МИКТОНОРМ 30 MG Модифицированные капсулы с контролируемым высвобождением

Содержание инструкции

1. Mictonorm 15 mg Coated Tablets
   1. WHAT IS MICTONORM AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICTONORM
   3. HOW TO TAKE MICTONORM
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MICTONORM
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
2. Mictonorm 30 mg extended-release capsules
   1. WHAT IS MICTONORM AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICTONORM
   3. HOW TO TAKE MICTONORM
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MICTONORM
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
3. Mictonorm 45 mg extended-release capsules
   1. What is Mictonorm and what is it used for
   2. What you need to know before taking Mictonorm
   3. How to take Mictonorm
   4. Possible side effects
   5. How to store Mictonorm
   6. Package Contents and Other Information

Mictonorm 15 mg Coated Tablets

Propiverine hydrochloride
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for you. Do not give it to other people, even if they have the same
symptoms as you, as it could be dangerous.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
The medicine that has been prescribed for you is called Mictonorm 15 mg coated tablets(hereinafter
referred to as Mictonorm).

Contents of this leaflet:

• 1. What Mictonorm is and what it is used for
• 2. What you need to know before you take Mictonorm
• 3. How to take Mictonorm
• 4. Possible side effects
• 5. How to store Mictonorm
• 6. Contents of the pack and other information

1. WHAT IS MICTONORM AND WHAT IT IS USED FOR

Mictonorm is used for the treatment of people who have difficulty controlling their bladder due to an overactive bladder or, in some cases, problems with the spinal cord.
Mictonorm contains the active ingredient propiverine hydrochloride. This substance prevents the bladder
from contracting and increases the volume it can hold. Mictonorm is used in the treatment of symptoms
of overactive bladder.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICTONORM

Do not take Mictonorm
if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the excipients of
Mictonorm (listed in section 6)
if you suffer from any of the following conditions:
obstruction of the intestine
obstruction of the urinary outflow (difficulty urinating)
myasthenia gravis (a disease that causes muscle weakness)
failure of the muscles that control bowel movements (intestinal atony)
severe inflammation of the intestine (ulcerative colitis) which can cause diarrhea containing blood and
mucus and abdominal pain
toxic megacolon (a disease with dilation of the intestine)
increased pressure inside the eye (uncontrolled closed-angle glaucoma)
moderate or severe liver disease
fast and irregular heartbeat

Warnings and precautions
Before treatment with Mictonorm, tell your doctor if you suffer from:
damage to the nerves that control blood pressure, heart rate, bowel
movements and bladder and other bodily functions (autonomic neuropathy)
kidney disease
liver disease
severe heart failure
enlarged prostate
recurrent urinary tract infection
tumors of the urinary tract
glaucoma
heartburn and indigestion due to the reflux of gastric juice into the throat (hiatal hernia with
reflux esophagitis)
irregular heartbeat
fast heartbeat
If you suffer from any of these conditions, contact your doctor. Your doctor will tell you what to do.

Other medicines and Mictonorm
Tell your doctor if you are taking or have recently taken any of the following medicines
that may interact with Mictonorm:
antidepressants (e.g. imipramine, clomipramine and amitriptyline),
sleeping pills (e.g. benzodiazepines),
anticholinergics taken orally or administered by injection (commonly used for the
treatment of asthma, stomach cramps, eye problems or urinary incontinence),
amantadine (used for the treatment of influenza and Parkinson's disease)
neuroleptics such as promazine, olanzapine, quetiapine (medicines used for the treatment of
psychotic disorders such as schizophrenia or anxiety)
beta-stimulants (used in the treatment of asthma)
cholinergics (e.g. carbacol, pilocarpine)
isoniazid (medicine against tuberculosis)
metoclopramide (used for the treatment of nausea and vomiting)
concomitant treatment with methimazole (used to treat hyperthyroidism) and medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
However, you may still be able to take Mictonorm. Your doctor will decide what is best
for you.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Mictonorm with food and drink
The tablets should be swallowed whole, before meals.

