SILOMAT

SILOMAT Cough Suppressant Ambroxol Hydrochloride 30mg/5ml

Important notes (mandatory information)

Silomat Cough Suppressant Ambroxol Hydrochloride 30 mg/5 ml Syrup. Areas of application: Application for mucolytic treatment of diseases of the bronchi and lungs with viscous mucus. Warning: Contains sorbitol and benzoic acid.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Silomat Cough Suppressant Ambroxol Hydrochloride 30 mg/5 ml Syrup, application for mucolytic treatment of diseases of the bronchi and lungs with viscous mucus in adults, adolescents and children from 2 years of age
Active ingredient: Ambroxol hydrochloride.

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

Keep the package insert. You may want to read it again later.

Ask your pharmacist if you need more information or advice.

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package insert. See section 4.

If you do not feel better or even worse after 4 - 5 days, contact your doctor.

What this package insert contains

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

1. WHAT IS SILOMAT COUGH SUPPRESSANT AMBROXOL HYDROCHLORIDE AND WHAT IS IT USED FOR?

Silomat Cough Suppressant Ambroxol Hydrochloride contains the active ingredient ambroxol hydrochloride, which belongs to a group of medicines called mucolytics (expectorants). It is a medicine for dissolving mucus in respiratory diseases with viscous mucus (expectorant).

Silomat Cough Suppressant Ambroxol Hydrochloride is used for mucolytic treatment of diseases of the bronchi and lungs with viscous mucus in adults, adolescents and children from 2 years of age.

If you do not feel better or even worse after 4-5 days, you must contact a doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SILOMAT COUGH SUPPRESSANT AMBROXOL HYDROCHLORIDE?

Silomat Cough Suppressant Ambroxol Hydrochloride must not be taken,

• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine listed in section 6,
• by infants under 2 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Silomat Cough Suppressant Ambroxol Hydrochloride.

If you have impaired kidney function or severe liver disease, Silomat Cough Suppressant Ambroxol Hydrochloride should only be taken on the instructions of a doctor.

If you suffer from a rare disease of the bronchi that is associated with excessive mucus accumulation (e.g. malignant ciliary syndrome), the mucus cannot be transported out of the lungs. In this case, take Silomat Cough Suppressant Ambroxol Hydrochloride only under medical supervision.

If you experience a worsening of symptoms in acute respiratory diseases or no improvement after 4-5 days of treatment, discontinue treatment with Silomat Cough Suppressant Ambroxol Hydrochloride and consult your doctor immediately.

There have been reports of serious skin reactions in connection with the use of ambroxol hydrochloride. If you develop a rash (including mucosal damage in the mouth, throat, nose, eyes and genital area), please stop using Silomat Cough Suppressant Ambroxol Hydrochloride and seek medical advice immediately.

Children

Silomat Cough Suppressant Ambroxol Hydrochloride must not be used in infants under 2 years of age.

Taking Silomat Cough Suppressant Ambroxol Hydrochloride with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Clinically unfavourable interactions between Silomat Cough Suppressant Ambroxol Hydrochloride and other medicines are not known. Do not use ambroxol together with medicines for dry cough.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is no evidence of side effects during pregnancy. Nevertheless, Silomat Cough Suppressant Ambroxol Hydrochloride should not be taken during the first 3 months of pregnancy. Ambroxol hydrochloride passes into breast milk, so taking Silomat Cough Suppressant Ambroxol Hydrochloride is not recommended during breast-feeding.

Driving and using machines

Studies on the effects of Silomat Cough Suppressant Ambroxol Hydrochloride on the ability to drive and use machines have not been conducted. However, there is no evidence that this medicine affects the ability to drive and use machines.

Silomat Cough Suppressant Ambroxol Hydrochloride contains sorbitol

This medicine contains 245 mg sorbitol per ml. Sorbitol is a source of fructose. Talk to your doctor before you (or your child) take (or receive) this medicine if your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which fructose cannot be broken down.

Silomat Cough Suppressant Ambroxol Hydrochloride contains benzoic acid

This medicine contains 1.75 mg benzoic acid per ml. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

3. HOW SHOULD SILOMAT COUGH SUPPRESSANT AMBROXOL HYDROCHLORIDE BE TAKEN?

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

The recommended dose is

Adults and adolescents over 12 years: 5 ml 3 times a day for 2 - 3 days, then 5 ml 2 times a day.
Children from 6 -12 years: 2.5 ml 2 to 3 times a day.
Children from 2 - 5 years: 1.25 ml 3 times a day.

