Consumer medicine information

Campral

Acamprosate calcium

BRAND INFORMATION

Brand name

Campral

Active ingredient

Acamprosate calcium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Campral.

What is in this leaflet

This leaflet answers some common questions about CAMPRAL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking CAMPRAL against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What CAMPRAL is used for

CAMPRAL is used in the treatment of alcohol dependence. It helps people who are dependent on alcohol to abstain from drinking alcoholic beverages.

Alcohol dependence is an illness that can and should be treated. Drinking too much alcohol may harm your health and cause physical, psychological and social problems. If this happens to you, your doctor may advise you to stop drinking alcohol altogether.

If you drink too much alcohol, your body and nervous system adapt to its effects. When you suddenly stop drinking, you may experience some unpleasant symptoms (known as alcohol withdrawal syndrome or the "shakes"), which can last up to 2 weeks.

During alcohol withdrawal, you may feel shaky, have an upset stomach, a fast heart beat and high blood pressure. You may also feel anxious, down or be in a bad mood.

Sometimes, you may see things that are not there, or suffer from a headache or not be able to sleep.

If these symptoms are severe, you may need observation in hospital.

After going through this difficult period, your doctor will encourage you to live without alcohol through counselling. CAMPRAL, in combination with counselling from a general practitioner, psychiatrist, psychologist, or a drug and alcohol counsellor, will help you to stop yourself from starting to drink again.

CAMPRAL works by acting on certain chemical changes that have taken place in your brain over the time that you have been drinking alcohol.

CAMPRAL is not recommended for use in children or elderly patients.

CAMPRAL is available only with a doctor's prescription.

There is no evidence that CAMPRAL is addictive.

Before you take CAMPRAL

When you must not take it

Do not take CAMPRAL if you have an allergy to:

  • any medicine containing acamprosate calcium
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take CAMPRAL if:

  • you have kidney disease
  • you have severe liver disease

Do not take this medicine if you are pregnant. The safety of CAMPRAL has not been established in pregnant women.

Do not take this medicine if you are breastfeeding. Like many other medicines, CAMPRAL can pass into breast milk and may affect your baby.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take it

As CAMPRAL does not treat the symptoms of alcohol withdrawal, it is recommended that you start taking CAMPRAL:

  • after you have stopped drinking; and
  • as soon as the withdrawal symptoms have ended

Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.

Tell your doctor if you have any other health problems or medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant or breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking CAMPRAL.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop. Some medicines and CAMPRAL may interfere with each other.

How to take CAMPRAL

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

The usual dose for adults weighing 60 kg or more is 2 tablets three times daily with meals.

For adults weighing less than 60 kg, the recommended dose is 2 tablets in the morning, 1 tablet at midday and 1 tablet at night. These doses are also to be taken with meals.

How to take it

Swallow the tablets whole with a glass of water.

Do not break, crush or chew the tablets. The tablets have a special coating to prevent a stomach upset.

How long to take it

CAMPRAL is usually taken for one year.

Continue taking your medicine for as long as your doctor tells you.

If you forget to take it

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

Otherwise, take the missed dose as soon as you remember, and then go back to taking your medicine as you would normally.

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

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much CAMPRAL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking CAMPRAL

Things you must do

It is important to continue taking CAMPRAL even if you have a short relapse.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CAMPRAL.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not use CAMPRAL to treat any other complaints unless your doctor tells you to.

Do not give CAMPRAL to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or change the dosage without checking with your doctor.

Things to be careful of

Drinking alcohol while taking CAMPRAL will not make you feel sick. However, you are advised not to drink alcohol at all during your treatment with CAMPRAL. Even if you only drink a little alcohol, you run the risk of making your treatment fail.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CAMPRAL. This medicine helps most people with alcohol dependence, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by this list of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • diarrhoea
  • nausea (feeling sick), vomiting, upset stomach
  • itching, skin rash
  • changes in sex drive

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using CAMPRAL

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store CAMPRAL or any other medicine in the bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

CAMPRAL is a 10mm round, white, coated tablet, debossed "333" on one side.

Each pack contains 180 tablets.

Ingredients

The active ingredient in CAMPRAL is acamprosate calcium.

Each enteric coated tablet contains 333 mg of acamprosate calcium.

The enteric coated tablets also contain:

  • crospovidone
  • microcrystalline cellulose
  • magnesium silicate dihydrate
  • sodium starch glycollate
  • colloidal anhydrous silica
  • magnesium stearate
  • purified talc
  • propylene glycol
  • EUDRAGIT L30D-55 (ARTG PI No: 3700)

Supplier

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in December 2022.

Australian registration number:
AUST R 68410

CAMPRAL® is licensed to the Viatris company group

CAMPRAL_cmi\Dec22/00

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Campral

Active ingredient

Acamprosate calcium

Schedule

S4

 

1 Name of Medicine

Acamprosate calcium.

2 Qualitative and Quantitative Composition

Each Campral enteric coated tablet contains acamprosate calcium 333 mg as the active ingredient.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Campral 333 mg enteric coated tablets: 10 mm round, white, coated tablets, debossed "333" on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Campral is indicated as therapy to maintain abstinence in alcohol dependent patients. It should be combined with counselling.

4.2 Dose and Method of Administration

Treatment with acamprosate calcium should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses. The recommended period of treatment is 1 year.
Campral tablets should be taken with meals and swallowed whole.
Based on the clinical results, the daily dose is fixed according to bodyweight.
For adults weighing 60 kg or more, the dose is 2 tablets taken three times daily (i.e. 2 tablets in the morning, at midday and at night).
In adults weighing less than 60 kg, the dose is 2 tablets in the morning, 1 tablet at midday and 1 tablet at night.
Lower doses might be ineffective. The efficacy and safety of higher doses have not been established.

4.3 Contraindications

Campral is contraindicated in: patients with a known hypersensitivity to the medicine;
pregnant or breastfeeding women;
renal insufficiency (serum creatinine > 120 micromol/L);
severe hepatic failure (Child-Pugh Classification C).

4.4 Special Warnings and Precautions for Use

Acamprosate does not constitute treatment for the withdrawal period.
Because the interrelationship between alcohol dependence, depression and suicidality is well recognised and complex, it is recommended that alcohol-dependent patients, including those treated with acamprosate, be monitored for respective symptoms.
Each tablet contains 33.3 mg of calcium. In preclinical studies, various signs of toxicity were observed, including diarrhoea, hyperkeratosis and dysplasia of the stomach, soft tissue calcification, and increased deaths due to renal and cardiac lesions in the rat.

Use in hepatic impairment.

The safety and efficacy of Campral has not been established in patients with severe hepatic failure (Child-Pugh Classification C).

Use in the elderly.

The safety and efficacy of Campral has not been established in patients older than 65 years. Campral should not be administered to the elderly.

Paediatric use.

The safety and efficacy of Campral has not been established in patients younger than 18 years. Campral should not be administered to children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The concomitant intake of alcohol and acamprosate calcium does not affect the pharmacokinetics of either alcohol or acamprosate.
Administering acamprosate calcium with food diminishes the bioavailability of the medicine compared with its administration in the fasting state.
Pharmacokinetic studies show no interaction between acamprosate calcium and diazepam, disulfiram or imipramine.
Since pharmacointeraction studies have not been performed with all psychotropic medicines, when acamprosate is administered simultaneously with such medicines, it is advisable to monitor the patient carefully for possible interactions.
Coadministration of naltrexone with acamprosate produced a 25% increase in AUC and a 33% increase in Cmax of acamprosate; however, this finding has limited clinical impact so that no adjustment of dosage is necessary in such patients. The pharmacokinetics of naltrexone and its major metabolite 6-beta-naltrexol were unaffected following coadministration with acamprosate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No adverse effects on fertility or reproduction were observed in male or female mice administered acamprosate at oral doses up to 2400 mg/kg daily (approximately 6 times human exposure at the maximum recommended clinical dose, based on BSA), prior to and throughout mating and gestation. In an equivalent study in rats, no effects were seen at daily oral doses up to 1000 mg/kg (approximately 5 times human exposure at the maximum recommended clinical dose, based on BSA).
(Category B2)
Acamprosate crosses the placenta and is distributed into fetal tissue following oral administration to pregnant rats. Acamprosate administered during organogenesis was not teratogenic in mice, rats or rabbits at daily oral doses up to 2400 mg/kg, 2000 mg/kg and 1000 mg/kg, respectively (approximately 6, 10 and 9 times human exposure at the maximum recommended clinical dose, based on BSA). The safety of acamprosate calcium has not been established in pregnant women. Campral should not be administered to pregnant women (see Section 4.3 Contraindications).
 Acamprosate calcium is excreted in the milk of lactating animals. Safe use of acamprosate calcium has not been demonstrated in lactating women. Campral must not be administered to breastfeeding women (see Section 4.3 Contraindications).
If a breastfeeding woman cannot abstain from drinking alcohol without being treated with acamprosate, a decision must be made whether to discontinue nursing or to discontinue Campral, taking into account the importance of the medicinal product to the woman.

4.7 Effects on Ability to Drive and Use Machines

Acamprosate should not impair the patient's ability to drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Gastrointestinal disorders.

Very common: diarrhoea.
Common: abdominal pain, nausea, vomiting, flatulence.

Skin and subcutaneous tissue disorders.

Common: pruritus, maculopapular rash.
Not known: vesiculo-bullous eruptions.

Immune system disorders.

Very rare: hypersensitivity reactions including urticaria, angioedema or anaphylactic reactions.

Reproductive system and breast disorders.

Common: frigidity or impotence.

Psychiatric disorders.

