Consumer medicine information

Urocarb Tablets

Bethanechol chloride

BRAND INFORMATION

Brand name

Urocarb

Active ingredient

Bethanechol chloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Urocarb Tablets.

SUMMARY CMI

UROCARB®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking UROCARB?

UROCARB contains the active ingredient bethanechol chloride. UROCARB is used to treat certain disorders of the urinary tract or bladder that may be caused by surgery, delivering a baby or other conditions.

For more information, see Section 1. Why am I taking UROCARB? in the full CMI.

2. What should I know before I take UROCARB?

Do not use if you have ever had an allergic reaction to bethanechol chloride or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take UROCARB? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with UROCARB and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take UROCARB?

  • The usual dose is 1 to 3 tablets, taken three to four times a day. Take UROCARB on an empty stomach. Swallow tablets whole with a full glass of water or let them dissolve under your tongue.

More instructions can be found in Section 4. How do I take UROCARB? in the full CMI.

5. What should I know while taking UROCARB?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking UROCARB.
  • Be careful when getting up suddenly from a sitting or lying position.
Driving or using machinesBe careful before you drive or use any machines or tools until you know how UROCARB affects you.
  • UROCARB may cause dizziness in some people.
Looking after your medicine
  • Keep your medicine in a cool, dry place where it stays below 30°C.

For more information, see Section 5. What should I know while taking UROCARB? in the full CMI.

6. Are there any side effects?

Side effects are rare, but are more likely to occur when the dose is increased.

Speak to your doctor if you have any side effects that worry you. Side effects may include stomach cramps or pain, nausea, diarrhoea, headache, fall in blood pressure with fast heartbeat, flushed or sweating skin, wheezing or asthma, blurred vision, urinary urgency or teary eyes.

Seizures have been reported but it is not clear whether these were caused by UROCARB.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

UROCARB®

Active ingredient(s): bethanechol chloride


Consumer Medicine Information (CMI)

This leaflet provides important information about taking UROCARB. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking UROCARB.

Where to find information in this leaflet:

1. Why am I taking UROCARB?
2. What should I know before I take UROCARB?
3. What if I am taking other medicines?
4. How do I take UROCARB?
5. What should I know while taking UROCARB?
6. Are there any side effects?
7. Product details

1. Why am I taking UROCARB?

UROCARB contains the active ingredient bethanechol chloride. UROCARB has a similar action to a natural chemical in the body called acetylcholine. It causes the smooth muscle in the bladder to contract and empty.

UROCARB is used to treat certain disorders of the urinary tract or bladder, such as urinary retention (trouble urinating) that may be caused by surgery, delivering a baby or other conditions.

2. What should I know before I take UROCARB?

Warnings

Do not take UROCARB if:

  • you are allergic to bethanechol chloride, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • you have asthma
  • you have an overactive thyroid
  • you have blocked coronary arteries
  • you have slow heartbeat or low blood pressure
  • you have epilepsy or other seizure disorder
  • you have Parkinson's disease
  • you have a kidney infection
  • you have an ulcer, blockage or recent surgery on your stomach or intestines
  • you have a bladder obstruction
  • you are pregnant or likely to become pregnant

Check with your doctor if you:

  • have any other medical conditions
  • have had a recent bladder or kidney infection
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or intend to become pregnant. UROCARB may cause muscle contractions that could lead to a miscarriage.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with UROCARB and affect how it works. These include:

  • Cholinergic drugs, especially cholinesterase inhibitors, that block the normal breakdown of acetylcholine and are most commonly used to treat Alzheimer's disease or dementia.
  • Medicines that affect the parasympathetic nervous system used to treat some conditions of the gut, eyes, heart or nerve-muscle disorders. These medicines may not work as effectively when used with UROCARB.
  • Procainamide or quinidine, medicines used to treat irregular heartbeats.
  • A group of medicines called ganglionic blocking agents.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect UROCARB.

4. How do I take UROCARB?

How much to take

  • The usual dose is 1 to 3 tablets, taken three to four times a day.
  • Follow the instructions provided and take UROCARB until your doctor tells you to stop.

