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MICTONORM 15 MG COATED TABLETS

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

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Version 4.0, 02/2016

Mictonorm 15 mg coated tablet

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MICTONORM® 15 mg COATED TABLETS
(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 15 mg coated tablets (referred to as Mictonorm
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:
1.
2.
3.
4.
5.
6.

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

1. WHAT MICTONORM IS AND WHAT IT IS USED FOR
Mictonorm is used for the treatment of people who have difficulty in controlling their bladder due to
bladder overactivity or, in some cases, problems with the spinal cord. Mictonorm contains the active
substance propiverine hydrochloride. This substance prevents the bladder from contracting and
increases the amount that the bladder can hold. Mictonorm is used to treat the symptoms of overactive
bladder.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICTONORM
Do not take Mictonorm
Do not take Mictonorm if you are allergic (hypersensitive) to propiverine hydrochloride or to any of
the other ingredients of Mictonorm (these are listed in section 6).
Do not take Mictonorm 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)
moderate or severe liver disease
fast and irregular heart beat
Warnings and precautions
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Before you take Mictonorm 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
You should tell your doctor if you are taking or have taken any of the following medicines as they
may interact with Mictonorm:
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. 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.
Taking Mictonorm with food and drink
The tablets should be swallowed whole before meals.
Pregnancy, breast-feeding and fertility
Do not take Mictonorm if you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby.
Driving and using machines
Mictonorm can sometimes cause sleepiness and blurred vision. You should not drive or operate
machinery if you suffer from sleepiness and blurred vision.
Mictonorm contains glucose, lactose, sucrose and cochineal red A (E124)
Mictonorm contains glucose, lactose, and sucrose (sugars). If you have been told by your doctor that
you have intolerance to some sugars, contact your doctor before taking this medicine.
Mictonorm contains cochineal red A (E124). This colourant may cause allergic reactions.

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3. HOW TO TAKE MICTONORM
Always take Mictonorm exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
The recommended dose is:
Adults and the elderly: The usual dose of Mictonorm is two or three tablets daily. You might already
respond to a dose of one tablet a day. The maximum recommended daily dose is 45 mg.
Use in children and adolescents: Mictonorm is not recommended for children.
Method of administration:
Take your tablets at the same times each day. Swallow your tablets whole with a drink of water before
meals.
If you take more Mictonorm 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 tablets with you.
If you forget to take Mictonorm
Do not worry. Take your recommended dose as soon as you remember, unless it is nearly time for the
next dose. 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 thismedicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mictonorm 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 tablets 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)
flushing
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altered sense of taste
decreased blood pressure with drowsiness
itching
difficultiy 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
-

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
Keep out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Mictonorm after the expiry date which is stated on the blister and carton. The expiry date
refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mictonorm contains
The active substance is propiverine hydrochloride. Each coated tablet contains 15 mg of propiverine
hydrochloride.
The other ingredients are lactose monohydrate; powdered cellulose; magnesium stearate; sucrose;
talcum; heavy kaolin; calcium carbonate; titanium dioxide (E171); acacia gum; colloidal anhydrous
silica; macrogol 6000; glucose monohydrate; cochineal red A (E124, lake); montan wax.
What Mictonorm looks like and contents of the pack
Mictonorm 15 mg coated tablets are rose-coloured sugar coated tablets.
They are available in blister packs of 14, 20, 28, 30, 50, 56, 60, 84, 100, 112, 168, 252 or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany

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This medicinal product is authorised in the Member States of the EEA under the following
names:
-

United Kingdom:
Belgium:
Italy:
Greece:
Ireland:

Mictonorm® 15 mg Coated Tablets
Mictonorm® 15 mg Comprimés Enrobés
Mictonorm® 15 mg Compresse rivestite
Mictonorm® 15 mg Επικαλυμμένα δισκία
Detrunorm® 15 mg Coated Tablets

This leaflet was last revised in December 2016.

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Expand Transcript

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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