Hapacol CF Fort



Paracetamol ............................................................ 325 mg

Phenylephrine HCl........................................................ 5 mg

Dextromethorphan HBr .............................................. 10 mg

Excipients q.s  ..........................................................1 tablet

(Pregelatinized starch, lactose monohydrate, microcrystalline cellulose M101, aerosil, sodium benzoate, PVP K30, croscarmellose sodium, magnesium stearate, sepifilm LP770, blue lake, eurolake green, silver sheen).

DOSAGE FORM: Film coated tablet.

PRESENTATION: Box of 10 blisters x 10 film coated tablets.

PHARMACODYNAMICS: Paracetamol produces analgesia, antipyresis. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow.

Dextromethorphan HBr exerts its antitussive activity by acting on the cough centre in the medulla oblongata. It has no significant analgesic and sedative properties.

Phenylephrine HCl is an alpha1 sympathomimetic agent with mainly direct effects on alpha1-adrenoceptors producing vasoconstriction. Phenylephrine is topically vasoconstrictive, so it relieves nasal and sinusal congestion caused by cold.


Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentration reaches within 30 to 60 minutes after taking the therapeutic dosage. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is quickly and evenly distributed in the most body tissues. Paracetamol is N-hydroxylated by cytochrome P450 and is excreted by the kidney.

Dextromethorphan HBr is rapidly absorbed from the gastrointestinal tract and has effect within 15-30 minutes after ingestion. It is metabolized by the liver and excreted in the urine.

Phenylephrine HCl is abnormally absorbed from the gastrointestinal tract by its direct metabolism on the gastrointestinal tract. Phenylephrine HCl is metabolized in the liver and intestine by MAOIs.


For the temporary relief of common cold, influenza symptoms including mild aches and pains, headache, sore throat, nasal stuffiness, cough, nasal congestion.


Hypersensitivity to any component of the drug. Patients with glucose-6-phosphate dehydrogenase deficiency. Patients with acute course of asthma, prostatomegaly, bladder neck stenosis, gastric ulcer, pyloro-duodenal obstruction.

No concomitant use of Hapacol CF Fort and other sympathomimetic decongestants or other paracetamol-containing drugs.

Phaeochromocytoma, closed angle glaucoma, severe hyperthyroidism, hypertension, cardiovascular disease, severe liver disease. Children under 12 years old.

Patients taking or have taken in the last two weeks MAOIs, tricyclic antidepressants or beta-adrenergic blockers.

Patients with respiratory failure.


Care is advised in the administration of paracetamol to patients with hepatic impairment, cardiac disease, hypertension, diabetes, thyroid disease, glaucoma. Patients with respiratory disease including chronic bronchitis, cough associated with excessive sputum, persistent or chronic cough such as asthma, hepatic, renal failure.

Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Due to containing paracetamol, the drug can lead to serious liver damage if use of more than 4 g of paracetamol within 24 hours; combination with other drugs containing paracetamol; use of alcoholic drinks every day: 3 glasses/day or more during administration of this product.

If severe sore throat lasts more than 2 days with fever, headache, rash, nausea, vomiting, seek physician's consult.

Contact the physician if tension, dizziness, insomnia; pains, nasal stuffiness occur; cough gets worse or lasts more than 7 days; fever gets worse or lasts more than 3 days; rash, swelling; new symptoms occur; cough comes back or occurs with persistent headache.

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).


Only use if really necessary. Administration of phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia.

Use of phenylephrine HCl and assisted reproductive medicines increases accidents in pregnant women. Very careful when using the drug for breastfeeding women.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Patients should be advised not to drive or operate machinery if affected by dizziness, vertigo.

INTERACTIONS: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol

Paracetamol increases the concentrations of chloramphenicol.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

Caution when combined simultaneously with MAOIs, tricyclic antidepressants, sympathomimetic drugs, beta-adrenergic receptors, antihypertensives, ergot alkaloids, digoxin and other cardiac glycosides.

Do not use the medication in conjunction with quinidine, phenytoin, central nervous inhibitors, ethanol or sedative drugs.


Frequently observed: fatigue, dizziness, nausea, tachycardia, flushing; agitation, anxiety, sleeping trouble, weakness, vertigo, chest pain, tremor, acroparesthesia, hypertension, pale, feeling of cold skin, hair stand on end, topical irritation.

Infrequently observed: urticaria; pulmonary edema associated with hypertension, arrhythmia, bradycardia, peripheral and visceral vasoconstriction, which reduces blood flow to organs, respiratory depression, euphoria attack, paranoid hallucinations, blurred cornea; rash, neutropenia, pancytopenia, anemia, kidney disease, renal toxicity due to long-term abuse.

Rarely observed: occasionally mild drowsiness, gastrointestinal disorders, myocarditis, pericardial bleeding, hypersensitivity reactions.

Inform your physician about any adverse effects occur during the treatment.

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 overdose include nausea, vomiting, colic, cyanosis on skin, mucosa, nails.

Treatment: In the event of severe paracetamol overdose, 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. Methionin, activated charcoal and/or salt cathartic are also advised to treat overdose.

Symptoms of dextromethorphan overdose include nausea, vomiting, drowsiness, blurred vision, nystagmus, urinary retention, stupor, hallucination, ataxia, respiratory insufficiency, and convulsions.

Treatment: Naloxone 2 mg intravenously may be given and repeated to the total dose of 10 mg if necessary.

Symptoms of phenylephrine overdose include hypertension, headache, convulsion, encephalorrhagia, palpitations, ventricular premature beats, paresthesia. Bradycardia occurs sooner.

Treatment: Hypertension may need to be treated with an alpha-adrenergic blocker, such as phentolamine 5-10 mg intravenously.


Adults and children aged > 12 years: oral dose of 2 tablets each time.

The interval between oral doses should be at least 4 hours. Do not use excess of 5 times per day.

Do not administer the drug to children aged < 12 years.

Or as prescribed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

The drug is for prescription only.

Shelf-life: 24 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.


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