Skip to Content

TOLTERODINE TARTRATE 1 MG FILM-COATED TABLET

Active substance(s): TOLTERODINE L-TARTRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE
USER

Tolterodine Tartrate 1 mg
Film-coated Tablet
Tolterodine Tartrate 2 mg
Film-coated Tablet
Tolterodine tartrate
Read all of this leaflet carefully before you
start using 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 medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms 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)

(medicines with an opposite mode of action to
tolterodine) properties. The reduction in gastric
motility caused by antimuscarinics may affect
the absorption of other drugs.
Tolterodine Tartrate with food and drink
This medicine can be taken before, after or
during a meal.
Pregnancy, breast-feeding and fertility
Pregnancy
You should not use tolterodine 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 tolterodine is excreted in the
mother's breast milk. Breast-feeding is not
recommended during administration of
tolterodine.
Ask your doctor or pharmacist for advice before
taking any medicine.

What is in this leaflet:
Driving and using machines
1. What Tolterodine Tartrate is and what it is used for
2. What you need to know before you take
Tolterodine Tartrate
3. How to take Tolterodine Tartrate
4. Possible side effects
5. How to store Tolterodine Tartrate
6. Contents of pack and other information

1. WHAT TOLTERODINE
TARTRATE IS AND WHAT IT
IS USED FOR
The active substance is tolterodine. Tolterodine
belongs to a class of medicinal products called
antimuscarinics.
Tolterodine 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. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
TOLTERODINE TARTRATE
Do not take Tolterodine Tartrate
• If you are allergic (hypersensitive) to tolterodine
or any of the other ingredients in the medicine
• If you are unable to pass urine from the bladder
(urinary retention)
• If you have uncontrolled narrow angle glaucoma
(increase in intraocular pressure)
• If you suffer from myasthenia gravis (excessive
weakness of the muscles)
• If you suffer from severe ulcerative colitis
(ulceration and inflammation of the colon)
• If you suffer from a toxic megacolon (acute
dilatation of the colon).
Warning and precautions
• 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 (renal
insufficiency)
• If you have a liver condition
• If you suffer from neuronal disorders that affect
your blood pressure, bowel or sexual function (any
neuropathy of the autonomic nervous system)
• If you have a hiatal hernia (herniation of an
abdominal organ)
• If you ever experience decreased bowel
movements or suffer from severe constipation
(decreased gastro-intestinal motility)
• If you have a heart condition such as:
- an abnormal heart tracing (ECG);
- a slow heart rate (bradycardia);
- relevant pre-existing cardiac diseases
(cardiomyopathy (weak heart muscle), myocardial
ischaemia (reduced blood flow to the heart),
arrhythmia (irregular heartbeat) and heart failure)
• If you have abnormally low levels of potassium
(hypokalaemia), calcium hypocalcaemia) or
magnesium (hypomagnesaemia) in your blood
• If you are taking any medicine for the treatment
of an irregular heartbeat (arrhythmia) (see
'taking other medicines').
Ask your doctor or pharmacist before starting this
treatment if you think any of these might apply to
you.

Tolterodine may make you feel dizzy, tired or
affect your sight; your ability to drive or operate
machinery may be affected.

3. HOW TO TAKE TOLTERODINE
TARTRATE
Dosage
Always take this medicine exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual dose is one 2 mg tablet twice daily,
except for patients who have a kidney or a liver
condition or troublesome side effects in which
case your doctor may reduce your dose to one 1
mg tablet twice daily.
Tolterodine Tartrate is not recommended for
children.
The tablets are for oral use and should be
swallowed whole.
Duration of treatment
Your doctor will tell you how long your treatment
with Tolterodine Tartrate 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.
The benefit of the treatment should be
re-evaluated after 2 or 3 months.
Always consult your doctor if you are thinking of
stopping the treatment.
If you have taken more Tolterodine Tartrate
than you should:
If you or somebody else takes too many tablets,
contact your doctor or pharmacist at immediately.
In case of tolterodine overdose, the following
symptoms are reported.
• Severe central anticholinergic effects (e.g.
hallucinations, severe excitation)
• Convulsions or pronounced excitation
• Respiratory insufficiency
• Tachycardia
• Urinary retention
• Mydriasis
• Increase in QT interval
If you forget to take Tolterodine Tartrate
Do not take a double dose to make up for a
forgotten one. If you have forgotten to take a
dose at the usual time, you can take it as soon as
you remember unless it is almost time for your
next dose. In that case follow the normal dose
schedule.
If you stop using Tolterodine Tartrate
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, tolterodine can cause side
effects, although not everybody gets them.

Other medicines and Tolterodine Tartrate
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Tolterodine, the active substance of tolterodine,
may interact with other medicinal products.
It is not recommended to use tolterodine in
combination with
• 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
Tolterodine should be used with caution when
taken in combination with
• medicines that affect the passage of food
(containing e. g. Metoclopramide, domperidone
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 antimuscarinic
(medicines with a similar mode of action to
tolterodine such as amantadine, some
antihistamines, phenothiazine antipsychotics
and tricyclic antidepressants) or cholinergic

