Tolterodine Tartrate 2mg Film-Coated Tablets
Tolterodine tartrate 1 mg and 2mg Film-coated Tablets
(Tolterodine tartrate)
Read all of this leaflet carefully before you start
taking 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.
• The full name of this medicine is Tolterodine tartrate 1mg and 2mg Film-coated Tablets but within the leaflet it will be referred to as Tolterodine tablets.
What is in this leaflet
j What Tolterodine tablets are and what they are used for
J] What you need to know before you take Tolterodine tablets
J] How to take Tolterodine tablets Possible side effects How to store Tolterodine tablets Contents of the pack and other information
j What Tolterodine tablets are and what they are used for
The active substance in Tolterodine tablets is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.
Tolterodine 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.
What you need to know before you take Tolterodine tablets
Do not take Tolterodine tablets if you
• are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6)
• are unable to pass urine from the bladder (urinary retention)
• have uncontrolled narrow angle glaucoma (increase in intraocular pressure)
• suffer from excessive weakness of the muscles (myasthenia gravis)
• suffer from ulceration and inflammation of the colon (severe ulcerative colitis)
• suffer from acute dilatation of the colon (a toxic megacolon).
Warnings and precautions
Take special care with Tolterodine tablets if you
• have difficulties in passing urine and/or a poor stream of urine
• have a gastrointestinal disease that affects the passage and/or digestion of food
• suffer from kidney problems (renal insufficiency)
• have a liver condition
• suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
• have herniation of an abdominal organ (a hiatal hernia)
• ever experience decreased bowel movements or suffer from severe constipation (decreased gastro-intestinal motility)
• 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)
• have abnormally low levels of potassium
(hypokalaemia), calcium (hypocalcaemia) or magnesium (hypomagnesaemia) in your blood
• are taking any medicine for the treatment of an irregular heartbeat (arrhythmia) (see 'Other medicines and Tolterodine tablets).
Talk to your doctor or pharmacist before taking Tolterodine tablets if you think any of these apply to you.
Other medicines and Tolterodine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tolterodine, the active substance of Tolterodine tablets, may interact with other medicinal products.
It is not recommended to use Tolterodine tablets 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 tablets 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 'Warnings and precautions')
• other medicines with antimuscarinic (medicines with a similar mode of action to tolterodine) or cholinergic (medicines with an opposite mode of action to tolterodine) properties. Ask your doctor if you are unsure.
Tolterodine tablets with food and drink
Tolterodine tablets can be taken before, after or during a meal.
Pregnancy and breast-feeding
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 tablets 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 during administration of Tolterodine tablets.
Driving and using machines
Tolterodine tablets may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.
31 How to take Tolterodine tablets Dosage
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one 2mg tablet twice daily, except for patients who have a kidney or a liver condition or troublesome side effects in which case your doctor may reduce your dose to one 1mg tablet twice daily.
The tablets are for oral use and should be swallowed whole.
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Use in children
Tolterodine tablets is not recommended for children.
Duration of treatment
Your doctor will tell you how long your treatment with Tolterodine tablets 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.
If you take more Tolterodine tablets than you should
If you or somebody else takes too many tablets, contact your doctor, accident and emergency department or pharmacy at once.
If you forget to take Tolterodine tablets
Do not take a double dose to make up for a forgotten one.
If you have forgotten to take a dose at the usual time, you can take it as soon as you remember unless it is almost time for your next dose. In that case you should not take the forgotten dose but follow the normal dose schedule.
If you stop taking Tolterodine tablets
Always consult your doctor if you are thinking of stopping the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
□ Possible side effects
Like all medicines, this medicine 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 you 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 Tolterodine tablets with the following frequencies.
Very Common (occurs in more than 1 in 10 patients) side effects are:
• Dry mouth
Common (occurs in less than 1 in 10 patients) side effects are:
• Headache
• Sinus pain
• Bronchitis
• Dizziness
• Sleepiness
• Sensation of pins and needles in the fingers and toes
• Dry eyes
• Blurred vision
• Spinning sensation
• Bad digestion (dyspepsia)
• Constipation
• Abdominal pain
• Excessive amounts of air or gases in the stomach or the intestine
• Diarrhoea
• Inability to empty the bladder
• Tiredness
• Extra fluid in the body causing swelling (e.g. in the ankles)
• Increased weight.
Uncommon (occurs in less than 1 in 100 patients) side effects are:
• Sensation of pins and needles in the fingers and toes
• Allergic reactions
• Nervousness
• Aware of the heartbeat (palpitations)
• Heart failure
• Irregular heartbeat
• Heart burn
• Memory impairment
• Painful or difficult urination
Not known (frequency cannot be estimated from the available data) side effects are:
• Increased heart rate
• Being sick (vomiting)
• Dry skin.
Additional reactions reported include severe allergic reactions, confusion, hallucinations (seeing, hearing, feeling, tasting or smelling things that are not there), disorientation, flushing and angioedema.
There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
B How to store Tolterodine tablets
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
B Contents of the pack and other information
What Tolterodine tablets contain
• The active substance in Tolterodine tartrate 1mg Film-coated Tablets is 1 mg of tolterodine tartrate, equivalent to 0.68 mg of tolterodine.
• The active substance in Tolterodine tartrate 2mg Film-coated Tablets is 2mg of tolterodine tartrate, equivalent to 1.37mg of tolterodine.
• The other ingredients are: magnesium stearate, silica colloidal anhydrous, sodium starch glycolate type
B, calcium hydrogen phosphate dihydrate, cellulose microcrystalline, polyethylene glycol 400, polyethylene glycol 8000, hypromellose (E 464), hydroxypropyl cellulose (E 463), titanium dioxide (E 171).
What Tolterodine tablets look like and contents of the pack
Film-coated tablets.
1mg: White, round, biconvex, 5.5mm film-coated tablets marked with "T1” on one side.
2mg: White, round, biconvex, 5.5mm film-coated tablets marked with "T2” on one side.
Pack sizes: Blister packs 56 tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland
Manufacturer
Actavis hf.
Reykjavikurvegur 78,
IS-220 Hafnafjordur Iceland
This leaflet was last revised in October 2012
If you would like a f*"' leaflet with larger % text, please contact 01271 311257.
Actavis, Barnstaple, EX32 8NS, UK
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