain and stiffness and improve impaired joint function.

Are FlexiSEQ products right for me?

Any patients with OA or joint pain and stiffness caused by wear and tear to the cartilage can use FlexiSEQ products. They are of particular interest to:

Patients for whom other treatment options (NSAIDs, COX-II inhibitors, paracetamol, etc.) should be avoided or used as little as possible, either because of their other medical conditions, patient age or their concomitant medications. This includes patients with cardio-vascular (CV) or gastro-intestinal (GI) risk factors and problems.

Patients who are not receiving adequate symptomatic relief from their current treatment and want to add another option.

Cautions: Patients with known sensitivity to any of the ingredients listed on the box should not use FlexiSEQ. Pregnant women should consult their doctor

What makes FlexiSEQ different from other gels for osteoarthritis?

FlexiSEQ is an aqueous gel packed with microscopic spheres called Sequessome vesicles (SEQ Tech), These spheres contain molecules called phospholipids which naturally occur in all cells of the body and variants of which contribute to the lubricating properties of synovial fluid and cartilage. FlexiSEQ is drug free because it uses these Sequessome vesicles, and therefore has none of the side effects associated with other OA gels that contain Non-Steroidal Anti-inflammatory Drugs (NSAIDs).

FlexiSEQ has a physical mode of action, whilst NSAIDs such as ibuprofen have a pharmacological effect and alter physiological pathways in the body. NSAID use is often associated with gastrointestinal (GI) side effects such as ulcers, and cardiovascular (CV) effects such as increased risk of heart attack, and these side effects can be very serious. In contrast, the side effects most commonly reported for FlexiSEQ are mild or moderate skin irritations at the site of application that are temporary and will resolve over time even without stopping treatment in some cases.

Is FlexiSEQ suitable for vegetarians?

Yes, FlexiSEQ contains no animal derived ingredients.

Is the glycerine or any other ingredient in FlexiSEQ derived from animals?

No, there are no ingredients in FlexiSEQ that are of animal origin.

Is FlexiSEQ tested on animals?

FlexiSEQ is regulated as a medical device and as such it had to go through some mandatory animal testing as part of its original development and registration. The company does not voluntarily test its products on animals and only when it is required to do so by medical device regulations.

The last tube of FlexiSEQ has a most peculiar odour and most definitely isn’t as effective as previous tubes.

We have not changed the formulation of FlexiSEQ and can assure you the contents inside are just as effective as any of our past FlexiSEQ tubes. Our new batches of FlexiSEQ have a stronger odour, but this will decrease once opened and once the tubes move closer to the expiry date.

I have just purchased a tube of gel and it has worked very well but the tube appears only to be half (or partially) full.

We would like to assure you that the tubes do contain 30g, 50g or 100g of gel as stipulated on the packaging. Because the capacity of the tubes is greater than 30g, 50g or 100g there is always some air in the tubes, which can give the impression that they are not filled properly. However, every single tube is weighed automatically on the production line and those falling outside the very strict tolerances are rejected. Therefore, we can be quite sure that the correct amount is in the tubes.

Do you make small sample size tubes?

We do not make sample size tubes.

The tube I purchased has been relabelled, is this the same product?

Thank you very much for bringing this issue to our attention. We would like to reassure you that the product is genuine. In order to be able to provide an uninterrupted supply of FlexiSEQ, in these current times of uncertainty; we had to make the decision to carry out a relabelling exercise. This is also in accordance to regulatory requirements.

Should you still wish us to have a look into this further, then please do provide us with a batch number and expiry date and we can of course investigate this for you. However, please be rest-assured that much of our e-commerce stock had to go through the relabelling process. So far, we have not come across any counterfeit FlexiSEQ products.

Where to buy / pricing

Where can I purchase FlexiSEQ?

All FlexiSEQ products are widely available without prescription at independent pharmacies, Boots, Lloyds Pharmacy, Tesco, Superdrug and Well Pharmacy. FlexiSEQ is also available online on Amazon.

I have been to my nearest advised store but FlexiSEQ was not on the shelf

If you could not find FlexiSEQ at our recommended stores you should consult their customer service departments as some retailers do not have 100% distribution of FlexiSEQ. Most stores have full availability online. If you can see a space for FlexiSEQ on retail shelves but it is empty, then please contact us at enquiries@flexiseq.com

How much does FlexiSEQ cost?

