Label:information for theuser

ALDOBRONQUIAL 2mg/5 mlsyrup

Salbutamol (sulfate)

Read this label carefully before startingto takethis medication, because it contains important information for you.

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

1. What isALDOBRONQUIAL 2mg/5 ml syrupand what is it used for

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

3. How totakeALDOBRONQUIAL 2mg/5 ml syrup

4. Possible side effects

5. Storage ofALDOBRONQUIAL 2mg/5 ml syrup

6. Contents of the container and additional information

ALDORONQUIALsyrup contains salbutamol as its active ingredient. It belongs to a group of medicines called bronchodilators.

ALDOBRONQUIAL syrup is indicated for the prevention and symptomatic treatment of bronchial spasm (closure of airways in the lungs) associated with asthma attacks and in processes associated with reversible obstruction of the respiratory tract. These are a group of lung diseases that cause inflammation of the respiratory tract, resulting in a blockage of airflow in the lungs.

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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 heart rhythm, 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 that this medication may cause 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 have not been adequately demonstrated in children under 2 years.

Use in athletes

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

Taking ALDOBRONQUIAL syrup with other medications

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

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

Pregnancy, breastfeeding, 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.

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 suspend treatment before.

If your doctor has diluted your ALDOBRONQUIAL syrup, the resulting mixture must be protected from light and must be 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 the one 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 exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor regarding the amount you should take and how often.DO NOT TAKE more than what has been indicated. In case of doubt, ask your doctor.

If you estimate that the action 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 Toxicological 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 service of the nearest hospital. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

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

If you forgot to take ALDOBRONQUIAL syrup

Do not take a double dose to compensate for the missed doses.If you forget to take a dose, take another as soon as you remember, but if it is close to the time to take the next dose, wait until it is time.

Like all medications,ALDOBRONQUIALsyrup may cause side effects, although not everyone will experience them.

The following side effects associated with salbutamol are classified by organ, system, and frequency. Frequencies have been defined as follows: very common (affecting 1 or more in 10 people), common (affecting 1 in 100 to 10 in 100 people), uncommon (affecting 1 in 1000 to 10 in 1000 people), rare (affecting 1 in 10,000 to 10 in 10,000 people), and very rare (affecting fewer than 1 in 10,000 people), including isolated reports. Very common, common, and uncommon reactions have been identified from clinical trial data. Rare and very rare events come from spontaneously reported data..

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 entry), hypotension, and collapse.

Metabolism and nutrition disorders

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

Therapy with β2 agonists (cardioselective β-blockers) 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 tells you to.

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

Vascular disorders

Rare: Peripheral vasodilation (dilation of peripheral blood vessel size).

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 do not appear in this prospectus.

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

No special storage conditions are required.

Expiration Date

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

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

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 contents of the package

ALDOBRONQUIAL syrupisan odorless and transparent liquid with an orange odor, which is presented in a 100 ml container, provided with a dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldà, 73

08950 Esplugues de Llobregat (Barcelona) SPAIN

Date of the last review of this leaflet:in May 2013

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/