DAFALGANCaps 1000 mg, 8 capsules, is an over-the-counter medication indicated for the symptomatic treatment of mild to moderate pain and fever, available at pharmacies.
For information on warnings, precautions, and contraindications, please refer to the package insert for the over-the-counter medication DAFALGANCaps 1000 mg, 8 capsules, UPSA
DAFALGANCaps 1000 mg is an easy-to-swallow capsule formulation designed for the symptomatic treatment of mild to moderate pain and fever. When the body sends signals such as pain or fever, it is a way of indicating that an imbalance is occurring.
Paracetamol, the active ingredient in DAFALGANCaps 1000mg, is known for its antipyretic and analgesic properties. It provides a way to manage these symptoms and is generally well tolerated by many people, including children, making it a preferred choice for a wide range of individuals. Please note that it is important to always use DAFALGANCaps 1000 mg according to the instructions. This medication is intended to treat symptoms, not the underlying causes of pain or fever. If symptoms persist, it is advisable to consult a healthcare professional.
Available online at our pharmacy, DAFALGANCaps 1000mg offers you a convenient and easy way to access effective symptomatic relief from pain and fever. Discover DAFALGANCaps 1000mg, your effective solution for pain and fever. With the active ingredient acetaminophen, these capsules are a powerful analgesic and antipyretic, designed to alleviate your discomfort and restore your well-being. Used to relieve mild to moderate pain, DAFALGANCaps 1000 mg provides fast and effective relief from headaches, toothaches, aches and pains, and other symptoms associated with the flu or a cold. It is also effective at reducing fever, providing you with welcome relief when you’re sick.
DAFALGANCaps 1000 mg capsules are intended for adults and children 15 years of age and older.
If symptoms persist, you mayalternate doses with an oralanti-inflammatory medication.
Precautions and Contraindications
Per capsule: Paracetamol 1000 mg
Excipient with known effect: azorubine-carmoisine (E122).
Packaging
DAFALGANCaps 1000 mg is available in a box containing 8 capsules, at the best price in our online organic pharmacy.
Warnings Regarding Pain Relievers
Please note: The over-the-counter medication DAFALGANCaps 1000 mg (8 capsules) is not like other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
There are several natural methods for relieving a fever. Here are a few suggestions:
Keep in mind that while these methods can help relieve a fever, they do not treat the underlying cause of the fever. If your fever persists for several days, or if it is accompanied by other serious symptoms, it’s important to see a healthcare professional.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on : 07/03/2025
Paracetamol
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 DAFALGANCAPS 1000 mg, capsule and what is it used for?
2. What do I need to know before taking DAFALGANCAPS 1000 mg, capsule?
3. How do I take DAFALGANCAPS 1000 mg, capsule?
4. What are the possible side effects?
5. How do I keep DAFALGANCAPS 1000 mg, capsule?
6. Package contents and other information.
1. WHAT IS DAFALGANCAPS 1000 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER ANALGESICS and ANTIPYRETIC-ANILIDES
ATC code: N02BE01.
This medicine contains paracetamol: an analgesic (pain reliever) and an antipyretic (fever reducer).
It is indicated in cases of pain and/or fever, such as headaches, flu-like symptoms, toothache, aches and pains, and painful menstruation.
This presentation is indicated for adults and children weighing 50 kg or more (aged 15 and over). Read the "Dosage" section of the package leaflet carefully.
For children weighing less than 50 kg (approx. 15 years), other paracetamol presentations are available: ask your doctor or pharmacist for advice.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING DAFALGANCAPS 1000 mg, capsule?
Never take DAFALGANCAPS 1000 mg, capsule:
- if you are allergic to the active substance or to 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 DAFALGANCAPS 1000 mg, capsule.
In the event of overdose or if you take too much by mistake, consult your doctor immediately.
This medicine contains paracetamol. Other medicines contain paracetamol.
Check that you are not taking any other medicines containing paracetamol, including those obtained without a prescription.
Do not combine them, so as not to exceed the recommended daily dose (see section 3 "How to take DAFALGANCAPS 1000 mg, capsule").
- If pain persists for more than 5 days or fever for more than 3 days, or in the event of insufficient efficacy or any other sign, do not continue treatment without consulting your doctor.
- Long-term use, incorrect use and/or high doses of this medicine in patients with chronic headaches may cause or aggravate headaches. Do not increase your dose of analgesics, but consult your doctor.
