Apogrip oral solution powder

Patient Information Leaflet

Introduction

Patient Information Leaflet

Apogrip effervescent powder for oral solution

Paracetamol / Phenylephrine hydrochloride / Chlorpheniramine maleate

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

Follow exactly the instructions for use provided 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
• You should consult your doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days.

Contents of this leaflet:

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

l

1. What Apogrip is and what it is used for

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

You should 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.

2. What you need to know before taking Apogrip

Do not take Apogrip

• 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 to increase heart rate),
• if you are being treated with beta-blockers (medicines for heart conditions or arterial diseases) (see: Taking Apogrip with other medicines),
• if you have glaucoma (increased pressure in the eye),
• if you have severe heart or arterial disease (such as coronary artery disease or angina pectoris),
• if you have severe liver or kidney disease,
• children under 12 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 Apogrip.
• 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 alcoholics should take care not to take more than 3 sachets of Apogrip per day.
• Patients with kidney, liver, heart, or lung disease, or patients with anemia.
• Asthmatic patients who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).
• Patients 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 stomach and intestine), thyroid disorders, or patients sensitive to the sedative effects of certain medicines.
• If you are being treated with tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, you must stop taking this medicine and consult a doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).
• If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

Children and adolescents

Children under 12 years of age must not take this medicine.

Other medicines and Apogrip

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, as it may be necessary to adjust the dose or discontinue treatment:
• 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.
• Medicines to prevent blood clotting (oral anticoagulants): acenocoumarol, warfarin.
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics causing potassium loss (such as diuretics used to treat hypertension or others).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat gout: probenecid and sulfinpyrazone.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Medicines to reduce blood cholesterol levels: colestyramine.
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of Apogrip 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 high blood pressure or other conditions (alpha-adrenergic blocking agents).
• Alpha- and beta-adrenergic blocking agents such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines to treat depression (tricyclic and tetracyclic antidepressants).
• General anesthetic medicines.
• Antihypertensive medicines (medicines to lower blood pressure).
• Medicines used for heart conditions, 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 (which have the adverse effect of damaging the ear).
• Photosensitizing medicines (which have the adverse effect of causing light allergy).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with laboratory tests:

• If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Apogrip powder with food, drinks, and alcohol

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

In addition, using medicines containing paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits... 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.

If necessary, Apogrip may 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 pain or fever do not improve or if you need to take the medicine more frequently.

Breastfeeding mothers must not take this medicine, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness. If you feel drowsy while being treated with this medicine, avoid driving vehicles or operating machinery.

Apogrip sachets contain sucrose

Apogrip contains 3.994 g of sucrose per sachet, which should be considered by patients with hereditary fructose intolerance, glucose/galactose malabsorption, sucrase-isomaltase deficiency, and diabetic patients.

3. How to take Apogrip

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

Recommended dose:

Adults and adolescents aged 12 years and older: 1 sachet every 6–8 hours as needed (3 or 4 sachets per day). Do not exceed 3 grams of paracetamol per day (4 sachets) every 24 hours.

Patients with hepatic impairment: these patients should not take more than 1 sachet every 8 hours. Under no circumstances should they take more than 3 sachets per day.

Patients with renal impairment: this medicine must not be taken due to the paracetamol dosage.

Use in children

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

Use in elderly patients

Elderly patients should not use this medicine without consulting their doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heart rate (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. They are also 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

Apogrip 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 it.

Always take the lowest effective dose.

This medicine should only be taken when symptoms occur. Treatment should be discontinued as symptoms resolve.

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

If you take more Apogrip than you should

If you have ingested an overdose, you must immediately go 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 (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). Dry mouth, nose, or throat. Overdose may also cause: coagulation disorders (blood clots and hemorrhages).

Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, and reduced urine production. Metabolic acidosis (decreased blood alkaline reserve). With prolonged use, plasma volume depletion (decreased blood volume) may occur.

Treatment for overdose is most effective if initiated within 4 hours of ingestion.

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

Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Apogrip may cause adverse effects, although not everyone will experience them.

During the period of use of paracetamol, phenylephrine, and chlorpheniramine, the following adverse effects have been reported, whose frequency has not been precisely 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): malaise, drop in blood pressure (hypotension), and increased levels of transaminases in blood. 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 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 (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 heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorpheniramine. Blood disorders (changes in blood cell count), 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): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar levels).

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

• Adverse effects with frequency not known (cannot be estimated from the available data): 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 the diameter of blood vessels (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 (hyperglycaemia), decreased potassium levels in blood, metabolic acidosis (metabolic disturbance), cold extremities (legs or arms), flushing, feeling of faintness (hypotension), a serious condition that may make the blood more acidic (called metabolic acidosis) in seriously ill patients using paracetamol (see section 2). At high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, reduction 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 Apogrip

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

Do not use Apogrip powder after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Apogrip sachets

• The active substances are 650 mg of paracetamol, 10 mg of phenylephrine hydrochloride (equivalent to 8.21 mg of phenylephrine), and 4 mg of chlorpheniramine maleate (equivalent to 2.8 mg of chlorpheniramine).
• The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, and orange flavour.

Appearance of the product and contents of the pack

Apogrip is a white, homogeneous powder, free of lumps, with an orange flavour. It is supplied in sachets contained in cardboard packages with 10 sachets.

Marketing Authorization Holder and Manufacturer

Aurovitas Spain S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid 82

28802 Alcalá de Henares (Madrid)

Date of the most recent revision of this leaflet: February 2025

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/.