Label: information for the user

Zorequin 30 mg/g gel

diclofenaco sódico

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 read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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.

1. What isZorequinand for what it is used

2. What you need to know before starting to useZorequin

3. How to useZorequin

4. Possible adverse effects

5. Storage ofZorequin

6. Contents of the package and additional information

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

Do not use Zorequin:

• If you are allergic to diclofenac 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 usingZorequin.

• The possibility of systemic adverse effects cannot be ruled out with the use of Zorequin if the gel is applied to a large skin surface area 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 easy bruising.

• During treatment with Zorequin, avoid exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.
• Do not apply the product to skin wounds, infected skin, or dermatitis.
• Avoid contact between the gel and your eyes, the inside of your 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 withZorequinand consult your doctor.
• After applying the gel to the skin, a non-occlusive breathable dressing (not airtight) may be applied. Do not use a tight, airtight dressing.

Children and adolescents

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

Other medications and Zorequin

Inform your doctor or pharmacist if you are using, have used recentlyor 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 use Zorequin during the first 6 months of pregnancy unless it is absolutely necessary and your doctor indicates so. If you need treatment during this period or while trying to become pregnant, use the lowest dose (<30>

Do not use Zorequin 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 diclofenac pass into breast milk. Consult your doctor if you are breastfeeding.Zorequinmay be used during breastfeeding, but do not apply it directly to the breast area or to large skin areas or for a prolonged period.

Driving and operating machinery

Zorequin does not affect your ability to drive or operate machinery.

Zorequin contains benzyl alcohol

This medication contains 10 mg of benzyl alcohol per g of gel. 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. In case of doubt, consult your doctor or pharmacist again.

• Pierce the mouth of the tube with the help of the plug 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 according to 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 (5 cm 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

Diclofenac is not suitable for children or adolescents.

If you use more Zorequin than you should

Remove any 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 Zorequin

Continue applying as instructed, 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 using Zorequin and inform your doctor as soon as possible:

Skin rash (urticaria); difficulty breathing (sibilant breathing); facial swelling, nasal discharge (allergic rhinitis) (very rare side effects, may affect up to 1 in 10,000 people). These symptoms indicate that you may be allergic to Zorequin.

If you consider any of the following side effects you are experiencing to be severe or persistent for more than a few days, stop using Zorequin 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.

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

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

Rare side effects:(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.

There have been reported cases of temporary hair discoloration in the application area. 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 container, 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 the product is opened, use within: 6 months.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Zorequin

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

Appearance of Zorequin and content 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 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

Local representative

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

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

DE: Diclofenac-ratiopharm 30mg/g Gel

ES: Zorequin 30 mg/g gel

LU:Diclofenac-ratiopharm Dermagel 30mg/g Gel

Last review 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/