Detrunorm Xl 30mg Modified Release Capsules
Package leaflet: information for the patient 103253/LF/014/03
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Detrunorm® XL 30 mg Modified Release Capsules
(Propiverine hydrochloride)
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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 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, 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, 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. 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 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
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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 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 30 MG MODIFIED RELEASE CAPSULES
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 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 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 capsules 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.
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
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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.
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 xl 30 mg modified release capsules
Keep this medicine out of sight and reach of children
Do not store the blister pack above 25°C.
Keep the capsules in the original package to protect from moisture.
Do not use after the expiry date printed on the carton. The expiry date refers to the last day of that month.
6. contents of the pack and other information
What Detrunorm contains
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).
What Detrunorm looks like and the contents of the pack
The capsules are orange and white and contain white to off white pellets.
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,
KyffhauserstraBe 27,
01309 Dresden,
Germany
Detrunorm is a registered trademark of Amdipharm AG This leaflet was last revised in August 2015.
12154 / C64 / v007uk-1
103253/LF/014/03
Creation date: 13.08.15, 14:35
Color: BlackFormat
pal-detrunormXL30-aug15-v007uk-1-druck
Format: 180 x 300 mm