Active substanceDiphenhydramine + ParacetamolDiphenhydramine + Paracetamol
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Dosage form: & nbspCapsules, film-coated tablets of blue color. In the break, the tablets are white.
Composition:

For 1 tablet

Active substances:

Paracetamol - 500.00 mg

Diphenhydramine hydrochloride - 25.00 mg

Excipients:

Croscarmellose sodium - 5.00 mg,

Carboxymethyl starch sodium - 5.56 mg.

Magnesium stearate - 6.00 mg,

Silicon dioxide - 3.00 mg,

Povidone - 11.12 mg,

Pregelatinized starch - 22.24 mg,

Stearic acid is 31.68 mg.

Tablet casing:

Hypromellose - 6.35 mg,

Magnesium silicate - 4.00 mg,

Triacetin - 1.37 mg,

Mineral oil - 0.69 mg,

Titanium dioxide - 2.67 mg,

Dye brilliant blue - 0.12 mg,

Dye quinoline yellow - 0.01 mg.

Description:
Capsules, film-coated tablets of blue color. In the break, the tablets are white.
Pharmacotherapeutic group:Analgesic non-narcotic agent + H1 - histamine receptor blocker
ATX: & nbsp

N.02.B.E.51   Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:Combined drug. Paracetamol has analgesic and antipyretic effect. Diphenhydramine - blocker H1 -gistaminovyh receptors of the first generation, eliminates the effects of histamine,mediated through this type of receptor. The effect on the central nervous system is due to the blockade of H3-gistaminovyh receptors of the brain and inhibition of central cholinergic structures. Has strong antihistaminic activity, reduces or prevents spasms of smooth muscle caused by histamine, increased capillary permeability, edema of the tissues, itching and flushing.
Indications:Pain syndrome of mild and moderate severity (headache and toothache, pain with sinusitis and cough, myalgia, arthralgia), dyscalogenemia; pain accompanied by insomnia.
Contraindications:Hypersensitivity, children under 12 years of age, pregnancy, breastfeeding.
Carefully:
Hepatic and / or renal failure, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), alcoholism; closed-angle glaucoma, urinary retention (prostatic hyperplasia), stenosing stomach ulcer and duodenal ulcer, stenosis of the neck of the bladder, bronchial asthma, chronic obstructive pulmonary disease, epilepsy.
Pregnancy and lactation:The drug is contraindicated during pregnancy and breastfeeding.
Dosing and Administration:

Inside, for 1 2 tablets every 6 hours until the pain disappears (no more than 8 tablets per day).

For insomnia caused by pain - 2 tablets at bedtime.

Duration of admission without consulting a doctor - no more than 10 days.

Side effects:Allergic reactions (skin rash, itching, hives, angioedema), nausea, epigastric pain; anemia, thrombocytopenia, agranulocytosis. Drowsiness, dry mouth, numbness of the oral mucosa, dizziness, tremor, nausea, headache, asthenia, decreased speed of the psychomotor reaction, photosensitivity, paresis of accommodation, movement coordination disorders. Children can paradoxically develop insomnia, irritability and euphoria. With prolonged use in large doses - hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis).
Overdose:

Symptoms (due to diphenhydramine): depression of the central nervous system, the development of excitation (especially in children) or depression, dilated pupils, dry mouth, paresis of the organs of the gastrointestinal tract.

Symptoms caused by paracetamol: pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Increased activity of "liver" transaminases, an increase in prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver failure develops lightly and can be complicated by renal failure (tubular necrosis).

Treatment: gastric lavage, if necessary - symptomatic therapy, incl. oxygenotherapy, plasma-substituting agents, donors of SH-groups and precursors of glutathione-methionine synthesis - 8-9 hours after overdose and N-acetylcysteine ​​- after 12 hours.

Can not use epinephrine.

Interaction:
Strengthens the action of ethanol and drugs that depress the central nervous system. Monoamine oxidase inhibitors increase the anticholinergic activity of diphenhydramine.Reduces the effectiveness of apomorphine, appointed as an emetic drug for the treatment of poisoning. Antagonistic interaction is noted when co-administered with psychostimulants. It enhances the anticholinergic effects of the drug with m-cholinoblocking activity. Increases the effect of monoamine oxidase inhibitors. Reduces the effectiveness of uricosuric medicines. Under the influence of paracetamol, the time of chloramphenicol elimination is increased by 5 times. With long-term admission paracetamol can enhance the effect of indirect anticoagulants. Simultaneous reception of paracetamol and ethanol increases the risk of hepatotoxic effects and acute pancreatitis. Barbiturates, phenytoin, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants and other stimulators of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of development of severe intoxication with small overdoses. Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects. Metoclopramide and domperidone increase, and colestramine reduces absorption.Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Special instructions:

Avoid UV radiation.

During the treatment it is necessary to refrain from using ethanol (it is possible to develop a hepatotoxic effect).

Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Form release / dosage:
Film-coated tablets.
Packaging:

For 8 tablets in a blister of PVC and aluminum foil.

1 or 2 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

List B.

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiration date indicated on the package.

Terms of leave from pharmacies:Without recipe
Registration number:П N014954 / 01
Date of registration:26.08.2009
Expiration Date:Unlimited
The owner of the registration certificate: Foor Ventures Enterprise, Inc. Foor Ventures Enterprise, Inc. USA
Manufacturer: & nbsp
Representation: & nbspMASKOVI COMPANY LTDMASKOVI COMPANY LTD
Information update date: & nbsp24.04.2018
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