Experience dual-action relief with Stilpane Syrup – effectively soothing both pain and fever. Our thoughtfully formulated solution targets discomfort and helps reduce elevated temperatures, providing comprehensive support for your well-being.
STILPANE SYRUP Is Used For
STILPANE SYRUP is indicated for the symptomatic treatment of pain and fever.
Dosage
Age 2 to 5 years: Take one medicine measure (5 ml) three times daily. Age 6 to 12 years: Take one to two medicine measures (5 ml to 10 ml) three times daily. DO NOT EXCEED THE RECOMMENDED DOSE.
STILPANE SYRUP Contains
Each 5 ml of STILPANE SYRUP contains 6,5 mg of promethazine hydrochloride, 5 mg of codeine phosphate and 120 mg of paracetamol.
Other Ingredients
Excipients: Acesulfame potassium, colour blackcurrant (C.I. 1458), dye Lennon blackcurrant (C.I. 42090 & 14720), flavour blackcurrant, glycerol, hydroxyethylcellulose, methyl hydroxybenzoate, polyvinylpyrrolidone (Povidone), propylene glycol, propyl hydroxybenzoate, purified water, sorbitol (70 % ) solution, sodium cyclamate, sodium saccharin. Preservatives: Methyl hydroxybenzoate 0,09 % m/v. Propyl hydroxybenzoate 0,01 % m/v. Contains sugar: Sorbitol 1,01 g. Contains sweeteners: Sodium cyclamate 50,46 mg, sodium saccharin 5,22 mg, acesulfame potassium 2,32 mg.
Therapeutic Classification
A 2.8 Analgesic combinations.
COMPOSITION
Each 5 ml of STILPANESYRUP contains 6,5 mg of promethazine hydrochloride, 5 mg of
codeine phosphate and 120 mg of paracetamol.
Excipients:
Acesulfame potassium, colour blackcurrant (C.I. 1458), dye Lennon blackcurrant (C.I.
42090 & 14720), flavour blackcurrant, glycerol, hydroxyethylcellulose, methyl
hydroxybenzoate, polyvinylpyrrolidone (Povidone), propylene glycol, propyl
hydroxybenzoate, purified water, sorbitol (70 %) solution, sodium cyclamate, sodium
saccharin
Preservatives:
Methyl hydroxybenzoate 0,09 % m/v
Propyl hydroxybenzoate 0,01 % m/v
Contains sugar: Sorbitol 1,01 g
Contains sweeteners: Sodium cyclamate 50,46 mg, sodium saccharin 5,22 mg,
acesulfame potassium 2,32 mg
CATEGORY AND CLASS
A 2.8 Analgesic combinations
PHARMACOLOGICAL ACTION
Pharmacodynamic properties
STILPANE SYRUP has analgesic, antipyretic and antihistaminic properties.
INDICATIONS
STILPANE SYRUP is indicated for the symptomatic treatment of pain and fever.
CONTRAINDICATIONS
STILPANE SYRUP is contraindicated in:
• Hypersensitivity to any of the ingredients.
• Patients sensitive to one antihistamine may be sensitive to others.
• Patients with severe liver or kidney complications.
• Patients with obstructive airway disease, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, and after operations on the biliary tract.
• Acute alcoholism.
• Convulsive disorders.
• Head injuries and conditions in which intracranial pressure is raised.
• Children under the age of two years.
• Pregnancy and lactation.
• Patients taking monoamine oxidase inhibitors or within 14 days of stopping such
treatment.
STILPANE SYRUP should not be given during an attack of bronchial asthma or in heart disease secondary to chronic lung disease.
Promethazine hydrochloride and codeine phosphate, as contained in STILPANE SYRUP, should not be given to comatose patients.
The use of promethazine hydrochloride may be associated with Sudden infant death syndrome.
WARNINGS AND SPECIAL PRECAUTIONS
Consult a doctor if no relief is obtained from the recommended dosage or if pain or fever
persists or gets worse, if new symptoms occur or if redness and swelling is present, as
these could be signs of a serious condition.
Do not use this product continuously without consulting a doctor:
• For pain: – for more than 10 days (adults).
– for more than 5 days (children).
• For fever: – for more than 3 days.
Promethazine hydrochloride
STILPANE SYRUP may lead to drowsiness and impaired concentration, that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants.
Caution should be used when the following medical conditions exist: prostatic hypertrophy, narrow angle glaucoma, emphysema or chronic bronchitis and porphyria.
Paradoxical hyperexcitability, nervousness and insomnia may occur in children and the elderly taking antihistamines. Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and to anticholinergic effects such as dry mouth and urinary retention.
Promethazine hydrochloride should not be used in patients with pre-existing central nervous system depression, bone marrow depression, phaeochromocytoma or Reye’s syndrome.
