SILOMAT

SILOMAT Cough Suppressant DMP with Honey Flavor 7.7mg LUP

Important notes (mandatory information)

Silomat Cough Suppressant Dextromethorphan with Honey Flavor 7.7 mg Lozenges. Active ingredient: Dextromethorphan hydrobromide monohydrate. Areas of application: For the symptomatic treatment of dry cough.Warning: One lozenge contains 168.5 mg of betadex (cyclodextrin).

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 with Honey Flavor 7.7 mg Lozenges, for the symptomatic treatment of dry cough in children aged 6 years and over and adults
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 is in this leaflet:

• WHAT IS SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES AND WHAT IS IT USED FOR?
• WHAT DO YOU NEED TO KNOW BEFORE TAKING SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES?
• HOW TO TAKE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES?
• WHAT SIDE EFFECTS ARE POSSIBLE?
• HOW TO STORE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES?
• CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES AND WHAT IS IT USED FOR?

Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges 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 DO YOU NEED TO KNOW BEFORE TAKING SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES?

Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges 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 activity (respiratory insufficiency),
• if you are breastfeeding,
• by children under 6 years of age,
• in rare congenital intolerances to one of the ingredients (see section "Warnings and precautions").

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 7.7 mg Lozenges 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 7.7 mg Lozenges

If you are taking medicines such as certain antidepressants or antipsychotics, Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges 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, increase in heart rate, unstable blood pressure and increased reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).

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 impaired cough reflex, Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges 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 7.7 mg Lozenges is 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 7.7 mg Lozenges should therefore be short-term and under the strictest medical supervision.

Caution is also advised if you are prone to alcohol abuse or have a history of psychiatric illness.

There have been reports of dextromethorphan abuse, mainly in adolescents.

Children

Children under 6 years of age must not take Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges. In children, serious adverse events, including neurological disorders, can occur in the event of an overdose.

Caregivers must not exceed the recommended dose.

Taking Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges 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 medicines (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 7.7 mg Lozenges 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 7.7 mg Lozenges with expectorant cough suppressants may lead to a (dangerous) accumulation of secretions in patients with existing respiratory diseases associated with increased mucus production, such as cystic fibrosis or bronchiectasis, due to the impaired cough reflex.

Taking Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges with alcohol

Do not consume alcoholic beverages while taking Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges, 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 become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Observations in humans have not so far shown any evidence of harmful effects of dextromethorphan on the fetus, but the available studies are not sufficient for a final assessment of the safety of dextromethorphan use in pregnancy. Therefore, dextromethorphan should only be used after a strict benefitrisk 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 must not be used during breastfeeding.

Fertility

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

Driving and operating machinery

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 increased extent in combination with alcohol or medicines that can themselves impair the ability to react.

Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges contains maltitol and invert sugar (honey). Invert sugar is a mixture of glucose and fructose.

Please only take Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges contains 168.5 mg of betadex (cyclodextrin) per lozenge.

This medicine contains less than 1 mmol (23 mg) sodium per lozenge, i.e. it is virtually "sodium-free".

3. HOW TO TAKE SILOMAT COUGH SUPPRESSANT DEXTROMETHORPHAN 7.7 MG LOZENGES?

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
Children from	1 lozenge	6 lozenges
6 to 12	Silomat	Silomat Cough Suppressant
years	Cough Suppressant Dextromethorphan 7.7 mg Lozenges (equivalent to 10.5 mg dextromethorphan hydrobromide monohydrate) every 4 to 6 hours	Dextromethorphan 7.7 mg Lozenges (equivalent to 63 mg dextromethorphan hydrobromide monohydrate)
Adolescents	1 to 3	12 lozenges
over 12	lozenges	Silomat Cough Suppressant
years	Silomat	Dextromethorphan
and	Cough Suppressant	7.7 mg Lozenges
adults	Dextromethorphan 7.7 mg Lozenges (equivalent to 10.5 to 31.5 mg dextromethorphan hydrobromide monohydrate) every 4 to 6 hours	(equivalent to 126 mg dextromethorphan hydrobromide monohydrate)

Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges must not be taken by children under 6 years of age (see section "Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges must not be taken,").

Method of administration

Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges are for oral use (sucking). Allow Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges to dissolve slowly in the mouth.

Duration of use

Do not take Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges for longer than 3 - 5 days without medical advice.

Even under medical prescription, Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges should not be taken for longer 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 7.7 mg Lozenges is too strong or too weak.

If you have taken more Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges than you should

If you take more Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges 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 are concerned that you have taken too high a dose of Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges, 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 symptom-related therapy may be necessary under certain circumstances. Naloxone can be used as an antagonist.

If you forget to take Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges

Do not take a double dose if you have forgotten the previous dose. Continue taking as recommended.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Silomat Cough Suppressant Dextromethorphan 7.7 mg Lozenges can have side effects, although not everybody gets them.

The following frequency information is used to assess 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, in case of abuse. Development of dependence.
Not known: Confusion.

Nervous system disorders

Common: Dizziness.
Very rare: Drowsiness.
Not known: Vertigo (dizziness), slurred speech