Tolterodine Tartrate 2mg Tablets

Leaflet

Ref: 1305/120115/1 /F

Detrusitol” 2mg Tablets

(tolterodine tartrate)

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

* 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Detrusitol 2mg Tablets but will be referred to as Detrusitol throughout this Patient Information Leaflet.

In this leaflet:

^ What Detrusitol is and what it is used for Before you take Detrusitol How to take Detrusitol Possible side effects How to store Detrusitol .6 Further information

^ What Detrusitol is and what it is used for

The active substance in Detrusitol is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.

Detrusitol 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.

Before you take Detrusitol

Do not take Detrusitol if you:

* Are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol;

_* 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).

Take special care with Detrusitol:

* 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 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 Detrusitol if you think any of these might apply to you.

Taking other medicines

Tolterodine, the active substance of Detrusitol, 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.

Detrusitol 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 Detrusitol (antimuscarinic properties) or medicines with an opposite mode of action to Detrusitol (cholinergic properties). Ask your doctor if you are unsure.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Detrusitol with food and drink

Detrusitol can be taken before, after or during a meal.

Pregnancy and breast-feeding Pregnancy

You should not use Detrusitol 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, the active substance of Detrusitol, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Detrusitol.

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

Driving and using machines

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

How to take Detrusitol

Dosage

Always take Detrusitol 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.

Detrusitol 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 Detrusitol 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.

Detrusitol ® 2mg Tablets

(tolterodine tartrate)

Patient Information Leaflet (continued)

If you have taken more Detrusitol than you should:

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

If you forget to take Detrusitol

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 one.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

^ Possible side effects

Like all medicines, Detrusitol can cause side effects, although not everybody gets them.

You should see your doctor immediately or go 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 Detrusitol with the following frequencies.

Very common side effects (occurs in more than 1 in 10 patients) are:

_* Dry mouth.

_* Headache.

Common side effects (occurs in less than 1 in 10 patients) are:

_* Bronchitis.

_* Dizziness, sleepiness, sensation of pins and needles in the fingers and toes.

_* Dry eyes, blurred vision.

* Vertigo.

_* Palpitations.

_* Difficulty with 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 side effects (occurs in less than 1 in 100 patients) are:

_* Allergic reactions.

* Nervousness.

* Increased heart rate, heart failure, irregular heartbeat.

_* Heart burn.

_* Memory impairment

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.

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.

How to store this medicine

* Keep this medicine out of the reach and sight of children.

_* Do not take your tablets out of the blister strip until it is time to take your dose.

_* Do not use this medicine after the expiry date shown on the carton label or blister strip. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

* Remember this medicine is for you. Only a doctor can prescribe it. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you.

Further information

What Detrusitol contains

Each film-coated tablet contains 2mg tolterodine L-tartrate as the active ingredient.

Your medicine also contains the following inactive ingredients: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycollate, colloidal anhydrous silica, hypromellose, stearic acid, titanium dioxide (E171), and magnesium stearate.

What Detrusitol looks like and contents of the pack

They are white, round, biconvex, film coated tablets. Engraved with arcs above and below the letters 'DT' one one side.

Each pack contains 28 or 56 tablets.

Manufacturer and Licence Holder

The tablets are manufactured by Pfizer Italia S.r.l, Localita Marino del Tronto, 63100 Ascoli Piceno, Italy and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 15184/1305 - Detrusitol 2mg Tablets

Detrusitol is a registered trademark of Pfizer Health AB. Leaflet revision date: 12/01/15

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Tolterodine tartrate 2mg Tablets

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine

* 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Your medicine is called Tolterodine tartrate tartrate 2mg Tablets but will be referred to as Tolterodine tartrate tartrate throughout this Patient Information Leaflet.

In this leaflet:

What Tolterodine tartrate is and what it is used for Before you take Tolterodine tartrate How to take Tolterodine tartrate Possible side effects How to store Tolterodine tartrate Further information

What Tolterodine tartrate is and what it is used for

The active substance in Tolterodine tartrate is tolterodine tartrate. 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.

Before you take Tolterodine tartrate

Do not take Tolterodine tartrate if you:

* Are allergic (hypersensitive) to tolterodine tartrate or any of the other ingredients in Tolterodine tartrate;

_* 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).

Take special care with 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 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 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 if you think any of these might apply to you.

Taking other medicines

Tolterodine tartrate, the active substance of 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 tartrate (antimus carinic properties) or medicines with an opposite mode of action to Tolterodine tartrate (cholinergic properties). Ask your doctor if you are unsure.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Tolterodine tartrate with food and drink

Tolterodine tartrate can be taken before, after or during a meal.

Pregnancy and breast-feeding 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 tartrate, the active substance of Tolterodine tartrate, is excreted in 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.

How to take Tolterodine tartrate

Dosage

Always take Tolterodine tartrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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.

Tolterodine tartrate 2mg Tablets

Patient Information Leaflet (continued)

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 immediately.

If you forget to take Tolterodine tartrate

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 one.

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 tartrate can cause side effects, although not everybody gets them.

You should see your doctor immediately or got the casualty department if you experience symptoms of angioedema, such as:

* Swollen face, tongue or pharynx;

* difficulty to swallow;

* hives and difficulty in breathing.