Tolterodine Tartrate 1 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Tolterodine Tartrate 1 mg film-coated Tablets Tolterodine Tartrate 2 mg 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 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 gets 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
What Tolterodine tartrate is and what it is used for
Tolterodine tartrate is used to treat symptoms of overactive bladder, such as:
• inability to control urination
• need to rush to the toilet with no advance warning and/or go to the toilet frequently
Tolterodine tartrate belongs to a class of urologic muscle relaxants, which relax the bladder muscle.
The following medicines can influence or be influenced
by Tolterodine tartrate:
• medicines to treat irregular heart beat, such as quinidine, procainamide, amiodarone, sotalol
• macrolide antibiotics, such as erythromycin, clarithromycin
• medicines to treat fungal infections, such as ketoconazole, itraconazole
• medicines to treat HIV containing active substances with names ending in “-navir”
• metoclopramide, cisapride medicines to increase intestinal motility
Before you take Tolterodine tartrate
Do not take Tolterodine tartrate
if you are/have
• allergic (hypersensitive) to tolterodine tartrate or any of the other ingredients
• inability to empty the bladder
• a chronic ulcerative and inflammatory bowel
disease (severe ulcerative colitis)
• increased eye pressure with loss of eyesight that is not being adequately treated (uncontrolled narrow-angle glaucoma)
• a certain muscle weakness, called Myasthenia gravis
• an acute enlargement of the colon (toxic megacolon)
Medicines with a similar mode of action (antimuscarinic properties) or medicines with an opposite mode of action (cholinergic properties) to Tolterodine tartrate could possibly interact with Tolterodine tartrate. Examples are:
• medicines which dilate the eye pupil, such as atropine, scopolamine, tropicamid
• medicines to lower pressure in the eye, such as carbachol, pilocarpine
• medicines to treat Parkinson disease, such as biperiden, bornaprin, metixen, procyclidin, trihexyphenidyl
• medicines to treat spasms of the stomach, bowel, bladder, genitals or the bronchial tubes, such as butylscopolaminium, ipratropium, tiotropium
• medicines to treat bladder and bowel muscle disturbances, such as oxybutynin, trospium, solifenacin, darifenacin, bethanechol.
Take special care with Tolterodine tartrate
if you have
• difficulty passing urine and poor urine output
• a very swollen, painful stomach, affecting swallowing and digesting
• kidney or liver problems
See chapter 3 “How to take Tolterodine tartrate”
• a nerve problem which sometimes occurs with diabetes and can lead to diarrhoea, impotence or low blood pressure (Autonomic neuropathy)
• Hiatus hernia, where part of your stomach protrudes through the diaphragm
• have or previously have had severe constipation
• a certain heart beat abnormality known as QT prolongation
• abnormally low levels of potassium, magnesium or calcium in your blood
• a pulse rate less than 60 beats per minute
• heart diseases, such as heart muscle disturbance, reduced blood flow to the heart muscle, irregular heartbeat or heart failure
Please tell your doctor or pharmacist before taking
this medicine if any of the above apply to you.
Children, under 18 years
Tolterodine tartrate is not recommended for children.
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.
Pregnancy and breast-feeding
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.
It is not known if the active substance in Tolterodine tartrate is excreted into mother's milk. Therefore, you should not take Tolterodine tartrate if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Tolterodine tartrate may cause dizziness, fatigue and blurred vision. Do not drive or operate machinery if this affects you.
How to 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.
The usual dose is: 2 mg twice daily (given as two 1 mg tablets or one 2 mg tablet twice daily)
Continued on the next page >>
In the case of impaired kidney or liver function or troublesome side effects the usual dose is 1 tablet twice daily.
Administration
Take the tablets whole with one glass of water independent of meals in the morning and in the evening.
Duration of use
To be decided by your attending doctor.
Do not stop treatment early because you do not see an immediate effect.Your bladder will need some time to adapt.Your doctor will evaluate the effect of your treatment after 2-3 months.
If you take more Tolterodine tartrate than you should
If you have taken too much Tolterodine tartrate, contact your doctor or pharmacist immediately.
If you forget to take Tolterodine tartrate
If you forget to take a dose, take the next dose normally, when it is due. Do not take a double dose to compensate the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Not known, frequency cannot be estimated from available data
• severe allergic reactions including swelling mainly of the face, tongue or throat, difficulty to swallow, hives and difficulty in breathing
• hallucinations
• confusion
• disorientation
• flushed skin
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.
How to store Tolterodine tartrate
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Tolterodine tartrate after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
4 Possible side effects
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
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 throat
• difficulty to swallow
• hives and difficulty in breathing
Side effects can occur with the following frequencies:
Very common, occurs in more than 1 per 10 users:
• dry mouth
This may occur in 35 % of patients.
• headache
Common, occurs in 1 to 10 per 100 users:
• constipation
• abdominal pain
• dizziness
• sleepiness
• decreased tear production, causing dry irritable eyes
• fatigue
• drowsiness
• altered sensation - pins and needles
• blurred vision
• vertigo
• chest pain
• flatulence
• vomiting
• diarrhoea
• pain or difficulty in passing urine
• inability to empty the bladder
• dry skin
• palpitations
• bronchitis
• extra fluid in the body causing swollen hands, ankles and/or feet
• increased weight
Uncommon, occurs in 1 to 10 per 1,000 users:
• allergic reactions
• heartburn
• nervousness
• memory impairment
• increased heart activity
• irregular heartbeat
• heart failure
What Tolterodine tartrate contains
• The active substance is tolterodine tartrate.
One tablet contains 1 mg of tolterodine tartrate, equivalent to 0.68 mg of tolterodine.
One tablet contains 2 mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.
• The other ingredients are:
Tablet core: cellulose, microcrystalline; calcium hydrogen phosphate, anhydrous; sodium starch glycolate (Type A); magnesium stearate; silica, colloidal anhydrous
Tablet coating: cellulose, microcrystalline; hypromellose; stearic acid; titanium dioxide (E171)
What Tolterodine tartrate looks like and contents of the pack
Tolterodine tartrate 1 mg tablets are white or almost white, round and biconvex film-coated tablets, coded with “1” on one side.
Tolterodine tartrate 2 mg tablets are white or almost white, round and biconvex film-coated tablets, coded with “2” on one side.
The film-coated tablets are supplied in blister packs or plastic bottles containing 7, 14, 28, 30, 50, 56, 60, 84, 98, 100 and 500 film-coated tablets.
Not all pack sizes or containers may be marketed.
Marketing Authorisation Holder and Manufacturer
MA Holder:
Hexal AG, Industriestrasse 25, 83607 Holzkirchen, Germany.
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke- Allee 1, 39179 Barleben, Germany or
Salutas Pharma GmbH, Dieselstrasse 5,
70839 Gerlingen, Germany
or
Lek Pharmaceuticals d.d., Verovskova 57,
1526 Ljubljana, Slovenia or
LEK S.A., UI. Podlipie 16 C, 95010 Strykow, Poland or
LEK S.A., UI. Domaniewska 50 C, 02-672 Warsaw, Poland.
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