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PROPIVERINE HYDROCHLORIDE 15 MG COATED TABLETS

Active substance(s): PROPIVERINE HYDROCHLORIDE

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Package Leaflet: Information for the User

Detrunorm® 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 pharmacist.
• This leaflet provides a summary of the information available on your
medicine.
• 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 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 Detrunorm® 15 mg Coated Tablets but
will be referred to as Detrunorm throughout the remainder of this
leaflet.
In this leaflet:
1. What Detrunorm is and what it is used for
2. What you need to know before you take Detrunorm
3. How to take Detrunorm
4. Possible Side Effects
5. How to store Detrunorm
6. Contents of the pack and other information
1. What Detrunorm is and what it is used for
Detrunorm 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. Detrunorm contains the active substance
propiverine hydrochloride. This substance prevents the bladder from
contracting and increases the amount that the bladder can hold.
Detrunorm is used to treat the symptoms of overactive bladder.
2. What you need to know before you take Detrunorm
Do not take Detrunorm if:
• You are allergic (hypersensitive) to propiverine hydrochloride or any of
the other ingredients of Detrunorm listed in section 6 (allergic reactions
include mild symptoms such as itching and/or rash. More severe
symptoms include swelling of the face, lips, tongue and/or throat with
difficulty in swallowing or breathing).
or if you are suffering 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 (uncontrolled angle closure glaucoma);
• moderate or severe liver disease;
• fast or irregular heartbeat.
Warnings and precautions
Take special care with this medicine if you have:
• damage to the nerves that control blood pressure, heart rate, bowel
and bladder movement and other bodily functions (autonomic
neuropathy);
• liver problems;
• kidney 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 heartbeat;
• fast heartbeat.
If you suffer from any of these conditions, contact your doctor. He/she will
tell you what to do.

Other medicines and Detrunorm
You should tell your doctor if you are taking or have taken any of the
following medicines as they may interact with Detrunorm:
• antidepressants (e.g. imipramine, clomipramine, 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 and anxiety);
• beta stimulants (drugs used to treat asthma);
• cholinergics (e.g. drugs used to decrease the heartbeat, to stimulate
the digestion and to treat glaucoma as Carbachol, Pilocarpine);
• isoniazid (a treatment for tuberculosis);
• metoclopramide (used to treat nausea and vomiting).
Nevertheless, it may still be all right for you to take Detrunorm. 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 Detrunorm with food and drink
The tablets should be swallowed before meals.
Pregnancy and breast-feeding
Do not take Detrunorm if you are pregnant, likely to become pregnant or
are breast-feeding.
Driving and using machinery
Detrunorm can sometimes cause sleepiness and blurred vision. You
should not drive or operate machinery until you are sure you are not
affected.
Important information about some of the ingredients of Detrunorm
Detrunorm 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.
Detrunorm also contains the colouring agent ponceau 4R (E124)
May cause allergic reactions.
3. How to take Detrunorm
Always take Detrunorm 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 to take and when.
Take your tablets at the same times each day. Swallow your tablets
whole before meals.
Adults and the elderly: the recommended dose of Detrunorm is two to
three tablets daily.
Detrunorm is not recommended for children.
If you take more Detrunorm than you should
If you accidentally take 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. Overdosage can cause symptoms such as restlessness, dizziness,
vertigo, disorders in speech and vision, muscular weakness, dry mouth,
faster heartbeat and problems passing urine.
If you forget to take Detrunorm
Do not worry. Simply leave out that dose completely. 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, Detrunorm 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.

6. Contents of the pack and other information
What Detrunorm contains
Each tablet contains 15 mg propiverine hydrochloride, equivalent to
13.64 mg propiverine.
The other ingredients are:
Lactose monohydrate, powdered cellulose, magnesium stearate,
sucrose, talc, heavy kaolin, calcium carbonate, titanium dioxide (E171),
acacia gum, colloidal anhydrous silica, macrogol 6000, glucose
monohydrate, ponceau 4R (E124) and montan wax.

If you get any of these symptoms during treatment, you should stop
taking the tablets and contact your doctor immediately.

What Detrunorm looks like and contents of the pack
Rose-coloured coated tablets with no markings on either side.
They are available in cartons of 30, 56 and 60 tablets.

