French pharmacy
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French pharmacy
ALKA-SELTZER 324MG aspirin analgesic
For the warnings, the precautions for use and the contraindications, please consult the instructions for use of ALKA-SELTZER 324MG analgesic aspirin.
Acetylsalicylic acid is better known by the term aspirin, the first brand under which it was marketed. Aspirin has antipyretic, analgesic, anti-inflammatory and anticoagulant properties . It is used to lower fever, reduce pain, reduce inflammation or promote blood circulation.
Aspirin (i.e. acetylsalicylic acid) first plays an anti-inflammatory role. The mode of action of aspirin is based on its ability to regulate the secretion of prostaglandins, these substances which are secreted when the body is attacked. By controlling these prostaglandins, aspirin will on the one hand contain inflammation but also lower fever and decrease pain . The action of aspirin takes place as soon as it is absorbed in the stomach, the molecules passing through the blood and then spreading throughout the body.
Alka-Seltzer contains aspirin . It is indicated in case of pain and / or fever such as headache, flu-like conditions, dental pain, body aches, in adults and children from 20 kg (approximately 6 years).
The aspirin dosage depends on the weight of the child; ages are given for information.
The recommended daily dose of aspirin is approximately 60 mg / kg / day, to be divided into 4 or 6 doses, i.e. approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.
IN CASE OF DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
The active substance is :
Acetylsalicylic acid 324 mg
For an effervescent tablet.
The other components are :
Sodium bicarbonate, sodium carbonate, anhydrous citric acid.
Alka-Seltzer comes in tablet form.
Please note, the ALKA-SELTZER 324MG aspirin pain reliever is not a product like any other. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 26/07/2017
ALKA SELTZER 324 mg, effervescent tablet
Acetylsalicylic acid
You should always take this medication exactly as prescribed by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· 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 experience no improvement or feel less well after 5 days in case of pain or 3 days in case of fever.
1. What is ALKA SELTZER 324 mg, effervescent tablet and in which cases it is used?
2. What should I know before taking ALKA SELTZER 324 mg, effervescent tablet?
3. How to take ALKA SELTZER 324 mg, effervescent tablet?
4. What are the possible side effects?
5. How to store ALKA SELTZER 324 mg, effervescent tablet?
6. Package contents and other information.
1. WHAT IS ALKA SELTZER 324 mg, effervescent tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group-ATC code: OTHER ANALGESICS AND ANTIPYRETICS N02BA01
This medication is an analgesic (it calms the pain) and an antipyretic (it lowers the fever).
This medicine contains aspirin. It is indicated for pain and / or fever such as headaches, flu-like conditions, dental pain, body aches, in adults and children from 20 kg (about 6 years).
For children of different weights or ages, there are other aspirin presentations: ask your doctor or pharmacist for advice.
You should contact your doctor if you experience no improvement or feel less well after 5 days in case of pain or 3 days in case of fever.
2. BEFORE YOU TAKE ALKA SELTZER 324 mg, effervescent tablet?
Never take ALKA SELTZER 324 mg, effervescent tablet:
· if you are allergic to the active substance (aspirin), or to a related drug (including non-steroidal anti-inflammatory drugs) or any of the other ingredients of this medication mentioned in section 6.
· if you have a history of asthma caused by the administration of aspirin or a related drug (including non-steroidal anti-inflammatory drugs),
· if you are over 5 months pregnant (24 weeks of amenorrhea) for doses above 100 mg per day
· if you have an ulcer of the stomach and the evolving duodenum,
· if you have a hemorrhagic disease or risk of bleeding,
· if you have a serious liver disease,
· if you have a serious kidney disease,
· if you are suffering from a serious heart disease,
· if you are taking methotrexate therapy at doses greater than 20 mg / week when using aspirin at high doses as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g / day) rheumatic conditions or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily)
· if you are taking oral anticoagulant therapy, if you have a history of peptic ulcer disease, and when aspirin is used as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g / day) in particular in the treatment of rheumatic conditions or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily)
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor or pharmacist before taking ALKA SELTZER 324 mg, effervescent tablet.
Special warnings
· In case of combination with other medicines, to avoid a risk of overdose, check the absence of aspirin in the composition of other medicines.
