COMPRALGYL 400MG + Codeine 20MG Strong severe pain

COMPRALGYL 400MG + Codeine 20MG Strong severe pain View larger

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Gifrer Gifrer

The drug Compralgyl 20mg 400mg is indicated for the treatment of moderate to severe pain that is not relieved by aspirin or paracetamol alone.

More details

The advice of your pharmacist

Used for : pain, toothache, severe pain, severe pain

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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.

 
For adults (from 15 years).
This medicine contains paracetamol and codeine.
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

 

For adults and children over 15 years.
 
1 tablet, repeated if necessary after 4 to 6 hours. Possibly, take 2 tablets in one take in case of severe pain, not to exceed 6 tablets per day.
 
This médcament was personally delivered to you in a specific situation:
 
  • It may not be suitable for another case.
  • Do not advise to another person.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
 
  • Method and route of administration

 
Oral use.
Tablets (or half tablets) should be swallowed with a glass of water.
 
  • Frequency of administration

 
Generally the plugs are separated by 6 hours and at least 4 hours. In case of persistent pain,
systematic jacks to avoid pain peaks. In case of severe kidney disease
(Severe renal impairment), the catch will be at 8-hour minimum.
 
  • 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

 

  • Active substances

 
Paracetamol 400mg
Codeine phosphate hemihydrate: 20mg
For a scored tablet.
 
  • Excipients

 
Povidone K30, corn starch, croscarmellose sodium (EXPLOCEL 7), lactose monohydrate, magnesium stearate.

 

 

Use with caution COMPRALGYL 400MG 20MG Strong severe pain

 

 

  • Special warnings

 
If overdose or taken by mistake too high a dose, contact your doctor immediately.
Prolonged use of this medication may cause dependence. Do not use extended so without medical advice.
This medicine contains paracetamol and codeine. Other drugs contain. Do not associate so as not to exceed the maximum recommended doses.
This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (rare hereditary disease).
 
  • Precautions

 
The use of alcohol is not recommended during treatment.
Tell your doctor if:
  • 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

COMPRALGYL

Analgesic combination: opiate and paracetamol

paracetamol, codeine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

COMPRALGYL 400 mg / 20 mg: scored tablet; box of 16.
-
List I

Laboratory Gifrer Barbezat

COMPOSITION (summary)
p cp
Paracetamol 400 mg
Codine phosphate 20 mg
Lactose +

INDICATIONS (summary)
This medicine contains two 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.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • 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 .
WARNING (Contents)
Paracetamol is present alone or in combination with other substances in many medicines: make sure not to take several medicines containing paracetamol simultaneously, as a joint dose leads to a risk of overdosage, which can be toxic to the liver.
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.
DRUG INTERACTIONS (summary)
This medication may interact with those containing nalbuphine, buprenorphine, or pentazocine, which may decrease the analgesic effect.
Inform your doctor or pharmacist if you are taking sedatives .
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
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.

Breastfeeding:
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.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets should be swallowed with a little water. They can be taken during or outside meals.
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.

Usual dosage:

  • 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.
TIPS (summary)
Like all analgesics , this drug is generally more effective in preventing pain than calming it. In the treatment of chronic pain, it is best to take this drug at regular intervals without waiting for the pain to settle.
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.
POSSIBLE ADVERSE EFFECTS (summary)
Related to codeine:
  • 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 .
Related to paracetamol: rare allergic reaction .


GLOSSARY (summary)


alcohol
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.


painkillers
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.
Synonym: analgesic.


asthma
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.


bronchospasm
Abnormal bronchial contraction resulting in difficult and often wheezing breathing. Bronchospasm is one of the factors responsible for asthma.


codeine
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).
This global sedative action is unfortunately causing inconvenient somnolence, when codeine is taken in high doses.
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.


addiction
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.


enzymes
A substance capable of activating a specific chemical reaction.


intracranial hypertension
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.


renal failure
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.


respiratory failure
Inability of the lungs to properly oxygenate the blood and remove excess carbon dioxide.


metabolism
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).


opiate
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.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


allergic reaction
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.


sedatives
  • 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.


overdose
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.


withdrawal syndrome
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

NOTICE

ANSM - Last updated: 11/04/2017

Name of the medicinal product

COMPRALGYL 400 mg / 20 mg, scored tablet

Paracetamol / Codeine hemihydrate Phosphate

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

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:

Review summary

In this notice :

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

1. WHAT IS COMPRALGYL 400 mg / 20 mg, scored tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

This medicine contains paracetamol and codeine.

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.

Therapeutic indications

This medication can be used in patients over 15 years of age for a short period of time for moderate pain not relieved by other analgesics such as paracetamol or ibuprofen alone.

2. BEFORE YOU TAKE COMPRALGYL 400 mg / 20 mg, scored tablet?

List of information needed before taking the medication

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Cons-indications

Do not take COMPRALGYL 400 mg / 20 mg tablets scored in the following cases:

· 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.

Precautions for use; special warnings

Warnings and Precautions

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.

Interaction with other medicines

Other medicines and COMPRALGYL 400 mg / 20 mg, scored tablet

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.

Interactions with food and beverages

Other medicines and COMPRALGYL 400 mg / 20 mg, scored tablet

Absorption of alcohol during treatment is discouraged.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy, breast-feeding and fertility

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

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.

feeding

Do not take this medicine if you are breast-feeding because it contains codeine. Codeine and morphine (derived from codeine) pass into breast milk.

Fertility

It is possible that paracetamol may alter the fertility of women, reversibly upon cessation of treatment.

Sport

Sportsmen, attention, this specialty contains a substance that can induce a positive reaction during the doping controls.

Effects on ability to drive or use machines

Driving and using machines :

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.

List of excipients with known effect

COMPRALGYL 400 mg / 20 mg, scored tablet contains lactose.

See section 2 "Talk to your doctor or pharmacist before taking COMPRALGYL 400 mg / 20 mg scored tablet" and "Precautions for use".

3. HOW TO TAKE COMPRALGYL 400 mg / 20 mg scored tablet?

Instructions for proper use

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

Reserved for adults and teenagers FROM 15 YEARS.

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 .

Elderly

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

Oral use.

The tablets should be swallowed as they are with a large glass of water.

Symptoms and Instructions for Overdose

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.

Instructions for omission of one or more doses

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.

Risk of withdrawal syndrome

Effects that may occur when treatment with COMPRALGYL 400 mg / 20 mg scored tablet stopped :

In case of prolonged treatment, abrupt withdrawal of this medication may lead to withdrawal syndrome.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, this medicine may cause side effects, although not everybody gets them.

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.

5. HOW TO STORE COMPRALGYL 400 mg / 20 mg tablet scored?

Keep out of sight and reach of children.

Expiration date

Do not use COMPRALGYL 400 mg / 20 mg, scored tablet after the expiry date which is stated on the carton.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does COMPRALGYL 400 mg / 20 mg contain, scored tablet?

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.

Pharmaceutical form and content

What is COMPRALGYL 400 mg / 20 mg, scored tablet and contents of the pack?

This medication is in the form of a scored tablet. Box of 16.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

GIFRER BARBEZAT

8 A 10, RUE PAUL BERT

69150 DECINES CEDEX

exploiting

GIFRER BARBEZAT

8-10 RUE PAUL BERT - BP 165

69 151 DECINES CEDEX

Maker

GIFRER BARBEZAT

8-10 RUE PAUL BERT - BP 165

69 151 DECINES CEDEX

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Ansm website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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