PACKAGELEAFLET: INFORMATION FOR THE USER

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

Tolterodine tartrate

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

•    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 or nurse. See Section 4.

What is in this leaflet:

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

2.    Before you take Toltrat XL

3.    How to take Toltrat XL

4.    Possible side effects

5.    How to store Toltrat XL

6.    Further information

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

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

Toltrat 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. What you need to know before you take Toltrat XL Do not take Toltrat XL:

•    if you are allergic (hypersensitive) to tolterodine or any of the other ingredients in [Tolterodine] (see section 6 for a list of the ingredients)

•    if you are unable to pass urine from the bladder (urinary retention)

•    if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with Loss of eye sight that is not being adequately treated)

•    if you suffer from myasthenia gravis (excessive weakness of the muscles)

•    if you suffer from severe ulcerative colitis (ulceration and inflammation of the colon)

if you suffer from atoxic megacolon (acute dilatation of the colon).

Take special care with Toltrat 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)

-    as low heart rate (bradycardia)

-    relevant pre-existing cardiac diseases such as: cardiomyopathy (weak heart muscle), myocardial ischaemia (reduced blood flow to the heart), arrhythmia (irregular heart beat) 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 Toltrat XL if you think any

of these might apply to you.

Other medicines and Toltrat XL

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 Toltrat 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, traconazole)

•    medicinal products used for the treatment of HIV

Toltrat 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 heart beat (containing e.g. amiodarone, sotalol, quinidine, procainamide

• Other medicines with a similar mode of action to Toltrat XL (antimuscarinic properties) or medicines with an opposite mode of action to Toltrat 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 Toltrat XL with food and drink

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

Pregnancy and breast-feeding

Pregnancy

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

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

Driving and using machines

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

Toltrat XL contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Toltrat XL Dosage:

Always take Toltrat 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 4mg 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 Toltrat XL daily.

Children:

Toltrat XL is not recommended for children.

If you have taken more Toltrat 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 Toltrat 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.

Duration of treatment

Your doctor will tell you how long your treatment with Toltrat 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 Toltrat 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 inbreathing

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 Toltrat 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 than1 in 10 patients) are:

•    Sinusitis

•    Sleepiness

•    Dry eyes

•    Difficulty with digestion

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

•    Allergic reactions    •

•    Nervousness    •

•    Palpitations    •

•    Inability to empty the bladder •

•    Vertigo    •

Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heartburn, vomiting, angioedema, dry skin, 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. Website: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Toltrat XL

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

Do not use Toltrat 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 Toltrat XL contains

The active substance in Toltrat XL 2 mg prolonged-release capsules, hard is 2 mg of tolterodine

tartrate, equivalent to 1,37 mg of tolterodine.

The active substance in Toltrat 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 laurel sulfate, sodium docusate, magnesium stearate, hydroxypropylmethyl cellulose 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 Toltrat XL looks like and contents of the pack

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

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

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

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

Blister packs containing: 28, 30, 100 prolonged-release capsules HDPE bottles containing 30, 100 capsules

Toltrat XL 4 mg prolonged-release hard capsules are available in the following pack sizes:

Blister packs containing: 7, 14, 28, 30, 49, 56, 84, 98, 100, 112, 126 prolonged-release HDPE bottles containing: 30, 100 capsules

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG StadastraBe 2 -18 61118 Bad Vilbel Germany

Manufacturer:

STADA Arzneimittel AG StadastraBe 2 -18 61118 Bad Vilbel Germany

And

Pharmathen S.A 6, Dervenakion Str.,

153 51 Pallini Attiki Greece

And

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

And

Eurogenerics N.V.

Heizel Esplanade B22 1020 Brussels Belgium

And

LAMP SAN PROSPERO S.p.A. Via della Pace, 25/A 41030 San Prospero (Modena) Italy

And

PharmaCoDane ApS Marielundvej 46 A,

DK-2730 Herlev Denmark

And

Clonmel Healthcare Ltd Waterford Road,

Clonmel, Co. Tipperary Ireland

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

UK: Toltrat XL 2 mg/4 mg Prolonged-release Capsules DK: Tolterodin “Stada”

ES: Tolterodina Neo STADA 4 mg capsulas duras de liberacion prolongada EFG IE: Toltertan SR 2 mg/4 mg Prolonged-Release Capsules SE : Tolterodin STADA depotkapsel, hard

This leaflet was last revised in 09/2016.

7