Copinal 300 mg oral suspension
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Copinal 300 mg oral suspension
Zinc acexamate
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
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Package leaflet contents:
- What Copinal suspension is and what it is used for
- What you need to know before taking Copinal suspension
- How to take Copinal suspension
- Possible side effects
- How to store Copinal suspension
- Contents of the pack and other information
1. What Copinal suspension is and what it is used for
Copinal suspension contains, as its active ingredient, a zinc salt, zinc acexamate, which belongs to a group of compounds known as antiulcer agents. Zinc acexamate reduces the amount of acid produced by the stomach and enhances the protective mechanisms of the gastric mucosa.
Copinal suspension is used:
- for the prevention of gastrointestinal injuries induced by non-steroidal anti-inflammatory drugs (NSAIDs).
- in the treatment of gastric ulcer and duodenal ulcer.
2. What you need to know before starting to take Copinal suspension
Do not take Copinal suspension
- 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
Talk to your doctor or pharmacist before starting to take Copinal suspension.
If you have taken zinc for a prolonged period, your doctor should monitor your copper and zinc levels, as they may become altered in your blood.
To monitor your treatment, your doctor will periodically perform blood and urine tests.
You must inform your doctor if you experience muscle weakness or abnormal sensations in the limbs, as this may indicate copper excess.
Taking Copinal suspension with other medicines
Tell 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, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 breast-feeding has not yet been established.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
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 him before taking this medicine.
It may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate, sodium salt (E-219) and propylparahydroxybenzoate, sodium salt (E-217).
3. How to take Copinal
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor again.
Remember to take your medicine.
Your doctor will tell you how long to take Copinal suspension.
Copinal suspension should be taken during or immediately after main meals. Press the sachet with your fingers in several directions before opening it to homogenize the suspension, and pour it into a small amount of water. Before ingestion, stir gently with a spoon. The contents may also be taken directly, without the need for mixing.
For the prevention of gastrointestinal injuries induced by NSAID medicines: the recommended dose is one sachet (300 mg of zinc acexamate) daily, during or immediately after the evening meal.
For the treatment of gastric ulcer and duodenal ulcer: 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
When several sachets are taken together, vomiting may occur, which contributes to self-elimination and may be facilitated by gastric lavage.
If you forget to take Copinal suspension
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 suspension 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 effects, Copinal suspension should always be taken during or immediately after meals.
The use of Copinal suspension 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 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 stated on the carton and sachet after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any changes in the appearance of the suspension.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Copinal suspension
- The active substance is zinc acexamate. Each 10 g sachet contains 300 mg of zinc acexamate.
- The other components (excipients) are: light liquid paraffin, self-emulsifying glycerol monoestearate, non-crystallizable liquid sorbitol, sucrose, light magnesium oxide, sodium benzoate, sodium saccharin, polysorbate 60, peppermint essential oil, polysorbate 20, methylparahydroxybenzoate, sodium salt (E-219), propylparahydroxybenzoate, sodium salt (E-217), and purified water.
Appearance of the medicinal product and contents of the package
Copinal suspension is supplied in polyester/aluminum/polyethylene laminate sachets, in packages containing 30 and 60 sachets of 10 g 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 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
Laboratorios Viñas sa
Provenza, 386 - 08025 Barcelona