Tell your doctor or pharmacist before taking this medicine if any of the following apply to you:
- If you are an adult and weigh less than 50 kg,
- If your liver function is slightly or moderately impaired,
- If you have renal insufficiency,
- If you have Gilbert's syndrome (familial non-hemolytic jaundice),
- Or if you regularly consume alcohol, or have recently stopped consuming alcohol,
- If you have nutritional problems (chronic malnutrition) (low hepatic glutathione reserves), or if you suffer from cachexia (severe weight loss),
- In case of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (may lead to hemolytic anemia),
- If you are receiving concomitant treatment with drugs affecting liver function (e.g. potentially hepatotoxic drugs or cytochrome P450 enzyme inducers such as phenobarbital, phenytoin, carbamazepine, topiramate, rifampin),
- If you are dehydrated,
- if you are elderly,
- Talk to your doctor if you are suffering from acute viral hepatitis, or if you discover that you are suffering from acute viral hepatitis during treatment with DAFALGANCAPS 1000 mg, capsule. Your doctor may suspend your treatment.
During treatment with DAFALGANCAPS 1000 mg, capsule, inform your doctor immediately:
- If you have any serious medical conditions, 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.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Children and adolescents
In children and adolescents treated with paracetamol, the combination of another fever-reducing drug (antipyretic) is not justified unless it is effective. In the event of persistent fever, medical advice is recommended.
Other drugs and DAFALGANCAPS 1000 mg, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Drugs which may alter the effects of DAFALGANCAPS 1000 mg, capsule:
- probenecid (a drug used to treat gout). A reduction in the dose of DAFALGANCAPS 1000 mg, capsule may be necessary, as probenecid increases the concentration of paracetamol in the blood,
- phenobarbital, phenytoin, carbamazepine, primidone (drugs used to treat epilepsy) and rifampicin (drug used to treat tuberculosis). Use of these drugs with paracetamol may cause liver damage,
- AZT (zidovudine, a drug used to treat HIV infection). The use of paracetamol with AZT may reduce the number of white blood cells (neutropenia). Therefore, DAFALGANCAPS 1000 mg, capsule, should not be taken at the same time as zidovudine, except on medical advice,
- metoclopramide (a drug used to treat nausea) and other drugs that accelerate stomach emptying. These drugs may increase absorption and accelerate the onset of the effect of DAFALGANCAPS 1000 mg, capsule,
- Drugs that slow stomach emptying. These drugs may delay the absorption and effect of DAFALGANCAPS 1000 mg, capsule,
- cholestyramine (a drug used to reduce high blood lipid levels). This medicine may reduce absorption and delay the effect of DAFALGANCAPS 1000 mg, capsule. Therefore, do not take cholestyramine within one hour of taking paracetamol,
- oral anticoagulants, in particular warfarin (blood-thinning drugs). Repeated use of paracetamol for more than a week increases the risk of bleeding. Long-term use of paracetamol should only be undertaken on medical advice. Occasional use of paracetamol has no significant effect on the risk of bleeding,
- aspirin (or acetylsalicylic acid) and salicylamide (drugs used to treat pain and fever) and chloramphenicol (antibiotic agent). Daspirin, salicylamide and chloramphenicol doses may need to be reduced under the supervision of a physician,
- flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (known as metabolic acidosis), which must be treated as an emergency (see section 2).
Effects of DAFALGANCAPS 1000 mgon blood tests:
If your doctor prescribes a uric acid or blood sugar test, tell him or her that you or your child is taking this medicine.
DAFALGANCAPS 1000 mg, capsule with food, drink and alcohol
Alcohol should not be consumed during treatment.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
If necessary, DAFALGANCAPS 1000 mg, capsule 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.
It is possible that paracetamol may impair fertility in women, reversible on discontinuation of treatment.
Driving vehicles and using machines
Paracetamol has no or negligible effect on the ability to drive vehicles and use machines.
DAFALGANCAPS 1000 mg, capsule contains sodium and zorubin-carmoisine (E122).
This drug contains less than 1 mmol (23 mg) sodium per capsule, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE DAFALGANCAPS 1000 mg, capsule?
CAUTION: this presentation contains 1000 mg (1g) of paracetamol per capsule: do not take 2 capsules at the same time.
Dosage
This presentation is indicated for adults and children weighing 50 kg or more (from around 15 years of age).
