Consumer medicine information

APO-Mebeverine

Mebeverine hydrochloride

BRAND INFORMATION

Brand name

APO-Mebeverine

Active ingredient

Mebeverine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Mebeverine.

SUMMARY CMI

APO-Mebeverine

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 using APO-Mebeverine?

APO-Mebeverine contains the active ingredient mebeverine hydrochloride. APO-Mebeverine is taken to relieve the symptoms of irritable bowel syndrome, which can include, abdominal pain and cramps, bowel spasm, diarrhoea and flatulence.

For more information, see Section 1. Why am I using APO-Mebeverine? in the full CMI.

2. What should I know before I use APO-Mebeverine?

Do not use if you have ever had an allergic reaction to APO-Mebeverine 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 use Apo-Mebeverine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Mebeverine 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 use APO-Mebeverine?

  • Take APO-Mebeverine at about the same time each day. The usual dose is one tablet three times a day.
  • Take APO-Mebeverine immediately before or during a meal. Swallow the tablets with a glass of water.

More instructions can be found in Section 4. How do I use APO-Mebeverine? in the full CMI.

5. What should I know while using APO-Mebeverine?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking APO-Mebeverine.
  • If you become pregnant while you are taking APO-Mebeverine, tell your doctor immediately.
Things you should not do
  • Do not take APO-Mebeverine to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not give APO-Mebeverine to anyone else, even if they have the same condition as you.
  • Do not stop taking APO-Mebeverine, or lower the dosage, without checking with your doctor.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how APO-Mebeverine affects you.
Looking after your medicine
  • Keep your tablets in the pack until it is time to take them.
  • Keep APO-Mebeverine in a cool, dry place where the temperature stays below 25°C.
  • Keep it where young children cannot reach it.

For more information, see Section 5. What should I know while using APO-Mebeverine? in the full CMI.

6. Are there any side effects?

Speak to your doctor if you have any of these less serious side effects and they worry you: indigestion or heartburn, constipation, dizziness, headache, tiredness, difficulty sleeping, loss of appetite. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects: swelling of the face, lips or tongue, difficulty swallowing or breathing.

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

APO-Mebeverine

Active ingredient(s): mebeverine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about taking APO-Mebeverine. 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 APO-Mebeverine.

Where to find information in this leaflet:

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

1. Why am I using APO-Mebeverine?

APO-Mebeverine contains the active ingredient mebeverine hydrochloride. APO-Mebeverine belongs to a group of medicines called known as antispasmodic agents.

APO-Mebeverine works by relaxing the muscles in the gut, thereby relieving the symptoms of irritable bowel syndrome.

APO-Mebeverine is taken to relieve the symptoms of irritable bowel syndrome, which can include, abdominal pain and cramps, bowel spasm, diarrhoea and flatulence.

2. What should I know before I use APO-Mebeverine?

Warnings

Do not use APO-Mebeverine if:

  • you are allergic to mebeverine hydrochloride, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can take this medicine.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Check with your doctor if you:

  • have any of the following medical conditions:
    - angina or other heart conditions
    - liver problems
    - kidney problems
    - lactose intolerance
  • 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

Check with your doctor if you are pregnant or intend to become pregnant.

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.

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

4. How do I use APO-Mebeverine?

How much to take

  • The usual dose is one tablet three times a day.
  • Follow the instructions provided and continue taking APO-Mebeverine until your doctor tells you to stop.
  • It is important to keep taking your medicine even if you feel well.

When to take APO-Mebeverine

  • Take APO-Mebeverine immediately before or during a meal.
  • Take APO-Mebeverine at about the same time each day.
  • Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How to take APO-Mebeverine

  • Swallow the tablets with a glass of water.

If you forget to take APO-Mebeverine

APO-Mebeverine should be taken at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking your medicine as you would normally.

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.

  • This may increase the chance of getting an unwanted side effect.
  • If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for advice.

If you use too much APO-Mebeverine

If you think that you have used too much APO-Mebeverine, 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 using APO-Mebeverine?

Things you should do

Call your doctor straight away if you:

  • become pregnant while you are taking APO-Mebeverine

If you are going to have surgery, tell the surgeon that you are taking APO-Mebeverine.

Remind any doctor, dentist or pharmacist you visit that you are taking APO-Mebeverine.

