Label: information for the user

Diclofenaco Teva 30 mg/g gel

diclofenac sodium

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Diclofenaco Teva contains diclofenac sodium as the active ingredient. Diclofenac sodium is an anti-inflammatory non-steroidal active ingredient. This medication is used, applied to the skin, for the treatment of a skin condition known as solar or actinic keratosis caused by prolonged exposure to solar radiation.

Do not use Diclofenaco Teva:

• If you are allergic to diclofenaco or any of the other components of this medication (listed in section 6).
• If you have previously experienced an allergic reaction, such as skin rash (urticaria), breathing difficulties (sibilant breathing) or nasal discharge (allergic rhinitis) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory medication.
• If you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before using Diclofenaco Teva.

• The possibility of systemic adverse effects cannot be ruled out with the application of topical diclofenaco if the gel is used on a large skin surface for an extended 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 easy bruising.

• Avoid exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.

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

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

Children and adolescents

The safety and efficacy of this medication in children have not been established. No data are available.

Other medications and Diclofenaco Teva

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not take diclofenaco during the first 6 months of pregnancy unless it is absolutely necessary and your doctor has indicated so. If you need treatment during this period or while trying to become pregnant, use the lowest dose (<30)

You should not use diclofenaco if you are in the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery.

Breastfeeding

Small amounts of diclofenaco pass into breast milk. Consult your doctor if you are breastfeeding. Diclofenaco Teva may be used during breastfeeding, but do not apply it directly to the breast area or to large skin areas or for an extended period.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

Diclofenaco Teva contains benzyl alcohol

This medication contains 10 mg of benzyl alcohol per gram.

Benzyl alcohol may cause allergic reactions and mild local irritation.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

• Pierce the mouth of the tube with the help of the cap before using the medication for the first time.
• Apply a small amount of gel gently to the area of skin you wish 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) is 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 tells you 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 of a duration close to 90 days. It may take up to 1 month from the end of treatment for complete healing.

Wash your hands after applying the gel, except if they are being treated.

Use in children and adolescents

Diclofenaco is not suitable for children or adolescents.

If you use more Diclofenaco Teva than you should

Remove the 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Diclofenaco Teva

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop applying Diclofenaco Teva and inform your doctor as soon as possible:

Skin rash (urticaria); difficulty breathing (sibilant breathing); facial swelling, nasal discharge (allergic rhinitis). These symptoms indicate that you may be allergic to topical diclofenac.

If you consider any of the following side effects you are experiencing to be severe or persistent for a few days, stop using this medication and inform your doctor: itching, skin reaction, skin redness, 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, pinpricks, muscle stiffness, dermatitis, eczema, dry skin, swelling, generalized redness (covered in scales or blisters), skin thickening, and skin ulcer.

Rare 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, greasy skin or skin rash similar to measles.

Side effects that are rare:(may affect up to 1 in 1,000 people)

Large blistering dermatitis.

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

Temporary hair discoloration in the application area has been described. This effect is usually reversible upon discontinuing treatment.

Unknown frequency (cannot be estimated from available data):Burning sensation at the application site

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the tube or the case, after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Keep the tube hermetically closed to protect it from light.

Once opened, use within: 6 months.

Medicines should not be disposed of through drains or in the trash. Deposit containers and unused medicines at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

Composition of Diclofenaco Teva

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

Appearance of Diclofenaco Teva and contents of the packaging

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 packaging sizes may be marketed.

Holder of the marketing authorization

Teva B.V.

Swensweg 5, Haarlem, 2031GA,

Netherlands.

Local Representative:

Teva Pharma S.L.U.

C/ Anabel Segura, 11 - Edificio Albatros B, 1st floor.

28108 – Alcobendas. Madrid (Spain)

Responsible for manufacturing

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

This medicine is authorized in the member states of the European Economic Area with the following names:

DE: Diclofenac AbZ 30mg/g Gel

ES: Diclofenaco Teva 30 mg/g gel

Revision date of this leaflet:December 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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 smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83054/P_83054.html