The drug Compralgyl 20mg 400mg is indicated for the treatment of moderate to severe pain that is not relieved by aspirin or paracetamol alone.
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COMPRALGYL 400MG 20MG Strong severe pain
For the warnings, the precautions and cons-indications, see the instructions.
Description COMPRALGYL 400MG 20MG Strong severe pain
Compralgyl The drug is indicated for the treatment of moderate to severe pain that is not relieved by aspirin or paracetamol alone.
Using advice and opinion on COMPRALGYL 400MG 20MG Strong severe pain
- It may not be suitable for another case.
- Do not advise to another person.
Method and route of administration
Frequency of administration
Duration of treatment
If pain persists for more than 4 to 5 days, do not continue treatment without consulting your doctor.
Composition COMPRALGYL 400MG 20MG Strong severe pain
Use with caution COMPRALGYL 400MG 20MG Strong severe pain
- Diseases of the kidneys or liver.
- Respiratory diseases (including asthma).
- In bronchial obstruction (cough with expectoration).
- In operation of the gallbladder.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
COMPRALGYL presentation 400MG 20MG Strong severe pain
This drug is in the form of scored tablets. Box of 16.
Warnings on drugs
Attention, the drug is not a product like any other. Read the package leaflet before ordering. Do not let the drugs out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Please tell your online pharmacist ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.
Click here to find the manual for this product on the website of the National Agency for Drug Safety and health products.
Pharmacovigilance : Reporting an or effect (s) junk (s) connected (s) to the use of a drug
VIDAL OF THE FAMILY
Analgesic combination: opiate and paracetamol
COMPRALGYL 400 mg / 20 mg: scored tablet; box of 16.
Laboratory Gifrer Barbezat
|Codine phosphate||20 mg|
analgesics : paracetamol, which prevents the transmission of pain, and an opiate (codeine). The analgesic effect of codeine is due to its transformation into morphine in the liver. It strengthens the action of paracetamol by acting on the perception of pain by the brain. The low codeine dosage allows it to be available without a prescription.
It is used in the treatment of pain, when it is not relieved by other analgesics used alone.
- severe liver disease;
- asthma and respiratory failure ;
- person known to be ultrafast metaboliser (a person whose activity of enzymes involved in drug metabolism is excessive);
- child under 18 years of age after removal of vegetation or tonsils in the context of sleep apnea;
- child under 15 years of age;
- in combination with drugs containing nalbuphine, buprenorphine or pentazocine;
- breastfeeding .
Codeine is partially transformed into morphine by the liver under the influence of an enzyme. In some people (approximately 1 to 6% of the white population), the activity of this enzyme is increased with the consequent increased risk of sometimes serious adverse effects. In others (around 7% of the white population), this enzyme is absent, with the result that the analgesic effect of codeine is reduced. If you experience any of the following side effects, consult your doctor or health care professional for help.
Prolonged high-dose use of codeine may cause a risk of dependence .
Precautions are necessary in cases of intracranial hypertension , fatty cough, in the elderly and in persons who have been removed from the gall bladder.
Avoid drinking alcohol during treatment.
This medication may induce somnolence, sometimes intense in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving and using hazardous machines are not recommended, especially within hours of taking the medication.
Inform your doctor or pharmacist if you are taking sedatives .
Adverse use of this medication is possible during pregnancy on medical advice. Inform the obstetrician about the use of this drug at the end of pregnancy: risk of respiratory insufficiency in the newborn if high dose codeine is used before delivery or risk of withdrawal syndrome in case of regular treatment , even at low doses, at the end of pregnancy. These risks can be prevented by monitoring and appropriate treatment.
This drug passes into breast milk. Passage of codeine into breast milk is low at usual doses, but toxic effects to the infant have been observed in very rare cases. Therefore, this medication is contraindicated during breast-feeding.
Observe a minimum interval of 4 hours between 2 doses. In case of renal insufficiency , the interval between 2 takes must be at least 8 hours.
- Adult: 1 or 2 tablets, to be renewed if necessary every 6 hours, without exceeding 6 tablets per day. In the elderly, the initial dosage is usually halved.
This codeine-containing analgesic is intended for second-line use, when aspirin, ibuprofen or paracetamol, used alone, is insufficiently effective. It can nevertheless be used from the outset in the treatment of severe pain.
This medication can delay a diagnosis by masking pain; do not take it without the advice of your doctor, do not advise it to a loved one.
