PHARMAGRIP FORTE CONGESTION & NASAL SECRETION ORAL SUSPENSION POWDER

2. What you need to know before taking Pharmagrip Forte Nasal Congestion and Secretion

Do not take Pharmagrip Forte Nasal Congestion and Secretion

• If you are allergic to paracetamol, phenylephrine, chlorphenamine, or any of the other components of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have any thyroid disease (hyperthyroidism).
• If you have any severe liver or kidney disease.
• If you have any severe heart or artery disease (severe coronary disease or angina pectoris).
• 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: Other medications and Pharmagrip Forte Nasal Congestion and Secretion).
• If you have glaucoma (elevated eye pressure).
• Children under 14 years old cannot take this medicine due to the paracetamol dose.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pharmagrip Forte Nasal Congestion and Secretion.

The following patients should consult their doctor before taking this medicine:

• Patient with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine)
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, anemia, thyroid disease, patient sensitive to sedative effects of some medications.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia)

If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medicine and consult a doctor immediately, as you may develop paralytic ileus (stop of normal bowel movements).

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Chronic alcoholics should be cautious not to take more than 2g of paracetamol (3 sachets per day).

Do not take more medicine than recommended in section 3 (How to take Pharmagrip Forte Nasal Congestion and Secretion powder for oral suspension).

Avoid simultaneous use of this medicine with other medications containing paracetamol, as high doses can cause liver damage. Do not use more than one medication containing paracetamol without consulting a doctor.

Children and adolescents

Due to the amount of paracetamol contained in this medicine, children under 14 years old cannot take this medicine.

Interference with analytical tests:

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

Chlorphenamine may interfere with the results of allergy tests. If you are going to undergo any, it is recommended to stop taking the medication at least 3 days in advance.

Other medications and Pharmagrip Forte Nasal Congestion and Secretion

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or separate the administration by a minimum of 15 days or interrupt treatment:

• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis (isoniazid, rifampicin).
• Medications for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics such as those in the furosemide group, or other diuretics) and other diuretics that produce potassium loss (such as diuretics for treating hypertension or other).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used in the treatment of gout (probenecid and sulfinpyrazone).
• Medications used in the treatment of 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)). A minimum of 15 days should separate the administration of Pharmagrip Forte Nasal Congestion and Secretion after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken for high blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• General anesthetic medications.
• Antihypertensive medications (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides and antiarrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases (atropine sulfate).
• Medications that produce depression on the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of producing allergy to light).

Also, inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anionic imbalance) that should be treated urgently (see section 2).

Taking Pharmagrip Forte Nasal Congestion and Secretion with food, drinks, and alcohol

While being treated with this medicine, you should not consume alcoholic beverages, as it may enhance the appearance of side effects of this medicine.

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

In chronic alcoholics, caution should be taken not to take more than 2g of paracetamol (3 sachets per day) divided into several doses.

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 cannot be taken during breastfeeding, as it may cause side effects in the baby.

Driving and using machines

This medicine may cause drowsiness, so if it occurs, avoid driving vehicles or using machines.

Pharmagrip Forte Nasal Congestion and Secretioncontains orange yellow S (E-110).

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Pharmagrip Forte Nasal Congestion and Secretioncontainssodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

Pharmagrip Forte Nasal Congestion and Secretion containsmannitol

It may produce a mild laxative effect because it contains mannitol.

3. How to take Pharmagrip Forte Nasal Congestion and Secretion

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:The recommended dose is 1 sachet every 6-8 hours (3-4 sachets per day). The maximum daily dose will be 4 sachets in 24 hours.

Adolescents from 14 years old:The recommended dose is 1 sachet every 6-8 hours (3-4 sachets per day). Do not take more than 3g of paracetamol (4 sachets) every 24 hours.

Patient with liver disease:In case of liver failure, do not exceed 2g of paracetamol (3 sachets per day) and the minimum interval between doses will be 8 hours.

Patient with kidney disease:This medicine is not indicated for patients with kidney failure due to the paracetamol dose (see section 2 What you need to know before taking this medicine).

Use in children and adolescents under 14 years old

Children under 14 years old cannot take this medicine due to the amount of paracetamol it contains.

Use in elderly people

Elderly people should not use this medicine without consulting a doctor, as some side effects of the medicine, such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of phenylephrine and chlorphenamine, may affect them especially. They are also more likely to experience side effects such as dizziness, sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Form of administration

This medicine is taken orally

Pour the entire contents of the sachet into approximately half a glass of water. Shake and drink.

Duration of treatment

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

If it worsens, or if the fever persists for more than 3 days of treatment, the pain or other symptoms persist for more than 5 days, or new ones appear, you should consult a doctor.

If you take more Pharmagrip Forte Nasal Congestion and Secretion than you should

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

The symptoms of 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 (the latter especially in children). Dryness of mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it can cause plasma volume depletion (decrease in blood volume).

Overdose can also cause: coagulation disorders (blood clots and bleeding).

Treatment of overdose is more effective if started within 4 hours after taking the overdose of the medicine.

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 all people suffer from them.

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

• Adverse effects that may appear more frequently are:

Mild drowsiness, dizziness, muscle weakness, which may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, or difficulty urinating, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• Adverse effects that may appear with low frequency (rare) are:

Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

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

• Adverse effects that may appear with very low frequency (very rare) are:

Kidney disease, cloudy urine, allergic reaction (skin rash or anaphylactic shock), jaundice (yellowish skin color), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

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

• Adverse effects whose frequency of appearance is not known are:

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Restlessness, anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension),

Chest pain or discomfort, very slow heartbeats (severe bradycardia), reduction of the caliber of blood vessels (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease.

Urinary retention, paleness, goosebumps, sweating, hypertension, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (alteration of metabolism), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, 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 or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Pharmagrip Forte Nasal Congestion and Secretion

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

Do not store at a temperature above 30°C.

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pharmagrip Forte Nasal Congestion and Secretion

• The active ingredients 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 are: sodium saccharin, sodium cyclamate, mannitol (E-421), orange flavor, yellow-orange colorant S (E-110), and povidone.

Appearance of the Product and Package Contents

Pharmagrip Forte nasal congestion and secretion oral powder is presented in monodose sachets composed of coated, extruded polyethylene, aluminum, and thermofusible resin.

Each sachet contains a fine, slightly orange-white powder.

They are packaged in boxes with 10 sachets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/