Skip to Content

TOLTERODINE 2MG FILM-COATED TABLETS

Active substance(s): TOLTERODINE TARTRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Tolterodine 1mg & 2mg Film-coated Tablets
Tolterodine tartrate
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 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 or pharmacist. This includes any possible side effects
not listed in this leaflet.

What is in this leaflet
1.
What Tolterodine is and what it is used for
2.
What you need to know before you take Tolterodine Film-coated Tablets
3.
How to take Tolterodine Film-coated Tablets
4.
Possible side effects
5.
How to store Tolterodine Film-coated Tablets
6.
Contents of the pack and other information

1.

What Tolderodine is and what it is used for

The active substance in Tolterodine Film-coated Tablets 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
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 Film-coated Tablets

Do not take Tolterodine Film-coated Tablets 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 uncontrolled narrow angle glaucoma (increase in intraocular pressure)
suffer from excessive weakness of the muscles (myasthenia gravis)
suffer from ulceration and inflammation of the colon (severe ulcerative colitis)
suffer from acute dilatation of the colon (a toxic megacolon).
Warnings and precautions
Take special care with Tolterodine Film-coated Tablets if you
have difficulties in passing urine and/or a poor stream of urine
have a gastrointestinal disease that affects the passage and/or digestion of food
suffer from kidney problems (renal insufficiency)
have a liver condition
suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any
neuropathy of the autonomic nervous system)
have herniation of an abdominal organ (a hiatal hernia)
ever experience decreased bowel movements or suffer from severe constipation (decreased gastrointestinal motility)
1

-

-

have a heart condition such as:

an abnormal heart tracing (ECG);

a slow heart rate (bradycardia);

relevant pre-existing cardiac diseases (weak heart muscle (cardiomyopathy), reduced blood flow
to the heart (myocardial ischaemia), irregular heartbeat (arrhythmia) and heart failure)
have abnormally low levels of potassium (hypokalaemia), calcium (hypocalcaemia) or magnesium
(hypomagnesaemia) in your blood
are taking any medicine for the treatment of an irregular heartbeat (arrhythmia) (see 'Other medicines
and Tolterodine Film-coated Tablets').

Talk to your doctor or pharmacist before taking Tolterodine Film-coated Tablets if you think any of these
apply to you.
Other medicines and Tolterodine Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Tolterodine, the active substance of Tolterodine Film-coated Tablets, 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 and cisapride)
medicines for the treatment of irregular heartbeat (containing e.g. amiodarone, sotalol, quinidine,
procainamide) (see 'Warnings and precautions')
other medicines with antimuscarinic (medicines with a similar mode of action to Tolterodine) or
cholinergic (medicines with an opposite mode of action to Tolterodine) properties. Ask your doctor if
you are unsure.
Tolterodine Film-coated Tablets with food and drink
Tolterodine Film-coated Tablets can be taken before, after or during 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 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.
Driving and using machines
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 Film-coated Tablets

2

Dosage
Always take this medicine exactly as your doctor 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.
The tablets are for oral use and should be swallowed whole.
Use in children
Tolterodine is not recommended for children.
Duration of treatment
Your doctor will tell you how long your treatment with Tolterodine 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.
If you take more Tolterodine than you should
If you or somebody else takes too many tablets, contact your doctor, accident and emergency department or
pharmacy at once.
If you forget to take Tolterodine Film-coated Tablets
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 you
should not take the forgotten dose but follow the normal dose schedule.
If you stop taking Tolterodine Film-coated Tablets
Always consult your doctor if you are thinking of stopping the treatment.
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.
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 you 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.

3

Very Common (occurs in more than 1 in 10 patients) side effects are:
Dry mouth
Headache
Common (occurs in less than 1 in 10 patients) side effects are:
Bronchitis
Dizziness
Sleepiness
Sensation of pins and needles in the fingers and toes
Dry eyes
Blurred vision
Spinning sensation
Aware of the heartbeat (palpitations)
Bad digestion (dyspepsia)
Constipation
Abdominal pain
Excessive amounts of air or gases in the stomach or the intestine
Being sick (vomiting)
Diarrhoea
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
Uncommon (occurs in less than 1 in 100 patients) side effects are:
Allergic reactions
Nervousness
Increased heart rate
Heart failure
Irregular heartbeat
Heart burn
Memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations (seeing, hearing,
feeling, tasting or smelling things that are not there), disorientation, flushing and angioedema.
There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet.

5.

How to store Tolterodine 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 pack after EXP. The expiry date refers to
the last day of that month.
Store below 30ºC.
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 to protect the environment.
4

6.

Contents of the pack and other information

What Tolterodine Film-coated Tablets contain
-

The active substance in Tolterodine 1 mg Film-coated Tablets is 1 mg of tolterodine tartrate,
equivalent to 0.68 mg of tolterodine.
The active substance in Tolterodine 2 mg Film-coated Tablets is 2 mg of tolterodine tartrate,
equivalent to 1.37 mg of tolterodine.
The other ingredients are: magnesium stearate, silica colloidal anhydrous, sodium starch glycolate type
B, calcium hydrogen phosphate dihydrate, cellulose microcrystalline, polyethylene glycol 400,
polyethylene glycol 8000, hypromellose (E 464), hydroxypropyl cellulose (E 463), titanium dioxide (E
171).

What Tolterodine Film-coated Tablets look like and contents of the pack
Film-coated tablets.
1 mg: White, round, biconvex, 5.5 mm film-coated tablets marked with “T1” on the one side
2 mg: White, round, biconvex, 5.5 mm film-coated tablets marked with “T2” on the one side

Pack sizes:
Blister packs: 4, 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 100, 280, 500, 560 tablets
Tablet container: 4, 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 100, 280, 500, 560 tablets
Not all pack sizes may be marketed1.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
Unit 4, Charlwood Court,
County Oak Way,
Crawley,
West Sussex
RH11 7XA
Manufacturer:
Actavis ehf.
Reykjavikurvegur 78,
IS-220 Hafnafjordur
ICELAND

This leaflet was last revised in 05/2015.
1

The printed leaflet will only state the actual marketed pack sizes

5

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