Pregnancy, breastfeeding and fertility
Do not take Mictonorm if you are pregnant, suspect you are pregnant, are planning a pregnancy, or
if you are breastfeeding.

Driving and operating machinery
Mictonorm may sometimes cause drowsiness and blurred vision. Do not drive and do not operate
machinery if you experience drowsiness and blurred vision.

Mictonorm contains glucose, lactose, sucrose and cochineal red A (E124)
Mictonorm contains glucose, lactose and sucrose (sugars). If your doctor has diagnosed you with a
sugar intolerance, contact him/her before taking this medicine.
Mictonorm contains cochineal red A (E124). This dye may cause allergic reactions.

3. HOW TO TAKE MICTONORM

Always take Mictonorm exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

Adults and the elderly: the usual dose of Mictonorm is two or three tablets a day. You may 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 in children.
Method of administration:
Take the tablets every day at the same time. Swallow the tablets whole with a glass of
water before meals.

If you take more Mictonorm than you should
If you have accidentally taken a dose higher than the prescribed one, contact the nearest emergency room or
immediately inform your doctor or pharmacist. Remember to bring the package and any remaining
tablets with you.

If you forget to take Mictonorm
Do not worry. Take the recommended dose as soon as you remember, unless it is almost
time for the next dose. Then take the next dose at the right time. Do not take a double
dose to make up for a missed dose.
If you have any doubts about the use of this medicine, 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, but serious allergic reactions are very rare.
The following symptoms are early signs of such reactions:
sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face,
lips or throat
peeling and blistering of skin, mouth, eyes and genitals
rash all over the body
Do not take any more tablets and contact your doctor immediately if, during treatment, you notice the
appearance of any of these symptoms.
An acute attack of glaucoma may occur. In this case, the patient sees colored rings
around lights or feels intense pain inside and around one or both eyes. If this should
happen, consult a doctor urgently.
The following side effects have been observed:
Very common (may affect more than 1 in 10 people)
dry mouth
Common (may affect up to 1 in 10 people)
vision abnormalities and difficulty focusing
fatigue
headache
abdominal pain
digestive disorders
constipation
Uncommon (may affect up to 1 in 100 people)
nausea and vomiting
dizziness
tremor
inability to empty the bladder (urinary retention)
hot flushes
taste alterations
reduction of blood pressure with drowsiness
itching
difficulty urinating
Rare (may affect up to 1 in 1,000)
skin rash
faster heartbeat
Very rare (may affect up to 1 in 10,000)
perception of heartbeat
restlessness and confusion
Not known (frequency cannot be estimated from available data)
perception of unreal things (hallucinations)
speech disorder
All side effects are transient and resolve following dose reduction or
discontinuation of therapy, within a maximum of 1-4 days.
In case of prolonged treatment, liver enzymes should be monitored, because, rarely, a reversible
alteration of these enzymes may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE MICTONORM

Keep this medicine 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 the packaging. The expiry
date refers to the last day of that month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mictonorm contains
The active ingredient is propiverine hydrochloride. Each coated tablet contains 15 mg of propiverine
hydrochloride.
The excipients are lactose monohydrate, powdered cellulose, magnesium stearate, sucrose, talc,
kaolin, calcium carbonate, titanium dioxide (E171), gum arabic, anhydrous colloidal silica, macrogol
6000, glucose monohydrate, cochineal red A (E124 lacca), montan wax.

Description of the appearance of Mictonorm and contents of the pack
Mictonorm 15 mg coated tablets are pink in colour and sugar-coated.
They are available in blisters containing 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
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany

Distributor for the sale:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47- Rome

Manufacturer
APOGEPHA Arzneimittel GmbH (registered office Kyffhäuserstraße 27-01309 Dresden - Germany)
(production site - Dohnaer Straße 205-01257 Dresden - Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

Mictonorm 30 mg extended-release capsules

Propiverine hydrochloride
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms
are the same as yours, as it could be dangerous.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
The medicine that has been prescribed for you is called Mictonorm 30 mg extended-release capsules
other information).

