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.

Do not take Spasmex® 30 mg
– if you are allergic to trospium chloride or any of the other
ingredients of this medicine (listed in section 6)
– 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).
If you suffer from a serious liver disease, you should not take Spasmex
30 mg. If you suffer from a mild to moderate liver disease, talk to your
doctor before taking this medicine.
Trospium chloride is mainly excreted via the kidneys. In patients with
severely impaired renal function notable increase in blood levels were
observed. Therefore, in these patient groups, even when kidney
function is only mildly to moderately impaired, treatment should only
be commenced with caution.
Prior to starting treatment, organic causes for pollakisuria and urge
symptomatology (see under therapeutic indications), such as heart or
kidney disorders, polydipsia (chronic thirst), infections and tumours in
the urinary organs, should be ruled out.
Children:
Spasmex® 30 mg is not recommended for children under 12 years old.
Other medicines and Spasmex® 30 mg
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
The effect of the following drugs can be affected if used concurrently
with Spasmex® 30 mg:
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.
Other possible interactions:
Because trospium chloride influences the flexibility and secretion (e.g.
the discharge of digestive juices) of the gastrointestinal tract, one can
not rule out the potential of trospium chloride to interfere with the
body’s ability to process drugs taken at the same time.
When taking medicines that contain substances such as guar,
colestyramine and colestipol at the same time, it cannot be ruled out
that the resorption of trospium chloride will be reduced. Therefore, the
concurrent use of medications which contain these substances is not
recommended.
Metabolic interactions have only been investigated in vitro, but without
findings. Due to the generally low metabolism and the type of
metabolism no metabolic interactions are to be expected.
In addition, neither clinical studies nor pharmacovigilance have shown
interactions which are expected to be relevant to the therapy.
Spasmex® 30 mg with food, drink and alcohol
During the use of Spasmex® 30 mg you should if possible drink no
alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
Animal studies have not provided any evidence of deformities.
However, trospium chloride should only be used during pregnancy
and while breast feeding under strict examination of the indication as
no experience exists for its use during pregnancy and breast feeding in
humans.
Driving and using machines
This medicine can even when used appropriately alter the clarity of
vision to such an extent that the ability to drive, to operate machinery,
or to work without a secure hold may be impaired.
This effect may especially occur at the beginning of therapy, after an
increase of dose or a change of medication as well as concomitantly
with alcohol.
Spasmex® 30 mg contains lactose
Therefore, please take Spasmex® 30 mg after consulting your doctor if
you are aware that you are intolerant of certain sugars.

Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
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

Special patient groups
Patients with reduced kidney function
In patients with moderate and severe renal impairment (creatinine
clearance between 10 and 50 ml/min/1.73m2) the starting dose should
be reduced according to the severity of renal impairment.
The recommended daily dose is 1 x 15 mg (corresponding to ½ tablet)
or 1 – 2 x 15 mg (corresponding to 1 – 2 x ½ tablet) every second day.
The individual dosage should be defined by weighing up individual
efficacy and tolerability. The 30 mg film-coated tablets can be split into
two equal parts each containing 15 mg, as shown in the picture below.
Patients with severe renal impairment should take the medication with
food.
In order to halve the standard daily dose of 45 mg, prescription of
divisible tablets containing 15 mg trospium chloride should be
considered as an alternative.
Patients with reduced liver function
Dose adjustment is not necessary in cases of mild to moderate
impairment in liver function. Treatment is not recommended in cases
of severe liver dysfunction.
Use in children
Treatment of children under 12 years old is not recommended as no
data is available.

How to take the tablets
As shown in the figure, the tablets can be broken into two pieces. To do
this, place the tablet on a hard surface and press down on the breaking
notch with the thumb (apply brief, strong pressure) in order to split the
tablet into two pieces of equal size.
Take the film coated tablets or their parts with a sufficient amount of
liquid (preferably a glass of drinking water). The film tablets should
preferably be taken mornings, at noon, and evenings, or mornings and
evenings before a meal on an empty stomach.
Length of treatment
The length of treatment is determined by your doctor. The need for
further treatment should be checked at regular intervals of every three
to six months.
If you take more Spasmex® 30 mg than you should
Symptoms of intoxication in humans have not been observed.
If you have taken too much Spasmex® 30 mg or symptoms of
intoxication arise please inform your doctor immediately.
Signs of an overdose are so called anticholinergic symptoms such as
visual disturbances, increased heart rate, dry mouth, and reddening of
the skin, which can be treated with a so called parasympathomimetika
such as neostigmine. Patients with glaucoma can receive locally
administered pilocarpine.
If you forget to take Spasmex® 30 mg
Do not take the double dose when you have forgotten the previous
dose but continue with the administration according to the
instructions or as prescribed by the doctor.
If you stop taking Spasmex® 30 mg
Do not interrupt or stop the intake of Spasmex® 30 mg without
consulting your doctor.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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.
Uncommon side effects: may affect up to 1 in 100 people
Disturbance in urination (e.g. formation of residual urine), tachycardia
(increased heart rate, palpitations, racing heart), accommodation
disorders (the ability of the eye to focus on close objects), diarrhoea,
flatulence (wind), skin rash, general body weakness or chest pains.
Rare side effects: may affect up to 1 in 1,000 people
Urinary retention, Tachyarrhythmia (fast and irregular heart rate),
angio-oedema (usually painful swelling of skin and subcutis, usually in
the face, caused by allergy), increase in hepatic parameters,
anaphylaxis (serious allergic reaction), dyspnoea (breathing problems)
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

5. How to store Spasmex® 30 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and on the blister strip. The expiry date refers to the last day of
that month.
Store below 30ºC.