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Panadol 500 mg 24 Tablets ingredient Paracetamol

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Panadol 500 mg 24 Tablets ingredient Paracetamol

Therapeutic indications

PANADOL is an analgesic and antipyretic.

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4.2. Posology and method of administration

Posology / frequency and duration of administration:

Adults and children over 12 years of age:

1-2 tablets are recommended with an interval of 4-6 hours. The highest daily dose is 4000 mg.

If there is no physician recommendation, it should not be used for more than three consecutive days.

Because of the risk of hepatotoxicity in people taking alcohol, the daily dose of germinated paracetamol should not exceed 2 grams.

Children between the ages of 6-12:

1 / 2-1 tablets with an interval of 4-6 hours are recommended. The highest daily dose is 10-15 mg / kg divided doses of 60 mg / kg. It is not suitable for children under six years of age.

Method:

of administrationOral administration. It should be taken with a glass of water.

Additional information on special populations:

Renal / hepatic impairment:

4.3. Contraindications

Pediatric population: Not

recommended for use in children under 6 years of age.

Geriatric population:

4.3. Contraindications Hypersensitivity to

paracetamol or any of the other components,

4.4. Special warnings and precautions for use In

patients with anemia, lung disease, liver and kidney dysfunction, caution should be exercised under medical supervision. For patients with pre-existing hepatic disease, liver function tests may be required at periodic intervals during high-dose or long-term treatments. In the case of renal failure (creatinine clearance <10 ml / min), the physician must carefully evaluate the benefit / risk ratio of paracetamol. Dose adjustment should be performed and the patient should be monitored continuously.

Liver damage has been reported in a patient who received hepatic necrosis and a shorter overdose in a patient receiving daily doses of therapeutic paracetamol for one year.

Liver enzymes may rise within 12-48 hours and prothrombin time may be prolonged. However, clinical symptoms may not appear until 1-6 days after the dose is taken.

Chronic daily doses and acute high doses may cause liver damage.

Because of the risk of hepatotoxicity, paracetamol should not be taken at higher doses or longer than recommended. Patients with mild or moderate hepatic impairment (Child-Pugh category <9) should use paracetamol with caution.

The serum alanine aminotransferase (ALT) level may be increased during the administration of paracetamol at therapeutic doses.

The simultaneous use of drugs that increase hepatic oxidative stress and decrease hepatic glutathione reserve with paracetamol at therapeutic doses, various conditions such as alcoholism, sepsis or diabetes mellitus may lead to an increased risk of hepatic toxicity.

Prolonged use of high doses of paracetamol may cause kidney damage.

In general, the use of continuous paracetamol in combination with other analgesics can lead to permanent kidney damage and the risk of renal failure (analgesic nephropathy).

The use of paracetamol in patients with Gilbert syndrome may cause clinical symptoms such as jaundice and more pronounced hyperbilirubinemia. Therefore, these patients should use paracetamol with caution.

Taking paracetamol concurrently with moderate alcohol may lead to an increased risk of liver toxicity. Alcoholic liver should be used with caution.

Concomitant use of other drugs containing paracetamol with PANADOL should be avoided.

4.5. Interactions with other medicinal products and other forms of interaction

Drugs that slow down gastric emptying, such as propentelin, may cause slow absorption of paracetamol and, consequently, the later occurrence of paracetamol.

Drugs that accelerate gastric emptying, such as metoclopramide, may cause the paracetamol to be absorbed more rapidly and therefore the effect of paracetamol may start faster.

Concomitant use of certain hypnotics and antiepileptic drugs (such as glutetimid, phenobarbital, phenytoin, carbamazepine, etc.) or inducing hepatic microsomal enzyme induction in the liver, such as rifampicin, may be associated with liver damage when administered alone with doses of paracetamol which are harmless. In case of excessive alcohol consumption, taking paracetamol even at therapeutic doses can also cause liver damage.

The use of paracetamol in combination with chloramphenicol may prolong the half-life of chloramphenicol and thus increase the risk of toxicity of this drug.

Paracetamol (or its metabolites) interacts with enzymes involved in the synthesis of vitamin K-dependent coagulation factor. Interactions between paracetamol and warfarin or coumarin derivatives can lead to an increase in the International Normalized Ratio (INR) and an increase in the risk of bleeding. Therefore, patients using oral anticoagulants should not use long-term paracetamol without medical supervision and control.

5-hydroxytryptamine (serotonin) type 3 receptor antagonists, tropisetron and granisetron, completely suppress the analgesic effect of paracetamol by pharmacodynamic interaction.

Simultaneous use of paracetamol and azidothymidine (AZT - zidovudine) increases the tendency of neutropenia. Therefore, paracetamol should not be taken with AZT unless there is medical advice.

It is recommended to avoid combination therapy with multiple painkillers. There is little evidence that this provides an extra benefit to the patient and often leads to an increase in undesirable effects.

The rate of paracetamol absorption may be increased by metoclopramide or domperidone and may be reduced by cholestyramine.

St. John's Wort (Hypericum perforatum) may reduce blood levels of paracetamol.

When taken together with nutrients, the rate of absorption of paracetamol may decrease.

Additional information on special populations No

data available.

Pediatric population:

4.6. Pregnancy and lactation

General advice

Pregnancy category: B

Women with childbearing potential / Contraception (Contraception)

There is no evidence that paracetamol has an effect on fertility.

