Propiverine 15mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Propiverine hydrochloride
Available from:
A A H Pharmaceuticals Ltd
ATC code:
G04BD06
INN (International Name):
Propiverine hydrochloride
Dosage:
15mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 07040200; GTIN: 5025903085775

Detrunorm 15mg coated tablets

(propiverine hydrochloride)

Patient Information Leaflet

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, pharmacist or 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 15 mg Coated Tablets (referred

to as Detrunorm throughout this leaflet).

What is in this leaflet:

What Detrunorm are and what they are used for

What you need to know before you take Detrunorm

How to take Detrunorm

Possible side effects

How to store Detrunorm

Contents of the pack and other information

What Detrunorm are and what they are used for

Detrunorm 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. Detrunorm contains the active substance

propiverine hydrochloride.

This substance prevents the bladder from contracting and increases the

amount that the bladder can hold. Detrunorm is used to treat the symptoms

of overactive bladder.

What you need to know before you take Detrunorm

Do not take Detrunorm:

*

if you are allergic to propiverine hydrochloride or any of the other

ingredients of this medicine 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);

*

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 or irregular heartbeat.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Detrunorm

*

if you have damage to the nerves that control blood pressure, heart rate,

bowel and bladder movement and other bodily functions (autonomic

neuropathy);

*

if you have liver problems;

*

if you have kidney 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 heartbeat;

*

if you have fast heartbeat.

Other medicines and Detrunorm

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:

*

antidepressants (e.g. imipramine, clomipramine, 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, 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, intraconazole).

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, 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 if you are pregnant, likely to become pregnant or are

breast-feeding.

Driving and using machines

Detrunorm can sometimes cause sleepiness and blurred vision. You should

not drive or operate machinery until you are sure you are not affected.

Detrunorm contains glucose, lactose and sucrose

Detrunorm contains glucose, lactose and sucrose (sugars). If you have been

told by your doctor that you have an intolerance to some sugars, contact

your doctor before taking this medicine.

Detrunorm also contain the colouring agent cochineal red A (E124)

May cause allergic reactions.

How to take Detrunorm

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 recommended dose of Detrunorm is two to three

tablets daily.

Use in children and adolescents

Detrunorm is not recommended for children.

Ref: 1755/020719/1/F

1

1

6

4

5

2

2

3

3

(propiverine hydrochloride)

Patient Information Leaflet (continued)

Method of administration

Take your tablets at the same time each day. Swallow your tablets whole

before meals.

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, 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 forgotten

dose.

If you have any further questions on the use of this medicine, ask your

doctor, pharmacist or nurse.

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 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 tablets and contact your doctor immediately.

You might suffer an acute attack of glaucoma. If you have been seeing

coloured rings around lights or if you should develop severe pain in and

around either eye you should seek medical attention urgently.

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, difficulty in passing urine (urinary retention), flushing, altered

sense of taste, decreased blood pressure with drowsiness, itching.

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 (hallucinations);

Speech disorder.

All possible side effects are transient and recede after a dose reduction or

termination of the therapy after maximum 1-4 days.

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 or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: 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.

How to store Detrunorm

*

Keep out of the sight and reach of children.

*

For oral use.

*

Do not take Detrunorm after the expiry date which is stated on the blister

label or carton. The expiry date refers to the last day of the month.

*

If your doctor tells you to stop taking this medicine, return any unused

tablets to your pharmacist (chemist) for safe disposal. Only keep this

medicine if your doctor tells you to.

*

If the medicine become discoloured or show any other signs of

deterioration, you should seek the advice of your pharmacist who will tell

you what to do.

*

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer

required. These measures will help to protect the environment.

Contents of the pack and other information

What Detrunorm contains:

Each coated tablet contains 15 mg propiverine hydrochloride (equivalent to

13.64 mg propiverine). Also contains lactose monohydrate, cellulose powder,

magnesium stearate, sucrose, talc, kaolin, calcium carbonate, titanium

dioxide (E171), arabic gum, colloidal anhydrous silica, macrogol 6000,

glucose monohydrate, Ponceau R (E124), montan glycol wax.

What Detrunorm looks like and contents of the pack

Detrunorm are rose-coloured, biconvex, round sugar-coated tablets.

Each pack contains 60 Tablets.

