Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Diclofenac diethylamine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2.What you need to know before you use Motusol MAX 12-Hour Pain Relief 3. How to use Motusol MAX 12-Hour Pain Relief 4.Possible side effects 5.How to store Motusol MAX 12-Hour Pain Relief 6. Contents of the pack and other information
1. What Motusol MAX 12-Hour Pain Relief is and what it is used for This medicine contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin. Motusol MAX 12-Hour Pain Relief is used to relieve pain and reduce inflammation and swelling in a number of painful conditions affecting the joints and muscles. This medicine can be used to treat: muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries), relieving pain and helping recovery back to normal function tendonitis (e.g. tennis elbow), swelling around elbow or knee. Motusol MAX 12-Hour Pain Relief is intended for use in adults and children aged 14 years and older.
e Motusol MAX 12-Hour
Pain Relief DO NOT use Motusol MAX Relief if you:
12-Hour Pain
are allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin (a substance also used to prevent blood clotting), or any of the other ingredients of this medicine (see Section 6 and end of Section 2). If you are not sure, ask your doctor or pharmacist. Symptoms of an allergic reaction may include: wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue; runny nose. have severe joint pain of recent onset that is not related to an injury or period of
overuse feel ill, have a temperature or any other symptoms that accompany the pain are in the last 3 months of pregnancy. If any of these apply to you, do not use this medicine.
Take special care with Motusol MAX
12-Hour Pain Relief ¢ Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product. Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice. ¢ Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight. ¢ This medicine is only for use on your skin. Do not use it in the mouth. Do not swallow it. Wash your hands after use unless they are the area to be treated. Be careful not to get Motusol MAX 12-Hour Pain Relief in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists. ¢ Due to an increased possibility of side effects, take care if you are using any other medicine containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen. ¢ A brace or wrap commonly used for injuries like sprains can be used, but do not use the gel under airtight (plastic) bandages. ¢ If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel. If you have or have ever had asthma speak to your doctor or pharmacist before using the gel. Do not smoke or go near naked flames risk of severe burns. Fabric (clothing, bedding, dressings, etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. If you have any questions, talk to your doctor or pharmacist before using
Motusol MAX 12-Hour Pain Relief. This medicine is not recommended for use in children under 14 years of age.
Taking other medicines with Motusol MAX 12-Hour Pain Relief Please tell your doctor or pharmacist if you are taking, or have recently taken, or want to start taking any other medicines, including
those obtained without a medical prescription. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Pregnancy Do not use Motusol MAX 12-Hour Pain Relief if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. You should not use Motusol MAX 12-Hour Pain Relief during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should be used. Oral forms (e.g. tablets) of Diclofenac can cause adverse effects in your unborn baby. It is not known if the same risk applies to Motusol MAX 12-Hour Pain Relief when it is used on the skin.
Breast-feeding –
Read all of this leaflet carefully before you Start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. You should check with your doctor or pharmacist if you are not sure. This medicine is available without prescription. However, you still need to use Motusol MAX 12-Hour Pain Relief carefully to get the best results from it. Note that this leaflet is revised ona regular basis with the latest information on your medicine. Please refer to the date at the end of the leaflet. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your signs of illness worsen or do not improve after 7 days. If you get any side effects which worry you (even side effects not listed in this leaflet), talk to your doctor or pharmacist.
This medicine should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Motusol MAX 12-Hour Pain Relief should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time. Consult your doctor or pharmacist for further information if you are pregnant or breast-feeding.
Motusol MAX 12-Hour Pain Relief contains: Propylene glycol (E1520) Proylene glycol may cause skin irritation. Butylhydroxytoluene (E321) Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. Fragrances This medicine contains fragrance with benzyl alcohol (0.15 mg/g, €1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions. In addition, benzyl! alcohol may cause mild local irritation.
Motusol MAX 12-Hour Pain Relief Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. How much Motusol MAX 12-Hour Pain Relief to use Adults and adolescents 14 years and over Apply the gel 2 times a day (preferably morning and evening) on the painful area. How to apply: 1.To remove the seal before first use, unscrew the cap from the tube, reverse the cap and engage with the nozzle. Do not use scissors or other sharp objects! 2. Twist and remove the plastic seal from the tube. Do not use if the seal is broken. 3.Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area, slowly rubbing into the skin. The amount needed will vary depending
upon the size of the painful or swollen area; an amount ranging in size froma 1 penny to a 2 pence piece will usually be sufficient (2-4 g). You may notice a slight cooling effect when you rub the gel in. Only use the smallest amount of this medicine needed to relieve your pain, but never use more than 8 g per day and 56 g in one week. 4.Unless the hands are the site being treated, wash your hands after rubbing in the gel, to avoid accidental contact with the mouth and eyes (see Section 2). This gel is for use only on the skin. How long to use Motusol MAX 12-Hour Pain Relief for
Do not use this medicine for more than 14 days unless longer treatment is recommended by a doctor. If the pain and swelling do not improve within 7 days, or if they get worse, tell your doctor.
