AMBROXOL 15 Syrup-1A Pharma

Important notes (mandatory information)

Ambroxol 15 Saft - 1A Pharma. Active ingredient: Ambroxol hydrochloride. Areas of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Ambroxol 15 Saft - 1A Pharma 15 mg/5 ml oral solution
Active ingredient: Ambroxol hydrochloride

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 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 leaflet. See section 4.
• If you do not feel better or even worse after 4 – 5 days, contact your doctor.

What this leaflet contains

1. WHAT IS AMBROXOL 15 SAFT – 1A PHARMA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING AMBROXOL 15 SAFT – 1A PHARMA?
3. HOW SHOULD AMBROXOL 15 SAFT – 1A PHARMA BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD AMBROXOL 15 SAFT – 1A PHARMA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS AMBROXOL 15 SAFT -1A PHARMA AND WHAT IS IT USED FOR?

Ambroxol 15 Saft - 1A Pharma is a medicine for dissolving mucus in respiratory diseases with viscous mucus (expectorant). Ambroxol 15 Saft - 1A Pharma is used for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING AMBROXOL 15 SAFT - 1A PHARMA?

Ambroxol 15 Saft - 1A Pharma must not be taken if you are allergic to ambroxol hydrochloride, sodium metabisulfite, benzyl alcohol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Ambroxol 15 Saft - 1A Pharma. There have been reports of serious skin reactions in connection with the use of ambroxol hydrochloride. If you develop a rash (including damage to the mucous membranes in the mouth, throat, nose, eyes and genital area), please stop taking Ambroxol 15 Saft - 1A Pharma and seek medical advice immediately.

Patients with impaired kidney and liver function

If you have impaired kidney function or severe liver disease, Ambroxol 15 Saft - 1A Pharma should only be taken on the instructions of a doctor. As with any medicine that is metabolised by the liver and then excreted by the kidneys, accumulation of the metabolites of ambroxol formed in the liver can be expected in the presence of severely impaired kidney function.

In some rare diseases of the bronchi that are associated with excessive secretion accumulation (e.g. malignant ciliary syndrome), Ambroxol 15 Saft - 1A Pharma should only be used under medical supervision due to a possible mucus congestion.

Children

Ambroxol 15 Saft - 1A Pharma should only be used in children under 2 years of age on the instructions of a doctor.

Taking Ambroxol 15 Saft - 1A Pharma 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.

Ambroxol/Antitussives

If Ambroxol 15 Saft -1A Pharma and cough suppressants (antitussives) are used at the same time, a dangerous mucus congestion can occur due to the restricted cough reflex, so that the simultaneous use should only take place after careful consideration of the benefits and risks.

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 taking this medicine. If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice, as large amounts of benzyl alcohol can accumulate in your body and cause side effects (so-called "metabolic acidosis").

Pregnancy

Ambroxol reaches the unborn child. You should not take this medicine during pregnancy, especially not during the first 3 months.

Breast-feeding

The active ingredient ambroxol passes into breast milk in animal studies. Use during breast-feeding is not recommended.

Fertility

Non-clinical studies have shown no evidence of harmful effects on fertility or reproductive capacity.

Driving and operating machinery

There is no evidence of an effect on driving and operating machinery; no corresponding studies have been conducted.

Ambroxol 15 Saft - 1A Pharma contains benzyl alcohol, sorbitol, benzoic acid, ethanol (alcohol) and sodium metabisulfite

This medicine contains a maximum of 0.5 mg benzyl alcohol, 1,750 mg sorbitol and 10 mg benzoic acid per 5 ml measuring spoon, corresponding to a maximum of 0.1 mg benzyl alcohol, 350 mg sorbitol and 2 mg benzoic acid per ml. It contains less than 1 mmol sodium (23 mg) per 5 ml measuring spoon, i.e. it is virtually "sodium-free". Benzyl alcohol can cause allergic reactions. Do not use this medicine in infants (under 3 years of age) for more than one week, unless advised by your doctor or pharmacist. If you have liver or kidney disease, ask your doctor or pharmacist for advice, as large amounts of benzyl alcohol can accumulate in your body and cause side effects (so-called "metabolic acidosis"). 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 (or your child) 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 a person cannot break down fructose. 1 measuring spoon (corresponding to 5 ml) contains 1.75 g sorbitol (a source of 0.44 g fructose). Sorbitol can cause gastrointestinal upset and may have a mild laxative effect. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old). This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml measuring spoon. Sodium metabisulfite can rarely cause severe hypersensitivity reactions and bronchial spasms (bronchospasms).

