Package Insert: Information for the Patient

Ambroxol Stada 6 mg/ml Syrup EFG

Read this entire package insert carefully before starting to take 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 other people, 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. See section 4.

1. What is Ambroxol Stada and how is it used

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

3. How to take Ambroxol Stada

4. Possible adverse effects

5. Storage of Ambroxol Stada

6. Contents of the package and additional information

Ambroxol Stada contains the active ingredient 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 with thick mucus (expectorant).

Ambroxol Stada is indicated for the treatment of mucus dissolution in conditions of the bronchi and lungs with thick mucus in adults, adolescents, and children aged 2 years and above.

Consult a doctor if symptoms worsen or do not improve after 4-5 days.

Do not take Ambroxol Stada:

• If you are allergic to ambroxol hydrochloride or any of the other ingredients 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 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, only take Ambroxol Stada under the supervision of a doctor.

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

Severe skin reactions have been reported associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions, for example, in 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

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

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

Do not use ambroxol with dry cough medications.

Pregnancy,Lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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, so Ambroxol Stada is not recommended during breastfeeding.

Driving and operating machines

No studies have been conducted on the effects of Ambroxol Stada on the ability to drive and operate machines. However, there is no evidence of effects that this medication may have on the ability to drive and operate machines.

Ambroxol Stada contains sorbitol

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

Ambroxol Stada contains benzoic acid

This medication contains 1.75 mg of benzoic acid in each 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 in each ml. If your baby is under 4 weeks of age, consult your doctor or pharmacist, particularly if the baby has been given other medications containing propylene glycol or alcohol.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years old

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

then:

5 ml, 2 times a day.

Children aged 6 to 12 years

2.5 ml, 2-3 times a day

Children aged 2 to 5 years

1.25 ml, 3 times a day

Children under 2 years old

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

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

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

If you takemore Ambroxol Stada than you should

No cases of intoxication with Ambroxol Stada have been reported.

According to reports of accidental overdose and/or medication errors, the symptoms observed 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Ambroxol Stada

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Unknown (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
• Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute pustular exanthema)

Other adverse effects that may occur:

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

• Nausea
• Decreased sensitivity of the mouth and throat (hypoaesthesia)
• Alteration of taste

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

• Vomiting, diarrhea, indigestion, abdominal pain
• Dry mouth
• Fever
• Mucous membrane reactions

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

• Hypersensitivity reactions
• Rash, urticaria
• Throat dryness

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 Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging label and on the case after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Expiration after the first opening: 6 months.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 components are: Hydroxyethylcellulose, Liquid Sorbitol (non-crystallizing) (E420), Glycerol (85 percent) (E422), Benzoic acid (E210), Potassium acesulfame, Strawberry flavor (Propylene glycol (E1520), Glycerol, 2-ethyl-3-hydroxy-4-pyrone, 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 contents of the packaging

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

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

Not all packaging sizes may be marketed.

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

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 medicine is authorized in the Member States of the European Economic Area with the following names:

ATAmbroxol Stada 30 mg/5 ml Syrup

DEAmbroxolhydrochlorid AL 30 mg/5 ml Syrup

ESAmbroxol Stada 6 mg/ml syrup EFG

Last review date of this leaflet: March 2019

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