The price of the FlexiSEQ products will vary in different countries so please contact your local pharmacy or online pharmacy. Our website contains a price comparison within the UK.

What is the reason for the difference in price between FlexiSEQ Max Strength (for Osteoarthritis) and FlexiSEQ (for Joint Wear & Tear)?

FlexiSEQ (for Joint Wear & Tear) contains a lower concentration of Sequessome vesicles (SEQ Tech), the most cost intensive ingredient and part of the manufacturing process, and therefore costs less.

Can FlexiSEQ products be prescribed by my doctor?

At the moment, whilst many doctors are recommending FlexiSEQ to their patients, FlexiSEQ is not included in the relevant section of the Drug Tariff therefore it is not possible for them to prescribe FlexiSEQ on the NHS.

What countries is FlexiSEQ available in?

FlexiSEQ is available in the United Kingdom and the EU particularly, Austria, Czech Republic, Germany, Ireland, Italy, Latvia, Lithuania, Malta, Poland and Slovakia. It is also available in Hong Kong, Malaysia, Singapore, Thailand, Australia, New Zealand, Turkey, Jordan, Iraq, Kenya and South Africa.

Why is FlexiSEQ more expensive than anti-inflammatory products?

A 50g tube of FlexiSEQ retails at £18.99 in the UK. It is worth noting that FlexiSEQ is applied twice per day and no more, whilst the majority of topical competitor products can require up to 6 applications per day to achieve similar results. With this in mind, FlexiSEQ is a cost-effective option.

Science

What is in FlexiSEQ products?

All FlexiSEQ products contain tiny lipid spheres (Sequessome vesicles) in a water-based gel. These spheres can pass through the skin into the joint below.

What is the composition of FlexiSEQ (for Joint Wear & Tear)?

FlexiSEQ Max Strength (for Osteoarthritis): Aqua, Phosphatidylcholine, Alcohol, Glycerin, Carbomer, Polysorbate 80, Disodium Phosphate, Sodium Hydroxide, Benzyl Alcohol, Methylparaben, Ethylparaben, Linalool, Disodium EDTA, Sodium Phosphate, Sodium Metabisulphite, BHT.

FlexiSEQ Active (for Joint Wear & Tear): Aqua, Phosphatidylcholine, Glycerin, Alcohol, Carbomer, Disodium Phosphate, Sodium Hydroxide, Polysorbate 80, Benzyl Alcohol, Methylparaben, Ethylparaben, Disodium EDTA, Linalool, Sodium Phosphate, Sodium Metabisulfite, BHT.

FlexiSEQ® is an aqueous gel packed with microscopic spheres called Sequessome vesicles (SEQ Tech). These spheres contain molecules called phospholipids which naturally occur in the body and variants of which contribute to the lubricating properties of synovial fluid and cartilage. The main phospholipid in Sequessome vesicles, phosphatidylcholine, is an extract of the soy bean. FlexiSEQ does not contain any ingredients of animal origin.

How well do FlexiSEQ products work?

There have been several clinical studies evaluating the safety and efficacy of FlexiSEQ across a range of doses representative of the three products, and these have consistently demonstrated average reductions in pain and average improvements in physical function.

One of the key studies in this extensive clinical programme also demonstrated that FlexiSEQ Max Strength (for Osteoarthritis) is as effective at alleviating joint pain as an oral prescription drug which, unlike FlexiSEQ Max Strength (for Osteoarthritis), but in common with other treatments in the same class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), has well recognised systemic side effects (problems resulting from the drug being spread throughout the body). In this comparison study, patients treated with FlexiSEQ Max Strength (for Osteoarthritis) reported a reduction in joint pain and stiffness that was equivalent to that reported by the patients taking oral celecoxib.

In a recent FlexiSEQ User Experience Study, the key findings were:

• 86% of participants agreed that FlexiSEQ Max Strength (for Osteoarthritis) helped improve their overall joint health.
• 84% of participants agreed that FlexiSEQ Max Strength (for Osteoarthritis) improved their joint mobility.
• 73% of participants reported they could go longer without taking pain relief.
• 48% of participants reported a reduction in the number of painkillers taken.
• 82% of participants would definitely recommend FlexiSEQ Max Strength (for Osteoarthritis) to a friend.

