Aspirina C 400 mg/240 mg effervescent tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

ASPIRIN C 400 mg / 240 mg effervescent tablets

Acetylsalicylic acid / Ascorbic acid

Package leaflet contents

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

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

This medicine contains acetylsalicylic acid and ascorbic acid (vitamin C) as active substances and works by reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, menstrual pain, muscle pain (muscle spasms), or back pain (lumbago), as well as febrile conditions.

2. What you need to know before taking ASPIRINA C

Do not take ASPIRINA C if

• you are allergic (hypersensitive) or have had any allergic reaction to acetylsalicylic acid, ascorbic acid, or any of the other components of this medicine,
• you have stomach or intestinal ulcer, or recurrent gastric discomfort,
• you have experienced allergic-type asthmatic reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or tartrazine dye,
• you have or have had asthma,
• you have nasal polyps associated with asthma that are caused or worsened by acetylsalicylic acid,
• you have haemophilia or other blood coagulation disorders,
• you are being treated with oral anticoagulant medicines,
• you have kidney and/or liver disease (renal and/or hepatic insufficiency),
• you have or have had renal lithiasis (kidney stones) accompanied by oxaluria (excretion of calcium oxalate in urine) or aciduria (acidic urine),
• you have hyperoxaluria (higher than normal levels of oxalic acid or oxalates in urine),
• you have any of the following conditions related to red blood cell disorders: glucose-6-phosphate dehydrogenase deficiency, haemochromatosis, sideroblastic anaemia, and/or thalassaemia,
• you are under 16 years of age, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious illness,
• you are in the third trimester of pregnancy.

Take special care with ASPIRINA C

You should consult your doctor if you need this medicine:

• if you have high blood pressure, or have reduced kidney, heart, or liver function, or have blood coagulation disorders,
• if you have previously had stomach or intestinal ulcers,
• if you are being treated with anticoagulants,
• if you are taking anti-inflammatory drugs or other medicines, as certain medicines may interact with Aspirina C and cause undesirable effects (see section “Use of other medicines”),
• if you are allergic to other anti-inflammatory or anti-rheumatic drugs,
• if you have glucose-6-phosphate dehydrogenase deficiency,
• if you have or have had rhinitis or urticaria,
• if you have a history of kidney stone formation or gout,
• if you have recently undergone or are scheduled to undergo surgery within the next 7 days, including dental surgery,
• do not administer systematically to prevent discomfort caused by vaccinations,
• if you are diabetic, because the ascorbic acid content of this medicine may lead to inaccurate results in urine glucose tests, including test strip methods.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines—even those obtained without a prescription—homeopathic remedies, medicinal plants, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

This is especially important in the case of:

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

Interference with diagnostic tests

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

Taking ASPIRINA C with food and drinks

Take this medicine after meals or with food.

If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits, etc.—per day), taking ASPIRINA C may cause stomach bleeding.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

This medicine should not be used during pregnancy.

If you are pregnant or think you might be, consult your doctor before taking this medicine.

Pregnancy – last trimester

Do not take Aspirina C during the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. This medicine may cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby, possibly delaying or prolonging labour.

Pregnancy – first and second trimesters

You should not take Aspirina C during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to become pregnant, the dose should be limited to the lowest possible for the shortest 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 prolonged treatment is needed, your doctor may recommend additional monitoring.

Under normal circumstances, vitamin C doses exceeding 100 mg per day are not required during pregnancy, and in any case, should always be taken under medical advice. Although there is no evidence of harmful effects, the fetal safety of high-dose vitamin C has not been established.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

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

Use in children

Do not administer to children under 16 years of age.

Use in people aged 65 years and over

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

Driving and using machines

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

Important information about some of the components of ASPIRINA C

This medicine contains 471 mg of sodium (the main component of table/cooking salt) in each effervescent tablet. This corresponds to 24% of the maximum daily sodium intake recommended for an adult.

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

3. How to take ASPIRINA C

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

Consult your doctor or pharmacist if you have any doubts.

This medicine is administered orally.

Adults and patients aged 16 years and older: 1 effervescent tablet every 6 hours, if necessary.

Do not exceed 4 effervescent tablets in 24 hours.

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

Completely dissolve the effervescent tablet in a glass of water and drink the entire contents of the glass once the fizzing has completely stopped.

Do not take this medicine on an empty stomach; it is recommended to take the medicine after meals or with food, especially if gastrointestinal discomfort occurs.

Always use the lowest effective dose.

Administration of this preparation should be based on the presence of painful or febrile symptoms. As these symptoms subside, the medication should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if symptoms worsen or new symptoms appear, discontinue treatment and consult your doctor.

If you take more ASPIRINA C than you should

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

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

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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.

4. Possible adverse effects

Like all medicines, ASPIRINA C may produce adverse effects, although not everyone experiences them.

Frequent adverse effects (observed in 1 to 10 out of every 100 people):

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

• Respiratory disorders, such as difficulty breathing (asthma, bronchospasm), nasal congestion, and rhinitis.

• Urticaria (red, raised, often itchy and burning rashes), skin eruptions, angioedema (inflammation and swelling affecting the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing), and pruritus (itching).

• Hypoprothrombinemia (a coagulation disorder) when administered at high doses.

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

• Reye's syndrome in individuals under 16 years of age with fever, influenza, or varicella (see "Before taking ASPIRINA C").
• Liver disorders, especially in patients with juvenile arthritis.
• Anemia
• Occasionally, and at doses exceeding 600 mg/day of vitamin C (3 tablets/day): diarrhea, skin flushing, headache, nausea, vomiting, and stomach cramps.
• Risk of kidney stone formation or gout attacks in predisposed individuals.

With prolonged use of acetylsalicylic acid, the following adverse effects have been observed, although their frequency cannot be accurately estimated: dizziness, tinnitus (ringing in the ears), deafness, sweating, headache, confusion, renal failure, and acute interstitial nephritis (inflammation at the kidney level).

If you notice any of the following:

• Stomach discomfort or pain, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unexpected 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 medicine and consult your doctor immediately, as these may indicate adverse effects requiring urgent medical attention.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ASPIRINA C

Keep out of the reach and sight of children.

Do not store above 25°C.

Expiry

Do not use ASPIRINA C after the expiry date stated on the packaging, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the Punto Sigre collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ASPIRIN C

Each effervescent tablet contains:

• Active substances: acetylsalicylic acid, 400 mg and ascorbic acid (vitamin C), 240 mg.
• Other components (excipients): sodium hydrogen carbonate, sodium carbonate, saccharin, sodium citrate, citric acid, tetraroma orange flavour, orange flavour, lemon flavour and raspberry flavour.

Appearance of the medicinal product and contents of the pack

This medicine consists of round, white effervescent tablets. It is available in packs containing 10 and 20 effervescent tablets.

Marketing Authorization Holder and Manufacturer

Bayer Hispania, S.L.