Slocol
SLOCOL
INFORMATION FOR MEDICAL STAFF
COMPOSITION:
Paracetamol ....................................................................... 500 mg
Chlorpheniramine maleate .................................................... 2 mg
Excipients q.s ..................................................................... 1 tablet
(Lactose monohydrate, microcrystalline cellulose M101, aerosil, sodium starch glycolate, talc, magnesium stearate, sodium benzoate, PVP K30, quinoline color).
PHARMACEUTICAL FORM: Tablet.
PHARMACODYNAMIC PROPERTIES:
ATC code: N02B E51
Paracetamol produces analgesia, antipyresis. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. Paracetamol produces analgesia by elevation of the pain threshold.
Chlorpheniramine maleate is an antihistamine. By competitive blockage of the H1-receptor, chlorpheniramine maleate reduces edema, urticaria in hypersensitivity reactions such as allergy and anaphylaxis. Chlorpheniramine also has an anticholinergic activity.
PHARMACOKINETIC PROPERTIES:
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Paracetamol has a plasma half-life of 1.25 to 3 hours. The drug is metabolized by the liver into N - acetyl - benzoquinoneimine, and is excreted through the kidneys.
Chlorpheniramine maleate is well absorbed by oral administration. It is rapidly and extensively metabolized. Unchanged drug and active metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow-rate. The half-life is about 12 to 15 hours.
PRESENTATION: Bottle of 100 tablets. Box of 25 blisters x 10 tablets.
THERAPEUTIC INDICATIONS:
For the treatment of flu symptoms, including fever, stuffy nose, coryza, runny nose, headache.
DOSAGE & ADMINISTRATION:
Adults and children aged > 12 years: The recommended dose should be 1 tablet 1 - 3 times daily.
The interval between oral doses should be 4 - 6 hours. Do not exceed 8 tablets daily.
The drug should not be used for longer than 4 days, unless directed by a physician.
CONTRAINDICATIONS:
Hypersensitivity to any components of the drug. Patients with glucose - 6 - phosphate dehydrogenase deficiency. Patients with severe hepatic impairment, narrow-angle glaucoma, acute course of asthma, prostatomegaly, bladder neck stenosis, gastric ulcer, pyloro-duodenal obstruction. Patients receiving MAOIs within 14 days before, up to the time of treatment. Breast-feeding women, neonatal and premature babies.
PRECAUTIONS AND SPECIAL WARNINGS FOR USE:
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be warned that the product contains aspartame. Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing food or drugs. Cautions should be taken in patients with previous anemia, hepatic and renal impairments. Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
Chlorpheniramine can increase the risk of urine retention, particularly in patients with prostatic hyperplasia, urinary obstruction, pyloro-duodenal obstruction; it causes more severity in myasthenia gravis patients. Sedative effect of chlorpheniramine has been increased by taking alcohols and co-administrating with other tranquillisers. Use with caution in patients with chronic lung disease, apnee or breathing troubles, glaucoma, and in the elderly. Risk of tooth decay occurs in patients having long-term treatment.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this drug.
For the paracetamol-containing drugs, the physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell's syndrome, acute generalized exanthematous pustulosis (AGEP).
Pregnancy and lactation:
Pregnancy: The drug should be administered to pregnant women if really necessary. Serious reactions (including epilepsy) in a newborn baby can happen if chlorpheniramine is used in the last trimester of pregnancy.
Lactation: A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Effects on works:
Risk of drowsiness may be happen during driving, operating machines, working at height, and other cases.
INTERACTIONS:
Paracetamol:
Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.
The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine) that induce hepatic microsomalenzymes may increase paracetamol-induced liver toxicity because of increased conversion of the drug to hepatotoxic metabolites. Excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Concomitant administration of isoniazid with paracetamol may result in an increased risk of hepatotoxicity. The speed of absorption of paracetamol is reduced by cholestyramine (Therefore, the cholestyramine should not be taken within one hour).
Chlorpheniramine:
The anti-acetylcholine effects of chlorpheniramine are intensified by the use of MAO inhibitors.
Ethanol or sedative medications can potentiate the CNS inhibitory effect of chlorpheniramine. Phenytoin metabolism is inhibited by chlorpheniramine and this can cause phenytoin toxicity.
