Salbutamol Vzf

Leaflet attached to the packaging: patient information

SALBUTAMOL WZF 2 mg tablets

SALBUTAMOL WZF 4 mg tablets

Salbutamol

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 WZF and what is it used for
• 2. Important information before taking Salbutamol WZF
• 3. How to take Salbutamol WZF
• 4. Possible side effects
• 5. How to store Salbutamol WZF
• 6. Contents of the packaging and other information

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

Salbutamol WZF belongs to a group of medicines called beta-adrenergic agonists. It causes relaxation of the bronchial muscles and airways.
Salbutamol WZF is used:

• in asthma;
• in bronchospasm and (or) reversible obstructive airway disease.

Salbutamol WZF is indicated for use in adults and children aged 6 years and older.

2. Important information before taking Salbutamol WZF

When not to take Salbutamol WZF

• If the patient is allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6).
• Although salbutamol in the form of a solution for injection is used in preterm labor without complications, it should not be used in threatened abortion.

Warnings and precautions

Before starting treatment with Salbutamol WZF, the patient should discuss it with their doctor or pharmacist.

When to exercise special caution when taking Salbutamol WZF

• If the patient has any of the following health problems, they should inform their doctor before taking the medicine:
• heart disease and circulatory disorders (symptoms such as chest pain, heart failure, rapid or irregular heartbeat, shortness of breath, high blood pressure, rapid pulse),
• hyperthyroidism,
• epilepsy,
• diabetes (elevated blood sugar levels).
• In elderly patients.
• If Salbutamol WZF is used as the only or primary medicine in patients with severe or unstable asthma, as there is a risk of a severe asthma attack.
• If the patient experiences any symptoms of an allergic reaction, such as bronchospasm, throat swelling, or a rash, during treatment with Salbutamol WZF, they should contact their doctor immediately - see section 4. "Possible side effects".
• Do not increase the dose or frequency of administration of the medicine without consulting a doctor.

Children

When using high doses of salbutamol, caution should be exercised. If side effects occur, discontinue the medicine and consult a doctor.

Salbutamol WZF and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Salbutamol WZF should not be taken at the same time as other bronchodilator medicines taken orally or intravenously, as this may cause severe side effects on the cardiovascular system, such as rapid or irregular heartbeat.
• Salbutamol WZF can only be taken after consulting a doctor:
• with medicines used to treat irregular or rapid heartbeat (such as digoxin);
• with beta-adrenergic blocking agents (such as atenolol or propranolol), including eye drops (e.g., timolol), as this may cause bronchospasm in patients with asthma;
• with xanthine derivatives (e.g., theophylline or aminophylline);
• with diuretics, especially those that cause potassium loss, such as furosemide;
• with corticosteroids (e.g., prednisolone);
• with medicines used to lower blood sugar levels in diabetes (e.g., insulin, metformin, or glibenclamide);
• with monoamine oxidase inhibitors and tricyclic antidepressants;
• with other bronchodilator medicines in the form of inhalations.
• If the patient is taking Salbutamol WZF and digoxin (a heart medicine), the doctor may recommend monitoring digoxin levels in the blood.

In the event of a planned surgical procedure with general anesthesia, the doctor should discontinue Salbutamol WZF 6 hours before the procedure, if possible, to protect the patient from side effects (e.g., irregular heartbeat).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
The medicine can inhibit uterine contractions and may make delivery more difficult.
The doctor may recommend using Salbutamol WZF during pregnancy only if the benefits to the mother outweigh the potential risks to the fetus.
Salbutamol is likely to pass into breast milk. If the medicine is necessary, the patient should stop breastfeeding.

Driving and operating machinery

There is no data on the effect of salbutamol on driving or operating machinery.

Salbutamol WZF contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

3. How to take Salbutamol WZF

This medicine should always be taken as directed by the doctor. If there are any doubts, the patient should consult their doctor or pharmacist.
Usually, the following doses are used:
Adults and children over 12 years old
Initial dose: 2 mg to 4 mg, up to three to four times a day.
If necessary, the initial dose can be repeated, but at least 6 hours should be allowed between doses. If the effect of these doses is insufficient, they can be gradually increased, but the dose should not exceed 8 mg four times a day.
If side effects occur during dose increases, the medicine should be discontinued.
Single doses greater than 4 mg should only be used if there is no response to lower doses.
Elderly patients and those with increased sensitivity to this medicine or similar medicines:
Initial dose: 2 mg up to four times a day.
If the effect is insufficient, the doctor may increase the dose to 8 mg three to four times a day.
The maximum daily dose of Salbutamol WZF is 32 mg.
Children aged 6 to 12 years
Initial dose: 2 mg up to three to four times a day. If necessary, the initial dose can be repeated, but at least 6 hours should be allowed between doses.
If the effect is insufficient, the dose can be gradually increased, but it should not exceed 6 mg four times a day (24 mg). If side effects occur during dose increases, the medicine should be discontinued.

Taking a higher dose of Salbutamol WZF than recommended

After taking a higher dose than recommended, the following may occur: chest pain, convulsions, increased or decreased blood pressure, rapid or irregular heartbeat, nervousness, headache, dizziness, tremors, dry mouth, nausea, and insomnia. The patient should stop taking the medicine and consult their doctor immediately.
If it has been less than an hour since taking the medicine, the doctor may perform gastric lavage. If necessary, the doctor will provide appropriate treatment.

Missing a dose of Salbutamol WZF

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Salbutamol WZF

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Salbutamol WZF can cause side effects, although not everybody gets them.
If the patient experiences the first symptoms of hypersensitivity (e.g., facial swelling, lip swelling, tongue swelling, throat swelling, causing difficulty breathing or swallowing, bronchospasm, acute circulatory failure), they should contact their doctor immediately. Such symptoms are very rare.
Very common (more than 1 in 10 people):

• tremors.

Common (less than 1 in 10 people):

• headache;
• rapid heartbeat (tachycardia), palpitations;
• muscle cramps.

Uncommon (less than 1 in 100 people):

• decreased potassium levels in the blood (hypokalemia);
• peripheral vasodilation.

Rare (less than 1 in 1,000 people):

• heart rhythm disorders (including irregular heartbeat, rapid heartbeat, and extra heartbeats);
• hyperactivity;
• muscle stiffness;
• hives.

Very rare (less than 1 in 10,000 people):

Chest pain (related to heart disease such as angina) may occur in some people. If such symptoms occur, the patient should not stop taking the medicine abruptly but should consult their doctor as soon as possible.
Frequency not known (frequency cannot be estimated from the available data):

• increased blood sugar and (or) lactic acid levels;
• decreased blood pressure, which may cause dizziness or lightheadedness;
• fluid accumulation in the lungs (pulmonary edema), which may cause difficulty breathing;
• sudden flushing of the face;
• hypotension.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Salbutamol WZF

Store in a temperature below 25°C.
Store blisters in the outer packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Salbutamol WZF contains

• The active substance of the medicine is salbutamol in the form of salbutamol sulfate. Each tablet contains 2 mg or 4 mg of salbutamol.
• The other ingredients are: cornstarch, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

What Salbutamol WZF looks like and what the packaging contains

Salbutamol WZF 2 mg is a white, round, flat tablet with a notch on one side and the letter "S" below it.
The packaging contains 30 tablets in 2 blisters of 15 tablets each, placed in a cardboard box.
Salbutamol WZF 4 mg is a white, round, flat tablet with a notch and the number "4" above it and the letter "S" below it.
The packaging contains 25 tablets in 1 blister, placed in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of the last update of the leaflet:December 2024