SILOMAT

SILOMAT Cough Suppressant Dextromethorphan Intensive

Important notes (mandatory information)

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules. Active ingredient: Dextromethorphan hydrobromide monohydrate. Indications: For the symptomatic treatment of dry cough.Warning: Contains lactose.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules, for the symptomatic treatment of dry cough in adults and adolescents aged 12 years and over
Active ingredient: Dextromethorphan hydrobromide monohydrate

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

• Keep the package leaflet. You may need 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 any side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse after 3 - 5 days, contact your doctor.

What this leaflet contains

1. WHAT IS SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES?
3. HOW TO TAKE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES AND WHAT IS IT USED FOR?

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules are used for the symptomatic treatment of dry cough.
Dry cough is a dry cough in which no mucus is coughed up (unproductive cough).

2. WHAT YOU NEED TO KNOW BEFORE TAKING SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES?

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules must not be taken:

• if you are allergic (hypersensitive) to dextromethorphan hydrobromide or any of the other ingredients of this medicine listed in section 6,
• if you are currently taking or have taken so-called MAO inhibitors (certain mood-elevating drugs) within the last two weeks,
• in bronchial asthma,
• in chronic obstructive pulmonary disease,
• in pneumonia,
• in respiratory depression,
• in insufficient respiratory function (respiratory insufficiency),
• if you are breastfeeding,
• in rare congenital intolerances to one of the ingredients (see section "Warnings and precautions").
• Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules are not suitable for children under 12 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before taking this medicine.

Patients with:

• impaired liver function,
• impaired kidney function,
• mastocytosis

should only use Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules after consulting a doctor. Patients with severe impairment of renal or hepatic function should take a lower dose or increase the intervals between doses (dosing intervals) after consulting their doctor.

Talk to your doctor or pharmacist before taking Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules

If you are taking medicines such as certain antidepressants or antipsychotics, Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules may interact with these medicines and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as a rise 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).

Combined use of preparations with expectorant and cough suppressant effects can improve the therapy of productive cough (cough with expectoration), with expectoration recommended during the day and cough suppression at night. In patients with a cough with significant mucus production (e.g. bronchiectasis or cystic fibrosis), as well as in patients with neurological disorders (stroke, Parkinson's disease, dementia) who have a significantly reduced cough reflex, Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules should only be used after consulting a doctor, as under these circumstances a reduced sensitivity to cough stimuli with a decrease in cough frequency may be undesirable.

Chronic cough can be an early symptom of bronchial asthma, so Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules are not indicated for suppressing this cough - especially in children.

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

In patients who are prone to drug abuse or drug dependence, treatment with Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules should therefore be short-term and under strict medical supervision.

Caution is also advised if you are prone to alcohol abuse or have a history of psychiatric illness. Cases of dextromethorphan abuse have been reported, mainly in adolescents.

Children

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules are not suitable for children under 12 years of age due to the high active ingredient content. Dextromethorphan-containing medicines are available in other dosage forms for children aged 6 years and over.

Taking Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules with other medicines

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

If dextromethorphan is used concomitantly or pre-treated with certain mood-elevating drugs (antidepressants of the MAO inhibitor or SSRI type), effects on the nervous system are possible (see section "Warnings and precautions").

Concomitant use of other substances with a depressant effect on the central nervous system, including alcohol (see next section "Taking Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules with alcohol"), may result in a mutual potentiation of effects.

Concomitant use of medicines that inhibit the cytochrome P450-2D6 enzyme system in the liver and thus the breakdown of dextromethorphan - such as amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenone, thioridazine, cimetidine, ritonavir, berberine, bupropion, cinacalcet, flecainide and terbinafine - may lead to an increase in the concentration of dextromethorphan. This information may also apply to medicines used recently.

Combined use of Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules with expectorant cough suppressants may lead to (dangerous) mucus congestion in patients with existing respiratory diseases associated with increased mucus production, such as cystic fibrosis or bronchiectasis, due to the reduced cough reflex.

Taking Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules with alcohol

Do not consume alcoholic beverages while taking Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules, as the active ingredient dextromethorphan enhances the depressant effect of alcohol on the central nervous system.

Pregnancy, breastfeeding and fertility

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.

Pregnancy

Observations in humans have so far shown no evidence of harmful effects of dextromethorphan on the foetus, but the available studies are not sufficient for a definitive assessment of the safety of dextromethorphan use in pregnancy. Therefore, dextromethorphan should only be used after a strict benefit-risk assessment by the treating physician and only in exceptional cases.

Breastfeeding

Studies on the passage of dextromethorphan into breast milk are not available. Since an inhibitory effect on the infant cannot be ruled out, dextromethorphan should not be used during breastfeeding.

Fertility

Non-clinical studies showed no effect of dextromethorphan on fertility.

Driving and using machines

Even when used as intended, this medicine can often cause mild drowsiness and dizziness 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.

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules contains lactose

Please only take Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES?

Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Do not take more and do not take it for longer than recommended.

Cases of dextromethorphan abuse have been reported, including cases in children and adolescents.

Ask your doctor or pharmacist if you are not sure.

The recommended dose is

Age	Single dose	Total daily dose
Adolescents over 12 years and adults	1 capsule every 6 hours (equivalent to 22 mg dextromethorphan every 6 hours)	4 capsules (equivalent to 88 mg dextromethorphan)

Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules must not be taken by children under 12 years of age (see section "Warnings and precautions").

Method of administration

The hard capsules are taken unchewed with sufficient liquid (e.g. a glass of water).

Duration of use

Do not take Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules for more than 3 - 5 days without medical advice. Even under medical prescription, Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules should not be taken for more than two to three weeks.

Please talk to your doctor or pharmacist if you have the impression that the effect of Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules is too strong or too weak.

If you have taken more Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules than you should

If you take more Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules 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 massive overdose may include:
Coma, severe respiratory problems and convulsions.

Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you are concerned that you have taken too high a dose of Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules, also notify a doctor immediately.

In the event of simultaneous overdose of dextromethorphan and other medicines, cases of fatal poisoning have occurred.

Intensive medical monitoring with symptomatic therapy may be necessary under certain circumstances. Naloxone can be used as an antagonist.

If you forget to take Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules

Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as recommended.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects

Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Side effects

Immune system disorders

Not known:
Hypersensitivity reactions including allergic shock, swelling of the face, tongue and/or lips (angioedema), shortness of breath (bronchospasm), hives, itching, rash and skin redness.

Psychiatric disorders

Very rare

Hallucinations, development of dependence in case of abuse.

Not known:
Confusion.

Nervous system disorders

Common:
Dizziness.

Very rare

Drowsiness.

Not known:
Dizziness (vertigo), slurred speech and uncontrolled eye movements, impaired muscle tone, especially in children.

General disorders and administration site conditions

Common:
severe fatigue.

Gastrointestinal disorders

Common:
nausea, gastrointestinal upset, vomiting.

Not known:
constipation.

Skin and subcutaneous tissue disorders

Not known:
fixed drug eruption.

Countermeasures

At the first signs of a hypersensitivity reaction, Silomat Cough Suppressant Dextromethorphan Intensive 22 mg hard capsules must not be taken again. Inform your doctor so that he/she can decide on the severity and any further measures that may be necessary.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this 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 provide more information on the safety of this medicine.

5. HOW TO STORE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN INTENSIVE 22 MG HARD CAPSULES?

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after "Use by". The expiry date refers to the last day of the month indicated.

Storage conditions:

Do not store above 25°C. Store in the original package to protect the contents from moisture.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment. For more information, see: www.