Dolospa^® tabs (Tablets) Instructions for Use

Marketing Authorization Holder

Nabros Pharma, Pvt. Ltd. (India)

ATC Code

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

Active Substances

Paracetamol (Rec.INN registered by WHO)

Dicycloverine (Rec.INN registered by WHO)

Dosage Form

Dolospa® tabs

Tablets 500 mg+20 mg: 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a creamy tint, round, flat, with beveled edges, with a score on one side.

Excipients: corn starch, gelatin, calcium hydrogen phosphate, talc, magnesium stearate.

10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (10) – carton packs.

Clinical-Pharmacological Group

Spasm analgesic

Pharmacotherapeutic Group

Combined analgesic agent (non-narcotic analgesic agent + spasmolytic agent)

Pharmacological Action

A combined drug, the action of which is determined by the properties of the medicinal substances included in the composition.

Paracetamol is a non-narcotic analgesic, it blocks cyclooxygenase (COX) 1 and 2 mainly in the CNS, affecting the centers of pain and thermoregulation. In inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX, which explains the almost complete absence of anti-inflammatory effect. The absence of a blocking effect on the synthesis of prostaglandin in peripheral tissues determines the absence of a negative effect on water-salt metabolism (retention of sodium and water) and the gastrointestinal mucosa.

Dicycloverine is a tertiary amine with a relatively weak non-selective m-cholinolytic and direct myotropic antispasmodic effect on the smooth muscles of internal organs. In therapeutic doses, it causes relaxation of smooth muscles, which is not accompanied by side effects characteristic of atropine.

Indications

• Diseases accompanied by spasm of the smooth muscles of internal organs: intestinal colic, renal colic, biliary colic, algodysmenorrhea, irritable bowel syndrome, spastic constipation, pylorospasm.

ICD codes

Dosage Regimen

Administer orally with water.

For adults, take 1 tablet2-3 times per day as needed for pain relief.

Do not exceed the maximum single dose of 2 tablets.

Do not exceed the maximum daily dose of 4 tablets.

Limit the treatment duration to no more than 5 days.

Consult a physician before increasing the dose or duration of therapy.

Avoid concomitant intake of other products containing paracetamol.

Discontinue use and seek medical advice if symptoms persist.

Adverse Reactions

Allergic reactions (skin rash, itching, urticaria, angioedema), nausea, pain in the epigastric region; anemia, thrombocytopenia, agranulocytosis, dry oral mucosa, dizziness, accommodation paresis, mydriasis, blurred vision, vomiting, decreased potency, urinary retention, drowsiness.

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

Contraindications

• Severe renal and/or hepatic impairment;
• Congenital glucose-6-phosphate dehydrogenase deficiency;
• Bone marrow depression;
• Pregnancy;
• Lactation period;
• Childhood;
• Hypersensitivity to paracetamol or dicycloverine, as well as to the excipients included in the drug.

With caution: mild and moderate hepatic and/or renal impairment, angle-closure glaucoma, urinary retention (including due to prostatic hyperplasia), congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), elderly age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

With caution: mild and moderate hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

With caution: mild and moderate renal impairment.

Pediatric Use

Contraindicated in children.

Geriatric Use

Use with caution in the elderly.

Special Precautions

With long-term use, monitoring of the peripheral blood picture and functional state of the liver is necessary during treatment.

Paracetamol distorts laboratory test indicators during the quantitative determination of glucose and uric acid in plasma.

To avoid toxic liver damage, paracetamol-containing drugs should not be combined with the intake of alcoholic beverages.

Effect on the ability to drive vehicles and machinery

During the treatment period, it is necessary to refrain from potentially hazardous activities requiring increased attention, because dicycloverine can lead to drowsiness and blurred vision.

Overdose

Symptoms within the first 24 hours after administration – pale skin, nausea, vomiting, anorexia, abdominal pain; impaired glucose metabolism, metabolic acidosis. Symptoms of impaired liver function may appear 12-48 hours after overdose. In severe overdose – liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis. The hepatotoxic effect in adults is manifested when taking 10 g or more. Symptoms caused by dicycloverine: tachycardia, tachypnea, hyperthermia, CNS excitation.

Treatment in case of recent overdose (at the prehospital stage) – gastric lavage, activated charcoal; in a hospital – administration of SH-group donors and precursors of glutathione synthesis – methionine within 8-9 hours after paracetamol overdose and acetylcysteine – within 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as the time elapsed after its intake. Symptomatic treatment is also carried out.

Drug Interactions

Paracetamol

Reduces the effectiveness of uricosuric drugs.

Concomitant use of paracetamol in high doses enhances the effect of anticoagulant drugs (decreased synthesis of procogulant factors in the liver).

Inducers of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which determines the possibility of developing severe intoxications even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol contributes to the development of acute pancreatitis while using paracetamol.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic action.

Long-term simultaneous use of paracetamol and NSAIDs increases the risk of developing analgesic nephropathy and renal papillary necrosis, and the onset of end-stage renal failure. Simultaneous long-term use of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer. Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.

Myelotoxic drugs enhance the manifestations of hematotoxicity of the drug.

Dicycloverine

The effect is enhanced by amantadine, antipsychotic and class I antiarrhythmic drugs, benzodiazepines, MAO inhibitors, narcotic analgesics, nitrates and nitrites, adrenergic stimulants, tricyclic antidepressants, m-cholinolytics, glucocorticosteroids. By reducing gastrointestinal motility, it increases the absorption of digoxin, increasing its concentration in the blood.

Storage Conditions

Store the drug in a dry, light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 4 years.

Do not use the drug after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.