You should see your doctor immediately or go to
the casualty department if you experience
symptoms of angioedema, such as
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulty in breathing
You should also seek medical attention if you
experience a hypersensitivity reaction (for
example itching, rash, hives, difficulty breathing).
This occurs uncommonly (occurs in less than 1 in
100 patients).
Tell your doctor immediately or go to the casualty
department if you notice any of the following:
• chest pain, difficulty breathing or getting tired
easily (even at rest), difficulty breathing at night,
swelling of the legs.
These may be symptoms of heart failure. This
occurs uncommonly (occurs in less than 1 in 100
patients).
The following side effects have been observed
during treatment with tolterodine with the
following frequencies.
Very common (occurs in more than 1 in 10
patients) side effects are:
• Dry mouth
• Headache

Common (occur in less than 1 per 10 patients)
side effects are:
• Bronchitis
• Dizziness
• Sleepiness
• Dry eyes
• Blurred vision
• Abdominal pain
• Spinning sensation
• Palpitations
• Dry skin
• Bad digestion (dyspepsia)
• Constipation
• Tiredness
• Painful or difficult urination
• Increased weight
• Chest pain
• Being sick (vomiting)
• Inability to empty the bladder
• Diarrhoea
• Sensation of pins and needles in the fingers
and toes
• Excessive amounts of air or gases in the
stomach or the intestine
• Extra fluid in the body causing swelling (e.g. in
the ankles)

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

Bulgaria
Cyprus
Estonia
Latvia
Poland
Austria
Germany
France
Ireland
Netherlands

Uncommon (occur in less than 1 per 100
patients) side effects are:

Sweden

• Allergic reactions
• Nervousness
• Irregular heartbeat
• Increased heart rate
• Heart failure
• Heart burn
• Memorial impairment

UK

Additional reactions reported from post marketing
experience include severe allergic reactions,
confusion, hallucinations (seeing, hearing, feeling,
tasting or smelling things that are not there),
flushing, angioedema and disorientation. There
have also been reports of worsening symptoms of
dementia in patients being treated for dementia.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. By reporting
side effects you can help provide more
information on the safety of this medicine.
For UK - You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For IE- You can also report side effects directly
HPRA Pharmacovigilance, Earlsfort Terrace, IRL
- Dublin 2; Tel: +353 1 6764971; Fax: +353 1
6762517. Website: www.hpra.ie; E-mail:
medsafety@hpra.ie.

5. HOW TO STORE
TOLTERODINE TARTRATE
Keep this medicine out of the sight and reach of
children.
Do not use tolterodine film-coated tablets after
the expiry date, which is stated on the
label/carton. The expiry date refers to the last day
of that month.
This medicinal product does not require any
special storage conditions.

6. CONTENTS OF PACK AND
OTHER INFORMATION
What Tolterodine Tartrate contains
The active substance is 1 mg of tolterodine
tartrate, equivalent to 0.68 mg of tolterodine.
The active substance is 2 mg of tolterodine
tartrate, equivalent to 1.37 mg of tolterodine.
The other ingredients are:
Core: Cellulose, microcrystalline; sodium starch
glycolate (Type A); magnesium stearate; colloidal
anhydrous silica
Film coating: Hypromellose (E464), titanium
dioxide (E171), macrogol 8000, talc (E553b)
What Tolterodine Tartrate looks like and
contents of the pack
Tolterodine Tartrate 1 mg film-coated tablets are
white to off white, round, approximately 6.35 mm in
diameter, biconvex, film-coated tablet, debossed
S16 on one side and plain on other side.
Tolterodine Tartrate 2 mg film-coated tablets are
white to off white, round, approximately 6.35 mm in
diameter, biconvex, film-coated tablet, debossed
S042 on one side and plain on other side.
Tolterodine Tartrate 1 mg film-coated tablets are
available in the following pack sizes:
Tolterodine Tartrate 2 mg film-coated tablets are
available in the following pack sizes:
Blister packs containing;
• 14 film-coated tablets (1 strip of 14)
• 28 film-coated tablets (2 strips of 14)
• 56 film-coated tablets (4 strips of 14)
• 20 film-coated tablets (2 strips of 10)
• 50 film-coated tablets (5 strips of 10)
• 100 film-coated tablets (10 strips of 10)
• 30 film-coated tablets (3 strips of 10 or 2 strips
of 15)
• 60 film-coated tablets (6 strips of 10 or 4 strips
of 15)
• 90 film-coated tablets (9 strips of 10 or 6 strips
of 15)
Please note that not all the above pack sizes may
be marketed.
Marketing authorisation holder and
manufacturer
Accord Healthcare Limited.
Sage house, 319 Pinner road,
North Harrow, HA1 4HF
United Kingdom

Proposed Name
Tolterodintartrat Accord
1 mg / 2 mg filmovertrukne
tabletter
Tolterodine Accord 2 mg
Film-coated Tablets
Tolterodine Accord 2 mg
Film-coated Tablets
Tolterodine Accord 1 mg / 2 mg
Tolterodine Accord 1 mg / 2 mg
Film-coated Tablets
Ranolteril, 1 mg/ 2 mg, tabletki
powlekane
Tolterodin Accord 1 mg/2 mg
Filmtabletten
Tolterodin Accord 1 mg/2 mg
Filmtabletten
Tolterodine Accord 1 mg/ 2 mg
comprimé pelliculé
Tolterodine Tartrate 1 mg/2 mg
Film-coated Tablet
Tolterodinetartraat Accord
1 mg/2 mg filmomhulde
tabletten
Tolterodintartrat Accord
1 mg / 2 mg filmdragerade
tabletter
Tolterodine Tartrate 1 mg/2 mg
Film-coated Tablet

This leaflet was last revised in 10/2015.

Expand view ⇕

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.

Hide