COPINAL 300 mg CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Copinal 300 mg capsules

Zinc acexamate

Contents of the pack:

1. What Copinal capsules are and what they are used for
2. What you need to know before you take 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 the active substance zinc acexamate, which belongs to a group of compounds called anti-ulcer agents. Zinc acexamate works by reducing the amount of acid produced by the stomach and enhancing the mechanisms that protect the stomach lining.

Copinal capsules are used:

• to prevent gastrointestinal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs).
• to treat gastric and duodenal ulcers.

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

Do not take Copinal capsules

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

Warnings and precautions

Consult your doctor or pharmacist before taking Copinal capsules.

If you have been taking zinc for a long time, your doctor should monitor your copper and zinc levels, as they may be altered in your blood.

To monitor your treatment, your doctor will perform periodic blood and urine tests.

You should inform your doctor if you experience muscle weakness or an abnormal sensation in your limbs, as this may indicate an excess of copper.

Taking Copinal capsules with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Be careful if you are taking tetracycline antibiotics, as zinc may lead to a reduced effect or lack of action against bacterial infections. It is recommended to leave an interval of at least 4 hours between taking one and the other.

Pregnancy, breastfeeding, and fertility

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.

Although no teratogenic effects have been observed in animal experiments, the safety of using zinc acexamate during pregnancy and breastfeeding has not been established yet.

Driving and using machines

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

3. How to take Copinal capsules

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

Remember to take your medicine.

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

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

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

In the treatment of gastric and duodenal ulcers: 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

With the simultaneous ingestion of several capsules, vomiting may occur, which contributes to self-elimination, which can be favored by gastric lavage.

If you forget to take Copinal capsules

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

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

4. Possible side effects

Like all medicines, Copinal capsules can cause side effects, although not everybody gets them.

In some cases, when taken on an empty stomach, nausea (feeling of dizziness) and transient stomach discomfort may appear. To avoid them, you should take Copinal capsules during or immediately after meals.

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

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

If you experience side effects, talk to your doctor or pharmacist, even if they are 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 stated.

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

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ingredients (excipients) are: corn starch, polyethylene glycol 4000, talc, polyvinylpyrrolidone, sodium carboxymethyl starch (type A) potato, polysorbate 80. Composition of the hard gelatin capsule: gelatin and titanium dioxide.

Appearance and packaging

Copinal capsules are presented in hard gelatin capsules, white in color, 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 last revision of this leaflet: August 2025

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

Laboratorios Viñas sa

Provenza, 386 - 08025 Barcelona