VOLTAREN FORTE gel 2.32% 150g
Leaflet: user information
VOLTAREN FORTE 2.32% Gel
Diclofenac diethylamine
VOLTAREN FORTE 2.32% Gel
Diclofenac diethylamine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use VOLTAREN FORTE 2.32% Gel exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 7 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What is VOLTAREN FORTE 2.32% Gel and what is it used for
2. What you should know before using VOLTAREN FORTE 2.32% Gel
3. How to use VOLTAREN FORTE 2.32% Gel
4. Possible side effects
5. How to store VOLTAREN FORTE 2.32% Gel
6. Contents of the package and additional information
1. What is VOLTAREN FORTE 2.32% Gel and what is it used for
VOLTAREN FORTE 2.32% Gel contains the active ingredient diclofenac diethylamine, which belongs to the group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs).
VOLTAREN FORTE 2.32% Gel is a specially designed medicinal form for rubbing and enhanced passage through the skin. Thus, the active ingredient reaches the inflamed tissues in a targeted manner.
VOLTAREN FORTE 2.32% Gel is used to relieve pain, reduce inflammation and swelling in a number of painful conditions affecting joints and muscles.
It is suitable for the treatment of:
Adults and adolescents over 14 years:
• muscle and joint injuries (sprains, sprains, strains, bruises, back pain, sports injuries). Leads to rapid relief of moderate to severe pain, improving patients' mobility and helping to restore normality;
• Inflammation of the tendons (for example "tennis elbow"), swelling of the elbow or knee;
Adult patients (over 18 years):
• mild forms of arthritis of the knees or fingers.
2. What you need to know before using VOLTAREN FORTE 2.32% GEL
Do not use VOLTAREN FORTE 2.32% Gel
- if you are allergic to diclofenac or other non-steroidal anti-inflammatory drugs used to treat pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid, or any of the other ingredients of this medicine (listed in section 6). Check with your doctor or pharmacist if you are not sure. Symptoms of an allergic reaction may include: wheezing or rapid breathing (asthma); skin rash with blisters or hives, swelling of the face or tongue; runny nose;
- if you are in the last 3 months of pregnancy;
- if you are under 14 years old.
Do not use VOLTAREN FORTE 2.32% Gel if any of the conditions mentioned apply to you.
Warnings and precautions
- Do not apply VOLTAREN FORTE 2.32% Gel to the skin in conditions such as cuts or open wounds, in the presence of rash or eczema on the skin. Discontinue treatment if a skin rash develops after applying VOLTAREN FORTE 2.32% Gel.
- Do not apply more than the specified amount of the product or for a longer period of time than approved, except in cases of medical recommendation.
- VOLTAREN FORTE 2.32% Gel is for external use only. Do not apply VOLTAREN FORTE 2.32% Gel in the mouth. Do not swallow VOLTAREN FORTE 2.32% Gel. Wash your hands after use. Be careful not to get VOLTAREN FORTE 2.32% Gel in your eyes. If this happens, rinse your eyes with clean water. Consult your doctor or pharmacist if you continue to feel any discomfort.
- You can apply it under elastic bandages or bandages, which are commonly used for injuries such as sprains or sprains, but do not use under airtight plastic bandages.
If you have any questions, consult your doctor or pharmacist before using VOLTAREN FORTE 2.32% Gel.
Children and adolescents
There are insufficient data on the efficacy and safety of VOLTAREN FORTE 2.32% Gel used in children and adolescents under 14 years of age (see point 2 "What you need to know before using VOLTAREN FORTE 2.32% Gel"). In adolescents aged 14 years and over, if the use of VOLTAREN FORTE 2.32% Gel for pain relief is required for more than 7 days or if symptoms worsen, it is recommended that patients or their parents seek medical attention.
Other medicines and VOLTAREN FORTE 2.32% Gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained by a doctor or without a prescription.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine.
VOLTAREN FORTE 2.32% Gel should not be used in the last 3 months of pregnancy, as it may harm your unborn child or cause complications at birth. VOLTAREN FORTE 2.32% Gel should be used only after a doctor's recommendation during the first 6 months of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
VOLTAREN FORTE 2.32% Gel should be used only after a doctor's recommendation during breastfeeding, as diclofenac passes in small amounts into breast milk.
For this reason, VOLTAREN FORTE 2.32% Gel should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin and for a prolonged period of time.
