DICLOFENAC TEVA 30 mg/g GEL

Introduction

Package Leaflet: Information for the User

Diclofenac Teva 30 mg/g Gel

diclofenac sodium

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Diclofenac Teva and what is it used for
2. What you need to know before using Diclofenac Teva
3. How to use Diclofenac Teva
4. Possible side effects
5. Storage of Diclofenac Teva
6. Package Contents and Additional Information

1. What is Diclofenac Teva and what is it used for

Diclofenac Teva contains diclofenac sodium as the active ingredient. Diclofenac sodium is a non-steroidal anti-inflammatory active ingredient. This medicine is used, applied to the skin, for the treatment of the skin problem known as solar or actinic 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 any of the other ingredients of this medicine (listed in section 6).
• If you have previously presented any allergic reaction, such as e.g. skin rash (urticaria), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory medicine.
• If you are in the last three months of pregnancy.

Warnings and Precautions

Consult your doctor or pharmacist before using Diclofenac Teva.

• It cannot be ruled out that systemic side effects may occur with the application of topical diclofenac if the gel is used on a large skin surface for a prolonged period. Consult your doctor in the following cases:

• if you have or have had a stomach ulcer or bleeding,
• if you have heart, liver, or kidney problems,
• if you have any type of bleeding disorder or are prone to bruising easily.

• During treatment with this medicine, avoid exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.

• Do not apply the product to wounds, infected skin, or dermatitis.
• Avoid getting the gel in contact with the eyes or the inside of the nose or mouth, and do not ingest it. If you accidentally ingest the diclofenac gel, consult your doctor immediately.
• If you develop a generalized skin rash, discontinue treatment with Diclofenac Teva and consult your doctor.

After applying the gel to the skin, a permeable dressing (not occlusive) may be applied. Do not use an occlusive hermetic bandage.

Children and Adolescents

The safety and efficacy of this medicine in children have not been established. There are no available data.

Other Medicines and Diclofenac Teva

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take diclofenac during the first 6 months of pregnancy unless absolutely necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose (<30% of the body surface area) for the shortest possible time (no more than 3 weeks).

Do not use diclofenac if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery.

Breastfeeding

Small amounts of diclofenac pass into breast milk. Consult your doctor if you are breastfeeding. Diclofenac Teva can be used during breastfeeding, but it should not be applied directly to the breast area or to large areas of skin or for a prolonged period.

Driving and Using Machines

This medicine does not affect the ability to drive or use machines.

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 administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Puncture the membrane of the tube mouth with the help of the cap before using the medicine for the first time.
• Gently apply a small amount of gel to the skin area you want to treat. The amount of gel needed varies depending on the size of the skin area to be treated. Generally, 0.5 grams of gel (approximately the size of a pea) are sufficient to treat a skin area (5cm x 5 cm), but do not apply more than 8 grams per day.
• The gel can be applied twice a day unless your doctor indicates otherwise. You will notice a slightly refreshing effect when applying the gel to the skin.

The usual treatment period is 60 to 90 days. The maximum effect has been observed in treatments with a duration close to 90 days. It may take up to 1 month from the end of treatment to complete healing.

Wash your hands after applying the gel, except if they 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Diclofenac Teva

Continue the application following the instructions, but do not apply a double dose of gel to make up for the missed application.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any of the following side effects, discontinue the application of Diclofenac Teva and inform your doctor as soon as possible:

Skin rash (urticaria); breathing difficulties (wheezing); swelling of the face, runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to topical diclofenac.

If you consider that any of the following side effects you are experiencing is serious or persists for a few days, discontinue the use of this medicine and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain, and blisters.

Other frequent side effects:(may affect up to 1 in 10 people)

Irritation or tingling in the treated area, conjunctivitis, allergy, painful sensation when touching the skin, pinching, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered with scales or blisters), skin thickening, and skin ulcers.

Uncommon side effects:(may affect up to 1 in 100 people)

Eye pain, excessive tearing/dry eyes, abdominal pain, diarrhea, nausea, hair loss, facial edema, excessive bleeding, oily skin, or rash similar to measles.

Rare side effects:(may affect up to 1 in 1,000 people)

Dermatitis with large blisters.

Very rare side effects:(may affect up to 1 in 10,000 people) Stomach bleeding, kidney problems, breathing difficulties (asthma), skin rash with infection, increased sensitivity to sunlight.

There have been reports of temporary hair discoloration in the application area. This effect is usually reversible when treatment is discontinued.

Frequency not known (cannot be estimated from available data):Burning sensation at the application site

Reporting Side Effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 expiration date stated on the tube or carton, after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep the tube tightly closed to protect it from light.

Once the product is opened, use within: 6 months.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diclofenac Teva

• The active ingredient is diclofenac sodium.
• Each gram of gel contains 30 mg of diclofenac sodium.
• The other ingredients are sodium hyaluronate, benzyl alcohol (E-1519), monomethyl ether of polyethylene glycol 350, and purified water.

Appearance of Diclofenac Teva and Package Contents

Clear, transparent, colorless, or pale yellow gel packaged in tubes with a content of 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,

Netherlands.

Local Representative:

Teva Pharma S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1ª planta.

28108 – Alcobendas. Madrid (Spain)

Manufacturer

Balkanpharma Troyan AD, 1 Krayrechna Str., Troyan 5600, Bulgaria

This medicine is authorized in the Member States of the European Economic Area under the following names:

DE: Diclofenac AbZ 30mg/g Gel

ES: Diclofenaco Teva 30 mg/g gel

Date of the last revision of this package leaflet:December 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in 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