Copinal 300 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

copinal 300 mg capsules

Zinc acexamate

Package leaflet contents:

1. What Copinal capsules are and what they are used for
2. What you need to know before taking Copinal capsules
3. How to take Copinal capsules
4. Possible side effects
5. Storage of Copinal capsules
6. Contents of the pack and other information

1. What Copinal capsules are and what they are used for

Copinal capsules contain as the active substance a zinc salt, zinc acexamate, which belongs to a group of compounds known as antiulcer agents. Zinc acexamate works by reducing the amount of acid produced by the stomach and enhancing the protective mechanisms of the gastric mucosa.

Copinal capsules are used:

• for the prevention of gastrointestinal injuries induced by non-steroidal anti-inflammatory drugs (NSAIDs).
• for the treatment of gastric ulcer and duodenal ulcer.

2. What you need to know before starting to take Copinal capsules

Do not take Copinal capsules

• if you are allergic to zinc acexamate or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe renal insufficiency (serious kidney disease).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Copinal capsules.

If you have taken zinc for a prolonged period, your doctor should monitor your copper and zinc levels, as these may become altered in your blood.

To monitor your treatment, your doctor will periodically carry out blood and urine tests.

You must inform your doctor if you experience muscle weakness or abnormal sensations in the limbs, as this may indicate excess copper.

Taking Copinal capsules with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Take special care if you are taking tetracycline-type antibiotics, as zinc may reduce their effectiveness or result in lack of action against bacterial infections. It is recommended to leave a minimum interval of 4 hours between taking each medicine.

Pregnancy, breastfeeding, and fertility

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.

Although teratogenic effects have not been observed in animal studies, the safety of zinc acexamate during pregnancy and breastfeeding has not yet been established.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

3. How to take Copinal capsules

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Copinal capsules.

The capsules should be taken during or immediately after the main meals. Swallow the capsules whole, without chewing or sucking them, with a glass of liquid, preferably water.

For the prevention of gastrointestinal injuries induced by NSAIDs: the recommended dose is one capsule (300 mg of zinc acexamate) per day, during or immediately after dinner.

For the treatment of gastric ulcer and duodenal ulcer: the recommended dose is one capsule (300 mg of zinc acexamate), up to 3 times a day, during or immediately after meals.

If you take more Copinal capsules than you should

If you have taken more Copinal capsules than you should, or in case of accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

When several capsules are ingested together, vomiting may occur, contributing to self-elimination, which may be assisted by gastric lavage.

If you forget to take Copinal capsules

Do not take a double dose to make up for missed doses. Continue your treatment with the recommended dosage.

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

4. Possible adverse effects

Like all medicines, Copinal capsules may cause adverse effects, although not everyone will experience them.

In some cases, when taken on an empty stomach, nausea (feeling of dizziness) and transient stomach discomfort may occur. To avoid these, Copinal capsules should always be taken during or immediately after meals.

Taking Copinal capsules may lead to a decrease in copper levels, and the following side effects may occur:

• Reduction in red blood cells, white blood cells, and myelodysplastic syndrome.
• Peripheral neuropathies and myelopathies.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Copinal capsules

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice any changes in the appearance of the capsules.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Copinal capsules

• The active substance is zinc acexamate. Each capsule contains 300 mg of zinc acexamate.
• The other components (excipients) are: maize starch, polyethylene glycol 4000, talc, polyvinylpyrrolidone, sodium carboxymethylstarch (type A) from potato, polysorbate 80. Composition of the hard gelatin capsule: gelatin and titanium dioxide.

Appearance of the product and contents of the pack

Copinal capsules are presented as white hard gelatin capsules, in packs containing 30 and 60 capsules.

Marketing Authorization Holder and Manufacturer

Laboratorios Viñas, S.A. - Provenza, 386 - 08025 Barcelona, Spain

Manufacturer

LABORATORIOS VIÑAS, S.A. Torrente Vidalet, 29 Barcelona 08012 Spain

Date of the most recent review of this leaflet: August 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Laboratorios Viñas sa

Provenza, 386 - 08025 Barcelona