ANTICATARRAL EDIGEN ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Anticatarral Edigen Powder for Oral Solution

Paracetamol, Phenylephrine Hydrochloride, Chlorphenamine Maleate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment. See section 4.

Contents of the Package Leaflet:

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

1. What is Anticatarral Edigen and what is it used for

Anticatarral Edigen is an association of paracetamol, phenylephrine, and chlorphenamine that is effective in reducing fever, pain, congestion, and nasal secretion.

It is used for the symptomatic relief of catarrhal and flu-like processes that occur with fever, mild or moderate pain, congestion, and nasal secretion in adults and adolescents from 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment.

2. What you need to know before taking Anticatarral Edigen

Do not takeAnticatarral Edigen:

• If you are allergic to the active substances or to any of the other components of this medicine (included 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 a monoamine oxidase inhibitor (MAOI) (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 arterial diseases) (see: Taking Anticatarral Edigen with other medications).
• If you have glaucoma (high eye pressure).
• If you have a severe heart or arterial disease (such as coronary artery disease or angina pectoris).
  • If you have a severe liver or kidney disease.

Children under 12 years of age cannot take this medicine.

Warnings and precautions:

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

• Do not take more than the recommended dose of the medicine in section 3: How to take Anticatarral Edigen.

• Chronic alcoholics should be cautious not to take more than 3 sachets of Anticatarral Edigen per day.

• Avoid simultaneous use of this medicine 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.

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

• Patient with kidney, liver, heart, or lung disease, 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 heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid disease, patients sensitive to the sedative effects of some medications.

• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia)

If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (the normal movements of a part of the intestine stop).

Children and adolescents

Children under 15 years of age cannot take this medicine.

Taking Anticatarral Edigen with other medications

Inform your doctor or pharmacist if you are taking or 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 interrupt 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.

• Medications to prevent blood clot formation: Oral anticoagulants (acenocoumarol, warfarin).

• Medications used to increase urine elimination (diuretics such as furosemide and others) and other diuretics that cause potassium loss (such as diuretics for treating hypertension and 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 (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)). You should separate the intake of Anticatarral Edigen and these medications by at least 15 days.

• 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 blocking medications (labetalol and carvedilol) used for the heart or to treat arterial diseases.

• Medications for treating depression of the tricyclic and tetracyclic type.

• Medications used for general anesthesia.

• Antihypertensive medications used 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, such as 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 an allergy to light).

• Medication used in the treatment of infections: Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that should be treated urgently and that can occur particularly in cases of severe renal failure, 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 analytical tests:

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

Taking Anticatarral Edigen with food, drinks, and alcohol

While being treated with this medicine, you should not consume alcoholic beverages, as it may increase the risk of side effects.

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

The medication 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.

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

This medicine should not be taken by mothers during breastfeeding, as it may cause side effects in the baby.

Driving and using machines

This medicine may cause drowsiness. If you experience drowsiness during treatment with this medicine, avoid driving vehicles or using machines.

Anticatarral Edigen

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause allergic reactions because it contains the yellow-orange colorant S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Anticatarral Edigen

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

The recommended dose is:

• Adults and children over 12 years: The usual dose is 1 sachet every 6-8 hours (3-4 times a day). Do not take more than 4 sachets per day. The maximum daily dose of paracetamol should not exceed 3 grams per day (see "Warnings and precautions").

Use in children and adolescents

• Children: The dose for children between 6 and 12 years will be established under medical advice.
• Do not administer to children under 6 years of age.

The administration of the medicine is subject to the appearance of painful, febrile, and congestive symptoms. As these symptoms disappear, this medication should be suspended.

The contents of the sachet are taken dissolved in half a glass of water.

If you take more Anticatarral Edigen than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medicine and the amount taken.

If you have ingested an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they may not appear until 3 days after ingestion, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, dry mouth, difficulty and pain when urinating, blurred vision, rapid and difficult breathing, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

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

Overdose can also cause coagulation disorders (blood clots and bleeding)

If you forget to take Anticatarral Edigen

Do not take a double dose to make up for forgotten doses.

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

If you interrupt treatment with Anticatarral Edigen

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Anticatarral Edigen can cause side effects, although not everyone gets them.

Paracetamol can cause liver damage at high doses or with prolonged treatment. Skin rashes and blood disorders can also occur. In some cases, in sensitive patients, transient drowsiness may appear. In rare cases, nightmares, excitement, nervousness, dry mouth, throat, and nose, and difficulty or pain when urinating may occur, being more likely in children and elderly patients.

Very rare cases of severe skin reactions have been reported.

If you think any of the side effects are serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting 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 leaflet. You can also report them directly through the national reporting system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anticatarral Edigen

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

Do not store above 30°C and protect from humidity.

Do not use Anticatarral Edigen after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Anticatarral Edigen

• The active substances are: Paracetamol, Phenylephrine Hydrochloride, and Chlorphenamine Maleate.

Each single-dose sachet contains 500 mg of paracetamol, 10 mg of phenylephrine hydrochloride, and 4 mg of chlorphenamine maleate.

• The other components are: Aerosil 200, povidone K29/32, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, orange flavor Givaudan 74016-71, yellow-orange colorant S (E-110)

Appearance of the product and contents of the pack

Sachets containing a homogeneous, clean, and granule-free orange powder.

Boxes of 10 and 20 sachets.

Marketing authorization holder and manufacturer

Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid - Spain

Manufacturer:

ALCALA FARMA, S.L

Carretera M-300 Km 29,920

1. Alcalá de Henares (Madrid)

Spain

O

MEDINFAR MANUFACTURING S.A

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada, 5

Condeixa-a-Nova

3150-194 Sebal

Portugal

This leaflet was approved in May 2022

This leaflet was revised in February 2025

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