Patient Information Leaflet: Package Insert

Copinal 300 mg Capsules

Zinc Acexamate

Copinal capsules contain as active ingredient a zinc salt, zinc acexamate, which belongs to a group of compounds called antiulcerous agents. Zinc acexamate acts by reducing the amount of acid produced by the stomach and enhancing the mechanisms that protect the stomach mucosa.

Copinal capsules is used:

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

Do not take Copinal capsules

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

Warnings and precautions

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

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

Taking Copinal capsules with other medications

Inform your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

Be especially careful if you are taking tetracycline antibiotics, as zinc may reduce the effect or lack of action against bacterial infections. It is recommended to leave a minimum interval of 4 hours between taking one and the other medication.

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 medication.

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

Driving and operating machinery

This medication does not affect your ability to drive vehicles and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Remember to take your medication.

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

Capsules are taken during or immediately after main meals. Swallow the capsules whole without chewing or sucking them with the help of a liquid, preferably water.

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

In the treatment of gastric ulcers and duodenal ulcers: the recommended dose is one capsule (300 mg of zinc acexamate), up to three 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Copinal capsules

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

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

Like all medications, Copinal capsules may produce adverse effects, although not all people will experience them.

In some cases, when fasting, nausea (sensation of dizziness) and a temporary feeling of discomfort in the stomach may appear. To avoid them, you should take Copinal capsules always during or immediately after meals.

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

This product does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe changes in the appearance of the capsules.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Copinal capsules

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

Appearance of the product and contents of the packaging

Copinal capsules are presented in hard gelatin capsules of white color, in packaging containing 30 and 60 capsules.

Holder of the marketing authorization and responsible for manufacturing

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

Responsible for manufacturing

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

Last review date of this leaflet: November 1993

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Laboratorios Viñas sa

Provenza, 386 - 08025 Barcelona