· In case of headaches occurring during prolonged use and with high doses of aspirin, you should not increase the doses but take the advice of your doctor or pharmacist.
The regular use of analgesics, in particular several analgesics in combination, can lead to kidney damage.
· Reye syndromes (a rare but very severe disease mainly associated with neurological disorders and liver damage) have been observed in children with viral diseases and receiving aspirin.
Consequently:
o in the event of a viral illness such as chickenpox or an episode of flu-like illness: do not administer aspirin to a child without the advice of a doctor,
o in the event of a conscious or behavioral disorder and vomiting in a child taking aspirin, tell a doctor immediately.
· Aspirin should only be used after advice from your doctor:
o in the case of G6PD (red blood cell inheritance) deficiency, as high doses of aspirin may cause hemolysis (destruction of red blood cells),
o in the case of a history of stomach or duodenal ulcer, digestive hemorrhage or gastritis,
o in case of kidney or liver disease,
o in asthma: the onset of an asthma attack in some subjects may be related to an allergy to nonsteroidal anti-inflammatory drugs or aspirin. In this case, this drug is contraindicated,
o in case of abundant rules
o in case of treatment by:
§ Oral anticoagulants, when aspirin is used at high doses in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily) and in the absence of a history of gastrointestinal ulcer, duodenal
§ Oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in case of a history of peptic ulcer disease,
§ Non-steroidal anti-inflammatory drugs, when aspirin is used at high doses as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g per day), especially in the treatment of rheumatic diseases or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day),
§ Glucocorticoids (except hydrocortisone as a substitute therapy), when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day), particularly in the treatment of rheumatic diseases,
§ Heparins used in curative doses and / or in patients over 65 years of age, when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day) treatment of rheumatic conditions, or in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g per day
§ The drugs used in the treatment of gout,
§ Clopidogrel,
§ Pemetrexed in subjects with low to moderate renal function,
§ Ticlopidine
· During treatment: in the case of gastrointestinal haemorrhage (blood rejection through the mouth, presence of blood in the stool, stool coloration in black), STOP TREATMENT AND IMMEDIATELY CONTACT AN EMERGENCY MEDICAL OR MEDICAL SERVICE .
· This medicine is reserved for adults and children from 20 kg (about 6 years). However, it is necessary to remember that if your child is under 1 month, medical advice is essential before using aspirin.
This medicine contains aspirin.
You or your child should not take this medication with other medicines containing aspirin and / or non-steroidal anti-inflammatory drugs.
Read the leaflets for other medicines you or your child has taken to ensure that there is no aspirin and / or nonsteroidal anti-inflammatory drugs.
Precautions for use
Pain or fever:
This dosage is suitable for adults and children from 20 kg (about 6 years).
For children under 20 kg (about 6 years), take a more suitable dosage
Ask your doctor or pharmacist for advice.
· If the pain persists more than 5 days or fever more than 3 days , or if there is insufficient efficacy or any other signs, do not continue treatment without your doctor's advice.
· Aspirin increases the risk of haemorrhage at very low doses even when the dose is several days old. PREVENT YOUR DOCTOR, THE SURGER, THE ANESTHESIST OR YOUR DENTIST, in case a surgical gesture, even minor, is envisaged.
· Aspirin alters uricemia (amount of uric acid in the blood).
· This medicine contains sodium. This medicine contains 477 mg of sodium per tablet. To be taken into account in patients controlling their sodium dietary intake.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other medicines and ALKA SELTZER 324 mg, effervescent tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
When aspirin is used at high doses as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g daily), particularly in the treatment of rheumatic conditions or in the treatment of fever or pain (≥ 500 mg per dosage and / or <3 g daily), this medicinal product MUST NOT BE USED in combination:
· With methotrexate used at doses above 20 mg / week,
· With oral anticoagulants and a history of peptic ulcer disease,
This medication MUST BE AVOIDED in association with:
· Oral anticoagulants, when aspirin is used at high doses in the treatment of fever or pain (≥ 500 mg per dose and / or <3 g daily) and in the absence of a history of gastrointestinal ulcer, duodenal
· Oral anticoagulants, when aspirin is used in low doses as an antiplatelet agent (50 to 375 mg per day) and in case of a history of peptic ulcer disease,
· Nonsteroidal anti-inflammatory drugs, when aspirin is used in high doses as anti-inflammatory drugs (≥ 1 g per dose and / or ≥ 3 g per day), especially in the treatment of rheumatic diseases, fever or pain ( ≥ 500 mg per dose and / or <3 g per day),
· Glucocorticoids (except hydrocortisone as an alternative treatment), when aspirin is used as a high dose anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day), particularly in the treatment of rheumatic conditions,
· Heparins used in curative doses and / or in patients over 65 years of age, when aspirin is used at high doses as an anti-inflammatory drug (≥ 1 g per dose and / or ≥ 3 g per day) treatment of rheumatic conditions, fever or pain (≥ 500 mg per dose and / or <3 g daily)
· The drugs used in the treatment of gout,
· Clopidogrel,
· Pemetrexed in subjects with low to moderate renal function,
· Ticlopidine (see section 2 "Special warnings").
