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TOLTERODINE 1 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tolterodine 1mg film-coated tablets
Tolterodine 2mg film-coated tablets
Tolterodine tartrate
Read all of this leaflet carefully before your child starts taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child. Do not pass it on to
others. It may harm them, even if their symptoms are the same as your child´s.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Tolterodine is and what it is used
for
2. Before you take Tolterodine
3. How to take Tolterodine
4. Possible side effects
5. How to store Tolterodine
6. Further information

1. WHAT TOLTERODINE IS AND
WHAT IT IS USED FOR
This medicine belongs to a class of
medicinal products called
antimuscarinics.
This medicine is used for the treatment
of the symptoms of overactive bladder
syndrome. If you have overactive
bladder syndrome you may find that
you are unable to control urination, that
you need to rush to the toilet with no
advance warning and/or go to the toilet
frequently.

2. BEFORE YOU TAKE
TOLTERODINE
Do not take Tolterodine
• If you are allergic (hypersensitive) to
tolterodine or any of the other
ingredients in this medicine (see
section 6. “Further information”).
• If you are unable to pass urine from
the bladder (urinary retention).
• If you have an increased eye pressure
that is not being adequately treated
(uncontrolled narrow angle glaucoma).
• If you suffer from a certain muscle
weakness (myasthenia gravis).
• If you suffer from an ulceration and
inflammation of the colon (severe
ulcerative colitis).
• If you suffer from an acute dilation of
the colon (toxic megacolon).
Take special care with Tolterodine
• If you have difficulties in passing urine
and/or a poor stream of urine.
• If you have a gastro-intestinal disease
that affects the passage and/or
digestion of food.
• If you suffer from kidney problems.
• If you have a liver condition.
• If you suffer from neuronal disorders
that affect your blood pressure,
bowel or sexual function (autonomic
neuropathy).
• If a part of your stomach protrudes
through the diaphragm (hiatus hernia).
• If you experienced decreased bowel
movements or suffer from severe
constipation.
• If you have a heart condition such as:
- an abnormal heart tracing (ECG)
- a slow heart rate
- relevant pre-existing cardiac
diseases (weak heart muscle
[cardiomyopathy], reduced blood
flow to the heart [myocardial
ischaemia], irregular heartbeat and
heart failure).
• If you have abnormally low levels of
potassium, calcium or magnesium in
your blood.
• If you are taking any medicine for the
treatment of an irregular heartbeat
(see “Taking other medicines”).
Ask your doctor or pharmacist before
starting treatment with this medicine if
you think any of these might apply to you.

Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.
The following medicines can influence,
or be influenced by Tolterodine:
• some antibiotics (containing e.g.
erythromycin, clarithromycin)
• medicinal products used for the
treatment of fungal infections
(containing e.g. ketoconazole,
itraconazole)
• medicinal products used for the
treatment of HIV.
• medicines that affect the passage of
food (containing e.g. metoclopramide
and cisapride)
• medicines for the treatment of
irregular heartbeat (containing
e.g. amiodarone, sotalol, quinidine,
procainamide) (see “Take special care
with Tolterodine”)
• other medicinal products with a
similar mode of action to Tolterodine
(antimuscarinic properties) or with an
opposite mode of action to Tolterodine
(cholinergic properties).
Taking Tolterodine with food and drink
This medicine can be taken before, after
or during a meal.

Pregnancy and Breast-feeding
Pregnancy
There is insufficient experience with the
use of this medicine during pregnancy.
As this medicine may harm your unborn
child, you should not use this medicine
when you are pregnant. Tell your doctor
immediately if you are pregnant, think
you are pregnant or are planning to
become pregnant.
Breast-feeding
It is not known if this medicine is passed
on in the mother’s breast milk. Breast
feeding is not recommended whilst
taking this medicine.
Driving and using machines
This medicine may make you feel
dizzy, tired or affect your sight. If you
experience any of these affects then you
should not drive your car or operate
heavy machinery.
Important information about some of
the ingredients:
This medicine contains lactose (a type
of sugar). If you have been told that you
have an intolerance to some sugars
speak to your doctor before taking this
medicine.

3. HOW TO TAKE TOLTERODINE
Always take this medicine exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
Adults
The usual dose is 2mg twice daily.
Patients with liver or kidney problems
If you have liver or kidney problems,
your doctor may reduce your dose to
1 mg twice daily.
Children
This medicine is not recommended for
children.
The tablets are for oral use and should
be swallowed whole.

