HUSTENSTILLER-

COUGH SUPPRESSANT-ratiopharm Dextromethorphan Capsules

Important notes (mandatory information)

Cough suppressant-ratiopharm Dextromethorphan hard capsules. Active ingredient: Dextromethorphan hydrobromide 1 H2O 30 mg. Areas of application: for the symptomatic treatment of irritating coughs (unproductive coughs).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cough suppressant-ratiopharm Dextromethorphan hard capsules for use in adolescents aged 12 and over and adults
Active ingredient: Dextromethorphan hydrobromide 1 H2O 30 mg

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 3 – 5 days, consult your doctor.

What this package leaflet contains

1. WHAT IS COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN?
3. HOW SHOULD COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN AND WHAT IS IT USED FOR?

Cough suppressant-ratiopharm Dextromethorphan is a cough suppressant (antitussive). Cough suppressant-ratiopharm Dextromethorphan is used for the symptomatic treatment of irritating coughs (unproductive coughs).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN?

Cough suppressant-ratiopharm Dextromethorphan must not be taken:

• if you are allergic to dextromethorphan hydrobromide or any of the other ingredients of this medicine listed in section 6.
• if you suffer from bronchial asthma.
• if you suffer from chronic obstructive pulmonary disease.
• if you suffer from pneumonia.
• if you suffer from respiratory depression.
• if you suffer from insufficient respiratory function (respiratory insufficiency).
• if you are breastfeeding.

Warnings and precautions

This medicine can lead to dependence. Therefore, treatment should be short-term.

Please talk to your doctor or pharmacist before taking Cough suppressant-ratiopharm Dextromethorphan:

• if you are taking medicines such as certain antidepressants or antipsychotics, Cough suppressant-ratiopharm Dextromethorphan may interact with these medicines and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as an increase in body temperature above 38°C, increased heart rate, unstable blood pressure and increased reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
• if you have impaired liver function.
• if you are taking certain mood-elevating medicines (MAO inhibitors) at the same time.

In the case of coughs with significant mucus production, you should only take Cough suppressant-ratiopharm Dextromethorphan in consultation with and on the instructions of a doctor, exercising particular caution, because suppressing the cough under these circumstances is undesirable. Chronic coughs can be an early symptom of bronchial asthma, which is why Cough suppressant-ratiopharm Dextromethorphan is not indicated for suppressing this cough, especially in children. Please note that Cough suppressant-ratiopharm Dextromethorphan can lead to psychological and physical dependence. In patients who are prone to drug abuse or drug dependence, treatment with Cough suppressant-ratiopharm Dextromethorphan should therefore be short-term and under the strictest medical supervision. In case of abuse, symptoms of overdose may occur (see 3. "If you have taken a larger amount of Cough suppressant-ratiopharm Dextromethorphan than you should").

Children

Cough suppressant-ratiopharm Dextromethorphan is not suitable for children under 12 years of age due to the high active ingredient content.

Taking Cough suppressant-ratiopharm Dextromethorphan with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

• If used at the same time or as a pre-treatment with certain mood-elevating medicines (antidepressants of the MAO inhibitor or SSRI type [fluoxetine, paroxetine]), effects on the central nervous system such as states of agitation and confusion, high fever and changes in respiratory and circulatory functions (so-called serotonin syndrome) are possible.
• If taken at the same time as other medicines with a sedative effect on the central nervous system, there may be a mutual increase in effect.
• If Cough suppressant-ratiopharm Dextromethorphan is used in combination with expectorant cough suppressants, a dangerous accumulation of secretions may occur due to the reduced cough reflex.
• If used at the same time as medicines that inhibit the cytochrome P450 – 2D6 enzyme system of the liver and thus the breakdown of dextromethorphan – in particular amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenone, thioridazine, cimetidine, ritonavir, terbinafine, flecainide, sertraline, bupropion, methadone, cinacalcet and perphenazine – the concentration of dextromethorphan may increase. In this context, symptoms of overdose have been observed (see 3. "If you have taken a larger amount of Cough suppressant-ratiopharm Dextromethorphan than you should").

