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DETRUNORM XL 30MG CAPSULES

Active substance(s): PROPIVERINE HYDROCHLORIDE

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Package leaflet: information for the patient

Detrunorm® XL 30mg 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.
The name of your medicine is Detrunorm XL 30mg capsules but
will be referred to as Detrunorm XL throughout this leaflet.
In this leaflet:
1. What Detrunorm XL is and what it is used for
2. What you need to know before you take Detrunorm XL
3. How to take Detrunorm XL
4. Possible Side Effects
5. How to store Detrunorm XL
6. Contents of the pack and other information

1. WHAT DETRUNORM XL IS AND WHAT IT IS
USED FOR.
Detrunorm XL is used for the treatment of people who have
difficulty in controlling their bladders due to bladder overactivity.
Detrunorm XL contains the active substance propiverine
hydrochloride. This substance prevents the bladder from
contracting and increases the amount that the bladder can hold.
Detrunorm XL 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
Do not take Detrunorm XL 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
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 heart beat;
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 XL
You should tell your doctor if you are taking or have taken any of
the following medicines as they may interact with Detrunorm XL:
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 heart beat, to
stimulate the digestion and to treat glaucoma as Carbachol,
Pilocarpin);
isoniazid (a treatment for tuberculosis);
metoclopramide (used to treat nausea and vomiting).
Nevertheless, it may still be all right for you to take Detrunorm
XL. 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 XL with food and drink
The capsules should be swallowed with or without food or drink.
Pregnancy and breast-feeding
Do not take Detrunorm XL if you are pregnant, likely to become
pregnant or are breast-feeding.
Driving and using machinery
Detrunorm XL 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 XL
Detrunorm XL 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.

3. HOW TO TAKE DETRUNORM XL
Always take Detrunorm XL exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Take your capsule at the same time each day. Swallow it without
food or drink. Do not crush or chew the capsules.
Adults and the elderly: the recommended dose is one capsule
daily.
Detrunorm XL is not recommended for children.
If you take more Detrunorm XL 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 capsules with you. Overdosage can cause symptoms
such as restlessness, dizziness, vertigo, disorders in speech and
vision, muscular weakness, dry mouth, faster heart beat and
problems passing urine.
If you forget to take Detrunorm XL
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 XL can cause side effects,
although not everybody gets them.
All medicines can cause allergic reactions although serious
allergic reactions are very rare. The following symptoms are first
signs for such reactions:
Any sudden wheeziness, difficulty in breathing or dizziness,
swelling of the eyelids, face, lips or throat;
Peeling and blistering of the skin, mouth, eyes and genitals;
Rash affecting your whole body.
If you get any of these symptoms during treatment, you should
stop taking the 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 urgently.
The following side effects have been reported:
Very Common (affects more than 1 user in 10)
Dry mouth.
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 heart beat, restlessness and confusion.
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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report any side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. HOW TO STORE DETRUNORM XL
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in original package in order to protect from moisture.
Do not take the capsules after the expiry date which is stated
on the carton and blister label after ‘Exp’. The expiry date
refers to the last day of that month.
If the capsules become discoloured or show any signs of
deterioration, seek the advice of 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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Detrunorm XL contains
The active ingredient in the Detrunorm XL is propiverine
hydrochloride.
Each modified-release capsule contains 30mg propiverine
hydrochloride (equivalent to 27.28mg propiverine).
The other ingredients are:
Pellets: citric acid, povidone (K25), lactose monohydrate, talc,
triethyl citrate, magnesium stearate, methacrylic acid-methyl
methacrylate copolymer (Ph. Eur.) (1: 1) (Ph. Eur.) 135000,
methacrylic acid-methyl methacrylate copolymer (1: 2) (Ph. Eur)
135000, ammonium methacrylate copolymer (type A)
(approximately 1: 2: 0.2; 150000), ammonium methacrylate
copolymer (type B) (ca. 1: 2: 0 , 1; 150,000).

Hard capsule: gelatin, titanium dioxide (E171), iron (III) oxide
(E172), yellow iron oxide (E172).
What Detrnorm XL looks like and contents of the pack
The capsules are orange and white. They contain white to offwhite pellets.
Detrnorm XL comes in blister packs containing 28 capsules.
Manufactured by: Apogepha Arzneimittel GmbH, Kyffhäuserstr.
27; 01309 Dresden, Germany.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Detrunorm® XL 30mg capsules; PL 18799/2998
Leaflet date: 19.01.2017

POM

Detrunorm is the registered trademark of Amdipharm Mercury
International Limited.

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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.

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