In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor. If you use more Motusol MAX 12-Hour Pain Relief than you should ¢ If you use more gel than you should, wipe off the surplus gel with a tissue. ¢ If you or a child accidentally swallows the gel, contact your doctor immediately. If you forget to use Motusol MAX
12-Hour Pain Relief If you miss your application of this medicine at the correct time, apply it when you remember and then carry on as normal. Do not apply a double quantity to make up for the forgotten application. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.Possible side effects Like all medicines, Motusol MAX 12-Hour Pain Relief can cause side effects, although not everybody gets them. Some rare and very rare side effects
might be serious If you experience any of the following signs of allergy, STOP using this medicine and tell a doctor or pharmacist immediately: ¢ Skin rash with blisters; hives. (These side effects are likely to affect 1 to 10 people in every 10,000). ¢ Wheezing, shortness of breath or feeling of tightness in the chest (asthma). (These
side effects are likely to affect less than 1 person in every 10,000). ¢ Swelling of the face, lips, tongue or throat. (These side effects are likely to affect less than 1 person in every 10,000), Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell a doctor or pharmacist): Common: may affect up to 1 in 10 people in every 100 people ¢ skin rash, itching, reddening or smarting of the skin, dermatitis (including contact dermatitis). Uncommon side effects (may affect up to 1 in 100 people in every 1000 people):
local application site irritation, peeling of the skin and discolouration, burning sensation at the application site, dry skin. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Motusol MAX 12-Hour Pain Relief Keep this medicine out of the sight and
reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions. Store in the original tube in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Please, do not apply the ointment shortly before taking a shower or bath. These measures will help protect the environment.
What Motusol MAX 12-Hour Pain Relief
contains ¢ The active substance is diclofenac. ¢ 1 g contains 23.2 mg diclofenac diethylamine corresponding to 20 mg
diclofenac sodium. The other ingredients are isopropyl alcohol, propylene glycol (E1520), cocoyl caprylocaprate, liquid paraffin, carbomer, macrogol cetostearyl ether, diethylamine, oleic acid (E570), butylhydroxytoluene (E321), fragrance (containing citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.
What Motusol MAX 12-Hour Pain Relief looks like and contents of the pack White to almost white, homogeneous gel, packed in aluminium laminated tubes, closed with PE seal and PP screw caps, available in pack sizes: 30g, 50g, 60g, 100g per tube. Not all pack sizes may be marketed.
Marketing Authorisation Holder Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5SHX, United Kingdom Manufacturer Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany This leaflet was last revised in September 2024. t PL 00289/2538
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Motusol MAX 12-Hour Pain Relief 2.32% w/w Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Motusol MAX 12-Hour Pain Relief 2.32% w/w Gel is diclofenac diethylamine.
Medicines with the same active substance, strength and form include: Boots Diclofenac Diethylamine 1.16% w/w Gel, Boots Diclofenac Diethylamine 2.32% w/w Gel, Care Pain Relief 2.32% w/w Gel. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Motusol MAX 12-Hour Pain Relief 2.32% w/w Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises
- localised forms of soft tissue rheumatism
For cutaneous use only
Adults and children aged 14 years and over: The gel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) of gel should be applied 2 times daily (preferably morning and evening). The maximum daily dose is 8g. Therefore the maximum weekly dose is 56g.
The gel can be used for up to 14 days under pharmacy supervision.
After application, the hands should be washed unless they are the site being treated.
If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Do not use for more than 14 days unless recommended by a doctor.
Use in the elderly: The usual adult dosage may be used.
Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents.
Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Hypersensitivity to any other ingredient of the gel.
During the third trimester of pregnancy.
The possibility of experiencing systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of the gel cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and/or over a prolonged period (see the product information of systemic forms of diclofenac e.g. oral or injection for systemic adverse reactions).
Concomitant use of systemic NSAIDs should be cautioned since the possibility of an increase in incidence of untoward effects, particularly systemic side effects, cannot be ruled out.
This medicine should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth.
Patients with a history of, or active, peptic ulceration. Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of asthma or allergic disease.
Discontinue the treatment if rash develops after applying the product.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
Information about ingredients of this medicine
This medicine contains propylene glycol, which may cause skin irritation. It also contains butylhydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes and benzyl alcohol which may cause mild local irritation. This medicinal product also contains fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely. There are no known interactions with diclofenac diethylamine, but for a list of interactions known with oral diclofenac the SPCs for oral dosage forms should be consulted.
Fertility
There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans.
Pregnancy
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors including diclofenac may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal toxicity, which may progress to renal failure with oligo-hydroamniosis;
The mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, diclofenac is contraindicated during the third trimester of pregnancy (see section 4.3).
There are no clinical data from the use of this medicinal product during pregnancy. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic Motusol MAX 12-Hour Pain Relief exposure reached after topical administration can be harmful to an embryo/foetus.
Lactation
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of this medicine no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, this medicine should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).
This medicine has no or negligible influence on the ability to drive and use machines.
Undesirable effects include mild and passing skin reactions at the site of application. In very rare instances, allergic reactions may occur.
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10) common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations
Very rare: Rash pustular
Immune system disorders
Very rare: Hypersensitivity (including urticaria), angioedema
Respiratory, thoracic and mediastinal disorders
Very rare: Asthma
Skin and subcutaneous tissue disorders
Common: Dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus
Uncommon: Exfoliative rash, oedema
Rare: Dermatitis bullous
Very rare: Photosensitivity reaction
Not known: Desquamation, skin discolouration, burning sensation at the application site, dry skin
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Signs and symptoms
The low systemic absorption of topical diclofenac renders overdose very unlikely. However undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if the gel is inadvertently ingested (e.g. 1 tube of 50 g contains the equivalent of 1 g diclofenac sodium.)
Treatment
Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from diclofenac overdosage.
Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti- inflammatory medicines should be used. The use of activated charcoal should be considered especially within a short time (within one hour) of ingestion of a toxic dose.
Ask anything about Motusol MAX 12-Hour Pain Relief 2.32% w/w Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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