ALDOBRONQUIAL 2 mg/5 ml SYRUP

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 any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take ALDOBRONQUIAL syrup:

• If you have a thyroid disease (hyperthyroidism)
• If you have a history of heart disease, irregular heartbeat, or angina pectoris
• If you have high blood pressure (hypertension)
• If you have acute asthma. This medication may cause a decrease in potassium levels, which could be increased by hypoxia (low oxygen)
• The decrease in potassium levels caused by this medication could be increased by other medications used to treat asthma
• If you are diabetic. This medication may increase blood glucose levels

Children and adolescents

The efficacy and safety of ALDOBRONQUIAL syrup have not been adequately demonstrated in children under 2 years of age.

Use in athletes

This medication contains salbutamol, which may produce a positive result in doping tests.

Taking ALDOBRONQUIAL syrup with other medications

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

Do not administer concurrently with non-cardioselective beta-blockers, such as propranolol or similar medications. Non-cardioselective beta-blockers are used to treat high blood pressure (hypertension), abnormal heart rhythm (arrhythmia), chest pain (angina pectoris), to prevent migraines, and topically to treat glaucoma. Beta-blockers are sometimes administered to patients who have suffered a heart attack to prevent further attacks.

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.

It should only be used during pregnancy or breastfeeding if the potential benefit clearly outweighs the potential risk.

Driving and using machines

The influence of ALDOBRONQUIAL syrup on the ability to drive and use machines is negligible or insignificant.

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

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with ALDOBRONQUIAL syrup. Do not stop treatment before then.

If your doctor has diluted your ALDOBRONQUIAL syrup, the resulting mixture should 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 a day.

Use in children and adolescents

Two to six years: the recommended dose is 2.5 ml to 5 ml (1 to 2 mg) three or four times a day.

Six to twelve years: the recommended dose is 5 ml (2 mg) three or four times a day.

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

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

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

For children, elderly people, and those with marked sensitivity to this medication, it is recommended to start treatment with 5 ml of ALDOBRONQUIAL syrup (2 mg) three or four times a day.

IT IS VERY IMPORTANT that you follow the administration instructions for this medication exactly as contained in this leaflet or as indicated by your doctor regarding the amount you should take and how often. DO NOT TAKE more than indicated. If you are unsure, ask your doctor.

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

If you take more ALDOBRONQUIAL syrup than you should

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

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

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

If you forget to take ALDOBRONQUIAL syrup

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take another as soon as you remember, but if it is almost time for your next dose, wait until then.

4. Possible side effects

Like all medications, ALDOBRONQUIAL syrup can cause side effects, although not everyone will experience them.

The following side effects are associated with salbutamol, classified by organ, system, and frequency. The frequencies have been defined as follows: very common (affect 1 or more out of 10 people), common (affect 1 to 10 out of 100 people), uncommon (affect 1 to 10 out of 1000 people), rare (affect 1 to 10 out of 10,000 people), and very rare (affect less than 1 out of 10,000 people), including isolated reports. The very common, common, and uncommon side effects have been identified from clinical trial data. The rare and very rare events come from spontaneous reports.

Immune system disorders

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

Metabolic and nutritional disorders

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

Therapy with beta-2 agonists may lead to potentially severe hypokalemia.

Nervous system disorders

Very common: Tremor

Common: Headaches.

Very rare: Hyperactivity.

Cardiac disorders

Common: Tachycardia (increased heart rate), palpitations.

Rare: Cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and extrasystoles (heart rhythm disorders).

Unknown: Myocardial ischemia* (see section 2).

Although the exact frequency is unknown, some people 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 medication unless your doctor indicates so.

*Spontaneous reports of post-marketing data, so the 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: Muscle tension sensation

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

5. Storage of ALDOBRONQUIAL 2mg/5 ml syrup

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Expiry date

Do not use this medication after the expiry date stated on the bottle after EXP. The expiry date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of ALDOBRONQUIAL 2mg/5 ml syrup

• The active ingredient 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 package contents

ALDOBRONQUIAL syrup is a colorless and transparent liquid with an orange odor, presented in a 100 ml bottle 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 last revision of this leaflet:May 2013

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