PATIENT INFORMATION LEAFLET

DESENFRIOL C effervescent granules

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

Follow exactly the administration instructions contained 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 not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 3 days for fever or 5 days for pain.

1. What is Desenfriol C 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. Storage of Desenfriol C

6. Contents of the pack and additional information

This medicationcontains acetylsalicylic acid, ascorbic acid (Vitamin C), chlorphenamine maleate, and caffeine as active ingredients.Acetylsalicylic acid acts by reducing pain and fever, chlorphenamine maleate is an antihistamine that reduces sneezing and tearing, and caffeine counteracts the fatigue that often accompanies the common cold. It also contains ascorbic acid or Vitamin C.

Desenfriol Cis indicated for the symptomatic relief of catarrhal and influenza-like processes that are accompanied by mild or moderate pain, fever, and nasal discharge in adults and adolescents over 16 years old.

You should consult a doctor if symptoms worsen or do not improve after 3 days for fever or 5 days for pain.

Do not take Desenfriol C:

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

• If you have or have had a stomach ulcer, duodenal ulcer, or recurring stomach discomfort.
• If you have had a previous stomach hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.

• If you have or have had asthma or have had allergic reactions of an asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or ringing in the ears) when taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics.
• If you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid.
• If you have hemophilia or other bleeding disorders that predispose you to internal bleeding.
• If you are taking oral anticoagulant medications.
• If you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).
• If you have heart disease (heart failure or severe cardiovascular alterations).
• If you are taking methotrexate at doses of 15 mg/week or more.
• If you have uncontrolled high blood pressure (hypertension).
• If you have mental alterations that cause nervous excitement, convulsive crises with or without loss of consciousness (epilepsy), anxiety states, and insomnia (difficulty sleeping).
• If you have oxalate urolithiasis (formation of oxalate stones in the urinary tract) or hyperoxaluria (elevated levels of oxalic acid or oxalates in the urine). If you have or have had kidney stones (nephrolithiasis).
• If you have hemochromatosis (a disease in which an excess of iron accumulates in the body).
• If you are under 16 years old, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious disease.
• If 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 will undergo surgery, including dental extraction within the next 7 days.
• If you detect the appearance of blood in stools or vomit, or if you experience severe fatigue, which may be symptoms of stomach hemorrhage. Interrupt treatment and consult your doctor. This is especially important in cases of increased dosage, in elderly patients, and in patients with a history of stomach ulcers, including chronic or recurrent ulcers, especially if complicated by hemorrhage or perforation, or in patients with a history of gastrointestinal hemorrhages.
• If you are taking other medications, as certain medications may interact with Desenfriol C and produce undesirable effects (see "Use of other medications").
• If you have reduced kidney, heart, or liver function, or if you have alterations in blood coagulation or are taking anticoagulants.
• If you have severe cardiovascular disease or uncontrolled hypertension.
• If you are allergic to other anti-inflammatory, antirheumatic, or analgesic medications.
• If you have a deficiency of glucose-6-phosphate dehydrogenase.
• 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 medication to prevent possible discomfort caused by vaccinations.
• If you are prone to kidney stone formation or gout attacks.
• If you are diabetic, as this medication may produce false results in blood tests and with certain glucose test strips in urine.
• If you have benign prostatic hypertrophy or urinary retention.
• If you are undergoing diagnostic tests (including blood, urine, skin tests, etc.), as this medication may alter the 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 had stomach or intestinal ulcers.

• If you have any of the following diseases: glaucoma (increased eye pressure), urethral obstruction (obstruction of the urethra), or hyperthyroidism (increased activity of the thyroid glands).
• If you have intolerance to certain antihistamines (used to treat allergies), as you may experience cross-sensitivity, which means that patients sensitive to one antihistamine may be sensitive to others.
• Older adults may be more susceptible to the adverse effects of antihistamines (dizziness, confusion, dry mouth, etc.) and may experience over-excitation. Precautions are recommended in these patients, especially in patients with kidney disease (renal insufficiency).

This medication contains a component that may establish a positive analytical result for doping control.

Children and adolescents:

Do not administer to children under 16 years old.

Use of Desenfriol C with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Certain medications may interact with acetylsalicylic acid, and in these cases, it may be necessary to change the dosage or discontinue treatment with one of the medications, so they should not be used without consulting a doctor.This is especially important in the case of:

• Analgesics and nonsteroidal anti-inflammatory drugs, medications used to treat pain and/or muscle inflammation, as it increases the risk of gastrointestinal bleeding.
• Corticosteroids, as it may potentiate the risk of gastrointestinal bleeding.
• Some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding.
• Medications for coagulation (oral anticoagulants) as it increases the risk of bleeding.
• Diuretics and ECA inhibitors (such as captopril, enalapril, etc.), medications used to control hypertension.
• Medications to lower blood sugar levels.
• Ciclosporin, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alpha, used to treat certain viral and tumor diseases.
• Lithium, used in some psychiatric diseases.
• Methotrexate, used to treat cancer and rheumatoid arthritis.
• Medications used to treat gout.
• Antacids, used to reduce stomach acidity.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat seizures.
• Zidovudine, used to treat HIV infections.
• Fenitoin and valproic acid, medications used to treat epilepsy.

