Solpadein (Solpadeine)

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"Trade product
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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCodeine + Caffeine + ParacetamolCodeine + Caffeine + Paracetamol
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  • Solpadein
    pills inwards 
    GlaxoSmithClean Consumer Helscher     United Kingdom
  • Solpadein
    capsules inwards 
    GlaxoSmithClean Consumer Helscher     United Kingdom
  • Solpadein
    pills inwards 
    GlaxoSmithClean Consumer Helscher     United Kingdom
    • Dosage form: & nbsp

    capsules

    Composition:

    One capsule contains:

    paracetamol 500 mg
    codeine phosphate hemihydrate 8 mg

    caffeine (anhydrous) 30 mg.

    Excipients: magnesium stearate, corn starch, titanium dioxide, gelatin, iron oxide red, Shellac 47,5 % at IMS 74 OP, butyl alcohol, purified water, IMS 74 OP, propylene glycol, isopropyl alcohol, iron oxide black (E 172).

    Description:

    Hard gelatin capsules of size "0". The cap of the capsule is opaque from red to reddish - brown, the body is opaque white. On both parts of the capsule is printed in black "Solpadeine". The contents of the capsule are a white amorphous powder with crystal inclusions.

    Pharmacotherapeutic group:Analgesic combined (analgesic opioid + analgesic non-narcotic + psychostimulant)
    ATX: & nbsp

    N.02.B.E   Anilides

    Pharmacodynamics:"Solpadein" contains a combination of three active ingredients: paracetamol, codeine and caffeine. Paracetamol has analgesic and antipyretic properties. Codeine has a moderate antitussive effect (due to suppression of excitability of the cough center) and analgesic effect (due to changes in the subjective perception of pain). Caffeine has light tonic (reduces drowsiness and fatigue, increases mental and physical performance, increases heart rate, increases blood pressure in hypotension), and diuretic effects.
    Pharmacokinetics:not described
    Indications:

    "Solpadein" is used for pain syndrome of mild and moderate severity: headache, migraine, ossalgia, myalgia, neuralgia, arthralgia, radiculitis, algodismenorea, toothache, sinusitis, sore throat, posttraumatic pains; febrile syndrome, "cold" diseases.

    Contraindications:

    - increased individual sensitivity to paracetamol, codeine, caffeine, or any other ingredient in the drug;

    - anxiety disorders (agoraphobia, panic disorder);

    - organic diseases of the cardiovascular system (including acute myocardial infarction, atherosclerosis);

    - paroxysmal tachycardia, frequent ventricular extrasystole;

    - arterial hypertension;

    - pulmonary heart failure, bronchial asthma, diseases accompanied by hypersecretion of sputum;

    - sleep disorders;

    - alcohol intoxication;

    - severe renal / hepatic insufficiency, blood diseases (thrombocytopenia, anemia, hematopoietic suppression (agranulocytosis, neutropenia));

    - hypocoagulation;

    - condition after traumatic brain injury;

    - increased intracranial pressure, epilepsy;

    - pregnancy, prenatal period, period of lactation;

    - children's age (up to 12 years).

    Carefully:

    With benign hyperbilirubinemia (including - Gilbert's syndrome, Dubin-Johnson syndrome), viral hepatitis, alcoholic liver damage, alcoholism, old age, glucose-6-phosphate dehydrogenase deficiency, glaucoma, increased excitability, propensity to convulsive seizures.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Adults: A single dose of 2 capsules.

    Repeated use of the drug is possible with an interval of at least 4 hours and no more than 4 times / day. The maximum daily dose should not exceed 8 capsules. The maximum duration of the drug without consulting a doctor is not more than 5 days as an anesthetic drug and more than 3 days as an antipyretic drug.

    Children from 12 to 16 years: Single dose 1 capsule. Repeated use of the drug is possible with an interval of at least 4 hours and no more than 4 times / day. The maximum daily dose should not exceed 4 capsules.

    Do not use in children younger than 12 years.

