Tolterodine tartrate 2mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tolterodine tartrate is and what it is used for
2. What you need to know before you take Tolterodine tartrate
3. How to take Tolterodine tartrate
4. Possible side effects
5. How to store Tolterodine tartrate
6. Contents of the pack and other information

• If you are allergic to tolterodine or any of the other ingredients in this medicine (see section 6. “Further information”).
• If you are unable to pass urine from the bladder (urinary retention).
• If you have an increased eye pressure that is not being adequately treated (uncontrolled narrow angle glaucoma).
• If you suffer from a certain muscle weakness (myasthenia gravis).
• If you suffer from an ulceration and inflammation of the colon (severe ulcerative colitis).
• If you suffer from an acute dilation of the colon (toxic megacolon).

Talk to your doctor or pharmacist before taking 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.
• If you have a liver condition.
• If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (autonomic neuropathy).
• If a part of your stomach protrudes through the diaphragm (hiatus hernia).
• If you experienced decreased bowel movements or suffer from severe constipation.
• If you have a heart condition such as:
  • an abnormal heart tracing (ECG)
  • a slow heart rate (bradycardia)
  • relevant pre-existing cardiac diseases (weak heart muscle [cardiomyopathy], reduced blood flow to the heart [myocardial ischaemia], irregular heartbeat [arrhythmia] and heart failure).
• If you have abnormally low levels of potassium, calcium or magnesium in your blood.
• If you are taking any medicine for the treatment of an irregular heartbeat (see “Other medicines and Tolterodine tartrate”).

Ask your doctor or pharmacist before starting treatment with Tolterodine tartrate if you think any of these might apply to you.

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

Tolterodine, the active substance of Tolterodine tartrate 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.

• 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 medicinal products with a similar mode of action to Tolterodine tartrate (antimuscarinic properties) or with an opposite mode of action to Tolterodine tartrate (cholinergic properties).

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 is excreted in the mother’s breast milk. Breast-feeding is not recommended while taking this medicine.

Tolterodine tartrate may make you feel dizzy, tired or affect your sight. Your ability to drive or operate machinery may be affected.

If you have been told that you have an intolerance to some sugars speak to your doctor before taking Tolterodine tartrate.

This medicine contains less than 1mmol sodium (23mg) per 1mg and 2mg film-coated tablets, that is to say essentially “sodium-free”.

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

Symptoms in case of overdose include convulsions, hallucinations, excitation, a heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.

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 the forgotten dose.

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.

Always consult your doctor if you are thinking of stopping the treatment.

If you get any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is Tolterodine L-tartrate.

Each 1mg film-coated tablet contains 1mg tolterodine L-tartrate (equivalent to 0.68mg of tolterodine).

Each 2mg film-coated tablet contains 2mg tolterodine L-tartrate (equivalent to 1.37mg of tolterodine).

The other ingredients are:

Core: Microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate.

Film-coating: Hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E171).

Tolterodine tartrate 1mg film-coated tablets are white, round biconvex film-coated tablets, embossed with “1” on one side. Tolterodine tartrate 2mg film-coated tablets are white, round biconvex film-coated tablets, embossed with “2” on one side and with a score line on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

PVC/PE/PVDC Aluminium blister:

Pack sizes of 14, 20, 28, 30, 50, 56, 60 and 100 film-coated tablets.

HDPE tablet container with a child-resistant PP screw cap:

Pack sizes of 60 film-coated tablets.

Not all pack sizes may be marketed.

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