DAFALGAN Paracetamol 1000mg 8 Capsules is a nonprescription medicine indicated for the symptomatic treatment of mild to moderate pain and febrile states, for sale in pharmacies .
For warnings, precautions for use and contraindications, please consult the instructions for use of the drug without prescription DAFALGAN Paracetamol 1000mg 8 capsules.
Fever and pain are common ailments. They are not dangerous to their health; they are simply signs that the body is sending to let you know that something is wrong.
Paracetamol is an active substance which fights against fevers (antipyretic) and against pain (analgesic). Its main advantage is that it is very well tolerated by most organisms, including children. It can thus be used in 1st intention by almost everyone.
DAFALGAN 500 mg capsule is reserved for adults and children from 15 years old.
PARACETAMOL (DCI) 1000 MG. EXCIPIENTS: MAGNESIUM STEARATE; GELATINE; TITANIUM DIOXIDE (E 171); AZORUBINE (E 122); QSP 1 CAPSULE.
Allergy to paracetamol or other constituents; hepatocellular insufficiency. DAFALGAN capsule is a medicine containing paracetamol. It is essential to avoid overdose by checking the absence of paracetamol in the composition of other drugs. The maximum recommended dose should not be exceeded. Taking the drug DALFAGAN in capsule which is possible during pregnancy and lactation under normal conditions of use.
Blister 8 capsules of DAFALGAN Paracetamol 1000mg 8 capsules
Please note, the non-prescription drug DAFALGAN Paracetamol 1000mg 8 capsules 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 - Updated on : 02/01/2025
Paracetamol
You must always take this medicine exactly as instructed in this leaflet or 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 pain persists for more than 5 days, or fever for more than 3 days, or if there are any other signs of insufficient efficacy.
What does this leaflet contain?
1. What is DAFALGAN 1000 mg, capsule and what is it used for?
2. What do I need to know before taking DAFALGAN 1000 mg, capsule?
3. How should DAFALGAN 1000 mg capsule be taken?
4. What are the possible side effects?
5. How should DAFALGAN 1000 mg capsule be stored?
6. Package contents and other information.
1. WHAT IS DAFALGAN 1000 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER ANALGESICS and ANTIPYRETIC-ANILIDES - ATC code: N02BE01.
DAFALGAN 1000 mg, capsule contains paracetamol. Paracetamol is an analgesic (pain reliever) and an antipyretic (fever reducer).
It is indicated for adults and children weighing 50 kg or more (around 15 years of age) to reduce fever and/or relieve mild to moderate pain (e.g. headaches, flu-like symptoms, toothache, aches and pains, painful menstruation, painful attacks of arthrosis).
Carefully read "Dosage" in section 3.
For children under 50 kg, other paracetamol presentations are available: ask your doctor or pharmacist for advice.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DAFALGAN 1000 mg, capsule?
Never take DAFALGAN 1000 mg, capsule:
- if you are allergic to paracetamol or any of the other ingredients of this medicine, as listed in section 6.
- if you have severe liver disease.
If in doubt, ask your doctor or pharmacist for advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking DAFALGAN 1000 mg, capsule:.
- if you are an adult weighing less than 50 kg,
- if you have kidney or liver disease,
- if you are elderly,
- if you regularly drink alcohol or have recently stopped drinking alcohol,
- in cases of chronic malnutrition, fasting, emaciation, anorexia or cachexia (low reserves or hepatic glutathione deficiency),
- in cases of dehydration,
- in case of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (may lead to hemolytic anemia),
- in Gilbert's syndrome (non-hemolytic familial jaundice).
In the event of acute viral hepatitis, discontinue treatment and consult your doctor.
Long-term, incorrect and/or high-dose use of this drug in patients with chronic headaches may cause headaches to develop or worsen. Do not increase your dose of painkillers, but consult your doctor.
During treatment with DAFALGAN 1000 mg, capsule, inform your doctor immediately:
If you have any serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you are malnourished, chronically alcoholic or also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients who regularly take paracetamol for a prolonged period or who take paracetamol in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
Children and adolescents
In children being treated with paracetamol, the combination with another fever-reducing drug (antipyretic) is justified only if it is effective. The combination should only be initiated and monitored by a physician.
