MictoNorm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mictonorm 15 mg Film-coated Tablets

Propiverine hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms
are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or
pharmacist. See section 4.
The medicine prescribed for you is called Mictonorm 15 mg film-coated tablets (referred to as
Mictonorm in this leaflet). The active substance is propiverine hydrochloride and the excipients
are listed at the end of this leaflet (section 6, Contents of the pack and other information).
Contents of this leaflet:

1. What Mictonorm is and what it is 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. 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 controlling their bladder due to an overactive bladder or, in some cases, spinal cord disorders.
Mictonorm contains the active substance propiverine hydrochloride. This substance prevents the bladder
from contracting and increases its capacity. Mictonorm is used in the treatment of symptoms of overactive bladder.

2. WHAT YOU NEED TO KNOW BEFORE TAKING 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:
intestinal obstruction
obstruction of the bladder outflow tract (difficulty urinating)
severe myasthenia gravis (a disease causing muscle weakness)
failure of the muscles controlling intestinal movement (intestinal atony)
severe inflammation of the intestine (ulcerative colitis) which may cause diarrhoea containing blood and mucus, and abdominal pain
toxic megacolon (a condition involving intestinal dilation)
increased pressure inside the eye (uncontrolled narrow-angle glaucoma)
moderate or severe liver disease
rapid and irregular heartbeat

Warnings and precautions
Before treatment with Mictonorm, inform your doctor if you suffer from:
nerve damage affecting control of blood pressure, heart rate, intestinal and bladder movements, 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 backflow of stomach acid into the throat (hiatal hernia with reflux oesophagitis)
irregular heartbeat
rapid heartbeat

If you have any of these conditions, contact your doctor. Your doctor will advise you on what to do.

Other medicines and Mictonorm
Inform your doctor if you are taking or have recently taken any of the following medicines, which may interact with Mictonorm:
antidepressants (e.g. imipramine, clomipramine and amitriptyline),
sleeping pills (e.g. benzodiazepines),
anticholinergics taken by mouth or administered by injection (commonly used to treat asthma, stomach cramps, eye problems or urinary incontinence),
amantadine (used to treat influenza and Parkinson’s disease),
neuroleptics such as promazine, olanzapine, quetiapine (medicines used to treat psychotic disorders such as schizophrenia or anxiety),
beta-agonists (used in the treatment of asthma),
cholinergics (e.g. carbachol, pilocarpine),
isoniazid (a medicine for tuberculosis),
metoclopramide (used to treat nausea and vomiting),
concomitant treatment with methimazole (used to treat overactive thyroid gland) and antifungal medicines (e.g. ketoconazole, itraconazole).

However, you may still be able to take Mictonorm. Your doctor will decide what is best for you.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring 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 may be pregnant, planning a pregnancy, or are breastfeeding.

Driving and using machines
Mictonorm may occasionally cause drowsiness and blurred vision. Do not drive or operate machinery if you experience drowsiness or 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 an intolerance to certain sugars, 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 directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
Adults and elderly : The usual dose of Mictonorm is two or three tablets daily. You may already
respond to a dose of one tablet per day. The maximum recommended daily dose is 45 mg.
Use in children and adolescents: Mictonorm is not recommended for use in children.
Method of administration:
Take the tablets at the same time every day. Swallow the tablets whole with a glass of water before
meals.
If you take more Mictonorm than you should
If you have accidentally taken more than the prescribed dose, contact the nearest emergency room or
inform your doctor or pharmacist immediately. Remember to bring the packaging 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. In that case, take the next dose at the usual time. Do not take a double dose to make up for a
missed dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Mictonorm can cause adverse reactions, although not everyone experiences 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 formation of blisters on the skin, mouth, eyes and genitals
rash affecting the entire body
Stop taking the tablets and contact your doctor immediately if you notice any of these symptoms during treatment.
An acute attack of glaucoma may occur. In this case, the patient may see colored halos around lights or experience severe pain inside and around one or both eyes. If this happens, consult a doctor urgently.
The following adverse reactions have been observed:
Very common (may affect more than 1 in 10 people)
dry mouth
Common (may affect up to 1 in 10 people)
visual disturbances 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)
flushing
taste disturbances
reduction in blood pressure with drowsiness
itching
difficulty urinating
Rare (may affect up to 1 in 1,000 people)
rash
faster heartbeat
Very rare (may affect up to 1 in 10,000 people)
awareness of heartbeat (palpitations)
restlessness and confusion
Not known (frequency cannot be estimated from the available data)
perception of unreal things (hallucinations)
speech disorder
All adverse reactions are transient and resolve within 1 to 4 days following dose reduction or discontinuation of therapy.
In case of prolonged treatment, liver enzymes should be monitored, as reversible alterations in these enzymes may rarely occur.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, 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 requires no special storage conditions.
Do not use Mictonorm after the expiry date stated on the blister and packaging. The expiry date refers to the last day of that month.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Mictonorm contains
The active substance is propiverine hydrochloride. Each coated tablet contains 15 mg of propiverine
hydrochloride.
The excipients are monohydrate lactose, powdered cellulose, magnesium stearate, sucrose, talc,
kaolin, calcium carbonate, titanium dioxide (E171), gum arabic, anhydrous colloidal silica, macrogol
6000, monohydrate glucose, carmine red A (E124 lake), montan wax.
Description of the appearance of Mictonorm and packaging contents
The Mictonorm 15 mg coated tablets are pink-coloured 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 Authorization Holder
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany
Marketing Authorization Holder in Italy:
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 authorized in the Member States of the European Economic Area under the
following names:

