Pharmagrip Nasal Congestion and Secretion Capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pharmagrip nasal congestion and nasal secretion capsules

Paracetamol/Phenylephrine hydrochloride/Chlorphenamine 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 adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen, do not improve, or if fever persists for more than 3 days or pain for more than 5 days (2 days for sore throat).

Contents of the leaflet

1. What Pharmagrip nasal congestion and nasal secretion capsules are and what they are used for
2. What you need to know before taking Pharmagrip nasal congestion and nasal secretion capsules
3. How to take Pharmagrip nasal congestion and nasal secretion capsules
4. Possible adverse effects
5. How to store Pharmagrip nasal congestion and nasal secretion capsules
6. Contents of the pack and other information

1. What Pharmagrip Nasal Congestion and Secretion Capsules Are and What They Are Used For

Pharmagrip Nasal Congestion and Secretion Capsules is a combination of paracetamol (an analgesic that reduces pain and fever), chlorpheniramine (an antihistamine that relieves nasal discharge), and phenylephrine (which acts to reduce nasal congestion).

This medicine is indicated for the relief of symptoms associated with catarrhal or flu-like conditions presenting with (mild or moderate) pain, fever, nasal congestion, and nasal discharge in adults and adolescents aged 12 years and older.

You should consult your doctor if your condition worsens or does 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 starting to take Pharmagrip Nasal Congestion and Runny Nose Capsules

Do not take Pharmagrip Nasal Congestion and Runny Nose Capsules

• If you are allergic to paracetamol, phenylephrine hydrochloride, chlorphenamine maleate, 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 disorder (hyperthyroidism).
• If you have severe liver or kidney disease.
• If you have a severe heart or arterial disease (such as severe coronary heart disease or angina pectoris).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressant medicines or medicines used to treat Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma, or medicines to increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: Other medicines and Pharmagrip Nasal Congestion and Runny Nose Capsules).
• If you have glaucoma (increased pressure in the eye).
• Children under 12 years of age must not take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Pharmagrip Nasal Congestion and Runny Nose Capsules.

Do not take more medicine than recommended in section 3 (How to take Pharmagrip Nasal Congestion and Runny Nose Capsules).

Chronic alcoholics should take care not to take more than 2 g of paracetamol (4 capsules of Pharmagrip Nasal Congestion and Runny Nose Capsules).

Concurrent use of this medicine with other medicines containing paracetamol should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Patients should consult their doctor before taking this medicine if they have:

• Kidney, liver, heart, or lung disease, or anemia.
• Asthma and are sensitive to acetylsalicylic acid.
• Sensitivity (allergy) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).
• Are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), stenosing peptic ulcer, pyloroduodenal obstruction (between the stomach and intestine), thyroid disorders, or if they are sensitive to the sedative effects of certain medicines.
• Are being treated with tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, as they should stop taking this medicine and consult a doctor immediately, as they may develop paralytic ileus (cessation of normal intestinal movements).
• Have severe conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if they suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality 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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
• 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.

Interference with laboratory tests

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

Other medicines and Pharmagrip Nasal Congestion and Runny Nose Capsules

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, dosage adjustments, a minimum 15-day separation between administrations, or discontinuation of treatment may be necessary:

• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine output (loop diuretics such as furosemide, or other diuretics) and other diuretics that cause potassium loss (such as diuretics for hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
• Medicines used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias) (propranolol).
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of Pharmagrip Nasal Congestion and Runny Nose Capsules must be separated by at least 15 days after stopping MAOI treatment.
• Medicines used to treat migraine; medicines taken during childbirth; medicines taken for blood pressure or other conditions (alpha-adrenergic blocking agents).
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines for depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Antihypertensives (medicines to lower blood pressure).
• Medicines for the heart such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart conditions 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).

Also inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Taking Pharmagrip Nasal Congestion and Runny Nose Capsules with food, drinks, and alcohol

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

Additionally, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

In chronic alcoholics, care should be taken not to exceed 4 capsules of Pharmagrip Nasal Congestion and Runny Nose Capsules per day (2 g of paracetamol), divided into several doses.

This medicine may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

This medicine must not be taken during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

3. How to take Pharmagrip nasal congestion and secretion capsules

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

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 is 6 capsules.

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

Use in children under 12 years of age:

This medicine must not be used in children under 12 years of age.

Use in elderly patients:

Elderly patients should not use this medicine without consulting a doctor, as certain adverse effects of the medicine may particularly affect them, such as the occurrence of slow heartbeats (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 excitation, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

This medicine is taken orally.

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

This medicine should only be taken when symptoms appear. Treatment should be discontinued as symptoms subside.

If fever persists for more than 3 days of treatment, or if pain or other symptoms last longer than 5 days, worsen, or new symptoms appear, 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 taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose has occurred, 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, faintness, 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 (fast or irregular heartbeats), palpitations, reduced urine output. Metabolic acidosis (decreased alkaline reserve in the blood). With prolonged use, depletion of plasma volume (decreased blood volume) may occur.

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

Treatment of overdose is most effective if initiated within 4 hours after the overdose has been taken.

Patients receiving treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 everyone will experience them.

The following adverse effects have been reported during the period of use of paracetamol, phenylephrine, and chlorphenamine, the frequency of which has not been accurately established:

• 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 with 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, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision, or other visual disturbances.

• Adverse effects that may occur less frequently (rare):

Malaise, drop in blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitation (usually at high doses and more frequently in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, and even seizures. 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, eyelid or periorbital swelling, swelling of the face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorphenamine. Blood disorders (changes in blood cell counts, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

• Adverse effects that may occur very infrequently (very rare):

Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

Paracetamol may cause liver damage when taken in high doses or during prolonged treatment.

• Adverse effects for which frequency of occurrence is unknown:

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2). Anxiety, irritability, weakness, increased blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a sign of hypertension), very slow heartbeat (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance particularly 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 (hyperglycemia), low potassium levels in blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pharmagrip Nasal Congestion and Secretion Capsules

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

Do not store above 25°C.

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

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

6. Contents of the package and other information

Composition of Pharmagrip congestion and nasal secretion capsules

• The active substances are: paracetamol 500 mg, phenylephrine hydrochloride 10 mg (equivalent to 8.21 mg of phenylephrine) and chlorpheniramine maleate 4 mg (equivalent to 2.8 mg of chlorpheniramine).
• The other components are: pregelatinized corn starch, 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 contents of the package

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

Packaged in PVC-PVDC/Aluminum blisters. Each package contains 14 capsules in an alveolar pack.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es