BROMHEXIN

BROMHEXIN 12 BC oral drops

Important notes (mandatory information)

Bromhexine 12 BC drops for oral administration. Active ingredient: Bromhexine 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.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bromhexine 12 BC 12 mg/ml, drops for oral administration, solution for use in children aged 2 years and over and adults
Active ingredient: Bromhexine hydrochloride

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 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 if you feel worse after 4 -- 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS BROMHEXINE 12 BC AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BROMHEXINE 12 BC?
3. HOW SHOULD BROMHEXINE 12 BC BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BROMHEXINE 12 BC BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BROMHEXINE 12 BC AND WHAT IS IT USED FOR?

Bromhexine 12 BC is a bronchosecretolytic (medicine for dissolving mucus in respiratory tract diseases with viscous mucus). Bromhexine 12 BC 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 BROMHEXINE 12 BC?

Bromhexine 12 BC must not be taken:

• if you are allergic to bromhexine hydrochloride, mint oil or any of the other ingredients of this medicine listed in section 6.
• by patients with bronchial asthma or other respiratory diseases associated with pronounced hypersensitivity of the respiratory tract. Inhalation of Bromhexine 12 BC can lead to shortness of breath or trigger an asthma attack.
• by infants and toddlers under 2 years of age (risk of laryngospasm).

Warnings and precautions

There have been reports of serious skin reactions in connection with the use of bromhexine. If you develop a rash (including damage to the mucous membranes in the mouth, throat, nose, eyes and genital area), please stop using Bromhexine 12 BC and seek medical advice immediately. Please talk to your doctor or pharmacist before taking Bromhexine 12 BC:

• if you have or have had a stomach or duodenal ulcer, as Bromhexine 12 BC can affect the mucous membrane barrier of the stomach and intestines.
• in some rare diseases of the bronchi that are associated with excessive mucus accumulation (e.g. malignant ciliary syndrome). In these cases, Bromhexine 12 BC should only be used under medical supervision due to a possible mucus congestion.
• in case of impaired renal function or severe liver disease (Bromhexine 12 BC is then used at longer intervals or in a reduced dose as directed by a doctor). In the case of severely impaired renal function, accumulation of the degradation products of Bromhexine 12 BC formed in the liver must be expected. Liver function should be monitored occasionally, especially during long-term treatment.

Taking Bromhexine 12 BC together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. When Bromhexine 12 BC is used in combination with cough suppressants (antitussives), a dangerous mucus congestion can occur due to the reduced cough reflex, so the indication for this combination treatment should be made with particular care. When using medicines that cause irritation in the gastrointestinal tract, the gastric mucosal irritation of Bromhexine 12 BC can be increased.

Pregnancy and breast-feeding

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. There is no experience with the use of this medicine in pregnancy in humans, therefore Bromhexine 12 BC should only be taken during pregnancy after careful consideration of the benefits and risks by the doctor and is not recommended in the first trimester of pregnancy. Bromhexine passes into breast milk. Since the effects on the infant have not been adequately investigated, Bromhexine 12 BC must not be taken during breast-feeding.

Driving and using machines

Bromhexine 12 BC has no or negligible influence on the ability to drive and use machines.

3. HOW SHOULD BROMHEXINE 12 BC 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. Dosage: The dosage is based on the information in the following table.

• Adults and adolescents over 14 years of age: 3 × daily 16 -- 33 drops (equivalent to 24 -- 48 mg bromhexine hydrochloride daily).
• Children and adolescents between 6 and 14 years of age and patients weighing less than 50 kg: 3 × daily 16 drops (equivalent to 24 mg bromhexine hydrochloride daily).
• Children from 2 to 6 years of age: 3 × daily 8 drops (equivalent to 12 mg bromhexine hydrochloride daily).

In case of impaired renal function or severe liver disease, this medicine should be used at longer intervals or in a reduced dose. Please ask your doctor for advice.

Method of administration

Drops for oral administration. To drop, please hold the bottle vertically downwards! Note: It may be useful to drink plenty of fluids.

Duration of use

The duration of use depends on the type and severity of the disease and should be decided by the attending physician. If your condition worsens or does not improve after 4 - 5 days, you should see a doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Bromhexine 12 BC is too strong or too weak.

If you have taken more Bromhexine 12 BC than you should

In the event of an overdose, no symptoms of illness are usually to be expected beyond the normal side effects. If severe symptoms of illness occur, circulatory monitoring and, if necessary, treatment based on the symptoms of illness may be necessary. If a small child has swallowed a significant amount of Bromhexine 12 BC, please contact the nearest doctor.

If you forget to take Bromhexine 12 BC

Do not take twice the amount if you have forgotten to take the previous dose. Continue taking Bromhexine 12 BC as described in the dosage instructions.

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. If you are affected by any of the side effects listed below, do not take Bromhexine 12 BC any more and see your doctor as soon as possible.

Occasional side effects (may affect up to 1 in 100 people):

• Fever
• Nausea, abdominal pain, vomiting, diarrhoea

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

• Hypersensitivity reactions
• Rash, hives

Frequency not known (cannot be estimated from the available data):

• allergic reactions up to anaphylactic shock (severe form of hypersensitivity reaction), 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). If the first signs of a hypersensitivity reaction or skin and mucous membrane changes occur, Bromhexine 12 BC must not be taken again. In this case, please contact the nearest doctor immediately.

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 provide more information on the safety of this medicine.

5. HOW SHOULD BROMHEXINE 12 BC 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 label and carton after "use by". The expiry date refers to the last day of the month indicated. Do not store below 15°C. Shelf life after opening the container: 3 months. Do not dispose of medicines in wastewater or household waste. 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 Bromhexine 12 BC contains

The active ingredient is bromhexine hydrochloride. 1 ml of Bromhexine 12 BC solution (25 drops) contains 12 mg of bromhexine hydrochloride. The other ingredients are: Citric acid, mint oil, propylene glycol, purified water.

What Bromhexine 12 BC looks like and contents of the pack

Clear, slightly viscous liquid; colourless to slightly yellowish, greenish in labelled brown glass bottle with dropper insert and screw cap. Original pack with 30 ml solution (N1) and original pack with 50 ml solution (N2). Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

This package leaflet was last revised in March 2016.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Bromhexine hydrochloride. Areas of application: for mucolytic treatment of acute and chronic diseases of the bronchi and lungs with viscous mucus.