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MICTONORM XL 45 MG MODIFIED-RELEASE CAPSULES

Active substance(s): PROPIVERINE HYDROCHLORIDE / PROPIVERINE HYDROCHLORIDE / PROPIVERINE HYDROCHLORIDE

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Version 4, 02/2016

Mictonorm XL 45 mg Modified-Release Capsules

PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MICTONORM® XL 45 mg
MODIFIED-RELEASE CAPSULES
(Propiverine hydrochloride)
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 your 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).
The name of your medicine is Mictonorm XL 45 mg Modified Release Capsules (referred to as
Mictonorm XL 45 mg throughout this leaflet). The active substance is propiverine hydrochloride and
the other ingredients are listed at the end of the leaflet (section 6, Contents of the pack and other
information).
What is in this leaflet:
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2.
3.
4.
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6.

What Mictonorm XL 45 mg is and what it is used for
What you need to know before you take Mictonorm XL 45 mg
How to take Mictonorm XL 45 mg
Possible side effects
How to store Mictonorm XL 45 mg
Contents of the pack and other information

1. WHAT MICTONORM XL 45 MG IS AND WHAT IT IS USED FOR
Mictonorm XL 45 mg is used for the treatment of people who have difficulty in controlling their
bladder due to bladder overactivity or who have problems with the spinal cord. Mictonorm XL 45 mg
contains the active substance propiverine hydrochloride. This substance prevents the bladder from
contracting and increases the amount that the bladder can hold. Mictonorm XL 45 mg is used to treat
the symptoms of overactive bladder. It is a modifiedrelease capsule that needs only to be taken once a
day.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICTONORM XL 45 MG
Do not take Mictonorm XL 45 mg
Do not take Mictonorm XL 45 mg if you are allergic (hypersensitive) to propiverine hydrochloride or
to any of the other ingredients of Mictonorm XL 45 mg (these are listed in section 6).
Do not take Mictonorm XL 45 mg if you suffer from any of the following conditions:
obstruction of the bowel
obstruction to the bladder outlet (difficulty in passing urine)
myasthenia gravis (a disease causing muscle weakness)
a loss of function of the muscles controlling your bowel movements (intestinal atony)
severe inflammation of the bowel (ulcerative colitis) that may lead to diarrhoea containing blood
and mucus and abdominal pain
toxic megacolon (a condition involving enlargement of the bowel)
increased pressure in the eye (uncontrolled angle closure glaucoma)
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moderate or severe liver disease
fast and irregular heart beat

