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Aponorm 15 Mg Coated Tablets

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PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aponorm® 15 mg Coated Tablets (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.

The name of your medicine is Aponorm 15 mg Coated Tablets (referred to as Aponorm 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 Aponorm is and what it is used for

2.    Before you take Aponorm

3.    How to take Aponorm

4.    Possible side effects

5.    How to store Aponorm

6.    Further information

1. WHAT APONORM IS AND WHAT IT IS USED FOR

Aponorm is used for the treatment of people who have difficulty in controlling their bladders due to bladder overactivity or, in some cases, problems with the spinal cord. Aponorm contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases the amount that the bladder can hold. Aponorm is used to treat the symptoms of overactive bladder.

2. BEFORE YOU TAKE APONORM Do not take Aponorm

-    if you are allergic (hypersensitive) to propiverine hydrochloride or to any of the other ingredients of the Aponorm (these are listed in section 6, Further information)

-    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)

-    intestinal atony

-    severe ulcerative colitis (inflammation of the bowel)

-    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 (tachyarrhythmias)

Take special care with Aponorm

Before you take Aponorm you should tell your doctor if you have:

-    autonomic neuropathy (paralysis of parts of the nervous system)

-    severe kidney problems

-    moderate or severe liver problems

-    severe heart failure

-    enlargement of the prostate gland (prostatic hypertrophy)

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

-    irregular heart beat (cardiac arrhythmia)

-    fast heart beat (tachycardia)

If you suffer from any of these conditions, contact your doctor. He 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 your Aponorm:

-    antidepressants (e.g. imipramine, sertraline, paroxetine),

-    sedatives (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)

-    neuroleptics such as phenothiazines, olanzapine, quetiapine (drugs usually used to treat hay fever, nausea and vomiting, difficulty in sleeping, anxiety),

-    beta stimulants (drugs used to treat asthma, heart conditions, eye problems, blocked nose),

-    isoniazide (a treatment for tuberculosis) and

-    metoclopramide (used to treat nausea and vomiting)

Nevertheless, it may still be all right for you to take Aponorm. 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 Aponorm with food and drink

The coated tablets should be swallowed whole before meals.

Pregnancy and breast-feeding

If you are pregnant, likely to become pregnant or are breast-feeding you should not take Aponorm. Driving and using machines

Aponorm 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 X

Aponorm 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.

3. HOW TO TAKE APONORM

Always take Aponorm exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The label on the carton will tell you how many coated tablets you should take and when. Take your coated tablets at the same time each day.

Adults and the elderly: The usual dose of Aponorm is two or three coated tablets daily.

Aponorm is not recommended for children.

If you take more Aponorm 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 coated tablets with you.

If you forget to take Aponorm

Do not worry. Take your recommended dose as soon as you remember, unless it is nearly time for the next dose.Then take your next dose at the right time. Do not take a double dose to make up for a missed 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, Aponorm can cause side effects although not everybody gets them.

The following side effects have also been reported:

Very common side effects (affects more than 1 user in 10)

-    dry mouth

Common side effects (affects 1 to 10 users in 100)

-    abnormal vision and difficulty in focussing

-    fatigue

-    headache

-    stomach pain

-    indigestion

-    constipation

Uncommon side effects (affects 1 to 10 users in 1,000)

-    feeling sick and vomiting

-    dizziness

-    trembling (tremor)

-    difficulty in passing urine (urinary retention)

-    flushing

-    altered sense of taste

-    decreased blood pressure with drowsiness Rare side effects (affects 1 to 10 users in 10,000)

-    rash

Very rare side effects (affects less than 1 user in 10,000)

-    irregular heartbeat

-    restlessness and confusion.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms during treatment, you should contact your doctor immediately:

-    • 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.

In theory, 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.

5. HOW TO STORE APONORM

Keep Aponorm out of the reach and sight of children.

Store in the original package to protect the coated tablets from light and moisture.

Do not use Aponorm after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last

6. FURTHER INFORMATION

What Aponorm contains:

The active substance is propiverine hydrochloride. Each coated tablet contains 15 mg of propiverine hydrochloride

The other ingredients are lactose monohydrate; powdered cellulose; magnesium stearate; sucrose; talcum; heavy kaolin; calcium carbonate; titanium dioxide (E171); acacia gum; colloidal anhydrous silica; Macrogol 6000; glucose monohydrate; Cochineal red A (E124, lake); Montan wax.

What Aponorm looks like and the contents of the pack:

Aponorm 15mg Coated Tablets are rose-colored sugar coated tablets.

PVC/aluminium blisters in cartons of 14, 20, 28, 30, 50, 56, 60, 100, 112, or 300 coated tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

APOGEPHA Arzneimittel GmbH KyffhauserstraBe 27 01309 Dresden Germany

This leaflet was last approved in January 2011.

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