- constipation, drowsiness, nausea, vomiting, feeling dizzy and, more rarely, allergy (itching, urticaria, skin redness), bronchospasm , slowing of breathing. These side effects may be more severe in some people (see Caution);
- acute abdominal pain (Oddi sphincter spasms) in people who no longer have gall bladder;
- in case of prolonged treatment at high doses: risk of dependence and withdrawal syndrome in the event of abrupt withdrawal .
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even at 60o) is a better antiseptic than alcohol at 90o.
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.
Abnormal bronchial contraction resulting in difficult and often wheezing breathing. Bronchospasm is one of the factors responsible for asthma.
Substance extracted from the poppy (opium), used for its sedative properties on the central nervous system, in particular:
- on the nervous centers of the cough (antitussive action),
- on the nerve centers of pain (analgesic action).
Moreover, the chemical kinship with morphine exposes a risk of dependence in case of prolonged treatment at high dose. However, codeine remains the most effective antitussive agent and a powerful analgesic agent, especially in combination with paracetamol.
Psychic or physical need caused by taking certain natural or medicinal substances. This condition may be accompanied, at cessation of the catch, by various symptoms, grouped under the term of withdrawal syndrome.
A substance capable of activating a specific chemical reaction.
Excess pressure inside the skull, due to hematoma, edema, or brain tumor. This rare condition is diagnosed by an ophthalmologic examination of the fundus of the eye. The pain of intracranial hypertension, intense, permanent and lasting, should not be confused with a mild headache or migraine, which usually give in a few hours or days.
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.
Inability of the lungs to properly oxygenate the blood and remove excess carbon dioxide.
All the transformation actions carried out by the organization, resulting in the creation of energy or the development of various substances. Anabolism (metabolism of manufacture) is distinguished from catabolism (degradation metabolism).
A chemical family that includes opium and its derivatives. In addition to drugs such as opium or heroin, the opiate family includes morphine (strong analgesic), codeine (antitussive and analgesic) and many other substances.
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.
- Quiets, calms down.
- Medication belonging to different families: anxiolytics, hypnotics, analgesics, cough suppressants, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative can be responsible for drowsiness and increase the effects of alcohol.
Excessive intake of a drug may result in an increase in the intensity of adverse effects or even in the development of specific adverse effects.
This overdose may result from accidental or voluntary poisoning for suicide, so consult your local Poison Control Center (listed in the appendix to the book). However, in most cases, overdose is the result of an error in the understanding of the prescription, or the search for an increase in efficacy by exceeding the recommended dosage. Finally, untimely self-medication may lead to excessive absorption of the same substance contained in different drugs. Some drugs are particularly prone to this risk because they are (wrongly) considered to be harmless: vitamins A and D, aspirin, etc. Stopping or decreasing drug intake helps to remove the disorders associated with an overdose.
Reaction due to the sudden deprivation of a substance (drug, toxic, alcohol, etc.) to which the organism has been accustomed. Some medications taken during pregnancy may cause this reaction in the newborn. A particular form of weaning syndrome is the lack of drug addicts when they are drug-free.
Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.
Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament
ANSM - Last updated: 11/04/2017
Paracetamol / Codeine hemihydrate Phosphate
You should always take this medication exactly as prescribed in this leaflet or 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 of the side effects, talk to your doctor or health care professional. 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 3 days.
Do not take this medicine with any of the following:
1. WHAT IS COMPRALGYL 400 mg / 20 mg, scored tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE COMPRALGYL 400 mg / 20 mg, scored tablet?
3. HOW TO TAKE COMPRALGYL 400 mg / 20 mg scored tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE COMPRALGYL 400 mg / 20 mg tablet scored?
6. ADDITIONAL INFORMATION
Paracetamol is an analgesic (calms the pain) and an antipyretic (lowers the fever).
Codeine belongs to a group of medications called opioid analgesics that work to relieve pain. It can be used alone or in combination with other analgesics such as paracetamol.
· Child under 15 years old.
· Child and adolescent (0-18 years) after removal of tonsils or vegetations as part of an obstructive sleep apnea syndrome.
· If you are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients of this medication mentioned in section 6 .
· If you have severe liver disease .
· If you are asthmatic.
· If you have respiratory failure.
· If you have a known diagnosis of high-speed metabolizer from codeine to morphine .
· If you are breastfeeding .