3. HOW SHOULD AMBROXOL 15 SAFT -1A PHARMA BE TAKEN?

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

The recommended dose is:

• Children up to 2 years (only on doctor's orders): 1/2 measuring spoon with 2.5 ml oral solution (corresponding to 15 mg ambroxol hydrochloride/day) is taken twice a day.
• Children from 2 – 5 years: 1/2 measuring spoon with 2.5 ml oral solution (corresponding to 22.5 mg ambroxol hydrochloride/day) is taken 3 times a day.
• Children from 6 – 12 years: 1 measuring spoon with 5 ml oral solution (corresponding to 30 – 45 mg ambroxol hydrochloride/day) is taken 2–3 times a day.
• Adults and adolescents from 12 years: Usually 2 measuring spoons with 5 ml oral solution (corresponding to 90 mg ambroxol hydrochloride/day) are taken 3 times a day for the first 2 – 3 days, then 2 measuring spoons with 5 ml oral solution (corresponding to 60 mg ambroxol hydrochloride/day) are taken 2 times a day. For adults and adolescents from 12 years of age, the effectiveness can be increased if necessary by administering 2 measuring spoons with 5 ml oral solution (corresponding to 120 mg ambroxol hydrochloride/day) 2 times a day.

Type and duration of use

The pack contains a 5 ml measuring spoon with graduations at 2.5 ml and 1.25 ml. Ambroxol 15 Saft - 1A Pharma is taken with or independently of meals using the enclosed dosing aid (measuring spoon). Please clean the measuring spoon after use by rinsing it with warm water. If your condition worsens or does not improve after 4-5 days, you should see a doctor.

If you have taken more Ambroxol 15 Saft - 1A Pharma than you should

Specific symptoms of an overdose have not been reported to date. The symptoms observed in the event of accidental overdose or drug mix-up correspond to the side effects that can occur at the recommended dosage (see section 4. "What side effects are possible?"). In the event of an overdose, please contact a doctor, as treatment of the symptoms may be necessary.

If you forget to take Ambroxol 15 Saft - 1A Pharma

If you forget to take Ambroxol 15 Saft -1A Pharma once, or if you have taken too little, please continue taking Ambroxol 15 Saft - 1A Pharma at the next time, as described in the dosage instructions.

If you stop taking Ambroxol 15 Saft - 1A Pharma

Premature discontinuation of treatment may worsen symptoms.

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.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Side effects

Immune system disorders:

• Rare: Hypersensitivity reactions.
• Not known: allergic reactions up to anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or tissue under the mucous membrane) and itching.

Skin and subcutaneous tissue disorders:

• Rare: Rash, hives.
• Not known: severe skin reactions (including erythema multiforme, Stevens–Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).

Nervous system disorders:

• Common: Taste disturbances.

Gastrointestinal disorders:

• Common: Nausea, numbness in the mouth.
• Uncommon: Vomiting, diarrhoea, indigestion, abdominal pain, dry mouth.
• Rare: Dry throat.
• Very rare: Increased salivation.

Respiratory, thoracic and mediastinal disorders:

• Common: Numbness in the throat.
• Not known: Shortness of breath (as a sign of a hypersensitivity reaction).

General disorders and administration site conditions:

• Uncommon: Fever, mucous membrane reactions.

Sodium metabisulfite can rarely cause hypersensitivity reactions and constriction of the airways (bronchospasms).

Countermeasures

At the first signs of a hypersensitivity reaction, Ambroxol 15 Saft - 1A Pharma must not be taken again.

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 leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, 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 AMBROXOL 15 SAFT -1A PHARMA 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". The expiry date refers to the last day of the month indicated. Store in the original package to protect from light. Note on shelf life after opening: Can be used for 12 months after opening. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ambroxol 15 Saft - 1A Pharma contains

The active ingredient is ambroxol hydrochloride. 1 measuring spoon with 5 ml oral solution contains 15 mg ambroxol hydrochloride. The other ingredients are: benzoic acid, citric acid monohydrate, glycerol 85%, sodium cyclamate, sodium metabisulfite (Ph.Eur.), sodium hydroxide, povidone K90, sorbitol solution 70% (non-crystallising) (Ph.Eur.), purified water, raspberry flavour (contains benzyl alcohol and ethanol [alcohol]).

What Ambroxol 15 Saft - 1A Pharma looks like and contents of the pack

Ambroxol 15 Saft - 1A Pharma is a clear or almost clear, colourless to slightly yellowish oral solution. Ambroxol 15 Saft - 1A Pharma is available in packs of 100 ml and 250 ml oral solution. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Phone: 089/6138825-0

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in January 2019.

Source: Information from the package leaflet
Status: 01/2020
Active ingredient: Ambroxol hydrochloride. Areas of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.