DETRUNORM XL 45 MG MODIFIED-RELEASE CAPSULES - patient leaflet, side effects, dosage

AMDIPHARM

Detrunorm® XL 45 mg Modified Release Capsules (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,pharmacistor nurse.

• - 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, 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:

• if you are allergic to propiverine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• - if you have obstruction of the bowel

• - if you have obstruction to the bladder outlet (difficulty in passing

urine)

• - if you have myasthenia gravis (a disease causing muscle weakness)

• - if you have a loss of function of the muscles controlling your bowel movements (intestinal atony)

• - if you have severe inflammation of the bowel (ulcerative colitis) that may lead to diarrhoea containing blood and mucus and abdominal pains

• - if you have toxic megacolon (a condition involving enlargement of the bowel)

• - if you have increased pressure in the eye (uncontrolled angle closure glaucoma)

• - if you have moderate or severe liver disease

• - if you have fast and irregular heart beat

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Detrunorm XL – if you have damage to the nerves that control blood pressure, heart rate, bowel and bladder movements and other bodily functions (autonomic neuropathy)

• - if you have kidney problems

• - if you have liver problems

• - if you have severe heart failure

• - if you have enlargement of the prostate gland

• - if you have recurrent urinary tract infection

• - if you have tumours of the urinary tract

• - if you have glaucoma

• - if you have heartburn and indigestion due to back flow of gastric juice into the throat (hiatus hernia with reflux oesophagitis)

• - if you have irregular heart beat

• - if you have fast heart beat

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:

• - 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),

• - 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)

• - cholinergics (e.g. carbachol, pilocarpin).

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 )

• - 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

• - inability to empty the bladder (urinary retention)

• - itching

• - dizziness

• - trembling (tremor)

• - difficulty in passing urine

• - flushing

• - altered sense of taste

• - decreased blood pressure with drowsiness

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 heartbeat

• - restlessness and confusion.

Not known (frequency cannot be estimated from the available data)

• - sensing things that are not real (hallucination)

• - Speech disorder

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

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

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