Prospect: information for the user

Bisolgrip Forte granulated for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

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

- Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor, or pharmacist.

- Keep this prospect, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist even if they are adverse effects that do not appear in this prospect. (See section 4).

- 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 for more than 5 days.

1.What isBisolgrip Forteand for what it is used

2.What you need to know before starting to takeBisolgrip Forte

3.How to takeBisolgrip Forte

4.Possible adverse effects

5.Storage ofBisolgrip Forte

6.Contents of the package and additional information

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 are accompanied by fever or mild to moderate pain, congestion and nasal secretion.

Consult a doctor if it worsens or does not improve or if the fever persists for more than 3 days or the pain for more than 5 days.

Do not take Bisolgrip Forte

• If you are allergic to the active ingredients or any of the other 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 increase heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat blood vessel diseases) (see Taking Bisolgrip Forte with other medications).
• If you have glaucoma (high eye pressure).
• If you have severe heart or blood vessel disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.

Patients under 15 years old cannot take this medication.

Warnings and precautions

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

• Do not take more medication than recommended in the section 3 How to take Bisolgrip Forte.
• Chronic alcoholics should be careful not to take more than 3 packets per day of Bisolgrip Forte.
• Avoid taking this medication with other medications that contain paracetamol, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• While taking this medication, do not take other medications that contain paracetamol, as it may cause a paracetamol overdose that could damage the liver.
• Consult your doctor before taking this medication:

• Patients with kidney, liver, heart, or lung diseases and patients with anemia.
• Patients with asthma who are sensitive to acetylsalicylic acid.
• Patients who are sensitive (allergic) to antihistamines, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients being treated with medications for: benign prostatic hyperplasia, 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 a similar effect and experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (intestinal paralysis).

Children and adolescents

Patients under 15 years old cannot take this medication.

Taking Bisolgrip Forte with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, if you are using any of the following medications, as it may be necessary to modify 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.
• Medications used to prevent blood clotting: 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 (probencid and sulfinpyrazone).
• Medications used to treat high blood pressure and heart rhythm disorders (propranolol).
• Medications used 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 taking of Bisolgrip Forte and these medications by at least 15 days.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat high blood pressure, or other diseases (alpha-blocker medications).
• Medications that block alpha and beta-adrenergic receptors (labetalol and carvedilol) used for the heart or to treat blood vessel diseases.
• Medications used to treat depression, such as tricyclic antidepressants and tetracyclic antidepressants.
• Medications used for general anesthesia.
• Medications used to lower blood pressure.
• Medications used for the heart, such as cardiac glycosides and antiarrhythmics.
• Medications that contain thyroid hormones (used to treat thyroid diseases).
• Medications used to treat heart or digestive diseases, such as atropine sulfate.
• Medications that cause depression of the central nervous system, such as those used for insomnia or anxiety.
• Medications that are ototoxic (can damage the ear).
• Medications that are photosensitizing (can cause an allergic reaction to light).

• Medication for the treatment of infections: flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Interference with laboratory tests

Inform your doctor if you are undergoing any laboratory tests (including blood and urine tests), as this medication may affect the results.

Taking Bisolgrip Forte with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may increase the risk of adverse effects of this medication.

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

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or plan to become pregnant before taking this medication.

Pregnancy

In case of need, Bisolgrip Forte can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest time possible. Contact your doctor if the pain or fever do not decrease or if you need to take the medication more frequently.

Breastfeeding

This medication should not be taken by women during breastfeeding, as it may cause adverse effects in the baby.

Fertility

No data is available on fertility.

Driving and operating machinery

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

Bisolgrip Forte contains mannitol (E-421)

This medication may cause a mild laxative effect due to the presence of mannitol.

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

The recommended dose is:

Adults and adolescents 15 years of age and older:

1 tablet every 6-8 hours as needed (3 or 4 tablets per day). Do not take more than 4 tablets (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").

Patients with liver disease:

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

Patients with kidney disease:

These patients cannot take this medication due to the paracetamol dose.

Use in children

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

Use in elderly patients

Elderly patients cannot use this medication without consulting a doctor because they may be especially affected by some side effects of the medication such as slow heartbeats (bradycardia) or reduced cardiac output, due to 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 Forte is taken orally. Dissolve the contents of the tablet completely in a little liquid, preferably half a glass of water and then drink.

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 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 a 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 the symptoms, since 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 (this last one 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 (decreased blood alkalinity reserve). In case of prolonged use, a decrease in blood volume may occur.

The treatment of an overdose is more effective if it is started within 4 hours of taking the overdose of 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 (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 side effects that may appear most frequently are:light 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 medicine is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, 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 (hypotension), 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 at high doses and more frequently in elderly patients 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-sensitivity (allergy) with related chlorphenamine medications. Blood disorders (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:kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

The paracetamol may damage the liver when taken at high doses or in prolonged treatments.

-The side effects whose frequency of appearance is unknown are:anxiety, irritability, weakness, high blood pressure (hypertension, usually at high doses and in sensitive patients), headache (at high doses and may be a symptom of hypertension), very slow heartbeats (bradycardia), reduction of peripheral blood vessel diameter (vasoconstriction), reduction of heart function that affects especially elderly patients and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (excess of acid in the blood caused by too much pyroglutamic acid due to low glutathione levels), coldness in the extremities (legs or arms), flushing, sensation of fainting (hypotension). At high doses, vomiting, palpitations, psychotic states with hallucinations may occur; in prolonged use, a decrease in blood volume may occur.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does 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 medicine.

Keep out of sight and reach of children.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Bisolgrip Forte

• The active principles 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 aroma (containing maltodextrin, a cornstarch derivative) and povidone.

Appearance of the product and contents of the packaging

Bisolgrip Forte is an oral granule solution of white or light yellowish color and orange flavor, presented in sachets that are packaged in cardboard boxes with 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Last review date of this leaflet: July 2022

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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 Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )