Package leaflet: Information for the patient

Salbutamol Hasco
2 mg/5 ml, syrup
Salbutamolum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

What Salbutamol Hasco is and what it is used for
Important information before taking Salbutamol Hasco
How to take Salbutamol Hasco
Possible side effects
How to store Salbutamol Hasco
Contents of the pack and other information

1. What Salbutamol Hasco is and what it is used for

Salbutamol Hasco is a bronchodilator. Its mechanism of action involves stimulating specific receptors, resulting in relaxation of bronchial smooth muscles.
Salbutamol Hasco is indicated for bronchospasm in bronchial asthma and reversible airway obstruction.

2. Important information before using Salbutamol Hasco

When not to use Salbutamol Hasco

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Salbutamol syrup should not be used to prevent threatened miscarriage
(bleeding during the first half of pregnancy) or to prevent premature labour,
even though salbutamol is used in these conditions in other forms (i.e. intravenous
or occasionally in tablet form).

Warnings and precautions

Before starting treatment with Salbutamol Hasco, discuss this with your doctor.

Special caution is required when using Salbutamol Hasco:

in patients with severe asthma who are simultaneously taking other medications for asthma and/or arterial hypertension, because tissue and organ hypoxia and concomitant use of other drugs such as xanthine derivatives (e.g. theophylline), glucocorticosteroids (anti-inflammatory drugs), or diuretics may exacerbate hypokalaemia (low potassium levels in blood). In such cases, the doctor should recommend monitoring serum potassium levels;
in patients with severe or unstable asthma (e.g. frequent asthma symptoms or exacerbations, or reduced physical performance) who are using salbutamol as the sole or main treatment, the doctor should consider adding anti-inflammatory therapy – oral and/or inhaled corticosteroids at maximum recommended doses;
in patients with hyperthyroidism;
in patients with diabetes, because the drug may cause transient metabolic disturbances such as increased blood glucose levels. This may lead to ketoacidosis (acid-base imbalance). Concomitant use of salbutamol and corticosteroids may intensify this effect;
in patients with concomitant severe heart disease, because there have been reports of rare cases of myocardial ischaemia associated with salbutamol use. Patients with concomitant severe heart disease (e.g. ischaemic heart disease, cardiac arrhythmias, or severe heart failure) who are taking salbutamol should consult their doctor if chest pain or other symptoms (including dyspnoea) suggestive of worsening heart disease occur.

If the response to the previously used dose has decreased or the previously observed duration of action has shortened, do not increase the dose or frequency of administration; instead, consult your doctor immediately.

Salbutamol Hasco with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not use salbutamol together with non-selective beta-adrenolytic agents, such as propranolol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the foetus.

Salbutamol is likely to pass into breast milk. If treatment with this medicine is necessary, breastfeeding should be discontinued.

Driving and operating machinery

There is no data available on the effect of salbutamol on the ability to drive vehicles or operate machinery.

Salbutamol Hasco contains sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine. 5 ml of syrup contains 1.92 g of sucrose. This should be taken into account in diabetic patients.

Salbutamol Hasco contains sodium benzoate

5 ml of syrup contains 6 mg of sodium benzoate.

Salbutamol Hasco contains carmine and brilliant black

The medicine may cause allergic reactions.

3. How to use Salbutamol Hasco

This medicine should always be used exactly as directed by your doctor or pharmacist. In case of doubt,
please consult your doctor or pharmacist.
Oral administration.
Recommended dose
Adults and adolescents over 12 years of age: 10 ml of syrup 3 to 4 times daily.
Use in children
Children aged 6 to 12 years: 5 ml of syrup 3 to 4 times daily.
Children aged 2 to 6 years: 2.5 to 5 ml of syrup 3 to 4 times daily.
A measuring device is provided with the package.
Taking more than the recommended dose of Salbutamol Hasco
If you take more than the recommended dose, seek medical advice immediately.
Salbutamol overdose may cause life-threatening reduction in blood potassium levels; therefore,
monitoring of blood potassium levels is necessary.
Missing a dose of Salbutamol Hasco
Do not take a double dose to make up for a missed dose.
Stopping Salbutamol Hasco
Do not stop taking salbutamol without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone experiences them.
Very common (affects more than 1 in 10 patients): muscle tremor.
Common (affects 1 to 10 patients in 100): headache, tachycardia (increased heart rate), palpitations, muscle cramps.
Rare (affects 1 to 10 patients in 10,000): decreased blood potassium levels, cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles), peripheral blood vessel dilation.
Very rare (affects less than 1 in 10,000 patients): excessive excitability, muscle weakness, hypersensitivity reactions, including angioedema (swelling, mainly of the face, lips, tongue or throat, causing difficulty in breathing or swallowing), urticaria, bronchospasm, hypotension and collapse (acute circulatory failure associated with a sudden drop in blood pressure, manifested by severe weakness, often with loss of consciousness).
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Frequency not known (cannot be estimated from available data): myocardial ischaemia.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: 22 49 21 301, Fax: 22 49 21 309
E-mail: [email protected]
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Salbutamol Hasco

Store below 25°C, in the original packaging, to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Salbutamol Hasco contains

The active substance is salbutamol. 5 ml of syrup contains 2 mg of salbutamol in the form of salbutamol sulfate.
The other ingredients (excipients) are: sucrose, monohydrate citric acid, sodium benzoate, carmine red (E 124), brilliant black (E 151), strawberry flavour, purified water.

What Salbutamol Hasco looks like and contents of the pack
Red-coloured syrup.
The pack contains 100 ml of syrup in a glass bottle with a cardboard carton. A measuring device is included in the pack.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicines Information
tel. 22 742 00 22
e-mail: [email protected]
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