BISOLTUSGRIP JUNIOR ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Bisoltusgrip Junior Powder for Oral Solution

Paracetamol / Chlorphenamine Maleate / Dextromethorphan Hydrobromide

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

Follow the administration instructions of 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 or pharmacist, even if they are side effects not listed in this package leaflet.
• You should consult your doctor if your condition worsens or does not improve after 3 days.

Contents of the Package Leaflet

1. What Bisoltusgrip Junior Powder for Oral Solution is and what it is used for
2. What you need to know before taking Bisoltusgrip Junior Powder for Oral Solution
3. How to take Bisoltusgrip Junior Powder for Oral Solution
4. Possible side effects
5. Storage of Bisoltusgrip Junior Powder for Oral Solution
6. Package Contents and Additional Information

1. What Bisoltusgrip Junior Powder for Oral Solution is and what it is used for

Bisoltusgrip Junior Powder for Oral Solution is an association of paracetamol, an analgesic that reduces fever and relieves pain, dextromethorphan, which is an antitussive, and chlorphenamine, which helps reduce nasal secretion.

This medicine is indicated for the symptomatic relief of colds and flu that present with mild or moderate pain, such as headache, fever, unproductive cough (irritative cough, nervous cough), and nasal secretion for children over 6 years and adolescents.

You should consult your doctor if your condition worsens, does not improve, or if symptoms persist after 3 days of treatment.

2. What you need to know before taking Bisoltusgrip Junior Powder for Oral Solution

This medicine can cause dependence. Therefore, treatment should be short-term.

Do not take Bisoltusgrip Junior Powder for Oral Solution

• If you are allergic to the active ingredients or to any of the other components of this medicine (listed in section 6).
• If you have a serious liver or kidney disease.
• If you are being treated with a class of medicines called monoamine oxidase inhibitors (MAOIs) or after 2 weeks of finishing treatment with these medicines.
• If you have respiratory failure, asthmatic cough, and cough accompanied by expectoration.
• If you are or have recently been treated with other medicines, such as those for the treatment of depression or Parkinson's disease, with linezolid, which is an antibiotic, or with procarbazine, which is a medicine for cancer (see section "Other Medicines and Bisoltusgrip Junior Powder for Oral Solution").
• Children under 6 years of age cannot take this medicine.

Warnings and Precautions

• Do not take more than the recommended dose in section 3. How to take Bisoltusgrip Junior Powder for Oral Solution. Taking more than the recommended dose (overdose) can result in liver damage. In case of overdose, seek medical help immediately. Quick medical attention is critical for adults, as well as for children, even if you do not perceive any signs or symptoms.
• Chronic alcoholics should ask their doctor if they can take paracetamol, other analgesics, or fever-reducing medicines. Additionally, they should be cautious not to take more than 6 sachets per day (2g of paracetamol).
• While taking this medicine, you cannot take other medicines that contain paracetamol, as this could lead to a paracetamol overdose that could damage the liver.

You should consult your doctor or pharmacist before starting to take this medicine:

• Patients with kidney, heart, or lung disease and patients with anemia.
• Patients with liver disease (with or without liver failure) or viral hepatitis, as this increases the risk of hepatotoxicity.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).

• Patients with hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, obstruction of the vesical neck, prostate hyperplasia with residual urine formation. Elderly patients may be more sensitive to the side effects of this medicine.
• Patients with atopic dermatitis.
• Patients with a persistent respiratory condition such as emphysema, chronic bronchitis, bronchial asthma, or cough accompanied by excessive secretions, glaucoma, or difficulty urinating due to prostate hyperplasia.
• Patients who are slow metabolizers of CYP2D6 or who use CYP2D6 inhibitors.
• If you are taking other medicines, such as antidepressants or antipsychotics, Bisoltusgrip Junior may interact with these medicines, and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, arterial hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• If you have severe 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 (an anomaly in blood and fluids) 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 of discomfort (nausea), and vomiting.

This medicine may cause drowsiness. Avoid consuming alcoholic beverages and certain medicines while taking this medicine, as they may potentiate this effect. Consult the sections "Other Medicines and Bisoltusgrip Junior Powder for Oral Solution" and "Taking Bisoltusgrip Junior Powder for Oral Solution with Food, Beverages, and Alcohol".

Sedated, debilitated, or bedridden patients should not take this medicine.

Rarely, severe skin reactions with redness, blisters, or eruptions can occur. If you notice any of these symptoms, stop treatment and consult your doctor.

Other Medicines and Bisoltusgrip Junior Powder for Oral Solution

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

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicines for treating epilepsy (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone).

• Medicines for treating tuberculosis (isoniazid, rifampicin).

• Medicine to prevent blood clots (oral anticoagulants) such as acenocoumarol, warfarin.