When to take UROCARB

  • UROCARB should be taken on an empty stomach as nausea and vomiting could occur if taken too soon after eating.

How to take UROCARB

  • Swallow tablets whole with a full glass of water or let them dissolve under your tongue.

If you forget to take UROCARB

UROCARB should be taken regularly at the same times each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you take too much UROCARB

If you think that you have taken too much UROCARB, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking UROCARB?

Things you should do

Call your doctor straight away if you:

  • Become pregnant while taking this medicine

Remind any doctor, dentist or pharmacist you visit that you are taking UROCARB.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how UROCARB affects you.

UROCARB may cause dizziness in some people.

Looking after your medicine

Follow the instructions on the bottle on how to take care of your medicine properly.

Store it in a cool dry place below 30°C, away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on windowsills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Possible side effects

Possible side effectWhat to do
  • feeling unwell
  • stomach cramps or pain
  • urgency to pass urine
  • nausea
  • diarrhoea
  • headache
  • flushed or sweating skin
  • wheezing or asthma
  • blurred vision or teary eyes
  • seizures
  • fall in blood pressure with fast heart rate
Speak to your doctor if you have any side effects and they worry you.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What UROCARB contains

Active ingredient
(main ingredient)
bethanechol chloride
Other ingredients
(inactive ingredients)
lactose monohydrate
acacia
amaranth
erythrosine
magnesium stearate
wheat starch
hydrogenated vegetable oil
Potential allergenslactose, sugars, gluten

Do not take this medicine if you are allergic to any of these ingredients.

What UROCARB looks like

UROCARB is a round, light pink tablet with a break line on one side. It is supplied in bottles of 100 tablets. Each tablet contains 10 mg bethanechol chloride.

(Aust R 14861).

Who distributes UROCARB

Mayne Pharma International Pty Ltd
1538 Main North Road
Salisbury South, SA 5106

UROCARB is a registered trademark of

Mayne Pharma International Pty Ltd.

This leaflet was prepared in July 2021.

CMI Version: 4.0

Published by MIMS September 2021

BRAND INFORMATION

Brand name

Urocarb

Active ingredient

Bethanechol chloride

Schedule

S4

 

1 Name of Medicine

Bethanechol chloride.

2 Qualitative and Quantitative Composition

Urocarb tablets contain 10 mg bethanechol chloride.
Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

Excipients with known effect.

Urocarb contains lactose monohydrate and wheat starch. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Urocarb tablets are round, light pink tablets with a break line on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Acute post-operative and postpartum non-obstructive urinary retention, and neurogenic atony of the urinary bladder with retention. Bethanechol has no clinically significant nicotinic stimulant activity.

4.2 Dose and Method of Administration

Oral or sublingual dose of 10 to 30 mg three to four times daily meets most needs. The effects sometimes appear within 30 minutes, but usually by 60 to 90 minutes and persist for about an hour. For urinary retention, it is preferable to give Urocarb on an empty stomach. If taken soon after eating, nausea and vomiting could occur.

4.3 Contraindications

Bethanechol is contraindicated in the following conditions and risk-benefit should be considered before prescribing:
Hypersensitivity to bethanechol or any of the ingredients in List of Excipients.
Bronchial asthma, latent or active - bethanechol may cause bronchospasm and may precipitate asthmatic attack.
Bradycardia (pronounced) - bethanechol slows heart rate and may exacerbate the condition.
Hyperthyroidism - risk of atrial fibrillation may be increased.
Coronary artery disease, especially occlusion (bethanechol may decrease coronary blood flow).
Vasomotor instability.
Hypotension - bethanechol may reduce blood pressure.
Peptic ulcer - bethanechol may aggravate symptoms probably by increasing acid secretion and/or by increasing gastric motility.
Epilepsy - although no causal relationship has been established, seizures have been reported in patients receiving bethanechol.
Parkinsonism - bethanechol may exacerbate this condition.
Conditions in which increased muscular activity of the gastrointestinal tract or urinary bladder might be harmful, such as anastomosis, recent bladder surgery, gastrointestinal resection; conditions in which strength or integrity of gastrointestinal (e.g. acute inflammation) or bladder wall is questionable, or gastrointestinal obstruction, or urinary tract obstruction (increased muscular activity of the gastrointestinal tract or urinary bladder may be harmful).

