Propiverine 15mg film-coated tablets – patient leaflet, side effects, dosage

1. WHAT PROPIVERINE TABLETS ARE AND WHAT THEY ARE USED FOR

Propiverine Tablets contain the active substance propiverine. Propiverine Tablets are a drug for relaxing the bladder muscles (bladder spasmolytic). Propiverine Tablets are used to treat the symptoms of:

• urinary incontinence (uncontrollable urination)

  and/or

• increased urinary frequency (very frequent

  urination) and

• urge to urinate.

These are manifested in patients with:

• an overactive bladder, whose cause is not clear

  (idiopathic detrusor overactivity), or • a nerve disorder of emptying the bladder

  (neurogenic detrusor overactivity, detrusor hyperreflexia). This occurs with disorders of the spinal cord, such as spinal cord injury or a congenital malformation of the spinal cord and spinal column (meningomyelocele).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPIVERINE TABLETS

Do not take Propiverine Tablets:

• if you are allergic to propiverine hydrochloride

  or any of the other ingredients of this medicine (listed in section 6).

• if you are suffering from any of the following

  diseases:

  • obstruction of the bowel (intestinal

    obstruction)

  • 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 inflammatory bowel disease

    (ulcerative colitis)

  • toxic megacolon (a condition involving

    enlargement of the bowel)

  • untreated or insufficiently treated glaucoma

    (uncontrolled narrow angle glaucoma as a result of increased intraocular pressure) ▪ moderate or severe liver dysfunction ▪ fast heart rhythms (tachyarrhythmias).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Propiverine Tablets:

• if you are suffering from any of the following

  diseases:

  • autonomic neuropathy (damage to the

    nerves that control blood pressure, heart rate, bowel and bladder movement and other bodily functions)

  • kidney dysfunction
  • mild liver dysfunction
  • recurrent urinary tract infection.

If you are suffering from the following diseases, the use of Propiverine Tablets may increase the symptoms of these diseases:

• severe heart muscle weakness (severe

  congestive heart failure (NYHA IV)) • prostate enlargement (prostatic hypertrophy) • heartburn and indigestion due to back flow of

  gastric juice into the throat (hiatus hernia with reflux oesophagitis)

• heart rhythm disorder (arrhythmia) • fast heartbeat (tachycardia).

Propiverine may cause unusual dilation or widening of the pupil of the eye (mydriasis). If you are suffering

from an increased pressure in the eye, you may be at an increased risk of an attack of glaucoma (sudden occurrence of red eyes, severe eye pain and headache, nausea and vomiting with subsequent worsening of eyesight). Therefore, your doctor should check your eye pressure.

During urinary tract infections, your doctor should pay particular attention to the amount of urine remaining in the bladder.

Prior to treatment with Propiverine Tablets your doctor should ensure you are not suffering from any of the following diseases:

• frequent emptying of small amounts of urine

  (pollakisuria) and increased night-time urination (nocturia) due to heart or kidney disease • organic bladder diseases (e.g. urinary tract

  infections, malignant tumours).

Please consult your doctor on this. This also applies if you have previously suffered from such diseases.

Children and adolescents

Propiverine Tablets are not recommended for use in children and adolescents below 18 years of age, because there is a lack of data on the safety and efficacy in this population.

Other medicines and Propiverine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

An increased effect may be experienced if any of the following medicines are taken with Propiverine Tablets:

• tricyclic antidepressants (e.g. imipramine) • 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) • medicines that relax muscles of the airways

  (beta-adrenergic agonists)

• beta stimulants (drugs used to treat asthma).

A decreased effect may be experienced if any of the following medicines are taken with Propiverine Tablets:

• cholinergics (including agents for lowering

  heartbeat, facilitating digestion and treatment of glaucoma, e.g. carbachol, pilocarpine) • isoniazid (used to treat tuberculosis) • metoclopramide (used to treat nausea and

  vomiting).

Tell your doctor if you are taking certain medicines to control or treat any of the following:

• a fungal infection (e.g. ketoconazole) • a bacterial infection (e.g. clarithromycin,

  erythromycin)

• thyroid hyperfunction (methimazole).

Increased levels of propiverine may occur in the blood. If you are taking these medicines, please contact your doctor.

Propiverine Tablets with food and drink

Do not take Propiverine Tablets together with a high fat meal. You should take the tablets before meals.

Pregnancy and breast-feeding

Do not take Propiverine Tablets if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Driving and using machines

Treatment with this medicine may cause drowsiness and blurred vision. Sedative medicines may increase these symptoms. Reactions may differ between individuals therefore you should not drive or operate machinery after taking this medicine. The effects may be more pronounced when you first start taking this medicine if the dosage has increased or if you drink alcohol.