Manufacturer and Licence Holder

Manufactured by APOGEPHA Arzneimittel GmbH, Kyffhäuserstraße 27,

01309 Dresden, Germany and is procured from within the EU and

repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or

pharmacist. They will have additional information about this medicine and

will be able to advise you.

PL 15184/1755

Detrunorm 15mg coated tablets

Detrunorm is a registered trademark of Amdipharm Mercury International

Limited.

Revision date: 02/07/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

POM

Ref: 1755/020719/1/B

5

6

Detrunorm 15mg coated tablets

4

Propiverine Hydrochloride 5mg coated tablets

Patient Information Leaflet

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, pharmacist or 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 Propiverine 15 mg Coated Tablets (referred to

as Propiverine throughout this leaflet).

What is in this leaflet:

What Propiverine are and what they are used for

What you need to know before you take Propiverine

How to take Propiverine

Possible side effects

How to store Propiverine

Contents of the pack and other information

What Propiverine are and what they are used for

Propiverine 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. Propiverine contains the active substance

propiverine hydrochloride. This substance prevents the bladder from

contracting and increases the amount that the bladder can hold. Propiverine

is used to treat the symptoms of overactive bladder.

What you need to know before you take Propiverine

Do not take Propiverine:

*

if you are allergic to propiverine hydrochloride or any of the other

ingredients of this medicine 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);

*

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 or irregular heartbeat.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Propiverine

*

if you have damage to the nerves that control blood pressure, heart rate,

bowel and bladder movement and other bodily functions (autonomic

neuropathy);

*

if you have liver problems;

*

if you have kidney 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 heartbeat;

*

if you have fast heartbeat.

Other medicines and Propiverine

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 Propiverine:

*

antidepressants (e.g. imipramine, clomipramine, 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, 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, intraconazole).

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

The tablets should be swallowed before meals.

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 Propiverine if you are pregnant, likely to become pregnant or are

breast-feeding.

Driving and using machines

Propiverine can sometimes cause sleepiness and blurred vision. You should

not drive or operate machinery until you are sure you are not affected.

Propiverine contains glucose, lactose and sucrose

Propiverine contains glucose, lactose and sucrose (sugars). If you have

been told by your doctor that you have an intolerance to some sugars,

contact your doctor before taking this medicine.

Propiverine also contain the colouring agent cochineal red A (E124)

May cause allergic reactions.

How to take Propiverine

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 recommended dose of Propiverine is two to three

tablets daily.

Use in children and adolescents

Propiverine is not recommended for children.

Method of administration

Take your tablets at the same time each day. Swallow your tablets whole

before meals.

Ref: 1755/020719/2/F

1

1

6

4

5

2

2

3

3

Patient Information Leaflet (continued)

If you take more Propiverine 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, disorders in speech

and vision, muscular weakness, dry mouth, faster heartbeat and problems

passing urine.

If you forget to take Propiverine

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.

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 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 tablets and contact your doctor immediately.

You might suffer an acute attack of glaucoma. If you have been seeing

coloured rings around lights or if you should develop severe pain in and

around either eye you should seek medical attention urgently.

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, difficulty in passing urine (urinary retention), flushing, altered

sense of taste, decreased blood pressure with drowsiness, itching.

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 (hallucinations);

Speech disorder.

All possible side effects are transient and recede after a dose reduction or

termination of the therapy after maximum 1-4 days.

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 or pharmacist. This includes

any possible side effects not listed on this leaflet. You can also report side

effects directly via the Yellow Card Scheme at: 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.

How to store Propiverine

*

Keep out of the sight and reach of children.

*

For oral use.

*

Do not take Propiverine after the expiry date which is stated on the blister

label or carton. The expiry date refers to the last day of the month.

*

If your doctor tells you to stop taking this medicine, return any unused

tablets to your pharmacist (chemist) for safe disposal. Only keep this

medicine if your doctor tells you to.

*

If the medicine become discoloured or show any other signs of

deterioration, you should seek the advice of your pharmacist who will tell

you what to do.

*

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer

required. These measures will help to protect the environment.

Contents of the pack and other information

What Propiverine contains:

Each coated tablet contains 15 mg propiverine hydrochloride (equivalent to

13.64 mg propiverine). Also contains lactose monohydrate, cellulose powder,

magnesium stearate, sucrose, talc, kaolin, calcium carbonate, titanium

dioxide (E171), arabic gum, colloidal anhydrous silica, macrogol 6000,

glucose monohydrate, Ponceau R (E124), montan glycol wax.