You might suffer an acute attack of glaucoma. If you have been seeing
coloured rings around lights or if you should develop severe pain in and
around either eye you should seek medical attention urgently.

Manufactured by
APOGEPHA Arzneimittel GmbH, Kyffhӓuserstrasse 27,
01309 Dresden, Germany.

The following side effects have been reported:

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.

Very Common (affects more than 1 user in 10)
Dry mouth.

Repackaged by MPT Pharma Ltd.
Common (affects more than 1 to 10 users in 100)
Abnormal vision and difficulty in focussing, fatigue, headache, stomach
pain, indigestion, constipation.
Uncommon (affects 1 to 10 users in 1,000)
Feeling sick and vomiting, dizziness, trembling (tremor), difficulty in
passing urine (urinary retention), flushing, altered sense of taste,
decreased blood pressure with drowsiness.
Rare (affects 1 to 10 users in 10,000)
Rash.
Very Rare (affects less than 1 user in 10,000)
Irregular heartbeat, restlessness and confusion.

The following organisations can offer independent advice:
The Continence Foundation
307 Hatton Square
16 Baldwin’s Gardens
London EC1N 7RJ
Help line Mon-Fri 9.30-4.30 Tel: 020 7831 9831
Incontact (Self help organisation for sufferers and carers)
Freepost LON12119
London NW7 1YU
Tel: 020 7530 3401
Help line Mon-Fri 9.30 am – 1.00 pm Tel. 0845 345 0165
PL: 33532/0786

Not known (frequency cannot be estimated from the available data)
Sensing things that are not real (hallucinations).
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, website
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 Detrunorm
• Keep out of the sight and reach of children.
• There are no special precautions for storage.
• Do not use this medicine after the expiry date which is stated on the
carton label and blister after EXP. The expiry date refers to the last day
of that month.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Leaflet dated 15th March 2017
Leaflet coded XXXXXXXX

POM

Detrunorm® is a registered trademark of
Amdipharm Mercury International Limited.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Package Leaflet: Information for the User

Propiverine Hydrochloride 15 mg Coated Tablets
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 pharmacist.
 This leaflet provides a summary of the information available on your
medicine.
 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 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 Propiverine Hydrochloride 15 mg
Coated Tablets but will be referred to as Propiverine Hydrochloride
throughout the remainder of this leaflet.
In this leaflet:
1. What Propiverine Hydrochloride is and what it is used for
2. What you need to know before you take Propiverine Hydrochloride
3. How to take Propiverine Hydrochloride
4. Possible Side Effects
5. How to store Propiverine Hydrochloride
6. Contents of the pack and other information
1. What Propiverine Hydrochloride is and what it is used for
Propiverine Hydrochloride 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. Propiverine Hydrochloride
contains the active substance propiverine hydrochloride. This substance
prevents the bladder from contracting and increases the amount that the
bladder can hold. Propiverine Hydrochloride is used to treat the
symptoms of overactive bladder.
2. What you need to know before you take
Propiverine Hydrochloride
Do not take Propiverine Hydrochloride if:
 You are allergic (hypersensitive) to propiverine hydrochloride or any of
the other ingredients of Propiverine Hydrochloride listed in section 6
(allergic reactions include mild symptoms such as itching and/or rash.
More severe symptoms include swelling of the face, lips, tongue and/or
throat with difficulty in swallowing or breathing).
or if you are suffering 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 (uncontrolled angle closure glaucoma);
 moderate or severe liver disease;
 fast or irregular heartbeat.
Warnings and precautions
Take special care with this medicine if you have:
 damage to the nerves that control blood pressure, heart rate, bowel
and bladder movement and other bodily functions (autonomic
neuropathy);
 liver problems;
 kidney 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 heartbeat;
 fast heartbeat.
If you suffer from any of these conditions, contact your doctor. He/she will
tell you what to do.

