Aldobronquial 2 mg/5 ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ALDOBRONQUIAL 2mg/5 ml syrup

Salbutamol (sulphate)

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, consult your doctor, pharmacist, or nurse.
• 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ALDOBRONQUIAL 2mg/5 ml syrup is and what it is used for

ALDOBRONQUIAL syrup contains as its active substance salbutamol. It belongs to a group of medicines called bronchodilators.

ALDOBRONQUIAL syrup is indicated for the prevention and symptomatic treatment of bronchospasm (airway narrowing in the lungs) associated with asthma attacks and in conditions involving reversible obstruction of the airways. These are a group of lung diseases that cause inflammation of the airways, resulting in blockage of airflow in the lungs.

2. What you need to know before starting to take ALDOBRONQUIAL 2mg/5 ml syrup

Do not take ALDOBRONQUIAL syrup

• if you are allergic to salbutamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking ALDOBRONQUIAL syrup:

• If you have a thyroid disorder (hyperthyroidism)
• If you have a history of heart disease, irregular heartbeat, or chest pain (angina)
• If you have high blood pressure (hypertension)
• If you are suffering from acute asthma. This medicine may reduce potassium levels, which could be exacerbated by hypoxia (low oxygen)
• The reduction in potassium levels caused by this medicine may be increased when used together with other drugs used to treat asthma
• If you are diabetic. This medicine may increase blood glucose levels

Children and adolescents

The efficacy and safety of this medicine have not been adequately established in children under 2 years of age.

Use in athletes

This medicine contains salbutamol, which may result in a positive doping test.

Taking ALDOBRONQUIAL syrup with other medicines

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

Do not administer concurrently with non-cardioselective β-blockers, such as propranolol or similar agents. Non-cardioselective β-blockers are used to treat high blood pressure (hypertension), abnormal heart rhythm (arrhythmia), chest pain (angina), for migraine prevention, and topically to treat glaucoma. β-blockers are sometimes given to patients who have had a heart attack to prevent further attacks.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should only be used during pregnancy or breast-feeding if the potential benefit clearly outweighs the potential risk.

Driving and using machines

The effect of ALDOBRONQUIAL syrup on the ability to drive and operate machinery is negligible or none.

3. How to take ALDOBRONQUIAL 2mg/5 ml syrup

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long your treatment with ALDOBRONQUIAL syrup should last. Do not stop the treatment prematurely.

If your doctor has diluted your ALDOBRONQUIAL syrup, the resulting mixture must be protected from light and used within 28 days.

Adults

The recommended dose is 5 ml to 10 ml (2 to 4 mg) administered three or four times daily.

Use in children and adolescents

Ages two to six years: the recommended dose is 2.5 ml to 5 ml (1 to 2 mg) three or four times daily.

Ages six to twelve years: the recommended dose is 5 ml (2 mg) three or four times daily.

Over twelve years: the recommended dose is 5 ml to 10 ml (2 to 4 mg) administered three or four times daily.

Your doctor may have prescribed a higher dose than the one recommended above.

ALDOBRONQUIAL syrup is suitable for adults and children who prefer to take liquid medication.

For children, elderly patients, and those who are particularly sensitive to this medicine, it is recommended to start treatment with 5 ml of ALDOBRONQUIAL syrup (2 mg) three or four times daily.

IT IS VERY IMPORTANT THAT YOU FOLLOW EXACTLY THE DOSING INSTRUCTIONS FOR THIS MEDICINE PROVIDED IN THIS LEAFLET OR AS INDICATED BY YOUR DOCTOR, REGARDING THE AMOUNT TO TAKE AND HOW OFTEN. DO NOT TAKE MORE THAN YOU HAVE BEEN TOLD. IF IN DOUBT, ASK YOUR DOCTOR.

If you think that the effect of ALDOBRONQUIAL syrup is too strong or too weak, inform your doctor or pharmacist AS SOON AS POSSIBLE. Your asthma may begin to worsen, and you may need a different type of medication.

If you take more ALDOBRONQUIAL syrup than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

However, if the amount ingested is significant, you should go to the doctor immediately or to the nearest hospital emergency department. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you accidentally take a larger dose than recommended, you are more likely to experience adverse effects such as increased heart rate, headache, tremors, or muscle cramps (see Possible side effects). You must inform your doctor as soon as possible if you have taken more than the recommended dose.

If you forget to take ALDOBRONQUIAL syrup

Do not take a double dose to make up for missed doses. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, wait and take the next dose at the scheduled time.

4. Possible adverse effects

Like all medicines, ALDOBRONQUIAL syrup may cause adverse effects, although not everyone will experience them.

Below are the adverse effects associated with salbutamol, classified by organ system and frequency. Frequencies are defined as follows: very common (affects 1 or more out of every 10 people), common (affects 1 to 10 out of every 100 people), uncommon (affects 1 to 10 out of every 1,000 people), rare (affects 1 to 10 out of every 10,000 people), and very rare (affects fewer than 1 out of every 10,000 people), including isolated case reports. Very common, common, and uncommon reactions have been identified from clinical trial data. Rare and very rare events are derived from spontaneously reported data.

Immune system disorders

Very rare: Hypersensitivity reactions (allergic), including angioedema (skin reactions with redness, swelling, and itching), urticaria, bronchospasm (narrowing of the bronchial walls with reduced airflow), hypotension, and collapse.

Metabolism and nutrition disorders

Rare: Hypokalaemia (low potassium levels in the blood).

Therapy with β2 agonists (cardioselective β-blockers) may lead to potentially serious hypokalaemia.

Nervous system disorders

Very common: Tremor

Common: Headache

Very rare: Hyperactivity

Cardiac disorders

Common: Tachycardia (increased heart rate), palpitations

Rare: Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (abnormal heart rhythms)

Unknown: Myocardial ischaemia* (see section 2)

Although the exact frequency is unknown, some individuals may occasionally experience chest pain (due to heart problems such as angina pectoris). Inform your doctor if you develop these symptoms while being treated with ALDOBRONQUIAL syrup, but do not stop taking this medicine unless instructed by your doctor.

*Spontaneously reported post-marketing data, therefore frequency is classified as unknown.

Vascular disorders

Rare: Peripheral vasodilation (dilation of peripheral blood vessels)

Musculoskeletal and connective tissue disorders

Common: Muscle cramps

Very rare: Feeling of muscle tension

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

5. Storage of ALDOBRONQUIAL 2 mg/5 ml syrup

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Expiry

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

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

6. ADDITIONAL INFORMATION

Composition of ALDOBRONQUIAL 2 mg/5 ml syrup

• The active substance is salbutamol (sulfate). Each 5 ml contains 2 mg of salbutamol (sulfate).
• The other components (excipients) are: sodium benzoate (E-211), hypromellose, sodium saccharin, citric acid, sodium citrate, orange flavor, and purified water.

Appearance of the product and contents of the container

ALDOBRONQUIAL syrup is a colorless and transparent liquid with an orange odor, supplied in a 100 ml container with a dosing cup.

Marketing Authorization Holder and Manufacturer

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldà, 73

08950 Esplugues de Llobregat (Barcelona) SPAIN

Date of the most recent review of this leaflet: May 2013

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