BISOLGRIP GRANULADO FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Bisolgrip Granules for Oral Solution

Paracetamol / Phenylephrine / Chlorphenamine

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.
• You should consult your doctor if your symptoms worsen or 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.

Contents of the Package Leaflet

1. What Bisolgrip Granules for Oral Solution are and what they are used for
2. What you need to know before taking Bisolgrip Granules for Oral Solution
3. How to take Bisolgrip Granules for Oral Solution
4. Possible side effects
5. Storage of Bisolgrip Granules for Oral Solution
6. Package Contents and Additional Information

1. What Bisolgrip Granules for Oral Solution are and what they are used for

Bisolgrip Granules for Oral Solution are 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 for the relief of symptoms of colds and flu that are accompanied by fever or mild to moderate pain, congestion, and nasal secretion, in adults and adolescents over 12 years of age.

You should consult your doctor if your symptoms worsen or 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.

2. What you need to know before taking Bisolgrip Granules for Oral Solution

Do not takeBisolgrip Granules for Oral Solution

• If you are allergic (hypersensitive) to paracetamol, phenylephrine, chlorphenamine, or any of the other components of this medicine (listed in section 6).
• If you have high blood pressure (arterial hypertension).
• If you have thyroid disease (hyperthyroidism).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with a 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 to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Taking Bisolgrip Granules for Oral Solution with other medications).
• If you have glaucoma (high eye pressure).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have a serious liver or kidney disease.

Children under 12 years of age cannot take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medicine.

• Do not take more than the recommended dose in section 3. How to take Bisolgrip Granules for Oral Solution.
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol (4 sachets per day of Bisolgrip).
• Avoid simultaneous use of this medicine with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

• While taking this medicine, you cannot take other medications that contain paracetamol because a paracetamol overdose could occur, which could damage the liver.
• If you have serious diseases, 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 disease 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.
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medicine.

• Patient with asthma sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).

• Patient taking medications for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal 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 medicine and consult your doctor immediately, as you may develop paralytic ileus (stop of normal movements of a part of the intestine).

Children and Adolescents

Children under 12 years of age cannot take this medicine.

Taking Bisolgrip Granules for Oral Solution with other medications

Tell your doctor or pharmacist if you are taking or 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 interrupt treatment:

• Medications for epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for tuberculosis: (isoniazid, rifampicin).
• Medications for convulsions and depression (barbiturics), 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 others), 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 (probenecid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications used to lower cholesterol levels in the blood (cholestyramine).

• Medications used to treat depression, Parkinson's disease, or other diseases (Monoamine Oxidase Inhibitors (MAOIs)). This medicine should be administered at least 15 days after finishing the treatment.
• Medications used to treat migraines; medications taken for childbirth; medications taken for high blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blocking medications (labetalol and carvedilol) used for the heart or to treat arterial diseases.
• Medications for depression (tricyclic and tetracyclic antidepressants).

• Anesthetic medications.
• Antihypertensive medications (medications used to lower blood pressure).
• Medications 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 produce depression of 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).
• Medication for the treatment of infections: Antibiotic (flucloxacillin), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

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

Taking Bisolgrip Granules for Oral Solution with food, beverages, and alcohol

While being treated with this medicine, you should not drink alcoholic beverages, as it may increase the risk of side effects.

Additionally, the use of medications containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor,... per day) may cause liver damage.

The medicine can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

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.

Pregnancy

This medicine can be used during pregnancy if necessary. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

This medicine cannot be taken during breastfeeding, as it may produce side effects in the baby.

Fertility

There is no available data on fertility.

Driving and Using Machines

This medicine may cause drowsiness, altering mental and/or physical ability. If you experience these effects while taking this medicine, avoid driving vehicles or using machines.

Bisolgrip Granules for Oral Solution contain mannitol (E-421)

This medicine may produce a mild laxative effect because it contains mannitol.

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

3. How to take Bisolgrip Granules for Oral Solution

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 15 years (or body weight over 50 kg): 1 sachet every 6-8 hours, if necessary (3-4 times a day). Do not exceed 4 sachets in 24 hours.

The maximum daily dose of paracetamol should not exceed 3 grams in 24 hours.

Pediatric population:

Adolescents over 12 years (body weight 33 kg to 50 kg): 1 sachet every 6-8 hours, if necessary (3-4 times a day). Do not exceed 4 sachets in 24 hours.

Patient with kidney disease: Should consult their doctor. The dose should be reduced according to the glomerular filtration rate.

Patient with liver disease: Should consult their doctor. In case of liver insufficiency, do not exceed 4 sachets in 24 hours, and the minimum interval between doses will be 8 hours (see section 2: What you need to know before taking Bisolgrip Granules for Oral Solution).

Use in Children

This medicine is contraindicated in children and adolescents under 12 years of age.

Use in Elderly Patients

Elderly patients cannot use this medicine without consulting their doctor, as they may be more susceptible to certain side effects of the medicine, such as bradycardia (slow heart rate) 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

Bisolgrip Granules for Oral Solution are taken orally. Pour the entire contents of the sachet into approximately half a glass of water. Stir and drink immediately.

Always take the smallest effective dose.

Treatment with this medicine is subject to the appearance of symptoms. As they disappear, you should stop treatment.

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 symptoms appear, you should consult your doctor.

If you take moreBisolgrip Granules for Oral Solutionthan you should

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they may not appear until 3 days after ingestion, 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 (especially in children). Dryness of mouth, nose, or throat. You may also notice effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decrease in blood alkaline reserve). In case of prolonged use, it can cause plasma volume depletion (decrease in blood volume).

Treatment of overdose is most effective if started within 4 hours after taking the overdose of the medicine.

Patient taking barbiturics or chronic alcoholics may be more susceptible to paracetamol toxicity.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service (Telephone 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 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 most 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 discomfort (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 is more frequent in the elderly 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 eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. 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), alterations in the ears, impotence, menstrual alterations.

• 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 alterations (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

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

Very rare cases of severe skin reactions have been reported.

• The adverse effects whose frequency of appearance is not known are: 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 the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium in the blood, a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2), 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, pharmacist, or nurse, 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 Bisolgrip Granulate for Oral Solution

Keep this medicine out of sight and reach of children.

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.

No special storage conditions are required.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in 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. Packaging Content and Additional Information

Composition of Bisolgrip Granulate for Oral Solution

Each sachet contains:

• As active ingredients: 500 mg of paracetamol, 8.21 mg of phenylephrine (in the form of bitartrate) and 2.8 mg of chlorphenamine (in the form of maleate).
• The other components (excipients) are: Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor, and povidone.

Appearance of the Product and Packaging Content

Bisolgrip granulate for oral solution is a granulate for oral solution of white or yellowish-white color and orange flavor, which is presented in sachets that are packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder

OPELLA HEALTHCARE SPAIN, S.L.

C/ Roselló I Porcel, 21

08016 Barcelona

Spain

Manufacturer

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the Last Revision of this Prospectus: September 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/