MUCOANGIN

MUCOANGIN Wild Berry 20 mg Lozenges

Important notes (mandatory information)

Mucoangin for sore throats Wild Berry, lozenges. Active ingredient: Ambroxol hydrochloride. Areas of application: for pain relief in acute sore throats.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Mucoangin for sore throats Wild Berry, lozenges for use in adults and adolescents over 12 years of age
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 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 notice any side effects, contact 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 even worse after 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS MUCOANGIN FOR SORE THROATS WILD BERRY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOANGIN FOR SORE THROATS WILD BERRY?
3. HOW TO TAKE MUCOANGIN FOR SORE THROATS WILD BERRY?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MUCOANGIN FOR SORE THROATS WILD BERRY?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MUCOANGIN FOR SORE THROATS WILD BERRY AND WHAT IS IT USED FOR?

Mucoangin for sore throats Wild Berry contains the active ingredient ambroxol hydrochloride. This active ingredient achieves the therapeutic effect of the lozenge. Mucoangin for sore throats Wild Berry is a local anesthetic for acute sore throats. Mucoangin for sore throats Wild Berry is used for pain relief in acute sore throats.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MUCOANGIN FOR SORE THROATS WILD BERRY?

Mucoangin for sore throats Wild Berry must not be taken:

• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine listed in section 6.
• if you have fructose intolerance.

Warnings and precautions

Please talk to your doctor or pharmacist before taking this medicine. You should not take Mucoangin for sore throats Wild Berry for more than 3 days. If you still have symptoms after 3 days or if you have a high fever, please consult a doctor. If you know that you suffer from an intolerance to certain sugars, please only take this medicine after consulting your doctor. Please also refer to "Important information about certain other ingredients of Mucoangin for sore throats Wild Berry". If you have impaired kidney function or severe liver disease, Mucoangin for sore throats Wild Berry should only be taken on medical advice. Mucoangin for sore throats Wild Berry is not approved for the treatment of painful lesions of the oral mucosa (e.g. ulcers or aphthae). In such a case, medical advice should be sought. Shortness of breath may be observed in connection with an underlying condition, such as swelling of the throat. The local anesthetic effect of Mucoangin for sore throats Wild Berry could cause a feeling of tightness in the throat. Allergic reactions can also cause swelling in the mouth and throat. The perception of taste in the mouth and throat may be impaired (numbness). There have been reports of severe skin reactions in connection with the use of ambroxol hydrochloride. If you develop a rash (including mucosal lesions in the mouth, throat, nose, eyes and genital area), please stop using Mucoangin for sore throats Wild Berry and seek medical advice immediately.

Children

Mucoangin for sore throats Wild Berry should not be used in children under 12 years of age.

Taking Mucoangin for sore throats Wild Berry together 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.

Taking Mucoangin for sore throats Wild Berry together with food and drink

There are no known relevant interactions.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Ambroxol passes into the body of the unborn child. You should not take this medicine during pregnancy, especially not during the first 3 months. Ambroxol passes into breast milk. Therefore, Mucoangin for sore throats Wild Berry should not be taken during breastfeeding.

Driving and using machines

No impairment of the ability to drive or operate machinery is known when taking Mucoangin for sore throats Wild Berry.

Mucoangin for sore throats Wild Berry contains sorbitol

One lozenge contains 1.381 g sorbitol (8.3 g per maximum recommended daily dose). Sorbitol is a source of fructose (a sugar). If you suffer from fructose intolerance, you should not take this medicine.

If you know that you suffer from an intolerance to certain sugars, only take Mucoangin for sore throats Wild Berry after consulting your doctor.

3. HOW TO TAKE MUCOANGIN FOR SORE THROATS WILD BERRY?

Always take this medicine exactly as described in this package 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: Adults and children over 12 years of age should suck 1 lozenge for pain relief. The number of 6 lozenges per day should not be exceeded. You should not take Mucoangin for sore throats Wild Berry for more than 3 days. If you still have symptoms after 3 days or if you have a high fever, please consult a doctor. Experience has shown that the pain-relieving effect of Mucoangin for sore throats Wild Berry sets in within 20 minutes. The duration of action is at least 3 hours.

If you have taken more Mucoangin for sore throats Wild Berry than you should

No specific symptoms of overdose are known. If you have taken too many lozenges (more than 6 per day) and you observe possible signs of an overdose, contact your doctor or pharmacist.

If you have any further questions on the use of the 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 experience any of the following side effects, you should stop treatment with Mucoangin for sore throats Wild Berry and contact a doctor immediately:

• allergic reaction with local swelling of the face, lips, mouth, tongue and/or throat (angioedema). This may lead to a feeling of tightness in the throat as well as difficulty swallowing and breathing.
• rapidly occurring allergic reactions that affect the entire body (anaphylactic reactions up to anaphylactic shock).

The severity of allergic reactions may increase if you take the product again or if you use another product with the same substance (see section 2: "What should you consider before taking Mucoangin for sore throats Wild Berry").

Other possible side effects

Common - may affect up to 1 in 10 people:

• nausea
• numbness in the mouth, tongue and throat
• taste disturbances

Uncommon - may affect up to 1 in 100 people:

• diarrhea
• indigestion
• abdominal pain
• dry mouth

Rare - may affect up to 1 in 1,000 people:

• hypersensitivity reactions
• rash, hives

Not known - frequency cannot be estimated from the available data:

• 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
• severe skin reactions (including erythema multiforme, Stevens–Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
• vomiting
• dry throat

Reporting of side effects

If you get 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 TO STORE MUCOANGIN FOR SORE THROATS WILD BERRY?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and blister after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not store above 30°C. 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 Mucoangin for sore throats Wild Berry contains

The active ingredient is ambroxol hydrochloride. One lozenge contains 20 mg ambroxol hydrochloride. The other ingredients are: Sorbitol 1.38 g (equivalent to approx. 0.12 BE), macrogol 6000, sucralose, talc and flavorings.

What Mucoangin for sore throats Wild Berry looks like and contents of the pack

Mucoangin for sore throats Wild Berry are round, white tablets with rounded edges. Both sides are flat. Mucoangin for sore throats Wild Berry are available in aluminum/aluminum blister packs. Mucoangin for sore throats Wild Berry is available in packs of 18 lozenges.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main

Telephone: 0800 56 56 010
Telefax: 0800 56 56 011
www.mucoangin.de

Manufacturer

Delpharm Reims
10 Rue Colonel Charbonneaux
51100 Reims
France

This package leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Ambroxol hydrochloride. Areas of application: for pain relief in acute sore throats.