Desenfriol C effervescent granules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: Information for the patient

DESENFRIOL C effervescent granules

Read all of this 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 those given 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 any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days for fever or 5 days for pain.

Contents of the leaflet

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

1. What Desenfriol C is and what it is used for

This medicine contains acetylsalicylic acid, ascorbic acid (Vitamin C), chlorpheniramine maleate, and caffeine as active substances. Acetylsalicylic acid acts by reducing pain and fever, chlorpheniramine maleate is an antihistamine that reduces sneezing and watery eyes, and caffeine helps counteract the fatigue commonly associated with the common cold. It also contains ascorbic acid or vitamin C.

Desenfriol C is indicated for the symptomatic relief of catarrhal and influenza-like conditions accompanied by mild to moderate pain, fever, and nasal discharge in adults and adolescents over 16 years of age.

You should consult a doctor if your condition worsens or does not improve after 3 days for fever or 5 days for pain.

2. What you need to know before starting to take Desenfriol C

Do not take Desenfriol C if:

• You are allergic to chlorpheniramine maleate, ascorbic acid, acetylsalicylic acid, other salicylates, nonsteroidal anti-inflammatory drugs, tartrazine (cross-reaction), caffeine, or any of the other components of this medicine (listed in section 6).

• You currently have or have previously had gastric or duodenal ulcer, or recurrent gastric discomfort.

• You have previously experienced stomach bleeding or suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.

• You currently have or have previously had asthma, or have experienced allergic-type asthmatic reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics.

• You have nasal polyps associated with asthma that are caused or worsened by acetylsalicylic acid.

• You have hemophilia or other blood coagulation disorders that predispose you to internal bleeding.

• You are currently being treated with oral anticoagulant medications.

• You have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).

• You have heart disease (heart failure or severe cardiovascular disorders).

• You are being treated with methotrexate at doses of 15 mg/week or higher.

• You have high blood pressure (uncontrolled hypertension).

• You have mental disorders causing nervous excitement, convulsive episodes with or without loss of consciousness (epilepsy), anxiety states, or insomnia (difficulty sleeping).

• You have oxalate urolithiasis (formation of oxalate stones in the urinary tract) or hyperoxaluria (higher than normal concentration of oxalic acid or oxalates in urine). If you currently have or have previously had nephrolithiasis (kidney stones).

• You have hemochromatosis (a disease in which excess iron accumulates in the body).

• You are under 16 years of age, since the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious illness.

• You are in the last trimester of pregnancy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Desenfriol C:

• If you have recently undergone or are scheduled to undergo surgery, including dental extraction, within the next 7 days.

• If you notice blood in your stool or vomit, or experience severe fatigue—these may be symptoms of stomach bleeding. In such cases, stop treatment immediately and consult your doctor. This is especially important if you increase the dose, are elderly, have a history of gastric ulcer (including chronic or recurrent ulcers), particularly if complicated by bleeding or perforation, or if you have a history of gastrointestinal bleeding.

• If you are taking anti-inflammatory drugs or other medications, as certain medicines may interact with Desenfriol C and cause undesirable effects (see "Use with other medicines").

• If you have impaired kidney, heart, or liver function, blood coagulation disorders, or are being treated with anticoagulants.

• If you currently have or have previously had a serious cardiovascular disease or suffer from hypertension.

• If you are allergic to other anti-inflammatory drugs, antirheumatic agents, or analgesics.

• If you have glucose-6-phosphate dehydrogenase deficiency.

• If you have rhinitis and/or urticaria.

• If you have asthma, fever, nasal polyps, or chronic respiratory diseases.

• If you have recently received a vaccine. Do not use this medicine to prevent discomfort possibly caused by vaccinations.

• If you are prone to kidney stones or gout attacks.

• If you are diabetic, as false results may occur in blood tests and with certain urine glucose test strips.

• If you have prostate hypertrophy or urinary retention.

• If you are undergoing any diagnostic tests (including blood and urine analyses, skin tests, etc.), as this medicine may alter test results.

• If you are allergic to xanthines (aminophylline, theophylline, etc.), you should not take Desenfriol C, as you may also be allergic to caffeine.

• If you have cardiac arrhythmia, increased thyroid function, or have previously had stomach or intestinal ulcers.

• If you have any of the following conditions: glaucoma (increased eye pressure), vesical neck obstruction (bladder obstruction), hyperthyroidism (increased thyroid gland activity).

• If you are intolerant to any antihistamine (used to treat allergies), as cross-sensitivity may occur—patients sensitive to one antihistamine may react to others.

• Elderly individuals may be more susceptible to adverse effects caused by antihistamines (dizziness, confusion, dry mouth, etc.) and may also experience over-excitation. Caution is advised, especially in patients with kidney disease (renal insufficiency).

Athletes are informed that this medicine contains a component that may lead to a positive result in doping control tests.

Children and adolescents

Do not administer to individuals under 16 years of age.

