Efferalgan Codeine
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Efferalgan Codeine

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IDENTIFICATION OF THE MEDICINAL PRODUCT

  • NAME

EFFERALGAN CODEINE, scored, effervescent tablet.

  • COMPOSITION

Paracetamol 500 mg

Codeine phosphate : 30 mg

Excipients : sodium hydrogen carbonate, anhydrous sodium carbonate, anhy­drous citric add, sorifttol, docusate sodium, sodium benzoate, povidone, aspar­tame, natural grapefruit flavouring, sq. for a SCored effemescent tablet old.25 g.

  • PHARMACEUTICAL FORM - PACKING SIZE

Scored effervescent tablet. Box of 25 blisters x 4 tablets. PHARMACO-THERAPEUTIC CLASS

PERIPHERAL ANALGESIC

OPIOID ANALGESIC

  • PHARMACODYNAMIC PROPERTIES

Per  analgesic.

Op old analgesic

ATC coda NO28E51

N. Central nervous system

     - Paracetamol: a na IgeN c-antipyr etic

- Codein phosphate: no old analgesic

The comb oat   of paracetamol and coder phosphate has a greater analgesic activity than that of the ingredients taken separately, with a longer sot ng effect.

  • PHARMACOKINETIC PROPERTIES

Paracetamol and codeine have idenhcal absorption and kinetics that are not modified when comffined.

Paracetamol

Absorption: Absorption of paracetamol by the oral mute is rapid and complete. Peak plas­ma concentrations are reached 30 to 60 rffinutes after ingestion.

Distribution : Paracetamol ft rapidly distributed in NI ftssues. Concentrations in blood, sali­va and by are comparable. Binding toplasma proteins is weak.

Metabolism: Paracetamol s ma nly metabolSed in the liver. The two chief metabolic pathways are by conjugation CO form glucurondes ad sulphates. The latter pathway S quickly saturable when dosages above the therapeutic range are administered. A fluor metabolic pathway catalysed by cytochrome Past cad s to the formation of an intermediate reagent (N-acetyl benzoquinone imine) which under normal conditions of use is *idly detoxified by reduced glutathione and eliminated in the urine after conjugation to cystane and mercaptopunc add. However, in mass ve poisoning the quantity M this toxic metabolite S increased.

Elimination: Elimination takes place many via the urine. 9090 of an ingested dOSe is eliminat­ed Optic ftdneys within 24 hours, mainly ft the form of glucuronide conjugates MO to 803S) and sulphate conjugates (20 to 3064 sot than 5% is excreted unchanged.

The elimination hablife is approximately 2 hours.

PathonhvsioloAical variations: Renal ftsufficiency: in the event of severe renal insufficnncy (crea­tiffine clearance below 10m1/min), the elimination of paracetamol and to metabolites S delayed. Elderly subjects: the con ugat on capacity snot modified.

Codeine

After oral intake, codeine is well absorbed and ffs relative bioavaiftbility compared to intra­11111SCuftr use sat to 70%. The peak plasma concentration is reached in 60 minutes and then decreases with a plasma half-life of between bard 4 nours. Codeiine S metabolized to yield codeine-6-ffimoronide, morphine and norcodeine.

Codeine and its metabolites are excreted almost entirely by renal route (85-90%k early ft the form of glucuronides excretion is considered to be completeafter 48 hours.The percentages of the dose administered (free conjugated produchfound in the urines are as follows about 10% ft morphine form, 10% norcodein and 5070% code ft Almost 25 to 30% of codeine admhstered is Inked to plasma proteins.

CASES IN WHICH THIS MEDICINE MUST BE USED

(THERAPEUTIC INDICATIONS)

Restricted to adults and chiddren weighing 15 kg or more tie about 3 years of age). absi medidne contains paracetamol and codeine it is an analgesic (it relieves pain).

iris intended for the treatment of moderate to severe pain not re eyed by aspirin paracetamol or ibuprofen used alone.

IMPORTANT!

  • CASE(S) IN WHICH THIS MEDICINE MUST NOT BE USED (CONTRAINDICATIONS)

This medicine MUST NEVER BE USED in the following cases

- alnrgies to paracetamol and        to codeine OS tO Me other ingredients, - severe lifter disease,

- in asthmatic subjects,

- respiratory fNlure,

- lactatftft apart from occasional admiNstratnn (see section on Pregnancy and Lactation), - phenylketonuria (metabolic disease) due to the presence of aspartame.

WHEN IN DOUBT ALWAYS CONSULT YOUR DOCTOR OR PHARMACIST

  • SPECIAL WARNINGS

This medicine contains paracetamol. Consult your doctor immedfttely in the event of overdose or accidental administration of an excessively high dose

This medicine contains paracetamol ond. codeine Other medicines also contain these substances. Do not combine such medicines in ordet notto e.xceed the maximum dosage iher§66tar onDbsagi 'and method oradministrationt

This medicine must be administered to children only on a doctor's prescription

Do not give this tieatment to your chid again, vothoot first seek ng medical advice again. This treatment most be accompanied by moniitoring of your child ; hose think your child is excessively drowsy, do not give him her another dose.

