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BLERONE XL 4MG 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 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 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).
• 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. 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, breast-feeding, think you might 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 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 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 4mg 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 2mg 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.
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):
• Dizziness
• Sinusitis
• Headache
• Sleepiness
• Blurred vision
• Dry eyes
• Constipation
• Difficulty with digestion
• Excessive amounts of
(dyspepsia)
air or gases in the
• Abdominal pain
stomach or the intestine
• Painful or difficult urination
• Extra fluid in the body causing • Diarrhoea
• Tiredness
swelling (e.g. in the ankles)

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 4mg prolonged-release
capsules, is 4 mg of tolterodine tartrate, equivalent to 2.74mg
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), 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 4mg prolonged-release capsules are light blue
opaque-light blue opaque.
Blister packs containing: 7, 14, 28, 49, 84, 98 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
This leaflet was last revised in May 2016

Uncommon (may affect up to 1 in 100 people):
• Irregular heartbeat
• Allergic reactions
• Chest pain
• Nervousness
• Sensation of pins and
• Palpitations
needles in the fingers
• Inability to empty the bladder
and toes
• Vertigo
• Memory impairment
• Heart failure
Not known (frequency cannot be estimated from the available
data):
• increased heart rate
• confusion, hallucinations
• flushed skin
and disorientation
• dry skin
• heart burn
• 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

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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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