Other medicines and Propiverine Hydrochloride
You should tell your doctor if you are taking or have taken any of the
following medicines as they may interact with Propiverine Hydrochloride:
 antidepressants (e.g. imipramine, clomipramine, 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 and anxiety);
 beta stimulants (drugs used to treat asthma);
 cholinergics (e.g. drugs used to decrease the heartbeat, to stimulate
the digestion and to treat glaucoma as Carbachol, Pilocarpine);
 isoniazid (a treatment for tuberculosis);
 metoclopramide (used to treat nausea and vomiting).
Nevertheless, it may still be all right for you to take Propiverine
Hydrochloride. 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 Propiverine Hydrochloride with food and drink
The tablets should be swallowed before meals.
Pregnancy and breast-feeding
Do not take Propiverine Hydrochloride if you are pregnant, likely to
become pregnant or are breast-feeding.
Driving and using machinery
Propiverine Hydrochloride can sometimes cause sleepiness and blurred
vision. You should not drive or operate machinery until you are sure you
are not affected.
Important information about some of the ingredients of
Propiverine Hydrochloride
Propiverine Hydrochloride 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.
Propiverine Hydrochloride also contains the colouring agent
ponceau 4R (E124)
May cause allergic reactions.
3. How to take Propiverine Hydrochloride
Always take Propiverine Hydrochloride 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 to take and when.
Take your tablets at the same times each day. Swallow your tablets
whole before meals.
Adults and the elderly: the recommended dose of
Propiverine Hydrochloride is two to three tablets daily.
Propiverine Hydrochloride is not recommended for children.
If you take more Propiverine Hydrochloride than you should
If you accidentally take 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. Overdosage can cause symptoms such as restlessness, dizziness,
vertigo, disorders in speech and vision, muscular weakness, dry mouth,
faster heartbeat and problems passing urine.
If you forget to take Propiverine Hydrochloride
Do not worry. Simply leave out that dose completely. 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, Propiverine Hydrochloride 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.

6. Contents of the pack and other information
What Propiverine Hydrochloride contains
Each tablet contains 15 mg propiverine hydrochloride, equivalent to
13.64 mg propiverine.
The other ingredients are:
Lactose monohydrate, powdered cellulose, magnesium stearate,
sucrose, talc, heavy kaolin, calcium carbonate, titanium dioxide (E171),
acacia gum, colloidal anhydrous silica, macrogol 6000, glucose
monohydrate, ponceau 4R (E124) and montan wax.

If you get any of these symptoms during treatment, you should stop
taking the tablets and contact your doctor immediately.

What Propiverine Hydrochloride looks like and contents of the pack
Rose-coloured coated tablets with no markings on either side.
They are available in cartons of 30, 56 and 60 tablets.

You might suffer an acute attack of glaucoma. If you have been seeing
coloured rings around lights or if you should develop severe pain in and
around either eye you should seek medical attention urgently.

Manufactured by
APOGEPHA Arzneimittel GmbH, Kyffhӓuserstrasse 27,
01309 Dresden, Germany.

The following side effects have been reported:

Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.

Very Common (affects more than 1 user in 10)
Dry mouth.

Repackaged by MPT Pharma Ltd.
Common (affects more than 1 to 10 users in 100)
Abnormal vision and difficulty in focussing, fatigue, headache, stomach
pain, indigestion, constipation.
Uncommon (affects 1 to 10 users in 1,000)
Feeling sick and vomiting, dizziness, trembling (tremor), difficulty in
passing urine (urinary retention), flushing, altered sense of taste,
decreased blood pressure with drowsiness.
Rare (affects 1 to 10 users in 10,000)
Rash.
Very Rare (affects less than 1 user in 10,000)
Irregular heartbeat, restlessness and confusion.

The following organisations can offer independent advice:
The Continence Foundation
307 Hatton Square
16 Baldwin’s Gardens
London EC1N 7RJ
Help line Mon-Fri 9.30-4.30 Tel: 020 7831 9831
Incontact (Self help organisation for sufferers and carers)
Freepost LON12119
London NW7 1YU
Tel: 020 7530 3401
Help line Mon-Fri 9.30 am – 1.00 pm Tel. 0845 345 0165
PL: 33532/0786

Not known (frequency cannot be estimated from the available data)
Sensing things that are not real (hallucinations).
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, website
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 Propiverine Hydrochloride
 Keep out of the sight and reach of children.
 There are no special precautions for storage.
 Do not use this medicine after the expiry date which is stated on the
carton label and blister after EXP. The expiry date refers to the last day
of that month.
 If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Leaflet dated 15th March 2017
Leaflet coded XXXXXXXX

POM

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

+ 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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