Patient leaflet - Motusol Max 12-hour Pain Relief 2.32% w/w gel
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.
2. What you need to know before you use Motusol MAX 12-Hour Pain Relief
DO NOT use Motusol MAX 12-Hour Pain Relief if you:
- 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. This medicine must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Motusol MAX 12-Hour Pain Relief should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible. 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.
Package leaflet: Information for the user
diclofenac diethylamine
2.32% w/w Gel
Motusol®
MAX
12-Hour Pain Relief
MA Holder & Packer: Teva UK Limited Licence, Teva Regulatory Team.
Packed at Ulm.
IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.
SKU (s): 32087767
32087714
(excluding codes) Perforated: Neo Sans For Teva,
Avenir, Madani.
11 pt Reason for revision: New item. V2: Proof-reading amend. V3: New text supplied.
TevaArt Ref: PID: 37846_s3 P: Diclofenac, Motusol® MAX All Day Pain Relief, UK, Gel, 2.32%, 50g, 100g, Ulm 27 January 2023
Version: 3
Fragrances
This medicine 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.
In addition, benzyl alcohol may cause mild local irritation.
3. How to use 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 from a 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):
- scaling, dehydration of the skin, swelling (oedema).
Very rare: may affect less than 1 in 10,000 people
- the skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.
Not known: frequency cannot be estimated from the available data
- 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 possible side effects 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.
5. How to store 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.
6. Contents of the pack and other information
What Motusol MAX 12-Hour Pain Relief
- 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 5HX, United Kingdom
Manufacturer
Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
This leaflet was last revised in January 2023.
PL 00289/2538
37846_s3