MOTOSOL 7.5 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Motosol 7.5 mg/ml Solution for Injection

Ambroxol Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is Motosol and what is it used for
2. What you need to know before you use Motosol
3. How to use Motosol
4. Possible side effects
5. Storage of Motosol
6. Contents of the pack and other information

1. What is Motosol and what is it used for

Motosol belongs to a group of medicines called mucolytics-expectorants.

Motosol is used to treat acute and chronic respiratory tract conditions that require dissolution and elimination of mucus for adults and children from 2 years of age.

2. What you need to know before you use Motosol

Do not use Motosol

• If you are allergic to ambroxol hydrochloride or any of the other ingredients 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 use Motosol.

If you have kidney or liver problems, you should tell your doctor.

There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you get 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.

Using Motosol with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

No harmful 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 harmful effects are expected in the breastfed infant, its use should be avoided during breastfeeding.

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

Driving and using machines

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

Motosol contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose, which means it is essentially "sodium-free".

3. How to use Motosol

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults: 1 ampoule (15 mg of ambroxol hydrochloride), 2-3 times a day (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride.

If necessary, the single dose can be increased to 2 ampoules.

Use in children

Children over 5 years: 1 ampoule (15 mg of ambroxol hydrochloride), 2-3 times a day (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride.

Children from 2 to 5 years: ½ ampoule (7.5 mg of ambroxol hydrochloride), 3 times a day (every 8 hours), which means a maximum daily dose of 22.5 mg of ambroxol hydrochloride.

How to administer

Motosol should be administered by slow intravenous injection over a minimum of 5 minutes.

It can be administered by intravenous drip.

This medicine should be diluted with physiological saline solution or Ringer's solution.

Motosol should not be mixed with other solutions that result in a final mixture with a pH above 6.3, as the ambroxol in its free base form may precipitate (appearance of solid particles at the bottom of the container).

In acute respiratory indications, if symptoms do not improve or worsen during treatment, you should inform your doctor.

If you use more Motosol than you should

If you have used more Motosol than you should, you may notice nausea 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, telephone 915 620 420, indicating the medicine and the amount used.

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

If you forget to use Motosol

Do not use a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:

• Common (may affect up to 1 in 10 people): nausea.
• Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, indigestion, abdominal pain.
• Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, exanthema, urticaria.

• Frequency not known (cannot be estimated from the available data): anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue swelling) 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Motosol

• The active substance is ambroxol hydrochloride. Each ampoule contains 15 mg of ambroxol hydrochloride.
• The other ingredients are: citric acid, sodium phosphate dihydrate, sodium chloride, and water for injections.

Appearance and packaging of the product

Motosol is available in packs of 10 ampoules of 2 ml of solution for injection. It is a clear and colorless solution.

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR)

Italy

Date of last revision of this leaflet: October 2020

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