Common: decreased libido.
Uncommon: increased libido.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Acute overdosage with acamprosate is usually benign. In all reported cases, the only symptom which could be reasonably ascribed to acamprosate overdose was diarrhoea. A risk of hypercalcaemia should be considered in chronic overdosage only. Treatment of overdosage should be 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

Mechanism of action.

Acamprosate calcium has a chemical structure similar to that of amino acid neuromediators, such as taurine or gamma-aminobutyric acid (GABA), including an acetylation to facilitate passage across the blood brain barrier. Pharmacodynamic studies have been unable to confirm any specific neuromodulatory effect via amino acid receptors. If acamprosate is administered to rats during the induction of ethanol-dependence, the elevation of extracellular brain glutamate concentrations seen during ethanol withdrawal is decreased. In studies in rats and dogs, there was inconclusive evidence of significant distribution of acamprosate into the brain following oral administration of radiolabelled medicine.
Animal experimental studies have demonstrated that acamprosate calcium decreases the voluntary intake of drinking water containing alcohol without affecting food and total fluid intake. The mechanism for this effect in rats is unclear.

Clinical trials.

In an extensive clinical research programme, acamprosate proved its efficacy as an adjuvant to psycho-social therapy over long treatment periods of up to one year, independent of the country where the trial was performed and the type of psycho-social programme applied.
The primary outcome criteria was abstinence, defined as no alcohol intake whatsoever. In the combined efficacy analysis which pooled data from 3338 weaned alcohol dependent patients, despite this very stringent definition (more reliable from a standardisation point of view), the clinical data demonstrated that:
there is a doubling of the absolute abstinence rate after one year treatment when compared to placebo with 22% of the acamprosate treated patients remaining completely abstinent for one year compared to 12% in the placebo group;
patient compliance to remain in the treatment was statistically significantly different from Day 90 onwards with 50% retention rate in patients on acamprosate compared with 40% on placebo at the end of the one year treatment period;
the drink-free periods (Cumulative Abstinent Duration calculated as a fraction of the total abstinent days over the total duration of exposure to treatment) were much longer in the active treatment group in 11 of 12 comparative studies: 53.3 ± 38.5% in acamprosate group compared to 40 ± 35.4% in the placebo group;
there is no overt rebound drinking after termination of treatment and no signs of medicine withdrawal.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Acamprosate calcium absorption across the gastrointestinal tract is moderate, slow and sustained and varies substantially from person to person. Food reduces the oral absorption of acamprosate calcium. Steady-state levels of acamprosate calcium are achieved by the seventh day of dosing. Acamprosate calcium is not protein bound.
Oral absorption shows considerable variability and is usually less than 10% of the ingested medicine in the first 24 hours. After a single acamprosate dose of 2 x 333 mg tablets, peak plasma concentrations of approximately 200 nanogram/mL are reached after 5 to 7 hours and longer. After a 15 minute infusion of 666 mg of acamprosate, the volume of distribution is on average 72 ± 3 L.

Metabolism and excretion.

The medicine is excreted in the urine and is not metabolised significantly. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate calcium. After oral dosing of 666 mg of acamprosate, the apparent elimination half life ranged from 13 to 28.4 hours. The pharmacokinetics of acamprosate calcium are not altered by hepatic dysfunction.

5.3 Preclinical Safety Data

Genotoxicity.

Acamprosate showed no evidence of genotoxicity in a series of assays for gene mutations (bacterial and mammalian cells) and chromosomal damage (human lymphocytes in vitro and micronucleus formation in vivo).

Carcinogenicity.

In carcinogenicity studies, mice and rats were administered acamprosate in the diet for 91 and 104 weeks, respectively. In mice, there was no evidence of an increased incidence of tumours at doses up to 400 mg/kg/day, a dose which approximates the human exposure at the maximum recommended clinical dose, based on body surface area (BSA). In male rats, there was an increased incidence of adrenal phaeochromocytomas at 400 mg/kg/day (approximately twice human exposure at the maximum recommended clinical dose, based on BSA). Dietary calcium can lead to adrenal medullary proliferative disease in rats but there is no evidence that increased dietary calcium poses a risk of increased adrenal medullary lesions in humans.

6 Pharmaceutical Particulars

6.1 List of Excipients

Campral enteric coated tablets contain the following inactive excipients: crospovidone, microcrystalline cellulose, magnesium silicate dihydrate, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, purified talc, propylene glycol and Eudragit L30D-55 (ARTG PI No: 3700).

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

Container type: PVC/PVDC/Aluminium blister packs.
Pack sizes: 18, 48, 54, 60, 84, 90, 168 and 180 enteric coated tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG).

AUST R 68410 - Campral acamprosate calcium 333 mg enteric coated tablet blister pack.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.


Molecular formula: C10H20N2O8S2Ca. Molecular weight: 400.48.

CAS number.

77337-76-9 (acamprosate).
Acamprosate calcium is a white, odourless or practically odourless powder with a bitter taste. It is freely soluble in water, practically insoluble in absolute ethanol and dichloromethane.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes