Read the entire leaflet carefully because it contains important information for you.
This medicine can be bought without a prescription. Nevertheless, to obtain the best results,
it should be used carefully.
- Keep this leaflet. You may need to read it again.
- If you need advice or further information, please see your pharmacist.
- If symptoms worsen or fever persists after 3 days, or the rest of the symptoms persist
after 5 days of treatment, consult your doctor.
- If you consider that any of the side effects that you suffer from is severe, or if you notice
any side effect not mentioned in this leaflet, inform your doctor or pharmacist.
In this leaflet:
1. What VIRALKEY is and what it is used for.
2. Before you use VIRALKEY.
3. How to use VIRALKEY.
4. Possible side effects.
5. Preservation of VIRALKEY.
6. Further information.
1. WHAT VIRALKEY IS AND WHAT IT IS USED FOR
It is an association of paracetamol, analgesic that reduces pain and fever, chlorphenamine, antihistaminic that relieves nasal secretion and phenylephrine, which acts reducing nasal congestion.
It is indicated for the symptomatic relief of cold and influenza processes involving fever, mild to moderate pain, nasal congestion and secretion.
2. BEFORE YOU USE VIRALKEY
Do not use VIRALKEY:
- If you are allergic (hypersensitive) to the active substances or to any of the other components of VIRALKEY.
- If you suffer from liver diseases.
- If you have high blood pressure.
- If you suffer from hyperthyroidism.
- If you suffer from any severe heart or artery disease (such as coronary disease or chest pain).
- If you suffer from tachycardia (rapid heartbeats).
- If you are in treatment with any medicine inhibitor of monoamine oxidase (MAOI) (such as some antidepressants or medicines for Parkinson’s disease, or others) (see: Use of other medicines).
- If you suffer from glaucoma (rise of eye pressure).
Be specially careful with VIRALKEY
- The dose recommended in section 3: How to use VIRALKEY should not be exceeded.
- In chronic alcoholics, the precaution of not taking more than 2 g/day of paracetamol (2 sachets/day de VIRALKEY) will have to be taken.
- In patients with kidney, heart or lung diseases and in patients with anaemia, a doctor will have to be consulted before taking this medicine.
- In asthmatic patients sensitive to acetylsalicylic acid, a doctor will have to be consulted before taking this medicine.
- In patients sensitive (allergic) to an antihistaminic, a doctor will have to be consulted before taking this medicine because they may be sensitive to others (such as chlorphenamine).
- In the next situations you will have to consult your doctor before taking this medicine, as they may worsen or interactions with medicines that treat them may occur: prostate hypertrophy, bladder neck obstruction, urinary retention, diabetes, bronchial asthma, slow heartbeats, low blood pressure, cerebral arteriosclerosis, pancreatitis (pancreas inflammation), stenosing peptic ulcer (digestive ulcer), pylorus-duodenum obstruction (between the stomach and the intestine), thyroid diseases, patients sensitive to sedative effects and epileptic patients. If you are in treatment with tricyclic antidepressants or medicines with anticholinergic action (paralyze lung and abdominal areas, among other actions), and gastrointestinal problems arise, paralytic ileum might occur (stop of the normal movement of a part of the intestine). Consult your doctor.
Use of other medicines
Inform your doctor or pharmacist if you are using or have used recently other medicines, even those bought without prescription.
Take into account that these instructions may be also applicable to medicines that have been used before or may be used later.
Interactions due to paracetamol
In particular, if you are using some of the following medicines, it may be necessary to modify the dose of any of them or to stop the treatment:
- Antibiotics (chloramphenicol).
- Oral anticoagulants (acenocumarol, warfarin).
- Oral contraceptives and treatments with oestrogens.
- Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Antituberculosis medicines (isoniazid, rifampicin).
- Barbiturates (used as hypnotics, sedatives and anticonvulsivants).
- Activated coal (adsorbent).
