Instruction for use: Next

Trade name of the drug – Next

International nonproprietary name Ibuprofen + Paracetamol

Ingredients per tablet

Active substance: 400 mg ibuprofen, 200 mg of paracetamol.

Excipients: Core: calcium hydrogen phosphate (Fudzhikalin) - 80.0 mg, microcrystalline cellulose - 64.5 mg sodium Valium - 24.3 mg, giproloza (hydroxypropyl cellulose (EF Klutsel)) - 19.3 mg talc - 12, 1 mg magnesium stearate - 7.3 mg colloidal silicon dioxide (aerosil) - 2.5 mg;

Coating: Opadry Red 20A250004 (20A250004 OPADRY RED) [Valium (hydroxy-propyl-cellulose lmetil) - 13.1 mg, giproloza (hydroxypropyl cellulose) - 8.1 mg talc - 6.4 mg titanium dioxide - 2.5 mg carmine dye [Ponceau 4R] (E 124) - 0.9 mg dye sunset yellow (E 110) - 0.5 mg] - 31.5 mg Opadry II 85F19250 CLEAR (OPADRY II 85F19250 CLEAR) [macrogol (polyethylene glycol) - 0.3 mg polyvinyl alcohol - 1.0 mg polysorbate 80 - 0.1 mg talc - 0.6 mg] - 2.0 mg.

Pharmacotherapeutic group:analgesic combination (NSAID + non-narcotic analgesic agent)

ATC code: M01AE51

Pharmacological properties:

pharmacodynamics

Combined product has analgesic, anti-inflammatory and antipyretic effect.

Paracetamol - non-narcotic analgesic, has antipyretic and analgesic effect due to blockade of cyclooxygenase in the central nervous system and the effect on pain centers and thermoregulation.

Ibuprofen - a non-steroidal anti-inflammatory drug has analgesic, antipyretic and anti-inflammatory effects associated with non-selective inhibition of cyclooxygenase activity that regulates the synthesis of prostaglandins.

The components of the drug affect both the central and the peripheral mechanisms of pain. Directed, complementary action of the two components has a rapid therapeutic effect and a pronounced analgesic action.

Pharmacokinetics
Paracetamol

Absorption - high, the maximum concentration (Cmax) is 5-20 mcg / ml, the time to reach maximum concentration (Tmax) - 0.5-2 hours; connection with plasma proteins - 15%. It penetrates through the blood-brain barrier.

It is metabolized in the liver by glucuronization, sulfation and hydroxylation to form both active and inactive metabolites. The metabolism of paracetamol is involved isoenzyme cytochrome P450 CYP2E1.

The half-life (T1 / 2) - 4/1 hour. Mainly excreted by the kidneys as metabolites - glucuronide and sulfate, 3% - unchanged.

Ibuprofen
It is well absorbed from the gastrointestinal tract. The time to maximum concentration (Tmax) in the fasting - 45 minutes when administered after a meal - Communication 1.5-2.5 hours with plasma proteins -. 90%. Drug concentration in synovial fluid than in plasma. Treated presistemnomu and post-systemic metabolism in the liver. In the metabolism of ibuprofen is involved isoenzyme cytochrome P450 CYP2C9. It has a two-phase kinetics of clearance, T1 / 2 is 2-2.5 hours excreted by the kidneys (unchanged to less than 1%) and to a lesser extent -. Bile.

Indications

- Headache (including migraine headache);

- toothache;

- Algomenorrhea (painful menstruation);

- Neuralgia;

- Myalgia;

- back pain;

- Joint pain, pain in inflammatory and degenerative diseases of the musculoskeletal system;

- The pain of bruises, sprains, dislocations, fractures;

- Post-traumatic and postoperative pain;

- Fevers (including the flu and colds).

Contraindications

- Hypersensitivity to the drug, including other non-steroidal anti-inflammatory drugs (NSAIDs);

- Erosive and ulcerative diseases of the gastrointestinal tract (exacerbation), gastrointestinal bleeding;

- Progressive kidney disease;

- Severe renal impairment (creatine clearance (CC) of less than 30 ml / min.);

- Severe hepatic impairment or active liver disease;

- Bleeding disorders (hemophilia, prolonged bleeding, bleeding tendency, bleeding diathesis);

- Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis, and paranasal sinuses and intolerance of aspirin or other nonsteroidal anti-inflammatory drugs, including in history;

- Condition after coronary artery bypass surgery;

- Confirmed by hyperkalemia;

- Deficiency of glucose-6-phosphate dehydrogenase;

- Pregnancy (III trimester);

- The period of breast-feeding;

- Children up to age 12 years.

Precautions
Chronic heart failure; viral hepatitis, alcoholic liver disease, liver and / or kidney failure moderate and mild, benign hyperbilirubinemia (Gilbert's syndrome, Dubin-Johnson and Rotor), liver cirrhosis with portal hypertension, nephrotic syndrome; diabetes, peripheral artery disease, peptic ulcer and duodenal ulcer (in history); gastritis, enteritis, colitis; asthma, bronchospasm; elderly age; pregnancy (I and II trimesters - the application can only be prescribed by a doctor in cases where the potential benefits outweigh the potential risk).

