Label: information for the user

MUXIMED EFG SYRUP

Ambroxol

In this label:

1. What it isMUXIMED syrupand its intended use.
2. Before takingMUXIMED syrup.
3. How to takeMUXIMED syrup.
4. Possible adverse effects.
5. Storage ofMUXIMED syrup.
6. Additional information

MUXIMED belongs to a group of medications called mucolytics. It works by reducing the viscosity of bronchial secretions and facilitating expectoration.

MUXIMED is indicated for acute and chronic respiratory tract conditions in which it is necessary to promote the elimination of secretions.

Do not take MUXIMED syrup:

• If you are allergic (hypersensitive) to ambroxol or to any of the other components of Muximed.
• This medication should not be used in children under 2 years.

Warnings and precautions

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

Be especially careful with MUXIMED syrup:

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication. Treatment with Muximed has not been shown to be harmful during pregnancy. However, your doctor will assess the benefit/risk of its administration.

Treatment with Muximed has not been shown to be harmful to the child. However, your doctor will assess the benefit/risk of its administration.

Children

Muximed is contraindicated in children under 2 years.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Important information about some of the components of Muximed

This medication contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause a mild laxative effect because it contains2.25 gof sorbitol per 5 ml. Caloric value: 2.6 kcal/g of sorbitol.

This medication may cause headaches, stomach discomfort, and diarrhea because it contains glycerol.

Follow exactly the administration instructions for Muximed indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the appropriate dose and treatment duration.

The usual dose is:

Adults:1 measure of 10 ml, 3 times a day.

Children over 5 years:1 measure of 5 ml, 2-3 times a day.

Children 2 to 5 years:1 measure of 2.5 ml, 3 times a day.

If you take more Muximed syrup than you should

If you have taken moreMUXIMED syrupthan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Muximed

Do not take a double dose to make up for the missed doses.

Take your dose as soon as possible. If there is little time left until the next dose, wait until then to take your dose.

If you interrupt treatment with Muximed

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

Like all medications, Muximed may have adverse effects, although not everyone will experience them.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Gastrointestinal disorders:

- Frequent (in at least 1 in 100 patients): diarrhea

- Infrequent: nausea, vomiting, and gastrointestinal discomfort.

• Rare (affecting at least 1 in 10,000 patients): heartburn

Immunological system disorders

- Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions.

- Unknown frequency (cannot be estimated from available data): anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus.

Skin disorders:

- Infrequent (affecting at least 1 in 1,000 patients): allergic reactions.

- Rare (may affect up to 1 in 1,000 people): exanthema, urticaria

- Unknown frequency (cannot be estimated from available data): severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute pustular psoriasis).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the National System for Pharmacovigilance of Medications for Human Use, website:www.notificaRAM.es

Do not store at a temperature above 30°C.

Do not use Muximed syrup after the expiration date that appears 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 packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Muximed syrup:

- The active ingredient is ambroxol hydrochloride.

- The other components are: raspberry aroma, citric acid monohydrate (E 330), glycerol (E 422), hydroxyethylcellulose, benzoic acid (E 210), propylene glycol, sorbitol (E 420), sodium saccharin, and purified water.

Appearance of the product and contents of the packaging:

Muximed syrup is presented in containers containing 200 ml.

Each 5 ml of syrup contains 15 mg of Ambroxol.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Amneal Pharma Spain, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte – Pamplona (Navarra) Spain.

O

LABORATORY BASI – PHARMACEUTICAL INDUSTRY, S.A.

Manuel Lourenço Ferreira Industrial Park

Lots 8, 15, and 16

3450-232 Mortágua

Portugal

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This prospectus was approved in May 2016

“Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”