VOLTAREN FORTE 2.32% Gel contains:
• Propylene glycol, which may cause skin irritation.
• Butylhydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or eye and mucous membrane irritation.
3. How to use VOLTAREN FORTE 2.32% Gel
Always use VOLTAREN FORTE 2.32% Gel exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
How much VOLTAREN FORTE 2.32% Gel to use
Adults and adolescents over 14 years:
Apply twice a day (morning and evening) to the painful area, which provides long-lasting pain relief for up to 12 hours.
How to use VOLTAREN FORTE 2.32% Gel
1. When using for the first time, unscrew and remove the cap. Remove the tube guard by placing the reverse side of the cap and twist.
2. Gently rub a small amount of gel into the skin on the painful or swollen area. The amount needed varies depending on the size of the painful or swollen area. A simple amount ranging in size from a cherry to a walnut is sufficient. You may feel a slight cooling effect as you rub the gel in.
3. After use, wash your hands except where they are the treated area (see point 2). VOLTAREN FORTE 2.32% Gel is for skin application only.
How long to use VOLTAREN FORTE 2.32% Gel
Do not use VOLTAREN FORTE 2.32% Gel more than:
Adults and adolescents aged 14 and over:
• 2 weeks - for muscle and joint injuries (sprains, sprains, strains, bruises) and tendon inflammation;
Adults (over 18 years)
• 3 weeks - for arthritis.
A longer period of treatment may be recommended by a doctor.
If within 7 days the pain and swelling do not decrease or your condition worsens, inform your doctor.
If you have used more than the required dose of VOLTAREN FORTE 2.32% Gel
• if you have squeezed out more than the required amount of gel, wipe off the excess with a suitable cloth;
• if you swallow VOLTAREN FORTE 2.32% Gel, contact your doctor immediately.
If you forgot to use VOLTAREN FORTE 2.32% Gel
If you forget to use VOLTAREN FORTE 2.32% Gel, apply it as soon as you remember and continue as usual.
Do not take a double dose to make up for a missed dose.
If you have any other questions about the use of this medicinal product, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, VOLTAREN FORTE 2.32% Gel can cause side effects, although not everybody gets them.
Some rare and very rare side effects can be serious.
If you notice any of the following signs of allergy, stop using VOLTAREN FORTE 2.32% Gel and inform your doctor or pharmacist immediately:
• Skin rash with formation of blisters on the skin; hives (may affect between 1 and 10 in 10,000 people).
• Wheezing, breathlessness or chest tightness (asthma) (may affect up to 1 in 10,000 people).
• Swelling of the face, lips, tongue or throat (may affect up to 1 in 10,000 people).
Other side effects that may occur are usually mild and go away quickly (tell your doctor or pharmacist if you are affected).
Common side effects (may affect between 1 and 10 in 100 people)
• Skin rash, itching, redness or tingling of the skin.
Very rare side effects (may affect less than 1 in 10,000 people).
• Skin may be more sensitive to sunlight. Possible signs of this are sunburn with itching, swelling and blisters.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store VOLTAREN FORTE 2.32% Gel
- To be stored in a place inaccessible to children.
- Do not use VOLTAREN FORTE 2.32% Gel after the expiration date marked on the package. The expiration date corresponds to the last day of the specified month.
- VOLTAREN FORTE 2.32% Gel does not require any special storage conditions. Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What does VOLTAREN FORTE 2.32% Gel contain
- The active substance is: diclofenac diethylamine. Each gram of the gel contains 23.2 mg diclofenac diethylamine.
- Excipients: butylhydroxytoluene, carbomer, cocoylcaprylocaprag, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetosteryl ether, oleyl alcohol, propylene glycol, flavoring (eucalyptus), purified water (See point 2).
This medicinal product contains 50 mg of propylene glycol and 0.2 mg of butylhydroxytoluene in each gram of the gel.
What VOLTAREN FORTE 2.32% Gel looks like and contents of the pack VOLTAREN FORTE 2.32% Gel is a white to off-white, cooling, non-greasy, non-staining creamy gel.
Aluminum laminated tube of 30 g, 50 g, 60 g, 100 g, 120 g, 150 g.
Not all types of packaging are available for sale.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline Dungarvan Limited,
Ireland
Manufacturers:
Novartis Consumer Health GmbH,
Germany
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG,
Germany
