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1. Tolthen Xl 4 Mg Prolonged-Release Capsules Hard
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tolthen XL 2 mg prolonged-release capsules, hard Tolthen XL 4 mg prolonged-release capsules, hard

Tolterodine tartrate

Read all of this leaflet carefully before you start using 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.

In this leaflet:

1.    What Tolthen XL is and what it is used for

2.    Before you take Tolthen XL

3.    How to take Tolthen XL

4.    Possible side effects

5.    How to store Tolthen XL

6.    Further information

1. What Tolthen XL is and what it is used for

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

Tolthen XL 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. Before you take Tolthen XL Do not take Tolthen XL if you:

•    are allergic (hypersensitive) to tolterodine or any of the other ingredients in Tolthen XL (see section 6 for a list of the ingredients)

•    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 Tolthen XL:

•    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 neurological disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system).

•    If you have a hiatus 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.

Contains approximately 67.2mg lactose (33.6mg glucose and 33.6mg galactose) per dose. This should be taken into account in patients with diabetes mellitus.

This medicinal product contains 0.00404 mmol (or 0.092988 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Talk to your doctor or pharmacist before starting your treatment with Tolthen XL if you think any of these might apply to you.

Taking other medicines

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

Tolterodine, the active substance of Tolthen XL, 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

Tolthen XL 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 Tolthen XL (antimuscarinic properties) or medicines with an opposite mode of action to Tolthen XL (cholinergic properties). The reduction in gastric motility caused by

antimuscarinics may affect the absorption of other drugs. Ask your doctor if you are unsure.

Taking Tolthen XL with food and drink

Tolthen XL can be taken before, after or during a meal.

Pregnancy and breast-feeding

Pregnancy

You should not use Tolthen XL 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 Tolthen XL, is excreted in the mother’s breast milk. Breast-feeding is not recommended during administration of [Tolterodine].

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

Driving and using machines

Tolthen XL may make you feel dizzy, tired or affect your sight. If you experience any of these affects then you should not drive your car or operate heavy machinery.

3. How to take Tolthen XL

Dosage:

Always take Tolthen XL exactly as your doctor has told you. You doctor or pharmacist if you are not sure.

The prolonged-release hard capsules are for oral use and should be

Do not chew the capsules.

Adults:

The usual dose is one 4 mg prolonged-release hard capsule daily.

Patients with liver or kidney problems:

In patients with liver or kidney problems your doctor may reduce your dose to 2 mg Tolthen XL daily.

Children:

Tolthen XL is not recommended for children.

If you have taken more Tolthen XL than you should:

If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. Symptoms in case of overdose include hallucinations, excitation, a heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.

If you forget to take Tolthen XL :

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 stop taking Tolthen XL

Your doctor will tell you how long your treatment with Tolthen XL 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 prolonged-release capsules 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.

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

4. Possible side effects

Like all medicines, Tolthen XL 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 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 Tolthen XL with the following frequencies.

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

•    Dry mouth

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

•    Sinusitis    •    Dizziness

•    Sleepiness    •    Headache

Additional reactionsreported include severe allergic reactions,confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.

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

5. How to store Tolthen XL

Keep Tolthen XL out of the reach and sight of children.

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

Do not store above 25°C

HDPE bottle: Shelf life after first opening is 200 days

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 Tolthen XL contains

The active substance in Tolthen XL 2 mg prolonged-release capsules, hard is 2 mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.

The active substance in Tolthen XL 4 mg prolonged-release capsules, hard is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.

The other ingredients are:

Lactose monohydrate, cellulose microcrystalline, poly (vinyl acetate), povidone, silica, sodium laurilsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose Capsule composition: indigo carmine (E132), quinoline yellow (only in 2 mg) (E104), titanium dioxide (E171), gelatin

Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, 1,2-Propylene glycol

What Tolthen XL looks like and contents of the pack

Tolthen XL is a hard prolonged-release capsule designed for once daily dosing.

Tolthen XL 2 mg prolonged-release hard capsules are opaque green-opaque-green.

Tolthen XL 4 mg prolonged-release hard capsules are light blue-opaque-light blue opaque.

Tolthen XL 2 mg prolonged-release hard capsules are available in the following pack sizes: Blister packs containing: 14, 28, 84 prolonged-release hard capsules

Tolthen XL 4 mg prolonged-release hard capsules are available in the following pack sizes: Blister packs containing: 7, 14, 28, 49, 84, 98 prolonged-release hard capsules

2mg and 4mg:

HPDE bottles containing: 30, 100 and 200 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Pharmathen S.A., 6 Dervenakion str., Pallini Attki, 153 51 Greece Manufacturer:

Pharmathen S.A., 6 Dervenakion str., Pallini Attki, 153 51 Greece Or

Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece Or

Portfarma ehf., Borgartuni 26, 105 Reykjavik, Iceland Or

Pharmadox Healthecare Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta Or

Pharmacare Premium Ltd., HHF 003, Hal Far Industrial Estate, Birzebbugia BBG3000. Malta

This medicinal product is authorized in the Member States of the EEA under the following names:

UK    Tolthen XL 2mg, 4mg prolonged release capsules

DE    Tolterodin-Hormosan 2 mg/4mg Hartkapseln, retardiert

PL    Titlodine 2mg, 4mg prolonged release capsules

IT    Tolterodina Doc

BE    Urolina 2mg, 4mg prolonged release capsules

LU    Urolina 2mg, 4mg prolonged release capsules

NL    Uroline 2mg, 4mg prolonged release capsules

This leaflet was last approved in 03/2012

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