ASPIRIN C 400 mg/240 mg EFFERVESCENT TABLETS

2. What you need to know before taking ASPIRINA C

Do not take ASPIRINA C if

• you are allergic (hypersensitive) or have had an allergic reaction to acetylsalicylic acid, ascorbic acid, or any of the other components of this medication,
• you have stomach ulcers, intestinal ulcers, or recurring gastric discomfort,
• you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking non-steroidal anti-inflammatory drugs, acetylsalicylic acid, other analgesics, as well as the tartrazine dye,
• you have asthma,
• you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid,
• you have hemophilia or other blood coagulation problems,
• you are being treated with oral anticoagulant medications,
• you have kidney and/or liver disease (renal and/or hepatic insufficiency),
• you have had kidney stones (nephrolithiasis) accompanied by oxaluria (elimination of oxalate calcium in the urine) or aciduria (acidic urine),
• you have hyperoxaluria (concentration of oxalic acid or oxalates in urine higher than normal),
• you have any of the following diseases related to alterations in red blood cells: glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, sideroblastic anemia, and/or thalassemia,
• you are under 16 years old, as the use of acetylsalicylic acid has been linked to Reye's Syndrome, a rare but serious disease,
• you are in the third trimester of pregnancy.

Be careful with ASPIRINA C

You should consult your doctor if you need this medication:

• if you have high blood pressure, or have reduced kidney, heart, or liver function, or have blood coagulation disorders,
• if you have had stomach or intestinal ulcers,
• if you are being treated with anticoagulants,
• if you are taking non-steroidal anti-inflammatory drugs or other types of medications, as certain medications can interact with Aspirina C and produce undesirable effects (see "Use of other medications"),
• if you are allergic to other non-steroidal anti-inflammatory drugs or antirheumatics,
• if you have a glucose-6-phosphate dehydrogenase deficiency,
• if you have had rhinitis or urticaria,
• patients with a history of kidney stone formation or gout,
• if you have recently undergone or are to undergo surgery in the next 7 days, including dental surgery,
• do not administer systematically to prevent possible discomfort caused by vaccinations,
• if you are diabetic, due to the content of this medication in ascorbic acid, there is a possibility that it may cause erroneous results in urine glucose tests, including tests with reactive strips.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic products, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is especially important in the case of:

• other analgesics or non-steroidal anti-inflammatory drugs, high doses of salicylates (medications used to treat muscle pain and/or inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin,
• hormonal contraceptives,
• oral antidiabetics (medications to lower blood sugar levels),
• barbiturates (medications used to treat seizures),
• beta-blockers (medications for blood pressure control),
• cimetidine and ranitidine (used for stomach acidity),
• medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as they may increase the risk of gastrointestinal bleeding,
• digoxin (heart medication),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (antiepileptics),
• interferon alpha (used to treat certain viral and tumor infections),
• lithium (used in certain psychiatric illnesses),
• cancer or rheumatoid arthritis (methotrexate),
• medications used to treat gout (probenecid),
• sulfonamides, trimethoprim/sulfamethoxazole, and vancomycin (antibiotics used for infections),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).

Interference with diagnostic tests

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

Taking ASPIRINA C with food and drinks

Take this medication after meals or with some food.

If you habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor, etc. - per day), taking ASPIRINA C may cause stomach bleeding.

Pregnancy

Consult your doctor or pharmacist before using any medication.

This medication should not be used during pregnancy.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication.

Pregnancy - last trimester

Do not take Aspirina 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 Aspirina 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.

Under normal conditions, doses of vitamin C above 100 mg per day do not need to be administered during pregnancy, and in any case, always under medical supervision. Although there is no evidence of harmful effects, the fetal safety of high doses of vitamin C has not been established.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should consult their doctor before taking this medication, as acetylsalicylic acid and ascorbic acid pass into breast milk.

Use in children:

Do not administer to children under 16 years old.

Use in adults over 65 years

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

Driving and using machines

No effects on the ability to drive or use machines have been described.

Important information about some components of ASPIRINA C

This medication contains 471 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 24% of the maximum daily recommended sodium intake for an adult.