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Talk to your doctor or pharmacist before taking COMPRALGYL 400 mg / 20 mg scored tablet:
· if you have kidney or liver disease,
· if you have a respiratory illness (including asthma),
· if you have a bronchial congestion (cough with expectoration),
· if you have been operated on from the gall bladder because codeine can cause acute abdominal pain,
· if you consume alcohol,
· if you have problems with nutrition (malnutrition) or dehydration,
· if you have lactose intolerance (rare hereditary disease).
In case of overdosage or mistake of too high a dose, consult your doctor immediately.
Precautions for use
This medicine contains paracetamol and codeine.
Make sure that you do not take any other medicines containing paracetamol or codeine, including medicines obtained without a prescription.
Do not combine them , so as not to exceed the recommended daily dose.
(See "Dosage" and "If you take more than COMPRALGYL 400 mg / 20 mg, scored tablets you should").
Prolonged use of this medication can be addictive. Do not use for more than 3 days without medical advice.
Codeine is transformed into morphine in the liver by an enzyme. Morphine is a substance that relieves pain. Some people have a variable enzyme level and this can affect them in different ways. For some people, morphine is not produced or produced in small quantities, and will not relieve pain enough. For some people, called rapid or ultra-rapid metabolizers, a significant amount of morphine is produced that can cause serious adverse effects. If you notice one of the following side effects, stop taking this medicine and ask your doctor for advice immediately: slow or shallow breathing, confusion, drowsiness, shrinkage of the pupil, constipation, lack of appetite or if you do not feel not good.
Children and Youth
This medication is not indicated for children under 15 years of age. Ask your doctor or pharmacist.
For adolescents over 15 years of age, this treatment must be accompanied by a supervision of your child; in case of drowsiness which would seem excessive, do not give him more dose
Use in children and adolescents after surgery:
Codeine should not be used after removal of tonsils or vegetations in the context of obstructive sleep apnea syndrome.
Use in children with respiratory problems:
Codeine is not recommended in children with respiratory problems because the symptoms of morphine toxicity are aggravated in these children.
If you or your teen have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with COMPRALGYL 400 mg / 20 mg scored tablet:
· Paracetamol: used to treat pain, do not take other medicines containing paracetamol. You may be overdosed.
· Codine: used to treat pain or cough, do not take other medicines containing codeine. You may be overdosed.
· Opioids: used to treat pain, cough or as surrogacy (in case of addiction). In particular, you may be overdosed.
Tell your doctor or prescriber about all prescription and nonprescription / herbal products you may use before using this medication.
Absorption of alcohol during treatment is discouraged.
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.
It is possible to take this medication during pregnancy, for a short time (a few days), at the doses recommended by your doctor. At the end of pregnancy, the use of codeine may cause toxicity in the newborn. Therefore, always seek the advice of your doctor before taking this medication and never exceed the recommended dose.
Do not take this medicine if you are breast-feeding because it contains codeine. Codeine and morphine (derived from codeine) pass into breast milk.
It is possible that paracetamol may alter the fertility of women, reversibly upon cessation of treatment.
Attention is drawn to the risk of somnolence caused by the presence of codeine in this drug, especially among vehicle drivers and machine users. This phenomenon diminishes after several catches, it may be useful to start this treatment at night. This phenomenon is accentuated by the consumption of alcoholic beverages.
See section 2 "Talk to your doctor or pharmacist before taking COMPRALGYL 400 mg / 20 mg scored tablet" and "Precautions for use".
The dosage depends on the intensity of the pain; the lowest effective dose should generally be used for the shortest possible duration.
The duration of treatment with this medication should not exceed 3 days. If pain is not relieved after 3 days, seek the advice of your doctor.
To avoid a risk of overdose, check the absence of codeine and paracetamol in the composition of other medicines, including medicines obtained without a prescription.
In the adult
1 tablet, to be renewed if necessary after 6 hours. Possibly, take 2 tablets in one dose in case of severe pain, without exceeding 6 tablets per day .
In children and adolescents
Children under 15 years of age
COMPRALGYL 400 mg / 20 mg scored tablets should not be administered to children under 15 years of age due to the risk of severe respiratory problems.
Adolescent aged over 15 years
Regular intakes prevent the pain from returning.
It is imperative to respect the dosage, which depends on the weight of the adolescent .
Adolescents over the age of 15 must take:
· Weight between 31 to 50 kg : 1 tablet every 6 hours, if necessary. Never take MORE than 4 tablets every 24 hours.
