Парацетамол инструкция на английском языке

Paracetamol is one of the most common analgesic and antipyretic drugs. It is a part of many different drugs-analgesics and a number of drugs used for colds.

Effectively lowers the temperature and eliminates pain syndrome. In addition, it copes well with headache, dental, menstrual pain, symptoms of neuralgia. The main advantage of the drug is low toxicity.

As defined by WHO, it is considered one of the safest and most effective medicines and is widely used to treat children.

Clinical and pharmacological group

Analgetic-antipyretic. Has analgesic, antipyretic and weak anti-inflammatory effect.

Conditions of leave from pharmacies

Released without a doctor’s prescription.

Price list

How much does Paracetamol cost in pharmacies? The average price is at the level of10 rubles.

Form of issue and composition

The following dosage forms of Paracetamol are available:

• Tablets: white with a creamy hue or white, flat-cylindrical, with a risk and facet (10 pcs. in contour mesh or cell-free packages; 2 or 3 packs in a pack of cardboard);
• Suppositories rectal for children: torpedo, from white with a yellowish or creamy hue to white (5 pcs. in packs of cell contour; 2 packs in a pack of cardboard);
• Syrup (100 ml in vials, 1 bottle in a cardboard box);
• Suspension for oral administration (100 ml in bottles of dark glass with a dosage spoon in the kit, 1 set in a pack of cardboard).

1 tablet contains:

• Active substance: paracetamol — 200 or 500 mg;
• Auxiliary components: lactose (milk sugar), stearic acid, potato starch, gelatin.

In 5 ml of syrup contains:

• Active substance: paracetamol — 24 mg;
• Auxiliary components: water, sodium benzoate, aromatic additives, riboflavin, ethyl alcohol, propylene glycol, sodium citric acid trisubstituted, citric acid, sorbitol, sugar.

In 5 ml of the suspension contains:

• Active substance: paracetamol — 120 mg;
• Auxiliary components: purified water, orange or strawberry flavor, sorbitol food (sorbitol), glycerol (glycerin), sucrose (sugar), propylene glycol, methylparahydroxybenzoate (nipagin), xanthan gum (xanthan gum), avicel RC-591 (microcrystalline cellulose, sodium carmellose).

In 1 suppository contains:

• Active substance: paracetamol — 100 mg;
• Auxiliary components: a solid fat base.

Pharmacological effect

Paracetamol belongs to the drugs of the group of analgesics-antipyretics, that is, analgesics and antipyretic agents. In addition to analgesic and antipyretic effect, the drug also has a mild anti-inflammatory effect.

The mechanism of pharmacological action of Paracetamol is related to its ability to slow down the synthesis of prostaglandins and to affect the center of thermoregulation in the hypothalamus. When using the drug, the maximum concentration of the drug in the blood plasma is observed after 10-60 minutes.

Indications for use

What helps? Paracetamol is prescribed for the symptomatic treatment of pain syndrome of mild or moderate severity, of different origin and localization.

However, the most common indication for the beginning of taking this medicine is an increase in body temperature (hyperthermia) against the background of catarrhal and viral diseases, as well as pain (ache) in the bones and muscles of influenza and other acute respiratory viral infections.

Diseases, and pathological conditions in which acetaminophen is recommended:

• neuralgia;
• fever, unspecified genesis;
• sciatica;
• arthrosis;
• toothache;
• headache (incl. migraine);
• arthralgia (joint pain);
• myalgia (muscle pain);
• algodismenorea (painful periods).

Contraindications

Contraindications include:

• individual hypersensitivity (hypersensitivity) to the active substance;
• «Aspirin triad» (combination of intolerance to NSAIDs, bronchial asthma and recurrent polyposis of the nose and paranasal sinuses);
• inflammatory diseases, erosion and ulcers of the gastrointestinal tract;
• gastrointestinal bleeding;
• pronounced functional kidney failure;
• diagnosed hyperkalemia;
• age to 6 years for taking tablets;
• state after coronary artery bypass grafting.

Particular care when taking this drug should be observed in the following diseases and pathological conditions:

• chronic alcoholism and alcoholic liver damage;
• ischemic heart disease and chronic heart failure;
• cerebrovascular disease;
• lesions of peripheral arteries;
• renal and hepatic insufficiency.

At a diabetes it is not recommended to accept Paracetamol in the form of a syrup.

Use in pregnancy and lactation

If you need to use during pregnancy and lactation (breastfeeding), you should carefully weigh the expected benefit of therapy for the mother and the potential risk to the fetus or child.