These same studies have also demonstrated the safety of FlexiSEQ products: the most commonly reported side effects were mild/moderate skin irritations. In addition, there have now been over 100 million applications of the product and, unlike other oral and topical treatments, there have been no reported incidences of systemic side effects (such as gastro-intestinal problems) related to the use of FlexiSEQ. This lack of systemic exposure also makes these products safe to use alongside any other therapy.

How does FlexiSEQ work?

FlexiSEQ treatments are drug-free and relieve the pain and stiffness associated with osteoarthritis. FlexiSEQ exerts its pain-relieving effect via lubrication of the joint which is a physical mode of action. It has no pharmacological, metabolic or immunological activity. FlexiSEQ is a gel containing Sequessome vesicles (SEQ Tech), which are tiny lipid spheres. As the gel dries on the skin, these spheres change their shape and pass through the skin, then into the joint where they lubricate the surface of the cartilage to provide relief from pain and stiffness. They are compressible and deformable, yet stable.

Patients with joint disorders such as OA have been found to have reduced levels of lubricants in their synovial fluid and this is one of the factors contributing to the pain and loss of joint function in patients with OA. There is also strong evidence in published literature that liposome vesicles can act as a bio-lubricant in the knee joint, and hence can reduce pain and improve mobility.

Research has shown that following topical application of FlexiSEQ, the Sequessome vesicles (SEQ Tech) pass through the skin and enter the synovial joint where they collect on cartilage surfaces. The physical properties of Sequessome vesicles (SEQ Tech) make them particularly efficient at lubricating the joint surfaces.

What is the evidence that Sequessome vesicles (SEQ Tech) get into the joint?

A study using fluorescent labelled Sequessome vesicles (SEQ Tech) demonstrated that following topical application of FlexiSEQ, they pass through the skin, penetrate the synovial fluid within the joint and collect on cartilage surfaces.

What is the longest time that any patient has been treated for with FlexiSEQ?

FlexiSEQ products are approved for long-term use and there is no maximum treatment duration. We have data from a 52-week study that shows that FlexiSEQ is extremely well tolerated for a year and that treatment effects are maintained. In addition, since the launch of FlexiSEQ over 8 years ago, there have been over 100 million applications of the product and, unlike other oral and topical treatments, there have been no reported incidences of systemic side effects related to the use of FlexiSEQ.

Application

How should I apply FlexiSEQ gel?

FlexiSEQ products should be applied twice daily to the affected joint, usually in the morning and the evening. Use enough gel to evenly cover the soft tissue around the joint.

How should I apply the gel to the knee?

In order to achieve optimum effect, FlexiSEQ gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry.

Application of a line of gel as long as your index finger is recommended. The gel should be evenly applied to the soft tissue at the sides and the back of the knee but should not be applied to the bony patella (knee cap).

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time. Please wash your hands after applying the gel.

How should I apply the gel to the hip?

In order to achieve optimum effect, FlexiSEQ gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry.

It is difficult to give precise dosing amounts for the hip as the size of this joint can vary widely from patient to patient. Use enough gel to evenly cover the soft tissue around the joint. Locate the edge of your pelvis (or hipbone) at your side and apply a line of gel approximately as long as your index finger to soft tissue below the edge of the hip bone. Do not spread towards the buttocks but instead towards your groin.

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time. Please wash your hands after applying the gel.

How should I apply the gel to the hand, wrist, thumb or fingers?

In order to achieve optimum effect, FlexiSEQ gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry.

You should apply a pea-sized amount of gel evenly to the area around the affected joint.

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time. Please avoid washing the affected hand for 10-15 minutes after application.

How should I apply the gel to the shoulder?

In order to achieve optimum effect, FlexiSEQ gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry.

Apply a line of gel as long as your index finger to the soft tissue around the area of pain, avoiding the shoulder blade. Please make sure you apply our gel on the top of your arm where your shoulder starts, making sure you cover the area around your joint leading into your armpit.

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time. Please wash your hands after applying the gel.

How should I apply the gel to the ankle?

In order to achieve optimum effect, FlexiSEQ gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry.

The easiest way to make sure that the affected ankle area is covered, is by applying a line of gel as long as your index finger from one side of the ankle joint all around the other side, making sure that the Achilles heel and the space between both ankle joints at the front is covered. You should not apply FlexiSEQ directly on your ankle bone but please make sure you do so on the soft tissue around it.

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time.

How should I apply the gel to the toes?

In order to achieve optimum effect, FlexiSEQ® gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry

You should apply a pea-sized amount of gel evenly to the area around the affected toe joint. Spread the gel on the top of the joint as well as under the sole of the foot.

