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.

-    Keep this leaflet. Y ou 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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:

- 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 stomach pains

-    toxic megacolon (a condition involving enlargement of the bowel)

-    increased pressure in the eye

-    moderate or severe liver disease

-    fast and irregular heart beat

-    you are pregnant or breast-feeding

Take special care with Mictonorm

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)

-    severe kidney problems

-    moderate or severe liver problems

-    severe heart failure

-    enlargement of the prostate gland

-    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.

Taking other medicines

Y ou should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your 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),

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

-    beta stimulants (drugs used to treat asthma),

-    isoniazid (a treatment for tuberculosis) and

-    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:

-    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.

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)

-    dry mouth

Common side effects (affecting up to 1 in 10 people)

-    abnormal vision and difficulty in focussing

-    fatigue

-    headache

-    stomach pain

-    indigestion

-    constipation

Uncommon side effects (affecting fewer than 1 in 100 people)

-    feeling sick and vomiting

-    dizziness

-    trembling (tremor)

-    difficulty in passing urine (urinary retention)

-    flushing

-    altered sense of taste

-    decreased blood pressure with drowsiness

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

-    rash

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

-    irregular heartbeat

-    restlessness and confusion.

Frequency is not known (cannot be estimated from the available data

-    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 Kyffhauserstrahe 27 01309 Dresden Germany

This medicinal product is authorised in the Member States of the EEA under the following name s :

Germany:	Propinorm ® 15 mg Uberzogene Tabletten
United Kingdom:	Mictonorm® 15 mg Coated Tablets
Portugal:	Mictonorm® 15 mg Comprimidos Revestidos
Belgium:	Mictonorm® 15 mg Comprimes Enrobes
Luxembourg:	Mictonorm® 15 mg Comprimes Enrobes
Italy:	Mictonorm 15 mg Compresse rivestite
Greece:	Mictonorm® 15 mg EniKaLnppeva Sioxia
Austria:	Mictonorm® 15 mg Uberzogene Tabletten
Ireland:	Detrunorm® 15 mg Coated Tablets

This leaflet was last revised in June 2014.