Other medicines and DAFALGAN 1000 mg, capsule
Inform your doctor or your pharmacist if you are taking, have recently taken or could be taking any other medicine, including one obtained without a prescription.
This medicine contains paracetamol. Other medicines contain paracetamol.
Check that you are not taking any other medicines containing paracetamol, including medicines obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose.
Consult your doctor or your pharmacist :
- if you are taking any medicines that are potentially toxic to the liver. The toxicity of paracetamol may be increased.
- if you or your child have been prescribed a uric acid or blood sugar test, as this medicine may alter the results.
- coagulation (oral anticoagulants ). A doses, DAFALGAN 1000 mg, capsule may increase the action of your anticoagulant. If necessary, your doctor will adjust the dosage of your anticoagulant.
- if you are taking flucloxacillin (antibiotic), as there is a serious risk of blood and fluid abnormalities (known as metabolic acidosis), which must be treated as an emergency (see section 2).
DAFALGAN 1000 mg, capsule with alcohol
The consumption of alcoholic beverages during le treatment isnot recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breast-feeding
If required, this drug may be used during pregnancy and lactation.
You should use the lowest possible dose to relieve pain and/or fever, and take it for the shortest possible time. Contact your doctor if the pain and/or fever do not subside, or if you need to take the medication more frequently.
Fertility
It is possible that paracetamol may impair fertility in women, reversible on discontinuation of treatment.
Driving and use of machinery
Paracetamol has no or negligible effect on the ability to drive vehicles and use machines.
DAFALGAN 1000 mg, capsule contains sodium and zorubin-carmoisine (E122).
This drug contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE DAFALGAN 1000 mg, capsule?
Dosage
Warning : this presentation contains 1000 mg (1 g) of paracetamol per capsule: do not take 2 capsules at a time.
For adults and children weighing 50 kg or more (approx. 15 years).
Use the lowest effective dose for the shortest possible duration. Use the 1000 mg dose for pain and/or fever not relieved by a 500 mg dose of paracetamol.
Dosage depends on weight; age is given for information only. If you don't know your child's weight, you should weigh him/her to determine the most appropriate paracetamol dosage. The recommended daily dose of paracetamol should be divided into several doses, without exceeding the maximum indicated in the table below.
|
Weight (approximateage ) |
Maximum dose per dose |
Interval between two doses |
Maximum doseper day |
|
Adults and children from 50 kg (approximately 15 years) |
1000 mg or 1 g (1 capsule)
|
4 hoursminimum |
3000 mg or 3 g (3 capsules) |
Caution: To avoid the risk of overdosing, check that paracetamol is not included in the composition of other medicines, including over-the-counter products. Respect the maximum recommended dose or the dose prescribed by your doctor : a higher dose will not relieve your pain any more, but may have serious consequences for your liver.
Adults weighing less than 50 kg, chronic malnutrition, dehydration, the elderly: ask your doctor or pharmacist for advice.
Hepatic insufficiency, chronic alcoholism and Gilbert's syndrome: never exceed 2000 mg (2 g) paracetamol per day.
Renal insufficiency: Dosage must be adapted to the degree of renal insufficiency. Consult your doctor before taking this medicine.
If you feel that the effect of this medicine is too strong or too weak, do not exceed the dose. Ask your doctor or pharmacist for advice.
Method of administration
Take by mouth.
Capsules should be swallowed whole with a glass of water.
Duration of treatment
Frequent or prolonged use without medical supervision is not recommended.
Unless medically indicated, treatment duration is limited to 5 days for pain and 3 days for fever.
If symptoms persist or worsen beyond this period, or if new symptoms appear, discontinue treatment and consult your doctor immediately.
If you have taken more DAFALGAN 1000 mg, capsule than you should have
Stop treatment and consult immediately your doctor or seek medical advice immediately.
Overdose can be fatal.
