Leaflet: information for the user

Friolgrip Decongestantpowderfor oral solution

Paracetamol / Phenylephrine 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 of 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 you worsen, or if you do not improve or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

1.What is Friolgrip Decongestant and what it is used for

2.What you need to knowbefore starting to take Friolgrip Decongestant

3.How to take Friolgrip Decongestant

4.Possible side effects

5.Storage of Friolgrip Decongestant

6.Contents of the pack and additional information

It is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults and adolescents over 12 years old for symptomatic relief of symptoms of colds and flu that are accompanied by fever, mild or moderate pain, congestion, and nasal secretion.

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 or other symptoms persist for more than 5 days

Do not take Friolgrip Descongestivo:

• If you are allergic to the active ingredients or any of the components of this medication (listed in section 6).
• If you have high blood pressure.
• If you have hyperthyroidism.
• 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 certain 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: Taking Friolgrip Descongestivo with other medications).
• If you have glaucoma (elevated eye pressure).
• If you have severe heart or artery disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Friolgrip Descongestivo.

Do not take more medication than recommended in section 3: How to take Friolgrip Descongestivo.

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

Chronic alcoholics should be careful not to take more than 3 packets in 24 hours.

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 heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease, pyloric obstruction, 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 experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal intestinal movements).
• In case of glucose-6-phosphate dehydrogenase deficiency (may cause hemolytic anemia).
• 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 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.

Children and adolescents

Children under 12 years old should not take this medication, as the paracetamol dose cannot be adjusted for this population.

Interference with laboratory tests:

Inform your doctor that you are taking/using this medication, as it may alter test results.

Taking Friolgrip Descongestivo with other medications

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 adjust the dose of some of them or discontinue 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 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 (arrhythmias): 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)). You should separate the administration of the medication from Phenylephrine by at least 15 days after completing 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).
• Medications for depression (tricyclic and tetracyclic antidepressants).

General anesthetics.

• Antihypertensives (medications to lower blood pressure).
• Medications used for the heart, such as cardiac glycosides, antiarrhythmics, and beta-blockers.
• 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 (that cause damage to the ear).
• Phototoxic medications (that cause an allergic reaction to light).
• Flucloxacillin (an antibiotic), due to a severe risk of blood and fluid alteration (metabolic acidosis) that requires urgent treatment (see section 2).

Taking Friolgrip Descongestivo 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.

The taking of this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you 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 used 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 experience these effects, avoid driving vehicles or operating machinery.

Friolgrip Descongestivo contains saccharose.If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 3.994 grams of saccharose per packet.

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

Adults and adolescents over 12 years:Take 1 tablet every 6-8 hours (3 or 4 times a day).Do not take more than 4 tablets (equivalent to 2.6 g of paracetamol) per day.Do not take more than 3 g of paracetamol every 24 hours (see "Warnings and precautions").

Patients with liver insufficiency:In case of liver insufficiency, do not exceed 3 tablets and the minimum interval between doses will be 8 hours.

Patients with renal insufficiency:This medication is not indicated for this population due to the 650 mg dose of paracetamol.

Children:Children under 12 years should not take this medication, as the paracetamol dose cannot be adjusted for this population.

Use in elderly patients

Elderly patients should not use this medication without consulting a doctor.

Because they may be especially affected by 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. 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.

How to take

This medication is taken orally.

The Friolgrip Descongestivo tablets are administered orally.

The contents of the tablet should be taken completely dissolved in a little liquid, preferably in a half glass of water.

Always take the smallest effective dose.

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

If fever persists for more than 3 days of treatment, pain or other symptoms persist for more than 5 days, or worsen or new ones appear, consult a doctor.

If you take more Friolgrip Descongestivo than you should

If you have ingested an overdose, go immediately to a medical center, even if you do not feel 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 somnolence), clumsiness, feeling of fainting, 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 heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkalinity reserve). In prolonged use, depletion of plasma volume (decrease in blood volume) may occur. Paracetamol overdose may also cause: coagulation disorders (blood clots and hemorrhages).

The treatment of an overdose is more effective if initiated within 4 hours of taking 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, go immediately to a medical center or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

Like all medicines, Friolgrip Descongestivo may cause side effects, although not everyone will experience them.

During the period of use of the association 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 appearmost 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 paresthesia, 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, nasal and throat dryness, 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 frequent in the elderly 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 noises, rapid or irregular heartbeats (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 heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-reactivity (allergy) with related chlorphenamine medications. To 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).

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

Very rarely, severe skin reactions have been reported.

• The side effects whose frequency of appearance is unknown, are:: 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 of peripheral blood vessel diameter (vasoconstriction periphery), reduction of heart function that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, paleness, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic alteration), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; in prolonged use, a decrease in blood volume may occur. A severe disease that may make the blood more acidic (denominated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even

if it is possible side effects that do not appear in this prospectus. You can also report them

directly through the Spanish System of 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 medication.In patients sensitive to

paracetamol, drowsiness may occur.

Due to the content in

Keep out of sight and reach of children.

Store below 30°C.

.

Do not use this medicine after the expiration date shown 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

medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your

pharmacist how to dispose of packaging and medicines you no longer need. By doing so,

you will help protect the environment.

Composition of Friolgrip Descongestivo

- The active principles are: paracetamol, phenylephrine hydrochloride, and chlorphenamine maleate. Each Friolgrip Descongestivo tablet contains: paracetamol 650 mg; phenylephrine hydrochloride 10 mg; chlorphenamine maleate 4 mg.

- The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, anhydrous sodium cyclamate, orange flavor.

Appearance of the product and contents of the packaging

Oral solution powder, white, homogeneous, dispersible in water, and with an orange flavor. Friolgrip Descongestivo is presented in single-dose sachets and packaged in boxes of 10 units.

Holder of the marketing authorization

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas. Madrid (Spain)

Responsible for manufacturing

Alcalá Farma, S.L.

Avenida de Madrid, 82,

28802 Alcalá de Henares (Spain)

Date of the last review of this leaflet: February 2025

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