ALKA SELTZER 324 mg, effervescent tablet with food, drink and alcohol
Not applicable.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medication is for the child from 20 kg (about 6 years). However, when used in exceptional circumstances in women of childbearing age, the following points should be noted:
Low doses, less than 100 mg daily:
Low doses of acetylsalicylic acid of less than 100 mg per day may be prescribed in exceptional circumstances requiring specialized surveillance.
For doses above 100 mg per day
At these doses, and unless absolutely necessary, acetylsalicylic acid should not be prescribed during the first two trimesters of pregnancy. If acetylsalicylic acid is administered to a woman wishing to be pregnant or pregnant within six months, the dose should be as low as possible and the treatment period should be as short as possible.
At doses above 100 mg per day, acetylsalicylic acid is contraindicated beyond 5 months of pregnancy (24 weeks of amenorrhoea). You should NOT take this medication during the third trimester of pregnancy because its effects on your child can have serious consequences, especially on a cardiopulmonary and renal plan, even with a single dose.
If you are taking this medication while you are pregnant, talk to your obstetrician gynecologist for appropriate monitoring.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
Aspirin passes into breast milk, this medication is not recommended during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
ALKA SELTZER 324 mg, effervescent tablet contains sodium.
3. HOW TO TAKE ALKA SELTZER 324 Mg, Effervescent Tablet?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist or in case of doubt.
In case of pain, in case of fever:
Dosage
This presentation is reserved for the adult and the child from 20 kg (approximately from 6 years).
The dosage of aspirin depends on the weight of the child; the ages are mentioned for information purposes.
If you do not know the weight of the child, weigh it to give it the best dose.
Aspirin exists in many dosages, allowing the treatment to be adapted to the weight of each child.
The recommended daily dose of aspirin is approximately 60 mg / kg / day, divided into 4 or 6 doses, approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.
· For children weighing 20 to 26 kg (about 6 to 10 years), the dosage is 1 unit per dose, to be renewed if necessary after 6 hours, but not more than 4 units per day.
· For children weighing 27 to 36 kg (about 8 to 12 years), the dosage is 1 unit per dose, to be renewed if necessary after 4 hours, but not more than 6 units per day.
· For children weighing 37 to 50 kg (approximately 11 to 15 years), the dosage is 2 units per dose, to be renewed if necessary after 6 hours, but not more than 8 units per day.
· For adults and children weighing more than 50 kg (from about 15 years of age): the maximum recommended daily dose is 3 g of aspirin, ie 9 units per day
The usual dosage is 2 units at 324 mg, to be renewed if necessary after 4 hours minimum, without exceeding 9 units per day.
· For the elderly :
The maximum recommended daily dose is 2 g of aspirin, 6 units per day. The usual dosage is 1 unit to 324 mg, to be renewed if necessary after 4 hours minimum, without exceeding 6 units per day .
IN CASE OF DOUBT, ASK FOR ADVICE TO YOUR DOCTOR OR YOUR PHARMACIST.
Method and route of administration
Oral use.
Drink immediately after dissolving the effervescent tablet in a large glass of water.
Frequency of Administration
Systematic catches help to avoid oscillations of pain or fever.
In adults , they should be regularly spaced at least 4 hours apart .
In children, they should be evenly spaced, including at night , preferably 6 hours and at least 4 hours: follow the dosage specified above.
