Tetramol

Pain syndrome of various intensities:

• dysmenorrhea and menstrual pain;
• headache;
• neuralgia;
• myalgia
• arthralgia
• toothache.

Fever (fever with flu and colds).

As part of the comprehensive treatment of postoperative pain, the weakening of the symptoms of rheumatoid arthritis and osteoarthritis.

Adults and adolescents aged 16 years should take 1-2 capsules 4 times a day, depending on the intensity of the pain and the recommendation of the doctor. The daily dose should not exceed 6 capsules. For children from 12 to 16 years: 1 capsule 1-2 times a day. The capsule should be taken without chewing, drinking enough liquid (a glass of water). Usually the duration of treatment is 3-7 days. If no improvement occurs during this time, treatment should be reviewed.

The maximum period of use for children without medical advice is 3 days.

The interval between receptions is at least 4 hours.

Do not exceed the recommended dose.

Hypersensitivity to paracetamol, ibuprofen, caffeine or to any other component of the drug, peptic ulcer disease, including in the anamnesis (two or more clear episodes of peptic ulcer exacerbation or bleeding); upper digestive tract bleeding or perforation in the anamnesis associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs); acute pancreatitis, severe liver and/or renal dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, severe anemia, leukopenia, thrombosis, thrombophlebitis, states of hyperexcitation; sleep disorders; severe arterial hypertension; organic diseases of the cardiovascular system; closed-angle glaucoma; epilepsy, hyperthyroidism, decompensated heart failure, cardiac conduction disturbance, severe atherosclerosis, tendency to vasospasm, ischemic heart disease, prostate hypertrophy, severe forms of diabetes mellitus, allergic reaction (e.g., bronchial asthma, rhinitis, Quincke's edema) after use of acetylsalicylic acid or other NSAIDs, concomitant use of the drug with NSAIDs, advanced age of the patient.

Do not use together with monoamine oxidase (MAO), cyclooxygenase-2 inhibitors and within 2 weeks after discontinuation of their use; contraindicated in patients taking tricyclic antidepressants or beta-blockers. Gilbert syndrome. Patient's age below 12 years. Contraindicated during pregnancy or lactation.

Interaction with other medicinal products and other types of interactions

With the simultaneous use of paracetamol with metoclamide and domperidone, it is possible to increase the absorption of paracetamol, with cholesterynamine - decrease the absorption.
In the case of long-term continuous use paracetamol may increase anticoagulation effect warfarin and other Kumarin, increased risk of bleeding. 

The PNICs may enhance the action of anticoagulants such as warfarin and weaken the action of drugs that reduce blood pressure or diuretics.
Simultaneous intake of other NSAIDs increases the risk of side effects. Corticosteroids may increase the risk of HCV side effects. Taking the drug can cause an increase in the concentration of lithium in the blood serum. Simultaneous use with methotrexate can lead to poisoning. Barbiturates reduce the anti-inflammatory effect of paracetamol.

Anticonvulsant drugs (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of microscopic liver enzymes, may increase the toxic effect of paracetamol on the liver by increasing the degree of transformation of the drug into hepatotoxic metabolites. When paracetamol is used with hepatotoxic agents, the toxic effects of the drugs on the liver are increased. The simultaneous use of high doses of paracetamol with isoniazide increases the risk of developing hepatotoxic syndrome. Paracetamol reduces the efficacy of diuretics. 

Do not use simultaneously with alcohol. It should not be used in combination with: acetylsalicylic acid, if a smaller dose of acetylsalicylic acid (not higher than 75 mg per day) was not prescribed by a doctor; non-steroidal anti-inflammatory drugs.

Application features

In patients with impaired liver function, as well as in those who take paracetamol for a long time, it is recommended to regularly conduct functional liver tests. If the patient uses warfarin or similar drugs that have an anticoagulant effect, it is necessary to consult a doctor before using the drug. Patients who take analgesics daily for mild arthritis should consult a doctor before using the drug. (more in the instructions for medical use of the drug).

Use during pregnancy or breastfeeding

It is contraindicated to use during pregnancy or breastfeeding. Starting from the 20th week of pregnancy, the use of ibuprofen can cause oligohydramnion due to fetal kidney dysfunction. In the case of exposure to ibuprofen for several days starting at week 20 of pregnancy, prenatal monitoring for oligohydramnion may be appropriate.

Children

Do not use the drug for children under the age of 12 years.

The ability to influence the speed of reaction when driving vehicles or other mechanisms.

In cases where adverse reactions from the nervous system are observed during treatment with the drug, one should refrain from driving vehicles and working with mechanisms.

