IMPORTANT INFORMATION

Safety Information

Carefully read the complete leaflet as it contains vital information for you. Although available without a prescription, use this medicine judiciously for optimal results. Do not use VIRALKEY after the expiration date stated on the package, following CAD (last day of the indicated month). Keep it out of reach and sight of children. No specific storage conditions are necessary. Dispose of unused medicine and packaging properly; consult your pharmacist for guidance on environmentally friendly disposal. Avoid discarding medicines in waste pipes or bins. By doing so, you contribute to environmental protection.

Retain this leaflet for future reference. Consult your pharmacist for advice or additional information. If symptoms worsen or fever persists after 3 days, or other symptoms persist after 5 days of treatment, consult your doctor. If you experience severe side effects or notice any unmentioned side effects, promptly inform your doctor or pharmacist. 

Do not use VIRALKEY if:

• You are allergic (hypersensitive) to the active substances or any other components.
• You have liver diseases.
• You have high blood pressure.
• You suffer from hyperthyroidism.
• You have severe heart or artery disease (e.g., coronary disease, chest pain).
• You suffer from tachycardia (rapid heartbeats).
• You are undergoing treatment with any monoamine oxidase inhibitor (MAOI) (e.g., certain antidepressants or Parkinson's disease medications) (refer to Use of other medicines).
• You suffer from glaucoma (increased eye pressure).

Exercise caution with VIRALKEY:

• Do not exceed the recommended dose in Section 5: (Instructions).
• In chronic alcoholics, do not exceed 2 g/day of paracetamol (2 sachets/day of VIRALKEY).
• Consult a doctor before use in patients with kidney, heart, or lung diseases, anaemia, or in asthmatic patients sensitive to acetylsalicylic acid.
• Consult a doctor if allergic to an antihistaminic, as sensitivity to others (such as chlorphenamine) may exist.
• Consult a doctor before use in the following situations, as they may worsen or interact with medicines: prostate hypertrophy, bladder neck obstruction, urinary retention, diabetes, bronchial asthma, slow heartbeats, low blood pressure, cerebral arteriosclerosis, pancreatitis, stenosing peptic ulcer, pylorus-duodenum obstruction, thyroid diseases, sensitivity to sedative effects, and epilepsy. If undergoing treatment with tricyclic antidepressants or medicines with anticholinergic action, and gastrointestinal problems occur, consult your doctor to prevent paralytic ileus (stoppage of normal intestinal movement).

Use of other medicines: Inform your doctor or pharmacist about current or recent use of any medications, including those obtained without a prescription. Note that these instructions apply to medicines used previously or in the future.

Interactions due to paracetamol: If you are using any of the following medicines, it may be necessary to adjust the dose of any of them or discontinue the treatment:

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• Antiepileptics (lamotrigine, phenytoin, hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosis medicines (isoniazid, rifampicin).
• Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Activated charcoal (adsorbent).
• Cholestyramine (used to reduce blood cholesterol levels).
• Medicines for gout (probenecid and sulfinpyrazone).
• Certain diuretics (loop diuretics like those in the furosemide group).
• Anticholinergic medicines (for stomach, intestine, and bladder spasms or contractions).
• Medicines for the heart (digitalis glycosides).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol for hypertension and cardiac arrhythmias.
• Zidovudine (used in the treatment of HIV/AIDS).

Interactions due to phenylephrine: With some of the following medicines, it may be necessary to discontinue treatment or administer them separately with a minimum 15-day interval:

• Monoamine oxidase inhibitors (MAOIs) (for depression, Parkinson's disease, or other conditions). VIRALKEY should be administered at least 15 days after finishing MAOI treatment.
• Alpha-adrenergic blockers (for migraines or other conditions related to childbirth, blood pressure, or others).
• Beta-adrenergic blockers (for blood pressure and other conditions).
• Tricyclic and tetracyclic antidepressants.
• General anesthetics.
• Antihypertensives (for blood pressure) with sympathetic nervous system-related mechanisms.
• Medicines causing potassium loss (such as diuretics for hypertension and others).
• Medicines affecting heart conduction (antiarrhythmics and cardiac glycosides).
• Thyroid hormones.
• Alpha- and beta-adrenergic blockers like labetalol and carvedilol (for heart or artery diseases).
• Atropine sulfate (for heart or digestive diseases).

Interactions due to chlorphenamine: The simultaneous use of the following medicines may increase the risk of side effects:

• Medicines causing central nervous system depression (used for insomnia, anxiety, or some antidepressants).
• Monoamine oxidase inhibitors (MAOIs) (for depression or other conditions).
• Medicines with anticholinergic action such as tricyclic and tetracyclic antidepressants, belladonna or belladonna alkaloids (antispasmodics for digestive or urinary disorders).
• Fosphenytoin and phenytoin (for epilepsy).
• Ototoxic medicines (causing ear damage as a side effect).
• Photosensitizing medicines (causing allergy to light as a side effect).
• Chlorphenamine maleate is incompatible (cannot be mixed) with the following medicines: calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, sodium pentobarbital, and meglumine.

Interferences with analytical tests: Before undergoing any diagnostic tests (blood or urine tests, skin tests using allergens, etc.), inform your doctor about your VIRALKEY treatment, as it may affect the test results.

Use of VIRALKEY with food and drink: Avoid alcohol consumption, especially in patients who typically consume three or more alcoholic drinks (beer, wine, liquor) daily, as the combination with paracetamol may harm the liver. Refrain from alcohol intake during VIRALKEY treatment to prevent potential symptoms, including heightened sedative effects.

