Package Insert: Information for the User

Motosol 7.5 mg/ml Injectable Solution

Ambroxol Hydrochloride

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Motosol belongs to a group of medications known as mucolytics-expectorants.

Motosol is used to treat acute and chronic respiratory tract conditions that require the dissolution and elimination of mucus in adults and children aged 2 years and above.

Do not use Motosol

• If you are allergic to ambroxol hydrochloride or to any of the other components of this medication (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 problems related to kidney or liver function, inform your doctor.

Severe skin reactions have been reported associated with the administration of ambroxol hydrochloride. If a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals) appears, stop using Motosol and consult your doctor immediately.

Children

Motosol is contraindicated in children under 2 years of age.

Use of Motosol with other medications

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

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 medication.

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

The active ingredient of this medication, ambroxol, may pass into breast milk, and although adverse effects are not expected in the infant, its use should be avoided during breastfeeding.

Studies in animals have not indicated direct or indirect adverse effects on fertility.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed.

Motosol contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:1 ampule (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 respectively.

If necessary, it is possible to increase the isolated dose to 2 ampules.

Use in children

Children over 5 years old: 1 ampule (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 respectively.

Children from 2 to 5 years old: ½ ampule (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 must be administered by slow intravenous route, for at least 5 minutes.

It can be administered drop by drop intravenously.

This medication must be diluted with physiological saline solution or Ringer's solution.

Motosol should not be mixed with other solutions that result in a final pH greater than 6.3, as, due to the increase in pH, the ambroxol in the form of free base 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, inform your doctor.

If you use more Motosol than you should

If you have used more Motosol than you should, you may experience nausea or any other adverse effect described in section 4 Possible adverse effects. In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount used.

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

If you forgot to use Motosol

Do not use a double dose to compensate for the missed doses.

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

Like all medications, Motosol may produce adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Motosol

• The active ingredient is ambroxol hydrochloride. Each ampoule contains 15 mg of ambroxol hydrochloride.
• The other components are: citric acid, sodium dihydrogen phosphate dihydrate, sodium chloride, and water for injection preparations.

Appearance of the product and contents of the packaging

Motosol is presented in packs of 10 ampoules of 2 ml injectable solution. It is a clear and colourless solution.

Holder of the marketing authorization

Opella Healthcare Spain, S.L.

C/Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR)

Italy

Last review date of this leaflet: October 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.