Tolterodine Tartrate 2 Mg Film-Coated Tablets
I
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tolterodine tartrate 2mg Film-coated Tablets
Tolterodine tartrate
Read all of this leaflet carefully before you start taking 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:
j What Tolterodine Tartrate is and what it is used for
^1 Before you take Tolterodine Tartrate How to take Tolterodine Tartrate Possible side effects How to store Tolterodine Tartrate Further information
3 WHAT TOLTERODINE TARTRATE IS AND WHAT IT IS USED FOR
The active substance in Tolterodine Tartrate is tolterodine. 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,
• 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 Tolterodine Tartrate
• 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 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 (renal insufficiency)
• If you have a liver condition
• If you suffer from neuronal disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system)
• If you have a hiatal hernia (herniation of an abdominal organ)
• If you ever experience decreased bowel movements or suffer from severe constipation (decreased gastrointestinal 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
Talk to your doctor or pharmacist before starting your treatment with Tolterodine Tartrate if you think any of these might apply to you.
Taking other medicines
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.
Tolterodine Tartrate 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 Tolterodine Tartrate (antimuscarinic properties) or medicines with an opposite mode of action to Tolterodine Tartrate (cholinergic properties). Ask your doctor if you are unsure.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Tolterodine Tartrate with food and drink
Tolterodine Tartrate can be taken before, after or during a meal.
Pregnancy and breast-feeding
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, the active substance of Tolterodine Tartrate, is excreted in the mother's breast milk. Breast-feeding is not recommended during administration of Tolterodine Tartrate.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tolterodine Tartrate may make you feel dizzy, tired or affect your sight; your ability to drive or operate machinery may be affected.
^ HOW TO TAKE TOLTERODINE TARTRATE
Dosage
Always take Tolterodine Tartrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual 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.
Tolterodine Tartrate is not recommended for children.
The tablets are for oral use and should be swallowed whole.
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Tolterodine Tartrate 2mg film-coated tablets PIL - UK |
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origination date: 15.07.13 |
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revision date: 09.08.13 |
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date sent: 15.07.13 | ||
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supplier: Specifar |
technically app. date: 3P°7.13 |
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Duration of treatment
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 take more Tolterodine Tartrate than you should
If you or somebody else takes too many tablets, contact your doctor or pharmacist immediately.
If you forget to take Tolterodine Tartrate
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 have any further questions on the use of this product, ask your doctor or pharmacist.
J 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, 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 Tolterodine Tartrate with the following frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are:
• Dry mouth
• Headache
Common side effects (occurs in less than 1 in 10 patients) are:
• Bronchitis
• Dizziness, sleepiness, sensation of pins and needles in the fingers and toes
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Difficulty with digestion (dyspepsia), constipation, abdominal pain, excessive amounts of air or gases in the stomach or the intestine, vomiting
• Dry skin
• Painful or difficult urination, inability to empty the bladder
• Tiredness, chest pain, extra fluid in the body causing swelling (e.g. in the ankles)
• Increased weight
• Diarrhoea
Uncommon side effects (occurs in less than 1 in 100 patients) are:
• Allergic reactions
• Nervousness
• Increased heart rate, heart failure, irregular heartbeat
• Heart burn
• Memory impairment
Additional reactions reported include severe allergic reactions, confusion, hallucinations, flushed skin, angioedema 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.
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5| HOW TO STORE TOLTERODINE TARTRATE
Keep Tolterodine Tartrate 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.
J FURTHER INFORMATION
What Tolterodine Tartrate contains
The active substance in Tolterodine Tartrate 2mg tablets is 2mg of tolterodine tartrate, equivalent to 1.37mg of tolterodine.
The other ingredients are: Cellulose, microcrystalline, calcium hydrogen phosphate dehydrate, sodium starch glycolate (Type B), magnesium stearate, silica colloidal anhydrous
Film coating: Opadry white20A28334 consisting of: Hydroxypropyl cellulose (E463),hypromellose 3cP (E464),talc(E5553b),titanium dioxide (E171).
What Tolterodine Tartrate looks like and contents of the pack
Tolterodine Tartrate 2mg film-coated tablets are white, round, biconvex, film-coated tablets, bearing a breakline on one side, having a diameter of 6.0mm approximately.
Tolterodine Tartrate 2mg tablets are available in the following pack sizes:
Blister packs containing;
- 10 tablets
- 20 tablets
- 28 tablets
- 30 tablets
- 56 tablets
- 60 tablets
- 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegi 76-78,
220 HafnarfjorSur, Iceland
Manufacturer
Specifar S.A., 1,28 Octovriou str., 123 51 Ag. Varvara, Athens, Greece
This leaflet was last approved in August 2013
If you would like a leaflet with larger text, please contact 01271 311257.
actavis
Actavis, Barnstaple, EX32 8NS, UK
|
Tolterodine Tartrate 2mg film-coated tablets PIL - UK |
colours/plates: | ||
|
1. Black | |||
|
Actavis creating value In pharmaceuticals t 0044 1271 311400 f 00441271311449 |
item no: AAAF6278 |
dimensions: 170x330 |
2. |
|
print proof no: 3 |
pharmacode: |
3. | |
|
4. | |||
|
origination date: 15.07.13 |
min pt size: 8pt |
5. | |
|
originated by: DR |
6. | ||
|
approved for print/date |
revision date: 09.08.13 |
Technical Approval |
Non Printing Colours |
|
1. | |||
|
revised by: jh |
date sent: 15.07.13 | ||
|
2. | |||
|
supplier: Specifar |
technically app. date: 3P°7.13 |
3. | |