1. Paracetamol penetrates the placental barrier. To date, there has been no adverse effect of paracetamol on the fetus in humans.
2. Paracetamol is excreted in breast milk: the content in milk is 0.04-0.23% of the dose taken by the mother.

In experimental studies, embryotoxic, teratogenic and mutagenic effects of paracetamol have not been established.

Dosage and route of administration

The instructions for use indicate that the tablets Paracetamol is prescribed orally.

1. Adults and children over 15 years of agesingle dose inside — 500 mg; the maximum single dose is 1000 mg. The maximum daily dose is 4000 mg.
2. Ages over 12 years old(with a body weight of more than 40 kg), a single dose of 500 mg, the maximum daily dose of 2000-4000 mg.
3. At the age of 9-12 years(body weight up to 40 kg), a dose of 500 mg, a maximum daily dose of 2000 mg.
4. Children from 6 to 9 years(with a body weight of 22-30 kg: single dose depends on the weight of the child and is 250 mg, the maximum daily dose of 1000-1500 mg.

The recommended interval between doses of the drug is 6-8 hours (not less than 4 hours).

Duration of treatment is no more than 3 days as an antipyretic agent and not more than 5 days as an anesthetic.

The need to continue treatment with the drug is decided by the doctor.

Side effects

The action of the drug in violation of the instructions, dosage provokes side effects. Overdose can cause:

• dysfunction of the liver or kidneys;
• rashes, redness, «urticaria». Allergy to a drug most often has such external manifestations;
• stomach ache. The stomach reacts so to improper intake or excess of the dose;
• sleepiness, I want to sleep. The cause of the condition is low pressure;
• a sharp drop in the level of glucose, hemoglobin in the blood.

If the dosage is disturbed or improperly taken, immediately call an ambulance.

Overdose

With prolonged use of tablets in large doses, the patient quickly develops symptoms of overdose, which clinically manifested in the form of strengthening of the above-described side effects and the development of hepatic insufficiency.

If you randomly ingest a large number of tablets, the patient should rinse the stomach as soon as possible and deliver it to the hospital. If necessary, symptomatic treatment is performed. Paracetamol antidote is H-acetylestein, it is administered orally or intravenously.

special instructions

With prolonged use of paracetamol, monitoring of the peripheral blood pattern and the functional state of the liver is necessary.

Caution is used in patients with impaired liver and kidney function, with benign hyperbilirubinemia, as well as in elderly patients.

It is used for the treatment of premenstrual tension syndrome in combination with pamabrom (diuretic, xanthine derivative) and mepirin (histamine H1 receptor blocker).

Drug Interactions

With simultaneous application:

1. activated carbon decreases the bioavailability of paracetamol.
2. with uricosuric means their effectiveness decreases.
3. with diazepam, a decrease in the excretion of diazepam is possible.
4. with carbamazepine, phenytoin, phenobarbital, primidone decreases the effectiveness of paracetamol, which is due to increase of its metabolism (processes of glucuronization and oxidation) and excretion from the body. The cases of hepatotoxicity with simultaneous application of paracetamol and phenobarbital are described.
5. for a period of less than 1 hour after paracetamol administration, a decrease in absorption of paracetamol is possible.
6. lamotrigine moderately increases the excretion of lamotrigine from the body.
7. with anticoagulants, a slight or moderate increase in prothrombin time is possible.
8. with anticholinergic agents, a reduction in paracetamol absorption is possible.
9. with oral contraceptives, the excretion of paracetamol from the body is accelerated and its analgesic effect may decrease.
10. with metoclopramide, it is possible to increase the absorption of paracetamol and increase its concentration in the blood plasma.
11. with probenecid, a decrease in paracetamol clearance is possible; with rifampicin, sulfinpyrazone — it is possible to increase the clearance of paracetamol due to an increase in its metabolism in the liver.
12. with inducers of microsomal liver enzymes, agents that have a hepatotoxic effect, there is a risk of intensifying the hepatotoxic effect of paracetamol.
13. With ethinyl estradiol, paracetamol is absorbed from the intestine.

Besides:

1. Cases of toxic effects of paracetamol when used with isoniazid are described.
2. There are reports of the possibility of enhancing the myelodepressant effect of zidovudine when used concomitantly with paracetamol. A case of severe toxic liver damage is described.