Contents of this leaflet:

• 1. What Mictonorm is and what it is used for
• 2. What you need to know before you take Mictonorm
• 3. How to take Mictonorm
• 4. Possible side effects
• 5. How to store Mictonorm
• 6. Contents of the pack and other information

1. WHAT IS MICTONORM AND WHAT IS IT USED FOR

Mictonorm is used for the treatment of people who have difficulty controlling their bladder due to hyperactivity of the bladder itself. Mictonorm contains the active ingredient propiverine hydrochloride. This substance prevents the bladder from contracting and increases the volume it can hold. Mictonorm is used in the treatment of symptoms of overactive bladder. It is a modified-release capsule that is to be taken only once a day.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICTONORM

Do not take Mictonorm
if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the excipients of
Mictonorm (listed in section 6).
Do not take Mictonorm if you suffer from any of the following conditions:
obstruction of the intestine
obstruction of the outflow pathways of the bladder (difficulty urinating)
myasthenia gravis (a disease that causes muscle weakness)
failure of the muscles that control the movements of the intestine (intestinal atony)
severe inflammation of the intestine (ulcerative colitis) which can cause diarrhea containing blood and
mucus and abdominal pain
toxic megacolon (a disease with dilation of the intestine)
increased pressure inside the eye (uncontrolled closed-angle glaucoma)
moderate or severe liver disease
fast and irregular heartbeat

Warnings and precautions
Before treatment with Mictonorm, tell your doctor if you suffer from:
damage to the nerves that control blood pressure, heart rate, movements
of the intestine and bladder and other bodily functions (autonomic neuropathy)
kidney disease
liver disease
severe heart failure
enlarged prostate
recurrent urinary tract infection
tumors of the urinary tract
glaucoma
heartburn and indigestion due to the reflux of gastric juice into the throat (hiatal hernia with
reflux esophagitis)
irregular heartbeat
fast heartbeat
If you suffer from any of these conditions, contact your doctor. The doctor will tell you what to do.

Other medicines and Mictonorm
Tell your doctor if you are taking or have recently taken any of the following medicines
that may interact with Mictonorm:
antidepressants (e.g. imipramine, clomipramine and amitriptyline),
sleeping pills (e.g. benzodiazepines),
anticholinergics taken orally or administered by injection (commonly used for the
treatment of asthma, stomach cramps, eye problems or urinary incontinence),
amantadine (used for the treatment of influenza and Parkinson's disease)
neuroleptics such as promazine, olanzapine, quetiapine (medicines used for the treatment of
psychotic disorders such as schizophrenia or anxiety)
beta-stimulants (used in the treatment of asthma)
cholinergics (e.g. carbacol, pilocarpine)
isoniazid (medicine against tuberculosis)
metoclopramide (used for the treatment of nausea and vomiting)
concomitant treatment with methimazole (used to treat hyperthyroidism) and medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
However, you may still be able to take Mictonorm. The doctor will decide what is best
for you.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
Do not take Mictonorm if you are pregnant, if you suspect or are planning a pregnancy, or
if you are breastfeeding.

Driving and using machines
Mictonorm can sometimes cause drowsiness and blurred vision. Do not drive and do not use
machines if you experience drowsiness and blurred vision.

Mictonorm contains lactose:
Mictonorm contains lactose (a sugar). If your doctor has diagnosed you with an intolerance to
certain sugars, contact him/her before taking this medicine.

3. HOW TO TAKE MICTONORM

Always take Mictonorm exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

Adults and the elderly:the usual dose of Mictonorm is one capsule a day.

Use in children and adolescents:Mictonorm is not recommended in children.
Method of administration:
Take the capsule every day at the same time. Swallow it whole with a glass of water. Do not
crush or chew the capsules. You can take them with or without food.

If you take more Mictonorm than you should
If you have accidentally taken a dose higher than prescribed, contact the nearest emergency room or
immediately inform your doctor or pharmacist. Remember to bring the package and any remaining
capsules with you.

