Medicinal Products

PARATABS 500 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Actavis Group Ptc Ehf

Orodispersible tablet
Box of 12
All forms

Indication

Symptomatic treatment of mild to moderate pain and / or fever.

Dosage PARATABS 500 mg Orodispersible Tablet Box of 12

Administration mode

Oral way.

The tablet should be placed on the tongue, where it will dissolve. The tablet will quickly disperse into the mouth so it can be ingested easily. For ease of setting, the tablet can be swallowed with a glass of water or, especially in young children, dispersed in a tablespoon or teaspoonful of water.

Dosage

The pediatric dose depends on the body weight and the appropriate presentation chosen. Age by weight is for information only.

Systematic catches prevent pain or fever oscillations. In children, they should be regularly spaced, including at night, preferably 6 hours, and at least 4 hours. The recommended daily dose of paracetamol is approximately 60 mg / kg / day, divided into 4 or 6 doses, approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours. The recommended maximum daily dose should not be exceeded due to the risk of severe liver injury (see Warnings and Precautions and Overdose sections).

For adults and adolescents weighing more than 50 kg

The usual dose is 500 mg to 1000 mg per dose, to be repeated every 4 hours if necessary, not exceeding 3 g per day.

For children and adolescents weighing 43 to 50 kg (approximately 12 to 15 years)

The usual dose is 500 mg per dose to be renewed every 4 hours if necessary without exceeding 3 g per day.

For children weighing 33 to 43 kg (approximately 11 to 12 years)

The usual dose is 500 mg per dose to be renewed every 6 hours if necessary, without exceeding 2 g per day.

For children weighing 25 to 33 kg (approximately 8 to 11 years)

The usual dose is 500 mg per dose to be renewed every 4 hours if necessary without exceeding 1.5 g per day.

This medicine is not recommended for children weighing less than 25 kg.

In case of high fever or signs of infection for more than three days, or in case of pain for more than 5 days, the patient should be advised to contact a doctor.

Renal failure

In case of renal failure, paracetamol will be used with caution; in severe renal impairment, it is recommended to increase the interval between two doses. When the creatinine clearance is less than 10 ml / min, the interval between two doses should be 8 hours.

Hepatic insufficiency

Paracetamol will be used with caution in case of hepatic insufficiency.

Against indications

Hypersensitivity to paracetamol or any of the components.

Paratabs side effects

Within each group frequency, adverse effects should be presented in order of decreasing severity.

At therapeutic doses, the side effects are few.

The frequency of adverse reactions is classified as follows: Very common (³ 1/10); frequent (³ 1/100 to <1/10); infrequent (³ 1 / 1, 000 to <1/100); rare (³ 1 / 10, 000 to <1 / 1, 000); very rare (<1 / 10, 000), unknown (the frequency can not be evaluated from the available data).

Frequency

System

sYMPTOMS

few

Hematologic disorders and

Platelet disorders, disease

> 1/10000 - <1/1000

lymphatic system

stem cells.

Immune system disorders

Allergies (with the exception of Quincke's edema / angio-edema).

Psychiatric disorders

Depression, confusion, hallucinations.

Nervous system disorders

Tremor, headache.

Eye disorders

Vision disorders.

Heart conditions

Edema.

Gastrointestinal disorders

Haemorrhage, abdominal pain, diarrhea, nausea, vomiting.

Hepatobiliary disorders

Abnormal liver function, liver failure, hepatic necrosis, jaundice.

Skin and subcutaneous tissue disorders

Pruritus, rash, sweating, purpura, angioedema, urticaria.

General disorders and administration site conditions

Dizziness (with the exception of dizziness), malaise, fever, sedation, drug interactions.

Injury, poisoning and procedural complications

Overdose and poisoning.

Very rare (<10 000)

Hepatobiliary disorders

Hepatotoxicity.

General disorders and administration site conditions

Hypersensitivity reaction (requiring discontinuation of treatment).

Blood and lymphatic system disorders

Thrombocytopenia, leukopenia, neutropenia, hemolytic anemia.

Metabolism and nutrition disorders

Hypoglycemia.

Renal and urinary disorders

Sterile pyuria (troubled urine) and renal side effects.

Few cases of epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, laryngeal edema, anaphylactic shock, anemia, hepatic changes and hepatitis, renal impairment (severe renal impairment, nephritis) interstitial, hematuria, anuria), gastrointestinal effects and vertigo have been reported.

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