4.4 Special Warnings and Precautions for Use

Bacteriuria.

In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Postural hypotension.

Patients should be advised to exercise caution when getting up suddenly from a lying or sitting position.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Caution is required when bethanechol is administered to patients being treated with other drugs that act on the parasympathetic nervous system, as pharmacologic interactions may occur. Some examples of drugs with potentials for such interactions are:
Cholinergic drugs, particularly cholinesterase inhibitors, where additive effects may occur.
Drugs with sympathomimetic properties, as their effects could be offset by bethanechol.
Drugs with anticholinergic properties (e.g. quinidine and procainamide), which may oppose the effect of bethanechol.
Ganglionic blocking agents (concurrent use with bethanechol may produce a critical fall in blood pressure, which is usually preceded by severe abdominal symptoms).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Adequate and well controlled studies in humans have not been done. Studies have not been done in animals. Bethanechol has a potent excitatory effect on smooth muscle and should be avoided during pregnancy.
No data available.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions are rare following oral administration of bethanechol chloride but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.
The following adverse reactions have been observed:

Body as a whole.

Malaise.

Digestive.

Abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhoea, borborygmi, salivation.

Renal.

Urinary urgency.

Nervous system.

Headache.

Cardiovascular.

A fall in blood pressure with reflex tachycardia, vasomotor response.

Skin.

Flushing producing a feeling of warmth, sensation of heat about the face, sweating.

Respiratory.

Bronchial constriction, asthmatic attacks.

Special senses.

Lacrimation, miosis.

Causal relationship unknown.

The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol chloride has not been established:

Nervous system.

Seizures.

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ("hot feeling"), sweating, nausea, and vomiting.
Treatment of overdosage consists of administration of atropine, which may be repeated every 2 hours according to the clinical response. Subcutaneous injection of atropine is preferred, however in emergencies the intravenous route may be used to counteract severe toxic cardiovascular or bronchoconstrictor effects of bethanechol.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Bethanechol chloride (Urocarb) is a quaternary ammonium parasympathomimetic agent with the muscarinic actions of acetylcholine. It is not inactivated by cholinesterase so that its action is more prolonged.
A selective stimulant of the smooth muscle of the gastrointestinal tract and the urinary bladder. It produces increase in tone and peristaltic activity of the stomach and intestines, increased oesophageal peristalsis and an increase in the resting pressure of the lower oesophageal sphincter. Bethanechol enhances the secretory activity of the pancreas and gastrointestinal tract and causes contraction of the detrusor muscle of the urinary bladder and decreased bladder capacity.
Effects on the Gl and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Bethanechol chloride is a quaternary amine which is poorly absorbed from the gastrointestinal tract. Following oral administration, the effects of the drug may appear within 30 minutes and are usually maximal within 60 to 90 minutes.

Distribution.

At standard doses, bethanechol does not cross the blood-brain barrier. No further information is available about the distribution of bethanechol.

Metabolism.

The metabolic rate has not been determined, however bethanechol is not hydrolysed by cholinesterases and therefore its actions are more prolonged than those of acetylcholine.

Excretion.

Choline esters are rapidly eliminated by the kidneys. No further information is available about the excretion of bethanechol.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Urocarb contains lactose monohydrate, acacia, amaranth, erythrosine, magnesium stearate, wheat starch and hydrogenated vegetable oil.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

HDPE bottles, 100 scored tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Bethanechol chloride is designated chemically as 1-propanaminium, 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-chloride.
It is a white to off white crystalline powder, soluble in water and alcohol, and has a molecular weight of 196.68.

CAS number.

CAS 590-63-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes