COPINAL 300 mg ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Copinal 300 mg Oral Suspension

Zinc Acexamate

Contents of the Package Leaflet:

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

1. What is Copinal Suspension and what is it used for

Copinal Suspension contains the active substance zinc acexamate, which belongs to a group of compounds called anti-ulcer agents. Zinc acexamate acts by reducing the amount of acid produced by the stomach and enhancing the mechanisms that protect the stomach mucosa.

Copinal Suspension is used:

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

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

Do not take Copinal Suspension

• 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 failure (severe kidney disease).

Warnings and precautions

Consult your doctor or pharmacist before taking Copinal Suspension.

If you have taken 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 feel muscle weakness or an abnormal sensation in your limbs, as it may indicate an excess of copper.

Taking Copinal Suspension 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.

Important information about some ingredients of Copinal Suspension

This medicine contains sorbitol and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217).

3. How to take Copinal Suspension

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Remember to take your medicine.

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

Copinal Suspension is taken during or immediately after main meals. Press the sachet with your fingers in several directions before opening to homogenize the suspension and pour it into a little water. Before ingestion, gently stir with a spoon. The contents can also be ingested directly, without needing to mix.

In the prevention of gastrointestinal lesions induced by NSAIDs: the recommended dose is one sachet (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 sachet (300 mg of zinc acexamate), up to 3 times a day during or immediately after meals.

If you take more Copinal Suspension than you should

If you have taken more Copinal Suspension 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 concurrent ingestion of several sachets, vomiting may occur, which contributes to self-elimination, which can be favored by gastric lavage.

If you forget to take Copinal Suspension

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

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

4. Possible side effects

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

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

Taking Copinal Suspension 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, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Copinal Suspension

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 which is stated on the carton and sachet after EXP. The expiry date is the last day of the month shown.

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

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 other information

Composition of Copinal Suspension

• The active substance is zinc acexamate. Each 10g sachet contains 300mg of zinc acexamate.
• The other ingredients (excipients) are: light liquid paraffin, self-emulsifying glycerol monostearate, non-crystallizable sorbitol liquid, sucrose, light magnesium oxide, sodium benzoate, sodium saccharin, polysorbate 60, peppermint essential oil, polysorbate 20, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), and purified water.

Appearance of the product and pack contents

Copinal Suspension is presented in sachets of laminated polyester/aluminum/polyethylene, in packs containing 30 and 60 sachets of 10g of white oral suspension.

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