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Package leaflet: information for the patient

Detrunorm® XL 30 mg Modified Release Capsules
(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.
In this leaflet:
1. What Detrunorm XL 30 mg Modified Release Capsules are and
what they are used for
2. What you need to know before you take Detrunorm XL 30 mg
Modified Release Capsules
3. How to take Detrunorm XL 30 mg Modified Release Capsules
4. Possible Side Effects
5. How to store Detrunorm XL 30 mg Modified Release Capsules
6. Contents of the pack and other information
1. What Detrunorm XL 30 mg Modified Release
Capsules are and what they are used for
The name of your medicine is Detrunorm XL 30 mg Modified Release
Capsules (to be referred to as Detrunorm throughout the leaflet).
Detrunorm is used for the treatment of people who have difficulty in
controlling their bladders due to bladder overactivity. 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. It is a modified-release capsule that needs only be
taken once a day.
2. What you need to know before you take
Detrunorm XL 30 mg Modified Release Capsules
Do not take Detrunorm if:
• you are allergic to propiverine hydrochloride or any of the other
ingredients of this medicine 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

Format: 180 x 300 mm

toxic megacolon (a condition involving enlargement of the
increased pressure in the eye (uncontrolled angle closure
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, amitryptiline);
• 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,
• 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
Taking Detrunorm with food and drink
The capsules should be swallowed with or without food or drink.
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 Capsules can sometimes cause sleepiness and blurred


Creation date: 13.08.15, 14:35
Color: BlackFormat

vision. You should not drive or operate machinery until you are sure
you are not affected.

passing urine (urinary retention), flushing, altered sense of taste,
decreased blood pressure with drowsiness.

Important information about some of the ingredients of
Detrunorm contains lactose (a sugar). If you have been told by your
doctor that you have intolerance to some sugars, contact your doctor
before taking this medicine.

Rare (affects 1 to 10 users in 10,000)

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

Each modified release capsule contains 30 mg of the active ingredient
propiverine hydrochloride (equivalent to 27.28 mg propiverine), along
with the following inactive ingredients: citric acid, povidone, lactose
monohydrate, talc, triethyl citrate, magnesium stearate, methacrylic
acid-methyl methacrylate copolymer, ammonio methacrylate
copolymer, gelatin, titanium dioxide (E171), red iron oxide (E172) and
yellow iron oxide (E172).

Very Rare (affects less than 1 user in 10,000)
Irregular heartbeat, restlessness and confusion.

Not known (frequency cannot be estimated from the available
3. How to take Detrunorm XL 30 mg Modified Release data)
Sensing things that are not real (hallucinations).
Always take Detrunorm exactly as your doctor has told you. You should
Reporting of side effects
check with your doctor or pharmacist if you are not sure.
If you get any side effects, talk to your doctor or pharmacist. This
Take your capsule at the same time each day. Swallow it without food
includes any possible side effects not listed in this leaflet. You can also
or drink. Do not crush or chew the capsules.
report side effects directly via the Yellow Card Scheme, website
Adults and the elderly: the recommended dose is one capsule daily.
By reporting side effects you can help provide more information on the
Detrunorm is not recommended for children.
safety of this medicine.
If you take more Detrunorm than you should
5. How to store Detrunorm XL 30 mg Modified
If you accidentally take more than your prescribed dose, contact your
Release Capsules
nearest casualty department or tell your doctor or pharmacist
immediately. Remember to take the pack and any remaining capsules Keep this medicine out of sight and reach of children
with you. Overdosage can cause symptoms such as restlessness,
Do not store the blister pack above 25°C.
dizziness, vertigo, disorders in speech and vision, muscular weakness,
Keep the capsules in the original package to protect from moisture.
dry mouth, faster heartbeat and problems passing urine.
Do not use after the expiry date printed on the carton. The expiry date
If you forget to take Detrunorm
refers to the last day of that month.
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 6. Contents of the pack and other information
missed dose.
What Detrunorm contains

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
• 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 capsules and contact your doctor immediately.
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
The following side effects have been reported:
Very Common (affects more than 1 user in 10)
Dry mouth.

What Detrunorm looks like and the contents of the pack
The capsules are orange and white and contain white to off white
They are available in cartons of 14, 20, 28, 30, 49, 50, 56, 60, 84, 98,
100, 112 or 280 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amdipharm UK Ltd.,
Capital House, 85 King William Street,
London EC4N 7BL, UK
Manufacturer responsible for release
APOGEPHA Arzneimittel GmbH,
Kyffhäuserstraße 27,
01309 Dresden,

Common (affects more than 1 to 10 users in 100)
Abnormal vision and difficulty in focussing, fatigue, headache, stomach Detrunorm is a registered trademark of Amdipharm AG
pain, indigestion, constipation.
This leaflet was last revised in August 2015.
Uncommon (affects 1 to 10 users in 1,000)
Feeling sick and vomiting, dizziness, trembling (tremor), difficulty in

12154 / C64 / v007uk-1

Format: 180 x 300 mm


Creation date: 13.08.15, 14:35
Color: BlackFormat

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.