The lowest effective dose should generally be used, for the shortest possible duration.
|
Weight (approximate age) |
Dose per dose |
Interval of administration |
Maximum dose per day |
|
At from 50 kg (from d 15 years) |
1 capsule of 1000 mg |
4 hours minimum |
3 capsules of 1000 mg perday |
Never exceed 3000 mg paracetamol per day (3 x 1000 mg capsules), 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.
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 doses.
If you feel that the effect of DAFALGANCAPS 1000 mg, capsule is too strong or too weak, consult your doctor or pharmacist.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Pediatric population
Children weighing 50 kg or more (aged 15 and over): see dosage above.
Children weighing less than 50 kg (under 15 years): other forms of this medicine may be used in children under 15: ask your doctor or pharmacist.
Duration of treatment
Unless medically indicated, the duration of treatment is limited to :
- 5days in case of pain,
- 3days in case of fever.
If pain persists for more than 5 days or fever for more than 3 days, if they worsen or if new symptoms appear, do not continue treatment without consulting your doctor.
Adults weighing less than 50 kg, the elderly, those suffering from malnutrition or dehydration: ask your doctor or pharmacist for advice before taking this medicine.
Patients with hepatic insufficiency, chronic alcoholism, Gilbert's syndrome (non-hemolytic familial jaundice): Never exceed 2000 mg paracetamol per day (2 capsules). Check with your doctor or pharmacist if in doubt.
Patients with renal insufficiency: dosage must be adjusted by your doctor. Consult your doctor before taking this medicine.
Method of administration
Oral administration.
Capsules should be swallowed whole with a drink (e.g. water, milk, fruit juice).
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
If you have taken more DAFALGANCAPS 1000 mg, capsule than you should have :
Stop use and consult your doctor immediately immediately consult your doctor or emergency physician.
Overdose can be fatal.
Within the first 24 hours, the main symptoms of intoxication are: nausea, vomiting, paleness, malaise, sweating, loss of appetite, abdominal pain.
If you forget to take DAFALGANCAPS 1000 mg, capsule:
Do not take a double dose to make up for the single dose you forgot to take.
If you stop taking DAFALGANCAPS 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 consult your doctor before taking any medication containing paracetamol.
- diarrhea, abdominal pain.
Very rare adverse reactions: may affect up to 1 in 10,000 people.
- severe skin reactions. Treatment must be stopped immediately, your doctor must be informed and paracetamol-containing drugs must never be taken again.
- biological changes requiring a blood test: abnormally low levels of certain white blood cells or blood cells such as platelets, which can lead to nosebleeds or bleeding from the gums. In this case, consult a doctor.
Undetermined frequency Frequency cannot be estimated on the basis of available data.
- redness or allergic reactions which may manifest as sudden swelling of the face and neck, or sudden malaise with a drop in blood pressure. Treatment should be stopped immediately, your doctor informed and you should never take paracetamol-containing medicines again.
- Excessive (and prolonged) contraction of airway muscles, causing difficulty in breathing.
- red-purple spots on the skin which reappear in the same place.
- 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 or pharmacist. This also applies to any side effect 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 are helping to provide more information on drug safety.
5. HOW DO I USE DAFALGANCAPS 1000 mg, capsule?
Keep out of sight and reach of children.
Store at temperatures not exceeding 30°C.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DAFALGANCAPS 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.
Composition of the 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 is DAFALGANCAPS 1000 mg, capsule and what does it contain?
This medicine comes in the form of a red capsule. Boxes of 8, 16, 24, 32, 40, 48 or 56.
Not all presentations may be marketed.
Marketing authorization holder
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
Marketing authorization holder
UPSA SAS
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
304, AVENUE DU DOCTEUR JEAN BRU
47000 AGEN
or
UPSA SAS
979, AVENUE DES PYRENEES
47520 LE PASSAGE
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed later 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 from one person to and between 36.5 °C and 37.5 °C. A rise in temperature above 38 °C can be considered a fever ,but it is notrecommended to treat fever with a medication below 38.5 °C.
This medication is indicated for adults and children from from 50 kg (from fromapproximately 15 years).
If thesymptoms that fever causes aretootroublesome, youcan take this medicine whichcontains paracetamol byobserving the dosages indicated.
You can improve theeffectiveness of treatment by thefollowing measures :
- uncoveryourself,
- drink regularly toavoid any risk of dehydration,
- donot stay in a place too hot.
With this medication, fever shouldfall 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.
WHAT 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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