DETRUNORM XL 30 MG MODIFIED RELEASE CAPSULES - Patient leaflet, side effects, dosage

1. what detrunorm xl 30 mg is and what it is used for detrunorm xl 30 mg is used for the treatment of people who have difficulty in controlling their bladder due to bladder overactivity.

Detrunorm XL 30 mg contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases the amount that the bladder can hold.

Detrunorm XL 30 mg is used to treat the symptoms of overactive bladder. It is a modified-release capsule that needs only to be taken once a day.

2. what you need to know before you take detrunorm xl 30 mg do not take detrunorm xl 30 mg

Do not take Detrunorm XL 30 mg if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other ingredients of Detrunorm XL 30 mg (these are listed in section 6).

Do not take Detrunorm XL 30 mg 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 heartbeat

Warnings and precautions

Before you take Detrunorm XL 30 mg 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)

• – 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 heartbeat

• – fast heartbeat

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

Other medicines and Detrunorm XL 30 mg

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with Detrunorm XL 30 mg: – 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 and anxiety),

• – beta stimulants (drugs used to treat asthma),

• – cholinergics (e.g. carbachol and 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, itraconazole).

Nevertheless, it may still be all right for you to take Detrunorm XL 30 mg. 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

Do not take Detrunorm XL 30 mg if you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Detrunorm XL 30 mg can sometimes cause sleepiness and blurred vision. You should not drive or operate machinery if you suffer from sleepiness and blurred vision.

Detrunorm XL 30 mg contains lactose:

Detrunorm XL 30 mg 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 30 mg

Always take Detrunorm XL 30 mg exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults and the elderly: T he usual dose of Detrunorm XL 30 mg is one capsule daily.

Use in children and adolescents: Detrunorm XL 30 mg is not recommended for children.

Method of administration:

Take your capsule at the same time each day. Swallow it with or without food or drink. Do not crush or chew the capsules.

If you take more Detrunorm XL 30 mg 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 30 mg

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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Detrunorm XL 30 mg 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. 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 heartbeat

• – restlessness and confusion.

Not known (frequency cannot be estimated from the available data) – sensing things that are not real (hallucination)

• – speech disorder

5. how to store detrunorm xl 30 mg

Keep this medicine out of the sight and reach of children Do not store above 30°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 date of the month.

If your tablets become discoloured or show signs of deterioration return them to your pharmacist who will advise you.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

What Detrunorm XL 30 mg contains

Each capsule contains 30 mg propiverine hydrochloride (equivalent to 27.28 mg propiverine). Other ingredients include citric acid, lactose monohydrate, talc, triethyl citrate, magnesium stearate, methacrylic acid-methyl methacrylate copolymer 1:1, povidone K25, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, methacrylic acid – methylmethacrylate copolymer (1:2).

Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

What Detrunorm XL 30 mg looks like and the contents of the pack

Detrunorm XL 30 mg capsules are orange and white and contain white to off white pellets.

They are available in cartons of 28.

Manufacturer

APOGEPHA Arzneimittel GmbH,

Kyffhauserstrape 27, 01309 Dresden, Germany

Product Licence holder:

Ecosse Pharmaceuticals Limited, 3 Young Place, East Kilbride G75 0TD.

Re-packaged by

Munro Wholesale Medical Supplies Limited,

3 Young Place,

East Kilbride G75 0TD.

I POM I PL 19065/0573

This leaflet was revised in 11.03.2022

Detrunorm® is a registered trademark of Apogepha Arzneimittel GmbH

E0573/4 05.21

If you are blind or partially sighted and require this leaflet in a different format, call 01355 574450 and ask for the Regulatory Department.