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time.

How should I apply the gel to the spine/neck?

In order to achieve optimum effect, FlexiSEQ gel should be applied twice daily, usually morning and evening, not rubbed in but left to dry.

Apply a line of gel as long as your index finger to the soft tissue around the area of pain.

FlexiSEQ must be allowed to dry before covering; drying should take no longer than 10 minutes if the product is applied to clean, dry skin. If drying takes longer than this, ensure that the skin is dry (for example, if applying after a bath or shower) and try using a little less gel. If the drying time is considerably less than 10 minutes, then a little more gel should be used next time.

Could you provide a diagram or video showing how to apply FlexiSEQ to the different joints?

Please visit our 'How to Apply' page to view videos that demonstrate the correct application of FlexiSEQ to various joints.

What should I do if FlexiSEQ is applied incorrectly?

FlexiSEQ has an excellent tolerability and safety profile.

Why should you not apply gel to bone?

We always recommend applying FlexiSEQ on the soft tissue around the joint and discourage it being applied to bone such as the kneecap or shoulder blade because the Sequessome vesicles (SEQ Tech) cannot travel through bone. There are no safety issues but it would merely be a waste of the gel.

What should I do if too much gel has been applied?

There are no safety issues with applying too much gel. It will simply take longer for all of the gel to dry off. You can wipe off excess gel and apply less the next time. As a general guide, it should not take longer than 10 minutes for the gel to dry off completely.

What should I do if gel has entered the eyes?

As with most topical treatments, you should avoid allowing the gel to enter the eyes. If gel does enter the eyes, they should be rinsed with plenty of cold water. If excessive stinging/symptoms occur, please consult a pharmacist or doctor.

What should I do if gel has been eaten?

The gel should not be taken orally, but if it has been ingested, it should not cause major problems. As with other medical products, care should be taken to store it out of reach of children. If symptoms occur, please consult a pharmacist or doctor.

As with all treatments, if you have any concerns, please consult a doctor or pharmacist.

How often should I apply FlexiSEQ products?

All FlexiSEQ products should be applied twice a day, usually morning and evening.

Do you have to use FlexiSEQ continuously?

The best results are achieved when using FlexiSEQ on a continuous twice daily basis as this will ensure that the joints are being continuously lubricated. In similarity to naturally occurring phospholipids, Sequessome vesicles (SEQ Tech) do degrade in the body over time and must be reapplied regularly.

Can I alter my treatment regimen to, say, every second day?

The proven clinical efficacy is based on twice daily dosing and we have no data to recommend reducing the dose. However, a lot of our long-term customers have found they can lower the dosage to one application daily or dose every second day in order to maintain Sequessome levels at a level effective for them.

How long can I use FlexiSEQ for?

FlexiSEQ products are approved for long-term use and there is no maximum treatment duration.

Can I use body lotions or massage oils, etc.?

If body lotion is applied alongside FlexiSEQ or before FlexiSEQ dries, it may reduce its effectiveness. However, patients may apply a little body lotion or light cream, preferably unperfumed, when necessary to keep their skin moisturised once FlexiSEQ is fully dried off and absorbed into the skin

If massage oils are applied before applying FlexiSEQ, it may reduce its effectiveness. It may also cause the gel ingredients to separate, making it unpleasant to apply to the skin.

Can I exercise or take a shower after I apply FlexiSEQ?

Please allow around 20 minutes after the application of FlexiSEQ before you start exercising or showering. Once the gel has dried and the Sequessome vesicles (SEQ Tech) have passed through the outer skin layer on their way to the joint, they do not reverse their journey.

Pain Relief

What are the differences between FlexiSEQ and other pain treatments?

Unlike most pain treatments, FlexiSEQ treatments are drug-free and therefore have an excellent safety profile. They can be used by patients with other conditions such as high blood pressure and by patients who take numerous medications. Despite being drug free, FlexiSEQ has been shown to be as effective at alleviating joint pain as the oral prescription drug, celecoxib (an oral NSAID). Unlike drug-based painkillers, which can only be used for short periods, FlexiSEQ can be safely used long-term as part of your daily healthcare regimen.

