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Tolterodin Pfizer

Information för alternativet: Tolterodin Pfizer 2 Mg Filmdragerad Tablett, visar 2 alternativ


Package leaflet: Information for the user


Tolterodin Pfizer 1 mg & 2 mg film-coated tablets

Tolterodine tartrate


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.



What is in this leaflet:


What Tolterodin Pfizer is and what it is used for

What you need to know before you take Tolterodin Pfizer

How to take Tolterodin Pfizer

Possible side effects

How to store Tolterodin Pfizer

Contents of the pack and other information


1. What Tolterodin Pfizer is and what it is used for


Tolterodin Pfizer contains the active substance tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.

Tolterodin Pfizer is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that:


2. What you need to know before you take Tolterodin Pfizer


Do not take Tolterodin Pfizer:



Warnings and precautions


Talk to your doctor or pharmacist before taking Tolterodin Pfizer

  • 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


Children and adolescents


Efficacy of Tolterodin Pfizer has not been demonstrated in children. Therefore, Tolterodin Pfizer is not recommended for children


Other medicines and Tolterodin Pfizer


Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


Tolterodine, the active substance of Tolterodin Pfizer, may interactwith other medicinal products.


It is not recommended to use tolterodine in combination with:


Tolterodin Pfizer should be used with caution when taken in combination with:


Tolterodin Pfizer with food and drink

Tolterodin Pfizer 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 Tolterodin Pfizer when you are pregnant.


Breast-feeding

It is not known if tolterodine, the active substance of Tolterodin Pfizer, is excreted in the mother’s breast milk. Breast-feeding is not recommended during administration of Tolterodin Pfizer.


Ask your doctor or pharmacist for advice before taking any medicine.


Driving and using machines

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


3. How to take tolterodinpfizer


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.



Method of administration:

The tablets are for oral use and should be swallowed whole.


Duration of treatment:

Your doctor will tell you how long your treatment with Tolterodin Pfizer 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 Tolterodin Pfizer than you should:

If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.


If you forget to take Tolterodin Pfizer

If you forget to take a dose at the usual time, take it as soon as you remember unless it is almost time for your 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 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:


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 Tolterodin Pfizer with the following frequencies.


Very common: (may affect more than 1 in 10 people)


Common: (may affect up to 1 in 10 people)


Uncommon: (may affect up to 1 in 100 people)


Additional reactions reported include 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.


If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Tolterodin Pfizer


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 carton, bottle label and blister after EXP. The expiry date refers to the last day of that month.


No special precautions for storage.


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 Tolterodin Pfizer contains

The active substance is tolterodine.

Each film-coated tablet contains 1 mg tolterodine tartrate, equivalent to 0.68 mg of tolterodine.

The active substance is tolterodine.

Each film-coated tablet contains 2 mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.


The other ingredients are:

Core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica.


Film coating: Hypromellose, microcrystalline cellulose, stearic acid and titanium dioxide (E171).


What Tolterodin Pfizer looks like and contents of the pack


Tolterodin Pfizer 1 mg tablets are white, round, biconvex and marked with arcs above and below the lettering TO.


Tolterodin Pfizer 2 mg tablets are white, round, biconvex and marked with arcs above and below the lettering DT.


Tolterodin Pfizer 1 mg and 2 mg tablets are available in the following pack sizes:

Blister packs containing 14, 20, 28, 30, 50, 56, 98 100, 280 or 560 tablets.


Bottles containing 60 or 500 tablets.

Not all pack sizes may be marketed.


Marketing authorisation holder and manufacturer


[To be completed nationally]


This medicinal product is authorised in the following Member States of the EEA under the trade name:

Tolterodine Pfizer: Belgium, France, Luxembourg, Netherlands

Tolterodin Pfizer: Austria, Finland, Germany, Sweden

Tolterodina Pfizer: Italy

Tolterodina Pharmacia: Spain

Santizor: Greece

Tolterodine tartrate (1 mg/2 mg) film-coated tablets: UK


This leaflet was last approved in: 2015-10-22