NOTICE
ANSM - Updated on : 18/09/2024
ATTENTION
ACTRON, effervescent tablet, WHICH IS A NON-STEROIDIC ANTI-INFLAMMATORY (NSAID), MAY CAUSE FTAL DEATH IF TAKEN FROM THE 6TH MONTH OF PREGNANCY (24 weeks of amenorrhea) EVEN AFTER A SINGLE TAKE.
Do not use if you are 6 months or more pregnant (24 weeks or more).
Before the 6th month or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary, as determined by your doctor.
Product name
ACTRON, effervescent tablet
Acetylsalicylic acid/Paracetamol/Caffeine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 3 days (in the case of fever) or 5 days (in the case of pain).
What does this leaflet contain?
1. What is ACTRON effervescent tablet and what is it used for?
2. What do I need to know before taking ACTRON, effervescent tablet?
3. How do I take ACTRON, effervescent tablet?
4. What are the possible side effects?
5. How should ACTRON effervescent tablets be stored?
6. Package contents and other information.
1. WHAT IS ACTRON, effervescent tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: ANTALGIC and ANTIPYRETIC - N: central nervous system
This medicine contains two analgesics: aspirin and paracetamol, plus caffeine.
It is indicated in adults for conditions involving pain and fever, such as headaches, flu, toothache and aches.
You should consult your doctor if you do not feel any improvement or if you feel less well after 3 days (in the case of fever) or 5 days (in the case of pain).
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ACTRON, effervescent tablet?
Never take ACTRON, effervescent tablet if you are 24 weeks or more pregnant (6 months or more of pregnancy) (see "Pregnancy, breast-feeding and fertility" below).
During the first 5 months of pregnancy, you should not take ACTRON, effervescent tablet unless absolutely necessary, as determined by your doctor.
If you are planning a pregnancy and are taking an NSAID, talk to your healthcare professional.
Never take ACTRON effervescent tablets:
- if you are allergic to laspirin or a related drug (in particular non-steroidal anti-inflammatory drugs), to paracetamol or caffeine, or to any of the other components of this medicine listed in section 6.
- Children under 15 years of age, due to the presence of caffeine.
- Pregnancy, from the beginning of the 6th month (beyond 24 weeks of amenorrhea),
- if you have serious liver, kidney or heart disease
- if you have an evolving stomach or duodenal ulcer,
- if you have a bleeding disease or risk of bleeding,
- if you have a history of asthma induced by daspirin or other molecules with a similar action, such as non-steroidal anti-inflammatory drugs.
- If treated with:
o methotrexate (doses greater than 20 mg per week),
o oral anticoagulants when aspirin is prescribed in analgesic or antipyretic doses (≥ 500 mg per dose and/or < 3 g/day) and in the event of a history of duodenal ulcer.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor or pharmacist before taking ACTRON, effervescent tablet.
If pain persists for more than 5 days, fever for more than 3 days or worsens, do not continue treatment without consulting your doctor or pharmacist.
In the event of overdose, or if you take too high a dose by mistake, contact a doctor immediately.
Reye's syndromes (a rare but very serious disease mainly associating neurological disorders and liver damage) have been observed in children with viral diseases receiving aspirin.
Consequently:
- in the event of viral illness, such as chickenpox or a flu-like episode: do not administer aspirin to a child without the advice of a physician,
- If a child taking aspirin becomes unconscious, vomits or exhibits behavioral problems, contact a physician immediately.
Before taking aspirin, CONSULT YOUR PHYSICIAN in the event of:
- gout.
- digestive history: bleeding, former stomach or duodenal ulcer,
- kidney or liver disease,
- impaired circulation
- asthma: the occurrence of asthma attacks in some individuals may be linked to allergy to aspirin or NSAIDs; in such cases, this drug is contraindicated.
- heavy menstrual bleeding or IUD contraception
- G6PD deficiency
- before any surgery, even minor (e.g. tooth extraction).
Aspirin increases the risk of bleeding at very low doses, even when taken for several days. PREVENT YOUR TREATMENT PHYSICIAN, SURGEON, ANESTHESIST OR DENTIST if you intend to undergo even minor surgery.
Before taking paracetamol, CONSULT YOUR DOCTOR in the event of :
- liver or kidney disease. Prolonged use of high-dose paracetamol can lead to liver and kidney damage.
- hereditary disease of red blood cell enzymes.