Duration of treatment
In case of pain, in case of fever:
The duration of use is limited:
· at 5 days in case of pain,
· at 3 days in case of fever.
If the pain persists for more than 5 days or fever for more than 3 days or if it worsens, do not continue treatment without your doctor's advice (see section "Precautions for use").
If you take more ALKA SELTZER 324 mg, effervescent tablet than you should
During the course of the treatment, it is possible that there may be ringing in the ears, a feeling of hearing loss, headache, dizziness, usually as an overdose of aspirin.
YOU MUST INTERRUPT YOUR TREATMENT OR TREATMENT OF YOUR CHILD AND PREVENT A DOCTOR.
In case of accidental poisoning (especially frequent in young children), CONSULT IMMEDIATELY A DOCTOR.
If you forget to take ALKA SELTZER 324 mg, effervescent tablet
If you stop taking ALKA SELTZER 324 mg, effervescent tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Your treatment should be discontinued immediately and your doctor should be advised if:
o digestive haemorrhages (see section 4.4). These are all the more frequent because the dosage used is high,
o allergic reactions such as rash, asthma attack, angioedema (facial urticaria with respiratory discomfort),
o headache, dizziness: these signs usually reflect an overdose of aspirin,
o Reye syndrome (onset of consciousness or behavioral disorder and vomiting) in a child with a viral disease and receiving aspirin (see section 4.4).
· Tell your doctor if you have abdominal pain, nosebleeds or gums.
Cases of stomach ulcers have been reported.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ALKA SELTZER 324 mg, effervescent tablet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ALKA SELTZER 324 mg contains, effervescent tablet
· The active substance is:
Acetylsalicylic acid................................................ .................................................. 324 mg
For an effervescent tablet.
· The other components are:
Sodium bicarbonate, sodium carbonate, anhydrous citric acid.
What is ALKA SELTZER 324 mg, effervescent tablet and contents of the pack
Effervescent tablet. Box 2.10, 14, 20, 24, 36 or 40.
Marketing Authorization Holder
220 AVENUE OF RESEARCH
59120 LOOS
Marketing Authorization Operator
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
OT GREPPIN
SALEGASTER CHAUSSEE 1
06803 BITTERFELD-WOLFEN
GERMANY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Health education councils:
"WHAT TO DO IN THE EVENT OF FEVER":
A child is considered to have a fever when the temperature exceeds 38 ° C.
Fever is a natural and frequent reaction of the body to fight infections, it is very rare that it is the only sign of a serious illness or that it leads to complications.
What has to be done:
Generally it is only above 38.5 ° C that treatment is envisaged; however this should not be systematic, especially if the fever is well supported by the child.
1) Before giving a medication for fever, always:
· remove blankets and superfluous layers of clothing,
· present often to drink to the child,
· do not overheat the room (about 18-20 ° C).
These 3 simple measures are sufficient in many cases to lower the fever.
Other measures are available (warm baths, ice packs, wet wraps ...), they are not necessarily more effective and will only be considered if they do not increase the child's illness.
2) Secondly, the child may be given a fever medication (medication called antipyretic).
Read carefully section 2 of the leaflet "INFORMATION REQUIRED BEFORE TAKING ALKA SELTZER 324 mg, effervescent tablet".
How should a fever medicine be used?
· respect the doses and delays between catches,
· give only one medication (do not combine or alter medications differently without medical advice),
· check that the child does not otherwise receive the same medication in another form (syrup, effervescent tablet, suppositories ...) or under another brand name.
If fever persists for several days, if new signs (especially stiffness of the neck, diarrhea, vomiting ...) or fever is badly supported (child slaughtered, losing its reactivity ...), you do not should not hesitate to consult a doctor.
"WHAT TO DO IF PAIN":
· In the absence of improvement after 5 days of treatment,
· If the pain returns regularly,
· If they are accompanied by fever,
· If they awaken your child at night,
CONSULT A DOCTOR.
Analgesic and antipyretic
aspirin
. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
ALKA-SELTZER: effervescent tablet (white); box of 20.
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ALKA-SELTZER: effervescent tablet (white); box of 40.
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Laboratory
| p cp | |
| Acetylsalicylic acid (aspirin) | 324 mg |
| Sodium | 477 mg |
Usual dosage:
