Solpadein - instructions for use, dose, side effects, contraindications

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: & nbsptablets, soluble

Composition:

Each capsule contains:

Active substances Paracetamol 500.0 mg

Codeine phosphate hemihydrate 8.0 mg

Caffeine 30.0 mg

Excipients: magnesium stearate - 6.0 mg, corn starch - 84.0 mg; Capsule: Capsule shell: Body: titanium dioxide (E 171) - 2.0 mg, gelatin - up to 100 %; Cap: ferric oxide red oxide (E 172) - 2.2 mg, gelatin - up to 100%; Ink: shellac 47.5% in alcohol methylated industrial 74 EP, butanol (removed during production), purified water, methylated industrial alcohol / 74 OP (removed in the manufacturing process), propylene glycol, isopropanol (removed in the manufacturing process), iron dye oxide black (E 172).

Description:

White flat tablets with a facet, smooth on one side and with a risk - on the other.

Pharmacotherapeutic group:analgesic non-narcotic remedy

ATX: & nbsp

N.02.B.E Anilides

Pharmacodynamics:

Solpadine contains a combination of three active ingredients: paracetamol has antipyretic, analgesic act, caffeine has a general tonic effect (reduces drowsiness and fatigue, increases mental and physical performance, increases the heart rate, increases blood pressure in hypotension), increases the dehydrating effect of the drug, codeine has an analgesic effect and improves the tolerance of pain.

Pharmacokinetics:not described

Indications:Solpadein is used in adults and children over 12 years with pain syndrome (headache, toothache, migraine, pain in muscles and joints, neuralgia, with painful menstruation, with radiculitis, sprains, with sinusitis and sore throat). In adults and children older than 12 years to reduce high fever, with "colds", other infectious and inflammatory diseases and flu.

Contraindications:

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

- simultaneous administration of other paracetamol-containing agents

- marked violations of the liver or kidneys;

- blood diseases (troobotopenia, anemia);

- genetic absence of glucose-6-phosphate dehydrogenase;

- glaucoma

- respiratory insufficiency, conditions after traumatic brain injury, increased intracranial pressure

- arterial hypertension;

- period of pregnancy and breastfeeding;

- children's age (up to 12 years)

Carefully:

with Gilbert syndrome (constitutional hyperbilirubinemia), congenital hyperbilirubinemia (Dubin-Johnson and Rotor), bronchial asthma, old age.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Adults: 2 tablets dissolve in half a glass of water. Take 3-4 times a day at intervals of not less than 4 hours. The maximum single dose is 2 tablets. The maximum daily dose is 8 tablets.

Children from 12 to 16 years: 1 tablet dissolve in half a glass of water. Take 3-4 times a day, with intervals of at least 4 hours. The maximum single dose is 1 tablet. The maximum daily dose is 4 tablets.

The drug should not be taken more than 5 days with an appointment as an anesthetic and more than 3 days as an antipyretic.The doctor adjusts the dose and the interval between doses.

Do not exceed the recommended dose. In case of an overdose, immediately consult a doctor even if you are feeling well.

Side effects:

There may be nausea, epigastric pain, allergic reactions (skin rash, itching, urticaria, and Quincke's edema).

Very rarely - anemia, thrombocytopenia, methemoglobinemia.

Rarely can occur rapid heartbeat, constipation, sleep disturbance, drowsiness, dizziness.

With prolonged use in doses much higher than recommended, the probability of impaired liver and kidney function is increased and a control of the blood picture is necessary.

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

Overdose:

Symptoms: nausea, vomiting, stomach pain, sweating, pale skin, tachycardia.

With light intoxication, ringing in the ears; severe intoxication - confused consciousness, drowsiness, collapse, convulsions, bronchospasm, shortness of breath.

If you suspect a poisoning, you should immediately seek medical help.

Treatment: the affected person should make a gastric lavage, prescribe adsorbents (Activated carbon) and see a doctor.

Interaction:

The drug, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding.

Stimulants of microsomal oxidation in the liver (phenytoin, diphenine, ethanol, barbiturates, carbamazepine, flumecinol, rifampicin, zidovudine phenylbutazone and tricyclic antidepressants) increase the production of hydroxylated active metabolites, which allows the development of severe intoxication with small overdoses. Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects. Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol.

Reduces the effectiveness of uricosuric drugs. Caffeine accelerates the absorption of ergotamine. Codeine intensifies the effect of sleeping pills, analgesics and sedatives.

Ethanol increases the half-life of paracetamol, increasing the risk of hepatotoxic effects.

Special instructions:

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

You have asthma or another disease of the respiratory system;

- You take antidepressants, drugs against nausea and vomiting, as well as lowering the level of cholesterol in the blood;

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.

TO AVOID THE TOXIC LESION OF THE LIVER PARACETAMOL DO NOT CONSTITUTE WITH THE RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TO TAKE PERSONS STRONG TO THE CHRONIC ALCOHOL CONSUMPTION.

Effect on the ability to drive transp. cf. and fur:Solpadein may cause drowsiness. In this case, when taking Solpadein should refrain from driving motor vehicles and classes potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Because the composition of the drug is codeine, you should keep in mind the possibility of developing addiction.

Form release / dosage:

Tablets are soluble.

Packaging:2 tablets in strips (paper / polyethylene / aluminum foil). By 2, 4, 6, 12, or 30 strips together with instructions for use in a cardboard box.

Storage conditions:At a temperature not higher than 25 ° C in a place inaccessible to children.

Shelf life:

4 years. Do not use after the expiry date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015458 / 02

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

GlaxoSmithKline Dungarvan, Ltd. Ireland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp09.04.2018

Illustrated instructions

Instructions

Solpadein (Solpadeine)