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PARACETAMOL CODEINA LEVEL 308X292

Paracetamol Codeína Level solución oral

Paracetamol and codeine.

Analgesic.

5ml of Paracetamol Codeína Level contain:

  • 12 mg of codeine.
  • 120 mg of paracetamol.


    Jar with 240 ml solution.

    Financed by the S.N.S.

    N.C. 679639.9

Paracetamol Codeína Level oral solution is administered orally.

 

Except with facultative prescription, the recommended dose is the following:

 

Adults:

15ml every 4 hours. Maximum daily dose is 150 ml of solution.

Children:

From 7-12: 10ml 3 or 4 times a day.

From 3-6: 5ml 3 or 4 times a day.

Under 3: According to medical criteria.

Paracetamol Codeína Level

oral solution

 

Composition..................................................................................Per 5 ml

Paracetamol.....................................................................................120mg

Codeine phosphate.........................................................................12mg

Sodium saccharin...........................................................................12mg

Ethanol............................................................................................0.35ml

Sucrose...........................................................................................2.97g

Other excipients: propylene glycol, essence of raspberry, sodium benzoate, azorubine, water.

 

Pharmaceutic form and packet contents

Jar with 240 ml solution.

Activity

Analgesic (codeine increases the analgesic effect of paracetamol), antipyretic and cough suppressant.

Indications

Symptomatic treatment of weak or moderate pain, such as neuralagia, headaches, lumbago, torticolis, dentistry; rheumatic, muscular, ciatic, post-surgery, post giving birth, menstruation pains, or pain provoked by a neoplasic process.

Counterindications

Hypersensibility to the components. Hepatic illness.

Precautions

It must be administered with precaution in patients with cranial injuries, or high intracranial pressure, acute abdominal conditions, elderly or weak patients, or in cases with the renal or hepatic condition seriously altered, hypothyroidism, Addison’s illness, prostatic hypertrophy, urethral contraction.

 

Do not exceed the recommended dose.

 

Prolonged and excessive treatment with codeine as with other major painkillers,can lead to psychic dependency, physical dependency and tolerance, with symptoms of abstinence after the sudden suppression of the drug.

For this reason it must be prescribed and administered with the same degree of precaution as with other major painkillers, particularly with patients who have a tendency to abuse and to addiction.

After prolonged periods of treatment you must gradually interrupt the treatment as indicated by your doctor.

Interactions

Can increase toxicity and cloramphenicol.

In the case of treatments with oral anti clotting medication it can sometimes be administered as the painkiller of choice.

Warnings

Pregnancy and breast feeding: It must only be used with medical recommendation.

 

Effects on driving ability: Care must be taken when driving, using dangerous machinery, and in general in those activities where a lack of concentration and skill supposes a risk.

 

As it contains ethanol as an excipient, it can be a risk for patients with hepatic illness, alcoholism, epilepsy, and in pregnant women and children.

 

This medicine contains 2.966 mg/5ml of sucrose, which must be considered by those with diabetes.

 

We inform sportspeople that this medicine contains a component that can produce a positive result in analytic doping tests.

Dosage

Paracetamol Codeína Level oral solution is administered orally.

 

Except with facultative prescription, the recommended dose is the following:

Adults: 15ml every 4 hours. Maximum daily dose is 150 ml of solution.

Children: From 7-12: 10ml 3 or 4 times a day.

From 3-6: 5ml 3 or 4 times a day.

Under 3: According to medical criteria.

 

Administration of the product is according to the apparition of symptoms of pain, as these disappear medication must be stopped.

 

Instructions for the correct administration of the product

It is recommended to dilute the solution in water, milk or fruit juice.

Cover the jar well after each use.

Overdose

Symptoms of overdose with paracetamol include, dizziness, nausea, vomiting loss of appetite, jaundice, and abdominal pain. The clinical cycle is characterised by the appearance of a period of latency of 2 or 3 days, during which there is only nausea and vomiting during the first hours. The toxic dose in an adult is of 15 g of paracetamol. Patients being treated with barbiturates, chronic alcoholics or those with hepatic sickness, can be more susceptible to the toxicity of an overdose with paracetamol.

Symptoms of codeine overdose with codeine consist of respiratory depression and drowsiness, even to the point of stupor or coma, cold skin, muscular flaccidity and on occasion, cardiac bradycardia and hypotension.

In the case of an overdose or accidental ingestion, you must quickly consult the Toxicological Information Service, telephone 915620420, or go to a medical centre, even if there are no symptoms, as these, which are very serious, generally appear from the third day after ingestion onwards.

Expiry

This medicine must not be used after the expiry date indicated on the container.

 

WITH PRESCRIPTION

MEDICINES MUST BE KEPT OUT OF REACH AND SIGHT OF CHILDREN.

 

Holder of the authorisation for the commercialisation and fabrication of the product.

 

Laboratorios ERN, S.A.

C/ Pedro IV, 499

08020 Barcelona – España

 

Responsible for manuafacturing

Laboratorios ERN, S.A.

Perú 228 - 08020  Barcelona. España

 

Laboratorios ERN, S.A.

Gorcs Lladó, 188 - 08210 Barberá del Vallés, Barcelona. España.

 

Text revised September 1996.