FlexiSEQ has a physical mode of action, while Non-Steroidal Anti-inflammatory Drugs (NSAIDs) have a pharmacological effect and alter physiological pathways in the body. NSAID use is often associated with gastrointestinal (GI) side effects such as ulcers, and cardiovascular (CV) effects such as increased risk of a heart attack and these side effects can be very serious. In contrast, the side effect most commonly reported for FlexiSEQ is mild or moderate skin irritations that are temporary and usually resolve over time without stopping treatment.

There is increasing awareness that oral NSAIDs are not suitable for patients with certain other conditions (such as heart disease, asthma and stomach ulcers), or those who are on specific medications or are elderly. These patients will therefore benefit from the availability of this drug free, effective topical treatment.

Patients already taking NSAIDs may also use FlexiSEQ in combination if additional pain relief is required, whereas topical NSAIDs cannot be used alongside oral NSAIDs at the same time. More details about the concerns with NSAIDs can be found at the National Institute for Health and Care at http://cks.nice.org.uk/nsaids-prescribing-issues.

How well does FlexiSEQ work compared with other topical products used for the same purpose?

No trials have been conducted comparing FlexiSEQ products with other topical treatments for pain associated with OA, but FlexiSEQ has been studied compared to a commonly prescribed oral NSAID (celecoxib), and has been shown to have equivalent efficacy, while avoiding the well-documented side effects (such as heart attacks, stroke and ulcers) associated with oral NSAID treatments.

One of the most commonly used class of topical treatments for pain is topical Non-Steroidal Anti- inflammatory Drugs (NSAIDs). Depending on the amount applied, these products can still result in absorption of the NSAID into the blood (systemic exposure) and hence can cause the same side effects, potentially serious, commonly seen with the oral NSAIDs. Many topical NSAIDs carry the same warnings as the oral NSAIDs and cannot be used alongside oral NSAIDs.

How quickly does FlexiSEQ work?

Twice-daily treatment with FlexiSEQ provides pain relief after as little as 2 days, which is comparable with the onset of sustainable pain relief to other OA therapies, including oral celecoxib. It may take several days for the full effect to be seen.

How long does the pain relief last once treatment is stopped?

FlexiSEQ works by delivery of lubricating Sequessome vesicles (SEQ Tech) into the joint. These vesicles are made of naturally occurring phospholipids and will degrade in the body over time and will need replacing. Pain will return a few days after stopping treatment; however, the severity of the condition will be a key influencing factor on the return of pain. Therefore, patients will need to continue to use FlexiSEQ in order to maintain efficacy.

Is FlexiSEQ as effective on other joints as it is on the knee?

FlexiSEQ products are registered for treatment of all joints affected by osteoarthritis (OA). The joints affected by OA, such as the knee, the hip, the hand, the elbow, etc., are all synovial (articulating) joints and it is established that treatment with FlexiSEQ would benefit any synovial joint with OA, regardless of its location.

Can FlexiSEQ be used on joints other than the knee?

Yes – FlexiSEQ is registered for the treatment of all joints affected by osteoarthritis, including the knee, hip, hand, shoulder etc.

Can I use FlexiSEQ on my toe joint?

Yes, FlexiSEQ can be used on any synovial (articulating) joint in the body such as the toe.

Does FlexiSEQ work on feet?

FlexiSEQ can be used on any synovial (articulating) joint within the foot such as the toes or ankle.

Can I use it on my spine and if so, how do I apply?

FlexiSEQ can be used to treat osteoarthritis of the spine. Please do bear in mind that the effects in that particular area might vary from person to person and you must be sure that your back pain is caused by osteoarthritis and not by muscular or nervous issues as can often be the case.

Can I use FlexiSEQ on my neck/collapsed disks in the neck?

If you suffer from osteoarthritis in your neck, then FlexiSEQ can most certainly be used on that area.

FlexiSEQ has been specifically designed for osteoarthritis and wear and tear of the joints. We have not received any anecdotal customer feedback regarding usage on collapsed disks in the neck yet. As FlexiSEQ is drug-free and targets the wear and tear of the material disks are made of, you can most certainly trial it for that particular issue and we would be grateful for your feedback.

Can I use FlexiSEQ if I have no cartilage left?

FlexiSEQ brings best results when used on joints with cartilage present. However, while Sequessome vesicles’ (SEQ Tech) main function is to lubricate cartilage surfaces, they also circulate in the synovial fluid to help its lubricating function too. We have therefore received very positive feedback from customers with very little or no cartilage left. Our product is drug-free and we would certainly advise you to try it out yourself.

