QUPEN JUNIOR

INSTRUCTIONS FOR USE

KUPIN JUNIOR

QUPEN JUNIOR

Trade name of the drug: Kupin Junior

Active ingredients ( INN ): Paracetamol and Ibuprofen

Release form : oral suspension.

Compound

Every 5 ml of suspension contains:

active substances :

Ibuprofen BF 100 mg

Paracetamol BF 162.5 mg

Scented base qs

Excipients:

Colloidal anhydrous silica, aspartame, methyl hydroxybenzoate, propyl hydroxybenzoate, orange flavor liquid essence, glycerol, sodium benzoate, sodium citrate, liquid sorbitol (crystallized) sorbitol 70%, polyoxyl 40 (hydrogenated castor oil), xanthan gum, sunset yellow supra ISI, purified water

Pharmacotherapeutic group: analgesic-antipyretic

ATX code: N02DE51

Pharmacodynamic properties

The pharmacological action of ibuprofen and paracetamol differs in location and mechanism of action. The complementary mechanisms of action are synergistic, which leads to greater antinociception and antipyretic effect than the action of each component separately.

Ibuprofen is a non-steroidal anti-inflammatory drug whose action is associated with peripheral inhibition of cyclooxygenase-2 (COX-2) isoenzyme with a subsequent decrease in the sensitivity of nociceptive nerve endings. The antipyretic effect of ibuprofen is caused by the central

inhibition of prostaglandin synthesis in the hypothalamus. Ibuprofen reversibly inhibits platelet aggregation. In humans, ibuprofen reduces inflammatory pain, swelling, and fever.

Paracetamol inhibits cyclooxygenase in the central nervous system more effectively. The antipyretic effect of paracetamol is associated with inhibition of the biosynthesis of prostaglandins directly in the hypothalamus, in particular, prostaglandins E ₂ and F ₂ , which are mediators of the thermoregulation center.

Pharmacokinetics

Ibuprofen is well absorbed from the gastrointestinal tract and binds to plasma proteins. Ibuprofen diffuses into the synovial fluid. Metabolized in the liver to two main metabolites with primary excretion through the kidneys, either as metabolites or as major conjugates, and also in small amounts as unchanged ibuprofen. Excretion by the kidneys is rapid and complete. The half-life is approximately 2 hours.

Paracetamol is easily absorbed from the gastrointestinal tract. Metabolized in the liver and excreted in the urine mainly in the form of glucuronide and sulfate conjugates, and about 10% in the form of glutathione conjugates. Less than 5% of paracetamol is excreted unchanged. The half-life is approximately 3 hours.

Indications for use

For the relief of fever, pain of various localizations of fever after immunization, toothache, infectious inflammation and musculoskeletal pain of all types, including sports injuries.

Directions for use and dosage

Inside

Children:

Up to 1 year, 1 teaspoon 3-4 times a day.

From 1 year to 5 years, 2 teaspoons 3-4 times a day.

Over 5 years: up to 4 teaspoons 3-4 times a day.

or as directed by a doctor.

Shake the bottle well before use.

Side effects

Hypersensitivity, peptic ulcer of the stomach and duodenum in the stage of exacerbation or bleeding of the gastrointestinal tract, pancreatitis, skin rashes, nausea, vomiting, discomfort in the epigastric region, dizziness and other allergic reactions. Symptoms of side effects (if any) should decrease after stopping the medication. If symptoms persist, consult your doctor.

Contraindications

This drug is contraindicated:

• patients with known hypersensitivity to NSAIDs, ibuprofen, paracetamol or any other components of the drug.
• patients with a history of hypersensitivity reactions (for example, bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• patients with a history of gastrointestinal ulcers/perforations or bleeding, including those associated with NSAIDs.
• patients with blood clotting disorders.
• patients with serious liver, kidney or heart disease.
• when used simultaneously with other drugs containing NSAIDs, including specific cyclooxygenase-2 (COX-2) inhibitors and doses of acetylsalicylic acid above 75 mg per day due to an increased risk of adverse reactions
• when used simultaneously with other paracetamol-containing drugs due to the increased risk of serious adverse reactions.
• during the last trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus with the possible development of pulmonary hypertension

Interaction with other drugs

Drugs containing ibuprofen and paracetamol should be used with caution with antihypertensive drugs, diuretics, cyclosporine, corticosteroids, anticoagulants, chloramphenicol and warfarin.

special instructions

Caution must be exercised when using the drug in patients with impaired renal and hepatic function. Check the expiration date on the package and do not use the product after the expiration date.

The drug should be stored out of the reach of children and not used after the expiration date.

Overdose

Paracetamol

Liver damage is possible in adults who have taken 10 g of paracetamol or more. Taking 5 g of paracetamol or more may cause liver damage if the patient is on long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin or other drugs that induce liver enzymes or regularly drinks alcohol. Ingestion of alcoholic products is not recommended.

Treatment with activated charcoal should be used within 1 hour of overdose.

Ibuprofen .

An overdose can cause symptoms such as nausea, vomiting, pain in the epigastric region, and less commonly, diarrhea, headache and gastrointestinal bleeding.

Treatment should be symptomatic and supportive and includes maintaining the airway and monitoring cardiovascular activity and vital signs at a stable level.

Release form

Suspension for oral administration, 60 ml (bottles) complete with a measuring cup.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25ºC.

Best before date

3 years.

Conditions for dispensing from pharmacies

On prescription.

Made in India :

Avison Pharmaceutical Pvt. Ltd., India

Coral Laboratories Limited

Plot no. 27-28, Pharmacity, Selaqui,

Dehradun, Uttarakhand – 248197, India