Reviews

We picked up some reviews of people who used the drug Paracetamol:

1. Igor. Paracetamol is always with me, I often am on the road, work is connected with traveling and this drug is constantly available in the car kit. He saved me many times. I take it with headache and toothache, with a cold. Good temperature, quickly improves well-being and unlike aspirin does not have a harmful effect on the stomach. It is quite inexpensive and is sold in any pharmacy.
2. Margarita. On the problem skin I know firsthand. I treat acne with a bolt, which I do on the basis of paracetamol and boric acid. In combination, these drugs perfectly relieve inflammation, remove redness and dry the rash. I heard that very good tablets eliminate toothache and stomach cramps with menstruation.
3. Sasha. Tablet Paracetamol and do not need additional medicine for the temperature, and all these powders, which he enters, just bullshit, diluted with any additional chemistry to sell more expensive. All these Nurofens, Teraflu and others. Drink pure Paracetamol and there will be happiness and health.

Analogues

Paracetamol has many analogues containing the same active substance. They are produced by many pharmaceutical companies under different brands. Here we give only some analogues of Paracetamol:

• Acetophene
• Aminadol
• Aminofen
• Apamid
• Apanol
• Biocetamol
• Valadol
• Valorine
• Deminofen
• Dolamine
• Metamol
• Mialgin
• Paramol
• Panadol Junior
• Pirinazine
• TempraMol
• Febridol
• Hemcetaphene
• Celiphane
• Efferalgan

Before using analogues, consult your doctor.

Which is better: Paracetamol or Ibuprofen?

Ibuprofen (Nurofen) has a broader spectrum of action and more favorably, in comparison with Paracetamol, affects the temperature curve. The effect from its application comes faster (already in 15-25 minutes) and lasts longer (up to 8 hours), in addition, the drug is considered less harmful and less likely to provoke allergic reactions. Ibuprofen better than its counterpart removes the critically high temperature. Repeatedly (to control hyperthermia) it is used much less often than Paracetamol.

The power of antipyretic action is comparable, however, ibuprofen, in addition to anesthetic and antipyretic action, also effectively removes inflammation in peripheral tissues. This is due to the fact that paracetamol acts primarily in the central nervous system, and ibuprofen — suppresses the synthesis of Pg not so much in the central nervous system as in inflamed peripheral tissues. That is, with expressed peripheral inflammation, the choice should be made in favor of Nurofen and other drugs based on ibuprofen.

Answering the question «What to choose, Paracetamol or Nurofen?», Doctors recommend starting treatment of young children with monotherapy with Ibuprofen. If you need to urgently reduce the temperature, you can use any of the drugs. Follow-up treatment should be agreed with the doctor. It should be noted that suppositories with ibuprofen are contraindicated in children weighing up to 6 kg, and suspension for children up to 3 months.

Storage conditions and shelf life

The drug in any dosage forms is released without the appointment of a doctor. Shelf life of Paracetamol is:

• Suppositories — 2 years at a temperature of up to 15 ° C;
• Tablets — 3 years at a temperature of up to 25 ° C;
• Syrup, solution for oral administration and suspension — 2 years at a temperature of up to 25 ° C.

Keep away from children!

Paracetamol dosage and administration

Dosage forms and strengths

Paracetamol is available in the following forms and strengths: 

1. Adults:

• Tablets – 325mg to 500mg
• Oral-disintegrating tablets – 80mg to 160mg
• Caplets – 325mg, 500mg and 650mg
• Extended-release caplets – 650mg
• Capsules – 500mg
• Gel caps / gel tabs – 500mg
• Oral suspension or solution – 160mg or 5ml
• Liquid (oral) – 500mg or 5ml
• Syrup (oral) – 160mg or 5ml
• Suppositories – 125mg, 250mg and 500mg

For the treatment of pain and fever…

The dosage recommendations of paracetamol products available over-the-counter may vary – products produced by different manufacturers may recommend specific dosages which may differ from similar products. It is thus a good idea to always check the leaflet or label before taking medication, especially if taking more than one product containing paracetamol.

Recommended dosages are calculated according to the use of a single product alone. If you are taking more than one medicated product containing paracetamol, you will need to take precautions to ensure that the general maximum daily allowance is not exceeded so as to avoid an overdose.

Unless directed otherwise by a medical doctor, general dosage recommendations are as follows:

Seniors who are 75 years of age or older may be given standard adult dosages, either via oral or intravenous administration. If pain is persistent, doses of between 325mg and 500mg may be given every 4 hours. Alternatively, 500mg to 1 000mg may be given every 6 hours. Daily dosages should not exceed 4 000mg a day. Should a senior show signs of liver impairment, dosages given as necessary should not exceed 2 000mg to 3 000mg per day.  

