Indolgen granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Indolgen granules for oral solution EFG

paracetamol/phenylephrine bitartrate/chlorpheniramine maleate

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

Follow exactly the instructions for administration of this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days (2 days for sore throat).

Leaflet contents

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

1. What Indolgen is and what it is used for

Indolgen is a combination of paracetamol (an analgesic that reduces pain and fever), chlorpheniramine (an antihistamine that relieves nasal discharge), and phenylephrine (which acts to reduce nasal congestion).

This medicine is indicated for the relief of symptoms in catarrhal or influenza-like conditions associated with pain (mild or moderate), fever, nasal congestion, and nasal discharge in adults and adolescents aged 14 years and older.

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.

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 ingredients of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you suffer from a thyroid disorder (hyperthyroidism).
• If you have severe liver or kidney disease.
• If you have severe heart or arterial disease (severe coronary heart disease or angina pectoris).
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs), 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 medicines to increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see section "Other medicines and Indolgen").
• If you have glaucoma (increased intraocular pressure).
• Children under 14 years of age must not take this medicine due to the paracetamol dose.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

During treatment with Indolgen, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or 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 regularly 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, malaise (nausea), and vomiting.

Patients should consult a doctor before taking this medicine if they:

• Have kidney, liver, heart, or lung disease, or if they have anemia.
• Are asthmatic and sensitive to acetylsalicylic acid.
• Are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).
• 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 the stomach and intestine), anemia, thyroid disorders, or if they are 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).

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

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

Concomitant use of this medicine with other medicines containing paracetamol should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Children and adolescents

Due to the amount of paracetamol contained in this medicine, children under 14 years of age must not take this medicine.

Interference with diagnostic tests:

If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking/using this medicine, as it may alter test results.

Chlorphenamine may interfere with allergy test results. If you are scheduled for such tests, it is recommended to stop taking the medicine at least 3 days beforehand.

Other medicines and Indolgen

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, dosage adjustments, a minimum 15-day interval between administrations, or discontinuation of treatment may be necessary:

• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics causing potassium loss (such as diuretics used to treat hypertension or other conditions).
• 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 (cardiac arrhythmias) (propranolol).
• Medicines to reduce blood cholesterol levels (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs). Administration of this medicine must be separated by at least 15 days after stopping MAOI treatment).
• 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 blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• General anesthetics.
• Antihypertensives (medicines to lower blood pressure).
• Medicines used for the heart such as cardiac glycosides and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart disease or digestive disorders (atropine sulfate).
• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).
• Ototoxic medicines (those with adverse effects damaging the ear).
• Photosensitizing medicines (those with adverse effects causing light allergy).

Also inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Taking Indolgen with food, drinks, and alcohol

While taking this medicine, you must not consume alcoholic beverages, as they may increase the risk of adverse effects.

In addition, using medicines containing paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc. per day) may cause liver damage.

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

This medicine 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 medicine.

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

If necessary, it may be used during pregnancy. Use the lowest possible dose that relieves 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.

This medicine must not be taken during breastfeeding, as it may cause adverse effects in the infant.

Driving and using machines

This medicine may cause drowsiness; if this occurs, avoid driving or operating machinery.

Indolgen contains Mannitol (E-421)

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

3. How to take Indolgen

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 is 4 sachets in 24 hours.

Adolescents aged 14 years and older: The recommended dose is 1 sachet every 6–8 hours (3–4 sachets per day). Do not exceed 3 g of paracetamol (4 sachets) every 24 hours.

Patients 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 should be 8 hours.

Patients with kidney disease: This medicine is not indicated for patients with renal insufficiency due to the paracetamol dose (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 must not take this medicine due to the amount of paracetamol it contains.

Use in elderly patients:

Elderly individuals should not use this medicine without consulting a doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. They are also more likely to experience adverse 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 medicine is taken orally.

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

Duration of treatment

This medicine should be taken only as long as symptoms are present. As symptoms subside, treatment should be discontinued.

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

If you take more Indolgen than you should

If you have ingested an overdose, you must go immediately to a medical center, even if you do not feel symptoms, as symptoms often do not appear until 3 days after the overdose, 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 intense drowsiness), clumsiness, fainting sensation, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine output. Metabolic acidosis (decrease in the blood's alkaline reserve). With prolonged use, depletion of plasma volume (reduction in blood volume) may occur.

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

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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can 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, although their frequency has not been established accurately:

• The adverse effects that may occur more frequently are:

Mild drowsiness, dizziness, muscle weakness, which may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urine retention, or difficulty in urination,

dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.

• Adverse effects that may occur less frequently (rare):

Malaise, drop in blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses and more frequently in elderly patients and children), which may include symptoms such as restlessness, insomnia, nervousness, tremors, delirium, palpitations, and even convulsions. 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 including anaphylactic reaction (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, fatigue, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to drugs 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.

• Adverse effects that may occur very rarely (very rare) are:

Kidney disorders, cloudy urine, allergic reaction (skin rash or anaphylactic shock), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Very rare cases of serious skin reactions have been reported.

Paracetamol may cause liver damage when taken in high doses or with prolonged treatment.

• Adverse effects whose frequency is unknown 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 heartbeat (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance particularly affecting elderly patients and patients with poor cerebral or coronary circulation, possible onset or worsening of heart disease.

Urinary retention, pallor, piloerection (goosebumps), sweating, hypertension, increased blood sugar (hyperglycaemia), low blood potassium, metabolic acidosis (metabolic disturbance), cold extremities (legs or arms), flushing, sensation of fainting (hypotension). With high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; with prolonged use, reduction in blood volume may occur.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

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 through 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 Indolgen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Indolgen

Each sachet contains:

• Active substances: 650 mg of paracetamol, 8.21 mg of phenylephrine (as bitartrate), and 2.8 mg of chlorphenamine (as maleate).

• Other components (excipients): mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor, and povidone.

Appearance of the medicinal product and contents of the pack

Indolgen is a white or yellowish-white granule for oral solution, presented in paper/aluminum sachets, packed in cardboard boxes containing 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 most recent review of this leaflet: February 2025

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