Use with care in patients with epilepsy, jaundice, Parkinsonism, diabetes mellitus, hypothyroidism and myasthenia gravis.
Risk of severe constipation if used with antidiarrhoeal medicines such as diphenoxylate.
Increased risk of constipation and urinary retention if used with other anticholinergic medicines. Use with caution in patients with obstructive bowel disorders, liver impairment, prostatic hypertrophy and impaired renal function.
Promethazine hydrochloride should be used cautiously in patients with cardiovascular or hepatic diseases, closed angle glaucoma or asthma.
Paracetamol
STILPANE SYRUP contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdosage and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison centre must be contacted immediately.
Dosages in excess of those recommended, may cause severe liver function damage.
Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take paracetamol.
Use with caution in renal disease.
Codeine phosphate
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.
Potentiates the effect of alcohol and other sedatives.
There is a risk of severe constipation if used with antidiarrhoeal medicines such as diphenoxylate. There is also an increased risk of constipation and urinary retention if used with other anticholinergic medicines.
Codeine phosphate, as contained in STILPANE SYRUP, should be given with caution or in reduced doses to patients with hypotension, hypothyroidism, compromised respiratory function, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock or head injury. It should be used with caution in patients with inflammatory or obstructive bowel syndrome. It should be given with caution to patients with myasthenia gravis.
The administration during labour may cause respiratory depression in the newborn infant.
The dosage should be reduced in elderly and debilitated patients.
Effects on ability to drive and use machines
Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.
Excipients
Patients with the rare hereditary condition of sorbitol intolerance should not take STILPANE SYRUP.
INTERACTIONS
Promethazine hydrochloride may potentiate the hypotensive effect of some antihypertensives.
False negative and positive results have been reported with some pregnancy tests.
All sedatives, including alcohol, will potentiate depressant effects on the central nervous system if taken with antihistamines.
The antiparkinsonian effects of levodopa may be inhibited.
Medications tending to cause extrapyramidal reactions and those with anticholinergic effects may be potentiated. These include tricyclic antidepressants, maprotiline and monoamine oxidase inhibitors.
Antihistamines may suppress positive skin test results and should be stopped several days before the test.
The central nervous system and respiratory depressant effects of codeine and promethazine hydrochloride are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.
Codeine may affect the activity of other medicines by delaying their absorption.
HUMAN REPRODUCTION
STILPANE SYRUP is contraindicated in pregnancy and lactation (see CONTRAINDICATIONS).
DOSAGE AND DIRECTIONS FOR USE
Age 2 to 5 years: Take one medicine measure (5 ml) three times daily.
Age 6 to 12 years: Take one to two medicine measures (5 ml to 10 ml) three times
daily.
DO NOT EXCEED THE RECOMMENDED DOSE.
SIDE EFFECTS
Paracetamol
Blood and the lymphatic system disorders
The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia, leucopenia and thrombocytopenia, agranulocytosis and anaemia.
Immune system disorders
Sensitivity reactions resulting in reversible skin rashes or blood disorders may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions. Other allergic reactions may occur.
Psychiatric disorders
Some of the most common side effects are confusion and hallucinations. A central effect includes euphoria.
Nervous system disorders
Some of the most common side effects are sedation, varying from slight drowsiness to deep sleep, and including dizziness and incoordination. Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, tachycardia, tremors, ataxia, irritability and convulsions. A central effect includes occasional headache.
Ear and labyrinth disorders
Tinnitus.
Vascular disorders
Hypotension.
Gastrointestinal disorders
Other side effects include gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation, anorexia or increased appetite, and epigastric pain. Pancreatitis may occur.
Hepatobiliary disorders
The use of paracetamol has been associated with the occurrence of hepatitis.
Skin and subcutaneous tissue disorders
The use of paracetamol has been associated with the occurrence of dermatitis.
Musculoskeletal, connective tissue and bone disorders
Other central effects include muscular weakness.
Renal and urinary disorders
Prolonged excessive use may cause irreversible kidney damage.
The use of paracetamol has been associated with the occurrence of renal colic, renal failure, sterile pyuria.
General disorders and administrative site conditions
The most common side effect is lassitude.
Promethazine hydrochloride
Blood and the lymphatic system disorders
Blood disorders, including agranulocytosis, leucopenia and haemolytic anaemia have been reported.
Nervous system disorders
Antihistamines may precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex. Extrapyramidal symptoms with muscle spasms and dystonia may develop with promethazine hydrochloride.
Eye disorders
Promethazine hydrochloride may also produce antimuscarinic effects including blurred vision.
Cardiac disorders
In high doses, transient bradycardia followed by tachycardia with palpitations and dysrhythmias can occur.