The prolonged use "itss medicine may lead to dependency. Do not use for prolonged periods with medical advice.

Oneot exceed the dosages indicated and consult a doctor quickly Tithe event of accidental overdose Do not use for prolonged periods without medical advice, in particular d the disorders last In r more than 5 days and/or in the event of the onset of any other symptom further to administration of the medicine.

This medicfte contains sorbitol and most not be taken in cases of intolerance to fructose (a heredftary metabolic disease).

  • PRECAUTIONS FOR USE

The intake of alcohol during tmatment ft not adftsable.

Inform your doctor in the event of

- kidney or liver disease,

respiratory Ire se 11Cludaag asthma),

- bronchial congestion (cough with expectoration- gallbladder surgery.

The sodum benzoate contained in this product can cause slight irritation to the sdn, eyes and mucous membranes. It may increase the risk of jaundice in newborn babns

In cases of sat free or ow-salt diets, the 380 mg sodium contained in each tablet must be taken into account in the daily intake.

WHEN IN DOUBT DO NOT HESITATE TO CONSULT YOUR DOCTOR OR PHARMACIST

  • MEDICINE INTERACTIONS AND OTHER INTERACTIONS

This medic,rata avoided wfth morphine agonisS and antagonists (buprenorphine, nalbuphine, pentazocine) and with the consumption of Ncohol.

IIV ORDER TO AVOID POTENTIAL INTERACTIONS BETWEEN DIFFERENT MEDICINES YOU SHOULD ALWAYS INFORM YOUR DOCTOR OR PHARMACIST IF OTHER MEDICINES ARE BEING TAKEN

If your doctor prescribes an assay of blood uric acid or sugar levels, you most inform him Mat you are taking this medicine.

  • PREGNANCY - LACTATION

Pregnancy: A short treatment (a few days), at the recommended doses S possible but chronic taftng of thft medicine must be avoided.

Ware erd of pregnancy, the taking of EFFERALGAN CODEINE, scoreff effervescent tablet can have effects on the newborn baby and consequently you muM inform your doctor d the medicine is be       taken.

IF YOLI DISCOVER THAT YOU ARE PREGNANT DURING TREATMENT WITH THIS MEDICINE, INFORM YOUR DOCTOR AS HE/SHE ALONE CAN DECIDE IF THE TREATMENT MUST CONTINUE OR NOT

Lactation This medicine passes into breast milk and is contraindicated during breast-feeding, apart from OCcasional ose.

AS A GENERAL RULE IT IS ALWAYS ADVISABLE TO CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINE DURING PREGNANCY OR WHEN BREAST-FEEDING.

  • DRIVERS AND PERSONS USING MACHINES

Attention S drawn to the risk of droveNness, particularly ft indftiduals drMng vehicles and using machinery due to the presence of codeine in this medicine. This phenomenon decreases after several doses; it may be useful to start taking ths treatment in the evening.This O henomenon is aCCentuated by drinking alcohol.

HOW TO USE THIS MEDICINE?

DOSAGE

It is usually unnecessary to exceed 6 effervescen( tablets per day However, in the event of more intense pan the maximum dosage can be increased to 3 effervescent tablets per day.

NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking into account all medicines which contain paracetamol). There must always be an interval of at least 4 h between admInistrations.

In children the paracetamol dosage depends on the child's weight; ages are given as guidance only.

If you do not know the child's weight, you should weigh the child in order to administer the most suitable dose.

Paracetamol is available at many ddferent strengths and consequently the treatment can be adapted to the weight of each chin.

The recommended daily dose of paracetamol is approximatMy 60 mg/kg/per - day to be divided into 4 or 6 administrations.

The recommended daily dose of codeine is approximately 3 mg/kg/per day to bedivided into 4 or 6 administrations.

For children wejgrvng from 15 to 22 kg (about 3 to 6 years M age), the dosage s a half of one effervescent tablet per administration, to be repeated if necessary after

an interval of 6 hours, without exceeding 4 half-tablets (effervescent) per day a For Children weighing from 23 to 30 kg  (about 7 to 10 years of age), the dosages a half of one effervescent tablet per adrninirtration, to be repeated if necessary after an interval of 4 hours, without exceeding 6 half.tablets (effervescent) per day. For children welangtrom 31 to4,g( about 11 to 14 years of age), the dosage S one effervescent tablet per administration, to be repeated if necessary after an intetval of 6 hours without exceed ng 4 effervescent tablets per day. Eel children weighing Mini 45 to so kg about 14 M 15 years of age), the dosage is one effervescent tablet per administration, to be repeated if necessary after an interval of 4 hours without exceeding 6 effervescent tablets per day.