Use in children: Not suitable for individuals under 18 years old.

Use in elderly people: Consult a doctor before use in elderly individuals. Due to phenylephrine and chlorphenamine content, elderly patients may be more susceptible to side effects like bradycardia (slow heartbeats) or reduced heart flow. Blood pressure should be monitored, especially in patients with heart diseases (refer to Possible side effects). The elderly may experience side effects more frequently, including sedation, confusion, hypotension, or excitation, and may be more sensitive to effects like dry mouth and urinary retention.

Pregnancy and breast-feeding: Seek advice from your doctor or pharmacist before taking any medication.

For women: If you are pregnant or suspect pregnancy, consult your doctor before using this medicine. Using medications during pregnancy can pose risks to the embryo or fetus and should be supervised by your doctor. Avoid using VIRALKEY during pregnancy unless your doctor deems it necessary. Both paracetamol and chlorphenamine can pass into breast milk, so nursing women should refrain from taking this medication.

Driving and use of machines: Refrain from driving or operating tools or dangerous machinery during treatment with this medicine, as it may induce drowsiness, sedation, and impair reaction capacity.

Important information about some components of VIRALKEY: This medicine contains sucrose. If your doctor has advised you of sugar intolerance, consult them before taking this medicine.

Indications

VIRALKEY is a combination of paracetamol, an analgesic for pain and fever relief, chlorphenamine, an antihistamine to alleviate nasal secretion, and phenylephrine, which reduces nasal congestion. It is recommended for symptomatic relief in cold and influenza, addressing fever, mild to moderate pain, nasal congestion, and secretion.

Ingredients

Composition of VIRALKEY: - Active substances per sachet: Paracetamol: 1,000 mg, Phenylephrine hydrochloride: 10 mg, Chlorphenamine maleate: 4 mg. Other components: Anhydrous colloidal silica, Anhydrous citric acid, Sodium saccharine, Sucrose (3,994 mg/sachet), Anhydrous sodium cyclamate, Orange aroma.

Instructions

1) Dosage: Follow these instructions unless otherwise directed by your doctor. If in doubt, consult your doctor or pharmacist.

• Adults over 18 years old: Take one sachet every 6-8 hours (three or four times daily). Do not exceed 4 sachets (4 grams of paracetamol) in 24 hours.
• Patients with liver or kidney diseases: Consult your doctor.

2) Form of use and administration route:

• The sachet's contents should be fully dissolved in a small amount of liquid, preferably half a glass of water.
• Administered orally.

3) Treatment duration:

• Use this medication as symptoms of pain or fever occur.
• Suspend the medication once symptoms disappear.

If fever persists for over 3 days or pain and other symptoms last beyond 5 days, or if symptoms worsen or new ones emerge, seek medical evaluation. 

If you find this medicine's effect too strong or weak, inform your doctor or pharmacist.

If you have taken more VIRALKEY than prescribed, seek immediate advice from your doctor or pharmacist. 

In the event of a paracetamol overdose: Seek urgent medical attention, even without apparent symptoms. Symptoms may not manifest until 3 days after overdose, especially in severe cases. Paracetamol overdose symptoms include dizziness, vomiting, loss of appetite, jaundice (yellowing of skin and eyes), and abdominal pain.

Phenylephrine overdose symptoms involve excessive nervous stimulation: anxiety, fear, agitation, headache, convulsions, insomnia, confusion, irritability; as well as anorexia, nausea, vomiting, psychosis with hallucinations (more common in children), and cardiovascular effects like hypertension, cerebral hemorrhage, lung edema.

Chlorphenamine overdose symptoms include instability, intense drowsiness, severe dryness in the mouth, nose, or throat, facial redness, respiratory difficulty, rapid or irregular heartbeats, and nervous system stimulation or depression. In children and the elderly, stimulation may cause movement disorders, excitement, shivering, hallucinations, convulsions, and insomnia; while in adults, depression may lead to drowsiness, coma, convulsions, progressing to respiratory failure and cardiovascular collapse.

Prompt treatment for paracetamol overdose is most effective within the first 4 hours. Individuals on barbiturates or chronic alcoholics may be more susceptible. The treatment for phenylephrine and chlorphenamine overdose is symptomatic and supportive. In case of overdose, go immediately to a medical center, providing details about the medication and the quantity ingested.

If you forget to take VIRALKEY: Do not double the dose to make up for missed doses. Take the missed dose as soon as possible, but if it's close to your next scheduled dose, return to your regular schedule. For any uncertainties about using this product, consult your doctor or pharmacist.

Possible Side Effects: Like all medicines, VIRALKEY may cause side effects, though not everyone experiences them. Phenylephrine side effects may include anxiety, nerves, irritability, weakness, dizziness, shivering, insomnia, increased blood pressure, headache, chest pain, severe bradycardia, urinary retention, respiratory difficulty, paleness, and more. Chlorphenamine side effects may involve drowsiness, dizziness, muscle weakness, altered sensations, dry mouth, loss of appetite, gastrointestinal discomfort, urinary retention, skin reactions, and rare allergic reactions. Paracetamol, if taken in high doses or prolonged treatments, may lead to kidney disorders, allergic dermatitis, jaundice, blood alterations, and hypoglycemia. If you experience severe side effects or notice any unmentioned ones, contact your doctor or pharmacist.

Product appearance and package content: VIRALKEY is powder for oral solution, presented in packages of 10 sachets.