What Propiverine looks like and contents of the pack

Propiverine are rose-coloured, biconvex, round sugar-coated tablets.

Each pack contains 60 Tablets.

Manufacturer and Licence Holder

Manufactured by APOGEPHA Arzneimittel GmbH, Kyffhäuserstraße 27,

01309 Dresden, Germany and is procured from within the EU and

repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or

pharmacist. They will have additional information about this medicine and

will be able to advise you.

PL 15184/1755

Propiverine Hydrochloride

15mg coated tablets

Revision date: 02/07/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you

POM

Ref: 1755/020719/2/B

5

6

Propiverine Hydrochloride 5mg coated tablets

4

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Detrunorm 15 mg Coated Tablets

Propiverine Hydrochloride 15mg Coated Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains 15 mg propiverine hydrochloride equivalent to 13.64 mg

propiverine.

Excipients with known effect:

Lactose monohydrate

(63.4 mg/ tablet)

Sucrose

(49.0 mg/ tablet)

Glucose monohydrate

(0.6 mg/ tablet)

Cochineal red A (E124, lake)

(0.2 mg/ tablet)

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Coated tablets

Rose-coloured, lenticular glazing coated tablets.

4.1

Therapeutic indications

Detrunorm 15 mg Coated Tablets are indicated in adults for the symptomatic

treatment of urinary incontinence and/or increased urinary frequency and urgency in

patients with overactive bladder syndrome or neurogenic detrusor overactivity

(detrusor hyperreflexia) from spinal cord injuries, e.g. transverse lesion paraplegia

4.2

Posology and method of administration

Posology

The recommended daily doses are as follows:

Adults

As a standard dose one coated tablet (= 15 mg propiverine hydrochloride)

twice a day is recommended, this may be increased to three times a day. Some

patients may already respond to a dose of 15 mg a day.

For neurogenic detrusor overactivity a dose of one coated tablet three times a

day is recommended. The maximum recommended daily dose is 45 mg.

Paediatric population

The safety and efficacy of propiverine in children has not yet been established.

Hence this product should not be used in children.

Elderly

Generally there is no special dose regimen for the elderly (see section 5.2).

Caution should be exercised and physicians should monitor patients carefully

for side effects in the following dispositions (see sections 4.4, 4.5, 5.2) .

Use in renal impairment

In patients with mild to moderate impaired renal function no dose adjustment

is required. In patients with severe renal impairment (creatinine clearance < 30

ml/min) the maximum daily dose is 30 mg (see section 5.2).

Use in hepatic impairment

In patients with mildly impaired hepatic function there is no need for a dose

adjustment, however, treatment should proceed with caution. No studies have

been performed to investigate the use of propiverine in patients with

moderately or severely impaired hepatic function. Its use is therefore not

recommended in these patients (see section 5.2).

Patients receiving concomitant treatment with drugs that are potent inhibitors

of CYP 3A4 combined with methimazole

In patients receiving drugs that are potent flavin-containing monooxygenase

(FMO) inhibitors such as methimazole in combination with potent CYP 3A4/5

inhibitors treatment should start with a dose of 15 mg per day. The dose may

thereafter be titrated to a higher dose. However, caution should be exercised

and physicians should monitor these patients carefully for side effects (see

sections 4.5, 5.2).

Intake of propiverine in relation to food

A high fat meal increases the bioavailability of propiverine hydrochloride.

Therefore, propiverine hydrochloride should be taken before a meal, especially

in patients with renal or hepatic impairment (see section 5.2).

This medicinal product contains 0.61 mg of glucose. Accordingly, a daily

dose of 2 coated tablets supplies 1.22 mg of glucose.

Method of administration

Coated tablets for oral use.

4.3

Contraindications

Detrunorm 15 mg Coated Tablets are contraindicated in patients with the following:

Hypersensitivity to the active substance or to any of the excipients listed in

section 6.1.

Obstruction of the bowel.

Significant degree of bladder outflow obstruction where urinary retention

may be anticipated.

Myasthenia gravis.

Intestinal atony.

Severe ulcerative colitis.

Toxic megacolon.

Uncontrolled angle closure glaucoma.

Moderate or severe hepatic impairment.

Tachyarrhythmias.

4.4

Special warnings and precautions for use

The drug should be used with caution in patients suffering from:

Autonomic neuropathy.