    Do not exceed the recommended dose.

    Do not take concomitantly with other medicines containing paracetamol or codeine. If symptoms persist when the drug is taken or the condition worsens, consult a doctor.

    Side effects:

    In recommended doses, the drug is usually well tolerated. There may be allergic reactions (skin rash, angioedema, bronchospasm, urticaria).

    Paracetamol can cause leukopenia, agranulocytosis, hemolytic anemia, thrombocytopenia, methemoglobinemia, long-term use can be hepatotoxic and nephrotoxic action.

    Codeine can cause constipation, nausea, vomiting, gastralgia, dizziness, drowsiness, palpitations, tachycardia, and sleep disturbances.

    Caffeine can cause agitation, anxiety, headache, palpitations, tachycardia, arrhythmias, increased blood pressure. With prolonged use in high doses, the likelihood of impaired liver and kidney function increases and a control of the blood picture is necessary.

    All side effects of the drug should be reported to the doctor.

    Stop taking the medication and consult a doctor immediately if:

    - earlier you have transferred operation of excision of a cholic bubble and you are disturbed by pains in a stomach, a nausea and vomiting;

    - if you have allergic reactions: skin itching or redness of the skin, difficulty breathing or swelling of the lips, tongue, throat, or face;

    - rash or peeling on the skin, the formation of sores on the oral mucosa;

    - if you have had a history of breathing problems with aspirin or other NSAIDs;

    - you have bruises or bleeding.

    Overdose:

    In case of an overdose, seek medical help immediately, even if you are feeling well.Signs of acute poisoning are due to the hepatotoxic effect of paracetamol - nausea, vomiting, a feeling of discomfort in the epigastrium. The sufferer should do a gastric lavage, prescribe adsorbents (Activated carbon) and see a doctor.

    Interaction:

    Barbiturates, rifampicin, salicylamide, antiepileptic drugs and other stimulants of microsomal oxidation contribute to the formation of toxic metabolites of paracetamol, which adversely affect liver function. Metoclopramide accelerates the absorption of paracetamol. Under the influence of paracetamol, the half-life of chloramphenicol increases five-fold. At repeated reception paracetamol can strengthen the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Caffeine accelerates the absorption of ergotamine. Simultaneous reception of paracetamol and ethanol increases the risk of hepatotoxic effects.

    Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects of paracetamol.

    Codeine can potentiate, effect the means,depressing central nervous system (including alcohol); However, this effect with a quantitative content of it in this dosage form of the drug "Solpadein" is insignificant.

    Special instructions:

    Before taking the drug, you should consult your doctor if:

    - you have liver or kidney disease;

    - You have problems with the intestines or you suffer from constipation;

    - if you have a gallbladder removed;

    - If you accept metoclopramide or domperidone (preparations against nausea and vomiting); drugs that can cause drowsiness: hypnotics, sedatives, tricyclic antidepressants, tranquilizers from the phenothiazine group; MAO inhibitors; drugs for the dilution of blood - indirect anticoagulants (warfarin), alcohol. During the intake of the drug, excessive drinking of tea and coffee is not recommended, as this can lead to excitation, sleep disturbance, tachycardia, cardiac arrhythmia. An increase in the daily dose or duration of treatment is possible only after consulting a doctor.

    With prolonged uncontrolled admission of the drug in large doses, it is possible to develop addiction (weakening analgesic effect) and drug dependence.

    Do not use medicines that contain paracetamol, as well as other analgesics.

    To avoid toxic damage, the liver is not combined with ethanol intake.


    Effect on the ability to drive transp. cf. and fur:During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:

    Capsules.

    Packaging:Primary: 6 or 12 capsules in blisters (PVC / aluminum foil).
    Secondary: 1 or 2 blisters for 6 capsules, or 1 blister for 12 capsules packed in a cardboard box along with instructions for use.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011396 / 01
    Date of registration:09.12.2009
    Date of cancellation:2018-04-09
    The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom
    Information update date: & nbsp09.04.2018
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