Product Description:

• Defopan is grape-anise flavored Hyoscine – N – butylbromide syrup. Hyoscine – N –butylbromide is antispasmodic with anti-muscarinic activity

Defopan is used to relieve cramps in the muscles of your:

• Stomach


• Gut (intestine)


• Bladder and the tubes that lead to the outside of your body (urinary system).


• It can also be used to relieve the symptoms of Irritable Bowel Syndrome (IBS).

How to use:

• Always take Defopan syrup exactly as your physician has told you.


• You should checkwith your physician or pharmacist if you are not sure.


• DEFOPAN Syrup should not be taken continuously for long periods of time.

How much to take:

Adults and children over 12 years

• The usual dose is 20 ml 4 times a day.


• For Irritable Bowel Syndrome, your doctor may give you a lower starting dose of 10ml 3 times a day. This dose may be increased, if further relief is necessary.

Children 6 - 12 years:

• The usual dose is 10 ml 3 times a day.


• DEFOPAN is not recommended for children under 6 years.


• If you take more DEFOPAN Syrup than you should


• If you take more DEFOPAN Syrup than you should, talk to a doctor or go to a hospitalstraight away. Take the medicine pack with you.


• If you forget to take DEFOPAN Syrup


• If you forget a dose, take it as soon as you remember. However, if it is time for thenext dose, skip the missed dose.


• Do not take a double dose to make up for a forgotten dose.

Caution & Warnings:

Before you take Defopan:

A -Do not take Defopan:

Don’t take this medicine if:

You are allergic (to hyoscine – N – butylbromide or any components of the drugOr have any of the following conditions:

• Enlarged prostate gland.




• Myasthenia gravis.


• Pregnant, likely to get pregnant, or are breast-feeding.

B -Take special care with DEFOPAN

Please tell your physician or pharmacist before taking Defopan if

• You have heart failure, or tachycardia.


• You have kidney or liver problems.


• You have an overactive thyroid.


• You are elderly.


• You have difficulty in urinating.


• You have constipation.


• You have a fever.

C -Taking other medicines, herbal or dietary supplements

Defopan may interact with the following medicines:

• Tricyclic antidepressants and antipsychotic drugs.


• " quinidine or disopyramide".


• Beta 2 adrenergic," salbutamol for asthma".


• Bronchodilators,"Ipratropium,Tritropium".



• Amantadine (an antiviral).

Please tell your physician or pharmacist if you are taking or have recently taken anyother medicines, including medicines obtained without prescription.

D- Taking DEFOPAN with food and drink

• DEFOPAN can be taken by mouth with or without food.

Pregnancy:

• Pregnancy risk factor for Defopan is (Category C).


• It should be given only if the potential benefit outweighs the potential risk to the fetus.

Breastfeeding:

• No information is available on the use of DEFOPAN during breastfeeding.


• Long-termuse of Defopan might reduce milk production, but a single dose is unlikely to interferewith breastfeeding.

Driving and using machines:

• Temporary blurred vision may occur which may affect on the ability to drive or usingmachine.

Important information about some of the ingredients of Defopan:

• E420 which may have a mild laxative effect

POSSIBLE SIDE EFFECTS:

Like all medicines, DEFOPAN Syrup can cause side effects, although not everybodygets them. The following side effects may happen with this medicine.

Stop taking your medicine and see a doctor straight away if you notice any of thefollowing serious side effects:

• Allergic reactions such as skin reactions e.g. nettle rash, itching (affects fewer than1 in 100 people), rash, redness of the skin.


• Severe allergic reactions (anaphylactic shock) such as difficulty breathing, feelingfaint or dizzy (shock).


• Painful red eye with loss of vision.

Other side effects

• Dry mouth (affects fewer than 1 in 100 people).


• Small blisters on hands and feet (affects fewer than 1 in 100 people).


• Increased heart rate (affects fewer than 1 in 100 people).


• Being unable to pass water (urine) (affects fewer than 1 in 1,000 people).


• If any of the side effects gets troublesome or serious, or if you notice any side effects


• not listed in this leaflet, tell your doctor or pharmacist.

Ingredients:

• Hyoscine – N – butylbromide 5 mg/5ml.