Within the first 24 hours, the main symptoms of toxicity are nausea, vomiting, paleness, malaise, sweating, loss of appetite and abdominal pain.
If you forget to take DAFALGAN 1000 mg, capsule:
Do not take a double dose to make up for the single dose you forgot to take.
If you stop taking DAFALGAN 1000 mg, capsule
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Rare adverse reactions: may affect up to 1 in 1,000 people.
- skin redness, rash, urticaria. Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- blood spots on the skin (purpura). Stop treatment immediately and inform your doctor. Treatment may be reintroduced only on the advice of your doctor.
- diarrhea, abdominal pain.
Very rare side effects: may affect up to 1 in 10,000 people.
- severe skin reactions. Treatment should be stopped immediately, your doctor informed, and paracetamol-containing drugs should never be taken again.
- biological changes requiring blood tests: abnormally low levels of certain white blood cells (leukopenia, neutropenia) or of certain blood cells such as platelets (thrombocytopenia), which may lead to nose or gum bleeding. In this case, consult a physician.
Undesirable effects of undetermined frequency frequency cannot be estimated from available data
- skin rash or redness, or allergic reaction manifested by sudden swelling of the face and neck which may cause difficulty in breathing (angioedema), or by sudden malaise with a drop in blood pressure (anaphylactic shock). Stop taking paracetamol immediately, tell your doctor and never take paracetamol again.
- Rounded, itchy, red patches of rash with a burning sensation, leaving coloured spots which may reappear in the same places if the drug is taken again (fixed erythema pigmentosa), difficulty in breathing (bronchospasm), particularly if you have already experienced difficulty in breathing with other drugs such as non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, consult a physician.
- a serious condition which can cause the blood to become more acidic (known as metabolic acidosis), in patients with serious illnesses taking paracetamol (see section 2).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 DAFALGAN 1000 mg, capsule?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°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 DAFALGAN 1000 mg capsule contains
- The active substance is :
Paracetamol................................................................................................................ 1000 mg
For one capsule
- The other ingredients are :
Hydroxypropylcellulose, Croscarmellose sodium*, Glycerol dibehenate, Magnesium stearate, Colloidal hydrophobic silica, Film-forming agent. *See section 2.
Film-forming agent: Hypromellose, hydroxypropyl cellulose, polyethylene glycol.
Capsule composition: Gelatin, azorubine-carmoisine (E122)*, yellow iron oxide and red iron oxide. *See section 2.
What DAFALGAN 1000 mg capsule is and what it contains
This medicine comes in the form of a red capsule. Box of 8.
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or
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Drug 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]
{month YYYY}
Detailed information on this drug is available on the ANSM (France) website.
Advice d'd'éducation sanitaire
WHAT TO DO IN CASE OF FEVER :
The normalbodytemperature is variable d'une personne à l'autre comprise entre 36,5°C et 37,5°C. A rise in temperature above 38°C canbe considered a fever ,but it isinadvisable to treat fever with a medication below 38.5°C.
This medication is reserved for l' adultand for l'enfant à de 50 kg (environ 15 ans).
If the troublesthat fever causes are toobothersome, you can take this medication whichcontains paracetamol respecting the dosages indicated.
To avoid any risk of dehydration, remember to drink frequently.
With this medication, the fever shoulddrop rapidly. Nevertheless :
- ifother unusual signsappear,
- if fever persists formore than 3 days or if it worsens,
- if headaches become violent, or if vomiting ,
CONSULT YOUR DOCTOR IMMEDIATELY.
QHAT TODO IN CASEOF PAIN :
Theintensity of theperception of the pain and the ability to it resist vary fromone person to another.
- If there is no improvement after 5 days treatment,
- if the pain is violent, unexpected and occurs de defaçon brutale (notamment une painforte dans lapoitrine and/or aucontraire revient régulièrement,
- if it isaccompanied byother signs such as a state of malaise general, a fever, unusual swelling of the painful area, a decrease of the strength in a limb,
- if it wakesyouup the night,
CONSULT YOUR DOCTORIMMEDIATELY.
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