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teva UK Ref: 231-30-84050-C LEA TOLTERODINE A/S TAB TUK	Version: 1	23 June 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

TOLTERODINE TARTRATE 1 mg FILM-COATED TABLETS TOLTERODINE TARTRATE 2 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 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.

IN THIS LEAFLET:

1.    What Tolterodine tartrate is and what it is used for

2.    Before you take Tolterodine tartrate

3.    How to take Tolterodine tartrate

4.    Possible side effects

5.    How to store Tolterodine tartrate

6.    Further information

OWHAT TOLTERODINE TARTRATE IS AND WHAT IT IS USED FOR

^^2 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 toiletwith 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 of Tolterodine tartrate Film-coated Tablets

•    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

•    Ifyou 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)

•    Ifyousufferfrom anyliverdisease

•    If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)

•    Ifyou have a hiatal hernia (herniation ofan abdominal organ)

•    Ifyou ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility)

•    If you have a heart condition such as:

•    anabnormalhearttracing(ECG);

•    aslowheartrate(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

•    Ifyouhaveabnormallylowlevelsof 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.

Taking 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 tartrate (antimuscarinic 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 ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking 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 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 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 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

Always takeTolterodine tartrate 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.

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 withTolterodine 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.

TEVA UK Ref: 231-30-84050-C LEA TOLTERODINE A/S TAB TUK	Version: 1	23 June 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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

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 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 go to the casualty department if you experience symptoms of angioedema such as

•    swollen face, tongue or pharynx

•    difficultytoswallow

•    hivesanddifficultyinbreathing.

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 Tolterodine tartrate with the following frequencies.

The most common reported side effects (occurs in more than 1 in 10 patients) are dry mouth and 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

•    Dryeyes,blurredvision

•    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 side effects (occurs in less than 1 in 100 patients) are:

•    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)

•    Memoryimpairment.

Not known side effects (frequency cannot be estimated from the available data) are:

•    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 TOLTERODINE TARTRATE

Keep out of the reach and sight of children.

Do not use Tolterodine tartrate after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.

No special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 FURTHER 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). Tolterodine tartrate 2 mg Film-coated Tablets The active substance is 2 mg of tolterodine-L-tartrate (1.37 mg tolterodine base).

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

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: 06/2014

PL 00289/1126 PL 00289/1127

TFWTI

Teva Pharmaceuticals Europe B.V

1.3.2

m

ated-tablets-ISR

Approvals

Signed by Meaning of Signature	Server Date
Divya Jain Regulatory Affairs Approval	24-Jun-2014 08:47:11 AM