Mae mum recommended doses

The codeine dose not to be exceeded in children is 1 mg/kg per administration and 6 mg/kg per day.

The total paracetamol dose must not exceed 80 mgikg in children we ghing less than 37 kO and 3 g per day in adults and older children weighing over 38 kg. Renal failure: in the event of renal failure

- the interval between two doses shaild be at least 8 hours,

- a reduction in the dose must be consnemd,

- rd stricter monitorftg of the chiM should be instil gated.

  • METHOD AND ROUTE OF ADMINISTRATION

Oral use. 01550Ive the tablets in no little liquid before use.

  • FREQUENCY AND TIMING OF ADMINISTRATION OF THE MEDICINE

Regular administration hens to prevent peaks in pain levels.

- in children, the interval should be meferably 6 hours, and at nest 4 hours.

- in the event of ftdney disease them shouki be an interval 01st least 8 hours between each administratiod

DURATION OF TREATMENT If pain persists for more than 4 or 5 days do not continue treatment without seeking medical advice

YOUR DOCTOR'S PRESCRIPTION MUST BE STRICTLY OBSERVED AT ALL TIMES.

  • OVERDOSE:

Symptoms of paracetamol overdose: genmNly appear ‘Mthin the first 24 hours and com­prise nausea, vomiting, anorexia, pallor and abdominal pNn.

Overdose, 10g or more of paracetamol in a single administration in adults or 150mg/kg of body weight ft a single administration in children, causes hepatic cytolysis likely to induce complete arid irreversible neCrUs/s, resulting in ile1113aaae"s13. msofficiency, menffolic aci­dosis and encephalopathy which may lead to curia and dealt

SimiStaneously increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin are observed together with decreased prothrombin levels that may appear 12M 48 hours after Mestion Emergency measures:

- Immeonte admission to hospital

- A tube of blood sample must be taken thr initial plasma paracetamol assay - Rapid elimination of ingested medicinal product by gastrft lavage.

- The usual treatment for overdose includes administration as early as mssible of the and- dote, N-acetylcysteine, by the im or oral route, ff possible before the 10th hour. - Symptomatic treatment.

Symptoms of codein overdose

Signs in adults Acute respiratory cent e depression (cyanosis, reduced respyaMry rate); drowsiness, rash; vomiting, punt es, ataxM pulmonary oedema (rarer).

Sign in children. (toxic threshold: 2mg/kg as a single dose). Reduced respiratory rate res­piratory pauses, myosts, convulsions. signs of histamine cleave : face flush and swelling, urticarm, collapses, urinary retention.

Emergency measures:

-Assisted ventilation

- AdmInistration of naioxone.

  • ACTION TORE TAKEN IF YOU HAVE OMITTED ONE OR MORE DOSES

Continue treatment in compliance with the mednal prescription.

Do not increase the dose and comply with the interval between emh dose.

  • RISK OF WITHDRAWAL SYNDROME

In the event of prolonged 1:ea tment, sudden discondnuanon of tins medidne may Mad to withdrayval syndrome.

UNWANTED AND UNPLEASANT EFFECTS (UNDESIRABLE EFFECTS)

LIKE ALL ACTIVE PRODUCTS THIS MEDICINE MAY IN CERTAIN INDIVIDUALS, BRING ABOUT EFFECTS OF GREATER OR LESSER SEVERITY.

  • RELATED TO THE PRESENCE OF CODEINE

Possibility of :

- feeling of sleeitiness, euphoria moodiness,

- contraction of the pupil, difficult urn tar

- hypersensitivity reaction (itching, urticarM extensive skin rep ions

- constipation, nausea, vomiting,

- drowsiness, vertigo,

- hypersensitivity reactions (pruntis, urticaria and in rare cases, extensive skin eruptions), - ctifficult breathing,

- acute abdominal pain occurs ng pmhcularly n pot ents who have undergone cholecys­tectomy (gall bladder removed).

  • RELATED TO THE PRESENCE OF PARACETAMOL

- in certain rare cases, there ft the possibility of the occurrenccola  skin eruption or a redness of the skin or an allergic reaction in the form M a sudden swelling of the ace or neck or a sudden ma aise with a drop in Olood pressum. St p the tieatmentimmedfttely inform your doctor and never again take ['Thanes contaiffing paracetamol.

-In exceptionally rare oases, changes in labmatory teM results have been observed which have necesdtated regular blood diecks : e.g. abnormally low levels of or an white celft or some types M blood cells (Notelets), possibly leading to bleeding from the nose or gums. Oh sitscura, consuft a doctor.

INFORM YOUR DOCTOR OR PHARMACIST OF ANY UNWANTED OR UNPLEASANT EFFECT THAT MAY NOT BE REFERRED TO IN THIS PACKAGE LEAFLET

STORAGE

  • DO NOT USE AFTER THE EXPIRY DATE SHOWN ON THE OUTER PACKAGING
  • SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25'C.

Store in the or original package, in order to protect from moisture.

 

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