If you forget to take Mictonorm
Do not worry. Completely skip that dose. Then take the next dose at the correct time.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of Mictonorm, consult 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, but serious allergic reactions are very rare.
The following symptoms are early signs of such reactions:
sudden onset of wheezing, difficulty breathing or dizziness, swelling of the eyelids,
face, lips or throat
peeling and blistering of the skin, mouth, eyes and genitals
rash all over the body
Do not take any more capsules and contact your doctor immediately if, during treatment, you notice the
appearance of any of these symptoms.
An acute attack of glaucoma may occur. In this case, the patient sees colored rings
around lights or feels intense pain inside and around one or both eyes. If this happens,
consult a doctor urgently.
The following side effects have been observed:
Very common (may affect more than 1 in 10 people)
dry mouth
Common (may affect up to 1 in 10 people)
vision abnormalities and difficulty focusing
fatigue
headache
abdominal pain
digestive disorders
constipation
Uncommon (may affect up to 1 in 100 people)
nausea and vomiting
dizziness
tremor
inability to empty the bladder (urinary retention)
hot flushes
taste alterations
reduction of blood pressure with drowsiness
itching
difficulty urinating
Rare (may affect up to 1 in 1,000)
skin rash
faster heartbeat
Very rare (may affect up to 1 in 10,000)
perception of heartbeat
restlessness and confusion
Not known (frequency cannot be estimated from available data)

• perception of unreal things (hallucinations)
• speech disorder

All side effects are transient and resolve following dose reduction or
discontinuation of therapy, within a maximum of 1-4 days.
In case of prolonged treatment, liver enzymes should be monitored, because, rarely, a
reversible alteration of these enzymes may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE MICTONORM

Keep this medicine out of the sight and reach of children.
Do not use Mictonorm after the expiry date which is stated on the blister or the bottle and the packaging.
The expiry date refers to the last day of that month.
Blisters: do not store at a temperature above 25°C. Store in the original package to
protect the capsules from moisture.
Bottles: keep the bottle tightly closed.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mictonorm contains
The active ingredient is propiverine hydrochloride. Each modified-release capsule contains 30 mg of
propiverine hydrochloride.
The excipients are citric acid, povidone, lactose monohydrate, talc, triethyl citrate, magnesium stearate,
acrylic acid-methyl methacrylate copolymer (1:1), acrylic acid-methyl methacrylate copolymer
(1:2), type A ammonium methacrylate copolymer, type B ammonium methacrylate copolymer, gelatine,
titanium dioxide E171, iron oxide red E172, iron oxide yellow E172.

Description of the appearance of Mictonorm and contents of the pack
Mictonorm 30 mg capsules are orange and white in colour and contain pellets ranging in colour from
white to off-white.
They are available in

• blisters containing 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100 or 280 capsules.
• bottles containing 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98 or 100 capsules. The screw cap made of polypropylene on the polyethylene bottles contains a desiccant based on silica gel. Not all pack sizes may be marketed. Marketing Authorisation HolderAPOGEPHA Arzneimittel GmbH Kyffhäuserstraße 27 01309 Dresden Germany Marketing Authorisation Holder:Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47- Rome ManufacturerAPOGEPHA Arzneimittel GmbH (registered office Kyffhäuserstraße 27-01309 Dresden - Germany) (production site - Dohnaer Straße 205-01257 Dresden - Germany) This medicinal product is authorised in the Member States of the European Economic Area with thefollowing denominations:Germany: Propinorm Uno 30 mg Extended-Release Hard Capsules United Kingdom: Propinorm XL 30 mg Modified-Release Capsules Ireland: Propinorm XL 30 mg Modified-Release Capsules Austria: Mictonorm 30 mg Extended-Release Hard Capsules Belgium: Mictonorm Uno 30 mg Capsules with controlled release Czech Republic: Mictonorm Uno 30 mg Controlled-Release Hard Capsules Greece: Mictonorm Uno 30 mg Καψάκιο ελεγχόμενης αποδέσμευσης Italy: Mictonorm 30 mg Modified-Release Capsules Luxembourg: Mictonorm Uno 30 mg Gélules à libération modifiée Slovakia: Mictonorm XL 30 mg Hard capsule with controlled release Slovenia: Detrunorm 30 mg Hard capsules with modified release Portugal: Mictonorm OD 30 mg Modified-Release Capsule

Mictonorm 45 mg extended-release capsules

Propiverine hydrochloride
Read this leaflet carefully before you start to take this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
The medicine that has been prescribed for you is called Mictonorm 45 mg extended-release capsules
other information).