- Cholestyramine (used to reduce blood cholesterol levels).
- Medicines used to treat gout (antigout medicines) (probenecid and sulfinpyrazone).
- Some medicines used to increase urine elimination (loop diuretics such as those of the furosemide group).
- Medicines used for the relief of stomach, intestine and bladder spasms or contractions (anticholinergic medicines).
- Medicines used for the heart (digitalis glycosides).
- Metochlopramide and domperidone (used to avoid nausea and vomiting).
- Propranolol used in the treatment of high blood pressure (hypertension) and alterations of heart rate (cardiac arrhythmias).
- Zidovudine (used in the treatment of patients infected by the human immunodeficiency virus, causing of AIDS).
Interactions due to phenylephrine
With some of the next medicines, it may be necessary to suspend the treatment or separate the administration a minimum of 15 days:
- Monoamine oxidase inhibitors (MAOIs) (medicines used for depression, Parkinson’s disease or other diseases). The administration of VIRALKEY should be separated a minimum of 15 days after finishing the treatment.
- Alpha-adrenergic blockers (medicines for migraine or others for childbirth, blood pressure or other diseases).
- Beta-adrenergic blockers (for blood pressure and other diseases).
- Tricyclic and tetracyclic antidepressants.
- General anaesthetics.
- Antihypertensives (medicines for blood pressure) with mechanism of action related to the sympathetic nervous system.
- Medicines producing loss of potassium (such as diuretics to treat hypertension and others).
- Medicines affecting heart conduction (used for the heart) such as antiarrhythmics and cardiac glycosides.
- Thyroid hormones.
- Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or artery diseases).
- Atropine sulfate (for the heart or digestion diseases).
Interactions due to chlorphenamine
The simultaneous use of the following medicines may favour the onset of side effects:
- Medicines producing depression on the central nervous system (such as those used for insomnia, anxiety or some antidepressants).
- Monoamine oxidase inhibitors (MAOIs) (medicines for depression or others).
- Medicines with anticholinergic action such as tricyclic and tetracyclic antidepressants, belladonna or belladonna alkaloids (antispasmodics for relief of digestive or urinary disorders).
- Fosphenytoin and phenytoin (for epilepsy).
- Ototoxic medicines (cause ear damage as a side effect).
- Photosensitizing medicines (as a side effect, they cause allergy to light).
- Chlorphenamine maleate is incompatible (it cannot be mixed) with the next medicines: calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, sodium pentobarbital and meglumine adipiodone.
Interferences with analytical tests:
If you are going to take any diagnostic test (blood or urine test, skin tests using allergens, etc…) tell your doctor that you are in treatment with VIRALKEY, as it may alter the results of these tests.
Use of VIRALKEY with food and drink
The use of paracetamol in patients that usually drink alcohol (three or more alcoholic drinks: beer, wine, liquor... daily) may damage the liver.
Alcohol should not be taken during the treatment with VIRALKEY because symptoms might occur, such as increased sedative effects.
Use in children
Do not use in children under 18 years old.
Use in elderly people
Do not use in elderly people without consulting a doctor.
Due to the content of phenylephrine and chlorphenamine, elderly patients may be specially affected by some side effects such as bradycardia (slow heartbeats) or heart flow reduction. Blood pressure should be controlled, especially in patients with heart diseases (see: Possible side effects). The elderly may also show side effects more probably such as sedation, confusion, hypotension or excitation, and may be more sensitive to effects such as dry mouth and urinary retention.
Pregnancy and breast-feeding
Consult your doctor or pharmacist before using any medicine.
IMPORTANT FOR WOMEN
If you are pregnant or think you are, consult your doctor before using this medicine. The consumption of medicines during pregnancy may be dangerous for the embryo or foetus and should be monitored by your doctor.
During pregnancy, VIRALKEY should not be used unless your doctor makes a decision that justifies it.
Paracetamol and chlorphenamine are known to pass into breast milk, so women in the breast-feeding period should not take this medicine.