· Weight over 50 kg : 1 tablet every 6 hours if necessary. Possibly, take 2 tablets in one dose in case of severe pain. Never take more than 6 tablets every 24 hours .
The initial dosage is usually halved compared to the recommended dosage in adults. Your doctor may increase the dosage depending on your tolerance and needs.
Patients with renal insufficiency
In case of kidney disease (kidney failure), there is a risk of accumulation of codeine and paracetamol. As a result, your doctor may have to decrease the dosage. The interval between two takes should be at least 8 hours .
· In a child with renal insufficiency, close supervision should be established. In case of unusual signs (eg drowsiness, or difficulty in breathing), contact a doctor.
Recommended maximum doses
To avoid a risk of overdose:
· check the absence of codeine and paracetamol in the composition of other medicines, including medicines obtained without a prescription,
· never exceed the recommended maximum doses (except medical advice) taking into account all medicines containing paracetamol in their formula.
If you feel that the effect of COMPRALGYL 400 mg / 20 mg scored tablet is too strong or too weak, talk to your doctor or pharmacist.
Method and route of administration
The tablets should be swallowed as they are with a large glass of water.
If you take or have given more than COMPRALGYL 400 mg / 20 mg, scored tablet you should:
Stop treatment and see your doctor or medical emergency immediately .
An overdose can be fatal.
Within the first 24 hours, the main symptoms of poisoning are: vomiting, abdominal pain, respiratory slowness, somnolence.
If you forget to take or give COMPRALGYL 400 mg / 20 mg, scored tablet:
Do not take a double dose to make up for the single dose you have forgotten to take. Continue treatment according to medical prescription.
In case of prolonged treatment, abrupt withdrawal of this medication may lead to withdrawal syndrome.
Related to the presence of codeine
· constipation, nausea, vomiting,
· somnolence, vertigo,
· difficulty breathing,
· hypersensitivity reactions (itching, urticaria, extensive rash),
· acute abdominal pain especially in patients operated on from the gall bladder. In this case, consult a doctor.
Prolonged use of codeine may lead to a state of dependence. In case of prolonged treatment, abrupt withdrawal of this medication may lead to withdrawal syndrome.
Related to the presence of paracetamol
In some rare cases, it is possible that a rash or reddening or allergic reaction can occur, which can be manifested by a sudden swelling of the face and neck or by a sudden discomfort with drop in blood pressure. Immediately stop treatment, tell your doctor and never take any medicines containing paracetamol.
Very rare cases of severe skin rash have been reported.
Exceptionally, biological changes requiring blood check have been observed: liver function disorders, abnormally low levels of certain white blood cells or certain blood cells such as platelets which can result in nosebleeds or gums. In this case, consult a doctor.
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.
Keep out of sight and reach of children.
No special storage conditions.
The active substances are:
Paracetamol ................................................. .................................................. 400 mg
Codeine phosphate hemihydrate .............................................. ........................................... 20 mg
For a scored tablet.
The other components are:
Povidone K30, corn starch, croscarmellose sodium (EXPLOCEL 7), lactose monohydrate, magnesium stearate.
This medication is in the form of a scored tablet. Box of 16.
8 A 10, RUE PAUL BERT
69150 DECINES CEDEX
8-10 RUE PAUL BERT - BP 165
69 151 DECINES CEDEX
8-10 RUE PAUL BERT - BP 165
69 151 DECINES CEDEX
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Medicine Fever Online Pharmacy
Order your medications online at your ARS approved online pharmacy to treat your pain and fever. Some common ailments can often be treated with non-prescription drugs. However, self-medication should not be taken lightly: it should be limited to a few days, to treat mild and common symptoms, without the intervention of the doctor, but with the help of the pharmacist. If symptoms persist for more than a few days, physician consultation is required. In the case of pain: headaches, migraines, aches and / or fever, several types of medications can alleviate these symptoms. Some may be obtained without a prescription; They are proposed here. Caution, in case of fever or prolonged pain (more than a few days), consult without waiting your doctor or your pharmacist. We advise you to refine your search (left part of the screen) to identify the most suitable medication for the patient (age, pregnant woman ...). Like all medicines, anti-fever and pain medications can cause side effects. Read the package leaflet before using it, and do not hesitate to ask your doctor or pharmacist for advice at firstname.lastname@example.org.
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