BUTALIN contains salbutamol, which is a bronchodilator. It opens up the breathing tubes of the lungs and makes breathing easier. Salbutamol can help you feel less tight-chested and less breathless or wheezy.

BUTALIN is used:

§ to treat asthma by relieving wheezing and shortness of breath

§ to prevent asthma following exercise

for the treatment of wheezing and shortness of breath caused by certain other chest diseases

Do not use BUTALIN and consult your doctor if you:

§ are allergic (hypersensitive) to salbutamol or any of the other ingredients of this medicine.

BUTALIN should NOT be used to treat premature labour or threatened miscarriage, as inhaled salbutamol products are not suitable for this purpose.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using this medicine if you:

§ have thyroid problems

§ have diabetes

§ have serious heart disease

§ suffer from fast irregular heart rhythms or high blood pressure

§ have acute severe asthma

§ have hypoxia (lack of oxygen in the body)

§ have a history of heart disease or angina.

Children and adolescents

Consult a doctor immediately if your usual treatment is not working or if you need more than 8 puffs per day (adult) or 4 puffs per day (children) or in case of worsening asthma symptoms.

Other medicines and BUTALIN

Tell your doctor or pharmacist if you are taking any other medicines:

§ xanthines e.g. aminophylline or theophylline

§ metronidazole

§ disulfiram

§ steroids

§ water tablets (diuretics)

§ long-term laxatives

§ beta-blockers e.g. propranolol

§ medicines used to treat heart disease e.g. digoxin

§ monoamine oxidase-inhibitors (anti-depressants) e.g. phenelzine

§ tricyclic antidepressants e.g. amitriptyline or trazodone.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any medicines obtained without a prescription.

If you are having treatment that requires a general anaesthetic, please tell your anaesthetist that you are taking BUTALIN. Do not use this medicine for at least six hours before the intended anaesthetic.

Pregnancy and breast-feeding

§ If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine. BUTALIN should only be used if recommended by a doctor.

Driving and using machines

§ BUTALIN may cause dizziness. If you are affected, DO NOT drive or operate machinery.

Always use BUTALIN exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. If you see any other doctor or dentist, please tell them that you are using BUTALIN.

The recommended dose is:

Adults (including the elderly)

§ For the relief of symptoms such as wheezing and shortness of breath

Either one or two puffs as needed.

§ For asthma due to exercise

Two puffs before exercising.

Do not take more than eight puffs in 24 hours.

Children (aged 4 to 11 years)

§ For the relief of symptoms such as wheezing and shortness of breath

Usually one puff as needed. This may be increased to two puffs if necessary.

§ For asthma due to exercise

Usually one puff before exercising. This may be increased to two puffs if necessary.

§ For chronic therapy

Usually up to two puffs four times daily.

Children (aged 12 years and over)

Dose as per adult population.

Children using this inhaler should be supervised by an adult and should use this inhaler only as advised by the doctor.

All patients

§ If you have taken a dose of two puffs, you should wait four hours before taking another dose. DO NOT take more than eight puffs in 24 hours.

§ If you are not sure how many puffs to take or how often to take them, please ask your doctor or pharmacist.

If your usual treatment is not working or you need more than eight puffs per day, please tell your doctor. You should NOT increase your dose without consulting your doctor.

Inhaler test before use:

Check that the inhaler is functioning, if you use a new inhaler or if it has not been used for 7 days or more. Remove the protective cap, shake the inhaler and spray twice into the air.

Directions for use

1.  Remove the protective cap from the mouthpiece and shake the inhaler vigorously.

2.  Holding the inhaler with the mouthpiece down towards your mouth and putting your thumb under the mouthpiece and your index over the bottom of the canister, breathe out gently (but not fully) and then immediately place the mouthpiece in the mouth and close your lips around it.

3.  After starting to breathe in slowly and deeply through your mouth, press the inhaler firmly by using your index to release BUTALIN and continue to breathe in.

4.  Hold your breath for 10 seconds, or as long as it is comfortable, before breathing out slowly.

5.  If you are to take a second inhalation, you should wait at least 1 minute before repeating steps 2, 3 and 4.

6.  After use replace the protective cap on the mouthpiece.

7.  Cleaning: Remove the canister, rinse the actuator in warm water, dry, and replace canister.

Notes

§ It is dangerous to exceed the recommended dose.

§ Children: BUTALIN inhaler should be used under the supervision of a responsible adult and only as instructed by the doctor. 

§ Caution: The canister is pressurized. Do not puncture, break, or burn, even when empty.

Inhaler content:

Shake the inhaler to check the remaining amount of medicine in your inhaler. Do not use BUTALIN if you do not detect any liquid in the inhaler while shaking.

If you use more of your BUTALINthan you should

If you accidentally take more puffs than your doctor told you to, please contact your nearest hospital casualty department, or tell your doctor, immediately. You may notice that your heart is beating faster than usual, that you feel shaky or tense, you may have a headache or your skin may look flushed and feel hot. These effects normally wear off in a few hours. Your doctor may want to check your blood potassium levels.

If you stop using BUTALIN

Do not stop taking your medicine without talking to your doctor first even if you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Like all medicines, BUTALIN can cause side effects, although not everybody gets them.

If, immediately after inhaling a puff, your asthma worsens, do not use BUTALIN again and contact your doctor straight away.

If the following happens, stop using BUTALIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

§ an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives, and a fall in blood pressure. You might collapse in very rare circumstances).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Common: may affect up to 1 in 10 people

§ Feeling tense

§ Headache

§ Dizziness

§ Mild tremor (shaking) especially of the hands.

Uncommon: may affect up to 1 in 100 people

§ Muscle pain.

Rare: may affect up to 1 in 1,000 people

§ Low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm

§ Sleep disturbances and sensing things that are not real have been reported especially in children

§ Faster heart beat

§ Abnormal heart beat

§ Widening of blood vessels

§ Throat irritation

§ Feeling sick

§ Vomiting

§ A dry, sore mouth

§ Mouth irritation

§ Muscle cramps.

Very rare: may affect up to 1 in 10,000 people

§ Difficulty in sleeping

§ Difficulty in breathing or wheezing

§ Irregular heartbeat, especially when used with beta-blockers

§ Chest pain

§ Itching skin.

Not known: frequency cannot be estimated from the available data

§ Restriction of blood supply to the heart.

Using BUTALIN may rarely lead to a buildup of lactic acid or low potassium levels in your blood. Your doctor may wish you to have regular blood tests to check your blood potassium levels.

Although it is not known exactly how often this happens, some people may experience chest pain (due to heart problems such as angina). Tell your doctor as soon as possible if you develop these symptoms whilst receiving treatment with BUTALIN, but do not stop taking this medicine unless told to do so.

If any of the side effects continue for more than a few days, get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

-  Keep out of the reach and sight of children.

-  Do not use Butalin after the expiry date which is stated on the carton.

-  Store below 30°C. Avoid storage in direct sunlight or heat. Do not refrigerate.

-  Do not use Butalin if you notice any visible sign of deterioration.

-  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.