Infants under 2 years

Silomat Cough Suppressant Ambroxol Hydrochloride must not be used in infants under 2 years of age.

Method of administration

The pack contains a measuring spoon to make it easier to take the syrup. Silomat Cough Suppressant Ambroxol Hydrochloride can be taken with or without meals.

Duration of use

Without medical advice, the duration of use should not exceed 4 - 5 days.

If you have taken more Silomat Cough Suppressant Ambroxol Hydrochloride than you should

No cases of poisoning with ambroxol hydrochloride are known.

The symptoms observed in the event of accidental overdose and/or medicinal product mix-ups correspond to the known side effects of ambroxol hydrochloride that can occur at the recommended dosage. Symptomatic treatment may be necessary.

If you forget to take Silomat Cough Suppressant Ambroxol Hydrochloride

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

If you have any further questions about taking 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.

Stop taking Silomat Cough Suppressant Ambroxolhvdrochloride immediately and see your doctor if any of the following side effects occur

Not known (frequency cannot be estimated from the available data):

• Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or tissue under the mucous membrane) and itching,
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Other side effects that may occur are

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

• Nausea,
• reduced sensitivity in the mouth and throat (hypesthesia),
• change in taste sensation.

Occasionally (may affect up to 1 in 100 people):

• Vomiting, diarrhoea, indigestion, abdominal pain,
• dry mouth,
• fever,
• mucosal reactions.

Rare (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions,
• rash, hives,
• dry throat.

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package insert. 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 about the safety of this medicine.

5. HOW SHOULD SILOMAT COUGH SUPPRESSANT AMBROXOL HYDROCHLORIDE 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 label after "use by" or "exp. by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not use for more than 6 months after opening the bottle.

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. In this way, you help to protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Silomat Cough Suppressant Ambroxol Hydrochloride 30 mg/5 ml Syrup contains

The active ingredient is ambroxol hydrochloride. Silomat Cough Suppressant Ambroxol Hydrochloride contains 30 mg ambroxol hydrochloride per 5 ml syrup. Each ml of Silomat Cough Suppressant Ambroxol Hydrochloride contains 6 mg ambroxol hydrochloride.

The other ingredients are: hytellose, sorbitol solution 70% (non-crystallising) (Ph.Eur.), glycerol (85%), benzoic acid, acesulfame potassium, strawberry flavour (propylene glycol, glycerol, 2-ethyl-3-hydroxy-4H-pyran-4-one, ethyl lactate, methyl cinnamate, butyric acid, pentanoic acid, hexanoic acid, butane-2,3-dione), vanilla flavour (ammonium sulphite caramel (E150d), propylene glycol), purified water.

What Silomat Cough Suppressant Ambroxol Hydrochloride 30 mg/5 ml Syrup looks like and contents of the pack

Silomat Cough Suppressant Ambroxol Hydrochloride 30 mg/5 ml Syrup is a clear, practically colourless and slightly viscous syrup in a type III brown glass bottle with a child-resistant white polyethylene cap.

Silomat Cough Suppressant Ambroxol Hydrochloride 30 mg/5 ml Syrup is available in packs of 100 ml, 125 ml, 200 ml and 250 ml syrup.

The pack contains a measuring spoon with markings for 1.25 ml, 2.5 ml, 3.75 ml and 5 ml.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

STADA Consumer Health Deutschland GmbH
Stadastraße 2-18
61118 Bad Vilbel
Telephone: 06101 603-0
Fax: 06101 603-259
Internet: www.stada.de

Manufacturer

Laboratorios Basi - Indüstria Farmaceutica S.A.
Parque Industrial Manuel Lourenco Ferreira
Lotes 8,15 e 16
3450-232 Mortagua
Portugal

This package insert was last revised in August 2023.

Source: Information from the package insert
Status: 01/2025
Areas of application: Application for mucolytic treatment of diseases of the bronchi and lungs with viscous mucus. Warning: Contains sorbitol and benzoic acid.