Label: Information for the Patient

Copinal 300 mg Oral Suspension

Zinc Acexamate

Copinal suspension contains as its active ingredient a zinc salt, zinc acexamate, which belongs to a group of compounds called antiulceratives. 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 nonsteroidal anti-inflammatory drugs (NSAIDs).
• for the treatment of gastric ulcers and duodenal ulcers.

Do not take Copinal suspension

• 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 suspension.

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

Taking Copinal suspension 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 effectiveness 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, or think you may be 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.

Important information about some components of Copinal suspension

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

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

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 suspension.

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

In the prevention of medication-induced gastrointestinal injuries: the recommended dose is one package (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 package (300 mg of zinc acexamate), up to three 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

With the ingestion of several packages, 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 suspension

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 suspension 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 suspension 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 conditions for conservation.

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 on the 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 suspension.

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

Composition of Copinal suspension

• The active principle is zinc acexamate. Each 10 g sachet contains 300 mg of zinc acexamate.
• The other components (excipients) are: light liquid paraffin, monoestearate of auto-emulsifiable glycerin, non-crystallizable liquid sorbitol, sucrose, light magnesium oxide, sodium benzoate, sodium saccharin, polisorbate 60, peppermint essential oil, polisorbate 20, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), and purified water.

Appearance of the product and contents of the packaging

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

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 Spain

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