3. HOW TO TAKE PROPIVERINE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults and elderly patients

For an overactive bladder take one tablet twice a day (equivalent to 30 mg propiverine hydrochloride per day). An increase to one tablet three times a day

(equivalent to 45 mg propiverine hydrochloride per day) is possible. For some patients one tablet daily (equivalent to 15 mg propiverine hydrochloride) may already be enough.

For nerve-related disorders, take one tablet three time a day (equivalent to 45 mg propiverine hydrochloride per day). The maximum recommended daily dose is 45 mg propiverine hydrochloride.

If you have a low body weight (less than 35 kg), the dose of Propiverine Tablets is not suitable due to the high potency. In this case, you should take medicines with a low content of propiverine.

Route and method of administration

Take the tablets (without chewing) with sufficient liquid (preferably a glass of water) before eating.

Your doctor will decide on the duration of treatment.

Talk to your doctor or pharmacist if you feel the effects of your Propiverine Tablets are too strong or too weak.

Use in children

Propiverine Tablets are not recommended for use in children.

Use in patients with impaired renal function

If your restriction of kidney function is large (creatine clearance <30 ml/min), the maximum daily dose is 30 mg.

Use in patients with impaired liver function

No dosage adjustments are necessary in patients with mild liver disorders. However, Propiverine Tablets should still be used with caution in these patients. Use in patients with severe liver disorders is not recommended.

If you take more Propiverine Tablets than you should

If you have taken more than your prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack, this leaflet and any remaining tablets with you. Signs of an overdose may appear as the following:

• severe dry mouth

• slow heart rate (bradycardia), possibly leading

  to a fast heart rate (tachycardia) in the future • unusual dilation or widening of the pupil of the

  eye (mydriasis), difficulty focusing (accommodation disorder of the eye) • inability to empty the bladder (urinary retention) • decreased bowel movements and/or severe

  constipation

• restlessness, confusion, hallucinations, memory

  error in which gaps in your memory are unconsciously filled with fabricated, misinterpreted, or distorted information (confabulation)

• dizziness, nausea, speech disorder, muscle

  weakness.

If you forget to take Propiverine Tablets

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 forgotten dose.

If you stop taking Propiverine Tablets

Talk to your doctor before you stop taking or want to change your dosage of Propiverine Tablets.

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 although serious allergic reactions are very rare. The following symptoms are the 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.

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.

If you get any of these symptoms during treatment, you should stop taking the tablets and contact your doctor immediately.

Other side effects

Very common (may affect more than 1 in 10 people):

• dryness of the mouth.

  Common (may affect up to 1 in 10 people): • abnormal vision, difficulty focusing

  (accommodation disorder of the eye) • tiredness and fatigue

  • headache
  • stomach (abdominal) pain
  • indigestion (dyspepsia)
  • constipation.

Uncommon (may affect up to 1 in 100 people): • nausea, vomiting

• dizziness
• shaking (tremor)
• inability to empty your bladder (urinary retention)
• flushing
• altered sense of taste (dysgeusia)
• decreased blood pressure (hypotension) with drowsiness
• itching
• difficulty in passing urine.

Rare (may affect up to 1 in 1,000 people): • skin rash

• fast heart rate (tachycardia).

Very rare (may affect up to 1 in 10,000 people): • irregular heartbeat (heart palpitation) • restlessness, confusion

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

• hallucinations
• speech disorder

All adverse effects are temporary. They should stop 1 to 4 days after dose reduction or when you stop taking the tablets.

During long-term therapy, liver enzymes should be controlled. In rare cases, liver enzyme changes may occur, but disappear after treatment is stopped.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PROPIVERINE TABLETS

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”. 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 Propiverine Tablets contain

The active substance is propiverine hydrochloride. Each film-coated tablet contains 15 mg propiverine hydrochloride equivalent to 13.64 mg propiverine.

The other ingredients are:

Core tablet: Colloidal anhydrous silica, pregelatinized starch, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate.

Film coating: Opadry II 85F18378 consisting of poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.

What Propiverine Tablets look like and contents of the pack

Propiverine Tablets are white, round, biconvex filmcoated tablets.

Propiverine Tablets are available in packs of 28, 30, 49, 50, 56, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Dragenopharm Apotheker Puschl GmbH, Gollstrasse 1, 84529 Tittmoning Germany.

This leaflet was last revised in March 2024.