Salbutamol Hasco

Leaflet attached to the packaging: patient information

Salbutamol Hasco

2 mg/5 ml, syrup

Salbutamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Salbutamol Hasco and what is it used for
• 2. Important information before taking Salbutamol Hasco
• 3. How to take Salbutamol Hasco
• 4. Possible side effects
• 5. How to store Salbutamol Hasco
• 6. Package contents and other information

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

Salbutamol Hasco is a bronchodilator. Its mechanism of action involves stimulating specific receptors, leading to the relaxation of smooth muscle in the bronchi. The indications for using Salbutamol Hasco include bronchial spasm in asthma and reversible airway obstruction.

2. Important information before taking Salbutamol Hasco

When not to take Salbutamol Hasco

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

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

Warnings and precautions

Before starting to take Salbutamol Hasco, discuss it with your doctor.
1/4
Particular caution should be exercised when taking Salbutamol Hasco:

• in patients with severe asthma, taking other asthma medications and/or antihypertensive medications at the same time, as tissue and organ hypoxia and concurrent use of other medications, such as xanthine derivatives (e.g., theophylline), glucocorticosteroids (anti-inflammatory medications), and diuretics, may exacerbate hypokalemia (decreased potassium levels in the blood). In such situations, the doctor should recommend monitoring potassium levels in the serum,
• in patients with severe or unstable asthma (e.g., if symptoms of asthma occur frequently or worsen, or if physical fitness is reduced) taking salbutamol as the only or primary medication, the doctor should consider concurrent use of anti-inflammatory medications - oral corticosteroids and/or inhaled corticosteroids in the maximum recommended doses,
• in patients with hyperthyroidism,
• in patients with diabetes, as the medication may cause transient metabolic disorders, such as increased glucose levels in the blood. This may lead to ketoacidosis (acid-base imbalance). Concurrent use of salbutamol and corticosteroids may enhance this effect,
• in patients with concomitant severe heart disease, as there have been reports of rare cases of myocardial ischemia associated with the use of salbutamol. Patients with concomitant severe heart disease (e.g., coronary artery disease, arrhythmias, or severe heart failure) taking salbutamol should consult their doctor if they experience chest pain or other symptoms (including shortness of breath) suggesting worsening of heart disease.

If the response to the previously used dose has decreased or the previously observed duration of action of the medication has shortened, the dose should not be increased, nor should the frequency of administration be increased, but rather the patient should immediately consult their doctor.

Salbutamol Hasco and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Do not take salbutamol concurrently with non-selective beta-adrenergic blockers, such as propranolol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.
The medication may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Salbutamol is likely to pass into breast milk. If the medication is necessary, the patient should stop breastfeeding.

Driving and operating machinery

There are no data on the effect of salbutamol on the ability to drive and operate machinery.

Salbutamol Hasco contains sucrose

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

Salbutamol Hasco contains sodium benzoate

2/4
5 ml of syrup contains 6 mg of sodium benzoate.

Salbutamol Hasco contains Ponceau 4R and Brilliant Black

The medication may cause allergic reactions.

3. How to take Salbutamol Hasco

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Oral administration.

Recommended dose

Adults and adolescents over 12 years: 10 ml of syrup 3 to 4 times a day.

Use in children

Children from 6 to 12 years: 5 ml of syrup 3 to 4 times a day.
Children from 2 to 6 years: 2.5 to 5 ml of syrup 3 to 4 times a day.
A measuring cup is included with the packaging.

Taking a higher dose of Salbutamol Hasco than recommended

In case of taking a higher dose of the medication than recommended, consult your doctor immediately.
Overdose of salbutamol may cause life-threatening hypokalemia, so it is necessary to monitor potassium levels in the blood.

Missing a dose of Salbutamol Hasco

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

Stopping treatment with Salbutamol Hasco

Do not stop taking salbutamol without consulting your doctor.
If you have any further doubts about taking this medication, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Salbutamol Hasco can cause side effects, although not everybody gets them.
Very common (more than 1 in 10 patients):muscle tremors.
Common (between 1 in 10 and 1 in 100 patients):headaches, tachycardia (increased heart rate), palpitations, muscle cramps.
Uncommon (between 1 in 100 and 1 in 1,000 patients):decreased potassium levels in the blood, arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles), peripheral vasodilation.
Rare (between 1 in 1,000 and 1 in 10,000 patients):excessive nervousness, muscle weakness, hypersensitivity reactions, including angioedema (swelling, mainly of the face, lips, tongue, or throat, causing difficulty breathing or swallowing), urticaria, bronchospasm, decreased blood pressure, and collapse (a state of acute circulatory failure associated with a sudden drop in blood pressure, characterized by severe weakness, often with loss of consciousness).
Frequency not known (cannot be estimated from the available data):myocardial ischemia.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Salbutamol Hasco

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

6. Package contents and other information

What Salbutamol Hasco contains

• The active substance of the medication is salbutamol. 5 ml of syrup contains 2 mg of salbutamol in the form of salbutamol sulfate.
• The other ingredients (excipients) are: sucrose, citric acid monohydrate, sodium benzoate, Ponceau 4R (E 124), Brilliant Black (E 151), strawberry flavor, purified water.

What Salbutamol Hasco looks like and what the packaging contains

A red-colored syrup.
The medication packaging contains 100 ml of syrup in a glass bottle and a cardboard box. A measuring cup is included with the packaging.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medication information

tel. 22 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet:

4/4