Novag Antigripal granules for oral solution

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Novag antigripal effervescent granules for oral solution

paracetamol / phenylephrine bitartrate / chlorpheniramine maleate

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

Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• 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.
• You should consult a doctor if your condition worsens or does not improve, or if fever persists for more than 3 days, or if pain or other symptoms last for more than 5 days.

Contents of the leaflet

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

1. What Novag antigripal is and what it is used for

This medicine is a combination of paracetamol, chlorpheniramine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents over 15 years of age for the relief of symptoms of colds and flu associated with fever or mild to moderate pain, nasal congestion, and nasal discharge.

You should consult your doctor if symptoms worsen, do not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

2. What you need to know before taking Novag antigripal

Do not take Novag antigripal

• If you are allergic to the active substances or to any of the other components of this medicine (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 inhibitor (MAOI) medicines (such as certain antidepressants 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 heart conditions or arterial diseases) (see: Taking Novag antigripal with other medicines).
• If you have glaucoma (increased pressure in the eye).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Novag antigripal.

Do not take more medicine than the recommended dose stated in section 3, How to take Novag antigripal.

Avoid using this medicine together with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Chronic alcohol users should take care not to exceed 2 g of paracetamol (equivalent to 3 sachets of Novag antigripal) in 24 hours.

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

Talk to your doctor or pharmacist before starting to take this medicine if you:

• Have kidney, liver, heart, or lung disease, or if you have anemia.
• Are an asthmatic patient sensitive to acetylsalicylic acid.
• Are sensitive (allergic) to an antihistamine, as you may also be sensitive to other antihistamines (such as chlorpheniramine).
• Are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the stomach and intestine), thyroid disorders, or if you are sensitive to the sedative effects of certain medicines.
• Are taking tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems. In such cases, you should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).

Children and adolescents

This medicine must not be given to children under 15 years of age due to the paracetamol dose (650 mg).

Interference with diagnostic tests:

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

Other medicines and Novag antigripal

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 taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

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

• Medicines for tuberculosis: (isoniazid, rifampicin).

• Medicines for 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 others), 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 for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.

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

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Novag antigripal should be taken at least 15 days after stopping treatment with these medicines.

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

• Medicines that are both alpha- and beta-adrenergic blockers (labetalol and carvedilol), used for heart conditions or arterial diseases.

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

• General anesthetics (medicines used for general anesthesia).

• Antihypertensives (medicines used to lower blood pressure).

• Medicines used for heart conditions or digestive disorders such as atropine sulfate.

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

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

• Photosensitizing medicines (those 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, or when maximum daily doses of paracetamol are used.

Interference with diagnostic tests:

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

Taking Novag antigripal with food, drinks, and alcohol

While taking this medicine, do not consume alcoholic beverages, as they may increase the risk of adverse effects.

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

This medicine may be taken with or without food.

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 taking this medicine.

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

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

Driving and use of machines

This medicine may cause drowsiness. If you feel drowsy during treatment with this medicine, avoid driving or operating machinery.

Novag antigripal contains mannitol (E-421)

This medicine may cause a mild laxative effect due to its mannitol content.

3. How to take Novag antigripal

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

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

Recommended dose:

Adults and adolescents over 15 years: 1 sachet every 6–8 hours (3 or 4 sachets per day) as needed. Do not take more than 4 sachets (equivalent to 2.6 grams of paracetamol) in 24 hours.

Do not exceed 3 grams of paracetamol in 24 hours (see section “Warnings and precautions”).

Patients with kidney disease: Must consult their doctor. These patients should not take this medicine due to the paracetamol content.

Patients with liver disease: Must consult their doctor. They should not take more than 3 sachets (equivalent to 2 grams of paracetamol) in 24 hours, and the minimum interval between doses must be 8 hours.

Use in children

This medicine must not be administered to children and adolescents under 15 years of age.

Use in elderly patients

Elderly individuals should not use this medicine without consulting their doctor.

How to take

Novag antigripal is taken orally. Empty the entire contents of the sachet into approximately half a glass of water. Stir and drink immediately.

Always take the lowest effective dose.

This medicine should only be taken when symptoms are present. As symptoms subside, treatment should be discontinued.

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

If you take more Novag antigripal than you should

In case of overdose, go immediately to a medical center even if you do not feel symptoms, as symptoms often do not appear until 3 days after the overdose, 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 (possibly a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, fainting sensation, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dryness of mouth, nose, or throat. Other possible effects include high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output, metabolic acidosis (decreased alkaline reserve in the blood). With prolonged use, plasma volume depletion (decreased blood volume) may occur.

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

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects 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, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of paracetamol, phenylephrine, and chlorpheniramine, whose frequency has not been accurately established:

• The adverse effects that may occur more 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, diarrhoea, 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, low blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses, and more common in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. 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 eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorpheniramine. Blood disorders (changes in blood cell counts, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, oedema (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, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Paracetamol can damage the liver when taken in high doses or during prolonged treatment.

Very rare cases of serious skin reactions have been reported.

• Adverse effects for which the frequency of occurrence is unknown are: Anxiety, irritability, weakness, increased 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 particularly 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 (hyperglycaemia), low potassium levels in blood, metabolic acidosis (metabolic disturbance), coldness in extremities (legs or arms), flushing, feeling of faintness (hypotension). At high doses, vomiting and palpitations may occur, as well as psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Novag antigripal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Novag antigripal

Each sachet contains:

• Active substances: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).
• Other components (excipients): Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavour (containing maltodextrin, which is a derivative of maize starch) and povidone.

Appearance of the medicine and contents of the pack

Novag antigripal is an oral granulate for solution, white or yellowish-white in colour and orange-flavoured, presented in sachets packed in cardboard boxes containing 10 sachets.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Via Carlos III, 94

08028 Barcelona

Manufacturer

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the most recent revision of this leaflet: November 2022

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