Text draft from 05.08.

2013

Spasmex 45 mg p 1/8
Film-coated tablets
Dokument1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Spasmex 45 mg film-coated tablets

Active substance: Trospium chloride

For use in adolescents over 12 years and adults

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medication has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Spasmex 45 mg is and what it is used for
2. What you need to know before you take Spasmex 45 mg
3. How to take Spasmex 45 mg
4. Possible side effects
5. How to store Spasmex 45 mg
6. Contents of the pack and other information
Text draft from 05.08.2013

Spasmex 45 mg p 2/8
Film-coated tablets
Dokument1

1. What Spasmex 45 mg is and what it is used for

Spasmex 45 mg contains the active substance trospium chloride.

Spasmex 45 mg is a medicine used to relax the muscles of the inner organs (antispasmodic
agent).

Spasmex 45 mg is used
- for the symptomatic treatment of increased frequency of urination and/or urgency
and/or urge incontinence in patients with overactive bladder syndrome
- by involuntary urgency and inability to control urination (incontinence) for unclear
reasons (idiopathic detrusor overactivity)
- by bladder dysfunction caused by a certain nervous disorder (neurogenic detrusor
overactivity).

Taking Spasmex 45 mg leads to a relaxation of the muscles of the bladder. Consequently the
frequency of feeling a full bladder and involuntary urination are reduced.

2. What you need to know before you take Spasmex 45 mg

Do not take Spasmex 45 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
 untreated increased intra-ocular pressure due to canthal obstruction; also
known as glaucoma (narrow-angle glaucoma)
 increased and irregular heartbeat (tacharrhythmia)
 a disorder which causes the muscles to weaken and tire easily (myasthenia
gravis)
 severe chronic inflammatory bowel disease (ulcerative colitis or Crohn’s
disease)
 a serious disorder with dilation of the colon and constipation (toxic megacolon)
 renal impairment requiring dialysis (creatinine clearance < 10 ml/ min/ 1.73
m 2 ).

Warnings and precautions

Talk to your doctor or pharmacist before taking Spasmex 45 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)
- disorders of the involuntary nervous system (autonome neuropathy)
Text draft from 05.08.2013

Spasmex 45 mg p 3/8
Film-coated tablets
Dokument1

- hiatal hernia with an inflammation of the oesophagus due to reflux of the stomach acid
(hiatus hernia with reflux oesophagitis)
- as well as where a fast heart rate is not desired. For example in those with thyroid
overactivity, narrowing of the coronary arteries (coronary heart disease) and
insufficient heart performance (heart insufficiency).

You should not take Spasmex 45 mg if you suffer from a serious liver disease. Talk to your
doctor before taking this medicine if you suffer from a mild to moderate liver disease.
Trospium chloride is mainly excreted via the kidneys. In patients with moderately and severely
impaired renal function, notable increases in the amount of the active ingredient in the blood
were observed. If you belong to this group of patients, or suffer from mildlyimpaired kidney
function, treatment should only be commenced after talking to your doctor.
Prior to starting treatment, your doctor should rule out organic causes for the increased urge
for passing urine without an increase in volume of excreted amount (pollakisuria) and urge
symptomatology (see under therapeutic indications), such as heart or kidney disorders,
polydipsia (chronic thirst), infections and tumours in the urinary organs.

Children and adolescents

Spasmex 45 mg is not recommended for use in children under 12 years of age.

Other medicines and Spasmex 45 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 45 mg:

Increased effect to the point of an increased risk of side effects:

- an increase in the effect on the involuntary nervous system (anticholinergic effect) 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)
- an increase in the effect on the increase in heart rate (tachycardia effect) of ß-
sympathomimetics (which have a stimulatory effect on a part of the vegetative nervous
system; amongst others used as a cardiac medicine, medicine for asthma and anti-
contraction medication).

Reduction in effect:
- Decrease in the effect of medicines which support the function of the gastrointestinal tract
(prokinetics). For example metoclopramide and cisapride, which are mainly used to treat
gastric emptying disturbances or reflux disease.

Other possible interactions:

Text draft from 05.08.2013

Spasmex 45 mg p 4/8
Film-coated tablets
Dokument1

Because trospium chloride influences the flexibility and the discharge of digestive juices
(secretion) of the gastrointestinal tract, the potential of trospium chloride to interfere with the
body's ability to process drugs taken at the same time cannot be ruled out.

When taking medicines that contain substances such as guar, colestyramine and colestipol
at the same time, one cannot rule out that the absorption into the blood stream (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 metabolisation and the type of metabolisation, no metabolic interactions are to
be expected in this respect.
In addition, neither clinical studies nor pharmacovigilance have shown any interactions which
are expected to be relevant to the therapy.

Please note that these statements can also apply to drugs which have been taken a short
time previously.

Spasmex 45 mg with food, drink and alcohol

There are no special precautions required.

Pregnancy, breast-feeding and fertility

Animal studies have not provided any evidence of deformities. No experience exists
regarding use during pregnancy and breast feeding in humans, Therefore, trospium chloride
should only be used during pregnancy and while breast feeding under strict examination of the
indication.
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 any medicine.

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 in dose,
following a change in medication as well as when taken concomitantly with alcohol.