Driving and use of machines
Do not drive or use tools or dangerous machines while you are in treatment with this medicine, because it may cause drowsiness and sedation, and it may alter reaction capacity.
Important information about some of the components of VIRALKEY
This medicine contains sucrose. If your doctor has indicated to you that you suffer from intolerance to certain sugars, consult him/her before taking this medicine.
3. HOW TO USE VIRALKEY
Follow these instructions unless your doctor has given you others. Consult your doctor or pharmacist if you have any doubts.
Adults over 18 years old: One sachet every 6-8 hours (three or four times daily).
4 sachets will not be exceeded (4 grams of paracetamol) in 24 hours (one day).
Patients with liver or kidney diseases: should consult their doctor.
2) Form of use and administration route
The content of the sachet will be taken totally dissolved in a little of liquid, preferably in half a glass of water.
3) Treatment duration
The administration of the preparation is subject to the onset of painful or feverish symptoms. As these disappear, this medication should be suspended.
If fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or symptoms worsen or new ones appear, the clinical situation will have to be assessed.
If you consider that the action of this medicine is too strong or weak, tell your doctor or pharmacist.
If you take more VIRALKEY than you should
You should consult immediately your doctor or pharmacist.
If you have ingested a paracetamol overdose, you should go rapidly to a medical centre although there are not symptoms, since these does not often manifest themselves until 3 days have passed from the ingestion of the overdose, even in cases of severe intoxication.
The symptoms of paracetamol overdose may be: dizziness, vomiting, loss of appetite, yellowish coloration of the skin and eyes (jaundice) and abdominal pain. Phenylephrine overdose causes excessive nervous stimulation: anxiety, fear, agitation, headache (may be a symptom of hypertension), convulsions, insomnia, confusion, irritability, shiver; also anorexia (loss of appetite), nausea, vomiting, psychosis with hallucinations (more frequent in children) and effects on the cardiovascular system such as hypertension, cerebral haemorrhage, lung oedema; peripheral vasoconstriction with possible reduction of the blood risk to vital organs (severe effects may appear more probable in hypovolemic patients, that is, with decreased blood volume, owing to haemorrhage, dehydration, etc.), severe bradycardia (slow heartbeats), increased heart work, irregular or rapid heartbeats, urine quantity reduction, metabolic acidosis (decreased blood alkaline reserve), paraesthesias (sensitivity alterations in body areas). In prolonged use, plasma volume depletion may occur (decreased blood volume). Because of chlorphenamine the following may appear: instability, intense drowsiness, severe dry mouth, nose or throat, face reddening, respiratory difficulty, rapid or irregular heartbeats, nervous system stimulation or depression, hypotension (fainting sensation), the nervous stimulation is more probable in children and elderly, causing movement disorders, excitation, shiver, hallucinations, convulsions and insomnia; nervous system depression is more common in adults, with drowsiness, coma, convulsions, and may progress to respiratory failure and cardiovascular collapse.
The treatment of paracetamol overdose is more effective if it starts within the 4 hours after the medicine ingestion.
Patients in treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
The treatment of phenylephrine and chlorphenamine overdose is symptomatic and of support.
In case of overdose or accidental ingestion, go immediately to a medical centre, indicating the medicine and the ingested quantity.
If you forgot to take VIRALKEY
Do not take a double dose to compensate the forgotten doses.
If you forget a dose, take it as soon as possible, but if it is nearly the moment of your next dose go back to your usual timetable.
If you have any doubt about the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFECTS
Like all medicines, VIRALKEY may have side effects, although not all the people suffer from them.
