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Document: leaflet MAH BRAND_PL 17277-0271 change

• leaflet ASPIRE PHARMA_PL 17277-0271
• leaflet MAH BRAND_PL 17277-0271

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Neditol XL 2mg prolonged-release capsules, hard Neditol XL 4mg 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 Neditol XL is and what it is used for

2.    Before you take Neditol XL

3.    How to take Neditol XL

4.    Possible side effects

5.    How to store Neditol XL

6.    Further information

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

The active substance in Neditol XL is tolterodine. Tolterodine antimuscarinics.

Neditol XL is used for the treatment of the symptoms of 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 Neditol XL Do not take Neditol XL if you:

•    are allergic (hypersensitive) to tolterodine or any of the other ingredients in Neditol 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 Neditol 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-inestinal 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 Neditol 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 Neditol 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

Neditol 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 Neditol XL (antimuscarinic properties) or medicines with an opposite mode of action to Neditol 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 Neditol XL with food and drink

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

Pregnancy and breast-feeding Pregnancy

You should not use Neditol 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 Neditol XL, is excreted in the mother's breast milk. Breastfeeding is not recommended during administration of Neditol XL.

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

Driving and using machines

Neditol 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 Neditol XL Dosage:

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

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

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 Neditol XL daily.

Children:

Neditol XL is not recommended for children.

If you have taken more Neditol 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 Neditol 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 Neditol XL

Your doctor will tell you how long your treatment with Neditol 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, Neditol 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 Neditol 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

•    Sleepiness

•    Dry eyes

•    Difficulty with digestion (dyspepsia)

•    Abdominal pain

•    Painful or difficult urination

•    Extra fluid in the body causing swelling (e.g. in the ankles)

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

•    Allergic reactions    •    Heart failure

•    Nervousness    •    Irregular heartbeat

•    Palpitations    •    Chest pain

•    Inability to empty the bladder    • Sensation of pins and needles in the fingers and toes

•    Vertigo    •    Memory impairment

Additional reactions reported 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 Neditol XL

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

Do not use Neditol 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 Neditol XL contains

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

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

The other ingredients are:

Lactose monohydrate, cellulose microcrystalline, poly(vinyl acetate), povidone, silica, sodium lauryl sulfate,

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, silica and sodium laurilsulfate

What Neditol XL looks like and contents of the pack

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

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

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

Neditol XL 2mg prolonged-release hard capsules are available in the following pack sizes:

Blister packs containing: 14, 28, 56, 84 prolonged-release hard capsules HPDE bottles containing: 30, 100 and 200 prolonged-release hard capsules.

Neditol XL 4mg prolonged-release hard capsules are available in the following pack sizes: Blister packs containing: 7, 14, 28, 49, 56, 84, 98 prolonged-release hard capsules 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 SA 6 Dervenakion str

This leaflet was last revised in 03/2012 1010082-P1.3