Spasmex 45 mg contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3. How to take Spasmex 45 mg

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Text draft from 05.08.2013

Spasmex 45 mg p 5/8
Film-coated tablets
Dokument1

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 mgafter 4
weeks of treatment by the attending physician. The dosage is then according to the following
table:

Daily dose Dose / day Corresponding single

dose
45 mg 3 times daily 1/3 film-coated tablet 15 mg trospium chloride

30 mg Twice daily 1/3 film-coated tablet 15 mg trospium chloride

Special patient populations

Patients with renal disease

In patients with moderate and severe renal impairment (creatinine clearance between 10 and
50nl/min/1.73m³) the starting dose should be reduced according to the severity of renal
impairment.

- The recommended daily dose is 15 mg trospium chloride once or twice per day, or
one to two times 15 mg every second day. The individual dosage should be
determined by weighing up individual efficacy and tolerability. Patients with severe
renal impairment should take their medication with food.
- In order to halve the daily dosage, prescription of dividable tablets containing 15 mg
trospium chloride should be considered as an alternative.

Patients with hepatic impairment

A study on the pharmacokinetics in patients with mild to moderate hepatic dysfunction did not
show dosage adjustment to be necessary.

There are no data on patients with severely impaired hepatic function. Therefore, use of
trospium chloride is not recommended in these patients.

Paediatric population
Spasmex 45 mg is not recommended for use in children under 12 years of age due to
insufficient data.

Method of administration

The film-coated tablet should be divided into three pieces as shown in the pictogram. Place
the tablet on a hard surface. By applying finger pressure on the score line (apply brief
pressure with full strength), the tablet can be divided into equal parts.
Text draft from 05.08.2013

Spasmex 45 mg p 6/8
Film-coated tablets
Dokument1

Pieces of the film-coated tablet should be taken with a sufficient amount of liquid (preferably a
glass of drinking water) before a meal on an empty stomach.

The film-coated tablets should be taken mornings, at noon, and evenings.

Duration of treatment

The length of treatment is determined by your doctor.

Let your doctor check the need for further treatment at regular intervals of three to six months.

If you take more Spasmex 45 mg than you should

Symptoms of intoxication in humans have not been observed.
If you have taken too much Spasmex 45 mg or symptoms of intoxication arise consult your
doctor immediately.

Signs of an overdose are clinical signs caused by the influence on the autonomic nervous
system (anticholinergic symptoms) such as visual disturbances, increased heart rate, dry
mouth, and reddening of the skin. For treatment, medicines which stimulate a part of the
vegetative nervous system are recommended (parasympathomimetika), such as e.g.
neostigmine. In the case of increased intra-ocular pressure, also known as glaucoma,
pilocarpin can be locally administered.

If you forget to take Spasmex 45 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 45 mg

Do not interrupt or stop the intake of Spasmex 45 mg without consulting your doctor.
If you have any further questions regarding the use of this medication, please ask your doctor
or pharmacist.

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

4. Possible side effects

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

Due to the special mode of action of trospium chloride, side effects can occur during
treatment with Spasmex 45 mg such as a dry mouth, gastrointestinal disorders and
constipation (anticholinergic side effects).
Text draft from 05.08.2013

Spasmex 45 mg p 7/8
Film-coated tablets
Dokument1

Frequency not known, cannot be estimated from the available data

Severe skin reactions with bleeding and formation of blisters which can possibly involve the
mucous membranes.

Seek urgent medical advice if you notice any of these very serious side effects.

Other side effects

Very common, may affect more than 1 in 10 people

Dry mouth

Common, may affect up to 1 in 10 people

Gastrointestinal disorders, constipation, stomach ache and nausea.

Uncommon, may affect up to 1 in 100 people

Disturbance in urination (e.g. formation of residual urine), increased heart rate, palpitations,
racing heart (tachycardia), disturbance in the ability of the eye to focus on close objects
(accommodation disorders), diarrhoea, wind (flatulence), skin rashes, general weakness or
chest pains.

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

Urinary retention, fast and irregular heart rate (Tachyarrhythmia), usually painful swelling of
skin and subcutis, commonly in the face, caused by allergy (angiooedema), increase in
hepatic parameters, serious allergic reaction (anaphylaxis), breathing problems (dyspnoea).

The following side effects have additionally been observed in other products containing
trospium chloride: dry eyes, disturbed vision, dry nose, urinary tract infection, muscle and joint
pain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the national
reporting system listed in Appendix V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Spasmex 45 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.

Text draft from 05.08.2013

Spasmex 45 mg p 8/8
Film-coated tablets
Dokument1

Do not store above 30 °C.

6. Contents of the pack and other information

What Spasmex 45 mg contains:

The active substance is: 45 mg trospium chloride.

The other ingredients are:

Core: Lactose-monohydrate, microcrystalline cellulose, maize starch, sodium starch
glycolate (Type A) (Ph. Eur.), stearic acid (Ph. Eur.), colloidal silicium dioxide, povidon K25.
Coating: Polyvinyl alcohol (partially hydrolysed), titanium dioxide, macrogol 3000, talc.

What Spasmex 45 mg looks like and contents of the pack:

White, round, biconvex film-coated tablet with 120 ° score line on one side for dividing into
three equal doses. Packets with 30, 50 and 100 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation Holder:
<[To be completed nationally]>

Manufacturers:
<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the
following names:

<[Name of the Member State]> <[Name of the medicinal product]>

<[Name of the Member State]> <[Name of the medicinal product]>

This package leaflet was last revised in {MM/YYYY}.