Pharmagrip Forte Nasal Congestion and Secretion Oral Suspension Powder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pharmagrip Forte nasal congestion and nasal discharge oral suspension powder

Paracetamol/Phenylephrine hydrochloride/Chlorpheniramine maleate

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 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 your condition worsens or does not improve after 5 days (2 days for sore throat).

Leaflet contents

1. What Pharmagrip Forte nasal congestion and nasal discharge is and what it is used for
2. What you need to know before taking Pharmagrip Forte nasal congestion and nasal discharge
3. How to take Pharmagrip Forte nasal congestion and nasal discharge
4. Possible side effects
5. How to store Pharmagrip Forte nasal congestion and nasal discharge
6. Contents of the pack and other information

1. What Pharmagrip Forte Nasal Congestion and Secretion is and what it is used for

Pharmagrip Forte Nasal Congestion and Secretion oral suspension powder 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 in catarrhal or influenza-like conditions presenting with pain (mild or moderate), fever, nasal congestion, and nasal discharge in adults and adolescents aged 14 years and older.

You should consult your doctor if your condition worsens, does not improve, if fever persists for more than 3 days, or if pain lasts for more than 5 days.

2. What you need to know before starting to take 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 a thyroid disease (hyperthyroidism).
• If you have severe liver or kidney disease.
• If you have severe heart or arterial disease (severe coronary disease or angina pectoris).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitor (MAOI) medicines (such as certain antidepressants 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 Forte Nasal Congestion and Secretion).
• If you have glaucoma (increased eye pressure).
• Children under 14 years of age must not take this medicine due to the dose of paracetamol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pharmagrip Forte Nasal Congestion and Secretion.

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

• Patients with kidney, liver, heart, or lung diseases, and patients with anemia.
• Asthmatic patients who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).
• Patients being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between stomach and intestine), anemia, thyroid diseases, or patients sensitive to the sedative effects of certain medicines.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

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

If you have serious conditions such as severe renal failure 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 (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

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

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

Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Children and adolescents

Due to the amount of paracetamol contained in this medicine, children under 14 years of age must not take it.

Interference with diagnostic tests:

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

Chlorphenamine may interfere with allergy test results. If you are scheduled for allergy testing, it is recommended to stop taking the medicine at least 3 days beforehand.

Other medicines and Pharmagrip Forte Nasal Congestion and Secretion

Tell 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, dose adjustments, separation of administration by at least 15 days, or discontinuation of treatment may be necessary:

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis (isoniazid, rifampicin).
• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics causing potassium loss (such as diuretics used to treat 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 to treat 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 Forte Nasal Congestion and Secretion must be separated by at least 15 days after stopping such treatment.
• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat 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).
• General anesthetics.
• Antihypertensives (medicines to lower blood pressure).
• Medicines used for the heart such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid diseases).
• Medicines used for heart or digestive diseases (sulfate atropine).
• Medicines that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medicines (which have adverse effects damaging the ear).
• Photosensitizing medicines (which as an adverse effect cause light allergy).

Also inform your doctor or pharmacist if you are taking:

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

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

While taking this medicine, do not consume alcoholic beverages, as they may increase the likelihood of adverse effects from this medicine.

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

In chronic alcoholics, care should be taken not to exceed 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, 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 must not be taken during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness; if this occurs, avoid driving vehicles or operating machinery.

Pharmagrip Forte Nasal Congestion and Secretion contains Sunset Yellow FCF (E-110)

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

Pharmagrip Forte Nasal Congestion and Secretion contains sodium

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

Pharmagrip Forte Nasal Congestion and Secretion contains mannitol

May produce a mild laxative effect because it contains mannitol.

3. How to take Pharmagrip Forte Nasal Congestion and Secretion

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.

The recommended dose is:

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

Adolescents aged 14 years and older: The recommended dose is 1 sachet every 6–8 hours (3–4 sachets per day). Do not exceed 3 g of paracetamol (4 sachets) in 24 hours.

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

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

Use in children and adolescents under 14 years of age

This medicine must not be used in children under 14 years of age due to the amount of paracetamol it contains.

Use in elderly patients

Elderly patients should not use this medicine without consulting a doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. They may also be more likely to experience adverse effects such as dizziness, sedation, confusion, hypotension, or agitation, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

This medicine is taken orally.

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

Duration of treatment

This medicine should be taken only as long as symptoms persist. As symptoms subside, treatment should be discontinued.

If your condition worsens, or if fever persists for more than 3 days, or pain or other symptoms last more than 5 days, or if new symptoms appear, you should consult your doctor.

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

If you have taken an overdose, you must go immediately to a medical center even if you do not experience 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 excessive drowsiness), clumsiness, fainting sensation, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeat), palpitations, reduced urine output. Metabolic acidosis (decreased blood alkaline reserve). With prolonged use, plasma volume depletion (reduced blood volume) may occur.

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

Treatment for overdose is most effective if started within 4 hours after the overdose was taken.

Patients undergoing 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 experiences them.

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

• The adverse effects that may occur more frequently are:

Mild drowsiness, dizziness, muscle weakness, which may disappear after 2–3 days of treatment. Difficulty in 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, diarrhoea, constipation, stomach pain, urinary retention, or difficulty urinating, 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) are:

Malaise, low 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 excitement (generally with high doses and more frequently in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, tremors, delirium, palpitations, and even convulsions. 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 anaphylactic reaction (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulty, fatigue, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorpheniramine. Blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, oedema (swelling), ear disturbances, impotence, menstrual disorders.

• Adverse effects that may occur very rarely (very rare) are:

Kidney disorders, cloudy urine, allergic reaction (skin rash or anaphylactic shock), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Very rare cases of serious skin reactions have been reported.

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

• Adverse effects for which the frequency of occurrence is unknown are:

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

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

Chest pain or discomfort, very slow heartbeat (severe bradycardia), reduction in blood vessel diameter (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), sweating, hypertension, increased blood sugar (hyperglycaemia), low blood potassium, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, reduction 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pharmagrip Forte nasal congestion and nasal secretion

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

Do not store above 30°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 in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pharmagrip Forte Nasal Congestion and Secretion

• The active substances are: 650 mg of paracetamol, 10 mg of phenylephrine hydrochloride (equivalent to 8.21 mg of phenylephrine), and 4 mg of chlorpheniramine maleate (equivalent to 2.8 mg of chlorpheniramine).

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

Appearance of the product and contents of the pack

Pharmagrip Forte Nasal Congestion and Secretion oral suspension powder is supplied in single-dose sachets made of coated paper, extruded polyethylene, aluminum, and heat-sealing resin.

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

Packaged in cardboard boxes containing 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 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 for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/