Diclofenac Teva 30 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Diclofenaco Teva 30 mg/g gel
diclofenac sodium
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Diclofenaco Teva is and what it is used for
- What you need to know before using Diclofenaco Teva
- How to use Diclofenaco Teva
- Possible adverse effects
- Storage of Diclofenaco Teva
- Contents of the pack and other information
1. What Diclofenac Teva is and what it is used for
Diclofenac Teva contains diclofenac sodium as the active substance. Diclofenac sodium is a non-steroidal anti-inflammatory active ingredient. This medicine is used, applied to the skin, for the treatment of a skin condition known as actinic or solar keratosis caused by prolonged exposure to solar radiation.
2. What you need to know before using Diclofenac Teva
Do not use Diclofenac Teva:
- If you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
- If you have previously experienced any allergic reaction, such as for example skin rash (urticaria), breathing difficulties (wheezing), or runny nose (allergic rhinitis) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug.
- If you are in the last three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac Teva.
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Systemic adverse effects cannot be ruled out when topical diclofenac gel is applied over a large skin surface area for a prolonged period. Consult your doctor if:
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you have or have previously had a stomach ulcer or gastrointestinal bleeding,
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you have heart, liver, or kidney problems,
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you suffer from any bleeding disorder or are prone to bruising easily.
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During treatment with this medicine, avoid exposure to sunlight, including tanning beds. If skin reactions occur, stop treatment.
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Do not apply the product on broken skin, infected skin, or dermatitis.
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Avoid contact of the gel with the eyes, inside the nose or mouth, and do not ingest it. If diclofenac gel is accidentally swallowed, contact your doctor immediately.
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If you develop a generalized skin rash, stop treatment with Diclofenac Teva and consult your doctor.
After applying the gel to the skin, a permeable (non-occlusive) dressing may be applied. Do not use an airtight occlusive dressing.
Children and adolescents
The safety and efficacy of this medicine in children has not been established. No data are available.
Other medicines and Diclofenac Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not take diclofenac during the first 6 months of pregnancy unless absolutely necessary and specifically advised by your doctor. If treatment is required during this period or while trying to become pregnant, the lowest dose (< 30% of body surface area) should be used for the shortest possible duration (no more than 3 weeks).
Do not use diclofenac during the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery.
Breastfeeding
Small amounts of diclofenac pass into breast milk. Consult your doctor if you are breastfeeding. Diclofenac Teva may be used during breastfeeding, but should not be applied directly to the breast area or over large skin areas or for prolonged periods.
Driving and using machines
This medicine does not affect the ability to drive or use machinery.
Diclofenac Teva contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram.
Benzyl alcohol may cause allergic reactions and mild local irritation.
3. How to use Diclofenac Teva
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
- Pierce the seal at the mouth of the tube using the cap before using the medicine for the first time.
- Gently apply a small amount of gel to the area of skin to be treated. The amount of gel required depends on the size of the skin area to be treated. Generally, 0.5 grams of gel (approximately the size of a pea) is sufficient to treat an area of skin (5 cm x 5 cm), but the daily amount applied should not exceed 8 grams.
- The gel may be applied twice a day unless otherwise directed by your doctor. You will notice a slightly cooling sensation when applying the gel to the skin.
The usual treatment duration is 60 to 90 days. Maximum effect has been observed with treatments lasting approximately 90 days. Complete healing may take up to 1 month after the end of treatment.
Wash your hands after applying the gel, unless the hands themselves are being treated.
Use in children and adolescents
Diclofenac is not suitable for children or adolescents.
If you use more Diclofenac Teva than you should
Remove excess gel by washing the treated skin area with water.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Diclofenac Teva
Continue applying the gel as instructed, but do not apply a double dose to make up for the missed application.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience any of the following adverse effects, stop using Diclofenac Teva and inform your doctor as soon as possible:
Skin rash (urticaria); difficulty breathing (wheezing); swelling of the face, runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to topical diclofenac.
If you consider any of the following adverse effects you are experiencing to be severe or if they persist for several days, stop using this medicine and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.
Other frequent adverse effects: (may affect up to 1 in every 10 people)
Irritation or tingling at the application site, conjunctivitis, allergy, painful sensation upon touching the skin, pricking sensations, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered with scales or blisters), skin thickening, and cutaneous ulcer.
Uncommon adverse effects: (may affect up to 1 in every 100 people)
Eye pain, excessive tearing/dry eyes, abdominal pain, diarrhea, nausea, hair loss, facial edema, excessive bleeding, oily skin, or measles-like skin rash.
Rare adverse effects: (may affect up to 1 in every 1,000 people)
Bullous dermatitis (dermatitis with large blisters).
Very rare adverse effects: (may affect up to 1 in every 10,000 people)
Gastrointestinal bleeding, kidney problems, breathing difficulties (asthma), skin rash with infection, skin sensitivity to sunlight.
Cases of temporary hair discoloration at the application site have been reported. This effect usually reverses when treatment is discontinued.
Frequency not known (cannot be estimated from available data): Burning sensation at the application site.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Diclofenac Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube or carton, after EXP or CAD. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Keep the tube tightly closed to protect it from light.
After first opening, use within: 6 months.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Diclofenac Teva
- The active substance is sodium diclofenac.
- Each gram of gel contains 30 mg of sodium diclofenac.
- The other components are sodium hyaluronate, benzyl alcohol (E-1519), polyethylene glycol 350 monomethyl ether, and purified water.
Appearance of Diclofenac Teva and contents of the pack
Clear, transparent, colourless or pale yellow gel, packed in tubes containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of gel. Not all pack sizes may be marketed.
Marketing Authorization Holder
Teva B.V.
Swensweg 5, Haarlem, 2031GA,
The Netherlands.
Local Representative:
Teva Pharma S.L.U.
C/ Anabel Segura, 11 - Edificio Albatros B, 1st floor.
28108 – Alcobendas, Madrid (Spain)
Manufacturer
Balkanpharma Troyan AD, 1 Krayrechna Str., Troyan 5600, Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
DE: Diclofenac AbZ 30mg/g Gel
ES: Diclofenac Teva 30 mg/g gel
Date of the most recent review of this leaflet: December 2023
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83054/P_83054.html