AMBROXOL STADA 6 mg/ml SYRUP

Introduction

Patient Information: Summary of Product Characteristics

Ambroxol Stada 6 mg/ml Oral Solution

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Ambroxol Stada and what is it used for
2. What you need to know before taking Ambroxol Stada
3. How to take Ambroxol Stada
4. Possible side effects
5. Storage of Ambroxol Stada
6. Package contents and additional information

1. What is Ambroxol Stada and what is it used for

Ambroxol Stada contains the active ingredient ambroxol hydrochloride, which belongs to the group of medications called mucolytics. It is used to facilitate the elimination of mucus from the respiratory tract in conditions with thick mucus (expectorant).

Ambroxol Stada is indicated for the treatment of mucus dissolution in bronchial and pulmonary conditions with thick mucus in adults, adolescents, and children from 2 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 4-5 days.

2. What you need to know before taking Ambroxol Stada

Do not take Ambroxol Stada:

• If you are allergic to ambroxol hydrochloride or 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 take Ambroxol Stada.

If you have kidney or liver problems, consult your doctor before using Ambroxol Stada.

If you suffer from a rare bronchial disease with increased mucus accumulation (e.g., primary ciliary dyskinesia), where the mucus cannot be transported out of the lungs, take Ambroxol Stada only under medical supervision.

In acute respiratory conditions, if you notice a worsening of symptoms or lack of improvement after 4-5 days of treatment, stop treatment with Ambroxol Stada and consult your doctor immediately.

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

Children

Ambroxol Stada should not be used in children under 2 years of age.

Other medications and Ambroxol Stada

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

No adverse interactions of Ambroxol Stada with other medications are known.

Do not use ambroxol with medications for dry cough.

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, Ambroxol Stada should not be taken during the first trimester of pregnancy.

Ambroxol hydrochloride is excreted in breast milk, so Ambroxol Stada is not recommended during breastfeeding.

Driving and using machines

There are no studies on the effects of Ambroxol Stada on the ability to drive and use machines. However, there is no evidence that this medication affects the ability to drive and use machines.

Ambroxol Stada contains sorbitol

This medication contains 245 mg of sorbitol (E420) per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, consult your doctor before taking this medication.

Ambroxol Stada contains benzoic acid

This medication contains 1.75 mg of benzoic acid per ml. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Ambroxol Stada contains propylene glycol

This medication contains 1.59 mg of propylene glycol per ml. If your baby is under 4 weeks of age, consult your doctor or pharmacist, especially if your baby has been given other medications that contain propylene glycol or alcohol.

3. How to take Ambroxol Stada

Follow the instructions for administration of the medication contained in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years

5 ml, 3 times a day for 2-3 days

then:

5 ml, 2 times a day.

Children from 6 to 12 years

2.5 ml, 2-3 times a day

Children from 2 to 5 years

1.25 ml, 3 times a day

Children under 2 years

Ambroxol Stada should not be used in children under 2 years of age.

Method of administration

To facilitate the administration of the syrup, the package contains a measuring spoon.

Ambroxol Stada can be taken with or without food.

Duration of use

Treatment should not exceed 4-5 days without consulting a doctor.

If you take more Ambroxol Stada than you should

No cases of overdose with Ambroxol Stada are known.

According to reports of accidental overdose and/or medication errors, the observed symptoms are consistent with the side effects of Ambroxol Stada when taken at the recommended dose, and symptomatic treatment may be necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Ambroxol Stada

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking Ambroxol Stada immediately and consult your doctor:

Unknown frequency (cannot be estimated from available data)

• anaphylactic reactions including anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue swelling) and pruritus
• severe adverse skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)

Other side effects that may occur:

Frequent (may affect up to 1 in 10 people):

• nausea
• decreased sensitivity of the mouth and throat (hypoesthesia)
• altered sense of taste

Uncommon (may affect up to 1 in 100 people):

• vomiting, diarrhea, dyspepsia, abdominal pain
• dry mouth
• fever
• mucous membrane reactions

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

• hypersensitivity reactions
• exanthema, urticaria
• throat dryness

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ambroxol Stada

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

Do not use this medication after the expiration date stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Shelf life after first opening: 6 months.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Ambroxol Stada

• The active ingredient is ambroxol hydrochloride. Ambroxol Stada contains 30 mg of ambroxol hydrochloride per 5 ml of syrup.

Each ml of Ambroxol Stada contains 6 mg of ambroxol hydrochloride.

• The other ingredients are: Hydroxyethylcellulose, Sorbitol liquid (non-crystallizing) (E420), Glycerol (85 percent) (E422), Benzoic acid (E210), Acesulfame potassium, Strawberry flavor (Propylene glycol (E1520), Glycerol, 2-ethyl-3-hydroxy-4-pyron, Ethyl lactate, Methyl cinnamate, Butyric acid, 2-methylbutyric acid, Hexanoic acid, Butanedione), Vanilla flavor (Caramel color (E150d), Propylene glycol (E1520)) and Purified water.

Appearance of the product and package contents

Ambroxol Stada is a clear, almost colorless, slightly viscous syrup presented in a brown glass type III bottle with a white polyethylene tamper-evident cap and a child-resistant closure system.

It is available in the following sizes: 100 ml, 125 ml, 200 ml, or 250 ml of syrup.

Not all package sizes may be marketed.

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel, Germany

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna, Austria

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16, Mortágua

3450-232, Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

AT Ambroxol Stada 30 mg/5 ml Syrup

DE Ambroxolhydrochlorid AL 30 mg/5 ml Syrup

ES Ambroxol Stada 6 mg/ml Oral Solution

Date of last revision of this leaflet: March 2019

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