PATIENT LEAFLET: INFORMATION FOR THE USER

Mictonorm 30 mg modified-release capsule

Propiverine hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms
are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
The medicine prescribed to you is called Mictonorm 30 mg modified-release capsule
(referred to as Mictonorm in this patient information leaflet). The active substance is propiverine hydrochloride and the excipients are listed at the end of this leaflet (section 6, Package contents and other information).
Contents of this leaflet:

1. What Mictonorm is and what it is 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

1. WHAT MICTONORM IS 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. Mictonorm contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases its capacity. Mictonorm is used in the treatment of symptoms of overactive bladder. It is a modified-release capsule to be taken once daily.

2. WHAT YOU NEED TO KNOW BEFORE TAKING 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 have any of the following conditions:
intestinal obstruction
obstruction of the bladder outflow tract (difficulty urinating)
severe myasthenia gravis (a disease causing muscle weakness)
loss of function in the muscles controlling intestinal movement (intestinal atony)
severe inflammation of the intestine (ulcerative colitis), which may cause bloody diarrhoea with mucus and abdominal pain
toxic megacolon (a condition involving intestinal dilation)
increased pressure inside the eye (uncontrolled narrow-angle glaucoma)
moderate or severe liver disease
rapid and irregular heartbeat

Warnings and precautions
Before starting treatment with Mictonorm, inform your doctor if you have:
nerve damage affecting blood pressure, heart rate, intestinal and bladder movements, and other bodily functions (autonomic neuropathy)
kidney disease
liver disease
severe heart failure
enlarged prostate
recurrent urinary tract infections
tumours of the urinary tract
glaucoma
heartburn and indigestion due to stomach acid reflux into the throat (hiatal hernia with reflux esophagitis)
irregular heartbeat
rapid heartbeat

If you have any of these conditions, contact your doctor. Your doctor will advise you on what to do.

Other medicines and Mictonorm
Inform your doctor if you are taking or have recently taken any of the following medicines, which may interact with Mictonorm:
antidepressants (e.g. imipramine, clomipramine, and amitriptiline),
sleeping pills (e.g. benzodiazepines),
anticholinergics taken by mouth or administered by injection (commonly used to treat asthma, stomach cramps, eye problems, or urinary incontinence),
amantadine (used to treat influenza and Parkinson's disease),
neuroleptics such as promazine, olanzapine, quetiapine (medicines used to treat psychotic disorders such as schizophrenia or anxiety),
beta-stimulants (used in the treatment of asthma),
cholinergics (e.g. carbachol, pilocarpine),
isoniazid (a medicine for tuberculosis),
metoclopramide (used to treat nausea and vomiting),
concomitant treatment with methimazole (used to treat overactive thyroid gland) and antifungal medicines (e.g. ketoconazole, itraconazole).

However, you may still be able to take Mictonorm. Your doctor will decide what is best for you.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.

Pregnancy, breastfeeding, and fertility
Do not take Mictonorm if you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding.

Driving and using machines
Mictonorm may sometimes cause drowsiness and blurred vision. Do not drive or operate machinery if you experience drowsiness or blurred vision.

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

3. HOW TO TAKE MICTONORM

Always take Mictonorm exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly: The usual dose of Mictonorm is one capsule per day.
Use in children and adolescents: Mictonorm is not recommended for use in 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 may take it with or without food.
If you take more Mictonorm than you should
If you accidentally take more than the prescribed dose, contact the nearest emergency department or inform your doctor or pharmacist immediately. Remember to bring the package and any remaining capsules with you.
If you forget to take Mictonorm
Do not worry. Simply skip that dose completely. Take the next dose at the correct time. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of Mictonorm, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Mictonorm may cause adverse reactions, although not everyone experiences 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
skin peeling and blistering affecting the skin, mouth, eyes, and genitals
rash affecting the entire body
Stop taking the capsules and contact your doctor immediately if you notice any of these symptoms during treatment.

