Effervescent Hapacol

RECIPE:

Paracetamol ..................... 500 mg

Excipients 1 capsule

(Tartaric acid, anhydrous citric acid, aspartame, PVP K30, anhydrous lactose, sodium bicarbonate, effersoda, acesulfam potassium, orange flavor powder, sodium benzoate, polyethylene glycol 6000, talc).

DOSAGE FORM: Effervescent tablets.

PRESENTATION: Box of 4 blisters x 4 tablets.

ACTIONS: Paracetamol is an effective analgesic - antipyretic. The drug acts on the hypothalamic heat-regulating center to cool down, increase heat dissipation due to vasodilation and increase peripheral blood flow to reduce body temperature in people with fever, but rarely with normal body temperature. At therapeutic doses, analgesic and antipyretic effects are similar to those of aspirin but Paracetamol has little effect on the cardiovascular and respiratory system, does not change the acid - base balance, does not cause irritation, scratches or stomach bleeding. .

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The elimination half-life is 1.25 - 3 hours. The drug is metabolized in the liver and excreted by the kidneys.

POINT:

- Treatment of pain symptoms in cases: headache, migraine, toothache, aches and pains caused by flu, sore throat, musculoskeletal pains, arthritis pain, pain after vaccination or tooth extraction.

- Reducing fever in patients with colds or diseases related to fever.

CONTRAINDICATIONS: Hypersensitivity to any components of the drug. Patients with glucose deficiency - 6 - phosphate dehydrogenase.

Special precautions and warnings when using the drug:

For people with phenylceton-urinary and people must limit the amount of phenylalanine introduced into the body should avoid using Paracetamol with drugs or food containing Aspartam.

For some people with hypersensitivity (asthma) Paracetamol should be avoided with medicines or sulfite-containing foods.

Must be used with caution in patients with preexisting anemia, impaired liver and kidney function.

Paracetamol may cause hepatotoxicity to the liver, so avoid or limit alcohol consumption.

Physicians should warn patients for signs of serious skin reactions such as Steven-Johnson syndrome (SJS), toxic skin necrosis syndrome (TEN) or Lyell syndrome, total pustular exanthema. acute body (AGEP).

Pregnant women and nursing mothers: The safety of Paracetamol has not been determined for the fetus when using the drug for pregnant women. Therefore, the drug should be used in pregnant women only if clearly needed. Research in lactating mothers, using Paracetamol did not show any undesirable effects in nursing infants.

DRIVING AND OPERATION OF MACHINERY: The drug does not affect the ability to drive and operate machinery.

INTERACTIONS: Prolonged use of high doses of Paracetamol slightly enhances the anticoagulant effect of Coumarin and Indandion derivatives.

Attention should be paid to the possibility of serious fever reduction in patients concurrently taking phenothiazine and hypothermia therapy.

Anticonvulsants (Phenytoin, Barbiturate, Carbamazepin), Isoniazid and anti-tuberculosis drugs may increase hepatotoxicity of Paracetamol.

Excessive and prolonged alcohol consumption can increase the risk of Paracetamol being toxic to the liver.

UNWANTED EFFECTS:

Uncommon: skin rash; nausea, vomiting; kidney disease, kidney toxicity when prolonged use; Neutropenia, anemia, anemia.

Rarely: hypersensitivity reactions.

Inform your doctor unwanted effects encountered when using the drug.

OVERDOSE AND TREATMENT: Paracetamol overdose due to single or multiple doses of paracetamol (7.5 - 10 g daily, for 1-2 days) or long-term medication. Dose-dependent hepatic necrosis is the most acute acute toxic effect due to an overdose and can be fatal.

Symptoms of Paracetamol overdose include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails.

Symptoms of severe Paracetamol poisoning: initially mild stimulation, agitation and delirium. Next is inhibition of the central nervous system: stupor, hypothermia, fatigue, rapid and shallow breathing; Fast, weak, irregular pulse, low blood pressure and circulatory failure.

Treatment: Early diagnosis is important in the treatment of paracetamol overdose.

When paracetamol poisoning is severe, aggressive supportive treatment is needed. Gastric lavage should be taken in all cases, preferably within 4 hours after ingestion.

The main detoxication therapy is the use of sulfhydryl compounds. N - acetylcysteine ​​has effect when taken orally or intravenously.

Alternatively, methionine, activated carbon and / or salt bleach may be used.

DOSAGE AND ADMINISTRATION:

Dissolve the tablet in the desired amount of water until the effervescence has disappeared. The interval between 2 doses should take more than 4 hours and do not exceed 8 tablets / day.

Adults and children> 12 years: 1 capsule / time.

Severe pain: adults can take 2 capsules / time.

Or as directed by a physician.

Note:

* Maximum dose / 24 hours:

- For children: drink no more than 5 times / day.

* Do not prolong the self-use of the drug but should consult a doctor when:

- There are new symptoms appear.

- High fever (39.5^oC) and lasting for more than 3 days or relapse

- Pain gets worse or lasts for more than 5 days.

Read the directions carefully before use.

Expiry date: 24 months from date of manufacture.

If you need further information, please consult your doctor.

Storage conditions: Store in dry places, not exceeding 30^oC, protect from light.

Standard: TCCS.