BISOLGRIP FORTE GRANULES FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Bisolgrip Forte Granules for Oral Solution

Paracetamol / Phenylephrine Bitartrate / Chlorphenamine Maleate

Read all of 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 as 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 side effects, consult your doctor or pharmacist even if it is a side effect not listed in this leaflet. (See section 4).
• 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 for more than 5 days.

Contents of the Package Leaflet

1. What is Bisolgrip Forte and what is it used for
2. What you need to know before you start taking Bisolgrip Forte
3. How to take Bisolgrip Forte
4. Possible side effects
5. Storage of Bisolgrip Forte
6. Contents of the pack and further information

1. What is Bisolgrip Forte and what is it used for

It is an association of 3 active principles, paracetamol, chlorphenamine, and phenylephrine. Paracetamol is an analgesic that reduces pain and fever. Chlorphenamine is an antihistamine that relieves nasal secretion, and phenylephrine acts by reducing nasal congestion.

It is indicated in adults and adolescents from 15 years old for the relief of symptoms of colds and flu that occur with fever or mild or moderate pain, congestion, and nasal secretion.

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 for more than 5 days.

2. What you need to know before you start taking Bisolgrip Forte

Do not take Bisolgrip Forte

• If you are allergic to the active substances or to any of the other components of this medicine (included 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 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 Forte with other medications).
• If you have glaucoma (high eye pressure).
• If you have any serious heart or arterial disease (such as coronary disease or angina pectoris).
• If you have any serious liver or kidney disease.

Children under 15 years old 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 Forte.
• Chronic alcoholics should be cautious not to take more than 3 sachets of Bisolgrip Forte per day.
• 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 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 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 the following conditions should consult their doctor before taking this medicine:

• Patient with kidney, liver, heart, or lung diseases, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, because they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal 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 you experience gastrointestinal problems, you should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (the normal movements of a part of the intestine stop).

Children and Adolescents

Children under 15 years old cannot take this medicine.

Taking Bisolgrip Forte with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: isoniazid, rifampicin.
• Medications for treating convulsions and depression (barbiturics), used as hypnotics, sedatives, and anticonvulsants.
• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (loop diuretics such as furosemide, or others) and other diuretics that cause potassium loss (such as diuretics for treating 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 (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)). Bisolgrip Forte and these medications should be taken at least 15 days apart.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat 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 treating depression of the tricyclic and tetracyclic type.
• Medications used for general anesthesia.
• Antihypertensive medications used to lower blood pressure.
• Medications for the heart of the type of cardiac glycosides and antiarrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart diseases or digestive diseases of the type of atropine sulfate.
• Medications that produce depression of the central nervous system, such as those used for insomnia or anxiety.
• Ototoxic medications (which can damage the ear as a side effect).
• Photosensitizing medications (which can cause light allergy as a side effect).

• Medication for treating infections: flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis 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 tests, urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Taking Bisolgrip Forte with food, drinks, and alcohol

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

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

This 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

In case of need, Bisolgrip Forte can be used during pregnancy. 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 should not be taken by women 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. If you experience drowsiness while being treated with this medicine, avoid driving vehicles or using machines.

Bisolgrip Forte contains mannitol (E-421)

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

3. How to take Bisolgrip Forte

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents from 15 years old:

1 sachet every 6-8 hours as needed (3 or 4 sachets per day). Do not take more than 4 sachets (equivalent to 2.6 grams of paracetamol) per day. The maximum daily dose of paracetamol should not exceed 3 grams per day (see "Warnings and Precautions" section).

Patient with liver disease:

These patients can only take 1 sachet every 8-12 hours as needed (2 or 3 sachets per day).

Patient with kidney disease:

These patients cannot take this medicine due to the dose of paracetamol.

Use in Children

This medicine is contraindicated in children and adolescents under 15 years old.

Use in Elderly Patients

Elderly people cannot use this medicine without consulting their doctor, as some side effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to phenylephrine and chlorphenamine, may affect them especially. It is also more likely that they may 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 Forte is taken orally. Dissolve the contents of the sachet completely in a little liquid, preferably half a glass of water, and then drink.

Always take the smallest effective dose.

Taking 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 for more than 5 days, or worsen, or new symptoms appear, you should consult your doctor.

If you take more Bisolgrip Forte than you should

If you have ingested an overdose, you should go immediately to a medical center, 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 (can 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). Dry 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 (a decrease in the alkaline reserve of the blood). In case of prolonged use, a decrease in blood volume may occur.

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

Patient being treated with barbiturics 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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of paracetamol, phenylephrine, and chlorphenamine, the following side effects have been reported, whose frequency has not been established with precision:

• The most frequent side effects that may appear are: mild drowsiness, dizziness, muscle weakness (these side effects may disappear after 2-3 days of treatment). Difficulty in facial movements, clumsiness, tremor, 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, dry nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The side 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 (usually with high doses and more frequently in elderly patients and children), which can 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 can be presented 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 disorders (changes in the blood cell formula, 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 disorders, impotence, menstrual disorders.

• The side effects that may appear with very low frequency (very rare) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

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

• The side effects whose frequency of appearance is not known are: anxiety, irritability, weakness, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and can be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of peripheral blood vessel caliber (vasoconstriction), reduction of cardiac output that especially affects 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 levels in the blood, metabolic acidosis (a serious disease that can make the blood more acidic in patients with severe disease using paracetamol), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following effects may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Bisolgrip Forte

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after CAD. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and any medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Bisolgrip Forte

• The active ingredients are: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).
• The other components (excipients) are: mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor (containing maltodextrin, which is a corn starch derivative) and povidone.

Appearance of the Product and Package Contents

Bisolgrip Forte is a white or yellowish-white granulate for oral solution with an orange flavor, presented in sachets packaged in cardboard boxes containing 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the Last Revision of this Leaflet: September 2025

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77832/P_77832.html

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)