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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

103244/LF/l

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AMDIPHARM

Detrunorm® XL 45 mg Modified Release Capsules (Propiverine hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. (See section 4.)

The name of your medicine is Detrunorm® XL 45 mg Modified Release Capsules (referred to as Detrunorm XL throughout this leaflet). The active substance is propiverine hydrochloride and the other ingredients are listed at the end of the leaflet (Section 6, Further Information).

In this leaflet:

1.    What Detrunorm XL is and what it is used for

2.    Before you take Detrunorm XL

3.    How to take Detrunorm XL

4.    Possible side effects

5.    How to store Detrunorm XL

6.    Further 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. BEFORE YOU TAKE DETRUNORM XL

Do not take Detrunorm XL

Do not take Detrunorm XL if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other ingredients of Detrunorm XL (these are listed in section 6, Further information).

Do not take Detrunorm XL 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 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 and irregular heart beat you are pregnant or breastfeeding.

Take special care with Detrunorm XL

Before you take Detrunorm XL you should tell your doctor if you have: damage to the nerves that control blood pressure, heart rate, bowel and bladder movements and other bodily functions (autonomic neuropathy) severe kidney problems moderate or severe liver 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 heart beat.

If you suffer from any of these conditions, contact your doctor, who will tell you what to do.

Taking other medicines

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 and 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 or anxiety) beta stimulants (drugs used to treat asthma) isoniazid (a treatment for tuberculosis) and 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 breastfeeding

Do not take Detrunorm XL if you are pregnant, likely to become pregnant or are breastfeeding.

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.

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.

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The label on the carton will tell you how many capsules you should take and when. Take your capsule at the same time each day. Swallow it with or without food or drink. Do not crush or chew the capsules.

Adults and the elderly: The usual dose of Detrunorm XL is one capsule daily.

Detrunorm XL is not recommended for children.

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.

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Detrunorm XL 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 also been reported:

Very common side effects (affecting more than 1 in 10 people) dry mouth.

Common side effects (affecting up to 1 in 10 people) abnormal vision and difficulty in focussing fatigue headache stomach pain indigestion constipation.

Uncommon side effects (affecting fewer than 1 in 100 people) feeling sick and vomiting dizziness

trembling (tremor)

difficulty in passing urine (urinary retention) flushing

altered sense of taste

decreased blood pressure with drowsiness.

Rore side effects (affecting fewer than 1 in 1,000 people) rash.

Very rare side effects (affecting fewer than 1 in 10,000 people) palpitation (awareness of one's own heartbeat) restlessness and confusion.

Frequency is not known (cannot be estimated from the available data) sensing things that are not real (hallucination).

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.

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AMDIPHARM

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 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 out of the sight and reach of children.

'For the capsules supplied in blisters, do not store above 25°C. Store in the original package to protect the capsules from moisture and light¹.

'For capsules supplied in bottles, keep the bottle tightly dosed'.

Do not use Detrunorm XL after the expiry date, which is stated on the blister or bottle and carton after EXP. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION

What Detrunorm XL contains

The active substance is propiverine hydrochloride. Each capsule contains 45 mg of modified release 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 El 71, red iron oxide El 72, and yellow iron oxide El 72.

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

- cartons of 14,20,28,30,49,50,56,60,84,98,100,112,168 or 280 capsules

bottles of 10,14,20,28,30,49,50,56,60,84,98 or 100 capsules. The polyethylene bottles with a polypropylene screw cap contain a silica gel desiccant.

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 KyffhauserstraBe 27 01309 Dresden Germany

Detrunorm is a registered trademark. This leaflet was last revised in 08/2014.

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.

Accept Artwork................................................................

Reject Artwork.................................................................

Signature..........................................................................

Name ................................................................................

Date...................................................................................

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