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

Active substanceCaffeine + ParacetamolCaffeine + Paracetamol

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GlaxoSmithKline Helsker, ZAO Russia

Solpadein Fast

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GlaxoSmithClean Consumer Helscher United Kingdom

Dosage form: & nbspfilm-coated tablets

Composition:

COMPOSITION per 1 tablet:

Component	Content in 1 tablet
Active substances:
Paracetamol	500.00 mg
Caffeine	65.00 mg
Excipients:
Pregelatinized starch	50.00 mg
Corn starch	41.40 mg
Povidone (K 22.5 - 27.0)	2.00 mg
Potassium sorbate	0.60 mg
Talc	15.00 mg
Stearic acid	5.00 mg
Croscarmellose sodium	10.00 mg
Film Sheath:
Hypromellose	5.00 mg
Triacetin	1.00 mg

Description:White, film-coated tablets are capsular shaped with a flat edge. On one side of the tablet, in the form of a stamping, a triangular and "+" sign is marked.

Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic medication + psychostimulant)

ATX: & nbsp

N.02.B.E.71 Paracetamol in combination with psycholeptics

Pharmacodynamics:The drug Solpadein Fast has an analgesic and antipyretic effect.The drug contains a combination of two active ingredients: paracetamol and caffeine.

Pharmacodynamics

Paracetamol

Paracetamol blocks cyclooxygenase (COX) in CNS cells, affecting the centers of pain and thermoregulation (in cellular tissues, cellular peroxidases neutralize the effect of paracetamol on COX), which explains the almost complete absence of anti-inflammatory effect. The absence of influence on the synthesis of prostaglandins in peripheral tissues causes the absence of a negative effect on the water-salt metabolism (sodium and water retention) and the mucosa of the gastrointestinal tract.

Caffeine

Stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance.

Pharmacokinetics:

Suction and distribution

Paracetamol quickly and almost completely absorbed from the gastrointestinal tract. Distribution in body fluids is relatively uniform. At therapeutic concentrations, the binding of paracetamol to plasma proteins is minimal.

Caffeine completely and quickly absorbed from the gastrointestinal tract and distributed throughout the body.

Metabolism

Paracetamol metabolized in the liver and excreted by the kidneys in the form of glucuronide and sulfate metabolites - less than 5% is excreted as unchanged paracetamol.

Caffeine almost completely metabolized in the liver by oxidation and demethylation in the form of metabolites, which are excreted by the kidneys.

Excretion

Average half-life paracetamol when taking a therapeutic dose is about 2 - 3 hours.

Average half-life caffeine when taking a therapeutic dose is about 4 - 9 hours.

Indications:

The drug Solpadein Fast is used in adults and children over 12 years of age as:

- an anesthetic (with pain syndrome of mild and moderate intensity) with:

- toothache, including with the removal of teeth and after dental interventions;

- headache and migraine;

- Sore throat;

- pain in the muscles and joints;

- pain caused by osteoarthritis;

back pain;

- neuralgia;

- painful menstruation (dysmenorrhea).

- as a symptomatic treatment to reduce elevated body temperature with:

- acute respiratory and acute respiratory viral diseases, including influenza;

- after vaccination.

Contraindications:

- Hypersensitivity to paracetamol, caffeine or any other component of the drug;

- Dysfunction of the liver and kidneys of a serious degree;

- Arterial hypertension;

- Glaucoma, sleep disturbances;

- Children up to 12 years;

- Pregnancy and lactation;

- Epilepsy;

- Simultaneous use with other medicinal products containing paracetamol.

Carefully:

- Benign hyperbilirubinemia (including Gilbert's syndrome).

- Viral hepatitis.

- Alcoholic liver disease.

- Chronic alcoholism.

- Deficiency of glucose-6-phosphate dehydrogenase.

- Dysfunction of the liver and kidneys of mild and moderate severity.

In the presence of any of the listed diseases / conditions / risk factors before taking the drug should consult with a doctor.

Pregnancy and lactation:

Pregnancy

In studies on animals and humans, there was no risk of paracetamol during pregnancy or adverse effects on fetal development,However, the use of caffeine can increase the risk of spontaneous abortion or the birth of a child with a low body weight, so the drug Solpadein Fast is not recommended for use during pregnancy.

Breastfeeding period

Paracetamol penetrates the placental barrier and into breast milk. In studies on humans, there was no adverse effect on the baby's body during breastfeeding.

Caffeine penetrates into breast milk and can have a stimulating effect on a baby who is breastfed, so the drug Solpadein Fast is not recommended for use during lactation.

Dosing and Administration:

For oral administration.

Do not exceed the indicated dose!

Use the smallest dose necessary to achieve the effect! The minimum interval between doses of Solpadein Fast should be 4 hours.

