PHARMAGRIP CONGESTION & NASAL SECRETION CAPSULES

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

Do not take Pharmagrip Nasal Congestion and Secretion Capsules

• If you are allergic to paracetamol, phenylephrine hydrochloride, chlorphenamine maleate, or any of the other components of this medication (listed in section 6).
• If you have high blood pressure (arterial 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 (such as severe coronary artery 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 Nasal Congestion and Secretion Capsules).
• If you have glaucoma (elevated eye pressure).
• Children under 12 years of age cannot take this medication.

Warnings and Precautions

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

Do not take more medication than recommended in section 3 (How to take Pharmagrip Nasal Congestion and Secretion Capsules).

Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol (4 capsules of Pharmagrip Nasal Congestion and Secretion Capsules) per day.

The simultaneous use of this medication with other medications containing paracetamol should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

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

• 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 heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloric duodenal obstruction, thyroid diseases, patient sensitive to sedative effects of some medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (stop of normal intestinal movements).
• If you have severe conditions such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid anomaly) 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 unwell (nausea) and vomiting.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia)

Children and Adolescents

Children under 12 years of age cannot take this medication.

Interference with laboratory tests:

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

Other Medications and Pharmagrip Nasal Congestion and Secretion Capsules

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 (loop diuretics such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or other conditions).
• 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 to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). The administration of Pharmagrip Nasal Congestion and Secretion Capsules should be separated by a minimum of 15 days after finishing treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other conditions (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• Medications for treating depression (tricyclic and tetracyclic antidepressants).
• 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 depress 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 light allergy).

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

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

Taking Pharmagrip Nasal Congestion and Secretion Capsules with Food, Drinks, and Alcohol

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

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 4 capsules of Pharmagrip Nasal Congestion and Secretion Capsules per day (2 grams of paracetamol) divided into several doses.

The medication 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 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 side effects in the baby.

Driving and Using Machines

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

3. How to Take Pharmagrip Nasal Congestion and Secretion Capsules

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

Posology

Adults and adolescents over 12 years of age: 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.

Patient with liver or kidney disease: Should consult their doctor. (See section 2 What you need to know before taking this medication).

Use in Children under 12 years:

Children under 12 years of age cannot take this medication.

Use in Elderly:

Elderly people should not use this medication without consulting their doctor, as 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, may affect them especially. They are also 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.

Method of Administration

This medication is taken orally.

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

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

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 Nasal Congestion and Secretion Capsules than 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 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 (the latter especially in children). Dryness of the 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 medication.

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 medication 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:

• The adverse effects that may appear more frequently are:

Mild drowsiness, dizziness, muscle weakness: these adverse effects 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 disorders (which may decrease if the medicine is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The 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 (increased 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 elderly patients and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in the blood cell formula, such as agranulocytosis, leukopenia, 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.

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

Kidney disease, cloudy urine, allergic dermatitis (skin rash), 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 for prolonged treatments.

• The 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). Anxiety, irritability, weakness, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of the caliber of blood vessels (peripheral vasoconstriction), reduction of heart performance that affects especially elderly patients and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolism alteration), 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 Congestion and Nasal Secretion Capsules

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°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 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 you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pharmagrip Congestion and Nasal Secretion Capsules

• The active ingredients are: paracetamol 500 mg, phenylephrine hydrochloride 10 mg (equivalent to 8.21 mg of phenylephrine) and chlorphenamine maleate 4 mg (equivalent to 2.8 mg of chlorphenamine).
• The other components are: pregelatinized cornstarch, talc (E-553b), magnesium stearate (E-470b), and anhydrous colloidal silica.

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

Appearance of the Product and Package Contents

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 an alveolar packaging.

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