Children's Panadol - instructions for use, dose, side effects, contraindications

Excipients: malic acid 2.5 mg, gum xanthan 35.0 mg, maltitol 3500.0 mg, sorbitol 70% crystalline 666.5 mg, sorbitol 105.0 mg, citric acid 1.0 mg, mixture of ethers with parahydroxybenzoic acids (methyl, ethyl, propyl parahydroxybenzoates sodium) 7.5 mg, strawberry flavor L1005 5 5.0 mg, azorubin dye 0.05 mg, water up to 5.0 ml.

Description:

Pink viscous liquid with a strawberry odor, in which crystals are present.

Pharmacotherapeutic group:Analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.01 Paracetamol

Pharmacodynamics:The drug has analgesic and antipyretic properties.It blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. The anti-inflammatory effect is practically absent. Has no effect on the state of the mucosa of the gastrointestinal tract and water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Pharmacokinetics:

Absorption is high - Panadol quickly and almost completely absorbed from the gastrointestinal tract. The connection with plasma proteins is about 15%. The peak concentration in plasma is achieved in 30-60 minutes.

The distribution of paracetamol in body fluids is relatively uniform.

Metabolized mainly in the liver with the formation of several metabolites. In newborns of the first two days of life and in children 3-10 years, the main metabolite of paracetamol is paracetamol sulfate, in children 12 years and older - conjugated glucuronide. Part of the preparation (approximately 17%) undergoes hydroxylation with the formation of active metabolites, which are conjugated to glutathione. With a lack of glutathione, these metabolites of paracetamol can block the enzyme systems of hepatocytes and cause their necrosis.

The half-life with a therapeutic dose is 2-3 hours.

When receiving therapeutic doses, 90-100% of the dose taken is excreted in the urine within one day. The main amount of the drug is released after conjugation in the liver. In unchanged form, not more than 3% of the received dose of paracetamol is released.

Indications:

Applied in children from 3 months to 12 years as:

- antipyretic agents - to reduce the elevated body temperature against the background of colds, influenza and childhood infectious diseases (chicken pox, mumps, measles, rubella, scarlet fever etc.)

- an anesthetic for dental pain, including teeth eruption, headache, earache with otitis and with sore throat.

For children 2 and 3 months of life, a single dose may be taken to lower the temperature after vaccination. If the temperature does not decrease, consult a doctor.

Contraindications:

- hypersensitivity to paracetamol or any other ingredient preparation;

- marked violations of the liver or kidneys;

- newborn period

Carefully:

Use with caution when violation of liver function (incl. Gilbert's syndrome), kidney, genetic absence of enzyme glucose-6-phosphate dehydrogenase, severe forms of blood diseases (severe form of anemia, leukopenia, thrombocytopenia). In the presence of any of the listed diseases before the drug should be taken consult a doctor.

Dosing and Administration:For oral administration.

Before use, the contents vial is needed well Shake for at least 10 seconds. Measuring syringe, embedded inside the package, allows for correct andrationally dose the drug. The dose of the drug depends on the age and body weight of the child.

Children (from 3 months to 12 years)

The maximum single dose is 15 mg / kg of body weight. The maximum daily dose is 60 mg / kg of body weight. Frequency of reception no more than 3-4 times a day. If necessary, you can give child recommended dose every 4-6 hours, but not more than 4 doses within 24 hours.

In all other cases before with the drug "Children's Panadol" you need a doctor's consultation.

Body weight (kg)	Age	Dose
		One-time		The maximum daily
		ml	mg	ml	mg
4,5-6	2-Crescent	Only by prescription of a doctor
6-8	3-6 months	4.0	96	16	384
8-10	6-12 months	5.0	120	20	480
10-13	1 -2 years	7.0	168	28	672
13-15	2-3 years	9.0	216	36	864
15-21	3-6 years old	10.0	240	40	960
21-29	6-9 years	14.0	336	56	1344
29-42	9-12 years old	20.0	480	80	1920

The duration of the application without a doctor's consultation is 3 days.

Do not exceed the recommended dose!

If the recommended dose is accidentally exceeded, the doctor should be consulted immediately, even if the child feels well, as there is a risk of developing liver damage (see "Overdose").

If the child's condition does not improve when taking the drug, consult a doctor.

Side effects:In recommended doses, the drug is usually well tolerated. The following side effects were revealed spontaneously during the post-marketing use of the drug.

Side effects are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (greater than or equal to 1/10), often (greater than or equal to 1/100 and less than 1/10), infrequently (greater than or equal to 1/1000 and less than 1/100), rarely (greater than or equal to 1/10 000 and less than 1/1000) and very rarely (greater than or equal to 1/100 000 and less than 1/10 000).

