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TOLTERODINE 1MG FILM-COATED TABLETS

Active substance(s): TOLTERODINE TARTRATE

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Package leaflet: Information for the user

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.

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.

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

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

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).

1. What Tolderodine is and what it is used for

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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.

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

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).

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.

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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.

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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

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 gastro-intestinal motility)
have a heart condition such as:
o
an abnormal heart tracing (ECG);
o
a slow heart rate (bradycardia);
o
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').

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If you get any side effects, talk to your doctor or pharmacist. This includes
any side effects not listed in this leaflet.
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
(see details below). By reporting side effects you can help provide more information on
the safety of this medicine.

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United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard

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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.

Tolterodine Film-coated Tablets with food and drink
Tolterodine Film-coated Tablets can be taken before, after or during a meal.

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.

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.

6. Contents of the pack and other information

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.

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).

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.

What Tolterodine Film-coated Tablets look like and contents of the pack

3. How to take Tolterodine Film-coated Tablets

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

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.

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 marketed.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court, County Oak Way,
Crawley, West Sussex
RH11 7XA

The benefit of the treatment should be re-evaluated after 2 or 3 months.

Manufacturer:
Actavis ehf.
Reykjavikurvegur 78,
IS-220 Hafnafjordur
ICELAND

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.

This leaflet was last revised in 09/2017.

8065212-7803

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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

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for your next dose. In that case you should not take the forgotten dose but follow the
normal dose schedule.

Tolterodine 1mg & 2mg Film-coated Tablets
Tolterodine tartrate

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2.
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4.
5.
6.

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Front

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Tolterodine 1mg & 2 mg
Leaflet cutter guide
size: 123 x 480 mm

Colour Black

LOCATION : -

COUNTRY : UK

SIZE : 123 x 480 mm_Front/Back

Supersedes A /W No.:
V. No.: 01

CODE : 8065212-7803

DATE : 28-09-2017

REMARK :
SUBSTRATE :
Activities

Department

Name

Signature

Date

Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Approved By Quality

This colour proof is not colour binding. Follow Pantone shade reference for actual colour matching.

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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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