INDOLGEN GRANULADO FOR ORAL SOLUTION EFG

Introduction

Package Leaflet: Information for the User

Indolgen Granules for Oral SolutionEFG

paracetamol/phenylephrine bitartrate/chlorphenamine maleate

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

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

• 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 they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days (2 days for throat pain).

Contents of the Package Leaflet

1. What is Indolgen and what is it used for
2. What you need to know before taking Indolgen
3. How to take Indolgen
4. Possible side effects
5. Storage of Indolgen
6. Package contents and additional information

1. What is Indolgen and what is it used for

Indolgen is an association of paracetamol (a pain reliever that reduces pain and fever), chlorphenamine (an antihistamine that relieves nasal secretion), and phenylephrine (which acts by reducing nasal congestion).

This medication is indicated for the relief of symptoms in catarrhal or flu-like processes that occur with pain (mild or moderate), fever, congestion, and nasal secretion for adults and adolescents from 14 years of age.

You should consult a 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 taking Indolgen

Do not take Indolgen

• If you are allergic to paracetamol, phenylephrine, chlorphenamine, or any of the other components of this medication (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have any thyroid disease (hyperthyroidism).
• If you have any severe liver or kidney disease.
• If you have any severe heart or artery disease (severe coronary artery disease or angina pectoris).
• 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 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 artery diseases) (see section Other medications and Indolgen).
• If you have glaucoma (elevated eye pressure).
• Children under 14 years of age cannot take this medication due to the paracetamol content.

Warnings and precautions

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

During treatment with Indolgen, inform your doctor immediately if:

If you have severe 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 severe disease called metabolic acidosis (an anomaly in the 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.

The following patients should consult their doctor before taking this medication:

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

Chronic alcoholics should be cautious not to take more than 2 g of paracetamol (3 sachets per day).

Do not take more medication than recommended in section 3 (How to take Indolgen).

Avoid simultaneous use of this medication with other medications containing paracetamol, as high doses can cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

Children and adolescents

Due to the paracetamol content in this medication, children under 14 years of age cannot take this medication.

Interference with analytical tests:

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

Chlorphenamine may interfere with the results of allergy tests. If you are going to have any, it is recommended to stop taking the medication at least 3 days in advance.

Other medications and Indolgen

Inform your doctor or pharmacist if you are taking, 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 separate the administration by a minimum of 15 days or interrupt the 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 (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics that produce 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 (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)). The administration of this medication should be separated by a minimum of 15 days after finishing the treatment.
• 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 blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• General anesthetic medications.
• Antihypertensive medications (medications to lower blood pressure).
• Medications used 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).

Also, inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Indolgen with food, drinks, and alcohol

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

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

In chronic alcoholics, caution should be taken not to take more than 2 g of paracetamol (3 sachets per day) divided into several doses.

The medication can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

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

If necessary, it 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 medication more frequently.

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

Driving and using machines

This medication may cause drowsiness, so if it occurs, you should avoid driving vehicles or using machines.

Indolgen contains Mannitol (E-421)

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

3. How to take Indolgen

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

Dosage

Adults: The recommended dose is 1 sachet every 6-8 hours (3-4 sachets per day). The maximum daily dose will be 4 sachets in 24 hours.

Adolescents from 14 years of age: The recommended dose is 1 sachet every 6-8 hours (3-4 sachets per day). Do not take more than 3 g of paracetamol (4 sachets) every 24 hours.

Patient with liver disease:in case of hepatic insufficiency, do not exceed 2 g of paracetamol (3 sachets per day) and the minimum interval between doses will be 8 hours.

Patient with kidney disease:this medication is not indicated for patients with renal insufficiency due to the paracetamol content (see section 2 what you need to know before taking Indolgen).

Use in children and adolescents under 14 years of age:

Children under 14 years of age cannot take this medication due to the paracetamol content.

Use in elderly people:

Elderly people should not use this medication without consulting their doctor, as some side effects of the medication, such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the phenylephrine and chlorphenamine content, may affect them especially. They are also more likely to experience side effects such as dizziness, sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

Method of administration

This medication is taken orally.

Pour the entire contents of the sachet into approximately half a glass of water. Shake and drink.

Duration of treatment

Taking this medication is subject to the appearance of symptoms. As they disappear, treatment should be discontinued.

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

If you take more Indolgen than 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 often do 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 (the latter especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it can cause depletion of plasma volume (decrease in blood volume).

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

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication 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:

• Adverse effects that may appear more frequently are:

Mild drowsiness, dizziness, muscle weakness, which 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, or difficulty urinating,

dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• Adverse effects that may appear with low frequency (rare) are:

Discomfort, lowering of blood pressure (hypotension) and increase in blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung fluid volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses and more frequently in elderly and child patients), which may include symptoms such as: restlessness, insomnia, nervousness, tremors, delirium, palpitations, and even convulsions. Other adverse effects that may appear with low frequency are: chest tension, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions, anaphylactic reaction (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, fatigue, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in blood cell formula, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; lowering or rising blood pressure, edema (swelling), alterations in the ears, impotence, menstrual disorders.

• Adverse effects that may appear with very low frequency (very rare) are:

Kidney disease, cloudy urine, allergic reaction (skin rash or anaphylactic shock), jaundice (yellowish skin discoloration), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Very rare cases of severe skin reactions have been reported.

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

• Adverse effects whose frequency of appearance is not known are:

Restlessness, anxiety, nervousness, irritability, weakness, dizziness, tremors, insomnia, increase in blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension),

Chest pain or discomfort, very slow heartbeats (severe bradycardia), reduction of blood vessel caliber (peripheral vasoconstriction), reduction of heart performance that affects especially elderly patients and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease.

Urinary retention, paleness, goosebumps, sweating, hypertension, increase in blood sugar (hyperglycemia), decrease in potassium in the blood, metabolic acidosis (metabolism alteration), coldness 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.

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Indolgen

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. Content of the Packaging and Additional Information

Composition of Indolgen

Each sachet contains:

• As active ingredients: 650 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 Content of the Packaging

Indolgen is a white or yellowish-white granulate for oral solution, presented in paper/aluminum sachets that are packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Pharma & Go S.A.

Avda. de Castilla 53-55, nave 7

28830 San Fernando de Henares - Madrid

Spain

Manufacturer

Laboratorios Alcala Farma S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares - Madrid

Spain

Date of the Last Revision of this Prospectus:September 2023

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/