For the management of symptoms associated with renal impairment:

Under the supervised care of medical professionals, paracetamol may be given with caution to patients with kidney dysfunction…

• Glomerular filtration rate (GFR): Oral administration of 10 to 50ml per minute, every 6 hours as needed. Less than 10ml may also be given per minute, every 8 hours.
• Continuous renal replacement therapy (CRRT): Dosages (oral) may be given every 6 hours.
• Intravenous administration: 30ml per minute may be given with caution. Medical doctors may decrease the (total) dosage per day as required and extend dosing intervals in the case of severe renal impairment. 

For the management of symptoms associated with liver impairment:

Paracetamol will be used by a medical professional with extreme caution, especially if a patient shows signs of severe dysfunction.

• Oral administration: Low dosages may be given and are generally well tolerated in those with liver disease or cirrhosis. A doctor will factor in a person’s overall nutritional profile, assess renal function and alcohol use (if relevant) before recommending a dosage schedule or treatment plan. If alcohol use is a factor, a doctor may avoid treating a patient with paracetamol altogether. If a doctor opts to treat a person with liver impairment, paracetamol may be recommended at up to 2g a day over a short period of time (dosages will depend on a person’s overall condition and the severity of impairment). Medical monitoring will be required.
• Intravenous administration: Mild to moderate impairment may also be treated with low dosages, following similar protocols to oral administration. Extreme caution will be exercised. Dosages may not be given at all where a person’s condition is severe.

2. Paediatric:

• Tablets – 325mg to 500mg
• Oral-disintegrating tablets – 80mg to 160mg
• Caplets – 325mg, 500mg and 650mg
• Extended-release caplets – 650mg
• Capsules – 500mg
• Gel caps / gel tabs – 500mg
• Oral suspension or solution – 160mg or 5ml
• Liquid (oral) – 500mg or 5ml
• Syrup (oral) – 160mg or 5 ml
• Suppositories – 125mg, 250mg and 500mg

As with products available for adults, dosage recommendations of over-the-counter medication may also vary for children. It is best to read all leaflets and labels before administering medication to a child. Alternatively, a medical doctor or pharmacist can assist with the most appropriate products and dosages for a child, based on their age and condition.

Unless directed otherwise by a medical doctor, general dosage recommendations are as follows:

For the management of symptoms associated with renal impairment:

• Glomerular filtration rate (GFR): 10ml per minute or less (every 8 hours). Intermittent haemodialysis or peritoneal dialysis may be required and can be administered every 8 hours as needed.
• Intravenous administration: Children 2 years of age and older may be given 30ml (or less) a minute. A medical doctor will exercise caution and reduce this dose, extending intervals in between as required should impairment be severe.

For the management of symptoms associated with liver impairment:

• Oral administration: Mild to moderate impairment may be treated with low dosages. Extreme caution will be exercised. Dosages may not be given at all where a person’s condition is severe. Chronic use is not recommended at all.

Factors to consider before taking paracetamol

1. Known reactions and warnings

Certain reactions are known to occur in some instances. Care should be taken where possible reactions may be anticipated before taking paracetamol.

Paracetamol can result in hypersensitivity reactions (or immune-mediated reactions) – especially when administered by injection. Some individuals may also experience hypersensitivity reactions to other formulation components in combination products. Reactions may range from mild to severe and include things like:

• Rash
• Joint stiffness
• Fever
• Anaphylaxis (a life-threatening allergic reaction)

Other reactions which can occur following an injection include severe liver dysfunction.

If self-medicating, all labels of products should be read carefully so as to ensure that a person is well informed regarding all active and inactive ingredients, especially if prone to allergic reactions. Caution is advised in those with an existing allergy to acetaminophen, any inactive ingredient in products containing paracetamol, foods and other substances. Reactions of an allergic nature can include itching skin, the formation of a rash, coughing, wheezing, shortness of breath and swelling of the face, lips, tongue or throat.

Care should also be taken to understand different product varieties and not to confuse medications. For instance, some product names available over-the-counter may sound similar but are not always available for the same treatment purposes. Misunderstandings regarding dosage amounts can also occur by confusing milligram and millilitre quantities.

Duplicate therapy is another flag for anyone using paracetamol and paracetamol-containing combination products. Taking more than one pain or fever medication at recommended dosages will increase the amount of paracetamol in the body. This can easily lead to an overdosage and hepatoxicity symptoms. Exceeding recommended daily dosages can induce severe toxicity symptoms. It is best not to take too many of the same medication class so as to avoid such unwanted effects.