Warnings and precautions
Before you take Mictonorm XL 45 mg you should tell your doctor if you have:
damage to the nerves that control blood pressure, heart rate, bowel and bladder movements and
other bodily functions (autonomic neuropathy)
kidney problems
liver problems
severe heart failure
enlargement of the prostate gland
recurrent urinary tract infection
tumours of the urinary tract
glaucoma
heartburn and indigestion due to back flow of gastric juice into the throat (hiatus hernia with
reflux oesophagitis)
irregular heart beat
fast heart beat
If you suffer from any of these conditions, contact your doctor. He will tell you what to do.
Other medicines and Mictonorm XL 45 mg
You should tell your doctor if you are taking or have taken any of the following medicines as they
may interact with Mictonorm XL 45 mg:
antidepressants (e.g. imipramine, clomipramine and amitriptyline),
sleeping tablets (e.g. benzodiazepines),
anticholinergics taken by mouth or injection (usually used to treat asthma, stomach cramps, eye
problems or urinary incontinence),
amantadine (used to treat flu and Parkinson’s disease),
neuroleptics such as promazine, olanzapine, quetiapine (drugs used to treat psychotic disorders
like schizophrenia or anxiety),
beta stimulants (drugs used to treat asthma),
cholinergics (e.g. carbachol, pilocarpin),
isoniazid (a treatment for tuberculosis),
metoclopramide (used to treat nausea and vomiting),
concomitant treatment with methimazole (used to treat hyperfunction of the thyroid gland) and
medicines used to treat fungal diseases (e.g. ketoconazole, itraconazole).
Nevertheless, it may still be all right for you to take Mictonorm XL 45 mg. Your doctor will be able to
decide what is suitable for you.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertiliy
Do not take Mictonorm XL 45 mg if you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby.
Driving and using machines
Mictonorm XL 45 mg can sometimes cause sleepiness and blurred vision. You should not drive or
operate machinery if you suffer from sleepiness and blurred vision.
Mictonorm XL 45 mg contains lactose
Mictonorm XL 45 mg contains lactose (a sugar). If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before taking this medicine.
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3. HOW TO TAKE MICTONORM XL 45 MG
Always take Mictonorm XL 45 mg exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The label on the carton will tell you how many capsules you should take and when.
The recommended dose is:
Adults and the elderly: The usual dose of Mictonorm XL 45 mg is one capsule daily.
Use in children and adolescents: Mictonorm XL 45 mg is not recommended for children.
Method of administration:
Take your capsule at the same time each day. Swallow the capsule whole with a drink of water. Do
not crush or chew the capsules. You may take them with or without food.
If you take more Mictonorm XL 45 mg than you should
If you have accidentally taken more than your prescribed dose, contact your nearest casualty
department or tell your doctor or pharmacist immediately. Remember to take the pack and any
remaining capsules with you.
If you forget to take Mictonorm XL 45 mg
Do not worry. Simply leave out that dose completely. Then take your next dose at the right time. Do
not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mictonorm XL 45 mg can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. The
following symptoms are first signs for such reactions:
Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or
throat
Peeling and blistering of the skin, mouth, eyes and genitals
Rash affecting your whole body.
If you get any of these symptoms during treatment, you should stop taking the capsules and contact
your doctor immediately.
You might suffer an acute attack of glaucoma. In this case, you have been seeing coloured rings
around lights or develop severe pain in and around either eye. You should seek medical attention
immediately.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people)
dry mouth
Common (may affect up to 1 in 10 people)
abnormal vision and difficulty in focussing
fatigue
headache
abdominal pain
indigestion
constipation
Uncommon (may affect up to 1 in 100 people)
feeling sick and vomiting
dizziness
trembling (tremor)
inability to empty the bladder (urinary retention)
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flushing
altered sense of taste
decreased blood pressure with drowsiness
itching
difficulty in passing urine
Rare (may affect up to 1 in 1,000 people)
rash
faster heart beat
Very rare (may affect up to 1 in 10,000 people)
feeling your heart beat
restlessness and confusion
Not known (frequency cannot be estimated from the available data)
sensing things that are not real (hallucination)
speech disorder
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All undesirable effects are transient and recede after a dose reduction or termination of the therapy
after maximum 1-4 days.
During long-term therapy hepatic enzymes should be monitored, because reversible changes of liver
enzymes might occur in rare cases.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 MICTONORM XL 45 MG
Keep out of the sight and reach of children.
Do not use Mictonorm XL 45 mg after the expiry date, which is stated on the blister or bottle and
carton. The expiry date refers to the last day of that month.
Blister: Do not store above 25 °C. Store in the original package to protect the capsules from moisture.
Bottle: Keep the bottle tightly closed.
Stability after first opening of the bottle: 100 days
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mictonorm XL 45 mg contains
The active substance is propiverine hydrochloride. Each modified-release capsule contains 45 mg of
propiverine hydrochloride.
The other ingredients are citric acid, povidone, lactose monohydrate, talc, triethyl citrate, magnesium
stearate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate
copolymer (1:2), ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B,
gelatine, titanium dioxide E171, red iron oxide E172, and yellow iron oxide E172.
What Mictonorm XL 45 mg looks like and contents of the pack
Mictonorm XL 45 mg capsules are orange containing white to off-white pellets.
They are available in
blister packs of 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, 168 or 280 capsules.
bottles of 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98 or 100 capsules.
The polypropylene screw cap of the polyethylene bottles contains a silica gel desiccant.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
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Germany:
United Kingdom:
Ireland:
Austria:
Belgium:
Czech Republic:
Greece:
Italy:
Luxembourg:
Slovak Republic:
Slovenia:
Portugal:

Mictonorm Uno® 45 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Mictonorm® XL 45 mg Modified-Release Capsules
Detrunorm® XL 45 mg Modified-Release Capsules
Mictonorm® 45 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Mictonorm® Forte 45 mg Capsule met gereguleerde afgifte
Mictonorm Uno® 45 mg Tvrdé tobolky s řízeným uvolňováním
Mictonorm® Uno 45 mg Καψάκιο ελεγχόμενης αποδέσμευσης
Mictonorm® 45 mg Capsule a rilascio modificato
Mictonorm® Forte 45 mg Gélules à libération modifiée
Mictonorm® XL 45 mg Tvrdé kapsuly s riadeným uvoľňovaním
Detrunorm® 45 mg Trde kapsule s prirejenim sproščanjem
Mictonorm® OD 45 mg Cápsula de libertação modificada

This leaflet was last revised in December 2016.

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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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