Renal impairment (see section 4.2)

Hepatic impairment (see section 4.2).

Symptoms of the following diseases may be aggravated following

administration of the drug:

- severe congestive heart failure (NYHA IV)

- prostatic enlargement

- hiatus hernia with reflux oesophagitis

- cardiac arrhythmia

- tachycardia.

patients

receiving

drugs

that

potent

inhibitors

such

methimazole in combination with potent CYP 3A4/5 inhibitors treatment

should start with a dose of 15 mg per day. The dose may be titrated to a higher

dose. However, caution should be exercised (see sections 4.2, 4.5, 5.2).

Angle-closure glaucoma

Propiverine

hydrochloride,

like

other

anticholinergics,

induces

mydriasis.

Therefore, the risk to induce acute angle-closure glaucoma in individuals

predisposed with narrow angles of the anterior chamber may be increased.

Drugs of this class including propiverine have been reported to induce or

precipitate acute angle-closure glaucoma.

Pollakiuria and nocturia

Pollakiuria and nocturia due to renal disease or congestive heart failure as well

as organic bladder diseases (e.g. urinary tract infections, malignancy) should

be ruled out prior to treatment.

Galactose intolerance, Lapp lactase deficiency and glucose-galactose

malabsorption.

Patients with rare hereditary problems of galactose intolerance, total lactase

deficiency or glucose-galactose malabsorption should not take this medicine.

Fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase

insufficiency

Patients

with

rare

hereditary

problems

fructose

intolerance,

glucose-

galactose intolerance or sucrase-isomaltase malabsorption should not take this

medicine.

Colouring Agent

Cochineal red A (E124, lake) may cause allergic reactions.

4.5

Interaction with other medicinal products and other forms of interaction

Increased effects due to concomitant medication with tricyclic antidepressants

(e.g. imipramine), tranquillisers (e.g. benzodiazepines), anticholinergics (if

applied systemically), amantadine, neuroleptics (e.g. phenothiazines) and beta-

adrenoceptor agonists (beta-sympathomimetics).

Decreased effects due to concomitant medication with cholinergic drugs.

Reduced blood pressure in patients treated with isoniazid.

The effect of prokinetics such as metoclopramide may be decreased.

Pharmacokinetic interactions are possible with other drugs metabolised by

cytochrome P450 3A4 (CYP 3A4). However, a very pronounced increase of

concentrations for such drugs is not expected as the effects of propiverine

hydrochloride

small

compared

classical

enzyme

inhibitors

(e.g.

ketoconazole or grapefruit juice). Propiverine may be considered as weak

inhibitor of cytochrome P450 3A4. Pharmacokinetic studies with patients

concomitantly receiving potent CYP 3A4 inhibitors such as azole antifungals

(e.g. ketoconazole, itraconazole) or macrolide antibiotics (e.g. erythromycin,

clarithromycin) have not been performed.

Patients receiving concomitant treatment with drugs that are potent inhibitors

of CYP 3A4 combined with methimazole:

In patients receiving drugs that are potent flavin-containing monooxygenase

(FMO) inhibitors such as methimazole in combination with potent CYP 3A4/5

inhibitors treatment should start with a dose of 15 mg per day. The dose may

thereafter be titrated to a higher dose. However, caution should be exercised

and physicians should monitor these patients carefully for side effects (see

sections 4.2, 5.2).

4.6

Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of propiverine in pregnant women. Studies in

animals have shown reproductive toxicity. Propiverine is not recommended

during pregnancy. (See section 5.3)

Breast-feeding

It is unknown whether propiverine or metabolites are excreted in human milk.

Available

pharmacodynamic/toxicological

data

animals

have

shown

excretion of propiverine or metabolites in milk. A risk to the newborn or infant

cannot be excluded.

decision

must

made

whether

discontinue

breast-feeding

discontinue/abstain from propiverine therapy taking into account the benefit of

breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no human data on the effect of propiverine on fertility.

Animal studies do not indicate direct or indirect harmful effects with respect to

fertility (see section 5.3).

4.7.

Effects on ability to drive and use machines

Propiverine hydrochloride has major influence on ability to drive and use

machines. No studies on the effects on the ability to drive and use machines

have been performed.

Propiverine hydrochloride may produce drowsiness and blurred vision. This

may impair the patient's ability to exert activities that require mental alertness

such as operating a motor vehicle or other machinery, or to exert hazardous

work while taking this drug.

