Viralkey powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viralkey Powder for oral solution

Paracetamol/Phenylephrine/Chlorpheniramine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Viralkey is and what it is used for
2. What you need to know before taking Viralkey
3. How to take Viralkey
4. Possible side effects
5. How to store Viralkey
6. Contents of the pack and other information

1. What Viralkey is and what it is used for

Viralkey is a combination of paracetamol, chlorpheniramine, and phenylephrine that works by reducing nasal congestion.

Paracetamol is an analgesic that reduces pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine is a sympathomimetic agent that reduces nasal congestion.

It is indicated in adults for the relief of symptoms of colds and flu associated with fever or mild to moderate pain, nasal congestion, and nasal discharge.

2. What you need to know before taking Viralkey

Do not take Viralkey

• If you are allergic (hypersensitive) to the active substances or to any of the other components of Viralkey (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs), such as certain antidepressant medicines or medicines used to treat Parkinson's disease.
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or medicines that increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: Taking X with other medicines).
• If you have glaucoma (increased intraocular pressure).
• If you have a serious heart or arterial disease (such as coronary heart disease or angina pectoris).
• If you have severe liver or kidney disease.

Children and adolescents under 18 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• Do not take more medicine than recommended in section 3: How to take Viralkey.

• Chronic alcoholics should take care not to take more than 2 sachets of Viralkey per day.

• While taking this medicine, do not take other products containing paracetamol, as this could lead to a paracetamol overdose, which may damage the liver.

• Patients should consult their doctor before taking this medicine if they have:

  • Kidney, liver, heart, or lung disease, or anemia.
  • Asthma sensitive to acetylsalicylic acid.
  • Sensitivity (allergy) to antihistamines, as they may also be sensitive to other antihistamines (such as chlorpheniramine).
  • Are being treated with medicines for: prostate hypertrophy, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between stomach and intestine), thyroid disorders, or if they are sensitive to the sedative effects of certain medicines.

• If you are taking tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, you must stop taking this medicine immediately and consult a doctor, as you may develop paralytic ileus (cessation of normal intestinal movements).

Children and adolescents

Children and adolescents under 18 years of age must not take this medicine.

Taking Viralkey with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are using any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medicines to treat tuberculosis: (isoniazid, rifampicin).

• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics used to treat hypertension or others).

• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.

• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).

• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.

• Medicines to lower blood cholesterol levels: (cholestyramine).

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of Viralkey must be separated by at least 15 days after stopping MAOI treatment.

• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking agents).

• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).

• Medicines to treat depression (tricyclic and tetracyclic antidepressants).

• General anesthetics.

• Antihypertensives (medicines to lower blood pressure).

• Medicines used for the heart, such as cardiac glycosides and antiarrhythmics.

• Medicines containing thyroid hormones (used to treat thyroid disorders).

• Medicines used for heart disease or digestive disorders (atropine sulfate).

• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).

• Ototoxic medicines (medicines that may damage the ear as an adverse effect).

• Photosensitizing medicines (medicines that may cause light allergy as an adverse effect).

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Viralkey with food, drinks, and alcohol

While being treated with this medicine, you must not consume alcoholic beverages, as this may increase the risk of adverse effects.

Additionally, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks—beer, wine, spirits, etc.—per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine must not be taken during pregnancy unless your doctor considers it strictly necessary.

This medicine must not be used during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

Viralkey contains sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3.994 g of glucose per sachet.

3. How to take Viralkey

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults from 18 years of age: 1 sachet every 6–8 hours as needed (3 or 4 sachets per day). Do not exceed 4 sachets in 24 hours.

Patients with liver or kidney disease: You must consult your doctor. (See section 2 – What you need to know before taking this medicine).

Use in children

This medicine is contraindicated in individuals under 18 years of age.

Use in elderly people

Elderly individuals must not use this medicine without first consulting a doctor.

This is because they may be particularly affected by certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output due to the presence of phenylephrine and chlorphenamine. They may also be more likely to experience adverse effects such as sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

Viralkey is taken orally.

Completely dissolve the contents of the sachet in a small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

This medicine should only be taken when symptoms appear. As symptoms improve, treatment should be discontinued.

If fever persists for more than 3 days of treatment, or if pain or other symptoms last more than 5 days, worsen, or new symptoms appear, consult your doctor.

If you take more Viralkey than you should

If you have taken an overdose, go immediately to a medical center even if you do not feel any symptoms, as symptoms often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output, metabolic acidosis (decreased alkaline reserve in the blood). With prolonged use, a reduction in blood volume may occur.

Treatment for overdose is most effective if started within 4 hours after the overdose has been taken.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Viralkey may produce adverse effects, although not everyone will experience them.

During the period of use of paracetamol, phenylephrine and chlorphenamine, the following adverse effects have been reported, for which the frequency has not been accurately established:

• The adverse effects that may occur most frequently are:

Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.

• The adverse effects that may occur less frequently (rare) are:

Malaise, drop in blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses and more frequent in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may occur less frequently are: chest tightness, lung sounds, rapid or irregular heartbeat (generally with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to drugs related to chlorphenamine. Blood disorders (changes in blood cell counts, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

• The adverse effects that may occur very rarely (very rare) are: Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of serious skin reactions have been reported.

Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.

• Adverse effects for which the frequency of occurrence is not known are: Anxiety, irritability, weakness, increase in blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in blood vessel diameter (peripheral vasoconstriction), reduced cardiac performance especially affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycemia), low potassium levels in blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Viralkey

Keep out of sight and reach of children.

Do not use Viralkey after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Viralkey:

• The active substances are: paracetamol, phenylephrine hydrochloride and chlorphenamine maleate.

Each sachet contains:

Paracetamol…………….1 g
Phenylephrine hydrochloride…..10 mg (equivalent to 8.21 mg of phenylephrine)
Chlorphenamine maleate……...4 mg (equivalent to 2.8 mg of chlorphenamine)

• Other components: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose (3,994 mg/sachet), anhydrous sodium cyclamate, orange flavouring.

Nature of the product and pack contents

Viralkey is a powder for oral solution, available in packs of 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

PHARMINICIO S.L.
Calle Aribau, 168
08036 Barcelona, Spain

Manufacturer:

Laboratorios Alcalá Farma, S.L.
Avda. de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain

This leaflet was approved in July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/