- Gilbert's syndrome
- diabetes mellitus
In the event of redness, blisters or scaling of the skin, discontinue use and consult a physician immediately.
Linked to the presence of caffeine :
This drug may cause insomnia, and should not be taken at the end of the day.
Caffeine is not recommended in cases of hyperthyroidism.
Due to the presence of caffeine, this drug should not be used in the event of :
- heart rhythm disorders and/or severe cardiovascular pathology
- severe and/or uncontrolled arterial hypertension.
This medicine contains 472 mg sodium (main component of table salt) per tablet. This is equivalent to 24% of the maximum recommended daily allowance of sodium for an adult. Talk to your doctor or pharmacist if you need one or more tablets daily for a prolonged period, especially if you are on a low-salt (sodium) diet.
This medicine may cause insomnia and should not be taken at the end of the day.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children
Not applicable.
Other medicinal products and ACTRON, effervescent tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine MUST NOT BE TAKEN with the following drugs (see "Never take ACTRON, effervescent tablet")
If you are being treated with :
- methotrexate (doses greater than 20 mg per week),
- oral anticoagulants when aspirin is prescribed in analgesic or antipyretic doses (≥ 500 mg per dose and/or < 3 g/day) and in the event of a history of duodenal ulcer.
This medicine MUST NOT BE USED, unless otherwise advised by your doctor, if you are being treated with:
- oral anticoagulants (for aspirin doses of less than 3 g/day) in the absence of a history of duodenal ulcer,
- other non-steroidal anti-inflammatory drugs (for high doses of aspirin greater than or equal to 3 g/day),
- lanagrelide (a drug used for blood disorders),
- clopidogrel, ticagrelor (drugs used to treat heart disease),
- defibrotide (used to treat liver vein disorders),
- injectable heparins,
- pemetrexed (cancer treatment),
- uricosurics (gout medication),
- ticlopidine,
- enoxacin.
Please inform your doctor or pharmacist if you are taking :
- flucloxacillin (antibiotic), due to a serious risk of blood and plasma abnormality (metabolic acidosis with high anion gap) which must be treated urgently and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.
This medicine contains two analgesics: aspirin and paracetamol, and caffeine. Other drugs contain caffeine. Do not combine them, so as not to exceed the maximum recommended doses. (see "Dosage").
ACTRON, effervescent tablet with food, drink and alcohol
The risk of liver toxicity may be increased in patients suffering from alcoholism.
Pregnancy, breast-feeding and fertility
Pregnancy
This medicine contains aspirin (acetylsalicylic acid). Do NOT take ANY OTHER medication containing aspirin (including over-the-counter medicines).
- up to 100 mg daily: Throughout pregnancy, if necessary, your specialist doctor may prescribe low doses of laspirin (up to 100 mg per day), in exceptional circumstances requiring specialist supervision. If this is the case, it is very important to follow your doctor's instructions to the letter, without exceeding the prescribed doses.
- between 100 and 500 mg per day: As a precautionary measure, the following recommendations apply unless otherwise prescribed by your specialist.
- 500 mg or more per day:
From the beginning of the 6th month (24th week of amenorrhea) until the end of pregnancy, ACTRON effervescent tablets are contraindicated . Under NO CIRCUMSTANCES should you take this medicine during this period, as its effects on your unborn child may be serious or even fatal. In particular, toxicity to the heart, lungs and/or kidneys has been observed, even with a single dose. It can also affect you and your baby, promoting bleeding and leading to a later or longer-than-expected delivery.
Before the start of the 6th month (up to the 24th week of amenorrhea) or if you are planning a pregnancy, you should not take this medicine unless absolutely necessary. This will be determined by your doctor. In such cases, the dose should be as low as possible and the duration of treatment as short as possible.
NSAIDs, including ACTRON, effervescent tablet, can cause miscarriage and, in some cases, malformations after exposure in early pregnancy.
From 2 1/2 months of pregnancy (12 weeks of amenorrhea), ACTRON effervescent tablets can cause kidney problems in your baby, if taken for several days, leading to a low level of amniotic fluid (oligohydramnios).
From the beginning of the 5th month of pregnancy (20 weeks of amenorrhea), a narrowing of the blood vessels in your baby's heart (constriction of the ductus arteriosus) may be observed. If treatment lasting several days is required during the 5th month of pregnancy (between 20 and 24 weeks' gestation), your doctor may recommend additional monitoring.