If you take more Tolterodine than you
should:
If you or someone else takes too many
tablets, contact your doctor or pharmacist
at once. Symptoms of overdose include
symptoms from central nervous system
(convulsions, hallucinations), difficulties
in breathing, heart problems (increased
heart rate), inability to pass urine,
abnormal dilation of pupils.

Not known (frequency cannot be
estimated from the available data):
• Confusion
• Flushing
• Disorientation
• Severe allergic reactions
• Hallucinations (seeing, hearing,
feeling, tasting or smelling things that
are not there)
• Angioedema

If you forget to take Tolterodine
Do not take a double dose to make
up for the forgotten dose. If you have
forgotten to take your tablet at the usual
time, you can take it as soon as you
remember unless it is almost time for
your next dose. In this case follow the
normal dose schedule.

There have also been reports of
worsening symptoms of dementia in
patients being treated for dementia.

If you stop taking Tolterodine
Your doctor will tell you how long your
treatment with this medicine will last.
Do not stop treatment early because
you do not see an immediate effect. Your
bladder will need some time to adapt.
Finish the course of tablets prescribed
by your doctor. If you have not noticed
any effect by then, talk to your doctor.
Always consult your doctor if you are
thinking of stopping the treatment.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine
can cause side effects although not
everybody gets them.
You should see your doctor immediately
or go to the casualty department
if you experience symptoms of
angioedema (allergic reaction), such as:
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulty in breathing
or if you experience symptoms of heart
failure:
• chest pain
• difficulty breathing or getting tired
easily (even at rest)
• difficulty breathing at night
• swelling of the legs
You should also seek medical attention
immediately if you experience a
hypersensitivity reaction (for example
itching, rash, hives, difficulty breathing).
The following side effects have been
observed during treatment with
Tolterodine with the following
frequencies.
Very common (affects more than 1 user
in 10):
• Dry mouth
• Headache
Common (affects 1 to 10 users in 100):
• Bronchitis
• Dizziness
• Sleepiness
• Sensations of pins and needles in the
fingers and toes
• Dry eyes
• Blurred vision
• Spinning sensation
• Palpitations
• Bad digestion (dyspepsia)
• Constipation
• Abdominal pain
• Excessive amounts of air or gases in
the stomach or the intestine
• Being sick (vomiting)
• Dry skin
• Diarrhoea
• Inability to empty the bladder
• Painful or difficult urination
• Chest pain
• Tiredness
• Increased weight
• Extra fluid in the body causing
swelling (e.g. in the ankles)
Uncommon (affects 1 to 10 users in
1,000):
• Allergic reactions
• Irregular heartbeat
• Nervousness
• Heart burn
• Increased heart rate
• Memory impairment
• Heart failure

If any of the side effects gets serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE TOLTERODINE
Keep out of the reach and sight of
children.
Do not use this medicine after the expiry
date which is stated on the label/carton.
The expiry date refers to the last day of
that month.
Store in original package in order to
protect from light.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required. These
measures will help to protect the
environment.

6. FURTHER INFORMATION
What Tolterodine contains
The active substance is tolterodine
tartrate.
Each film-coated tablet contains 1 mg
tolterodine tartrate.
Each film-coated tablet contains 2 mg
tolterodine tartrate.

The other ingredients are:
Core: Microcrystalline cellulose,
dibasic calcium phosphate, sodium
starch glycolate, colloidal silicon oxide,
magnesium stearate.
Film-coating: Hypromellose, lactose
monohydrate, polyethylene glycol,
titanium dioxide (E171).
What Tolterodine looks like and contents
of the pack
1 mg: White, round biconvex
film-coated tablets, embossed
with “1” on one side.
2 mg: White, round biconvex
film-coated tablets, embossed
with “2” on one side and with a
score line on the other side.
PVC/PE/PVDC Aluminium blister.
Pack sizes of 10, 14, 20, 28, 30, 50, 56 and
100 film-coated tablets.
HDPE tablet container with a
child-resistant PP screw cap.
Pack sizes of 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation holder:
ratiopharm GmbH, Graf-Arco-Str.3,
89079 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle Str.3,
89143 Blaubeuren, Germany.
or
Pharmathen S.A, 6 Dervenakion Str., 153
51 Pallini Attiki, Greece.
This leaflet was last revised in:
April 2010.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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