Package Insert: Information for the User

Pharmagrip Nasal Congestion and Secretion Capsules

Paracetamol/Fenilefrina Hydrochloride/Chlorphenamine Maleate

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice or further information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days (2 days for sore throat).

Pharmagrip congestion and nasal secretion capsules is an association of paracetamol (a pain reliever 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 of catarrhal or flu-like processes that are accompanied by pain (mild or moderate), fever, congestion and nasal secretion in adults and adolescents from 12 years old.

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 congestion and nasal secretion capsules

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pharmagrip congestion and nasal secretion capsules.

Do not take more medication than recommended in section 3 (How to take Pharmagrip congestion and nasal secretion capsules).

Chronic alcoholics should be careful not to take more than 2 g of paracetamol (4 capsules of Pharmagrip congestion and nasal secretion capsules).

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

Consult your doctor before taking this medication:

• 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 heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (peptic ulcer stenosis), pyloric obstruction (between the stomach and the 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 you 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.

Interference with laboratory tests:

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

Other medications and Pharmagrip congestion and nasal secretion capsules

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 separate the administration by at least 15 days or interrupt the 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.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics of the loop, such as furosemide, or other diuretics) and other diuretics that produce potassium loss (such as diuretics for hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used for the treatment of gout (probencid and sulfinpyrazone).
• Medications used for the treatment of high blood pressure (hypertension) and heart rhythm disturbances (arrhythmias) (propanolol).
• Medications to reduce blood cholesterol levels (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). You should separate the administration of Pharmagrip congestion and nasal secretion capsules by at least 15 days after completing the treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken for 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).
• Medications for depression (tricyclic antidepressants and tetracyclic antidepressants).
• 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 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 (which have as an adverse effect that they damage the ear).
• Phototoxic medications (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 (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Pharmagrip congestion and nasal secretion capsules 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.

In chronic alcoholics, be careful not to take more than 4 capsules of Pharmagrip congestion and nasal secretion capsules per day (2 g of paracetamol) divided into several doses.

The medication 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 using this medication.

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

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

Driving and operating machinery

This medication may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or operating machinery.

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

Posology

Adults and adolescents over 12 years:The recommended dose is 1 capsule every 6 or 8 hours (3 or 4 capsules per day). The maximum daily dose will be 6 capsules.

Patients with liver or kidney disease:They should consult their doctor. (See section 2 What you need to know before taking this medicine).

Use in children under 12 years:

Children under 12 years cannot take this medicine.

Use in elderly people:

Elderly people should not use this medicine without consulting their doctor because they may be especially affected by some side effects of the medicine such as the appearance of slow heartbeats (bradycardia) or a reduction in cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be more likely to experience side effects such as 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.

Take 1 capsule with a little liquid, preferably half a glass of water.

The taking of this medicine is subject to the appearance of symptoms. As they disappear, 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 ones appear, you should consult your doctor.

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

You should consult your doctor or pharmacist immediately:

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice 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 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). 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.

An overdose may also cause: coagulation disorders (blood clots and hemorrhages).

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

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 medicine and the amount ingested.

Like all medicines, this medicine can 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: 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:

Discomfort, 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 more frequently 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 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 (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 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; 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:

Renal diseases, cloudy urine, allergic dermatitis (skin rash), 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 can damage the liver when taken in high doses or with prolonged treatment.

• The side effects whose frequency of appearance is unknown are:

A severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2). 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 (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduction in heart function that affects especially elderly patients 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, 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 25°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 the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pharmagrip congestion and nasal secretion capsules

The gelatin capsule is composed of: gelatin, titanium dioxide (E-171), indigo carmine (E-132).

Appearance of the product and contents of the packaging

Hard capsules with a light blue cap and a white body.

It is presented in PVC-PVDC/Aluminum blisters. Each package contains 14 capsules in a ventilated packaging.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi, 10 Highway. Industrial Area Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2025

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