Leaflet: information for the user

Apogrip powder for oral solution

Paracetamol / Phenylephrine hydrochloride / Chlorphenamine maleate

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

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

- Keep this leaflet, as you may have 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.

- You should consult a doctor if it worsens or does not improve or if the fever persists for more than 3 days or the pain for more than 5 days.

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It 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 for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion, and nasal secretion, in adults and adolescents 12 years of age and older.

Consult a doctor if symptoms worsen or do not improve or if fever persists for more than 3 days or pain for more than 5 days.

Do not take Apogrip

• 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 some antidepressants or medications for Parkinson's disease),
• if you are being treated with sympathomimetic medications (medications used to treat asthma or medications to accelerate heart rate),
• if you are being treated with beta-blocker medications (medications for the heart or to treat artery diseases) (see: Taking Apogrip with other medications),
• if you have glaucoma (elevated eye pressure),
• if you have severe heart or artery disease (such as coronary artery disease or angina pectoris),
• if you have severe liver or kidney disease,
• children under 12 years old cannot take this medication.

Warnings and precautions

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

• Do not take more medication than recommended in section 3: How to take Apogrip.
• 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 3 packets of Apogrip per day.
• Patients with kidney, liver, heart, or lung diseases and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to antihistamines, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (peptic ulcer stenosis), 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 movements in a part of the intestine).
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia).

Children and adolescents

Children under 12 years old cannot take this medication.

Other medications and Apogrip

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

• Particularly 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 used to prevent blood clotting (oral anticoagulants): acenocoumarol, warfarin.
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide, or other diuretics), 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: probenecid and sulfinpyrazone.
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• Medications used to lower cholesterol levels in the blood: cholestyramine.
• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). You should separate the administration ofApogripby 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-blockers).
• Alpha and beta-blockers, such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• Medications used to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Anti-hypertensive medications (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides and anti-arrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases (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 severe risk of blood and fluid alteration (metabolic acidosis) that must be treated urgently (see section 2).

Interference with analytical tests:

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

Taking Apogrip powder 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... per day) may cause liver damage.

The medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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.

If necessary, Apogrip can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever do not decrease or if you need to take the medication more frequently.

This medication cannot be taken by mothers 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.

Apogrip sachets contain saccharose

Apogrip contains 3.994 g of saccharose in each sachet, which should be taken into account by patients with hereditary fructose intolerance, glucose/galactose absorption problems, saccharose-isomaltase deficiency, and diabetic patients.

Follow these 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 recommended dose is:

Adults and adolescents 12 years of age and older: 1 tablet every 6-8 hours as needed (3 or 4 tablets a day). Do not take more than 3 grams of paracetamol per day (4 tablets) every 24 hours.

Patients with liver insufficiency:These patients cannot take more than 1 tablet every 8 hours. In no case can they take more than 3 tablets a day.

Patients with renal insufficiency:They cannot take this medication due to the paracetamol dose.

Use in children

This medication is contraindicated in children under 12 years of age.

Use in elderly people

Elderly people cannot use this medication without consulting their doctor because they may be especially affected by some side effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine. They are also more likely to present side effects such as sedation, confusion, hypotension, or excitement and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

Apogrip is taken orally.

Dissolve the contents of the packet completely in a little liquid, preferably half a glass of water and then drink.

Always take the smallest effective dose.

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

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

If you take more Apogrip 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, yellowish discoloration 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 somnolence), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (this last especially in children). Dry mouth, nose, or throat. An overdose can also cause: coagulation disorders (blood clots and hemorrhages).

Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkalinity reserve). In 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.

Do not take a double dose to compensate for missed doses.

Like all medicines, Apogrip 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 appearmost 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 (hypotension), 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 elderly patients 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 disorders (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 alterations, impotence, menstrual alterations.

• 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 in prolonged treatments.

• The side effects with unknown frequency (cannot be estimated from available data):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 especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium levels in the blood, metabolic acidosis (metabolic disorder), cold extremities (legs or arms), flushing, sensation of fainting (hypotension), a severe disease that can make the blood more acidic (denominated metabolic acidosis) in patients with severe disease using paracetamol (see section 2). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; in prolonged use, a decrease in blood volume may occur.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

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

Do not use Apogrip powder 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition of Apogrip tablets

• The active principles are 650 mg of paracetamol, 10 mg of phenylephrine hydrochloride (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: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate and orange flavor.

Appearance of the product and contents of the packaging

Apogrip is a white, homogeneous, odorless powder with an orange flavor, presented in blisters that are packaged in cardboard containers with 10 blisters.

Holder of the marketing authorization and responsible for manufacturing

Aurovitas Spain S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Responsible for manufacturing

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet:February 2025

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/.