Migrenol^® PM (Tablets) Instructions for Use

Marketing Authorization Holder

Avivir LLC (Russia)

Manufactured By

V-MIN, LLC (Russia)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Diphenhydramine (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Dosage Form

Migrenol® PM

Film-coated tablets, 25 mg+500 mg: 8 or 16 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue in color, oval, biconvex; on the cross-section, the tablet core is white or almost white.

Excipients: croscarmellose sodium, sodium carboxymethyl starch, magnesium stearate, colloidal silicon dioxide, povidone K30, pregelatinized starch, stearic acid.

Shell composition Opadry KB 310A180023 White (OPADRY KB 310A180023 WHITE): macrogol (PEG) and polyvinyl alcohol copolymer, titanium dioxide, kaolin, copovidone, sodium lauryl sulfate, Opadry KB 310A105021 Blue (OPADRY KB 310A105021 BLUE): macrogol (PEG) and polyvinyl alcohol copolymer, kaolin, brilliant blue dye, titanium dioxide, copovidone, sodium lauryl sulfate.

8 pcs. – blister packs (1) – cardboard packs.
8 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Analgesic-antipyretic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

Combined medicinal product.

Paracetamol has analgesic and antipyretic effects.

Diphenhydramine is a first-generation histamine H₁-receptor blocker; it eliminates the effects of histamine mediated through this type of receptor. The effect on the CNS is due to the blockade of histamine H₃ receptors in the brain and inhibition of central cholinergic structures. It has pronounced antihistamine activity, reduces or prevents histamine-induced smooth muscle spasms, increased capillary permeability, tissue edema, itching, and hyperemia.

Indications

Mild to moderate pain syndrome: headache and toothache; pain with sinusitis and cough; myalgia; arthralgia; algodysmenorrhea; pain accompanied by insomnia.

ICD codes

Dosage Regimen

Take Migrenol^® PM tablets orally with a full glass of water.

Adults and children 12 years and older: take one to two tablets as a single dose.

Wait at least 6 hours between doses.

Do not exceed four tablets (2 g paracetamol) in a 24-hour period.

For insomnia caused by pain, take a single dose 30 minutes before bedtime.

Limit self-treatment to a maximum of 10 consecutive days for pain or 3 days for fever.

Consult a physician if symptoms persist beyond these durations or if a higher, more frequent dosage is required.

Reduce dosage or increase dosing interval in patients with hepatic impairment, renal impairment, or chronic alcoholism.

Do not crush or chew the tablets; swallow them whole.

Adverse Reactions

Allergic reactions skin rash, itching, urticaria, angioedema.

From the digestive system nausea, epigastric pain; dryness of the oral mucosa, numbness of the oral mucosa, nausea.

From the hematopoietic system anemia, thrombocytopenia, agranulocytosis.

From the nervous system drowsiness, dizziness, tremor, headache, asthenia, decreased speed of psychomotor reactions, paresis of accommodation, impaired coordination of movements.

Other photosensitivity.

In children paradoxical development of insomnia, irritability, and euphoria is possible.

With long-term use in high doses hepatotoxic effect, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; nephrotoxicity (renal colic, glucosuria, interstitial nephritis, papillary necrosis).

Contraindications

Hypersensitivity to paracetamol and/or diphenhydramine; children under 12 years of age.

With caution

Hepatic and/or renal insufficiency, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson, and Rotor syndromes), alcoholism; angle-closure glaucoma, urinary retention (prostatic hyperplasia), stenosing peptic ulcer of the stomach and duodenum, stenosis of the bladder neck, bronchial asthma, COPD, epilepsy. Pregnancy, lactation (breastfeeding).

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible only under medical supervision.

Use in Hepatic Impairment

With caution hepatic insufficiency.

Use in Renal Impairment

With caution renal insufficiency.

Pediatric Use

Contraindication — children under 12 years of age.

Special Precautions

Consult a doctor if taking sedative medications simultaneously.

Avoid UV radiation during treatment with diphenhydramine.

It is necessary to inform the doctor about the use of this combination: the antiemetic effect may complicate the diagnosis of appendicitis and the recognition of symptoms of overdose of other medicinal products.

Do not use simultaneously with other products containing Paracetamol, as well as other non-narcotic analgesics, NSAIDs (metamizole, acetylsalicylic acid, ibuprofen, etc.), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

During treatment, it is necessary to refrain from consuming ethanol (development of hepatotoxic effects is possible).

Effect on ability to drive vehicles and mechanisms

During treatment, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

MAO inhibitors enhance the anticholinergic activity of diphenhydramine. The combination enhances the effect of MAO inhibitors.

Reduces the effectiveness of apomorphine prescribed as an emetic for the treatment of poisoning.

Antagonistic interaction is noted with simultaneous administration with psychostimulants.

Enhances the anticholinergic effects of medicinal products with m-cholinoblocking activity.

Reduces the effectiveness of uricosuric medicinal products.

Under the influence of paracetamol, the elimination time of chloramphenicol increases 5 times.

With long-term use, Paracetamol may enhance the effect of indirect anticoagulants.

Barbiturates, phenytoin, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants and other microsomal oxidation stimulators increase the production of hydroxylated active metabolites, creating the possibility of severe intoxication with small overdoses.

Microsomal oxidation inhibitors (cimetidine) reduce the risk of hepatotoxic action.

Metoclopramide and domperidone increase, and cholestyramine reduces absorption.

Myelotoxic medicinal products enhance the manifestations of hematotoxicity.

Diphenhydramine enhances the effect of ethanol and medicinal products that depress the CNS. Simultaneous intake of paracetamol and ethanol increases the risk of hepatotoxic effects and acute pancreatitis.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.