Side effects due to phenylephrine:
-Often unknown: anxiety, nerves, irritability, weakness, dizziness, shiver, insomnia, increased blood pressure (generally with high doses and in sensitive patients), headache (with very high doses and may be a symptom of hypertension), chest pain or discomfort, severe bradycardia (very slow heartbeats), peripheral vasoconstriction (blood vessel calibre reduction), heart performance reduction that especially affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, respiratory difficulty, paleness, spiky hair, increased sweating, increased blood sugar, decreased blood potassium, metabolic acidosis, cold in limbs (legs or arms), flush, decreased blood pressure (fainting sensation); with high doses the following may occur: vomiting, palpitations, psychotic states with hallucinations; in prolonged use, decreased blood volume may occur.
-Rarely the following may appear: heart attack, ventricular arrhythmia, lung oedema and brain haemorrhage (at high doses or in sensitive patients).
Side effects due to chlorphenamine:
-Those that may appear more frequently: slight drowsiness, dizziness, muscle weakness; these side effects may disappear after 2-3 days of treatment, difficulty in face movements, clumsiness, shiver, sensation alterations and tingling sensation, dry mouth, loss of appetite, taste or sense of smell alterations, gastrointestinal discomfort that may diminish if the medicine is administered together with food (nausea, vomiting, diarrhoea, constipation, stomachache), urinary retention, dry nose and throat, mucus thickening, exfoliative dermatitis, sweating, blurred vision or other eye disorders.
-Less often or rarely: occasionally nervous excitation (generally with high doses and more frequent in the elderly and children) with symptoms such as worry, insomnia, nerves or occasionally convulsions; chest tension, lung noise, rapid or irregular heartbeats (generally with overdose), liver disorders (that may occur with stomachache or abdominal pain, dark urine or other symptoms), allergic reaction such as rash, severe hypersensitivity reactions (cough, difficulty to swallow, rapid heartbeats, itch, swelling of eyelids or around the eyes, face and tongue, respiratory difficulty, etc.), sensitization to sunlight, crossed sensitivity (allergy) with medicines related to chlorphenamine, rarely blood alterations (such as agranulocytosis, leucopoenia, aplastic anaemia, thrombocytopaenia, with symptoms such as not usual haemorrhage, sore throat or tiredom); increased or decreased blood pressure, oedema (swelling), ear alterations, impotence, menstrual alterations.
Side effects due to paracetamol:
-At least 1 of each 10.000 patients: Kidney disorders, cloudy urine, allergic dermatitis (rash), jaundice (yellowish coloration of the skin), blood alterations (agranulocytosis, leucopoenia, neutropaenia, thrombocytopaenia, haemolytic anaemia) and hypoglycaemia (decreased blood sugar). Paracetamol may damage the liver when taken in high doses or in prolonged treatments.
If you consider that any of the side effects that you suffer from is severe, or if you notice that any side effect not mentioned in this leaflet, inform your doctor or pharmacist.
5. PRESERVATION OF VIRALKEY
Keep out of reach and sight of children.
Do not use VIRALKEY after the expiry date that appears on the package, after CAD. The expiry date is the last day of the indicated month.
No special conditions of preservation are required.
Medicines should not be thrown to waste pipes or to the rubbish bin. Ask your pharmacist how to get rid of the packages and medicines that you do not need. Thus, you will help to protect the environment.
6. FURTHER INFORMATION
Composition of VIRALKEY:
-The active substances are: paracetamol, phenylephrine hydrochloride and chlorphenamine maleate.
Each sachet contains:
Phenylephrine hydrochloride…....10 mg
Chlorphenamine maleate……...….4 mg
-The rest of the components are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharine, sucrose (3.994 mg/sachet), anhydrous sodium cyclamate, orange aroma.
Product appearance and package content
VIRALKEY is powder for oral solution, presented in packages of 10 sachets.
Marketing authorization holder and company responsible for manufacturing
Marketing authorization holder:
C/ Aribau 168-170
08036 Barcelona (Spain)
Company responsible for manufacturing
Laboratorios Alcalá Farma, S.L.
Ctra. M-300, Km. 29,920.
28802 Alcalá de Henares (Madrid)
This leaflet was approved in August 2007.