Use of Desenfriol C with other medicines

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

Certain medicines may interact with acetylsalicylic acid. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. Therefore, they should not be used without consulting a doctor. This is especially important with:

• Analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain and/or muscle inflammation, as they increase the risk of gastrointestinal bleeding.
• Corticosteroids, as they may increase the risk of gastrointestinal bleeding.
• Certain antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), as they increase the risk of bleeding.
• Medicines affecting blood coagulation (oral anticoagulants), as they increase the risk of bleeding.
• Diuretics and ACE inhibitors (such as captopril, enalapril, etc.), medicines used to control hypertension.
• Medicines used to lower blood sugar levels.
• Cyclosporine, used in transplant patients.
• Vancomycin, an antibiotic used for certain infections.
• Interferon alpha, used in the treatment of certain viral and tumoral diseases.
• Lithium, used in certain psychiatric conditions.
• Methotrexate, used in the treatment of cancer and rheumatoid arthritis.
• Medicines used to treat gout.
• Antacids, used to reduce stomach acidity.
• Digoxin, used for heart problems.
• Barbiturates, medicines used as sedatives for sleep disorders and to treat seizures.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medicines used for epilepsy.

Particularly, Desenfriol C should be used with extreme caution if you are being treated with high doses of trimethoprim/sulfamethoxazole.

High doses of ascorbic acid may alter the action of algeldrate, deferoxamine, ethinylestradiol, propranolol, and warfarin.

Monoamine oxidase inhibitors (MAOIs) prolong and intensify the effects of antihistamines, potentially causing a sudden drop in blood pressure. This product must not be used if you are currently being treated for high blood pressure or are taking antidepressant medication containing a monoamine oxidase inhibitor (MAOI).

Taking Desenfriol C with food, drinks, and alcohol

Take this medicine after meals or with food.

Do not take this medicine on an empty stomach.

Do not consume alcohol, as it increases gastrointestinal adverse effects of acetylsalicylic acid and is a triggering factor in chronic irritation caused by acetylsalicylic acid. If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, liquor—per day), taking Desenfriol C may cause stomach bleeding.

Pregnancy and breastfeeding

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 used throughout the entire breastfeeding period.

Pregnancy – third trimester

Do not take Desenfriol C during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth. This medicine may cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby, potentially delaying labor or causing it to last longer than expected.

Pregnancy – first and second trimester

You should not take Desenfriol C during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If you require treatment during this period or while trying to become pregnant, the dose should be limited to the lowest possible for the shortest possible time.

If you take this medicine for several days starting from week 20 of pregnancy, it may cause kidney problems in the fetus, which could lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you require treatment for several days, your doctor may recommend additional monitoring.

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood or urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Use in the elderly

Elderly individuals should not take this medicine without consulting their doctor, as they are more likely to experience its adverse effects.

Driving and use of machines

Desenfriol C may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

Desenfriol C contains sucrose, sodium, and sunset yellow FCF (E-110)

This medicine contains sucrose. If your doctor has advised you of an intolerance to certain sugars, consult with them before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 3.723 mg of sucrose per dose.

This medicine contains 345.7 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 17.3% of the maximum daily sodium intake recommended for an adult.

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

3. How to take Desenfriol C

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and patients over 16 years of age: One sachet every 6 hours. Do not exceed 4 sachets per day.

Patients with reduced liver, kidney, or heart function: consult your doctor, as the dose may need to be reduced.

If fever persists for more than 3 days, pain for more than 5 days, or if the patient worsens or develops new symptoms, the clinical situation should be reassessed.

Not to be used in children and adolescents under 16 years of age.

Method of administration:

Dissolve the contents of one sachet in a glass of 100–200 ml of water. Once dissolved, the entire solution should be taken immediately. Do not store the solution for later administration or ingestion.

Take the medicine after meals or with food, especially if gastrointestinal discomfort occurs. Do not take this medicine on an empty stomach.

If you feel that the effect of Desenfriol C is too strong or too weak, inform your doctor or pharmacist.

If you take more Desenfriol C than you should

The main symptoms of overdose are: headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, nausea, vomiting, and occasionally diarrhea.

Treatment is symptomatic. Standard measures to remove unabsorbed medication from the stomach should be considered, such as adsorption by administering activated charcoal suspended in water. Gastric lavage should be considered. Isotonic or semi-isotonic saline solutions are the preferred options for lavage. Saline laxatives draw water into the intestine by osmosis and may therefore be valuable in rapidly diluting intestinal contents. Dialysis is of little value in antihistamine intoxication. After emergency treatment, the patient should remain under medical supervision.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desenfriol C

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Common adverse effects (may affect up to 1 in 10 patients):

• Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric discomfort, diarrhea, nausea, vomiting.
• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinaemia (with high doses).

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Reye's syndrome in patients under 16 years of age with febrile conditions, influenza or varicella (see “What you need to know before taking Desenfriol C”)
• Hepatic disorders, especially in patients with juvenile arthritis.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Somnolence.
• Dry mouth.

During long-term treatment and with high doses, dizziness, tinnitus, hearing loss, sweating, headache, confusion, and kidney problems may occur.

Treatment must be stopped immediately if the patient experiences any episode of hearing loss, tinnitus or dizziness.

In patients who have previously shown allergic reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity to these drugs.

If you notice any of these or other adverse effects not described in this leaflet, consult 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Desenfriol C

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desenfriol C

Each sachet contains:

• The active substances are: Chlorphenamine maleate 2.0 mg, ascorbic acid (Vitamin C) 500.0 mg, acetylsalicylic acid 388.8 mg and caffeine 32.4 mg.
• The other components (excipients) are: mannitol (E-421), sodium saccharin, anhydrous citric acid, sodium hydrogen carbonate, sucrose, orange flavor, anhydrous sodium carbonate, orange yellow S (E-110).

Appearance of the product and contents of the pack

Desenfriol C is an effervescent granulate.

It is supplied in packs containing 10 single-dose sachets.

Marketing authorization holder and manufacturer

Date of last revision of this leaflet: October 2023

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/