Desenfriol C should be used with extreme caution if you are taking high doses of trimetoprim/sulfamethoxazole.

Acetylsalicylic acid, in high doses, may modify the action of algeldrate, deferoxamine, ethinylestradiol, propranolol, and warfarin.

Inhibitors of monoamine oxidase (IMAOs) prolong and intensify the effects of antihistamines, potentially causing a sudden drop in blood pressure. This product cannot be used if you are currently being treated for hypertension or taking antidepressant medication containing an IMAO.

Taking Desenfriol C with food, drinks, and alcohol:

Take this medication after meals or with some food.

Do not take this medication on an empty stomach.

Do not ingest alcohol, as it increases the adverse gastrointestinal effects of acetylsalicylic acid and is a trigger for chronic irritation caused by acetylsalicylic acid. If you habitually consume alcohol (three or more alcoholic beverages – beer, wine, liquor, etc. – per day), taking Desenfriol C may cause stomach hemorrhage.

Pregnancy and lactation:

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

This medication should not be used during the entire lactation period.

Pregnancy – last trimester:

Do not take Desenfriol C if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. This medication may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of your baby, causing a possible delay in delivery or prolonging it beyond what is expected.

Pregnancy – first and second trimester:

Do not take Desenfriol C during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises it. If you need treatment during this period or while trying to become pregnant, the dose will be limited to the lowest possible for the shortest time possible.

If you take this medication for several days from week 20 of pregnancy, it may cause kidney problems in the fetus that may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for several days, your doctor may recommend additional follow-up.

Interference with diagnostic tests:

If you are undergoing any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use in the elderly:

Older adults should not take this medication without consulting their doctor, as they are more prone to its adverse effects.

Driving and operating machinery:

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

Desenfriol C contains saccharose, sodium, and yellow S (E-110):

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with diabetes mellitus should note that this medication contains 3,723 mg of saccharose per dose.

This medication contains 345.7 mg of sodium (main component of table salt/for cooking) in each packet. This is equivalent to 17.3% of the recommended daily maximum sodium intake for an adult.

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

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

The recommended dose is :

Adults and individuals over 16 years: One packet every 6 hours. Do not exceed the amount of 4 packets per day.

Patients with reduced liver, kidney, or heart function: consult your doctor as they may decide to reduce the dose.

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

Do not use in children and adolescents under 16 years.

Administration form:

Dissolve the contents of one packet in a glass with 100 - 200 ml of water. Once dissolved, it should be ingested in its entirety, avoiding conservation in solution for administration or subsequent ingestion.

Take the medication after meals or with some food, especially if digestive discomfort is noticed. Do not take this medication on an empty stomach.

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

If you take more Desenfriol C than you should

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

The treatment is symptomatic. Standard measures should be considered to eliminate the medication that has not been absorbed in the stomach, such as adsorption through the administration of activated charcoal suspended in water. Gastric lavage should be considered. The preferred solutions for lavage are isotonic or semi-isotonic saline solutions. Saline purgatives attract water to the intestine by osmosis, making them useful for rapidly diluting intestinal content. Dialysis is of little use in antihistamine poisoning. After emergency treatment, the patient should continue under medical supervision.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desenfriol C

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent 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, bronchial spasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinemia (with high doses).

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

• Reye's syndrome in patients under 16 years with febrile illnesses, flu, or chickenpox (see "What you need to know before starting to take Desenfriol C")
• Hepatic disorders, especially in patients with juvenile arthritis.

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

• Drowsiness.
• Xerostomia.

In long-term treatments and with high doses, the following may occur: dizziness, ear noises, hearing loss, sweating, headache, confusion, and kidney problems.

Treatment should be immediately suspended if the patient notes any episode of hearing loss, ear noises, or dizziness.

In patients who have presented an allergic reaction to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity to these medications.

If you observe n these or any other adverse effect not described in this prospectus, consult your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Desenfriol C

Each sachet contains:

• The active principles 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 aroma, anhydrous sodium carbonate,yellow-orange S(E-110).

Appearance of the product and contents of the packaging

Desenfriol C is an effervescent granule.

It is presented in packaging with 10 single-dose sachets.

Holder of the marketing authorization and responsible for manufacturing

Last review date of this leaflet:October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/