UNDESIRABLE EFFECTS:
Paracetamol: Severe dermatologic reactions including Stevens - Johnson syndrome, Lyell's syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis are rare, but potentially fatal. If rash and other skin reactions occur, discontinuation of the drug and physician visit should be recommended.
Skin rashes and other allergic reactions sometimes occur. Erythema and urticaria are common, but sometimes more severe and may be accompanied by drug-induced fever and mucosal lesions. In some individual cases, paracetamol causes neutropenia, thrombocytopenia and pancytopenia.
Uncommon, 1/1 000 < ADR < 1/100
Skin disorders: rash. Gastrointestinal disorders: nausea, vomiting. Blood disorders: blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia. Kidney disorders: kidney disease, kidney toxicity due to chronic ingestion.
Rare, ADR < 1/ 1 000
Skin disorders: Stevens - Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, acute generalized exanthematous pustulosis. Others: hypersensitivity reactions.
Chlorpheniramine: Adverse reactions which are considered to be common (occurring in 1 - 10% of subjects) or very common (occurring in ≥10% of subjects). The frequency of other adverse events identified during post-marketing use is unknown.
Very common:
Nervous system disorders: sedation, somnolence.
Common:
Nervous system disorders: disturbance in attention, dizziness, headache. Gastrointestinal disorders: nausea, dry mouth. Eye disorders: blurred vision. Others: fatigue.
Not known:
Blood and lymphatic system disorders: haemolytic anaemia, blood dyscrasias. Immune system disorders: allergic reaction, angioedema, anaphylactic reactions. Metabolism and nutrition disorders: anorexia. Psychiatric disorders: confusion, excitation, irritability, nightmares, depression. Ear and labyrinth disorders: tinnitus. Cardiac disorders: tachycardia, arrhythmia. Vascular disorders: hypotension. Respiratory, thoracic and mediastinal disorders: thickening of bronchial secretions. Gastrointestinal disorders: vomiting, abdominal pain, diarrhoea, dyspepsia. Hepatic disorders: hepatitis including jaundice. Skin and subcutaneous tissue disorders: dermatitis, rash, urticaria, photosensitivity. Musculoskeletal and connective tissue disorders: muscular twitching, muscle weakness. Renal and urinary disorders: urinary retention. Others: chest tightness.
Note: Children and the elderly are more susceptible to anticholinergic effects and paradoxical excitation (e.g. restlessness, nervousness).
OVERDOSE:
Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 - 10 g daily for 1 - 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.
Symptoms of paracetamol overdosage include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails. In severe poisoning, CNS stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulse; low blood pressure; and circulatory failure. Vascular collapse results from the relative hypoxia and from a central depressant action that occurs only with massive doses. Shock may develop if vasolidation is marked. Fatal asphyxial seizures may occur. Coma usually precedes death, which may occur suddenly or may be delayed for several days.
Management: In the event of severe paracetamol intoxication, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours.
The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion. N-acetylcysteine should be administered as soon as possible, preferably within 36 hours of overdosage. N-acetylcysteine is more effective if administered within 10 hours of overdosage. It can be diluted with water or alcohol-free drinks to a 5% solution and orally taken within 1 hour. Oral N-acetylcysteine is given as a 140 mg/kg body-weight initial dose followed by 70 mg/kg body-weight every four hours for 17 more doses.
Methionin, activated charcoal and/or salt cleaners are also used to treat overdose.
Symptoms of chlorpheniramine overdosage include sedation, psychosis, epilepsy, apnea, seizures, anti-acetylcholine effect, etc.
Management: Gastric lavage or emesis with ipecacuanha syrup is given; then, administering activated charcoal and cathartic to reduce absorption. In cases of hypotension and arrhythmias, an active treatment should be applied. Convulsions can be treated with diazepam or phenytoin intravenously.
Keep out of reach of children.
Read the direction carefully before use.
Consult a physician for more information.
STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT: April 16, 2018
INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine.
Keep out of reach of children
Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Paracetamol .......................................................................... 500 mg
Chlorpheniramine maleate ........................................................ 2 mg
Excipients q.s ........................................................................ 1 tablet
(Lactose monohydrate, microcrystalline cellulose M101, aerosil, sodium starch glycolate, talc, magnesium stearate, sodium benzoate, PVP K30, quinoline color).
PRODUCT DESCRIPTION: Two-layer (white to off-white and yellow), round tablet, a sign on one side, a word “DHG” on the other, intact edges.