Alcohol consumption should also be kept to a minimum (if consumed at all) when taking paracetamol.

2. Factors which a medical doctor or pharmacist may wish to know before recommending paracetamol include:

• Disclosure of all known
• Disclosure of all medications (prescription, non-prescription, supplements, and herbal or natural substances) being taken or recently taken.
• Previous experience of developing a rash after paracetamol ingestion (if relevant).
• Disclosure of pregnancy or the fact that a woman is breastfeeding a baby.
• Disclosure of excessive alcohol use.
• Mention if the medication is intended to be given to a young child (aged up to 11 years) — especially if seeking a combination product that contains antihistamines, cough suppressants, expectorants or nasal decongestant ingredients.

How to take this medication correctly

1. Oral administration:

• Paracetamol can be taken with or without food. Tablets and capsules (unless chewable) should be swallowed whole with water. Gastrointestinal upset can sometimes occur if taken on an empty stomach. This can be alleviated by taking paracetamol after eating or along with a meal.
• Chewable tablets should be reasonably well chewed before swallowing (along with a little water).
• Suspension forms should always be well shaken before being swallowed. Many products include a measuring device (e.g. measuring spoon) to assist with administering the correct quantities.
• Disintegrating tablets can be allowed to dissolve in the mouth (on the tongue). Alternatively, these may be chewed before swallowing.
• Extended-release variations should never be crushed, split, dissolved or chewed. These must be swallowed whole with water.

2. Injection / intravenous infusion

• Doses are generally administered undiluted. Once solution vials are opened, they should be used within 6 hours.
• For dosages being administered at less than 1 000mg at a time, correct quantities are placed in sterile containers (like a syringe, syringe pump or IV container).
• Higher dosages can be placed in a vented IV set and administered through a vial stopper. Alternatively, a non-vented IV set can be used, and a dose administered through the spike port of a bag.
• Vials should not be used if any discolouration is noted. No other medications should ever be added to paracetamol for IV / infusion use.

3. Rectal (suppository)

• Hands should be thoroughly cleansed with soap and water before administering a suppository.
• The wrapping should be removed and the tip of the correct suppository (i.e. dosage quantity) dipped in water.
• To administer the suppository, one should lie on one’s side with the top knee raised towards the chest. The suppository (pointed end first) can then be easily inserted into the rectum (no further than an inch). Once inserted the suppository should be held in place for a minute or so.
• Staying still for about 15 minutes after insertion is helpful and allows the suppository to ‘dissolve’.
• Hands should be thoroughly washed following the insertion.
• Suppositories are for rectal use only. It is recommended that the bowel and bladder be empty before use. A patient should try and not use the toilet soon after insertion.

General considerations regarding use

• Use paracetamol only as instructed by a medical professional or as directed on a product package label. Care should be taken to never exceed the maximum single dosage (e.g. 1 gram per dose for adults) and daily total dosage (e.g. 4g a day for adults) recommendations — this way, hepatoxicity effects can be prevented.
• Generally, dosages of paracetamol should only be given at least 4 hours apart if a person is on a dosing schedule. If a dosage is missed during an interval period, it should be taken as soon as remembered if close to the time it should have been taken. If an additional dosage is required, this should be taken at least 4 hours later. If remembered close to the time of the next scheduled dose, skip the missed one and continue with the normal routine. Double dosages (making up for missed doses) should never be taken so as to avoid overdosage.
• Paracetamol should be stored at room temperature and kept away from moisture and heat. All oral products are best stored in their original containers with lids tightly closed. Suppositories can be stored at room temperature or in a refrigerator (not the freezer). Intravenous / injection vials may be kept at room temperature (not refrigerated or frozen). All products should be kept well out of reach from children and pets.
• Unused or expired products should be disposed of safely. Medications should not be flushed down the toilet or drain. Many countries have drug take-back-programmes for safe disposal purposes. A medical doctor or pharmacist can advise on procedures if relevant. Alternatively, unused medications can be sealed in bags or throw-away containers and disposed of along with normal trash.
• Seek a medical consultation and discontinue use in the following situations –
  • A fever has not subsided within 3 days of paracetamol use.
  • Pain persists for more than 10 days (in adults), 5 days (children and adolescents), or 3 days (infants).
  • Children with a sore throat that persists for more than 2 days following paracetamol treatment or who develop additional symptoms should be attended to by a medical doctor.
  • If other symptoms develop, or existing ones worsen.