Skip to Content

DETRUNORM 15MG FILM-COATED TABLETS

Active substance(s): PROPIVERINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Version 4.0, 02/2016

Detrunorm 15 mg film-coated tablets

PACKAGE LEAFLET

v001uk

PACKAGE LEAFLET: INFORMATION FOR THE USER
DETRUNORM 15 mg FILM-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 your pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness 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 film-coated tablets, referred to as Detrunorm
throughout this leaflet.
What is in this leaflet:
1. 
2. 
3. 
4. 
5. 
6. 

What Detrunorm 15 mg film-coated tablets are and what they are used for 
What you need to know before you take Detrunorm 15 mg film-coated tablets 
How to take Detrunorm 15 mg film-coated tablets 
Possible side effects 
How to store Detrunorm 15 mg film-coated tablets 
Contents of the pack and other information 

1. What Detrunorm 15 mg film-coated tablets are and what they are used for
Detrunorm is used for the treatment of people who have difficulty in controlling their bladder 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 15 mg film-coated tablets
Do not take Detrunorm
-

-

if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other
ingredients of Detrunorm (these are listed in section 6).
if you suffer 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 abdominal pain



toxic megacolon (a condition involving enlargement of the bowel)



increased pressure in the eye (uncontrolled angle closure glaucoma)



moderate or severe liver disease



fast and irregular heart beat

Warnings and precautions
Before you take Detrunorm you should tell your doctor or pharmacist if you have:
- damage to the nerves that control blood pressure, heart rate, bowel and bladder movements and
other bodily functions (autonomic neuropathy)
- kidney problems
- liver problems
- severe heart failure
- enlargement of the prostate gland
- recurrent urinary tract infection
- tumours of the urinary tract
- glaucoma
- heartburn and indigestion due to back flow of gastric juice into the throat (hiatus hernia with
reflux oesophagitis)
- irregular heart beat
- fast heart beat
If you suffer from any of these conditions, contact your doctor. He/she will tell you what to do.
Due to its high strength Detrunorm should not be used in children younger than 12 years and adults
with a body weight below 35 kg.
Other medicines and Detrunorm
You should tell your doctor or pharmacist if you are taking or have taken any of the following
medicines as they may interact with your Detrunorm:
- antidepressants (e.g. imipramine, clomipramine and 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 or anxiety),
- beta stimulants (drugs used to treat asthma),
- cholinergics (e.g. carbachol, pilocarpin),
- isoniazid (a treatment for tuberculosis),
- metoclopramide (used to treat nausea and vomiting),
- concomitant treatment with methimazole (used to treat hyperfunction of the thyroid gland) and
medicines used to treat fungal diseases (e.g. ketoconazole, intraconazole).
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 whole before meals.
Pregnancy, breast-feeding and fertility

Do not take Detrunorm if you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby.
Driving and using machines
Detrunorm can sometimes cause sleepiness and blurred vision. You should not drive or operate
machinery if you suffer from sleepiness and blurred vision.
Important information about some of the ingredients of Detrunorm
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.
3. How to take Detrunorm 15 mg film-coated tablets
Always take Detrunorm exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Take your tablets at the same times each day. Swallow your tablets whole with a drink of water before
meals.
Adults and the elderly:
The usual dose of Detrunorm is two or three tablets daily. You might already respond to a dose of one
tablet a day.
The maximum recommended daily dose is 45 mg.
Due to its high dose Detrunorm should not be used in adults with a body weight below 35 kg.
Children:
Detrunorm is not recommended for children.
If you take more Detrunorm than you should
If you have accidentally taken 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.
If you forget to take Detrunorm
Do not take a double dose to make up for a forgotten dose.
If you stop taking Detrunorm
A break or change of the dose may only be done on medical advice.
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.
If you get any of these symptoms during treatment, you should contact your doctor immediately.

You might suffer an acute attack of glaucoma. In this case, you have been seeing coloured rings
around lights or develop severe pain in and around either eye. You should seek medical attention
immediately.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people)
- dry mouth
Common (may affect up to 1 in 10 people)
- abnormal vision and difficulty in focussing
- fatigue
- headache
- abdominal pain
- indigestion
- constipation
Uncommon (may affect up to 1 in 100 people)
- feeling sick and vomiting
- dizziness
- trembling (tremor)
- inability to empty the bladder (urinary retention)
- flushing
- altered sense of taste
- decreased blood pressure with drowsiness
- itching
- difficulty in passing urine
Rare (may affect up to 1 in 1,000 people)
- rash
- faster heart beat
Very rare (may affect up to 1 in 10,000 people)
- feeling your heart beat
- restlessness and confusion
Not known (frequency cannot be estimated from the available data)
- sensing things that are not real (hallucination)
- speech disorder
All undesirable effects are transient and recede after a dose reduction or termination of the therapy
after maximum 1-4 days.
During long-term therapy hepatic enzymes should be monitored, because reversible changes of liver
enzymes might occur in rare cases.
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 15 mg film-coated tablets

Keep out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Detrunorm after the expiry date, which is stated on the blister and carton. The expiry date
refers to the last day of that month.
6. Contents of the pack and other information
What Detrunorm contains
The active substance is propiverine hydrochloride. Each film-coated tablet contains 15 mg of
propiverine hydrochloride.
The other ingredients are lactose monohydrate; cellulose, powdered; magnesium stearate;
hypromellose; cellulose, microcrystalline; stearic acid; talc; titanium dioxide (E171).
What Detrunorm looks like and contents of the pack
Detrunorm are white, round, biconvex film-coated tablets.
They are available in blister packs of 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, 168, 252, 300 or
500 tablets and multipacks containing 280 (10 packs of 28) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL, UK
Manufacturer
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

Detrunorm is a registered trademark of Amdipharm AG.

This medicinal product is authorised in the Member States of the EEA under the following
names:
-

Germany:
Czech Republic:
Slovak Republic:
United Kingdom:

Mictonorm FT
Mictonorm 15 mg potahované tablety
Mictonorm 15 mg filmom obalené tablety
Detrunorm 15 mg film-coated tablets

This leaflet was last revised in July 2016.

Expand view ⇕

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.

Hide