Sedative

drugs

enhance

drowsiness

caused

propiverine

hydrochloride.

4.8

Undesirable effects

Within each system organ class, the undesirable effects are ranked under heading of

frequency using the following convention:

Very common (

1/10)

Common (

1/100 to <1/10)

Uncommon (

1/1,000 to <1/100)

Rare (

1/10,000 to <1/1,000)

Very rare (<1/10,000)

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

All undesirable effects are transient and recede after a dose reduction or

termination of the therapy after maximum 1-4 days.

System organ class

(Disorders according to MedDRA)

Adverse reactions

Immune system disorders

Rare

- hypersensitivity

Psychiatric disorders

Very rare

restlessness, confusion

Not known

hallucinations

Nervous system disorders

Common

headache

Uncommon

dizziness, tremor, dysgeusia

Not known

speech disorder

Eye disorders

Common

accommodation disorder,

visual impairment

Cardiac disorders

Rare

tachychardia

Very rare

palpitations

Vascular disorders

Uncommon

decreased blood pressure with

drowsiness, flushing

Gastrointestinal disorders

Very common

dry mouth

Common

constipation, abdominal pain, dyspepsia

Uncommon

nausea/vomiting

Skin and subcutaneous tissue

disorders

Uncommon

pruritus

Rare

rash

Renal and urinary disorders

Uncommon

urinary retention,

bladder and urethral

symptoms

General disorders and administration

site conditions

Common

fatigue

During long-term therapy hepatic enzymes should be monitored, because reversible

changes of liver enzymes might occur in rare cases.

Reporting of suspected adverse effects

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse reactions

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

4.9

Overdose

Symptoms

Overdose with the muscarinic receptor antagonist propiverine hydrochloride

can potentially result in central anticholinergic effects.Peripheral and central

nervous system disturbances may occur, such as:

severe dry mouth

bradycardia, possibly leading to tachycardia in the further course

mydriasis and accommodation disorder

urinary retention

inhibition of intestinal motility

restlessness, confusion, hallucination, confabulation

dizziness, nausea, speech disorder, muscular weakness

Management

In the event of overdose with propiverine the patient should be treated

with activated charcoal suspension with plenty amount of water.

Gastric lavage should only be taken into consideration with protective

intubation, use of an oiled tube (dryness of mucosa) and if performed within 1

hour after ingestion of propiverine. Vomiting must not be induced.

Forced diuresis or hemodialysis is not effective to enhance the renal

elimination.

In case of severe central anticholinergic effects such as hallucinations or

pronounced

excitation

antidote

treatment

with

physostigmine

attempted.

Convulsion or pronounced excitation: treatment with benzodiazepines

Respiratory insufficiency: treatment with artificial respiration

Urinary retention: treatment with catheterization

Mydriasis: treatment with pilocarpine eye drops and/or darkening of the

patient’s room

5.1

Pharmacodynamic properties

ATC code: G04B D06

Pharmacotherapeutic group: Drugs for urinary frequency and incontinence

Mechanism of action

Inhibition of calcium influx and modulation of intracellular calcium in urinary

bladder smooth muscle cells causing musculotropic spasmolysis.

Inhibition of the efferent connection of the nervus pelvicus due to anticholinergic

action.

Pharmacodynamic effects

In animal models propiverine hydrochloride causes a dose-dependent decrease of the

intravesical pressure and an increase in bladder capacity.

The effect is based on the sum of the pharmacological properties of propiverine and

three active urinary metabolites as shown in isolated detrusor strips of human and

animal origin.

5.2

Pharmacokinetic properties

General characteristics of the active substance

Propiverine is nearly completely absorbed from the gastrointestinal tract. It

undergoes extensive first-pass metabolism. Effects on urinary bladder smooth

muscle cells are due to the parent compound and three active metabolites as

well, which are rapidly excreted into the urine.

Absorption

After oral administration of Detrunorm 15 mg Coated Tablets propiverine is

rapidly

absorbed

from

gastrointestinal

tract

with

maximal

plasma

concentrations reached after 2.3 hours. The mean absolute bioavailability of

Detrunorm 15 mg Coated Tablets is 40.5% (arithmetic mean value for AUC

(p.o.)

/ AUC

(i.v.)