Pregnancy and lactation
If necessary, use I and II trimester of pregnancy should be careful - the application can only be prescribed by a doctor in cases where the potential benefits outweigh the possible risk. Use of the drug in the III trimester of pregnancy is contraindicated. During the period of breastfeeding, if necessary, the drug should stop breast-feeding.

Next Dosage and administration:

Inside, after a meal.

Adults: 1 tablet 3 times a day. The maximum daily dose - 3 tablets.

Children older than 12 years (body weight more than 40 kg): 1 tablet 2 times a day.

Duration of treatment is not more than 3 days as antipyretic and not more than 5 days - as an analgesic. Continuation of treatment is possible only after consultation with your doctor.

Next Side effect

Side effects are listed with frequency of occurrence in accordance with the WHO classification: very common (with a frequency of more than 1/10), common (with a frequency of not less than 1/100 and less than 1/10), uncommon (with a frequency of not less than 1/1000 but less than 1/100), rarely (with a frequency of not less than 1/10000 and less than 1/1000), very rare (with a frequency of less than 1/10000, including isolated reports) frequency not known (can not be established from the available data ).

From the nervous system: rarely - headache, dizziness, sleep disturbances, anxiety, hallucinations, confusion, rarely - aseptic meningitis, rarely - depression.

Since the cardiovascular system: often - peripheral edema, rarely - tachycardia, increased blood pressure, heart failure. With the respiratory system: very rarely - dyspnea, bronchospasm.

From the gastrointestinal tract: often - abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, erosive and ulcerative lesions of the gastrointestinal tract; rarely - constipation, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, gastrointestinal bleeding.

Senses: rarely - hearing loss, ringing or noise in the ears, blurred vision, blurred vision or diplopia, the frequency is unknown - dryness and irritation of the eyes. From the urinary system: very rarely - acute renal failure, nephrotic syndrome, cystitis; the frequency is unknown - polyuria.

Allergic reactions: seldom - skin rash, itching, allergic rhinitis, angioedema; very rarely - exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the side of hematopoiesis: rarely - anemia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, eosinophilia.

Skin and subcutaneous tissue disorders: often - a rash.

With prolonged use at high doses - hepatotoxic and nephrotoxic effects (hepatitis, interstitial nephritis and papillary necrosis); hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

If you have any side effects should see a doctor.

Next Overdose

Symptoms: abdominal pain, nausea, vomiting, agitation or lethargy, drowsiness, confusion, tachycardia, arrhythmia, acute renal failure, metabolic acidosis, frequent urination, pyrexia, headache, tremors or muscle twitching; increased activity of "hepatic" transaminases, increased prothrombin time. If you suspect an overdose, you should immediately seek medical help.

Treatment: gastric lavage, followed by the appointment of activated carbon; alkaline water, forced diuresis, symptomatic therapy, the introduction of donators sulfhydryl groups (acetylcysteine) and precursors of glutathione synthesis (methionine).

Next Interaction with other drugs

Inductors microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumetsinol, rifampin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes the possibility of severe toxicity in overdose.

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

Myelotoxic drugs increase the expression gematotoksichnosti drug.

Cyclosporine and gold preparations increase the nephrotoxicity of the drug.

The combination of ibuprofen with ethanol, corticosteroids increase the risk of erosive and ulcerative lesions of the gastrointestinal tract.

Concomitant use of paracetamol with ethanol increases the risk of acute pancreatitis.

Paracetamol and ibuprofen increase the effect of anticoagulants of indirect action and reduce the effectiveness of uricosuric drugs.

Prolonged use of barbiturates, reduces the effectiveness of paracetamol.

Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.

Ibuprofen reduces the hypotensive activity of vasodilators, natriuretic and diuretic - hydrochlorothiazide and furosemide.

Antacids and cholestyramine reduce the absorption of ibuprofen.

Caffeine increases the analgesic effect of ibuprofen.

Ibuprofen increases the effect of oral hypoglycemic agents and insulin.

Ibuprofen increases the blood concentration of digoxin, drugs lithium and methotrexate.

When concomitant administration with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and antiplatelet effect.

Cefamandol, Cefaperazon, Cefotetan, valproic acid, plikamitsin increase the incidence of gipopro-thrombinemia.

Special instructions

the simultaneous use of the drug should be avoided with other drugs containing acetaminophen and / or non-steroidal anti-inflammatory drugs.

In an application with indirect anticoagulants requires monitoring of hemostasis.

In applying the drug over 5-7 days should be monitored indicators of peripheral blood and functional state of the liver.

Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma.

If you have symptoms of NSAID-gastropathy (nausea, vomiting, abdominal pain, heartburn, loss of appetite, bloating, discomfort in the epigastric region) shows a close monitoring, including the conduct of esophagogastroduodenoscopy, blood analysis with determination of hemoglobin and hematocrit, fecal occult blood.

If necessary, the definition of 17-keto steroids drug should be discontinued 48 hours prior to the study.

During treatment is not recommended to take alcoholic beverages.

Release Form

Tablets, film-coated 400 mg + 200 mg.

2, 6, 10 or 12 tablets in blisters.

1 or 2 blisters with instruction for use in a pile of cardboard.

Storage conditions and shelf life

At a temperature of not higher than 25C.

Keep out of the reach of children.

Shelf life

2 years. Do not use beyond the expiration date printed on the package.

Conditions of supply of pharmacies

Without recipe.