Allergic reactions:

Very rarely - in the form of rashes on the skin, itching, hives, angioedema, Stevens-Johnson syndrome, anaphylaxis;

On the part of the hematopoiesis system:

Very rarely - thrombocytopenia, anemia, leukopenia;

From the respiratory system:

Very rarely - bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs);

From the hepatobiliary system:

Very rarely - a violation of the liver.

Sometimes nausea, vomiting, pain in the stomach area are possible.

If any of these side effects occur, stop taking the medication and consult a doctor immediately.

Overdose:Symptoms: during the first 24 hours after an overdose, nausea, vomiting, stomach pain, sweating, pallor of the skin, anorexia. After 1-2 days, signs of liver damage are determined (soreness in the liver, increased activity of "liver" enzymes). It is possible to develop a violation of carbohydrate metabolism and metabolic acidosis. In adult patients, liver damage develops after taking more than 10 g of paracetamol in children - when taking more than 125 mg / kg of the child's body weight. In the presence of factors that affect the toxicity of paracetamol for the liver (see section "Interaction with other drugs", "Special instructions"), liver damage is possible after taking 5 or more grams of paracetamol.

In severe cases of overdose, as a result of liver failure, encephalopathy (impaired brain function), bleeding, hypoglycemia, cerebral edema can occur, up to a lethal outcome. It is possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (blood or erythrocyte admixture in the urine), proteinuria (high protein in the urine), with severe liver damage may be absent. There were cases of heart rhythm disturbances, pancreatitis.

With prolonged use with excess of the recommended dose, hepatotoxic and nephrotoxic effects (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis) can be observed.

Treatment: If you suspect an overdose, even if the first symptoms are not pronounced, stop using the drug and seek medical help immediately. Within 1 hour after an overdose it is recommended to wash the stomach and receive enterosorbents (Activated carbon, polyphepan).It is necessary to determine the level of paracetamol in the blood plasma, but not earlier than 4 hours after an overdose (earlier results are not reliable). Introduction of acetylcysteine within 24 hours after an overdose. The maximum protective effect is achieved within the first 8 hours after an overdose, with time the effectiveness of the antidote drops sharply. If necessary, enter acetylcysteine intravenously. If there is no vomiting before the patient enters the hospital, methionine may be used. The need for additional therapeutic (further introduction of methionine, intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

Interaction:If the child is already taking other medications, before taking the drug "Children's Panadol" should consult a doctor.

Barbiturates, carbamazepine, phenytoin, diphenine, primidon and other anticonvulsants, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, butadione, preparations of St. John's wort perfumed and others inducers of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more).

Inhibitors of microsomal liver enzymes reduce the risk of hepatotoxic effects.

Under the action of paracetamol, the time for removal of levomycetin (chloramphenicol) is increased by 5 times, as a result of which the risk of poisoning with levomycetin (chloramphenicol) increases.

With regular intake for a long time, the drug enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants. Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. The drug may reduce the effectiveness of uricosuric drugs.

Special instructions:

Children under the age of 3 months and children born prematurely, "Children's Panadol" can be given only on the instructions of a doctor.

When conducting tests for the determination of uric acid and blood sugar, tell your doctor about the use of the drug "Children's Panadol".

When taking the drug for more than 7 days, it is recommended control peripheral blood and functional state of the liver. Deficiency of glutathione due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion causes the possibility of developing severe liver damage with small overdoses paracetamol (5 g or more).

The drug should not be used at the same time from other paracetamol-containing preparations.

"Children's Panadol" contains maltitol and sorbitol. Patients with a rare hereditary intolerance to fructose should not take this drug. The preparation contains a mixture of parahydroxybenzoic acid esters (methyl, ethyl, propyl parahydroxybenzoates of sodium), which can cause delayed allergic reactions.

"Children's Panadol" does not contain sugar, alcohol and acetylsalicylic acid.

Form release / dosage:Suspension for oral administration, 120 mg / 5 ml.

Packaging:Primary packaging

For 100, 300 and 1000 ml in bottles of dark glass.

Secondary packaging

1 bottle together with a measuring syringe and instructions for use will prevent the cardboard pack.

Packing for hospitals

10-50 bottles of 1000 ml along with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature not higher than 30 ° C. Protect from light. Do not freeze. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N011292 / 01

Date of registration:23.04.2010 / 26.04.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

FARMACLAIR France

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp04.10.2015

Illustrated instructions

Instructions

Children's Panadol (Panadol Baby)