- propiverine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 20072/0218 .
Detrunorm XL 45 mg Modified-Release Capsules
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Detrunorm® XL 45 mg Modified Release Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Detrunorm® XL 45 mg Modified Release Capsules (referred to as Detrunorm XL throughout this leaflet).
What is 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 or who have had a spinal cord injury. Detrunorm XL contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases the amount that the bladder can hold.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM XL
Do not take Detrunorm XL:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Detrunorm XL
If you suffer from any of these conditions, contact your doctor who will tell you what to do.
Other medicines and Detrunorm XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines as they may interact with Detrunorm XL:
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.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Detrunorm XL if you are pregnant, likely to become pregnant or are breast feeding.
Driving and using machines
Detrunorm XL can sometimes cause sleepiness and blurred vision. You should not drive or operate machinery if you suffer from sleepiness and blurred vision.
Detrunorm XL contains lactose
Detrunorm XL contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE DETRUNORM XL
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and the elderly: The usual dose of Detrunorm XL is one capsule daily.
Use in children and adolescents
Detrunorm XL is not recommended for children.
Method of administration
Take your capsule at the same time each day. Swallow the capsule whole with a drink of water. Do not crush or chew the capsules. You may take them with or without food.
If you take more Detrunorm XL 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 capsules with you. Overdosage can cause symptoms such as restlessness, dizziness, disorders in speech and vision, muscular weakness, dry mouth, faster heartbeat 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 forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions. If you get any symptoms of allergic reaction (like itching and skin rash), you should stop taking the capsules and 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 )
Common (may affect up to 1 in 10 people )
Uncommon (may affect up to 1 in 100 people )
Rare (may affect up to 1 in 1,000 people )
Very rare (may affect up to 1 in 10,000 people )
Not known (frequency cannot be estimated from the available data)
All the possible side effects mentioned above are temporary and will go away in maximum 1-4 days after the dose reduction or termination of the therapy. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme under 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 this medicine out of the sight and reach of children.
For the capsules supplied in blisters, do not store above 30°C. Store in the original package to protect the capsules from moisture.
Do not use this medicineafter the expiry date, which is stated on the blister and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Detrunorm XL contains
The active substance is propiverine hydrochloride. Each modified release capsule contains 45 mg of propiverine hydrochloride (equivalent to 40.92 mg propiverine).
The other ingredients are citric acid, povidone, lactose monohydrate, talc, triethyl citrate, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1), methacrylic acid-methyl methacrylate copolymer (1:2), ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, gelatine, titanium dioxide E171, red iron oxide E172, and yellow iron oxide E172.
What Detrunorm XL looks like and contents of the pack
Detrunorm XL capsules are orange containing white to off-white pellets.
They are available in
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Detrunorm is a registered trademark
This leaflet was last revised in February 2019
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