Things you should not do

  • Do not take APO-Mebeverine to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not give APO-Mebeverine to anyone else, even if they have the same condition as you.
  • Do not stop taking APO-Mebeverine, or lower the dosage, without checking with your doctor

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-Mebeverine affects you.

Looking after your medicine

  • Keep your tablets in the pack until it is time to take them.
  • If you take the tablets out of the box or the blister pack they may not keep well.
  • Keep the medicine in a cool, dry place where the temperature stays below 25°C.

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

Store it in a cool dry place 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 window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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.

Less serious side effects

Less serious side effectsWhat to do

The below list includes the more common side effects of your medicine. They are usually mild and short-lived.

  • indigestion or heartburn
  • constipation
  • dizziness
  • headache
  • tiredness
  • difficulty sleeping
  • loss of appetite
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • These side effects are rare.
  • swelling of the face, lips or tongue
  • Difficulty swallowing or breathing
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 APO-Mebeverine contains

Active ingredient
(main ingredient)		135mg mebeverine hydrochloride
Other ingredients
(inactive ingredients)		Lactose monohydrate
Sodium starch glycolate type A
Povidone
Purified talc
Magnesium stearate
OPADRY complete film coating system 03F58763 White.
Potential allergensThis medicine contain sugars as lactose.

This medicine does not contain gluten.

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

What APO-Mebeverine looks like

APO-Mebeverine is white, round biconvex film-coated tablets and plain on both sides. [Aust R 288817].

Who distributes APO-Mebeverine

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne, VIC 3121

This leaflet was prepared in May 2022

Published by MIMS November 2022

BRAND INFORMATION

Brand name

APO-Mebeverine

Active ingredient

Mebeverine hydrochloride

Schedule

S4

 

1 Name of Medicine

Mebeverine hydrochloride.

2 Qualitative and Quantitative Composition

Each APO-Mebeverine tablet contains mebeverine hydrochloride 135 mg.

Excipients with known effect.

Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Mebeverine tablets are white, round, biconvex, film coated and plain on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

APO-Mebeverine tablets are indicated in the management of the irritable bowel syndrome ('irritable colon', 'spastic colon', 'functional bowel disorders', 'spastic constipation', 'nervous diarrhoea'). APO-Mebeverine is used to treat the symptoms of this condition - i.e. abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.

4.2 Dose and Method of Administration

The recommended adult dose is one APO-Mebeverine, mebeverine hydrochloride 135 mg (1 tablet) three times daily, preferably before or with food. In case one or more doses are missed, the patient should continue with the next dose as prescribed, the missed doses are not to be taken in addition to the regular dose.
After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

4.3 Contraindications

Hypersensitivity to any component of the product.

4.4 Special Warnings and Precautions for Use

Although not reported, APO-Mebeverine tablets should be used with caution in patients with the following conditions on the basis of potential clinical significance: cardiac dysrhythmia; in particular patients with partial or complete atrioventricular heart block, and/or angina or severe ischaemic heart disease.

Pharmaceutical precaution.

APO-Mebeverine tablets contain lactose monohydrate and consideration should be given to patients with a potential diagnosis of lactose intolerance simulating irritable bowel syndrome. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Use in hepatic impairment.

Hepatic dysfunction i.e. patients with advanced liver disease e.g. cirrhosis (because of metabolic pathway). Liver function tests may be indicated if patient develops gastrointestinal symptoms or jaundice suggesting hepatic sensitivity.

Use in renal impairment.

Advanced renal disease (because of excretory pathway).

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

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Safe use in pregnancy has not been established relative to adverse effects on foetal development. Therefore, APO-Mebeverine tablets are not recommended during the first trimester of pregnancy, and otherwise risk-benefit must be considered in its use in pregnant women.
 Mebeverine is secreted in breast milk (< 10 microgram/mL following an oral dose of 100 mg mebeverine hydrochloride). Although problems have not been documented, as a general rule APO-Mebeverine tablets should not be given to a woman who is breast feeding unless the anticipated benefits outweigh possible risks.

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)

Because of the low incidence of adverse drug effects reported a meaningful estimate of adverse reactions is difficult to obtain.
The following side effects have been reported in clinical studies: indigestion, heartburn, dizziness, insomnia, anorexia, headache, decrease in pulse rate, constipation, general malaise.
In very rare cases allergic reactions have been reported, in particular hypersensitivity, urticaria, angioedema, face oedema and exanthem.
Adverse effects reported during post-marketing use have been consistent with those reported in clinical studies, with the following additional side effect reported:

Immune system disorders.