Contents of this leaflet:

• 1. What Mictonorm is and what it is used for
• 2. What you need to know before you take Mictonorm
• 3. How to take Mictonorm
• 4. Possible side effects
• 5. How to store Mictonorm
• 6. Contents of the pack and other information

7. What is Mictonorm and what is it used for

Mictonorm is used for the treatment of people who have difficulty controlling their bladder due to excessive activity of the bladder itself or who have problems with the spinal cord. Mictonorm contains the active ingredient propiverine hydrochloride. This substance prevents the bladder from contracting and increases the volume it can contain. Mictonorm is used in the treatment of symptoms of overactive bladder. It is a modified-release capsule that should be taken only once a day.

8. What you need to know before taking Mictonorm

Do not take Mictonorm
Do not take Mictonorm if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the
ingredients of Mictonorm (listed in section 6).
Do not take Mictonorm if you suffer from any of the following conditions:
obstruction of the intestine
obstruction of the outflow pathways of the bladder (difficulty urinating)
myasthenia gravis (a disease that causes muscle weakness)
failure of the muscles that control the movements of the intestine (intestinal atony)
severe inflammation of the intestine (ulcerative colitis) which may cause diarrhoea containing blood and
mucus and abdominal pain
toxic megacolon (a disease with dilation of the intestine)
increased pressure inside the eye (uncontrolled closed-angle glaucoma)
moderate or severe liver disease
fast and irregular heartbeat

Warnings and precautions
Before treatment with Mictonorm, tell your doctor if you suffer from:
damage to the nerves that control blood pressure, heart rate, movements of the
intestine and bladder and other bodily functions (autonomic neuropathy)
kidney disease
liver disease
severe heart failure
enlarged prostate
recurrent urinary tract infection
tumours of the urinary tract
glaucoma
heartburn and indigestion due to reflux of gastric juice into the throat (hiatal hernia with
reflux esophagitis)
irregular heartbeat
fast heartbeat
If you suffer from any of these conditions, contact your doctor who will tell you what to do.

Other medicines and Mictonorm
Tell your doctor if you are taking or have recently taken any of the following medicines
that may interact with Mictonorm:
antidepressants (e.g. imipramine, clomipramine and amitriptyline),
sleeping pills (e.g. benzodiazepines),
anticholinergics taken orally or administered by injection (commonly used for the
treatment of asthma, stomach cramps, eye problems or urinary incontinence),
amantadine (used for the treatment of influenza and Parkinson's disease)
neuroleptics such as promazine, olanzapine, quetiapine (medicines used for the treatment of
psychotic disorders such as schizophrenia or anxiety),
beta-stimulants (used in the treatment of asthma)
cholinergics (e.g. carbacol, pilocarpine),
isoniazid (medicine against tuberculosis),
metoclopramide (used for the treatment of nausea and vomiting),
concomitant treatment with methimazole (used to treat hyperfunction of the thyroid
gland) and medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
However, you may still be able to take Mictonorm. The doctor will decide what is best
for you.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
Do not take Mictonorm if you are pregnant, suspect you are pregnant, or are planning a pregnancy,
or if you are breastfeeding.

Driving and operating machinery
Mictonorm can sometimes cause drowsiness and blurred vision. Do not drive vehicles and do not
operate machinery if you experience drowsiness and blurred vision.

Mictonorm contains lactose
Mictonorm contains lactose (a sugar). If your doctor has diagnosed you with intolerance to
some sugars, contact them before taking this medicine.

9. How to take Mictonorm

Always take Mictonorm exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

Adults and the elderly:the usual dose of Mictonorm is one capsule a day.

Use in children and adolescents:Mictonorm is not recommended for children.
Method of administration:
Take the capsule every day at the same time. Swallow the capsule whole with a glass of water.
Do not crush or chew the capsules. You can take them with or without food.