Adults (including the elderly) and children over 12 years of age: 1-2 tablets up to 4 times a day, as needed. The interval between receptions should be not less than 4 hours. The maximum single dose is 2 tablets, the maximum daily dose is 8 tablets. The drug is not recommended for more than 5 days as an anesthetic and for more than 3 days as an antipyretic agent without prescribing and monitoring the doctor.

The increase in the duration of taking the drug is only possible under supervision doctor.

If the recommended dose is exceeded, seek medical help immediately, even if you are feeling well. Overdose of paracetamol can cause hepatic insufficiency.

Special patient groups

Patients with impaired renal function:

Before using Solpadein Fast, patients with impaired renal function should first consult with a physician. Restrictions associated with the use of drugs containing a combination of caffeine and paracetamol in patients with impaired renal function are predominantly related to the content of paracetamol in the drug.

Patients with impaired hepatic function:

Before using the drug Solpadein Fast, patients with a dysfunction of the liver should first consult with a doctor. Limitations associated with the use of drugs containing a combination of caffeine and paracetamol,in patients with impaired liver function, are mainly associated with the content of paracetamol in the drug.

Side effects:

In recommended doses, the drug is usually well tolerated.

The following undesirable reactions were detected spontaneously during the post-marketing application of the drug.

Undesirable reactions are classified according to the body systems and in accordance with the frequency of development. The frequency of development of undesired reactions is determined as follows: Often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and < 1/100), rarely (≥ 1/10 000 and <1/1000), rarely (< 10 000), frequency unknown (the frequency can not be estimated from the available data).

Paracetamol

Violations from the blood and lymphatic system:

Rarely: thrombocytopenia, leukopenia, pancytopenia, methemoglobinemia, agranulocytosis, hemolytic anemia.

Immune system disorders:

Rarely: anaphylaxis, skin reactions of hypersensitivity, including skin rash, itching, hives, angioedema (Quincke's edema), Stevens-Johnson syndrome.

Disturbances from the respiratory system, chest and mediastinal organs:

Rarely: bronchospasm in patients with hypersensitivity to acetylsalicylic acid and intolerance to other non-steroidal anti-inflammatory drugs.

Disorders from the liver and bile ducts:

Rarely: violations of the liver.

With prolonged use of the drug in high doses, the probability of hepatotoxic action, nephrotoxic action and pancytopenia increases. In the case of long-term use of the drug, blood control is necessary.

Caffeine

Impaired nervous system:

Frequency unknown: increased excitability, sleep disturbances, insomnia, dizziness, headaches.

Vascular disorders:

Frequency unknown: tachycardia.

Disturbance of the gastrointestinal tract:

Frequency unknown: dyspeptic disorders (including nausea, epigastric pain).

When using the drug Solpadein Fast, it is not recommended to take caffeine-containing products, tk. this increases the risk of such undesirable effects as insomnia, irritability, anxiety, headache, gastrointestinal disturbances, tachycardia, cardiac arrhythmia.

If any of these unwanted reactions occur, stop taking the medication and consult a doctor immediately.

Overdose:

Symptoms (due to paracetamol)

In case of an overdose of paracetamol, hepatic insufficiency may develop, which may lead to the need for liver transplantation or death.

Hepatotoxic effect in adults is manifested when taking paracetamol in an amount of 10 g or more. In the presence of factors that affect the toxicity of paracetamol for the liver (see the sections on "Interaction with other drugs", "Special instructions"), liver damage can occur after taking paracetamol in an amount of 5 g or more.

With prolonged use of the drug beyond the recommended dose, the drug may have nephrotoxic effects (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis).

During the first 24 hours after an overdose, the following symptoms may appear: nausea, vomiting, stomach pain, pale skin, anorexia, metabolic acidosis. After 1-2 days, signs of liver damage are determined (soreness in the liver, increased activity of "liver" enzymes),it is possible to develop a violation of carbohydrate metabolism and metabolic acidosis.

In severe cases of overdose, as a result of liver failure, encephalopathy (a violation of brain function), bleeding, hypoglycemia, cerebral edema, up to a lethal outcome, the need for liver transplantation, death may develop. It is also possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (blood or erythrocyte in the urine), proteinuria (high protein in the urine), with severe liver damage may be absent. There were cases of heart rhythm disturbances, pancreatitis.

Treatment

In case of suspicion of an overdose of Solpadein Fast, even in the absence of pronounced first symptoms, it is necessary to stop using the drug and immediately consult a doctor for medical assistance. During the first hour after an overdose, but no later than 4 hours, gastric lavage and intake of enterosorbents (Activated carbon, polyphepan).It is necessary to determine the concentration of paracetamol in the blood plasma, but not earlier than 4 hours after an overdose (earlier results are not reliable).