Nevertheless, caution should be exercised when giving to women with childbearing potential.

The

safety of PANADOL during pregnancy has not been established. Paracetamol passes through the placenta and reaches similar levels in the fetal circulation as in the maternal circulation. However, there is epidemiological evidence that short-term maternal intake of therapeutic doses of paracetamol is not associated with teratogenic effects in humans.

There is no sufficient clinical data for paracetamol exposure in pregnancies. Animal studies do not show any direct or indirect adverse effects related to pregnancy / embryonal / fetal development / birth or postnatal development.

Lactation In

a pharmacokinetic study of lactating mothers, less than 1% of the dose of 650 mg was found in breast milk. Similar results were found in other studies. Therefore, taking therapeutic doses by the breastfeeding mother does not pose a risk to the baby.

Reproductive ability / Fertility

4.7. Effects on ability to drive and use machines

4.8. Undesirable effects The

frequency classification is as follows:

Very wide> 1/10 Width> 1/100 and <1/10 Uncommon> 1,000 and <1/100 Sparse> 1 / 10.000 and <1 / 1,000 Very infrequently <1 / 10.000.

Unknown (unpredictable from available data) The

adverse effects of paracetamol are usually mild. If it is taken over 10 g, toxicity is likely to occur.

Blood and lymph system diseases

Rare: When taken in large amounts, anemia, methemoglobinemia, hemolytic anemia-induced thrombocytopenia in long-term use, thrombocytopenic purpura, leukopenia, neutropenia and pancytopenia such as blood count changes

These side effects are not in the cause-effect relationship with paracetamol.

Very sparse: Agranulocytosis Immune system diseases

Rare: Allergic reactions, anaphylaxis Very rare: Lyell syndrome

Unknown: Bronchospasm, positive allergy test, immune thrombocytopenia Nervous system diseases

Common: Headache, dizziness, somlonance, paresthesia

Unknown: Central nervous system stimulation, encephalopathy, insomnia, tremor

Respiratory, chest diseases, and mediastinal diseases.

Diffuse: Symptoms of upper respiratory tract infection.

Infrequent: asthma and bronchospasm, including analgesic asthma syndrome.

Gastrointestinal diseases

Width: nausea, vomiting, dyspepsia, flatulence, abdominal pain, constipation Uncommon: Gastrointestinal haemorrhage Rare: Diarrhea

Hepatobiliary diseases

Rare: Hepatic impairment when taken in large quantities Skin and subcutaneous tissue disorders

Rare: Skin rash, itching, urticaria, allergic edema and angioedema, acute generalized exanthematous pustulosis, erythema multiform, Stevens-Johnson syndrome and toxic epidermal necrolysis (including fatal outcomes).

This symptom disappears when the drug is discontinued.

Kidney and urinary tract diseases

4.9. Overdose

There is a possibility of toxicity in adults if more than 10 grams are used. Furthermore, overdose is greater in patients with non-cirrhotic alcoholic liver disease. Following excessive dose in children, liver damage is relatively less frequent. Paracetamol half-life, which is about 2 hours in normal adults with an overdose of paracetamol in combination with liver cell damage, usually lasts 4 hours or longer. A reduction in excretion 14C02 after 14C-aminopyridine has been reported. This plasma better demonstrates the relationship between paracetamol overdose and liver cell damage compared to paracetamol concentration or half-life or conventional liver function test measurements. Kidney failure may occur due to acute tubular necrosis following fulminant liver failure due to paracetamol. However, the incidence of this is not more common in this group of patients compared to patients with fulminant liver failure for other reasons. Occasionally, 2-10 days after taking the drug, renal tubular necrosis may occur only in spite of minimal liver toxicity. It has been reported that chronic alcohol intake contributes to the development of acute pancreatitis in a patient with overdose of paracetamol. In addition to acute overdose, liver damage and nephrotoxic effects have been reported after daily intake of paracetamol.

Symptoms and symptoms:

pallor, anorexia, nausea, and vomiting are common early symptoms of paracetamol overdose. Hepatic necrosis is a dose-related complication of overdose of paracetamol. Hepatic enzymes may rise and prolong the prothrombin time within 12 to 48 hours, but clinical symptoms may not be apparent within 1 to 6 days following the administration of the drug.

Treatment:

Overdosage of paracetamol should be treated immediately to protect the patient against delayed hepatotoxicity. For this, intravenous N-acetylcysteine ​​or oral methionine should be given following reduction of absorption (gastric lavage or activated charcoal). Methionine should not be used if the patient is vomiting or conjugated with activated charcoal. Peak plasma paracetamol concentrations may be delayed up to 4 hours following overdose. Therefore, plasma paracetamol levels should be measured at least 4 hours after drug intake to determine the risk of hepatoxicity. Additional treatment (additional oral methionine or intravenous N-acetylcysteine) should be evaluated in terms of blood paracetamol content and time elapsed since drug intake. In patients receiving hepatic enzyme-inducing drugs, it is recommended to lower the treatment threshold with N-acetylcysteine ​​30-50% in patients with long-term alcohol-dependent or chronic nutritional deficiencies, as these patients may be more susceptible to the toxic effects of paracetamol. Treatment of fulminant liver failure that may develop following overdosing of paracetamol requires expertise.

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