PRESENTATION: Bottle of 100 tablets. Box of 25 blisters x 10 tablets.
WHAT THE DRUG IS USED FOR:
For the treatment of flu symptoms, including fever, stuffy nose, coryza, runny nose, headache.
HOW TO TAKE THIS MEDICINE:
Adults and children aged > 12 years: The recommended dose should be 1 tablet 1 - 3 times daily.
The interval between oral doses should be 4 - 6 hours. Do not exceed 8 tablets daily.
The drug should not be used for longer than 4 days, unless directed by a physician.
Or as directed by a physician.
WHEN SHOULD YOU NOT TAKE THIS MEDICINE:
Hypersensitivity to any components of the drug. Patients with glucose - 6 - phosphate dehydrogenase deficiency. Patients with severe hepatic impairment, narrow-angle glaucoma, acute course of asthma, prostatomegaly, bladder neck stenosis, gastric ulcer, pyloro-duodenal obstruction. Patients receiving MAOIs within 14 days before, up to the time of treatment. Breast-feeding women, neonatal and premature babies.
UNDESIRABLE EFFECTS:
Paracetamol: Severe dermatologic reactions including Stevens – Johnson syndrome, Lyell's syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis are rare, but potentially fatal. If rash and other skin reactions occur, discontinuation of the drug and physician visit should be recommended.
Skin rashes and other allergic reactions sometimes occur. Erythema and urticaria are common, but sometimes more severe and may be accompanied by drug-induced fever and mucosal lesions. In some individual cases, paracetamol causes neutropenia, thrombocytopenia and pancytopenia.
Uncommon, 1/1 000 < ADR < 1/100
Skin disorders: rash. Gastrointestinal disorders: nausea, vomiting. Blood disorders: blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia. Kidney disorders: kidney disease, kidney toxicity due to chronic ingestion.
Rare, ADR < 1/ 1 000
Skin disorders: Stevens - Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, acute generalized exanthematous pustulosis. Others: hypersensitivity reactions.
Chlorpheniramine: Adverse reactions which are considered to be common (occurring in 1 - 10% of subjects) or very common (occurring in ≥10% of subjects). The frequency of other adverse events identified during post-marketing use is unknown.
Very common:
Nervous system disorders: sedation, somnolence.
Common:
Nervous system disorders: disturbance in attention, dizziness, headache. Gastrointestinal disorders: nausea, dry mouth. Eye disorders: blurred vision. Others: fatigue.
Not known:
Blood and lymphatic system disorders: haemolytic anaemia, blood dyscrasias. Immune system disorders: allergic reaction, angioedema, anaphylactic reactions. Metabolism and nutrition disorders: anorexia. Psychiatric disorders: confusion, excitation, irritability, nightmares, depression. Ear and labyrinth disorders: tinnitus. Cardiac disorders: tachycardia, arrhythmia. Vascular disorders: hypotension. Respiratory, thoracic and mediastinal disorders: thickening of bronchial secretions. Gastrointestinal disorders: vomiting, abdominal pain, diarrhoea, dyspepsia. Hepatic disorders: hepatitis including jaundice. Skin and subcutaneous tissue disorders: dermatitis, rash, urticaria, photosensitivity. Musculoskeletal and connective tissue disorders: muscular twitching, muscle weakness. Renal and urinary disorders: urinary retention. Others: chest tightness.
Note: Children and the elderly are more susceptible to anticholinergic effects and paradoxical excitation (e.g. restlessness, nervousness).
Inform your physician any undesirable effect occur during the treatment.
WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:
Paracetamol:
Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.
The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine) that induce hepatic microsomal enzymes may increase paracetamol-induced liver toxicity because of increased conversion of the drug to hepatotoxic metabolites. Excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Concomitant administration of isoniazid with paracetamol may result in an increased risk of hepatotoxicity. The speed of absorption of paracetamol is reduced by cholestyramine (Therefore, the cholestyramine should not be taken within one hour).
Chlorpheniramine: The anti-acetylcholine effects of chlorpheniramine are intensified by the use of MAO inhibitors.
Ethanol or sedative medications can potentiate the CNS inhibitory effect of chlorpheniramine. Phenytoin metabolism is inhibited by chlorpheniramine and this can cause phenytoin toxicity.
WHAT SHOULD YOU DO IF YOU MISS A DOSE:<