Introduction of acetylcysteine within 24 hours after an overdose. The maximum protective effect is achieved within the first 8 hours after an overdose, with time the effectiveness of the antidote drops sharply. If necessary, enter acetylcysteine intravenously. If there is no vomiting before the patient enters the hospital, methionine may be used. The need for additional therapeutic measures (methionine intake, intravenous acetylcysteine) is determined depending on the concentration of paracetamol in the blood plasma, as well as on the time elapsed after its administration. Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

Symptoms (due to caffeine)

Pain in epigastrium, vomiting, frequent urination, tachycardia, arrhythmia, CNS stimulation (insomnia, anxiety, agitation, anxiety, increased neural reflex excitability, tremors and convulsions).It should be borne in mind that the appearance of clinically significant symptoms of caffeine overdose when taking the drug is always associated with severe liver damage against a background of paracetamol overdose.

Treatment

There is no specific antidote. Treatment includes supportive activities, such as copious drinking and maintaining vital signs. For 1 hour to 4 hours after an overdose, it is recommended to take activated charcoal. To reduce the effect of caffeine on the functions of the central nervous system, it is recommended that intravenous and beta-adrenoceptor antagonists be administered to reduce the cardiotoxic effect.

Interaction:

If the patient is already taking other medications, before taking the medication preparation of Solpadein Fast should consult a doctor.

With regular intake for a long time, the drug enhances the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants. Increases the effect of MAO inhibitors. Barbiturates, carbamazepine, phenytoin, diphenine, primidon and other anticonvulsants, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, butadione, preparations of St. John's wort and other inducers of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of developing severe liver damage with small overdoses of paracetamol (5 g or more).

Inhibitors of microsomal liver enzymes (cimetidine) reduce the risk of hepatotoxic effects.

Under the action of paracetamol, the time for removal of levomycetin (chloramphenicol) is increased 5-fold, which increases the risk of poisoning with levomycetin (chloramphenicol).

Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol. The drug may reduce the effectiveness of uricosuric drugs. Long-term combined use of paracetamol and other NSAIDs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure. Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

Co-administration of flucloxacillin with paracetamol can lead to metabolic acidosis, especially in patients with risk factors for glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.

Simultaneous administration of paracetamol and alcoholic beverages increases the risk of developing liver damage and acute pancreatitis.

Caffeine accelerates the absorption of ergotamine. Do not take the drug simultaneously with caffeine-containing products.

Special instructions:

Data on the effect of the drug on fertility are not available.

If there is no improvement in the condition when the drug is taken or the headache becomes permanent, it is necessary to consult a doctor.

The drug Solpadein Fast should not be used with other paracetamol-containing medications, as the combined use of drugs can cause an overdose of paracetamol.

In case of an overdose of paracetamol, hepatic insufficiency may develop, which may lead to the need for liver transplantation or death.

The drug Solpadein Fast should not be taken with caffeinated foods (tea, coffee, etc.), becausethis can lead to anxiety, anxiety, irritability, insomnia, headache, disorders of the gastrointestinal tract, tachycardia, cardiac arrhythmia.

Patients with glutathione deficiency due to eating disorders, dietary fibrosis, HIV infection, starvation, exhaustion, are overdose, therefore precautions should be taken and it is recommended to consult a doctor before taking the drug. There have been reported cases of hepatic insufficiency / liver function disorders with a small overdose of paracetamol (5 g or more) in patients with low glutathione levels, particularly in extremely malnourished patients with anorexia, chronic alcoholism or patients with a low body mass index.

The use of the drug Solpadein Fast in patients with low levels of glutathione, for example, with sepsis, may increase the risk of metabolic acidosis, accompanied by symptoms of rapid, shortness of breath (feeling short of air, shortness of breath), nausea, vomiting, loss of appetite. If these symptoms occur simultaneously, you should immediately consult a doctor.

TO AVOID THE TOXIC LESION OF THE LIVER PARACETAMOL DO NOT CONSTITUTE WITH RECEPTION OF ALCOHOLIC BEVERAGES, AND ALSO TO TAKE PERSONS INCLUDED TO THE CHRONIC CONSUMPTION OF ALCOHOL. Concomitant liver diseases increase the risk of further damage to the liver when taking the drug Solpadein Fast. When taking the drug in patients with non-alcoholic cirrhosis, there is a high risk of overdose. In patients with atopic bronchial asthma, pollinosis, there is an increased risk of allergic reactions.

When analyzing the determination of uric acid and blood glucose levels, the doctor should be informed of the drug.

The drug can change the results of doping tests of athletes.

Effect on the ability to drive transp. cf. and fur:

The effect of the drug on the ability to drive and drive is unlikely.

Form release / dosage:

Film-coated tablets.

Packaging:

For 12 tablets in a PVC / aluminum blister.

For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:П N014577 / 01

Date of registration:05.11.2008 / 11.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Helsker, ZAO GlaxoSmithKline Helsker, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Dungarvan, Ltd. Ireland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp13.02.2017

Illustrated instructions

Instructions

Solpadein Fast (Solpadeine Fast)