I am suffering from Frozen Shoulder/Impingement and also tendonitis such as Tennis Elbow. Would FlexiSEQ be of help with this?

FlexiSEQ has been specifically designed for osteoarthritis and wear and tear of the joints. As Frozen Shoulder and Impingement is caused by inflamed tissue/impingement of the tendon around the shoulder joint, FlexiSEQ would not be the right product for you. The same applies to tendonitis as this is caused by inflammation of the tendons, rather than an issue with the joints. However, if you do suffer from osteoarthritis or wear and tear of the shoulder joint, then you can certainly use FlexiSEQ.

Will FlexiSEQ work on a degenerative neck condition?

FlexiSEQ has been specifically designed for osteoarthritis and wear and tear of the joints. We have not had any anecdotal feedback from patients who suffer from degenerative neck conditions but as our product is free of medication and has no contraindications, it could be a viable treatment for degeneration of the disks in that FlexiSEQ targets the wear and tear of the material the disks in the neck and spine are made of.

Will FlexiSEQ work on chronic degenerative disk disease in the back?

FlexiSEQ has been specifically designed for osteoarthritis and wear and tear of the joints. So far, we have not received any anecdotal feedback from customers who used it on chronic degenerative disk disease. We would certainly advise you to try FlexiSEQ as it is drug free and lubricates cartilage, the key material making up spinal disks.

I am suffering from cervical and dorsal spondylitis and I’m wondering if FlexiSEQ could help me?

FlexiSEQ has been specifically designed for osteoarthritis and wear and tear of the joints. FlexiSEQ has not been tested in patients with spondylitis so we do not have any evidence to claim the product will work for that condition.

Does FlexiSEQ work on muscles/bones?

No, FlexiSEQ has been specifically developed for osteoarthritis and wear and tear of the joints. Our product is a joint lubricant only.

Does FlexiSEQ work on artificial joints?

Although not targeted for such use, we have received some positive feedback in the past from patients who have used FlexiSEQ on their artificial joints. As FlexiSEQ is drug free it is absolutely safe to use and we would certainly advise you to try it. We would also be very grateful if you could share your feedback and experience with us.

Does FlexiSEQ work on Rheumatoid Arthritis (RA)?

FlexiSEQ is not indicated for rheumatoid arthritis as that is an autoimmune disease that can cause joint pain and stiffness throughout the body. However, any pain arising from arthritic joint damage (wear and tear) can be treated using FlexiSEQ as it will still lubricate the affected joints, increasing the flexibility and lessen the wear and tear. RA patients may be on an array of medication to control their condition however since FlexiSEQ is drug free it remains a viable addition to the treatment approach.

I suffer from osteoporosis. I hate taking tablets. Would FlexiSEQ be of benefit?

FlexiSEQ has not been tested on patients with osteoporosis and since the condition results in bone degeneration, it is unlikely FlexiSEQ should be of benefit to patients suffering from this condition. However, osteoarthritis can often occur as a related condition (a co-morbidity) to the disease and if this is the case then FlexiSEQ may be worth considering.

FlexiSEQ does not work/I have not received any beneficial effect from these products – why?

No treatment will work for all patients. However, before it is assumed that you are one of those for whom this treatment does not work, please check that:

• You are applying FlexiSEQ correctly – the product will not be effective if you do not apply a thin layer of gel and let it dry, have under-dosed or if you are covering the treated area too soon.
• Treatment has been ongoing for long enough for an effect to be seen (we recommend waiting for up to 4 weeks although an effect will usually be seen sooner, normally within 2 days; some more severely affected patients may take longer)
• FlexiSEQ has been specifically developed for osteoarthritis and wear and tear of the joints. Our product is a joint lubricant only. FlexiSEQ will not relieve pain from muscle soreness or nerve damage

If you are using the gel correctly and not receiving benefit, then unfortunately it may simply not be the treatment for you.

FlexiSEQ has caused increased pain, what is the reason for this?

There is no logical reason as to why FlexiSEQ would cause increased pain. FlexiSEQ is totally drug free, which makes it very easy on the body and the main component is the extract of the soy bean. The Sequessome vesicles in our gel help to lubricate the joint, which in turn increases flexibility and lessens the pain associated with wear and tear.

Safety

Are there any contraindications for FlexiSEQ?

FlexiSEQ is drug-free and has no contraindications.

Can FlexiSEQ products be used by patients with other disorders such as MS, diabetes or asthma?