Please note that this information may also apply to medicines that have been used recently.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Observations in humans have not so far shown any evidence of harmful effects of dextromethorphan on the foetus, but the available studies are not sufficient for a definitive assessment of the safety of using dextromethorphan during pregnancy. Therefore, dextromethorphan should only be used after careful consideration of the benefits and risks by the treating doctor and only in exceptional cases. Studies on the transfer of dextromethorphan into breast milk are not available. Since a respiratory depressant effect on the infant cannot be ruled out, dextromethorphan must not be used during breastfeeding.

Driving and operating machinery

Even when used as intended, this medicine can often cause mild drowsiness and thus alter the ability to react to such an extent that the ability to actively participate in road traffic or operate machinery is impaired. This applies to an even greater extent in combination with alcohol or medicines that can themselves impair the ability to react.

Cough suppressant-ratiopharm Dextromethorphan contains lactose

Therefore, please only take Cough suppressant-ratiopharm Dextromethorphan after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW SHOULD COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is

Adolescents over 12 years of age and adults take 1 capsule of Cough suppressant-ratiopharm Dextromethorphan (equivalent to 30 mg dextromethorphan hydrobromide 1 H2O) every 6 hours; the maximum daily total dose is 4 capsules of Cough suppressant-ratiopharm Dextromethorphan (equivalent to 120 mg dextromethorphan hydrobromide 1 H2O).

Method of administration

The capsules are taken whole with sufficient (e.g. 1 glass of water) liquid. It is preferable to take the medicine at night in order to maintain its effectiveness through intermittent use. Do not take Cough suppressant-ratiopharm Dextromethorphan for more than 3 - 5 days without medical advice. Even under medical prescription, Cough suppressant-ratiopharm Dextromethorphan should not be taken for more than two to three weeks.

If you have taken a larger amount of Cough suppressant-ratiopharm Dextromethorphan than you should

If you take more Cough suppressant-ratiopharm Dextromethorphan than you should, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, restlessness, confusion, drowsiness, impaired consciousness, involuntary and rapid eye movements, impaired heart function (rapid heartbeat), impaired coordination, psychoses with visual hallucinations and overexcitability. Other symptoms in the event of a massive overdose may include: coma, severe breathing problems and convulsions. Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take Cough suppressant-ratiopharm Dextromethorphan

Do not take twice the amount if you have forgotten to take the previous dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people):

• mild tiredness, dizziness
• nausea, gastrointestinal complaints, vomiting

Very rare (may affect up to 1 in 10,000 people):

• drowsiness, hallucinations, development of dependence in case of abuse
• skin reactions such as fixed drug eruption

At the first signs of a hypersensitivity reaction, Cough suppressant-ratiopharm Dextromethorphan must not be taken again. Inform your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD COUGH SUPPRESSANT-RATIOPHARM DEXTROMETHORPHAN BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cough suppressant-ratiopharm Dextromethorphan contains

The active ingredient is dextromethorphan. Each hard capsule contains 30 mg dextromethorphan hydrobromide 1 H2O, equivalent to 22 mg dextromethorphan. The other ingredients are: Capsule contents: lactose monohydrate, talc, macrogol 6000, magnesium stearate (Ph.Eur.). Capsule shell: gelatine, purified water, indigo carmine, titanium dioxide.

What Cough suppressant-ratiopharm Dextromethorphan looks like and contents of the pack

Capsule shell: light blue lower part with dark blue cap, contents: white powder. Cough suppressant-ratiopharm Dextromethorphan is available in packs of 10 hard capsules.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This package leaflet was last revised in November 2019.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Dextromethorphan hydrobromide 1 H2O 30 mg. Areas of application: for the symptomatic treatment of irritating coughs (unproductive coughs).