If you take more Mictonorm than you should
If you have accidentally taken a dose higher than that prescribed, contact the nearest emergency room or
immediately inform your doctor or pharmacist. Remember to bring the package and any remaining
capsules with you.

If you forget to take Mictonorm
Do not worry. Completely skip that dose. Then take the next dose at the correct time.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, Mictonorm can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, but serious allergic reactions are very rare.
The following symptoms are early signs of such reactions:
sudden onset of wheezing, difficulty breathing or dizziness, swelling of the eyelids,
face, lips or throat
peeling and blistering of the skin, mouth, eyes and genitals
rash all over the body
Do not take any more capsules and contact your doctor immediately if, during treatment, you notice the
appearance of any of these symptoms.
An acute attack of glaucoma may occur. In this case, the patient will see colored rings
around lights or experience intense pain inside and around one or both eyes. If this should
happen, consult a doctor urgently.
The following side effects have been observed:
Very common (may affect more than 1 in 10 people)
dry mouth
Common (may affect up to 1 in 10 people)
vision abnormalities and difficulty focusing
fatigue
headache
abdominal pain
digestive disorders
constipation
Uncommon (may affect up to 1 in 100 people)
nausea and vomiting
dizziness
tremor
inability to empty the bladder (urinary retention)
hot flushes
altered taste
reduction of blood pressure with drowsiness
itching
difficulty urinating
Rare (may affect up to 1 in 1,000)
skin rash
faster heartbeat
Very rare (may affect up to 1 in 10,000)
perception of heartbeat
restlessness and confusion
Not known (frequency cannot be estimated from available data)

• unreal sensations (hallucinations)
• speech disorders All side effects are transient and resolve following dose reduction or discontinuation of therapy, within a maximum of 1-4 days. In case of prolonged treatment, liver enzymes should be monitored, because, rarely, a reversible alteration of these enzymes may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine

11. How to store Mictonorm

Keep this medicine out of the sight and reach of children.
Do not use Mictonorm after the expiry date which is stated on the blister or the bottle and on the packaging.
The expiry date refers to the last day of that month.
Blister: Do not store at a temperature above 25°C. Store in the original package to
protect the capsules from humidity.
Bottle: keep the bottle tightly closed.
Stability of the bottle after first opening: 100 days

12. Package Contents and Other Information

What Mictonorm contains
The active ingredient 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, acrylic acid-methyl methacrylate copolymer (1:1), acrylic acid-methyl
methacrylate copolymer (1:2), type A ammonium methacrylate copolymer, type B ammonium methacrylate copolymer,
gelatin, titanium dioxide E171, red iron oxide E172, yellow iron oxide E172.

Description of Mictonorm’s appearance and package contents
Mictonorm capsules are orange in colour and contain pellets ranging in colour from white to off-white.
They are available in

• blisters containing 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, 168 or 280 capsules
• bottles containing 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98 or 100 capsules

The screw cap made of polypropylene on the polyethylene bottles contains hygroscopic silica gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany

Distributor for sale:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47- Rome

Manufacturer
APOGEPHA Arzneimittel GmbH (registered office Kyffhäuserstraße 27 - 01309 Dresden - Germany)
(production site - Dohnaer Straße 205-01257 Dresden - Germany)

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Germany: Mictonorm Uno 45 mg Hard capsules with modified release
United Kingdom: Mictonorm XL 45 mg Modified-Release Capsules
Ireland: Detrunorm XL 45 mg Modified-Release Capsules
Austria: Mictonorm 45 mg Hard capsules with modified release
Belgium: Mictonorm Forte 45 mg Capsules with controlled release
Czech Republic: Mictonorm Uno 45 mg Hard capsules with controlled release
Greece: Mictonorm Uno 45 mg Καψάκιο ελεγχόμενης αποδέσμευσης
Italy: Mictonorm 45 mg modified-release capsules
Luxembourg: Mictonorm Forte 45 mg Gélules à libération modifiée
Slovakia: Mictonorm XL 45 mg Hard capsules with controlled release
Slovenia: Detrunorm 45 mg Hard capsules with modified release
Portugal: Mictonorm OD 45 mg Modified-release capsule