MOTOSOL 3mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

Motosol 3 mg/ml Syrup

Ambroxol Hydrochloride

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What is Motosol and what is it used for
2. What you need to know before taking Motosol
3. How to take Motosol
4. Possible side effects
5. Storage of Motosol

Contents of the packaging and additional information

1. What is Motosol and what is it used for

Ambroxol, the active substance of this medicine, belongs to a group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults and children from 2 years of age.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Motosol

Do not take Motosol

• If you are allergic to ambroxol hydrochloride or any of the other components of this medicine (listed in section 6).
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Motosol.

If you have kidney or liver problems, consult your doctor before using this medicine.

There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Motosol and consult your doctor immediately.

Children

Motosol is contraindicated in children under 2 years of age.

In children from 2 to 6 years, consult a doctor.

Taking Motosol with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Taking Motosol with food and drinks

Motosol can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

No adverse effects have been observed during pregnancy. However, the usual precautions regarding the use of medicines during pregnancy should be followed. The use of Motosol is not recommended, especially during the first trimester of pregnancy.

The active substance of this medicine, ambroxol, may pass into breast milk, and although no adverse effects are expected in the breastfed infant, its use should be avoided during breastfeeding.

Studies in animals have not shown any adverse effects on fertility.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

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3. How to take Motosol

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years: 1 measure of 10 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 90 mg of ambroxol hydrochloride.

Use in children

Children from 6 to 12 years: 1 measure of 5 ml, 2-3 times a day (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.

Children from 2 to 5 years: 1 measure of 2.5 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage can be reduced to 2 times a day every 12 hours.

How to take:

Motosol is taken orally.

Measure the amount of medicine to be taken with the measuring device included in the box.

It is recommended to drink a glass of water after each dose and plenty of liquid throughout the day.

You should consult a doctor if it worsens or does not improve after 5 days of treatment (3 days in children under 6 years).

If you take more Motosol than you should

If you have taken more Motosol than you should, you may notice nausea, alteration of the sense of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth, or any other adverse effect described in section 4 Possible side effects. In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

In case of massive accidental administration, symptomatic treatment is recommended.

4. Possible side effects

Like all medicines, Motosol can cause side effects, although not everybody gets them.

The following side effects may occur:

• Frequent (may affect up to 1 in 10 people): nausea, alteration of the sense of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth.
• Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, indigestion, abdominal pain, dry mouth.
• Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria, dry throat.

• Frequency not known (cannot be estimated from the available data): anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus. Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Motosol

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Motosol

• The active substance is ambroxol hydrochloride. Each ml of syrup contains 3 mg of ambroxol hydrochloride.
• The other components are: hydroxyethylcellulose, sucralose, benzoic acid (E 210), wild berry flavor, vanilla flavor, and purified water.

Appearance of the product and contents of the packaging

Motosol is presented in bottles of 125 ml or 200 ml of syrup with a child-resistant plastic cap. Its appearance is slightly viscous, clear, and practically colorless. It has a fruity aroma.

Marketing authorization holder and

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

• Nattermann & Cie. GmbH

Nattermannallee 1

50829 Köln

Germany

Or

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims

France

Or

Opella Healthcare Italy, S.r.l.

Viale Europa 11, 21040

Origgio (Va)

Italy

Date of the last revision of this package leaflet: May 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.