Trillblad Xl 4 Mg Prolonged-Release Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Trillblad XL 4 mg Prolonged-release Capsules
Tolterodine tartrate
Read all of this leaflet carefully before you start using 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. 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.
What is in this leaflet:
1. What Trillblad XL Prolonged-release Capsules are and what they are used for
2. Before you take Trillblad XL Prolonged-release Capsules
3. How to take Trillblad XL Prolonged-release Capsules
4. Possible side effects
5. How to store Trillblad XL Prolonged-release Capsules
6. Further information
1. What Trillblad XL Prolonged-release Capsules are and what they are used for
The active substance in Trillblad XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics.
Trillblad XL 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. What you need to know before you take Trillblad XL Prolonged-release Capsules Do not take Trillblad XL if you:
• are allergic (hypersensitive) to tolterodine or any of the other ingredients in Trillblad XL (see section 6 for a list of the ingredients)
• 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 Trillblad XL if you:
• have difficulties in passing urine and/or a poor stream of urine.
• have a gastro-intestinal disease that affects the passage and/or digestion of food.
• suffer from kidney problems (renal insufficiency).
• have a liver condition.
suffer from neurological disorders that affect your blood pressure, bowel or sexual function (any neuropathy of the autonomic nervous system). have a hiatus hernia (herniation of an abdominal organ).
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 such as: cardiomyopathy (weak heart muscle), myocardial ischaemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat) and heart failure
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 Trillblad XL if you think any of these might apply to you.
Other medicines and Trillblad XL
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tolterodine, the active substance of Trillblad XL, 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
Trillblad XL 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 Trillblad XL (antimuscarinic properties) or medicines with an opposite mode of action to Trillblad XL (cholinergic properties). The reduction in gastric motility caused by antimuscarinics may affect the absorption of other drugs. Ask your doctor if you are unsure.
Taking Trillblad XL with food and drink
Trillblad XL can be taken before, after or during a meal.
Pregnancy and breast-feeding
Pregnancy
You should not use Trillblad XL 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 Trillblad XL, is excreted in the mother’s breast milk. Breast-feeding is not recommended during administration of Trillblad XL.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Trillblad XL may make you feel dizzy, tired or affect your sight. If you experience any of these effects then you should not drive your car or operate heavy machinery.
Trillblad XL contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Trillblad XL Prolonged-release Capsules
Dosage:
Always take Trillblad XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The prolonged-release hard capsules, are for oral use and should be swallowed whole.
Do not chew the capsules.
Adults:
The usual dose is one 4 mg prolonged-release hard capsule daily.
Patients with liver or kidney problems:
In patients with liver or kidney problems your doctor may reduce your dose to 2 mg Trillblad XL
daily.
Children:
Trillblad XL is not recommended for children.
If you have taken more Trillblad XL than you should:
If you or somebody else takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. Symptoms in case of overdose include hallucinations, excitation, a heartbeat faster than usual, dilation of the pupil and inability to urinate or breathe normally.
If you forget to take Trillblad XL:
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.
Duration of treatment Your doctor will tell you how long your treatment with Trillblad XL 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 prolonged-release capsules 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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Trillblad XL 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 Trillblad XL with the following frequencies.
Very common side effects (occurs in more than 1 in 10 patients) are:
• Dry mouth
Common side effects (occurs in less than 1 in 10 patients) are:
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• |
Sinusitis |
• |
Dizziness |
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• |
Sleepiness |
• |
Headache |
|
• |
Dry eyes |
• |
Blurred vision |
|
• |
Difficulty with digestion (dyspepsia) |
• |
Constipation |
|
• |
Abdominal pain |
• |
excessive amounts of air or gases in the stomach or the intestine |
|
• |
Painful or difficult urination |
• |
Diarrhoea |
|
• |
Extra fluid in the body causing swelling (e.g. in the ankles) |
• |
Tiredness |
|
Uncommon side effects (occurs in less than 1 |
in |
100 patients) are: | |
|
• |
Allergic reactions |
• |
Heart failure |
|
• |
Nervousness |
• |
Irregular heartbeat |
|
• |
Palpitations |
• |
Chest pain |
|
• |
Inability to empty the bladder |
• |
Sensation of pins and needles in the fingers and toes |
|
• |
Vertigo |
• |
Memory impairment |
Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, flushed skin, heart burn, vomiting, angioedema, dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for dementia.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Trillblad XL Prolonged-release Capsules
Keep Trillblad XL out of the reach and sight of children.
Do not use Trillblad XL after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
Do not store above 25°C
HDPE bottle: Shelf life after first opening is 200 days
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 Trillblad XL Prolonged-release Capsules
The active substance in Trillblad XL 4 mg Prolonged-release Capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
The other ingredients are:
Lactose monohydrate, cellulose microcrystalline, poly(vinyl acetate), povidone, silica, sodium laurilsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose Capsule composition: indigo carmine (E132), quinoline yellow (only in 2 mg) (E104), titanium dioxide (E171), gelatin
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, 1,2-Propylene glycol
What Trillblad XL Prolonged-release Capsules look like and contents of the pack
Trillblad XL Prolonged-release Capsules is a hard prolonged-release capsule designed for once daily dosing.
Trillblad XL Prolonged-release Capsules are light blue-opaque-light blue opaque.
Trillblad XL Prolonged-release Capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 50, 80, 84, 90, 98, 100, 160, 200, 280 prolonged-release HDPE bottles containing: 30, 60, 100, 200 capsules
Not all pack sizes may be marketed
Marketing authorisation holder and manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom
OR*
Manufacturer:
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem The Netherlands
OR*
TEVA UK Ltd
Eastbourne, BN22 9AG, United Kingdom OR*
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
OR*
Portfarma ehf
Borgartuni 26, 105 Reykjavik Iceland
OR*
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate,
Malta
OR*
Pharmadox Healthecare Ltd KW20A Kordin Industrial Park Malta
OR*
BioCentrum Sp. z o.o Bobrzynskiego 14, 30-348 Krako Poland
OR*
Teva Operations Poland Sp. z.o.o Ul. Sienkiewicza 25, 99-300 Kutno Poland
OR*
Teva Operations Poland Sp. z.o.o ul. Mogilska 80. 31-546, Krakow Poland
OR*
Pharmathen International S.A
Sapes Industrial Park, Block 5, 69300 Rodopi
Greece
OR*
Pharmathen S.A
6, Dervenakion Str., 153 51 Pallini, Attikis Greece
* Only the actual site of batch release will appear on the printed version of the leaflet This leaflet was last revised in November 2015 PL 00289/1774