• Medicines used to increase urine elimination (diuretics of the loop type, such as those in the furosemide group, or other diuretics), and other diuretics that produce potassium loss (such as diuretics for treating hypertension or others).
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medicines used for treating gout (probenecid).
• Medicines used for treating high blood pressure (hypertension), such as propranolol, and heart rhythm disorders (cardiac arrhythmias), such as amiodarone or quinidine.
• Medicines used to decrease cholesterol levels in the blood (cholestyramine)

• Medicines used for treating depression (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion), Parkinson's disease (selegiline), or other diseases, such as cancer (procarbazine), infections (linezolid, furazolidone). The administration of Bisoltusgrip Junior should be separated by a minimum of 14 days after finishing treatment
• Other medicines for treating depression, called tricyclic and tetracyclic antidepressants (such as maprotiline)
• Medicines for schizophrenia (such as haloperidol)

• Medicines that produce depression of the central nervous system (such as those used for insomnia or anxiety, for Parkinson's disease, for allergies)
• Ototoxic medicines (which have the adverse effect of damaging the ear)
• Photosensitizing medicines (which have the adverse effect of producing allergy to light)

• Medicines used for pain and inflammation relief (celecoxib, parecoxib, valdecoxib)
• Medicines used to increase mucus secretion.
• Metoprolol, used for treating cardiovascular system diseases (hypertension, acute myocardial infarction).
• Isavuconazole, used for treating invasive aspergillosis and invasive mucormycosis
• Flucloxacillin (antibiotic), 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 undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking/using this medicine, as it may alter the results.

Taking Bisoltusgrip Junior Powder for Oral Solution with Food, Beverages, and Alcohol

While taking this medicine, you cannot consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medicine.

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

Do not take the medicine with grapefruit or bitter orange juice, as it may potentiate the effects of one of its components (dextromethorphan).

Pregnancy, Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The consumption of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

This medicine should not be taken during pregnancy unless your doctor considers it strictly necessary.

The 3 active ingredients of this medicine are excreted in breast milk, so breastfeeding women should not take Bisoltusgrip Junior.

Driving and Using Machines

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

Bisoltusgrip Junior Powder for Oral Solution contains sucrose and sodium:

This medicine contains 1.937g of sucrose per sachet, which should be taken into account in patients with diabetes mellitus.

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

3. How to take Bisoltusgrip Junior Powder for Oral Solution

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

The powder contained in the sachets of Bisoltusgrip Junior is for oral administration.

The recommended dose is:

Children from 6 to 12 years old (weight between 21.5 kg and 43 kg): 1 sachet every 6-8 hours as needed (3 or 4 times a day).

Over 12 years old (weight over 44 kg): 2 sachets every 6-8 hours (3 or 4 times a day) as needed.

Preferably take 1 dose before bedtime. Do not exceed 4 doses per day.

This medicine is contraindicated in children under 6 years of age.

Always use the smallest effective dose.

Start treatment when the first symptoms appear and stop as they disappear.

The medication should not be used for more than 3 consecutive days without consulting a doctor (see section 1. What Bisoltusgrip Junior Powder for Oral Solution is and what it is used for).

Pediatric Population:

Severe side effects can occur in children in case of overdose, including neurological disorders. Caregivers should not exceed the recommended dose.

How to take:

This medicine is taken orally.

Pour the entire contents of a sachet into a half glass of water and stir vigorously. Take immediately.

If you take more Bisoltusgrip Junior Powder for Oral Solution than you should

If you take more Bisoltusgrip Junior than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability. Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions. Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

Go to a medical center immediately, even if you do not have symptoms, as they often do not manifest until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The most severe effect of a medicine overdose is liver damage caused by paracetamol. You may feel dizzy, vomit, confused, excited, nervous, and irritable (hyperactivity), more common in children and elderly patients, a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

There have been cases of abuse with medicines containing dextromethorphan, which can lead to severe side effects, such as agitation, confusion, conversion disorders, hallucinations, ataxia (uncoordinated movements), coma, decreased consciousness, dysarthria (speech difficulty), apathy, dystonia, nystagmus (involuntary and uncontrolled eye movement), convulsions, serotonin syndrome, tremor, depression, and central nervous system excitement, miosis, and mydriasis (pupillary contraction and dilation), respiratory depression, and urinary retention, tachycardia, hypertension, and ischemic colitis.

The symptoms of an overdose of chlorphenamine can be central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased intestinal noises), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, convulsions, or arrhythmias. Patients with prolonged agitation, coma, or convulsions may rarely develop rhabdomyolysis and renal failure.

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine. Patients treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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 Side Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects were reported in at least 1 in 100 subjects during clinical trials with chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis, and dyspepsia.

During the period of use of the association of paracetamol, dextromethorphan, and chlorphenamine, the following side effects have occurred, whose frequency could not be established with precision: anaphylactic reaction, hypersensitivity, insomnia, excitement, nervousness, and restlessness (psychomotor hyperactivity), more common in children and elderly patients, a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Similarly: gastrointestinal disorders, such as abdominal pain, diarrhea, nausea, vomiting, and indigestion (dyspepsia), angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash, pruritic rash, skin eruption, skin lesions after taking the medicine (fixed drug eruption), as well as increased transaminases.

The simultaneous consumption of alcohol during treatment may accentuate the appearance of side effects.

Do not consume alcoholic beverages during the same.

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 not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es

5. Storage of Bisoltusgrip Junior Powder for Oral Solution

Keep this medicine out of the sight and reach of children.

Do not use Bisoltusgrip Junior Powder for Oral Solution after the expiration date stated 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 via wastewater or household waste. 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 will help protect the environment.

6. Packaging Content and Additional Information

Composition of Bisoltusgrip Junior powder for oral solution

-The active ingredients are: paracetamol 300 mg, dextromethorphan 15 mg (as hydrobromide) and chlorphenamine 2 mg (as maleate).

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

Appearance of the product and packaging content

Bisoltusgrip Junior powder for oral solution is a white or yellowish-white powder with an orange flavor, presented in sachets packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder and Manufacturer

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

Alcalá de Henares 28802

Madrid

Date of the last revision of this leaflet: September 2025

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