DETRUNORM 15MG COATED TABLETS

Active substance: PROPIVERINE HYDROCHLORIDE

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3. HOW TO TAKE DETRUNORM 15 MG COATED TABLETS
Always take Detrunorm Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

PATIENT INFORMATION LEAFLET
752-9266

Detrunorm Tablets should be taken by mouth with or without food.

DETRUNORM®15 mg Coated Tablets

Do not crush or chew the tablets.

Propiverine hydrochloride

Adults and elderly patients: the usual dose is one tablet two to three times
a day. Your doctor may increase your dose to one tablet four times a day,
if necessary.

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Read this leaflet carefully before you start taking this
medicine.
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 any of the side effects becomes severe, or you notice
any side effect not listed in this leaflet please tell your
doctor or pharmacist.

In this leaflet:
1. What Detrunorm 15 mg Coated Tablets are and what
they are used for
2. Before you take Detrunorm 15 mg Coated Tablets
3. How to take Detrunorm 15 mg Coated Tablets
4. Possible Side Effects
5. How to store Detrunorm 15 mg Coated Tablets
6. Further Information
1. WHAT DETRUNORM 15 MG COATED TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Detrunorm 15 mg Coated Tablets.
Each tablet contains 15 mg of the active ingredient, propiverine
hydrochloride. Propiverine hydrochloride is one of a group of
medicines called anticholinergics.
Detrunorm is used to treat people who have difficulty controlling their
bladder (incontinence). It reduces the contraction of the bladder and
helps to increase how much urine it can hold.
Detrunorm can, in some cases be used for people who have an over active
bladder because of spinal injuries.
2. BEFORE YOU TAKE DETRUNORM 15 MG COATED TABLETS
Detrunorm is not for use in children
Do not take Detrunorm if you:
• have ever had an allergic reaction to Detrunorm or medicines like
Detrunorm, or any of its ingredients, including cochineal red A (E124,
lake) which may cause allergic reactions including asthma, particularly
in those who are allergic to aspirin (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);
• are pregnant or breast-feeding.
or if you are suffering from any of the following conditions :
• bowel problems (e.g. bowel obstruction, severe ulcerative colitis or
muscle weakness) that may lead to diarrhoea containing blood
and mucous; or stomach pains;
• bladder obstruction, causing difficulty in passing urine;
• muscle weakness (myasthenia gravis);
• fever, pain and tenderness of the abdomen (toxic megacolon);
• increased pressure in the eye (uncontrolled angle closure glaucoma);
• moderate or severe liver disease;
• fast or irregular heart beat.

If any of the above affect you, or you are unsure if they do, tell your doctor
who will be able to advise you.
Take special care with this medicine if:
• you have damage to the nerves which supply the internal
organs (autonomic neuropathy);
• you have severe heart failure, or a fast or irregular heart beat;
• you have an enlarged prostate gland (men only);
• you suffer from heartburn and indigestion due to a back flow of acid
into the food pipe (hiatus hernia with reflux oesophagitis);
• your liver or kidneys do not work properly.
Tell your doctor before taking this medicine if you have been told you have
an intolerance to some sugars. This is because Detrunorm 15 mg
Coated Tablets contain lactose, a type of sugar.
Taking Detrunorm 15 mg Coated Tablets with other medicines.
Please tell your doctor or pharmacist if you have recently taken any other
medicines, including medicines obtained without a prescription. It is especially
important that you tell your doctor if you are taking:
• medicines to treat problems, such as depression (e.g. imipramine,
clomipramine and amitryptiline) anxiety or psychosis (e.g. neuroleptics
such as promazine, olanzapine, quetiapine) or sleep difficulties;
• medicines belonging to a class known as sympathomimetics (these
are used to treat a range of conditions; including asthma, heart conditions,
eye problems);
• medicines belonging to a class known as anticholinergics (these are used
to treat a range of conditions, including asthma, stomach cramps, eye
problems, urinary incontinence);
• medicines to treat stomach problems or nausea and vomiting
(e.g. metoclopramide);
• a medicine called amantadine (used to treat Parkinson’s disease);
• a medicine called isoniazid (used to treat tuberculosis);
If you take Detrunorm Tablets for a long time, your doctor may occasionally
test your liver function.

If you take more Detrunorm than you should
If you accidentally take too much of your medicine, tell your doctor at
once or contact your nearest hospital casualty department immediately.
Take your medicine and this leaflet with you.
If you forget to take Detrunorm
If you forget to take a dose, just take the next dose at the usual time,
DO NOT take a double dose.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Detrunorm 15 mg Coated Tablets can cause side
effects, although not everybody gets them.
If you notice;
• Itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.
Stop taking the tablets and tell your doctor immediately.
These may be signs of an allergic reaction.
In theory it is possible that 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.
Very Common Side Effects (more than 1 in 10 people)
Dryness of the mouth.
Common Side Effects (more than 1 in 100 but less than
1 in 10 people)
Constipation, blurred vision.
Uncommon Side Effects (more than 1 in 1000 but less than
1 in 100 people)
Decreased blood pressure (with drowsiness), problems passing urine,
flushing of the face and neck, shaking, dizziness, tiredness, nausea and
vomiting.

If you are at risk of developing glaucoma, your doctor may check your
eyes, whilst you are being treated with Detrunorm Tablets.

Rare Side Effects (more than 1 in 10,000 but less than
1 in 1000 people)
Hypersensitivity, rash or irritation.

Pregnancy and breast-feeding
Do not take this medicine if you are, or think you might be pregnant, or
if you are breast-feeding.

Very Rare Side Effects (less than 1 in 10,000)
Irregular heartbeats, confusion or restlessness.

Driving or operating machinery
Detrunorm Tablets can sometimes cause drowsiness and blurred vision. You
should not drive or operate machinery until you are sure you are not affected.

Frequency Unknown
Hallucinations
These side effects will pass and will stop altogether within 1 to 4 days after
having your dose reduced, or if you stop taking the tablets. If you are worried
by these or any other effects, you should tell your doctor or pharmacist.
If any of the side effects becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DETRUNORM 15 MG COATED TABLETS
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Do not store the blister pack above 25ºC.
Keep the tablets in the original package.
Do not use after the expiry date printed on the carton.
The information in this leaflet applies only to Detrunorm
15 mg coated Tablets. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
6. FURTHER INFORMATION
What Detrunorm 15 mg Coated Tablets contain
Each tablet contains 15.00mg propiverine hydrochloride (equivalent to 13.64 mg
propiverine) as the active ingredient along with the following inactive
ingredients: lactose monohydrate; powdered cellulose; magnesium stearate;
sucrose; talcum; heavy kaolin; calcium carbonate; titanium dioxide (E171);
acacia gum; colloidal anhydrous silica; Macrogol 6000; glucose monohydrate;
cochineal red A (E124, lake); Montan wax.
What Detrunorm 15 mg Coated Tablets look like and the
contents of the pack
The tablets are rose-coloured biconvex, round sugar coated tablets. The
carton the tablets come in contain blister packs with 28 or 56 coated tablets
per carton.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is:
Amdipharm Plc, Regency House,
Miles Gray Road, Basildon, Essex SS14 3AF
The manufacturer responsible for release is:
APOGEPHA Arzneimittel GmbH,
Kyffhäuserstraße 27, 01309 Dresden, Germany.
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
Date of preparation: May 2008

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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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