AOTAL 333 mg Uses, Dosage, Side Effects, Precautions & Warnings
what is AOTAL 333 ?
This medication helps maintain abstinence in alcohol-dependent patients (excessive consumption of alcoholic beverages).
what is AOTAL 333 mg medication used for and indication?
Acamprosate is indicated for the “maintenance of abstinence in the alcohol-dependent patient”. It must be associated with psychological care.
AOTAL 333 mg Dosage
- Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if in doubt.
- The dosage is 6 tablets per day for a weight greater than 60 kg, and 4 tablets per day for a weight less than 60 kg.
- Swallow the tablets with a little water, without chewing or chewing them.
Frequency of administration
- The tablets are divided into 3 doses per day, either as prescribed by your doctor:
- To 6 tablets: 2 tablets morning, noon and night,
- For 4 tablets: 2 tablets in the morning, 1 tablet at noon and 1 tablet in the evening
- It is best to take the tablet between meals if you do not have digestive problems. (See section 4 “What are the possible side effects?”).
Duration of treatment
The duration of treatment is on average 1 year.
If you take more AOTAL 333 mg, gastro-resistant coated tablet than you should:
- If you take more AOTAL than you should, talk to your doctor or pharmacist.
If you forget to take AOTAL 333 mg, gastro-resistant coated tablet:
- Do not take a double dose to make up for the dose you forgot to take.
If you stop taking AOTAL 333 mg, gastro-resistant coated tablet:
- Acamprosate does not cause dependence syndrome.
- If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.
Acamprosate is contraindicated:
In patients with known hypersensitivity to acamprosate or to any of the excipients;
– in the event of renal insufficiency (serum creatinine> 120 µmol / l);
In women who are breast-feeding (see section Pregnancy and breast-feeding ).
HOW TO TAKE AOTAL 333 mg?
How it works ?
- Absorption of acamprosate through the gastrointestinal tract is moderate. It is slow and sustained, with significant inter-individual variability.
- Administration of acamprosate with food decreases the bioavailability of the drug compared to administration on an empty stomach.
- Steady state is reached within 5-7 days after repeated oral administration.
- Acamprosate is not bound to plasma proteins.
- The elimination of acamprosate occurs exclusively via the renal route and in unchanged form, the renal clearance of acamprosate being almost identical to the total plasma clearance. In addition, taking acamprosate by injection shows that there is a linear relationship between the degree of renal failure and the prolongation of the plasma elimination half-life.
- While digestive absorption is prolonged, elimination of acamprosate is rapid. The half-life of between 15 and 30 hours is therefore more representative of absorption than elimination.
- The pharmacokinetics of acamprosate are not affected by impaired hepatic function.
AOTAL Side Effects
- Abdominal pain
- Maculopapular erythema
- Vesiculobullous rash
- Hypersensitivity reaction
- Allergic urticaria
- Anaphylactic reaction
- Decreased libido
- Increased libido
Based on data collected during clinical studies and spontaneous notifications since the marketing authorization, the following side effects may occur under treatment with AOTAL.
Adverse reactions were classified according to the frequency used below:
- Very common (> 1/10)
- Common (> 1/100, <1/10).
- Uncommon (> 1/1000, <1/100)
- Rare (> 1/10000, <1/1000)
- Very rare (<1/10000)
Not known (cannot be estimated from the available data).
- Very common: diarrhea.
- Common: abdominal pain, nausea, vomiting, gas
Skin and subcutaneous tissue disorders
- Common: pruritus, maculopapular rash.
- Not known: vesico-bullous rashes.
Immune system disorders
- Very rare: hypersensitivity reactions including urticaria, angioedema, anaphylactic reaction.
Reproductive system and breast disorders
- · Common: frigidity and impotence.
- Common: decreased libido
- Uncommon: increased libido
AOTAL 333 mg Interactions
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Drive and use machines
Warnings and Precautions
- This medication should not be administered to children and the elderly.
Precautions for use
- Acamprosate is not a treatment for the acute symptoms of alcohol withdrawal.
- In the absence of efficacy and safety data, acamprosate is not recommended in patients under 18 years of age and in subjects over 65 years of age.
- In the absence of efficacy and safety data, acamprosate is not recommended in patients with severe hepatic impairment (Group C of the Child-Plugh classification).
- Since alcohol, depression and suicide are closely related, monitoring of changes in mood or behavior in patients withdrawing from acamprosate should be observed.
Abuse and addiction
- Non-clinical studies suggest that acamprosate has little or no potential for abuse. No evidence of acamprosate dependence was found in clinical studies, thus demonstrating the absence of significant potential for acamprosate dependence.
PREGNANCY & BREAST-FEEDING & FERTILITY
- There are no adequate data from the use of AOTAL in pregnant women. Animal studies have not produced any evidence of foetotoxic or teratogenic effects. AOTAL can therefore be administered during pregnancy only after careful consideration of the risk / benefit ratio when the patient cannot abstain from alcohol consumption without being treated with AOTAL and, therefore, there is a risk of fetotoxicity. or teratogenesis due to alcohol.
Feeding with milk
- AOTAL is excreted in human milk in animals. It is not known whether acamprosate is excreted in human breast milk. There are no adequate data from the use of acamprosate in infants. Therefore, AOTAL should not be used in nursing women.
- If a breastfeeding woman cannot abstain from alcohol consumption without being treated with acamprosate, a decision should be made to either discontinue breastfeeding or to discontinue treatment, taking into consideration the importance of treatment for the mother.
- Animal studies do not show harmful effects on fertility. The effect of acamprosate on fertility in men and women is not known.
What happens if I overdose from AOTAL 333 mg ?
- Acute acamprosate overdoses are usually mild.
- In the reported cases, the only symptom that could reasonably be related to the overdose is diarrhea.
- During these overdoses, no case of hypercalcemia has been described. In case of overdose, treatment is symptomatic.
What should I do if I miss a dose?
If you take more AOTAL 333 mg, gastro-resistant coated tablet than you should:
- If you take more Aotal than you should, talk to your doctor or pharmacist.
What is Forms and Composition ?
|SHAPES and PRESENTATIONS|
- 333 mg gastro-resistant coated tablet: Boxes of 60 and 180, in blister packs.
|Acamprosate (DCI) sel de calcium||333 mg|
- Excipients: crospovidone (Kollidon CL), microcrystalline cellulose (Avicel PH 101), magnesium silicate (Compressil), sodium carboxymethyl starch (Explotab), colloidal anhydrous silica (Aerosil 200), magnesium stearate. Coating: anionic copolymer of polymethacrylic acid and acrylic acid ester (Eudragit L 30 D), talc, propylene glycol.
- Calcium content: 33.3 mg / tab.
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- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
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- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
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