Bisolgrip Forte granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisolgrip Forte granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorpheniramine maleate

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

• Always follow the instructions for taking this medicine as described in this leaflet or as advised 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 not listed in this leaflet. (See section 4.)
• You should consult your doctor if your condition worsens, does not improve, or if fever persists for more than 3 days or pain for more than 5 days.

Contents of this leaflet:

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

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

Bisolgrip Forte is a combination of three active substances: paracetamol, chlorpheniramine, and phenylephrine. Paracetamol is an analgesic that reduces pain and fever. Chlorpheniramine is an antihistamine that relieves nasal discharge, and phenylephrine acts to reduce nasal congestion.

It is indicated in adults and adolescents aged 15 years and older for the relief of symptoms associated with colds and flu accompanied by fever or mild to moderate pain, nasal congestion, and nasal discharge.

You should consult your doctor if symptoms worsen, do 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 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 (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medicine (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 to increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see Taking Bisolgrip Forte with other medicines).
• If you have glaucoma (high pressure in the eye).
• If you have a severe heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.

This medicine must not be used in patients under 15 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• Do not take more medicine than the recommended dose stated in section 3, How to take Bisolgrip Forte.

• Chronic alcoholics should take care not to take more than 3 sachets per day of Bisolgrip Forte.

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

• While taking this medicine, do not take any other medicines containing paracetamol, as this may lead to a paracetamol overdose which could damage the liver.

• If you have serious conditions such as severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you 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 breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

• The following patients should consult their doctor before taking this medicine:

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.

• Asthmatic patients who are sensitive to acetylsalicylic acid.

• Patients who are sensitive (allergic) to one antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).

• Patients who are 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), thyroid disorders, or patients sensitive to the sedative effects of certain medicines.

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).

Children and adolescents

This medicine must not be used in patients under 15 years of age.

Taking Bisolgrip Forte with other medicines

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, as it may be necessary to adjust the dose or discontinue treatment:

• 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.

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).

• Medicines used to increase urine elimination (loop diuretics such as furosemide, or others) and other diuretics that cause potassium loss (such as diuretics used to treat hypertension or others).

• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).

• Medicines used to treat gout (probenecid and sulfinpyrazone).

• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (propranolol).

• Medicines used to lower blood cholesterol levels (cholestyramine).

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Bisolgrip Forte and these medicines should be taken at least 15 days apart.

• 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 blocking agents (labetalol and carvedilol) used for heart conditions or arterial diseases.

• Medicines used to treat depression of the tricyclic and tetracyclic antidepressant type.

• Medicines used for general anesthesia.

• Antihypertensive medicines used 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 such as atropine sulfate.

• Medicines that cause central nervous system depression, such as those used for insomnia or anxiety.

• Ototoxic medicines (which may cause ear damage as an adverse effect).

• Photosensitizing medicines (which may cause light allergy as an adverse effect).

• Medicine used to treat infections: flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring urgent treatment (see section 2).

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 this medicine, as it may alter test results.

Taking Bisolgrip Forte with food, drinks, and alcohol

Do not drink alcoholic beverages while taking this medicine, as they may increase the risk of adverse effects.

In addition, the use of medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc. per day) may 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

Bisolgrip Forte may be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Breastfeeding

This medicine must not be used by women who are breastfeeding, as it may cause adverse effects in the infant.

Fertility

No data on fertility are available.

Driving and using machines

This medicine may cause drowsiness. If you experience drowsiness during treatment, avoid driving vehicles or operating machinery.

Bisolgrip Forte contains mannitol (E-421)

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

3. How to take Bisolgrip Forte

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and adolescents aged 15 years and over:

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 section “Warnings and precautions”).

Patients with liver disease:

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

Patients with kidney disease:

These patients must not take this medicine due to the paracetamol content.

Use in children

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

Use in elderly patients

Elderly patients must not use this medicine without consulting a doctor, as they may be particularly affected by certain adverse effects of the medicine such as slow heart rate (bradycardia) or reduced cardiac output due to phenylephrine and chlorphenamine. 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.

How to take

Bisolgrip Forte is taken orally. Dissolve the contents of the sachet completely in a small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

This medicine should only be taken when symptoms appear. As symptoms improve, treatment should be discontinued.

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

If you take more Bisolgrip Forte than you should

If you have taken an overdose, you must go immediately to a medical centre even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose has been taken, 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, feeling faint, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (the latter especially in children). Dryness of the mouth, nose, or throat. You may also experience effects such as high blood pressure, arrhythmias (fast or irregular heartbeat), palpitations, reduced urine output, metabolic acidosis (decreased alkaline reserve in the blood). With prolonged use, a decrease in blood volume may occur.

Treatment of overdose is most effective if started within 4 hours after the overdose has been 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, go immediately to a medical centre 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 may cause adverse effects, although not everyone will experience them.

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

• The 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 in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, taste or smell disturbances, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.

• The 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 oedema (increased fluid volume in the lungs), and cerebral haemorrhage (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, 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, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorphenamine. 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.

• The adverse effects that may occur very infrequently (very rare) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

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

• Adverse effects whose frequency of occurrence is unknown: anxiety, irritability, weakness, increased blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom 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 (hyperglycaemia), decreased potassium in blood, metabolic acidosis (a serious condition that may make blood more acidic in severely ill patients using paracetamol), cold 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, 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 they are possible adverse effects 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 Bisolgrip Forte

Keep out of the sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisolgrip Forte

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

Appearance of the product and contents of the pack

Bisolgrip Forte is an oral granular solution for oral solution, white or yellowish-white in colour, with an orange flavour. It is supplied in sachets contained in cardboard cartons with 10 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the most recent revision of this package leaflet: September 2025

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and carton 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 of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)