An acute attack of glaucoma may occur. In this case, the patient may see colored halos around lights or experience severe pain inside and around one or both eyes. If this occurs, consult a doctor urgently.

The following adverse reactions have been observed:

Very common (may affect more than 1 in 10 people)
dry mouth

Common (may affect up to 1 in 10 people)
visual disturbances and difficulty focusing
fatigue
headache
abdominal pain
digestive disturbances
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 disturbances
reduced blood pressure with drowsiness
itching
difficulty urinating

Rare (may affect up to 1 in 1,000 people)
rash
faster heartbeat

Very rare (may affect up to 1 in 10,000 people)
awareness of heartbeat (palpitations)
restlessness and confusion

Not known (frequency cannot be estimated from the available data)

• perception of unreal things (hallucinations)
• speech disorder

All adverse reactions are transient and resolve within 1 to 4 days following dose reduction or discontinuation of therapy.
In case of prolonged treatment, liver enzymes should be monitored, as reversible changes in these enzymes may rarely occur.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, 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 stated on the blister or bottle and on the outer packaging.
The expiry date refers to the last day of that month.
Blister: do not store above 25°C. Keep in the original packaging to protect the capsules from moisture.
Bottles: keep the bottle tightly closed.

6. PACK CONTENTS AND OTHER INFORMATION

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

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

• Blister packs containing 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112 or 280 capsules.
• Bottles containing 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, or 100 capsules. The polypropylene screw cap of the polyethylene bottles contains a desiccant based on silica gel. Not all pack sizes may be marketed.

Marketing Authorization Holder
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany

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

Manufacturer
APOGEPHA Arzneimittel GmbH
(Legal address: Kyffhäuserstraße 27 - 01309 Dresden - Germany)
(Production site: Dohnaer Straße 205 - 01257 Dresden - Germany)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Propinorm Uno 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung
United Kingdom: Propinorm XL 30 mg Modified-Release Capsules
Ireland: Propinorm XL 30 mg Modified-Release Capsules
Austria: Mictonorm 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Belgium: Mictonorm Uno 30 mg Capsule met gereguleerde afgifte
Czech Republic: Mictonorm Uno 30 mg Tvrdé tobolky s řízeným uvolňováním
Greece: Mictonorm Uno 30 mg Καψάκιο ελεγχόμενης αποδέσμευσης
Italy: Mictonorm 30 mg Capsule a rilascio modificato
Luxembourg: Mictonorm Uno 30 mg Gélules à libération modifiée
Slovakia: Mictonorm XL 30 mg Tvrdá kapsula s riadeným uvoľňovaním
Slovenia: Detrunorm 30 mg Trde kapsule s prirejenim sproščanjem
Portugal: Mictonorm OD 30 mg Cápsula de libertação modificada

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Mictonorm 45 mg modified-release capsule

Propiverine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms
are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
The medicine prescribed for you is called Mictonorm 45 mg modified-release capsule
(referred to as Mictonorm in this patient information leaflet). The active substance is propiverine hydrochloride and the excipients are listed at the end of this leaflet (section 6, Package contents and other information).
Contents of this leaflet:

1. What Mictonorm is and what it is 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

7. What Mictonorm is 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 who have spinal cord problems. Mictonorm contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases its capacity. Mictonorm is used in the treatment of symptoms of overactive bladder. It is a modified-release capsule to be taken only once daily.

8. What you should 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 excipients in Mictonorm (listed in section 6).
Do not take Mictonorm if you have any of the following conditions:
intestinal obstruction
obstruction of the bladder outflow tract (difficulty urinating)
severe myasthenia gravis (a disease causing muscle weakness)
lack of function in the muscles controlling intestinal movement (intestinal atony)
severe intestinal inflammation (ulcerative colitis), which may cause diarrhoea containing blood and
mucus, and abdominal pain
toxic megacolon (a condition involving intestinal dilation)
increased pressure inside the eye (uncontrolled narrow-angle glaucoma)
moderate or severe liver disease
rapid and irregular heartbeat

Warnings and precautions
Before starting treatment with Mictonorm, inform your doctor if you have:
nerve damage affecting blood pressure, heart rate, intestinal and bladder movements, and other
bodily functions (autonomic neuropathy)
kidney disease
liver disease
severe heart failure
enlarged prostate
recurrent urinary tract infections
tumours of the urinary tract
glaucoma
heartburn and indigestion due to stomach acid reflux into the throat (hiatal hernia with reflux
esophagitis)
irregular heartbeat
rapid heartbeat

If you have any of these conditions, contact your doctor, who will advise you on what to do.