Yes, FlexiSEQ is drug-free and has no contraindications. There is no evidence from the extensive and growing market experience and the study programme that FlexiSEQ in any way influences other underlying conditions or interacts with treatments for such conditions. This therefore should reassure you that using FlexiSEQ will not compromise your existing condition or medication. As with any treatment, if you have specific concerns, please consult your doctor or pharmacist.

Can FlexiSEQ products be used if the patient has a blood condition such as ITP (Idiopathic thrombocytopenic purpura)?

Please consult your GP before using FlexiSEQ, but as FlexiSEQ is drug-free you should be able to use FlexiSEQ if you have a blood disorder.

Can FlexiSEQ be used alongside acupuncture?

Yes, as FlexiSEQ is drug-free you can have acupuncture at the same time as using FlexiSEQ.

Can I use FlexiSEQ if I have a pacemaker?

Yes, you can use FlexiSEQ if you have a pacemaker.

Can FlexiSEQ be used alongside medications?

FlexiSEQ does not contain any active pharmaceutical ingredients and therefore cannot compromise any existing oral medications, such as low-dose aspirin, paracetamol, diuretics. If you have any specific concerns, a pharmacist or doctor should be consulted.

Can I use FlexiSEQ if I am taking Warfarin?

Yes, as FlexiSEQ is drug-free you can use Warfarin at the same time with no drug-to-drug interactions.

Can I use FlexiSEQ with herbal medicine?

Yes, FlexiSEQ can be used alongside herbal medicine.

Can FlexiSEQ be used with any topical anti-inflammatory drug?

Yes, FlexiSEQ can be used alongside topical anti-inflammatory drugs however they should not be applied at the same time. Please allow at least 30 minutes after FlexiSEQ has dried before applying your other topical gel or cream.

Can FlexiSEQ be used with blood pressure medication?

Yes, as FlexiSEQ is drug-free you can use blood pressure medications at the same time with no drug-to- drug interactions.

I had a cortisone injection a week ago. Can I use FlexiSEQ?

Yes, you can use FlexiSEQ after a cortisone injection.

Can FlexiSEQ products be used in pregnancy or breastfeeding?

FlexiSEQ has not been tested on pregnant women in clinical trials, and therefore use of FlexiSEQ products during pregnancy is not advised unless deemed appropriate by your doctor or physician. Likewise, it is unknown whether FlexiSEQ may be harmful to your child if you are breastfeeding. Please ask your doctor or pharmacist for advice before using the product.

My child is suffering from growing pains in their knee joints, I wondered if FlexiSEQ would ease the pain?

Our product has not been tested on children in clinical trials and therefore use of FlexiSEQ products on children is not advised unless deemed appropriate by your doctor or physician. However, we have had some fantastic feedback from parents in the past, who have used FlexiSEQ on their children's joints successfully.

Can FlexiSEQ be applied to my child who has Spastic Diplegia, Cerebral Palsy?

Our product has not been tested on children in clinical trials and therefore use of FlexiSEQ products on children is not advised unless deemed appropriate by your doctor or physician. However, we have had some fantastic feedback from parents in the past, who have used FlexiSEQ on their children's joints successfully. FlexiSEQ is drug-free and has no contraindications.

Can you please tell me if there is shell fish in FlexiSEQ as I am allergic to shellfish?

FlexiSEQ does not contain any shellfish produce.

Can I use FlexiSEQ on animals?

FlexiSEQ has been formally tested on horses with arthritic joints and has demonstrated great efficacy and we do also have anecdotal evidence that it works well in treating the arthritic hips of some breeds of dog. This is not altogether surprising as it is the same disease as observed in humans and the product works by lubricating the joints to reduce wear and tear which can occur in both human and animal species.

What is the total number of patients treated with FlexiSEQ?

In the clinical programme, just under 2000 patients have been treated with FlexiSEQ with the duration of treatment lasting from 6 to 52 weeks. Some of these patients received FlexiSEQ alone whilst others received FlexiSEQ in combination with other treatments.

How have the safety and efficacy of FlexiSEQ products been studied?

Unlike many medical devices, the safety and efficacy of FlexiSEQ have been demonstrated in an extensive trial programme where just under 2000 patients have been treated with FlexiSEQ for up to 52 weeks. Several key studies have demonstrated that FlexiSEQ reduces pain associated with OA of the knee, improves joint stiffness and physical function and has an excellent safety and tolerability profile.

