200 mg and 400 mg effervescent tablet
disulfiram
1. What Antabus is and what it is used for
Antabus is a cessation drug for alcohol dependence.
If you drink alcohol while taking Antabus, a number of very unpleasant symptoms occur, such as severe redness on the face, throbbing headache, palpitations, nausea, vomiting, and shortness of breath.
These symptoms can occur even after small amounts of alcohol. Therefore, you should avoid all forms of alcohol, even e.g. liqueur pralines and certain liquid cough medicines and vitamin solutions, which contain alcohol.
If you drink large amounts of alcohol while taking Antabus, the consequences can be very serious. You may become unconscious and need medical attention.
The symptoms, which can appear after only 5-10 minutes, are mainly caused by a breakdown product of alcohol (acetaldehyde) that accumulates in the body if you drink alcohol during treatment. The effect of the tablets gradually builds up over the first 3 days of treatment. The effect then remains for some time after you stop taking the tablets. An alcohol-Antabus reaction can occur up to 2 weeks after your last Antabus dose.
Disulfiram contained in Antabus may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
2. What you need to know before using Antabus
Do not use Antabus
- if you are allergic to disulfiram or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from untreated heart disease, which can pose a serious risk of possible alcohol-Antabus reaction.
- in case of severe mental disorder.
- in severe brain damage.
- in case of ongoing liver disease or if you have previously had liver effects during treatment with Antabus.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Antabus.
Take special care with Antabus if you have or have had liver disease. The liver function should then be checked during treatment with Antabus. If you get symptoms such as loss of appetite, fatigue, nausea, vomiting, weakness, fever, itching, yellow whites of the eyes, yellow skin, dark urine, or light stools, consult your doctor. The symptoms may be due to liver inflammation.
Because Antabus, along with alcohol, causes unpleasant and sometimes very serious symptoms, Antabus should never be given to anyone without their knowledge.
Other medicines and Antabus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Drugs containing metronidazole ( for infections ), warfarin (inhibits blood clotting ability), phenytoin (for epilepsy ), diazepam (for anxiety, anxiety, epilepsy ), imipramine (for depression) and theophylline (for asthma, bronchitis ) affect or be affected by treatment with Antabus.
Antabus with food, drink, and alcohol
All forms of alcohol should be avoided, even the small amounts that may be present in certain foods and medicines.
Pregnancy and breastfeeding
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.
Limited experience of use during pregnancy.
There is a risk that children who are breastfed may be affected.
Driving and using machines
Antabus can cause fatigue and drowsiness, which you should keep in mind when driving and using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Antabus contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use Antabus
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
The usual starting dose is 200-400 mg 2-3 times a week.
A standard maintenance dose is 600-800 mg twice a week or 100-200 mg daily.
Dose one is taken in the morning, but if Antabus makes you tired, dose one can be taken in the evening.
The tablets should be slurried in 1/2 glass of water immediately before ingestion or at most 1 hour before. Stir before ingestion.
Signs of overdose include nausea, vomiting, headache, fatigue, impaired coordination, restlessness, irritability, and hallucinations. Severe overdose can lead to unconsciousness, seizures, low body temperature, drop in blood pressure, and rapid heartbeat.
4. Possible side effects
It can often be difficult, especially at the beginning of treatment, to distinguish symptoms caused by Antabus from symptoms of non-alcohol consumption or damage from previous alcohol consumption.
Common (may affect up to 1 in 10 people):
- fatigue, drowsiness
- stomach upset
- diarrhea
- bad breath
- metallic taste
- headache
- mania
- Depression.
Uncommon (may affect up to 1 in 100 people):
- acne-like rash or allergic rash with itching and/or redness
- disturbed sexual function.
Rare (may affect up to 1 in 1,000 people):
- tingling, numbness, and muscle weakness in especially the arms and legs
- impaired vision and pain in and around the eye
- altered blood count
- liver dysfunction, sometimes with jaundice
- mental disorders in the form of personality change.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Antabus
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is disulfiram 200 mg and 400 mg respectively.
- Other excipients are corn starch, microcrystalline cellulose, povidone, tartaric acid, colloidal anhydrous silica, magnesium stearate, talc, sodium bicarbonate, and polysorbate 20.
What the medicine looks like and the contents of the pack
200 mg effervescent tablet: white with incision, diameter 11 mm, marked CD C.
400 mg effervescent tablet: white with a cross notch, diameter 15 mm, marked CJ.
Plastic jar (PEHD).
200 mg tablet: 100 pcs
400 mg tablet: 50 pcs
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group hf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Recipharm Uppsala AB
Björkgatan 30
751 82 Uppsala