Other medicines and Mictonorm
Inform your doctor if you are taking or have recently taken any of the following medicines, which may
interact with Mictonorm:
antidepressants (e.g. imipramine, clomipramine, and amitriptyline),
sleeping pills (e.g. benzodiazepines),
anticholinergics taken by mouth or administered by injection (commonly used to treat asthma,
stomach cramps, eye problems, or urinary incontinence),
amantadine (used to treat influenza and Parkinson's disease),
neuroleptics such as promazine, olanzapine, quetiapine (medicines used to treat psychotic disorders
such as schizophrenia or anxiety),
beta-stimulants (used in the treatment of asthma),
cholinergics (e.g. carbachol, pilocarpine),
isoniazid (a medicine for tuberculosis),
metoclopramide (used to treat nausea and vomiting),
concomitant treatment with methimazole (used to treat overactive thyroid gland) and antifungal
medicines (e.g. ketoconazole, itraconazole).

However, you may still be able to take Mictonorm. Your doctor will decide what is best for you.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those not requiring a prescription.

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

Driving and using machines
Mictonorm may occasionally cause drowsiness and blurred vision. Do not drive or operate machinery
if you experience drowsiness or blurred vision.

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

9. How to take Mictonorm

Always take Mictonorm exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and elderly: the usual dose of Mictonorm is one capsule daily.
Use in children and adolescents: Mictonorm is not recommended for use in 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 may take them with or without food.
If you take more Mictonorm than you should
If you have accidentally taken more than the prescribed dose, contact your nearest emergency department or inform your doctor or pharmacist immediately. Remember to bring the pack and any remaining capsules with you.
If you forget to take Mictonorm
Do not worry. Simply skip the missed dose completely. Take the next dose at the correct time.
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

10. Possible side effects

Like all medicines, Mictonorm can cause side effects, although not everyone experiences 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 affecting the entire body
Stop taking the capsules and contact your doctor immediately if you notice any of these symptoms during treatment.
An acute attack of glaucoma may occur. In this case, the patient may see coloured halos around lights or experience severe 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)
visual disturbances and difficulty focusing
fatigue
headache
abdominal pain
digestive disturbances
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 disturbances
reduction in blood pressure with drowsiness
itching
difficulty urinating
Rare (may affect up to 1 in 1,000 people)
rash
faster heartbeat
Very rare (may affect up to 1 in 10,000 people)
awareness of heartbeat (palpitations)
restlessness and confusion
Not known (frequency cannot be estimated from the available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the blister or bottle and on the outer packaging.
The expiry date refers to the last day of that month.
Blister: Do not store above 25°C. Keep in the original packaging to protect the capsules from moisture.
Bottle: keep the bottle tightly closed.
Bottle stability after first opening: 100 days

12. Package contents and other information

What Mictonorm contains
The active substance is propiverine hydrochloride. Each modified-release capsule contains 45 mg of
propiverine hydrochloride.
The other ingredients are citric acid, povidone, monohydrate lactose, 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,
gelatin, titanium dioxide E171, red iron oxide E172, yellow iron oxide E172.
Description of the appearance of Mictonorm and package contents
Mictonorm capsules are orange in colour and contain white to off-white pellets.
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 polypropylene screw cap of the polyethylene bottles contains hygroscopic silica gel.
Not all pack sizes may be marketed.
Marketing Authorization Holder
APOGEPHA Arzneimittel GmbH
Kyffhäuserstraße 27
01309 Dresden
Germany
Local Distributor:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Viale Shakespeare, 47 - Rome
Manufacturer
APOGEPHA Arzneimittel GmbH (legal address Kyffhäuserstraße 27 - 01309 Dresden - Germany)
(production site - Dohnaer Straße 205 - 01257 Dresden - Germany)
This medicinal product is authorized in the European Economic Area countries under the
following names:
Germany: Mictonorm Uno 45 mg Hartkapseln mit veränderter Wirkstofffreisetzung
United Kingdom: Mictonorm XL 45 mg Modified-Release Capsules
Ireland: Detrunorm XL 45 mg Modified-Release Capsules
Austria: Mictonorm 45 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Belgium: Mictonorm Forte 45 mg Capsule met gereguleerde afgifte
Czech Republic: Mictonorm Uno 45 mg Tvrdé tobolky s řízeným uvolňováním
Greece: Mictonorm Uno 45 mg Καψάκιο ελεγχόμενης αποδέσμευσης
Italy: Mictonorm 45 mg capsule a rilascio modificato
Luxembourg: Mictonorm Forte 45 mg Gélules à libération modifiée
Slovakia: Mictonorm XL 45 mg Tvrdé kapsuly s riadeným uvoľňovaním
Slovenia: Detrunorm 45 mg Trde kapsule s prirejenim sproščanjem
Portugal: Mictonorm OD 45 mg Cápsula de libertação modificada