Consult your doctor or pharmacist if you need to take 1 or more tablets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take ASPIRINA C

Follow these instructions unless your doctor has given you different instructions.

Consult your doctor or pharmacist if you have doubts.

This medication is administered orally.

Adults and children over 16 years old: 1 effervescent tablet every 6 hours, if necessary.

Do not exceed 4 effervescent tablets in 24 hours.

Patient with reduced liver or kidney function: consult your doctor, as the dose should be reduced.

Dissolve the effervescent tablet completely in a glass of water and drink the entire contents of the glass when the bubbling has stopped completely.

Do not take this medication on an empty stomach, so it is recommended to take the medication after meals or with some food, especially if you notice digestive discomfort.

Always use the lowest effective dose.

The administration of this preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.

If the pain persists for more than 5 days, or the fever for more than 3 days, or the symptoms worsen or other symptoms appear, you should interrupt treatment and consult your doctor.

If you take more ASPIRINA C than you should

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

Doses of vitamin C above 1 gram per day (5 or more tablets per day) may cause diarrhea, kidney stones, and abdominal cramps. There is also a risk of stone formation and triggering acute gout attacks in predisposed individuals.

It is recommended to take the package and package leaflet of the medication to the healthcare professional.

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.

4. Possible side effects

Like all medications, ASPIRINA C can cause side effects, although not everyone will experience them.

Common side effects (observed in 1 to 10 out of every 100 people):

• Gastrointestinal disorders, such as stomach ulcers, intestinal ulcers, gastrointestinal bleeding, abdominal pain, indigestion, heartburn, acidity, gastric discomfort, nausea, and vomiting.

• Respiratory disorders, such as difficulty breathing (asthma, bronchospasm), nasal congestion, and rhinitis.
• Urticaria (red, raised, and often itchy rashes), skin rashes, angioedema (inflammation and swelling that affects the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing), and itching.
• Hypoprothrombinemia (coagulation disorder) when administered in high doses.

Uncommon side effects (observed in 1 to 100 out of every 1,000 people):

• Reye's Syndrome in children under 16 years old with febrile processes, flu, or chickenpox (see "Before taking ASPIRINA C").
• Liver disorders, especially in patients with juvenile arthritis.
• Anemia
• Occasionally, and at doses above 600 mg/day of vitamin C (3 tablets/day): diarrhea, skin redness, headache, nausea, vomiting, and stomach cramps.
• There is a risk of stone formation in the urinary tract or gout attacks in predisposed individuals.

With prolonged doses of acetylsalicylic acid, the following side effects have been observed, whose frequency cannot be established with certainty: dizziness, ringing in the ears, deafness, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis.

If you notice the appearance of:

• Stomach discomfort or pain, gastrointestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unforeseen changes in the amount or appearance of urine.
• Swelling of the face, feet, or legs.
• Deafness, ringing in the ears, or dizziness.

stop taking the medication and consult your doctor immediately, as they may indicate the appearance of side effects that require urgent medical attention.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this package 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 ASPIRINA C

Keep out of the reach and sight of children.

Do not store above 25°C.

Expiration Date

Do not use ASPIRINA C after the expiration date shown on the package, after the abbreviation CAD. 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 packages and medications you no longer need in the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of ASPIRINA C

Each effervescent tablet contains:

• As active ingredients: acetylsalicylic acid, 400 mg, and ascorbic acid (vitamin C), 240 mg.
• The other components (excipients) are: sodium hydrogen carbonate, sodium carbonate, saccharin, sodium citrate, citric acid, tetraroma orange flavor, orange flavor, lemon flavor, and raspberry flavor.

Appearance of the product and package contents

This medication is round, white, effervescent tablets. It is available in packages containing 10 and 20 effervescent tablets.

Marketing Authorization Holder and Manufacturer

Bayer Hispania, S.L. Bayer Bitterfeld GmbH

Av. Baix Llobregat, 3-5 OT Greppin

08970 Sant Joan Despí (Barcelona) Salegaster Chausee, 1

Spain 06803- Bitterfeld-Wolfen (Germany)

Date of the last revision of this package leaflet: October 2023

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