Food intake increases the bioavailability of propiverine (mean increase 1.3

fold), but does not significantly affect the maximum plasma concentrations of

propiverine or of its main metabolite, propiverine-N-oxide. This difference in

bioavailability is unlikely to be of clinical significance but adjustment of dose

in relation to food intake could be required in patients suffering from impaired

renal

hepatic

function.

Therefore,

regular

intake

before

meals

recommended.

Distribution

After administration of Detrunorm

15 mg Coated Tablets t.i.d., steady state is

reached after four to five days at a higher concentration level than after single

dose application (C

average

= 61 ng/ml). The volume of distribution was

estimated

healthy

volunteers

after

intravenous

administration

propiverine hydrochloride to range from 125 to 473 l (mean 279 l) indicating

that

large

amount

available

propiverine

distributed

peripheral

compartments. The binding to plasma proteins is 90 - 95% for the parent

compound and about 60% for the main metabolite.

Plasma concentrations of propiverine in 16 healthy volunteers after single and

repeated administration of Detrunorm

15 mg Coated Tablets

(t.i.d. for 6 days):

time [h]

[ng/ml]

single dose

time [h]

[ng/ml]

multiple dose

Steady

state

characteristics

propiverine

following

multiple-dose

administration to 16 healthy volunteers of Detrunorm

15 mg Coated Tablets

(t.i.d. for 6 days):

Dose interval

average

h/ml]

CV [%]

CV [%]

[ng/ml]

CV [%]

0 – 8

8 – 16

16 – 24

CV: coefficient of variation

PTF: peak-trough fluctuation

Biotransformation

Propiverine is extensively metabolised by intestinal and hepatic enzymes. The

primary metabolic route involves the oxidation of the Piperidyl-N and is

mediated by CYP 3A4 and flavin-containing-monoxygenases (FMO) 1 and 3

and leads to the formation of the much less active N-oxide, the plasma

concentration of which greatly exceeds that of the parent substance. Four

metabolites were identified in urine; three of them are pharmacologically

active and may contribute to the therapeutic efficacy of Detrunorm 15 mg

Coated Tablets.

In vitro there is a slight inhibition of CYP 3A4 and CYP 2D6 detectable which

occurs at concentrations exceeding therapeutic plasma concentrations 10- to

100-fold (see section 4.5).

Elimination

Following administration of 30 mg oral dose of

C-propiverine hydrochloride

to healthy volunteers, 60% of radioactivity was recovered in urine and 21%

was recovered in faeces within 12 days. Less than 1% of an oral dose is

excreted unchanged in the urine. Mean total clearance after single dose

administration of 30 mg is 371 ml/min (191 – 870 ml/min). In three studies

including a total of 37 healthy volunteers the mean elimination half-life was

14.1, 20.1, and 22.1 hours, respectively.

Linearity/non-linearity

Pharmacokinetic parameters of propiverine and propiverine-N-oxide following

oral administration of 10 - 30 mg of propiverine hydrochloride are linearly

related to dose. There are no changes of pharmacokinetics during steady state

compared to single dose administration.

Characteristics in patients

Renal impairment

Severe

renal

impairment

does

significantly

alter

disposition

propiverine and its main metabolite, propiverine-N-oxide, as deduced from a

single dose study in 12 patients with creatinine clearance < 30 ml/min. No

dose adjustment is to be recommended as long as the total daily dose does not

exceed 30 mg (i.e. Detrunorm15 mg Coated Tablets given b.i.d.). In case that

higher dose (i.e. 45 mg) shall be administered a careful titration of dose is

recommended considering anticholinergic effects as a marker for tolerability.

Hepatic insufficiency

There were similar steady state pharmacokinetics in 12 patients with mild to

moderate impairment of liver function due to fatty liver disease as compared

to 12 healthy controls. No data are available for severe hepatic impairment.

Elderly

comparison

trough

plasma

concentrations

during

steady

state

(Detrunorm 15 mg Coated Tablets t.i.d. for 28 days) reveals no difference

between elderly (60 – 85 years; mean 68) and young healthy subjects. The

ratio of parent drug to metabolite remains unchanged in elderly indicating the

metabolic conversion of propiverine to its main metabolite, propiverine-N-

oxide, not to be an age-related or limiting step in the overall excretion.

Patients with glaucoma

Intraocular pressure in patients with open angle glaucoma and in patients with

treated (controlled) angle closure glaucoma is not increased by Detrunorm 15

mg Coated Tablets t.i.d., as demonstrated by two placebo-controlled studies.

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