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Spasmex® 30 mg is a medicine used to relax the muscles of the inner organs (antispasmodic agent). Spasmex® 30 mg is used to treat bladder instability (involuntary urgency and incontinence for unclear reasons) or detrusor hyperreflexia (bladder dysfunction caused by a certain nervous disorder) with the symptoms frequent urge to urinate, an uncontrollable urge to urinate and uncontrollable urination (enuresis) with urgency. How to use The recommended daily dose is 45 mg trospium chloride. After consideration of individual efficacy and tolerance to the medication, the daily dose can be reduced to 30 mg by the attending physician. The dosage is then according to the following table: Daily dose Dose / day Corresponding single dose 45 mg (recommended daily dose) 3 times daily ½ film-coated tablet or mornings 1 film-coated tablet and evenings ½ film-coated tablet 15 mg trospium chloride 30 mg trospium chloride 15 mg trospium chloride 30 mg Twice daily ½ film-coated tablet 15 mg trospium chloride Warnings and precautions Do not take Spasmex® 30 mg if you are allergic to trospium chloride or any of the other ingredients of this medicine in case of: urinary retention increased intra-ocular pressure due to canthal obstruction; also known as glaucoma (narrow-angle glaucoma) increased and irregular heartbeat (tachyarrhythmia) a disorder which causes the muscles to weaken and tire easily (myasthenia gravis) chronic inflammatory bowel disease (ulcerative colitis and Crohn’s disease) serious disorder with dilation of the colon and constipation (toxic megacolon) renal impairment requiring dialysis. Warnings and precautions Talk to your doctor or pharmacist before taking Spasmex® 30 mg in case of: an obstruction in the stomach-intestinal passage (e.g. narrowing of the pylorus (pyloric stenosis)) obstructed passage of urine out of the bladder with the risk of residual urine (e.g. benign prostatic hyperplasia) hiatal hernia with an inflammation of the oesophagus due to reflux of the stomach acid (hiatus hernia with reflux oesophagitis) disorders of the involuntary nervous system (autonome neuropathy) as well as in patients where a fast heart rate is not wanted (e.g. thyroid overactivity, coronary heart disease (narrowing of the coronary arteries), insufficient heart performance (heart insufficiency). Side Effects Like all medicines, this medicine can cause side effects, although not everybody gets them. During the use of Spasmex® 30 mg anticholinergic side effects can occur (side effects due to the special mode of action of trospium chloride at the transmission site of nerve impulses) such as a dry mouth, gastrointestinal disorders and constipation. Not known (cannot be estimated from the available data): Severe skin reactions with bleeding and formation of blisters have been reported which can possibly involve the mucous membranes. A causal link with trospium chloride (the active ingredient in Spasmex® 30 mg) cannot definitely be confirmed. Contact a doctor immediately if you notice one of these serious side effects. Other side effects Very common side effects: may affect more than 1 in 10 people Dry mouth Common side effects: may affect up to 1 in 10 people Gastrointestinal disorders, constipation, stomach ache and nausea. Storage Information Store below 30ºC. Drug Interactions Increased effect to the point of an increased risk of side effects: An increase in the anticholinergic effect (see side effects) of amantadine (drug used to treat Parkinson’s disease), tricyclic antidepressants (certain drugs taken for the treatment of pathological sadness), quinidine and disopyramide (drugs used to treat irregular heart beat), anti-histamines (a group of drugs used in the treatment of allergies) as well as an increase in the tachycardic effect (increase of the heart beat) of ß-sympathomimetics (amongst others used as a cardiac medicine, medicine for asthma and contraction inhibitor). Reduction in effect: Decrease in the effect of prokinetics (e.g. metoclopramide and cisapride, used to treat gastric emptying disturbances or reflux disease. Ingredients The active substance is: 30 mg trospium chloride. The other ingredients are: sodium starch glycolate (Type A) (Ph. Eur.), hypromellose, lactose-monohydrate, maize starch, microcrystalline cellulose, povidone K25, colloidal silicium dioxide, stearic acid, titanium dioxide (E 171). Specifications White, round, on one side convex film coated tablet with a breaking notch (SNAP-TAB) to divide the film tablets in half. The tablet can be split into two equal doses.
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