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BLERONE XL 2MG PROLONGED RELEASE CAPSULES

Active substance(s): TOLTERODINE L-TARTRATE / TOLTERODINE L-TARTRATE / TOLTERODINE L-TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Blerone XL 2mg and 4mg 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 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. See section 4.
In this leaflet
1. What Blerone XL is and what it is used for
2. What you need to know before you take Blerone XL
3. How to take Blerone XL
4. Possible side effects
5. How to store Blerone XL
6. Contents of the pack and other information
1.

What Blerone XL is and what it is used for

The name of your medicine is Blerone XL 2mg and 4mg prolonged-release capsules (called Blerone XL
throughout this leaflet). The active substance in Blerone XL is tolterodine. Tolterodine belongs to a
class of medicinal products called antimuscarinics.
Blerone 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 Blerone XL

Do not take Blerone XL if you:
 are allergic to the active substance or any of the other ingredients in this medicine (listed in
section 6)
 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).
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suffer from severe ulcerative colitis (ulceration and inflammation of the colon).
suffer from a toxic megacolon (acute dilatation of the colon).

Warnings and precautions
Talk to your doctor or pharmacist before taking Blerone 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.
Other medicines and Blerone XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tolterodine, the active substance of Blerone 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.
Blerone 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 Blerone XL
(antimuscarinic properties) or
medicines with an opposite mode of action to Blerone XL (cholinergic properties). The
reduction in gastric motility caused by antimuscarinics may affect the absorption of other drugs.
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Ask your doctor if you are unsure.
Blerone XL with food and drink
Blerone XL 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 Blerone XL w hen 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 Blerone XL, is excreted in the mother’s breast
milk. Breast-feeding is not recommended during administration of Blerone XL.
Driving and using machines
Blerone 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.
Blerone 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 Blerone XL

Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Adults:
The recommended 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 Blerone XL daily.
Children:
Blerone XL is not recommended for children.
The prolonged-release hard capsules are for oral use and should be swallowed whole.
Do not chew the capsules.
3

If you have taken more Blerone 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 Blerone 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.
If you stop taking Blerone XL
Your doctor will tell you how long your treatment with Blerone 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 medicine, ask your doctor or pharmacist.
4.

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:
 severe allergic reaction or angioedema (frequency is not known, cannot be estimated from the
available data), such as:
 swollen face, tongue or pharynx.
 difficulty in swallowing or breathing.
 hives, rash, itching.
 heart failure (occurs uncommonly, may affect up to 1 in 100 people), such as:
 chest pain, difficulty breathing or getting tired easily (even at rest), difficulty breathing at
night, swelling of the legs.
The following side effects have been observed during treatment with Blerone XL with the following
frequencies.
Very common (may affect more than 1 in 10 people):
 dry mouth
Common (may affect up to 1 in 10 people):
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sinusitis
sleepiness
dry eyes
difficulty with digestion (dyspepsia)
abdominal pain
painful or difficult urination
extra fluid in the body causing swelling
(e.g. in the ankles)

Uncommon (may affect up to 1 in 100 people):
 allergic reactions
 nervousness
 palpitations
 inability to empty the bladder
 vertigo
 heart failure














dizziness
headache
blurred vision
constipation
excessive amounts of air or gases in the
stomach or the intestine
diarrhoea
tiredness

irregular heartbeat
chest pain
sensation of pins and needles in the
fingers and toes
memory impairment

Not known (frequency cannot be estimated from the available data):
 confusion,
hallucinations
and
 increased heart rate
disorientation
 flushed skin
 heart burn
 dry skin
 vomiting
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 Blerone XL

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 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
5

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 protect the environment.
6.

Contents of the pack and other information

What Blerone XL contains
The active substance in Blerone XL 2 mg prolonged-release capsules is 2 mg of tolterodine
tartrate, equivalent to 1.37 mg of tolterodine.
The active substance in Blerone 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
laurylsulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose
Capsule composition: indigo carmine (E132), quinoline yellow (only in 2 mg) (E104), titanium
dioxide (E171), gelatine.
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid – ethyl acrylate
copolymer, 1,2-propylene glycol
What Blerone XL looks like and contents of the pack
Blerone XL is a hard prolonged-release capsule designed for once daily dosing.
Blerone XL 2 mg prolonged-release capsules are opaque green-green opaque.
Blerone XL 4 mg prolonged-release capsules are light blue opaque-light blue opaque.
Blerone XL 2 mg prolonged-release capsules:
Blister packs containing: 14, 28, 84 prolonged-release hard capsules
Blerone XL 4 mg prolonged-release capsules:
Blister packs containing: 7, 14, 28, 49, 84, 98 prolonged-release hard capsules
For all procedures 2mg and 4mg:
HPDE bottles containing: 30, 100 and 200 prolonged-release hard capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer:
Pharmathen S.A, 6, Dervenakion Str., 153 51 Pallini, Attikis, Greece
Or
Pharmathen International S.A, Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
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This medicinal product is authorized in the Member States of the EEA under the following
names:
UK/H/4752/001-002/DC
UK
Blerone XL 2mg, 4mg prolonged release capsules
EE
Uroflow 4mg
LT

Uroflow 4mg pailginto atpalaidavimo kietosios kapsulės

This leaflet was last revised in May2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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