Overdose

With long-term use of high doses, aplastic anemia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia, leukopenia are possible. When taking high doses, it is possible to have CNS disorders (dizziness, psychomotor excitation, impaired orientation and attention, insomnia, tremor, nervousness, anxiety), from the urinary system - nephrotoxicity (renal colic, interstitial nephritis, papillary necrosis).

In case of overdose, there may be increased sweating, psychomotor arousal or depression of the central nervous system, drowsiness, impaired consciousness, heart rhythm, tachycardia, extrasystole, tremor, hyperreflexia, convulsions.

Adverse reactions

The following adverse drug reactions are distributed according to MedDRA terminology.

From the immune system: hypersensitivity in the form of hives and itching; severe hypersensitivity reactions with the following manifestations: swelling of the face, tongue and larynx, shortness of breath, tachycardia, arrhythmia, decreased or increased blood pressure, anaphylaxis, Quincke's edema, hepatorenal syndrome, exacerbation of bronchial asthma and bronchospasm.
Nervous system: headache, dizziness, irritability, nervousness, depression, drowsiness, insomnia, anxiety, psychomotor agitation, emotional instability, convulsions, paresthesia, aseptic meningitis, some symptoms of which (stiff neck, headache, nausea, vomiting, fever or disorientation) may occur in patients with existing autoimmune diseases, such as systemic lupus erythematosus, mixed connective tissue disease.
Blood and lymphatic system: hematopoietic disorders, agranulocytosis, anemia (including hemolytic and aplastic), hematocrit and hemoglobin decreased, sulfhemoglobinemia and methemoglobinemia (cyanosis, dyspnea, heart pain), leukopenia, neutropenia, pancytopenia, thrombocytopenia. The first signs are: high fever, sore throat, mouth ulcers, flu symptoms, severe exhaustion, unexplained bleeding and bruising.
Gastrointestinal disorders: abdominal pain, heartburn, ulcerative stomatitis, dyspepsia and nausea; diarrhea, flatulence, constipation and vomiting, pancreatitis, duodenitis, esophagitis, gastritis, peptic ulcer, perforation or gastrointestinal bleeding, which in some cases can lead to death, especially in the elderly; exacerbation of ulcerative colitis and Crohn's disease.
From the urinary system: acute renal failure; renal colic; papillonecrosis, especially with prolonged use, is associated with increased serum urea, and edema; cystitis; hematuria; interstitial nephritis; nephrotic syndrome; oliguria; polyuria; tubular necrosis; glomerulonephritis; aseptic piuria.
On the part of the senses: hearing impairment, hearing loss, ringing or tinnitus, blurred vision, change in color perception, toxic amblyopia.
Respiratory: bronchospasm in patients sensitive to aspirin and other NSAIDs.
From the heart: heart failure, edema, Kounis syndrome.
From the vascular system: arterial thrombosis (myocardial infarction or stroke).
From the endocrine system and changes in metabolism: hypoglycemia, up to hypoglycemic coma; decreased appetite; dryness of the mucous membranes of the eyes and oral cavity; rhinitis.
From the liver: liver disorders; increased activity of hepatic enzymes, hepatonecrosis (dose-dependent effect), hepatic insufficiency with prolonged treatment, hepatitis and jaundice may occur.
Skin and subcutaneous tissue: skin allergic reactions, rashes, purpura, peeling of the skin, itching, alopecia, photosensitization; angioedema, severe cutaneous adverse reactions (ESRD) (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), Drug-induced eosinophilia with systemic symptoms (DRESS syndrome), Acute generalized exanthematous pustulosis (GGEP). If these symptoms occur, the patient should stop taking Tetramol and seek immediate medical attention.

General disorders: malaise and fatigue.

Concomitant administration of the drug in recommended doses with caffeine-containing products may exacerbate caffeine-induced side effects, such as:
mental disorders: headache, dizziness, increased excitability, anxiety, irritability, palpitations, anxiety, insomnia due to CNS stimulation;
gastrointestinal tract: nausea caused by gastrointestinal irritation.

Active substances: paracetamol, ibuprofen, caffeine;

1 capsule contains paracetamol 325 mg, ibuprofen 200 mg, caffeine 30 mg

Excipients: talc, colloidal silicon dioxide, sodium lauryl sulfate, gelatin, kandurin (titanium dioxide (E 171), potassium aluminosilicate (E 555)).

Capsules.
6 capsules in blisters.
6 capsules in a blister; 5 blisters in a cardboard box.
10 capsules in a blister; 3 blisters in a cardboard box.

Store in the original packaging at a temperature not exceeding 25 °C out of the reach of children.

JSС «Grindeks», Latvia

Dragenopharm Apotheker Püschl GmbH.

UA/13734/01/01