Vascular disorders
Promethazine hydrochloride may also produce antimuscarinic effects including flushing.
Respiratory, thoracic and mediastinal disorders
Promethazine hydrochloride may also produce antimuscarinic effects including thickened respiratory tract secretions, dryness of the nose, tightness of the chest.
Gastrointestinal disorders
Promethazine hydrochloride may also produce antimuscarinic effects including dryness of the mouth and reduction in tone and motility of the gastrointestinal tract resulting in constipation and increased gastric reflux.
Hepatobiliary disorders
Jaundice has also been reported.
Skin and subcutaneous tissue disorders
Photosensitivity, skin rashes, allergic dermatitis and thrombocytopenic purpura have also been reported.
Renal and urinary disorders
Promethazine hydrochloride may also produce antimuscarinic effects including difficulty in micturition and dysuria.
General disorders and administrative site conditions
Medicine fever has also been reported.
Codeine phosphate
Psychiatric disorders
One of the most common side effects is confusion. The euphoric activity of codeine phosphate and similar compounds has led to its abuse. Restlessness and changes of mood also occur.
Nervous system disorders
One of the most common side effects is drowsiness. Raised intracranial pressure occurs in some patients.
Eye disorders
Miosis also occurs.
Ear and labyrinth disorders
Vertigo also occurs.
Cardiac disorders
Bradycardia and palpitations also occur.
Vascular disorders
Facial flushing and orthostatic hypotension also occur.
Gastrointestinal disorders
The most common side effects are nausea, vomiting and constipation. Dry mouth also occurs.
Hepatobiliary disorders
There may be biliary spasm. There is also an antidiuretic effect. These effects occur more commonly in ambulant patients than in those at rest in bed.
Skin and subcutaneous tissue disorders
Reactions such as urticaria and pruritus can occur but they are not common. Contact dermatitis has been reported.
Musculoskeletal, connective tissue and bone disorders
Muscle rigidity has been reported at high doses.
Renal and urinary disorders
Micturition may be difficult and there may be ureteric spasm. There is also an antidiuretic
effect. These effects occur more commonly in ambulant patients than in those at rest in bed.
General disorders and administrative site conditions
Hypothermia also occur. One of the most common side effects is sweating.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTS
Paracetamol
Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 g/day to 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.
Symptoms
In the first 24 hours symptoms include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage.
Liver damage may become apparent 12 hours to 48 hours, or later after ingestion of paracetamol, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentrations and prolongation of the prothrombin time.
Liver damage may lead to encephalopathy, coma and death.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur.
Cardiac dysrhythmias have been reported.
Treatment
Although evidence is limited it is recommended that an adult person who has ingested 5 grams to 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given
via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above).
In patients who are stuporous or comatose, endotracheal intubation should precede gastric lavage in
order to avoid aspiration.
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children.
Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water as a 5 % solution may be administered initially, followed by 70 mg/kg every four hours for seventeen doses.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading.
Patients at risk of liver damage, and hence requiring continued treatment with Nacetylcysteine, can be identified according to their plasma paracetamol level.
The plasma paracetamol level can be plotted against time since ingestion in the treatment nomogram below. The nomogram should be used only in relation to a single acute ingestion.
Those whose plasma paracetamol levels are above the “Normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the “High-risk treatment line”.
Prothrombin index correlates best with survival.
Monitor all patients with significant ingestions for at least ninety-six hours.
Overdosage with promethazine hydrochloride causes a central excitatory effect which constitutes its greatest danger.
Symptoms include drowsiness or paradoxical excitement, hallucinations, ataxia, incoordination, athetosis and convulsions.
Fixed dilated pupils with a flushed face, sinus tachycardia, dyspnoea, urinary retention, dry mouth and fever can occur. Other symptoms include a terminally, deepening coma with cardiorespiratory collapse. Children and the elderly are more likely to exhibit anticholinergic and central nervous system stimulant effects. The elderly are prone to hypotension.
The stomach should be emptied by emesis or lavage. There is no specific antidote and treatment is symptomatic and supportive. It may be necessary to treat extrapyramidal reactions with barbiturates or diphenhydramine.
Respiratory depression is the most important feature of overdosage with codeine containing preparations and it occurs with circulatory failure and a deepening coma.
Pinpoint pupils, hypotension and hypothermia, excitement and convulsions, especially in children, and non-cardiogenic pulmonary oedema occur. Immediate attention should be given to maintaining adequate respiration.
Death may occur from respiratory failure. Naloxone should be given intravenously in a dose of 0,4 mg to 2 mg every 2 minutes to 3 minutes until improvement occurs to a maximum of 10 mg. Children may be given 0,01 mg/kg initially followed by a dose of 0,1 mg/kg.
