Tolterodine Tartrate 2 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tolterodine tartrate 1mg film-coated tablets Tolterodine tartrate 2mg film-coated tablets
Tolterodine L-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 further questions, ask your doctor or your 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 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
1. WHAT TOLTERODINE TARTRATE IS AND WHAT IT IS USED FOR
Tolterodine 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, that you need to rush to the toilet with no advance warning and/or go to the toilet frequently.
2. BEFORE YOU TAKE TOLTERODINE TARTRATE
Do not take Tolterodine tartrate
• If you are allergic (hypersensitive) 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 megacoion).
Take special care with 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'Taking other medicines').
Ask your doctor or pharmacist before starting treatment with Tolterodine tartrate if you think any of these might apply to you.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tolterodine 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. Tolterodine 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) (see'Take special care with Tolterodine tartrate')
• 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).
Taking Tolterodine tartrate with food and drink
Tolterodine tartrate can be taken before, after or during a meal. Pregnancy and Breast-feeding
Pregnancy
There is insufficient experience with the use of Tolterodine tartrate during pregnancy. As Tolterodine tartrate may harm your unborn child, 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 passed on in the mother's breast milk. Breast-feeding is not recommended while taking Tolterodine tartrate.
Driving and using machines
Tolterodine tartrate 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. Important information about some of the ingredients:
This medicine contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars speak to your doctor before taking Tolterodine tartrate.
3. HOWTO TAKE TOLTERODINE TARTRATE
Always take Tolterodine tartrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
The usual dose is 2mg twice daily.
Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may reduce your dose to 1 mg twice daily.
Children
Tolterodine tartrate is not recommended for children.
The tablets are for oral use and should be swallowed whole. The benefit of the treatment should be re-evaluated after 2 or 3 months.
If you take more Tolterodine tartrate than you should:
If you or someone else takes too many tablets, contact your doctor or pharmacist at once. Symptoms of overdose include symptoms from central nervous system (convulsions, hallucinations), difficulties in breathing, heart problems (increased heart rate), inability to pass urine, abnormal dilation of pupils.
If you forget to take Tolterodine tartrate
Do not take a double dose to make up for the forgotten dose.
If you have forgotten to take your tablet at the usual time, you can take it as soon as you remember unless it is almost time for your next dose. In this case follow the normal dose schedule.
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
If you stop taking Tolterodine tartrate
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.
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,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 (allergic reaction), such as:
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulty in breathing
or if you experience symptoms of heart failure:
• chest pain
• difficulty breathing or getting tired easily (even at rest)
• difficulty breathing at night
• swelling of the legs
You should also seek medical attention immediately if you experience a hypersensitivity reaction (for example itching, rash, hives, difficulty breathing).
The following side effects have been observed during treatment with Tolterodine tartrate with the following frequencies.
very common common uncommon rare
very rare not known
Very common:
• Dry mouth
• Headache Common:
• Bronchitis
• Dizziness
• Sleepiness
• Sensations of pins and needles in the fingers and toes
• Dry eyes
• Blurred vision
• Spinning sensation
• Palpitations
• Bad digestion (dyspepsia)
• Constipation
• Abdominal pain
• Excessive amounts of air or gases in the stomach or the intestine
• Being sick (vomiting)
• Dry skin
• Diarrhoea
• Inability to empty the bladder
• Painful or difficult urination
• Chest pain
• Tiredness
• Increased weight
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Vertigo Uncommon:
• Allergic reactions
• Irregular heartbeat
• Nervousness
• Heart burn
• Increased heart rate
• Memory impairment
• Heart failure
Not known:
• Confusion
• Flushing
• Disorientation
• Severe allergic reactions
• Hallucinations (seeing, hearing, feeling, tasting or smelling things that are not there)
• Angioedema
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 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
The active substance is Tolterodine L-tartrate.
Each Img film-coated tablet contains Img 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, polyethyleneglycol, titanium dioxide (E171).
What Tolterodine tartrate looks like and contents of the pack
Tolterodine tartrate Img film-coated tablets are white, round biconvex film-coated tablets, embossed with'l'on one side. Tolterodine tartrate 2 mg 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.
Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder:
Aspire Pharma Ltd Bellamy House Winton Road Petersfield Hampshire GU323HA United Kingdom Manufacturers:
Pharmathen S.A.
6, Dervenakion Str.
153 5l Pallini Attiki
Greece
and
Pharmathen International S.A.
Sapes Industrial Park Block 5,69300 Rodopi Greece
This leaflet was last approved in
02/2013