SALBUTAMOL 2mg./5ml syrup. 125 ml.

WHAT SALBUTAMOL SOPHARMA AND WHAT IT IS USED
Sopharma salbutamol syrup is a medicine group of the so called bronchodilators . It provides short-term ( 4-6 hours) bronchodilation by relaxing the smooth muscle of the bronchi , contributes to the expansion of the airways , relieves chest tightness , wheezing and eases breathing.
It is used for alleviating respiratory asthma and other pulmonary diseases. It is suitable for use in children and adults, which are not capable of using inhaled agents.

2 . BEFORE YOU TAKE SALBUTAMOL SOPHARMA
Do not take Salbutamol Sopharma
if you are allergic (hypersensitive ) to the active substance or to any of the ingredients of Salbutamol Sopharma .
Take special care with Salbutamol Sopharma
Medicinal product Salbutamol Sopharma not be used alone or as primary treatment for severe or unstable asthma . Not apply to arrest asthma attacks .

Tell the doctor if you have:
thyroid disease associated with increased its function ;
heart disease , particularly associated with abnormal heart rhythms or angina (chest pain) ;
high blood pressure ;
diabetes .
When athletes possible positive doping test during treatment with salbutamol .

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor if you take:
other medicines used to treat bronchospasm ( sympathomimetics ksantiniteofilin , aminophylline ) ;
corticosteroids ;
water pills ( diuretics) ;
drugs for the treatment of heart failure ( digitalis ) ;
drugs for the treatment of depression ( MAO- inhibitors or tricyclic antidepressants) ;
drugs for the treatment of diseases of the thyroid ( thyroid hormone ) ;
beta- blockers ( propranolol , atenolol , metoprolol ) .
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
Due to insufficient data on safety in pregnant women is not recommended its use to them.
If you are breastfeeding and require treatment with salbutamol , breastfeeding should be discontinued.

Driving and using machines
Sopharma salbutamol can cause tremors, dizziness and weakness, and therefore should be used with caution when driving or operating machinery.

Important information about some of the ingredients of Salbutamol Sopharma
This medicinal product contains 3.84 vol. % Ethanol , ie to 0,155 g of alcohol in a dose of 5 ml, corresponding to 3,84 ml 1,6 ml of beer and wine . Be given to pregnant and lactating women , children and high-risk groups such as patients with liver disease , epilepsy and suffering from alcoholism
This product contains 37,5 g of sucrose. When taken according to the dosage recommendations each dose of 5 ml provide up to 1,5 g sucrose. If your doctor told you that you have an intolerance to some sugars , consult him before taking this medicine .
Syrup contains methyl and propyl para-hydroxybenzoate which may cause allergic reactions (possibly delayed) .

3 . HOW TO TAKE SALBUTAMOL SOPHARMA
Always take Salbutamol Sopharma exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
The syrup is taken orally .
The usual dose is:
Adults and children over 12 years: in 5-10 ml syrup (2-4 mg salbutamol ) 3-4 times daily. If necessary, the dose may be increased to 20 ml ( 8 mg) 4 times per day ( maximum daily dose of 32 mg).
Children 6 to 12 years: 5 ml syrup ( 2 mg) 3-4 times daily. The dose may be increased to 15 ml ( 6 mg) 4 times per day ( maximum daily dose of 24 mg).
Children 2 to 6 years: The starting dose is 2,5-5 ml syrup (1-2 mg) 3-4 times daily.
Children under 2 years: Safety, efficacy and dosage of the product in children under 2 years has not been established .
If during treatment you feel that the effect of the drug is weaker ( have the need for more frequent use of syrup than usual ) , it is necessary to immediately contact your doctor . He will assess your condition and may change treatment. Do not change the dose of the drug without consulting a doctor !
Elderly : It is recommended that treatment be initiated with lower doses - 5 ml syrup ( 2 mg) 3-4 times daily.

If you take more dose Salbutamol Sopharma
If you take a dose larger than indicated in the leaflet may appear Tremors , increased sweating, nausea , vomiting , particularly in children ( overdose of salbutamol ) , chest pain , abnormal heart rhythm. Consult immediately with your doctor.

If you forget to take Salbutamol Sopharma
If you miss a dose, take it as soon as possible . If almost time for your next dose , take it as normal, with skip the dose you forgot . Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 . POSSIBLE SIDE EFFECTS
Like all medicines, Sopharma Salbutamol can cause side effects, although not everybody gets them .
Common ( affects less than 1 in 10 patients), tremor (shaking of the limbs) , headache , fast heartbeat, chest pain .
Rare (affects less than 1 in 1000 patients): muscle cramps, nausea , vomiting (especially in children overdose medicinal product) , irregular heartbeat , palpitations, elevated blood glucose levels and decreased blood potassium .
Very rare (affects less than 1 in 10,000 patients) : allergic reactions as hives, angioedema ( otochnost the face, lips , mouth , tongue or throat which may cause difficulty swallowing and breathing) , spasm airway , reduced blood pressure and collapse , ADHD, sensation of tension in the muscles.
Not known ( data can not be estimated ) . Although it is not known exactly how often it happens , some patients may experience chest pain (due to heart disease) , insomnia , anxiety, dizziness, in patients with Parkinson's disease - tremor gain and muscle cramps.
Tell your doctor if you experience any of these symptoms while you are being treated with salbutamol Sopharma , but do not stop the drug without advice and recommendation of your doctor .
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.

5 . HOW TO STORE SALBUTAMOL SOPHARMA
Keep in the original container at a temperature below 25 ° C.
The syrup can be used within 1 month after opening the bottle .
Keep out of reach of children.
Do not use Salbutamol Sopharma after the expiry date stated on the pack ..
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . ADDITIONAL INFORMATION
What does Salbutamol Sopharma
The active substance is salbutamol sulphate , Eq. to 2 mg salbutamol in 5 ml of syrup.
Other ingredients are: ethanol , sucrose, methyl parahydroxybenzoate ( E218 ) , propyl parahydroxybenzoate ( E216 ), sodium citrate dihydrate, citric acid monohydrate, a liquid extract " Lemon " , purified water .

Looks like Salbutamol Sopharma and contents of the pack
Clear, viscous , yellow liquid with a characteristic smell of lemon and sweet taste.
125 ml syrup in dark brown glass bottles with aluminum or polyethylene cap or dark brown bottles made of polyethylene terephthalate plastic caps ; 1 bottle in a cardboard box with a measuring cup and leaflet.