DESENFRIOL C GRANULATED EFFERVESCENT

2. What you need to know before taking Desenfriol C

Do not take Desenfriol C:

• If you are allergic to chlorphenamine maleate, ascorbic acid, acetylsalicylic acid, or other salicylates, non-steroidal 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 stomach ulcers, duodenal ulcers, or recurring stomach discomfort.
• If you have had a stomach hemorrhage or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.

• If you have or have had asthma or have presented allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) 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 blood coagulation problems that predispose you to internal bleeding.
• If you are being treated with 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 disorders).
• If you are being treated with methotrexate at doses of 15 mg/week or more.
• If you have uncontrolled high blood pressure.
• If you have mental disorders that cause nervous excitement, seizures in which convulsive movements appear, 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 (higher than normal concentration of oxalic acid or oxalates in urine). If you have had kidney stones.
• If you have hemochromatosis (a disease in which excess iron accumulates in the body).
• If you are under 16 years of age, as the use of acetylsalicylic acid has been linked to 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 are going to undergo surgery, including dental extraction, in the next 7 days.
• If you detect the appearance of blood in stools or vomit, or you suffer from extreme fatigue, these may be symptoms of stomach bleeding; in these cases, interrupt treatment and consult your doctor. This is especially important in cases of increased dose, in elderly patients, and in patients with a history of stomach ulcers, including chronic or recurrent ulcers, especially if they were complicated by bleeding or perforation, or in patients with a history of gastrointestinal bleeding.
• If you are taking anti-inflammatory drugs or other types of medications, as certain medications can interact with Desenfriol C and produce unwanted effects (see "Use of other medications").
• If you have reduced kidney, heart, or liver function, present blood coagulation disorders, or are being treated with anticoagulants.
• If you have a history of severe cardiovascular disease or suffer from hypertension.
• If you are allergic to other anti-inflammatory drugs, antirheumatics, or analgesics.
• 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 stones or gout attacks.
• If you are diabetic, as it may produce false results in blood and certain urine glucose tests.
• If you have prostate hypertrophy or urinary retention.
• If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests, etc.), as it may alter the results.

• If you are allergic to xanthines (aminophylline, theophylline...), you should not take Desenfriol C, as you may also be allergic to caffeine.
• If you have a cardiac arrhythmia, have increased thyroid function, or have had a stomach ulcer or intestine.

• If you have any of the following diseases: glaucoma (increased eye pressure), obstruction of the vesical neck (obstruction of the bladder), hyperthyroidism (increased thyroid gland activity).
• If you have an intolerance to any antihistamine medication (used to treat allergies), as cross-sensitivity may occur, which means that patients sensitive to one antihistamine may be sensitive to others.
• Elderly people may be more susceptible to the adverse effects produced by antihistamines (dizziness, confusion, dry mouth...), and may also present an over-excitement reaction. Caution is recommended in these patients, especially with kidney disease (renal insufficiency).

It is informed to athletes that this medication contains a component that can establish a positive doping control result.

Children and adolescents

Do not administer to children under 16 years of age.

Use of Desenfriol C with other medications

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

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

• Analgesics and non-steroidal anti-inflammatory drugs, medications used to treat pain and/or muscle inflammation, as they increase the risk of gastrointestinal bleeding.
• Corticosteroids, as they can increase the risk of gastrointestinal bleeding.
• Certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Coagulation medications (oral anticoagulants), as they increase the risk of bleeding.
• Diuretics and ACE inhibitors (such as captopril, enalapril...), medications for controlling hypertension.
• Medications to lower blood sugar levels.
• Cyclosporine, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Alpha-interferon, used to treat certain viral and tumor infections.
• 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 convulsions.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medications for epilepsy.

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

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

Monoamine oxidase inhibitors (MAOIs) prolong and intensify the effects of antihistamines, which can cause a sudden drop in blood pressure. This product cannot be used if you are currently being treated for arterial hypertension or taking antidepressant medication that contains an MAOI.

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 consume alcohol, as it increases the gastrointestinal adverse effects of acetylsalicylic acid and is a triggering factor in the chronic irritation produced by acetylsalicylic acid. If you habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor... - per day), taking Desenfriol C may cause a stomach hemorrhage.

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 medication.

This medication should not be used during the entire breastfeeding 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 can cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby, causing a possible delay in delivery or prolonging it more than 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 you to do so. If you need treatment during this period or while trying to become pregnant, the dose will be limited to the lowest possible dose for the shortest possible time.

If you take this medication for several days from the 20th week of pregnancy, it may cause kidney problems in the fetus that could lead to low levels of amniotic fluid (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 monitoring.

Interference with diagnostic tests

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

Use in elderly patients

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

Driving and using machines

Desenfriol C may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Desenfriol C contains sucrose, sodium, and orange yellow S (E-110)

This medication contains sucrose. If your doctor has told you 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 sucrose per dose.

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

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

3. How to take Desenfriol C

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

The recommended dose is:

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

Patient 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 other symptoms appear, the clinical situation should be evaluated.

Do not use in children and adolescents under 16 years of age.

Method of administration:

Dissolve the contents of one sachet 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 you notice digestive discomfort. Do not take this medication on an empty stomach.

If you think the action 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, ringing in the ears, blurred vision, drowsiness, sweating, nausea, vomiting, and occasionally diarrhea.

Treatment is symptomatic. Standard measures to eliminate the medication that has not been absorbed in the stomach should be considered, such as adsorption by administering activated charcoal suspended in water. Gastric lavage should be considered. The solutions of choice for lavage are isotonic or semi-isotonic saline solutions. Saline purgatives attract water to the intestine by osmosis, so they can be valuable in rapidly diluting the intestinal contents. Dialysis is of little use in antihistamine intoxication. 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Desenfriol C

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

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

• Reye's syndrome in children under 16 years of age with febrile, flu-like, or varicella processes (see "What you need to know before taking Desenfriol C").
• Hepatic disorders, especially in patients with juvenile arthritis.

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

• Drowsiness.
• Dry mouth.

In long-term treatments and with high doses, the following may appear: dizziness, ringing in the ears, deafness, sweating, headache, confusion, and kidney problems.

Treatment should be suspended immediately if the patient notices any episode of deafness, ringing in the ears, or dizziness.

In patients who have presented an allergic reaction to acetylsalicylic acid and 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 medications.

If you observe these or any other side effects not described in this leaflet, consult 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 Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Desenfriol C

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

Do not store at a temperature above 25°C.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Desenfriol C

Each sachet contains:

• The active ingredients 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, and orange yellow S (E-110).

Appearance of the Product and Packaging Content

Desenfriol C is an effervescent granulate.

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

Marketing Authorization Holder and Manufacturer

Date of the Last Revision of this Leaflet:October 2023

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