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PACKAGE LEAFLET: INFORMATION FORTHE USER

Talk to your doctor or pharmacist before

f you take more Efflosomyl XL than

If you get any side effects, talk to your

EFFLOSOMYL XL 4 mg

starting your treatment with Efflosomyl XL

you should

doctor or pharmacist.This includes any side

PROLONGED-RELEASE

if you think any of these might apply

f you or somebody else takes too many

effects not listed in this leaflet.

CAPSULES, HARD

to you.

capsules, contact your doctor or pharmacist

mmediately or go to the nearest hospital

5. HOWTO STORE EFFLOSOMYL XL

Other medicines and Efflosomyl XL

emergency department.

Tolterodine tartate, the active substance

Keep out of the sight and reach of children.

Read all of this leaflet carefully before

of Efflosomyl XL, may interact with other

Signs of overdose to look for are:

you start taking this medicine because

medicinal products.

hallucinations, severe excitation,

Do not take this medicine after the expiry

it contains important information

convulsions, increased heart beat,

date, which is stated on the carton.

for you.

It is not recommended to take this

shortness of breath, difficulty to pass urine

The expiry date refers to the last day of

• Keep this leaflet. You may need to read

medicine in combination with:

or widening of pupils.

that month.

it again.

• some antibiotics (e.g.

• If you have any further questions, ask

erythromycin, clarithromycin)

f you forget to take Efflosomyl XL

Store below 30°C.

your doctor or pharmacist.

• medicinal products used for the

f you forget to take a dose at the usual

• This medicine has been prescribed for

treatment of fungal infections (e.g.

time, take it as soon as you remember

Do not throw away any medicine via

you only. Do not pass it on to others.

ketoconazole, itraconazole)

unless it is almost time for your next dose.

wastewater or household waste. Askyour

It may harm them, even if their signs of

• medicinal products used for the treatment

n that case, omit the forgotten dose and

pharmacist how to throw away medicines

illness are the same as yours.

of HIV.

ollow the normal dose schedule. Do not

you no longer use.These measures will

• If you get any side effects, talk to your

take a double dose to make up for a

help protect the environment.

doctor or pharmacist.This includes

Efflosomyl XL should be used with caution

forgotten dose.

any possible side effects not listed in

when taken in combination with:

6. CONTENTS OF THE PACK AND

Text

this leaflet.

• medicines that affect the passage of food

Text

f you stop taking Efflosomyl XL

OTHER INFORMATION

(e.g. metoclopramide and cisapride)

Do not stop taking this medicine unless

12mm

What is in this leaflet:

• medicines for the treatment of irregular

12mm

your doctor advises you to stop.

What Efflosomyl XL contains

<-

->

1. What Efflosomyl XL is and what it is

heartbeat (e.g. amiodarone, sotalol,

<-►

The active substance is tolterodine tartrate.

used for.

quinidine, procainamide)

f you have any further questions on the

Each prolonged-release capsule contains

2. What you need to know before you take

• other medicines with a similar mode of

use of this medicine, askyour doctor

4 mg of tolterodine tartrate which is

Efflosomyl XL.

action to Efflosomyl XL (antimuscarinic

or pharmacist.

equivalent to 2.74 mg of tolterodine.

3. How to take Efflosomyl XL.

properties) or medicines with an

4. Possible side effects.

opposite mode of action to Efflosomyl XL

4. POSSIBLE SIDE EFFECTS

The other ingredients are sugar spheres

5. How to store Efflosomyl XL.

(cholinergic properties). Askyour doctor if

(sucrose and maize starch), ethylcellulose

6. Contents of the pack and

you are unsure.

C

o

Like all medicines, this medicine can cause

(E462), hypromellose (E464) and talc

other information.

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side effects, although not everybody

(E553b).The capsule shell contains

Tell your doctor or pharmacist if you

4—

T3

gets them.

indigo carmine (E132), titanium dioxide

1. WHAT EFFLOSOMYL XL IS AND WHAT IT

are taking or have recently taken any

CT>

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(E171) and gelatin (E441).The printing

IS USED FOR

other medicines.

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T3

03

You should see your doctor immediately or

ink contains shellac (E904), propylene

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go to the hospital emergency department

glycol (E1520), black iron oxide (E172) and

The active substance in Efflosomyl XL is

Taking Efflosomyl XL with food and drink

T3

O

f you experience symptoms of angioedema

potassium hydroxide.

tolterodine tartrate.Tolterodine belongs

Efflosomyl XL can be taken before, after or

u

such as:

to a class of medicinal products called

during a meal.

swollen face, tongue, throat

What Efflosomyl XL looks like and

antimuscarinics.

difficulty to swallow

contents of the pack

Pregnancy and breast-feeding

hives and difficulty in breathing.

Efflosomyl XL 4 mg prolonged-release

Efflosomyl XL is used in adults and the

Pregnancy

E

capsules are powder-blue opaque,

elderly for the treatment of the symptoms

You should not take Efflosomyl XL

LTJ

You should also seek medical attention if

hard-shell gelatin capsules filled with

of overactive bladder syndrome. If you

when you are pregnant. Tell your doctor

you experience a hypersensitivity reaction

white to off-white beads.The capsules are

have overactive bladder syndrome, you

immediately if you are pregnant, think

(for example itching, rash, hives or difficulty

marked with MYLAN over 3404 in black ink

may find that you are unable to control

you are pregnant or are planning to have a

breathing). This occurs uncommonly

on both parts of the capsule.

urination or you need to rush to the toilet

baby.

