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 diethylammonium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Voltarol Max Strength Pain Relief 2.32% Gel 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. This medicine is used to relieve pain and reduce inflammation and swelling in a number of painful conditions affecting the joints and muscles. Voltarol Max Strength Pain Relief 2.32% Gel 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. mild arthritis (symptoms of mild arthritis include joint pain at rest, joint pain on movement, joint swelling or stiffness (after sleep or long rest)).
This medicine is intended for use in adults and children aged 14 years and older.
2.
What you need to know about Voltarol Max Strength Pain Relief 2.32% Gel:
Do not use Voltarol Max Strength Pain Relief 2.32% Gel if you:
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• • •
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 Voltarol Max Strength Pain Relief 2.32% Gel
This medicine 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. Voltarol Max Strength Pain Relief 2.32% Gel should only be used under medical advice during breastfeeding as diclofenac passes into breast milk in small amounts. However, 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. Consult your doctor or pharmacist for further information if you are pregnant or breast-feeding. 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 diclofenac when it is used on the skin. Effects of other ingredients Voltarol Max Strength Pain Relief 2.32% Gel contains:
Voltarol Max Strength Pain Relief 2.32% Gel 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 Voltarol Max Strength Pain Relief 2.32% Gel to use For 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 Voltarol Max Strength Pain Relief 2.32% Gel Do not use if tamper evidence seals are broken. 1. a) For the flip-top lid cap: Use a finger, thumb, side of your hand or even edge of a table against the underside of the cap lid to open the flip-top cap easily. b) For the screw cap: To remove the seal before first use, unscrew and remove the cap. Use the reverse side of the cap to insert, twist and remove the seal from the tube. 2. 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 (2-4g). 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 8g per day and 56g in one week. 3. After use, if needed, remove remaining amount of the gel from the flip-top cap with cotton towel or absorbent paper until visually clean and dry. Close the flip-top cap, until you hear a 'click' sound. Hold the tube upright when opening or closing the flip-top cap to avoid possible leaking of the gel. This medicine is for use only on your skin.
After application: Unless they are the site being treated, the hands should be wiped with a tissue and then washed, to avoid accidental contact with the mouth and eyes. The tissue should be disposed of in the household waste and not in the toilet to prevent the product reaching the wastewater system. Before dressing or applying a non-airtight bandage, let the gel dry for a few minutes on the skin. If you need to shower or to bathe, apply the product afterwards How long to use Voltarol Max Strength Pain Relief 2.32% Gel for Do not use this medicine for more than 21 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 Voltarol Max Strength Pain Relief 2.32% Gel than you should
Like all medicines, Voltarol Max Strength Pain Relief 2.32% Gel 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:
Some side effects have unknown frequency (cannot be estimated from available information):
Voltarol Max Strength Pain Relief 2.32% Gel
Voltarol Max Strength Pain Relief 2.32% 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 Voltarol Max Strength Pain Relief 2.32% Gel is diclofenac diethylammonium.
Medicines with the same active substance, strength and form include: Voltarol 1.16% Emulgel, gel, Voltarol Back and Muscle Pain Relief 1.16% Gel, Voltarol Joint & Back Pain Relief 2.32% Gel. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Voltarol Max Strength Pain Relief 2.32% 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 the relief of pain of non-serious arthritic conditions.
For cutaneous use only.
The gel is applied to the affected parts of the body and gently rubbed into the skin. Afterwards, the hands should be wiped with a paper towel and then washed, unless the hands are the area to be treated.
If too much gel is accidentally applied, the excess gel should be wiped with a paper towel.
The paper towel should be disposed in the household waste to prevent unused product reaching the aquatic environment.
Before applying a bandage, the gel should be left to dry for a few minutes on the skin.
Adults and children 14 years and over: 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 a day (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 21 days under pharmacy supervision.
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 21 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 last trimester of pregnancy.
The possibility of experiencing systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of this medicine 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, bronchial asthma.
Discontinue the treatment if a skin rash develops after applying the product.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
Information concerning excipients
This medicine contains propylene glycol, which may cause mild, localised skin irritation in some people. It also contains butylhydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
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 this medicine, 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
There is no clinical data from the use of diclofenac during pregnancy.
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic diclofenac exposure reached after topical administration can be harmful to an embryo/fetus. 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/fetal 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-fetal 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, all prostaglandin synthesis inhibitors may expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligohydroamniosis;
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).
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.
Rare: Dermatitis bullous.
Very rare: Photosensitivity reaction
Not known: Desquamation, skin discolouration
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 at: 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 this medicine 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 Voltarol Max Strength Pain Relief 2.32% 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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