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TUSSIPAX, film-coated tablet

Codeine/ethylmorphine hydrochloride

Boxed

Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

· Keep this leaflet. You may need to read it again.

· If you have any further questions, ask your doctor or pharmacist.

· This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

· If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

· You should contact your doctor if you do not feel any improvement or if you feel worse.

What does this leaflet contain?

1. What is TUSSIPAX, film-coated tablet and what is it used for?

2. What you need to know before you take TUSSIPAX, film-coated tablet?

3. How to take TUSSIPAX, film-coated tablet?

4. What are the possible side effects?

5. How to store TUSSIPAX, film-coated tablet?

6. Package contents and other information.

1. WHAT IS TUSSIPAX, film-coated tablet AND WHAT IS IT USED FOR?  

Pharmacotherapeutic group: ANTITUSIVE – ATC code: R05DA20.

This medicine contains two cough suppressants: codeine and ethylmorphine.

This medicine is recommended to calm dry coughs and irritating coughs in adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TUSSIPAX, film-coated tablet?  

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Never take TUSSIPAX, film-coated tablet:

· if you are allergic to codeine, ethylmorphine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

· if you know that your body metabolizes codeine into morphine very quickly,

· asthmatic cough,

· respiratory failure,

· breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking TUSSIPAX, film-coated tablet:

– if you are or have ever been addicted to opioids, alcohol, prescription drugs or illicit substances.

– Regular and prolonged use of codeine (one of the active substances in this medicine) can lead to addiction and misuse leading to an overdose that can be fatal. Do not take this medicine for longer than necessary. Do not give this medicine to anyone else.

Do not treat a productive cough with this medicine. In this case, coughing is a natural defense mechanism necessary for the evacuation of bronchial secretions.

If symptoms persist or if the cough becomes productive or is accompanied by bronchial congestion, expectoration (expelling bronchial secretions by coughing up them), fever, seek medical advice from a doctor.

In case of chronic (long-term) illness of the bronchi or lungs accompanied by expectoration, medical advice is essential.

This medicine contains an azo colouring agent (cochineal red A) and may cause allergic reactions.

This medicine contains sucrose. The use of this medicine is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases).

Codeine is converted into morphine by an enzyme in the liver. Morphine is the substance that produces the effects of codeine. Some people have variations of this enzyme, which can affect different people differently. For some people, very little or no codeine is converted into morphine by the body. The codeine given will then have no effect on their cough. Other people are more likely to experience serious side effects because a very large amount of morphine is produced. If you notice any of the following side effects, you should stop taking this medicine and seek medical advice immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling or being sick, constipation, loss of appetite.

Precautions for use

Tell your doctor if you have liver failure (severe liver disease), chronic liver disease, or have had gallbladder surgery.

NEVER LEAVE WITHIN REACH OF CHILDREN.

Children and adolescents

Generally, the codeine contained in this medicine is contraindicated in children under 12 years of age. In addition, codeine is not recommended in adolescents over 12 years of age with impaired respiratory function.

Other medicines and TUSSIPAX, film-coated tablet

Tell your doctor or pharmacist before taking Tussipax film-coated tablets.

Do not combine an antitussive medication with a medication that thins bronchial secretions (expectorant, mucolytic).

Concomitant use of TUSSIPAX film-coated tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty in breathing (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes TUSSIPAX film-coated tablets at the same time as sedative medications, the dosage and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about all sedative medications you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform your friends or relatives so that they are alert to the signs and symptoms mentioned above. Contact your doctor if you notice such symptoms.