ZOREQUIN 30 MG/G GEL

Introduction

Package Leaflet: Information for the User

Zorequin 30 mg/g Gel

diclofenac sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zorequin and what is it used for
2. What you need to know before you use Zorequin
3. How to use Zorequin
4. Possible side effects
5. Storage of Zorequin
6. Contents of the pack and further information

1. What is Zorequin and what is it used for

Zorequin 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 you use Zorequin

Do not use Zorequin:

• 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 Zorequin.

• It cannot be excluded that systemic adverse effects may occur with the application of Zorequin 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 in the past a stomach ulcer or bleeding,
• if you have heart, liver or kidney problems,
• if you suffer from any type of bleeding disorder or are prone to having bruises easily.

• During treatment with Zorequin, avoid exposure to the sun, including tanning centers. If skin reactions occur, discontinue treatment.
• Do not apply the product to wounds in the skin, 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 Zorequin 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 Zorequin in children have not been established. There are no available data.

Other medicines and Zorequin

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use Zorequin 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, the lowest dose (<30% of the body surface) should be used for the shortest possible time (no more than 3 weeks).

Do not use Zorequin 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. Zorequin 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

Zorequin does not affect the ability to drive or use machines.

Zorequin contains benzyl alcohol

This medicine contains 10 mg of benzyl alcohol per gram of gel. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Zorequin

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 (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 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 Zorequin 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Zorequin

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 everybody gets them.

If you experience any of the following side effects, stop using Zorequin and inform your doctor as soon as possible:

Skin rash (urticaria); breathing difficulties (wheezing); swelling of the face, runny nose (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 that any of the following side effects you are suffering from is serious or persists for a few days, stop using Zorequin and inform your doctor: itching, skin reaction, redness of the skin, inflammation, contact dermatitis, pain and blisters.

Other common 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), thickening of the skin and skin ulcer.

Uncommon 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, 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, skin 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 the available data):Burning sensation at the application site

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Zorequin

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

Do not use this medicine after the expiry date which is stated on the tube or carton, after CAD or EXP. The expiry date is the last day of the month stated.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Zorequin

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

Appearance of Zorequin and contents of the pack

Clear, transparent, colorless or pale yellow gel 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 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

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 under the following names:

DE: Diclofenac-ratiopharm 30mg/g Gel

ES: Zorequin 30 mg/g gel

LU: Diclofenac-ratiopharm Dermagel 30mg/g Gel

Date of the last revision of this 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/