Leaflet: information for the user

Pharmagrip Forte nasal congestion and secretion powder for oral suspension

Paracetamol/Fenilefrina hydrochloride/Chlorphenamine maleate

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 it worsens or does not improve after 5 days (2 days for sore throat).

Pharmagrip Forte nasal congestion and secretion powder for oral suspensionis an association of paracetamol (an analgesic that reduces pain and fever), chlorphenamine (an antihistamine that relieves nasal secretion) and phenylephrine (which acts by reducing nasal congestion).

This medication is indicated for the relief of symptoms in catarrhal or flu-like processes that are accompanied by pain (mild or moderate), fever, congestion, and nasal secretion in adults and adolescents 14 years of age and older.

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.

Do not take Pharmagrip Forte for nasal congestion and secretion

• If you are allergic to paracetamol, phenylephrine, chlorphenamine, or any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have a thyroid disease (hyperthyroidism).
• If you have a severe liver or kidney disease.
• If you have a severe heart or artery disease (severe coronary artery disease or angina pectoris).
• If you have diabetes mellitus.

• If you have tachycardia (rapid heartbeats).
• If you are taking a monoamine oxidase inhibitor (MAOI) (such as some antidepressants or medications for Parkinson's disease).
• If you are taking sympathomimetic medications (medications used to treat asthma, or medications to accelerate heart rate).
• If you are taking beta-blocker medications (medications for the heart or to treat artery diseases (see: Other medicines and Pharmagrip Forte for 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 for nasal congestion and secretion.

You should consult a doctor before taking this medicine:

• 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 taking medications to treat: benign prostatic hyperplasia, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (gastric ulcer), pyloric obstruction (between the stomach and the intestine), anemia, thyroid diseases, patients sensitive to the sedative effects of some medications.
• Patients with G6PD deficiency (may cause hemolytic anemia)

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

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.

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

Do not take more of the medicine than recommended in section 3 (How to take Pharmagrip Forte for nasal congestion and secretion powder for oral suspension).

Avoid taking this medicine with other medications that contain paracetamol, as high doses may cause liver damage. Do not use more than one paracetamol-containing medicine without consulting a doctor.

Children and adolescents

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

Interference with analytical tests:

Inform your doctor if you are taking/using this medicine, as it may alter the results of any analytical tests (including blood, urine, etc.).

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

Other medicines and Pharmagrip Forte for nasal congestion and secretion

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or separate the administration by at least 15 days or interrupt the treatment:

• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications to treat tuberculosis (isoniazid, rifampicin).
• Medications to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics 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 (probencid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (propranolol).
• Medications to lower cholesterol levels in the blood (colestiramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). It is recommended to separate the administration of Pharmagrip Forte for nasal congestion and secretion by at least 15 days after completing the treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure or other diseases (alpha-adrenergic blockers).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• General anesthetics.
• Anti-hypertensives (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 to treat heart or digestive diseases (atropine sulfate).
• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Medications ototoxic (which have as an adverse effect that damage the ear).
• Medications photosensitizing (which, as an adverse effect, produce allergy to light).

Also inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a severe risk of alteration of the blood and fluids (denominated metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Pharmagrip Forte for nasal congestion and secretion with food, drinks, and alcohol

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

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.

Chronic alcoholics should be careful not to take more than 2 g 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, or if you think you may be 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 adverse effects in the baby.

Driving and operating machines

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

Pharmagrip Forte for nasal congestion and secretion contains yellow-orange S (E-110).

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

Pharmagrip Forte for nasal congestion and secretion contains sodium

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

Pharmagrip Forte for nasal congestion and secretion contains mannitol

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 tablet every 6-8 hours (3-4 tablets per day). The maximum daily dose will be 4 tablets in 24 hours.

Adolescents 14 years and older:The recommended dose is 1 tablet every 6-8 hours (3-4 tablets per day). Do not take more than 3 g of paracetamol (4 tablets) per 24 hours.

Patients with liver disease:In case of hepatic insufficiency, do not exceed 2 g ofparacetamol (3 tablets per day) and the minimum interval between doses will be 8 hours.

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

Use in children and adolescents under 14 years

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

Use in elderly people

Elderly people should not 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 reduction of cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be 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.

Administration form

This medication is taken orally

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

Treatment duration

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

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 your doctor.

If you take more Pharmagrip Forte congestion and nasal secretion than you should

If you have ingested an overdose, you should go immediately to a medical center even if you do not notice the 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 (this last especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduction of urine production. Metabolic acidosis (decrease in blood alkalinity reserve). In prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

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

The treatment of 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 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:

Mild drowsiness, dizziness, muscle weakness, which 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, or difficulty urinating, dry nose and throat, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

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

Discomfort, 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 at 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 side effects that may appear with low frequency are: chest tightness, lung sounds, 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 anaphylactic reaction (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, fatigue, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) with related chlorphenamine medications. Blood alterations (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; hypotension, edema (swelling), ear alterations, impotence, menstrual alterations.

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

Renal diseases, cloudy urine, allergic reaction (skin rash or anaphylactic shock), jaundice (yellow discoloration of the skin), blood alterations (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Very rarely, severe skin reactions have been reported

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

• Side effects whose frequency of appearance is unknown are:

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

Restlessness, anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, hypertension (usually at high doses and in sensitive patients),

Chest pain or discomfort, very slow heartbeats (severe bradycardia), peripheral vasoconstriction, reduced heart function that affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease.

Urinary retention, pallor, goosebumps, sweating, hypertension, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disturbance), cold extremities (legs or arms), flushing, feeling 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 or pharmacist, 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 store at a temperature above 30°C.

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.

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

Composition of Pharmagrip Forte congestion and nasal secretion

• The other components are:ssodium saccharin, sodium cyclamate, mannitol (E-421), orange aroma, yellow-orange S colorant (E-110) and povidone.

Appearance of the product and contents of the packaging

Pharmagrip Forte congestion and nasal secretion powder for oral suspension is presented in single-dose sachets composed of starch, extruded polyethylene, aluminum, and heat-fusible resin.

Each sachet contains fine, slightly orange-white powder.

They are packaged in boxes with 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2025

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