If you have taken this medicine while pregnant, tell your doctor immediately, so that suitable monitoring can be offered if necessary.
This medicine passes into breast milk. It is therefore not recommended during breast-feeding, regardless of the dose of aspirin taken.
Laspirin, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women and cause difficulties in becoming pregnant, reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Athletes
Sportsmen and women should be aware that this medicine contains an active substance which may produce a positive reaction in tests carried out during doping controls.
Driving vehicles and using machines
Paracetamol may cause dizziness or drowsiness. Patients should exercise caution in activities requiring alertness.
ACTRON effervescent tablets contain sodium.
3. HOW TO TAKE ACTRON, effervescent tablet?
Dosage
FOR ADULTS ONLY
Take at least 4 hours apart.
- Adults:
As a guide: 1 tablet, repeated if necessary after 4 hours. For more intense pain, 2 tablets per dose.
Do not exceed 7 tablets per day.
The maximum daily dosage of aspirin and paracetamol is 3 g.
- Elderly subjects:
As a guide: 1 tablet, repeated if necessary after 4 hours. For more intense pain, 2 tablets per dose.
Do not exceed 5 tablets per day.
The maximum daily dosage of aspirin and paracetamol is 2 g.
Method of administration
ORAL ROUTE
Drink immediately after complete dissolution of effervescent tablet in a glass of water.
Frequency of administration
Take at intervals throughout the day to avoid fever or pain peaks. They should be taken at least 4 hours apart.
In cases of severe kidney disease (severe renal failure), doses should be taken at least 8 hours apart.
Due to the presence of caffeine, avoid taking at the end of the day.
Duration of treatment
Do not exceed 3 days' treatment in case of fever, or 5 days' treatment in case of pain, without your doctor's advice.
DO NOT USE FOR PROLONGED PERIODS WITHOUT MEDICAL ADVICE.
If you have taken more ACTRON effervescent tablets than you should have
Consult your doctor or pharmacist immediately.
During treatment, you may experience ringing in the ears, a sensation of reduced hearing, headaches or dizziness: these are usually signs of aspirin overdose. IN THIS CASE, DISCONTINUE USE AND CONSULT YOUR DOCTOR.
In the event of paracetamol overdose, the liver is the main organ at risk. The overdose threshold may be lowered in people taking certain medications, drinking alcohol or who are malnourished.
In the event of accidental intoxication, SEEK MEDICAL ATTENTION IMMEDIATELY, even if no symptoms are apparent.
If you forget to take ACTRON, effervescent tablet
Not applicable.
If you stop taking ACTRON, effervescent tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
IMMEDIATELY STOP YOUR TREATMENT and inform your doctor in the following cases:
- Allergic reactions such as rash, severe skin reactions, asthma attacks, angioedema (facial hives with breathing difficulties),
- Hemorrhage(discharge of blood into the mouth or stools, black stools). The higher the dosage used, the more frequent this occurs.
- Unexplained abdominal pain, unusual constipation which may indicate narrowing of the intestine,
- Ringing in the ears, dizziness, sensation of reduced hearing, headaches: these usually indicate an overdose of aspirin.
Tell your doctor if you experience abdominal pain, nosebleeds or bleeding gums.
Possible excitation, insomnia and palpitations due to the presence of caffeine.
Stomach ulcers have been reported.
Abnormally low levels of certain blood elements (platelets) may occur, leading to nose or gum bleeding. This requires a blood test.
Nausea, vomiting, upset stomach, diarrhea, liver and kidney disease, dizziness, drowsiness, bronchospasm and asthma may also occur.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE ACTRON, effervescent tablet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ACTRON effervescent tablet contains
- The active ingredients are :
Acetylsalicylic acid.................................................................................................... 0.267 g
Paracetamol .................................................................................................................. 0.133 g
Caffeine anhydrous ............................................................................................................ 0.040 g
For one effervescent tablet
- The other excipient components are :
Citric acid, sodium bicarbonate
What ACTRON effervescent tablet is and what it contains
This medicine takes the form of an effervescent tablet. Boxes of 10, 20, 30 or 40
Not all presentations may be marketed.
Marketing authorization holder
BAYER HEALTHCARE SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE SAS
33 RUE DE LINDUSTRIE
74240 GAILLARD
Manufacturer
BAYER BITTERFELD GmbH
SALEGASTER CHAUSSEE 1
06803 GREPPIN
GERMANY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{MM/YYYY} {month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.