Ambroxol Stada 6 mg/ml syrup EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ambroxol Stada 6 mg/ml syrup EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ambroxol Stada is and what it is used for
2. What you need to know before taking Ambroxol Stada
3. How to take Ambroxol Stada
4. Possible adverse effects
5. How to store Ambroxol Stada
6. Contents of the pack and other information

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

Ambroxol Stada contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics. It is used to facilitate the removal of mucus from the respiratory tract in conditions associated 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 condition worsens or does not improve after 4–5 days.

2. What you need to know before starting to take/use Ambroxol Stada

Do not take Ambroxol Stada:

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

If you have kidney or liver function 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). In this case, mucus cannot be transported out of the lungs. Therefore, take Ambroxol Stada only under medical supervision.

In acute respiratory conditions, if symptoms worsen or there is no improvement after 4–5 days of treatment, stop treatment with Ambroxol Stada and consult your doctor immediately.

Serious skin reactions have been reported following administration of ambroxol hydrochloride. If you develop a skin rash (including lesions of mucous membranes such as in the mouth, throat, nose, eyes, and genitals), stop using Ambroxol Drehm and consult your doctor immediately.

Children

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

Other medicines and Ambroxol Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No adverse interactions between Ambroxol Stada and other medicines are known.

Do not use ambroxol with cough suppressants (antitussives) for dry cough.

Pregnancy, breastfeeding and fertility

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

No harmful 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; therefore, 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 or operate machinery. However, there is no evidence suggesting that this medicine may affect the ability to drive or use machines.

Ambroxol Stada contains sorbitol

This medicine contains 245 mg of sorbitol (E420) per ml. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Ambroxol Stada contains benzoic acid

This medicine 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 medicine contains 1.59 mg of propylene glycol per ml. If your baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

3. How to take Ambroxol Stada

Follow exactly the instructions for taking the medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, 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 must not be used in children under 2 years of age.

Method of administration

To facilitate syrup administration, the package includes a measuring spoon.

Ambroxol Stada may be taken with or without food.

Duration of use

Treatment must not exceed 4–5 days without consulting a doctor.

If you take more Ambroxol Stada than you should

There are no known cases of poisoning with Ambroxol Stada.

According to reports of accidental overdose and/or medication errors, 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Ambroxol Stada

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Not known (frequency cannot be estimated from available data)

• anaphylactic reactions including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissues, mucous membranes or submucosal tissues), and pruritus
• serious cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Other possible adverse effects:

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
• mucosal membrane reactions

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

• hypersensitivity reactions
• rash, urticaria
• sore throat

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambroxol Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container label and the carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Expiry after first opening: 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in any doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambroxol Stada

• The active substance is ambroxol hydrochloride. Ambroxol Stada contains 30 mg of ambroxol hydrochloride in each 5 ml of syrup.

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

• The other components are: Hydroxyethylcellulose, Liquid sorbitol (non-crystallizing) (E420), Glycerol (85 percent) (E422), Benzoic acid (E210), Potassium acesulfame, Strawberry flavour (Propylene glycol (E1520), Glycerol, 2-ethyl-3-hydroxy-4-pyrone, Ethyl lactate, Methyl cinnamate, Butyric acid, 2-methylbutyric acid, Hexanoic acid, Butanedione), Vanilla flavour (Caramel colour (E150d), Propylene glycol (E1520)), and Purified water.

Appearance of the product and contents of the pack

Ambroxol Stada is a clear, practically colourless, slightly viscous syrup presented in an amber glass type III bottle with a white polyethylene child-resistant closure and a tamper-evident system.

It is available in pack sizes of 100 ml, 125 ml, 200 ml or 250 ml of syrup.

Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

AT Ambroxol Stada 30 mg/5 ml Sirup

DE Ambroxolhydrochlorid AL 30 mg/5 ml Sirup

ES Ambroxol Stada 6 mg/ml syrup EFG

Date of the most recent revision of this leaflet: March 2019

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