You claim to have an extensive clinical program, yet I cannot find the studies you refer to online.

FlexiSEQ was commercialised and branded at the end of its clinical study program and therefore its name will not appear in published clinical research papers. If you would like to research FlexiSEQ clinical studies, you must search for its study reference code “TDT 064”.

Is FlexiSEQ tested on animals?

FlexiSEQ is regulated as a medical device and as such it had to go through some mandatory animal testing as part of its original development and registration. The company does not voluntarily test its products on animals and only when it is required to do so by medical device regulations.

I am worried about using FlexiSEQ as it contains two parabens (endocrine disrupters) which Breast Cancer UK advises against using

Parabens are included in our formulation as preservatives to protect the Sequessome vesicles. We only use a minimal amount of parabens in our FlexiSEQ range in order to guarantee an acceptable shelf life without compromising the efficacy of our gel. Parabens are deemed safe and are used commonly by most cosmetic and pharmaceutical companies. Consequently, we have no current plans to reformulate our product.

Please may I have the Summary of Product Characteristics for FlexiSEQ?

As FlexiSEQ is a medical device rather than a medicine there is no Summary of Product Characteristics. The Patient Information Leaflet – Instructions for Use provided within the carton provides relevant information on FlexiSEQ and can be downloaded from our website.

I have developed a rash/itchiness on the area I applied FlexiSEQ to. Is that normal?

We're sorry to hear that you have developed a skin irritation. Unfortunately, this is a potential side effect of FlexiSEQ and many therapeutic topical products for that matter. The issue is dealt with extensively in the Patient Information Leaflet – Instructions for Use that can be found inside the carton. Customers, who have complained about skin irritation, have advised us that they have used moisturising lotion whilst using FlexiSEQ and this helped to calm the skin in that particular area. The skin irritation usually disappears by itself after a certain amount of time. In the case of continuing side effects, you may first reduce the dose (e.g. from twice daily to once daily). If the area feels too sore to continue with the treatment, then discontinue using FlexiSEQ. If you have to stop treatment, once the condition is resolved, usually within a few days, you may then be able to restart administration if there is no evidence of a hypersensitive reaction as a result of skin contact. If you are at all worried, please consult a doctor or a pharmacist.
Please also have a look at the ingredients list to make sure you are not allergic to any of its components.

What are the commonly reported side effects of FlexiSEQ?

FlexiSEQ products are drug-free topical treatments and the side effect most commonly reported is mild or moderate skin irritations manifesting in rash, dry skin, itchiness and erythema (redness). The majority of the skin irritations that have been reported were temporary and minor and resolved over time, sometimes without the need to stop treatment.

I have experienced a reaction to FlexiSEQ, should I stop treatment?

FlexiSEQ has an excellent safety and tolerability profile. Unlike many painkillers taken by patients, the majority of the side effects seen in clinical trials were mild-to-moderate skin irritations. Most patients in the clinical trials continued using the product, even if skin reactions were experienced. The majority of these irritations will resolve over time without stopping treatment. In the case of continuing side effects, you may first reduce the dose (e.g. from twice daily to once daily) and only if this does not improve the condition should you consider interrupting or stopping treatment. If you have to stop treatment, once the condition is resolved, usually within a few days, you may then be able to restart administration if there is no evidence of an allergic reaction as a result of skin contact.
If you are at all worried, please consult a doctor or a pharmacist.

Storage

How should I store FlexiSEQ?

FlexiSEQ is easy to look after, and can be stored at room temperature (between 8°C and 25°C). It does not need to be refrigerated and should not be stored in the fridge. After first opening the tube, the product should be used within 3 months.

Regulatory

What is the regulatory status of FlexiSEQ?

FlexiSEQ products have been classified by the UK, European and other Regulatory Agencies as Medical Devices and not pharmaceutical drugs, as FlexiSEQ gels have a physical mode of action and do not contain any pharmaceutically active ingredients.

What company is marketing FlexiSEQ?

FlexiSEQ products are sold under global licence by Ascension Healthcare plc and its affiliates.

Where is FlexiSEQ manufactured?

FlexiSEQ products are manufactured in state-of-the-art manufacturing facilities in Germany and Italy.

Contact

Who should I report concerns or product issues to?

Any questions or concerns relating to the product or use of FlexiSEQ should be addressed preferably via email to enquiries@flexiseq.com.