Anticatarral Edigen powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anticatarral Edigen powder for oral solution

Paracetamol, Phenylephrine hydrochloride, 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 use provided 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 more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.
• You should consult a doctor if you worsen or do not improve after 5 days of treatment. See section 4.

Contents of this leaflet:

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

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

Anticatarral Edigen is a combination of paracetamol, phenylephrine, and chlorpheniramine that is effective in reducing fever, pain, and nasal congestion and discharge.

It is used for the symptomatic relief of catarrhal and influenza-like conditions associated with fever, mild to moderate pain, and nasal congestion and discharge in adults and adolescents aged 12 years and older.

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

2. What you need to know before taking Anticatarral Edigen

Do not take Anticatarral Edigen:

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medicine (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 that increase heart rate).
• If you are being treated with beta-blockers (medicines for heart conditions or arterial diseases) (see: Taking Anticatarral Edigen with other medicines).
• 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 severe liver or kidney disease.

Children under 12 years of age must not take this medicine.

Warnings and precautions:

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

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

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

• Avoid using this medicine together with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

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

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.

• Asthmatic patients who are sensitive to acetylsalicylic acid.

• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorphenamine).

• Patients who 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 stomach and intestine), thyroid disorders, or patients sensitive to the sedative effects of certain medicines.

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

If you are taking 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).

Children and adolescents

Children under 12 years of age must not take this medicine.

Taking Anticatarral Edigen with other medicines

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 adjustment or treatment interruption may be necessary:

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medicines to treat tuberculosis: (isoniazid, rifampicin).

• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

• Medicines used to increase urine elimination (loop diuretics such as furosemide or others), and other diuretics causing potassium loss (such as diuretics used to treat hypertension or others).

• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone).

• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).

• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (propranolol).

• Medicines used to reduce blood cholesterol levels (cholestyramine).

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). At least 15 days must separate the administration of Anticatarral Edigen and these medicines.

• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat high blood pressure or other conditions (alpha-adrenergic blocking agents).

• Alpha- and beta-adrenergic blocking agents (labetalol and carvedilol) used for heart conditions or arterial diseases.

• Tricyclic and tetracyclic antidepressants.

• Medicines used for general anesthesia.

• Antihypertensive medicines used to lower blood pressure.

• Medicines for heart conditions such as cardiac glycosides and antiarrhythmics.

• Medicines containing thyroid hormones (used to treat thyroid disorders).

• Medicines used for heart conditions or digestive disorders such as 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 causing light allergy as an adverse effect).

• The medicine flucloxacillin (an antibiotic) used to treat infections, due to a serious risk of blood and fluid disturbances (metabolic acidosis with high anion gap imbalance), which must be urgently treated and may 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 when maximum daily doses of paracetamol are used.

Interference with laboratory tests:

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

Taking Anticatarral Edigen with food, drinks, and alcohol

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

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

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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.

Breastfeeding mothers must not take this medicine, as it may cause adverse effects in the infant.

Driving and using machines

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

Anticatarral Edigen

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine may cause allergic reactions as it contains the colouring agent sunset yellow FCF (E-110). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Anticatarral Edigen

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult 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 daily). Do not take more than 4 sachets per day. The maximum daily dose of paracetamol must not exceed 3 grams per day (see section "Warnings and precautions").

Use in children and adolescents

• Children: Doses for children between 6 and 12 years of age should always be determined under medical advice.
• Do not administer to children under 6 years of age.

Administration of the medicine should be based on the presence of painful, febrile, and congestive symptoms. As these symptoms subside, the medication should be discontinued.

The contents of the sachet should be dissolved in half a glass of water.

If you take more Anticatarral Edigen than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91-562 04 20, indicating the name of the medicine and the amount taken.

If an overdose has been ingested, seek urgent medical attention even if no symptoms are present, as symptoms often do not appear until after 3 days following the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: 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 overdose is most effective if initiated within 4 hours of ingestion of the medicine.

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

Overdose may also cause coagulation disorders (blood clots and hemorrhages).

If you forget to take Anticatarral Edigen

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

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

If you stop taking Anticatarral Edigen

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Anticatarral Edigen may produce adverse effects, although not everyone will experience them.

Paracetamol may damage the liver at high doses or during prolonged treatment. Skin rashes and blood disorders may also occur. In some cases, transient drowsiness may occur in sensitive patients. Rarely, nightmares, excitement, nervousness, dryness of the 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 consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You may also report them directly through the national reporting system: www.notificaRAM.es. By reporting adverse 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 moisture.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the package and other 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 flavour Givaudan 74016-71, orange-yellow dye S (E-110).

Nature of the product and contents of the container

Sachets containing an orange-coloured, homogeneous, clean and free-flowing powder.

Cartons containing 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

Alcalá de Henares (Madrid)

Spain

or

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