Patient Information Leaflet

Novag Antigripal Granulated for Oral Solution

Paracetamol / Phenylephrine Bitartrate / Chlorphenamine Maleate

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you worsen, or if you do not improve, or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

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

2.What you need to knowbefore starting to take Novag Antigripal

3.How to take Novag Antigripal

4.Possible side effects

5.Storage of Novag Antigripal

6.Contents of the pack and additional information

This medication is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that alleviates nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents over 15 years old for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion, and nasal secretion.

You should consult a doctor if symptoms worsen or do not improve or if fever persists for more than 3 days or pain or other symptoms persist for more than 5 days.

Do not take Novag antigripal

-If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).

- If you have high blood pressure.

- If you have hyperthyroidism.

- If you have diabetes mellitus.

- If you have tachycardia (rapid heartbeats).

- If you are being treated with any monoamine oxidase inhibitor (MAOI) medication (such as certain antidepressants or medications for Parkinson's disease).

- If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to increase heart rate).

- If you are being treated with beta-blocker medications (medications for the heart or to treat blood vessel diseases) (see: Taking Novag antigripal with other medications).

- If you have glaucoma (elevated eye pressure).

- If you have a severe heart or blood vessel disease (such as coronary artery disease or angina pectoris).

Warnings and precautions

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

Do not take more medication than recommended in section 3. How to take Novag antigripal.

Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not take more than one medication containing paracetamol without consulting your doctor.

Chronic alcoholics should be careful not to take more than 2 g of paracetamol (equivalent to 3 packets of Novag antigripal) in 24 hours.

While taking this medication, do not take other medications that contain paracetamol, as it may cause a paracetamol overdose that could damage the liver.

Consult your doctor or pharmacist before starting to take this medication in the following cases:

• Patients with kidney, liver, heart, or lung diseases, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).

• Patients being treated for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (gastric ulcer), pyloric obstruction (between the stomach and intestine), thyroid diseases, patients sensitive to the sedative effects of some medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal intestinal movements).

Children and adolescents

This medication should not be administered tochildren under 15 yearsdue to the paracetamol dose (650 mg).

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, skin tests, etc...) inform your doctor that you are taking/using this medication, as it may alter the results.

Other medications and Novag antigripal

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

In particular, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for tuberculosis: (isoniazid, rifampicin).
• Medications for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medications to prevent blood clotting: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics such as furosemide, or others), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arhythmias): Propanolol.
• Medications used to lower cholesterol levels in the blood (colestiramine).

• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine oxidase inhibitors (MAOIs)). You should separate the intake of Novag antigripal and these medications for at least 15 days after completing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure, or other diseases (alpha-blocker medications).
• Alpha and beta-blocker medications (labetalol and carvedilol) used for the heart or to treat blood vessel diseases.
• Medications used to treat depression (tricyclic and tetracyclic antidepressants).

• General anesthetics (medications used for general anesthesia).
• Anti-hypertensive medications (medications used to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides, anti-arrhythmics, and beta-blockers.

• Medications containing thyroid hormones(used to treat thyroid diseases).
• Medications used to treat heart or digestive diseases, such as atropine sulfate.
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (that cause damage to the ear).
• Phototoxic medications (that cause an allergic reaction to light).

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.

Interference with diagnostic tests:

If you are to undergo any diagnostic test (including blood, urine, etc...) inform your doctor that you are taking/using this medication, as it may alter the results.

Novag antigripal with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

Additionally, the use of medications containing paracetamol by patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc... per day) may cause liver damage.

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

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

This medication should not be taken during breastfeeding, as it may cause adverse effects in the baby.

Driving and operating machinery

This medication may cause drowsiness. If you experience drowsiness during treatment with this medication, avoid driving vehicles or operating machinery.

Novag antigripal contains mannitol (E-421)

This medication may cause a mild laxative effect due to the presence of mannitol.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The taking of this medication is subject to the appearance of symptoms. As these symptoms disappear, this medication should be discontinued.

The recommended dose is:

Adults and adolescents over 15 years:1 tablet every 6-8 hours (3 or 4 tablets a day) as needed. Do not take more than 4 tablets (equivalent to 2.6 grams of paracetamol) every 24 hours.

Do not take more than 3 grams of paracetamol every 24 hours (see "Warnings and precautions").

Patients with kidney disease:They should consult their doctor. These patients cannot take this medication due to the paracetamol dose it contains.

Patients with liver disease:They should consult their doctor. They should not take morethan 3 tablets (equivalent to 2 grams of paracetamol) in 24 hours, and the minimum interval between taking will be 8 hours.

Use in children

This medication should not be administeredto children and adolescents under 15 years.

Use in elderly patients

Elderly patients should not use this medication without consulting their doctor.

How to take

Novag antigripal is taken orally.Pour the entire contents of the packet into approximately half a glass of water. Shake and drink immediately.

Always take the smallest effective dose.

The taking of this medication is subject to the appearance of symptoms. As these symptoms disappear, the treatment should be discontinued.

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

If you take more Novag antigripal than you should

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

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice) and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (this last one especially in children). Dry mouth, nose or throat. You may also notice effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decrease in blood alkalinity reserve). In cases of prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the overdose of the medication.

Patients undergoing barbiturate treatment 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 Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the period of use of paracetamol, phenylephrine, and chlorphenamine, the following side effects have been reported, whose frequency has not been established with precision:

• The side effects that may appear most frequently are:Light drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

• The side effects that may appear with low frequency (rare) are:Uncomfortable feeling, low blood pressure, and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually with high doses, and is more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other side effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disturbances (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with related chlorphenamine medications. Blood disorders (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disturbances.

• The side effects that may appear with very low frequency (very rare) are:Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or with prolonged treatment.

There have been very rare reports of severe skin reactions.

• The side effects whose frequency of appearance is unknown are:Anxiety, irritability, weakness, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), peripheral vasoconstriction, reduced heart function that affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). With high doses, vomiting, palpitations, psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Novag antigripal

Each sachet contains:

- As active principles: 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)

- The other components (excipients) are: Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange aroma (containing maltodextrin, a cornstarch derivative) and povidone.

Appearance of the product and contents of the packaging

Novag antigripal is an oral granule solution of white or light yellowish color and orange flavor, presented in sachets that are packaged in cardboard boxes with 10 sachets.

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Via Carlos III, 94

08028 Barcelona

Responsible for manufacturing

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last review of this leaflet: November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/