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MICTONORM 15 MG COATED TABLETS

Active substance(s): PROPIVERINE HYDROCHLORIDE

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PACKAGE LEAFLET

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.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or your pharmacist.

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This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.

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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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, Further Information).
In this leaflet:
1.

What Mictonorm is and what it is used for

2.

Before you take Mictonorm

3.

How to take Mictonorm

4.

Possible side effects

5.

How to store Mictonorm

6.

Further 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 bladders 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. Before you take Mictonorm
Do not take Mictonorm if
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, Further information).
Do not take Mictonorm if you suffer from any of the following conditions:
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obstruction of the bowel

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obstruction to the bladder outlet (difficulty in passing urine)

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myasthenia gravis (a disease causing muscle weakness)

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a loss of function of the muscles controlling your bowel movements (intestinal atony)

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severe inflammation of the bowel (ulcerative colitis) that may lead to diarrhoea containing blood
and mucus and stomach pains

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toxic megacolon (a condition involving enlargement of the bowel)

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increased pressure in the eye

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moderate or severe liver disease

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fast and irregular heart beat

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you are pregnant or breast-feeding

Take special care with Mictonorm
Before you take Mictonorm you should tell your doctor if you have:
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damage to the nerves that control blood pressure, heart rate, bowel and bladder movements and
other bodily functions (autonomic neuropathy)

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severe kidney problems

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moderate or severe liver problems

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severe heart failure

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enlargement of the prostate gland

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heartburn and indigestion due to back flow of gastric juice into the throat (hiatus hernia with
reflux oesophagitis)

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irregular heart beat

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fast heart beat

If you suffer from any of these conditions, contact your doctor. He will tell you what to do.
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines as they may
interact with your Mictonorm:
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antidepressants (e.g. imipramine, clomipramine and amitriptyline),

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sleeping tablets (e.g. benzodiazepines),

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anticholinergics taken by mouth or injection (usually used to treat asthma, stomach cramps, eye
problems or urinary incontinence),

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amantadine (used to treat flu),

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neuroleptics such as promazine, olanzapine, quetiapine (drugs used to treat psychotic disorders
like schizophrenia or anxiety),

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beta stimulants (drugs used to treat asthma),

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isoniazid (a treatment for tuberculosis) and

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metoclopramide (used to treat nausea and vomiting).

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 and breast-feeding
Do not take Mictonorm if you are pregnant, likely to become pregnant or are breast-feeding.
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.
Important information about some of the ingredients of Mictonorm
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 tablets contain Cochineal red A (E124). This colourant may cause allergic reactions.

3. How to take Mictonorm
Always take Mictonorm exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The label on the carton will tell you how many tablets you should take and when. Take your tablets at
the same times each day. Swallow your tablets whole before meals.
Adults and the elderly: The usual dose of Mictonorm is two or three tablets daily.
Mictonorm is not recommended for children.
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
missed dose.
If you have any further questions on the use of this product, 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:

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Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or
throat

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Peeling and blistering of the skin, mouth, eyes and genitals

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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.
In theory, 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 also been reported:
Very common side effects (affecting more than 1 in 10 people)
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dry mouth

Common side effects (affecting up to 1 in 10 people)
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abnormal vision and difficulty in focussing

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fatigue

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headache

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stomach pain

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indigestion

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constipation

Uncommon side effects (affecting fewer than 1 in 100 people)
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feeling sick and vomiting

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dizziness

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trembling (tremor)

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difficulty in passing urine (urinary retention)

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flushing

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altered sense of taste

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decreased blood pressure with drowsiness

Rare side effects (affecting fewer than 1 in 1,000 people)
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rash

Very rare side effects (affecting fewer than 1 in 10,000 people)
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irregular heartbeat

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restlessness and confusion.

Frequency is not known (cannot be estimated from the available data
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sensing things that are not real (hallucination)

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 Mictonorm out of the reach and sight of children.
There are no special precautions for storage.
Do not use Mictonorm after the expiry date, which is stated on the blister and carton after EXP. The
expiry date refers to the last day of that month.

6. Further 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 15mg Coated Tablets are rose-coloured sugar coated tablets.
They are available in cartons 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

This medicinal product is authorised in the Member States of the EEA under the following
names:
Propinorm ® 15 mg Überzogene Tabletten

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Germany:

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United Kingdom: Mictonorm® 15 mg Coated Tablets

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Portugal:

Mictonorm® 15 mg Comprimidos Revestidos

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Belgium:

Mictonorm® 15 mg Comprimés Enrobés

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Luxembourg:

Mictonorm® 15 mg Comprimés Enrobés

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Italy:

Mictonorm® 15 mg Compresse rivestite

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Greece:

Mictonorm® 15 mg Επικαλυμμένα δισκία

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Austria:

Mictonorm® 15 mg Überzogene Tabletten

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Ireland:

Detrunorm® 15 mg Coated Tablets

This leaflet was last revised in June 2014.

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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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