Detrunorm 15 mg Tablets

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 15 mg coated tablets are and what they are used for
2. What you need to know before you take Detrunorm 15 mg Coated Tablets
3. How to take Detrunorm 15 mg Coated Tablets
4. Possible Side Effects
5. How to store Detrunorm 15 mg Coated Tablets
6. Contents of the pack and other information

Do not take Detrunorm if:

• You are allergic (hypersensitive) to propiverine hydrochloride or any of the other ingredients of Detrunorm 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 condtions:

• 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 tablets should be swallowed before meals.

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 Tablets can sometimes cause sleepiness and blurred 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 Tablets contains glucose, lactose and sucrose (sugars). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Detrunorm Tablets also contain the colouring agent Cochineal red A (E124)

May cause allergic reactions.

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 tablets 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.

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.

What Detrunorm 15 mg Coated Tablets contain

Each tablet contains 15 mg propiverine hydrochloride (equivalent to 13.64 mg propiverine) as the active ingredient along with the following other ingredients: lactose monohydrate; powdered cellulose; magnesium stearate; sucrose; talc; heavy kaolin; calcium carbonate; titanium dioxide (E171); acacia gum; colloidal anhydrous silica; Macrogol 6000; glucose monohydrate; cochineal red A (E124, lake); Montan wax.

What Detrunorm 15 mg Coated Tablets look like and the contents of the pack

The tablets are rose-coloured sugar coated tablets. They are available in cartons of 28 or 56 tablets.

Marketing Authorisation Holder:

Manufacturer responsible for release is:

The following organisations can offer independent advice:

Help line Mon-Fri 9.30-4.30 Tel: 020 7831 9831

Help line Mon-Fri 9.30 am – 1.00 pm Tel. 0845 345 0165