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TOLTERODINE TARTRATE 2 MG FILM-COATED TABLETS

Active substance(s): TOLTERODINE L-TARTRATE / TOLTERODINE TARTRATE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Tolterodine-L-tartrate
Package leaflet: Information for the user

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, pharmacist or nurse
• This medicine 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:

NEW
POSITION
105mm

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 the pack and other information

1

What Tolterodine tartrate is and
what it is used for

The active substance in Tolterodine tartrate
film-coated tablets is tolterodine.
Tolterodine tartrate belongs to a class of
medicinal products called antimuscarinics.
Tolterodine tartrate 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,
• 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 to tolterodine or any of the other
ingredients of this medicine (listed in section
6)..
• are unable to pass urine from the bladder
(urinary retention)
• have an uncontrolled narrow-angle glaucoma
(high pressure in the eyes with loss of
eyesight that is not being adequately treated)
• suffer from myasthenia gravis (excessive
weakness of the muscles)
• suffer from severe ulcerative colitis
(ulceration and inflammation of the colon)
• suffer from a toxic megacolon (acute
dilatation of the colon).
Warning and precautions
Talk to your doctor, pharmacist or nurse before
taking Tolterodine tartrate:
• 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
impairment)
• if you suffer from any liver disease.
• 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 such
as:
• 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.
Talk to your doctor or pharmacist before
starting your treatment with Tolterodine
tartrate Film-coated Tablets if you think any of
these might apply to you.
Other medicines and Tolterodine tartrate
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Tolterodine tartrate may interact with other
medicinal products.
It is not recommended to use tolterodine
tartrate 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 tartrate should be used with
caution when taken in combination with:
• 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)
• other medicines with a similar mode of
action to tolterodine (antimuscarinic
properties) or medicines with an opposite
mode of action to tolterodine (cholinergic
properties). Ask your doctor if you are
unsure.
Tolterodine tartrate with food and drink
There are no special instructions.
Tolterodine tartrate can be taken either before,
during or after a meal.
Pregnancy and breast-feeding
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.
Pregnancy
You should not use Tolterodine tartrate 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 into
the mother's breast milk. Breast-feeding is not
recommended during administration of
Tolterodine tartrate.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Tolterodine tartrate 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 or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended 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

Top of page cut-off to middle of registration mark: 44 mm.

Tolterodine tartrate 1 mg
film-coated tablets
Tolterodine tartrate 2 mg
film-coated tablets

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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 take more Tolterodine tartrate than you
should
If you or somebody else have taken too many
tablets, contact your doctor or go to the
nearest hospital.
If you forget to take Tolterodine tartrate
If you have forgotten to take Tolterodine, take it
as soon as you remember, unless it is time for
the next dose. In that case, omit the forgotten
dose and follow the normal dose schedule
Do not take a double dose to make up for a
forgotten dose.
If you stop taking Tolterodine tartrate
Before stopping to take the medicine, please
consult your doctor.
Currently there is no known negative effect due
to abrupt withdrawal of the medicine.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

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 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 (may
affect up to 1 in 100 people).
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 (may affect up to 1 in 100
people).
The following side effects have been observed
during treatment with Tolterodine tartrate with
the following frequencies.
Very common (may affect more than 1 in 10
people) are dry mouth and headache.
Common (may affect up to 1 in 10 people)
• Bronchitis
• Dizziness, sleepiness, sensation of pins and
needles in the fingers and toes
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Difficulty in digestion(dyspepsia),
constipation, abdominal pain, excessive
amounts of air or gases in the stomach or
the intestine, vomiting
• Dry skin
• Painful or difficult urination, inability to
empty the bladder
• Tiredness, chest pain, extra fluid in the body
causing swelling (e.g in the ankles)
• Increased weight
• Diarrhoea
Uncommon (may affect up to 1 in 100 people)
• Allergic reactions
• Nervousness
• Increased heart rate, heart failure, irregular
heartbeat
• Gastroesophageal reflux (stomach acid
coming up from the stomach into
oesophagus with typical symptom heartburn)
• Memory impairment

Not known (frequency cannot be estimated
from the available data)
• severe allergic reactions, confusion,
hallucinations, flushed skin 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. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

5

How to store Tolterodine tartrate
film-coated tablets

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 label/carton. The expiry
date refers to the last day of that month..
This medicine does not require any special
storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Tolterodine tartrate contains
Tolterodine tartrate 1 mg film-coated tablets
The active substance is 1 mg of
tolterodine-L-tartrate (0.68 mg tolterodine base)
in each film-coated tablet.
Tolterodine tartrate 2 mg film-coated tablets
The active substance is 2 mg of
tolterodine-L-tartrate (1.37 mg tolterodine base)
in each film-coated tablet.
The other ingredients are:
Sodium starch glycolate (Type B),
microcrystalline cellulose, colloidal anhydrous
silica, calcium hydrogen phosphate dihydrate,
magnesium stearate, partially hydrolysed
polyvinyl alcohol, titanium dioxide E171, talc,
and macrogol.
What Tolterodine tartrate looks like and
contents of the pack
Description:
Film-coated tablets
Tolterodine tartrate 1 mg film-coated tablets:
White to off-white, round film-coated tablets
debossed with ‘93’ on one side and ‘10’ on the
other side.
Tolterodine tartrate 2 mg film-coated tablets:
White to off-white, round film-coated tablets
debossed with ‘93’ on one side and ‘18’ on the
other side.
Transparent PVC/PVdC-aluminium blister
package and cardboard box
1 mg:
14, 20, 28, 30, 50, 56, 60, 90 and 100
film-coated tablets in blisters. Hospital: 50, 60,
250, 280, 500 and 560 film-coated tablets.
2 mg:
14, 20, 28, 30, 50, 56, 60, 90 and 100
film-coated tablets in blisters. Hospital: 50, 280
and 560 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer:
TEVA UK Ltd, Eastbourne, BN22 9AG,
United Kingdom
This leaflet was last revised: July 2015
PL 00289/1126
PL 00289/1127

84050-D

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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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