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EFFLOSOMYL XL 4 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): TOLTERODINE TARTRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EFFLOSOMYL XL 4 mg
PROLONGED‑RELEASE
CAPSULES, HARD
(tolterodine tartrate)

Read all of this leaflet carefully before
you start taking 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.
What is in this leaflet:
1. What Efflosomyl XL is and what it is
used for.
2. What you need to know before you take
Efflosomyl XL.
3. How to take Efflosomyl XL.
4. Possible side effects.
5. How to store Efflosomyl XL.
6. Contents of the pack and
other information.
1. WHAT EFFLOSOMYL XL IS AND WHAT IT
IS USED FOR
The active substance in Efflosomyl XL is
tolterodine tartrate. Tolterodine belongs
to a class of medicinal products called
antimuscarinics.
Efflosomyl XL is used in adults and the
elderly 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 or 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 EFFLOSOMYL XL
Do not take Efflosomyl XL:
• if you are allergic to tolterodine or any
of the other ingredients of this medicine
(listed in section 6)
• if you are unable to pass urine from the
bladder (urinary retention)
• if you have high pressure in the eyes
with loss of eyesight that is not being
adequately treated (uncontrolled
narrow‑angle glaucoma)
• if you suffer from excessive weakness of
the muscles (myasthenia gravis)
• if you suffer from severe ulceration
and inflammation of the colon (severe
ulcerative colitis)
• if you suffer from acute widening of the
colon (toxic megacolon).
Warnings and precautions
Talk to your doctor or pharmacist before
taking Efflosomyl 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 neuronal disorders that
affect your blood pressure, bowel or
sexual function (any neuropathy of the
autonomic nervous system)
• have a hiatal hernia (a hernia in the upper
part of stomach)
• 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)
*have a pre‑existing heart disease 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 Efflosomyl XL
if you think any of these might apply
to you.
Other medicines and Efflosomyl XL
Tolterodine tartate, the active substance
of Efflosomyl XL, may interact with other
medicinal products.
It is not recommended to take this
medicine in combination with:
• some antibiotics (e.g.
erythromycin, clarithromycin)
• medicinal products used for the
treatment of fungal infections (e.g.
ketoconazole, itraconazole)
• medicinal products used for the treatment
of HIV.
Efflosomyl XL should be used with caution
when taken in combination with:
• medicines that affect the passage of food
(e.g. metoclopramide and cisapride)
• medicines for the treatment of irregular
heartbeat (e.g. amiodarone, sotalol,
quinidine, procainamide)
• other medicines with a similar mode of
action to Efflosomyl XL (antimuscarinic
properties) or medicines with an
opposite mode of action to Efflosomyl XL
(cholinergic properties). Ask your doctor if
you are unsure.
Tell your doctor or pharmacist if you
are taking or have recently taken any
other medicines.
Taking Efflosomyl XL with food and drink
Efflosomyl XL can be taken before, after or
during a meal.
Pregnancy and breast‑feeding
Pregnancy
You should not take Efflosomyl XL
when you are pregnant. Tell your doctor
immediately if you are pregnant, think
you are pregnant or are planning to have a
baby.
Breast‑feeding
Tell your doctor if you are breast‑feeding or
about to start breast‑feeding. Efflosomyl XL
is not recommended for mothers who are
breast‑feeding.
Ask your doctor or pharmacist for advice
before taking this medicine.
Driving and using machines
Do not drive or operate machinery whilst
taking Efflosomyl XL as it may make you
feel dizzy, tired or affect your sight.
Efflosomyl XL contains sucrose
(a type of sugar)
If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicine.
3. HOW TO TAKE EFFLOSOMYL XL
Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended dose is one 4 mg
capsule daily. For patients who have a
kidney or a liver condition or troublesome
side effects, your doctor may reduce your
dose to one 2 mg capsule daily.
Use in Children
Efflosomyl XL is not recommended
for children.
The capsules should be swallowed whole
with a glass of water with or without food.
Do not chew the capsules.
Duration of treatment
Your doctor will tell you how long your
treatment with Efflosomyl XL will last.
Your bladder will need some time to adapt.
Do not stop treatment early because you
do not see an immediate effect. Finish the
course of 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.

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If you take more Efflosomyl XL than
you should
If you or somebody else takes too many
capsules, contact your doctor or pharmacist
immediately or go to the nearest hospital
emergency department.
Signs of overdose to look for are:
hallucinations, severe excitation,
convulsions, increased heart beat,
shortness of breath, difficulty to pass urine
or widening of pupils.
If you forget to take Efflosomyl 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 dose.
If you stop taking Efflosomyl XL
Do not stop taking this medicine unless
your doctor advises you to stop.
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 hospital emergency department
if you experience symptoms of angioedema
such as:
• swollen face, tongue, throat
• 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 or difficulty
breathing). This occurs uncommonly
(occurs in less than 1 in 100 patients).
Tell your doctor immediately or go to the
hospital emergency 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 Efflosomyl XL with the
following frequencies.
Very common side effects
(may affect more than 1 in 10 patients):
• dry mouth.
Common side effects
(may affect up to 1 in 10 patients):
• sinusitis
• dizziness, 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
• tiredness
• extra fluid in the body causing swelling
(e.g. in the ankles)
• diarrhoea.

If you get any side effects, talk to your
doctor or pharmacist. This includes any side
effects not listed in this leaflet.
5. HOW TO STORE EFFLOSOMYL XL
Keep out of the sight and reach of children.
Do not take this medicine after the expiry
date, which is stated on the carton.
The expiry date refers to the last day of
that month.
Store below 30°C.
Do not throw away any medicine 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 Efflosomyl XL contains
The active substance is tolterodine tartrate.
Each prolonged‑release capsule contains
4 mg of tolterodine tartrate which is
equivalent to 2.74 mg of tolterodine.
The other ingredients are sugar spheres
(sucrose and maize starch), ethylcellulose
(E462), hypromellose (E464) and talc
(E553b). The capsule shell contains
indigo carmine (E132), titanium dioxide
(E171) and gelatin (E441). The printing
ink contains shellac (E904), propylene
glycol (E1520), black iron oxide (E172) and
potassium hydroxide.
What Efflosomyl XL looks like and
contents of the pack
Efflosomyl XL 4 mg prolonged‑release
capsules are powder‑blue opaque,
hard‑shell gelatin capsules filled with
white to off‑white beads. The capsules are
marked with MYLAN over 3404 in black ink
on both parts of the capsule.
Your medicine is packed in perforated unit
dose or in standard blisters containing 28x1
or 7, 10, 14, 20, 28, 30, 49, 60, 84, 90, 98
and 100 prolonged‑release capsules and
in bottles containing 30, 100, 250 and 500
prolonged‑release capsules. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13,
Ireland.
Generics [UK] Ltd., Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
Mylan Hungary Kft, H‑2900 Komarom,
Mylan utca 1, Hungary.
This leaflet was last revised in April 2013

Uncommon side effects
(may affect up to 1 in 100 patients):
• allergic reactions
• nervousness
• sensation of pins and needles in the
fingers and toes
• feeling of spinning, dizziness (vertigo)
• palpitations, heart failure, irregular
heartbeat
• inability to empty the bladder
• chest pain
• 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.
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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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