Hypersensitivity (anaphylactic reactions).

Reporting suspected adverse effects.

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

On theoretical grounds, it may be predicted that CNS excitability might occur in cases of overdosage. Observed symptoms of overdose have included those of neurological and cardiovascular nature.
No specific information is available on the treatment of overdosage of mebeverine hydrochloride and no specific antidote is available. Therapy with APO-Mebeverine tablets should be discontinued, and the patients vital functions monitored closely. Treatment is symptomatic and supportive.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Category: Antispasmodic; smooth muscle relaxant.

Mechanism of action.

Mebeverine has a direct non-specific relaxant effect on vascular, cardiac, and other smooth muscle. Studies indicate that the spasmolytic activity of mebeverine is not restricted to one particular system, but the compound possesses a polyvalent spasmolytic action in which at least three types of mechanisms are involved:
a direct musculotropic action involving calcium ion exchange and stabilization of excitable membranes;
a competitive antimuscarinic activity of about 0.05 - 0.1 times that of atropine;
a local anaesthetic activity together with potentiation of sympathetic inhibitory influences due to blockade of noradrenaline uptake into sympathetic nerve endings.
In in vitro studies mebeverine hydrochloride has been shown to have a papaverine-like spasmolytic effect on the smooth muscle of the ileum, uterus and the gall bladder. It possesses a strong local anaesthetic activity.
When tested in vivo in various species, mebeverine hydrochloride was found to be three to five times more powerful than papaverine in blocking spasm of smooth muscle and in relieving the carbachol-induced spasm of the sphincter of Oddi in rabbits, mebeverine hydrochloride proved to be twenty times more active than papaverine. In vivo studies also demonstrate that mebeverine has only minor effects on normal intestinal peristalsis but possesses spasmolytic activity when hypermotility is induced. The spasmolytic activity is found in all parts of the gastrointestinal tract and in some experiments has been found to be more active on colonic smooth muscle.
Studies with mebeverine hydrochloride 100 mg tablets indicate that mebeverine is free of central anticholinergic effects, and practically free of peripheral effects with an activity of less than 0.001 times that of atropine. Mebeverine does not show central depressant or analgesic effects, and only in high doses are some central stimulating effects observed. No ganglion blocking or interference with neuromuscular transmission occurs.
Mebeverine injected intravenously in animals produces transient cardiac arrhythmias, bradycardia and ECG changes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following oral administration of 3H and 14C labelled mebeverine hydrochloride in man, absorption was followed by the appearance in the plasma of veratric acid and an oxidised metabolite of the mebeverine alcohol moiety of the drug, mebeverinic acid.

Distribution.

Maximum plasma radioactivity levels were found 1-3 hours after dosing. Binding of mebeverine to human serum albumin was 75%.

Metabolism.

The primary metabolic step in mebeverine degradation is hydrolysis of the ester function.

Excretion.

The major route of excretion of the metabolites is via the urine (95%) and the peak rate of excretion usually occurs within two hours. Virtually 98% urinary recovery of the conjugated and unconjugated metabolites was observed after a period of 24 hours. No unchanged mebeverine was excreted with the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Teratogenicity has not been demonstrated in teratology studies in rats and rabbits.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet contains microcrystalline cellulose, lactose monohydrate, sodium starch glycolate A, povidone, magnesium stearate, purified talc and Opadry complete film coating system 03F58763 White.

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 25°C.

6.5 Nature and Contents of Container

APO-Mebeverine tablets are available in cartons of 10, 30 and 90 tablets in PVC/PVDC/Al blister packs.

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.


Mebeverine hydrochloride is 4-[ethyl-[2-(4-methoxyphenyl)-1-methylethyl] aminobutyl veratrate hydrochloride, a derivative of phenylethylamine. It is a white to almost white, crystalline powder having a very bitter taste, very soluble in water, freely soluble in ethanol and practically insoluble in ether. The empirical formula is C25H35NO5.HCl. MW: 466.0.

CAS number.

2753-45-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4: Prescription Only Medicine.

Summary Table of Changes