(occurs in less than 1 in 100 patients).

with no advance warning and/or go to the

Your medicine is packed in perforated unit

toilet frequently.

Breast-feeding

Tell your doctor immediately or go to the

dose or in standard blisters containing 28x1

Tell your doctor if you are breast-feeding or

hospital emergency department if you

or 7,10, 14, 20, 28, 30, 49, 60, 84, 90, 98

2. WHAT YOU NEED TO KNOW BEFORE

about to start breast-feeding. Efflosomyl XL

notice any of the following:

and 100 prolonged-release capsules and

YOU TAKE EFFLOSOMYL XL

is not recommended for mothers who are

1

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chest pain, difficulty breathing or getting

in bottles containing 30, 100, 250 and 500

)

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breast-feeding.

tired easily (even at rest), difficulty

prolonged-release capsules. Not all pack

Do not take Efflosomyl XL:

breathing at night, swelling of the legs.

sizes may be marketed.

if you are allergic to tolterodine or any

Askyour doctor or pharmacist for advice

These may be symptoms of heart failure.

of the other ingredients of this medicine

before taking this medicine.

This occurs uncommonly (occurs in less

Marketing Authorisation Holder

(listed in section 6)

than 1 in 100 patients).

Mylan, Potters Bar, Hertfordshire, EN6 1TL,

if you are unable to pass urine from the

Driving and using machines

At

United Kingdom.

bladder (urinary retention)

Do not drive or operate machinery whilst

The following side effects have

if you have high pressure in the eyes

taking Efflosomyl XL as it may make you

been observed during treatment

Manufacturer

with loss of eyesight that is not being

feel dizzy, tired or affect your sight.

with Efflosomyl XL with the

Gerard Laboratories, 35/36 Baldoyle

adequately treated (uncontrolled

ollowing frequencies.

Industrial Estate, Grange Road, Dublin 13,

narrow-angle glaucoma)

Efflosomyl XL contains sucrose

Ireland.

if you suffer from excessive weakness of

(a type of sugar)

Very common side effects

the muscles (myasthenia gravis)

If you have been told by your doctor that

(may affect more than 1 in 10 patients):

Generics [UK] Ltd., Potters Bar,

if you suffer from severe ulceration

you have an intolerance to some sugars,

dry mouth.

Hertfordshire, EN6 1TL, United Kingdom.

and inflammation of the colon (severe

contact your doctor before taking this

‘nJ

Ln

ulcerative colitis)

medicine.

Common side effects

Mylan Hungary Kft, H-2900 Komarom,

B

if you suffer from acute widening of the

(may affect up to 1 in 10 patients):

Mylan utca 1, Hungary.

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colon (toxic megacolon).

3. HOWTO TAKE EFFLOSOMYL XL

sinusitis

dizziness, sleepiness, headache

This leaflet was last revised in April 2013

Warnings and precautions

Always take this medicine exactly as your

dry eyes, blurred vision

Talk to your doctor or pharmacist before

doctor has told you. Check with your doctor

difficulty with digestion (dyspepsia),

taking Efflosomyl XL if you:

or pharmacist if you are not sure.

constipation, abdominal pain, excessive

have difficulties in passing urine and/or a

amounts of air or gases in the stomach or

poor stream of urine

The recommended dose is one 4 mg

the intestine

have a gastro-intestinal disease that

capsule daily. For patients who have a

painful or difficult urination

affects the passage and/or digestion

kidney or a liver condition or troublesome

tiredness

of food

side effects, your doctor may reduce your

extra fluid in the body causing swelling

suffer from kidney problems

dose to one 2 mg capsule daily.

(e.g. in the ankles)

(renal insufficiency)

diarrhoea.

have a liver condition

Use in Children

suffer from neuronal disorders that

Efflosomyl XL is not recommended

Uncommon side effects

affect your blood pressure, bowel or

for children.

(may affect up to 1 in 100 patients):

sexual function (any neuropathy of the

allergic reactions

autonomic nervous system)

The capsules should be swallowed whole

nervousness

have a hiatal hernia (a hernia in the upper

with a glass of water with or without food.

sensation of pins and needles in the

part of stomach)

Do not chew the capsules.

fingers and toes

ever experience decreased

feeling of spinning, dizziness (vertigo)

bowel movements or suffer from

Duration of treatment

palpitations, heart failure, irregular

severe constipation (decreased

Your doctor will tell you how long your

heartbeat

gastro-intestinal motility)

treatment with Efflosomyl XL will last.

inability to empty the bladder

have a heart condition such as:

Your bladder will need some time to adapt.

chest pain

*an abnormal heart tracing (ECG)

Do not stop treatment early because you

memory impairment.

*a slow heart rate (bradycardia)

do not see an immediate effect. Finish the

*have a pre-existing heart disease such

course of capsules prescribed by your

Additional reactions reported include

as cardiomyopathy (weak heart muscle),

doctor. If you have not noticed any effect

severe allergic reactions, confusion,

myocardial ischaemia (reduced blood

by then, talk to your doctor.

hallucinations, increased heart rate, flushed

flow to the heart), arrhythmia (irregular

skin, heart burn, vomiting, angioedema,

heartbeat) and heart failure

The benefit of the treatment should be

dry skin, and disorientation. There have

have abnormally low levels of potassium

re-evaluated after 2 or 3 months.

also been reports of worsening symptoms

(hypokalaemia), calcium (hypocalcaemia)

of dementia in patients being treated for

or magnesium (hypomagnesaemia) in

dementia.

your blood.

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