Information about UNADOL SPASMA
Film Coated Tablets

Composition: 
Each film coated tablet contains: Hyoscine Butylbromide 10mg + Paracetamol 500mg.
Indications: 
For patients with convulsive pain in the stomach and intestine disorders, convulsive pain and dysfunction in the area of the bile ducts, the urinary tract and the female genital organs (eg: dysmenorrhea).
Dosage and Administration:
1.Adults and adolescents from 12 years of age:
Film coated tablets:1 - 2 film coated tablets Up to 3 times daily.
The maximum dose per day of 6 filmcoated tablets must not be exceeded. The time interval between doses should be at least 8 hours (film coated tablets).
2.Children from 6 -12 years old:
The film coated tablets should be swallowed whole with sufficient liquid. 
The use of this drug over a period of more than 3 - 4 days is to be weighed by a doctor.
Contraindications:
*Hypersensitivity to the active substances or to any of the excipients.
*Mechanical stenosis of the gastrointestinal tract.
*Megacolon.
*Urinary retention in subvesical obstruction (eg: prostate adenoma).
*Angular glaucoma.
*Tachycardia and tachyarrhythmia.
*Myasthenia gravis.
*Severe hepatic insufficiency (Child-Pugh C).
Pregnancy: 
There are no adequate data on the use of this drug in pregnant women.
It is not known whether Hyoscine Butylbromide passes the placenta, so that pharmacological effects on the fetus are possible. Therefore, the use
of this drug during pregnancy is therefore not recommended.
Lactation:
It is not known whether Hyoscine Butylbromide passes into the mothers milk. Muscarine receptor antagonists are known to inhibit the production of milk.
The use of this drug during breastfeeding should only be done after a strict indication
Storage Conditions: 
Don’t store above 30°C.
Packaging: 
Carton pack of 24 film coated tablets in blisters.