Leaflet: information for the user

aceclofenac cinfa 100 mg film-coated tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

aceclofenaco cinfa are film-coated tablets for oral administration.

Aceclofenaco has analgesic, anti-inflammatory and antirheumatic activity.

Your doctor will prescribe this medication for the treatment of inflammatory and painful processes such as lower back pain (lumbalgia), toothache (odontalgia) and joint pain (periarthritis of the shoulder and elbow and extra-articular rheumatism). Aceclofenaco cinfa is also indicated for the chronic treatment of pain and inflammation associated with chronic joint processes: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

It is essential to use the smallest effective dose to alleviate/control pain and not to take aceclofenaco cinfa for longer than necessary to control your symptoms.

Do not take aceclofenaco cinfa:

• If you are in the third trimester of pregnancy or breastfeeding your child.
• If you are allergic to aceclofenaco or any of the other components of this medication (listed in section 6).
• If you have had asthma, rhinitis, urticaria, or other allergic reactions caused by aspirin or other nonsteroidal anti-inflammatory drugs.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you have bleeding or coagulation problems (bleed easily).
• If you have severe kidney failure.
• If you have severe liver failure.
• If you have established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the heart or brain blood vessels, or coronary bypass surgery.
• If you have or have had peripheral arterial disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take aceclofenaco cinfa.

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

Elderly patients have a higher incidence of adverse effects, specifically gastrointestinal bleeding and perforation (in some cases fatal).

• If you have liver disease.
• If you have kidney failure.
• If you have heart problems or have had a stroke (cerebral hemorrhage).
• If you smoke.
• If you have diabetes.
• If you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Medications like aceclofenaco cinfa may be associated with an increased risk of heart attacks ("myocardial infarctions"). Adverse effects can be minimized by using the lowest effective dose for the shortest possible period. Do not exceed the recommended dose or treatment duration.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

• If you have blood disorders.

• If you are taking anticoagulant medications such as warfarin, or antiplatelet agents like aspirin, inform your doctor. You should also mention the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as medications like aceclofenaco cinfa may worsen these conditions.
• If you are recovering from a significant surgical operation.
• If you have a history of bronchial asthma.
• In the case of chickenpox, avoid using this medication, as it may cause severe skin infections in rare cases.
• May cause hypersensitivity reactions and, very rarely, severe allergic reactions (see section 4. Possible adverse effects). The risk is higher during the first month of treatment. Discontinue treatment immediately if you experience the first symptoms of skin rash, mucosal lesions, or other signs of hypersensitivity.

Consult your doctor, even if any of the above circumstances have occurred at some point.

Taking aceclofenaco cinfa with other medications

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

Certain medications may interact with aceclofenaco. In these cases, you may need to adjust the dose or discontinue treatment with one of the medications.

This is especially important if you are taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, antiplatelet agents, hypoglycemic agents, methotrexate, corticosteroids, aspirin, or other nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRIs), cyclosporine, tacrolimus, or zidovudine.

Taking aceclofenaco cinfa with food and beverages

Aceclofenaco cinfa can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy and women of childbearing age:

Do not take aceclofenaco if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take aceclofenaco during the first 6 months of pregnancy unless it is strictly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, aceclofenaco may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it is essential to consider that medications like aceclofenaco have been associated with a decrease in the ability to conceive.

Breastfeeding

Aceclofenaco should not be taken if you are breastfeeding.

Driving and operating machinery

If you experience dizziness, fainting, vertigo, or other central nervous system disturbances while taking aceclofenaco, do not drive or operate any hazardous tools or machinery.

Aceclofenaco cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

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

The recommended dose is 200 mg per day, that is, one tablet in the morning and another at night (1 tablet every 12 hours).

The tablets should be taken whole with a little water.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

The duration of treatment will be established by your doctor. Do not stop treatment before the indicated time, even if you feel well.

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

Use in children:

Not recommended.

Use in elderly patients:

Your doctor will indicate the dose to take and should perform periodic checks.

Use in patients with renal insufficiency or heart failure:

Your doctor will indicate the dose to take and should perform periodic checks.

Use in patients with liver insufficiency:

The dose should be reduced to 1 tablet per day.

Long-term treatment:

If you take aceclofenaco for a long period of time, your doctor should perform quarterly checks, for example, of the kidneys, liver, and blood tests.

If you take more Aceclofenaco Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicological Information Service (phone: 915 620 420), indicating the medication and the amount ingested.

If you forgot to take Aceclofenaco Cinfa

Do not worry. Do not take a double dose to compensate for the missed doses. Take the next dose according to the usual schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects that may occur with aceclofenac include:

Frequent (may affect up to 1 in 10 patients)

• Stomach discomfort, abdominal pain, nausea, and diarrhea.
• Dizziness.
• Increased liver enzymes.

Infrequent (may affect up to 1 in 100 patients)

• Gas, stomach inflammation, constipation, vomiting, and mouth sores.
• Itching, skin rash, skin inflammation (dermatitis), and urticaria.
• Increased urea, increased creatinine.

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

• Blood in stool, digestive bleeding, digestive ulcer.
• Face inflammation.
• Heart failure, high blood pressure.
• Anemia.
• Severe allergic reaction, allergies.
• Vision anomalies.
• Difficulty breathing.

Very rare (may affect up to 1 in 10,000 patients)

• Mouth mucosa inflammation, pancreas inflammation, intestinal perforation, vomiting with blood.
• Also, worsening of ulcerative colitis and Crohn's disease has been observed.
• Violet spots on the skin, severe skin reactions.
• Medicines like aceclofenac may be associated, in very rare cases, with very severe mucocutaneous reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.
• Palpitations, redness, heat, inflammation of blood vessels (vasculitis).
• Liver damage (including hepatitis), increased alkaline phosphatase.

Medicines like aceclofenac may be associated with liver disorders that cause yellow skin and eye discoloration, sometimes with high fever or swelling and abdominal sensitivity. If any of the following reactions occur: yellow skin or eye discoloration, discontinue treatment and IMMEDIATELY report to your doctor.

• Decreased white blood cells, decreased platelets, bone marrow depression, hemolytic anemia.
• Increased potassium in the blood.
• Depression, sleep disturbances, difficulty falling asleep.
• Tickling, drowsiness, headache, taste alterations, tremors.
• Dizziness, tinnitus.
• Respiratory noise, bronchospasm.
• Leg cramps.
• Renal function alteration (nephrotic syndrome), renal failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear 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 side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. 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 point at 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 aceclofenac cinfa

The active ingredient is aceclofenac. Each tablet contains 100 mg of aceclofenac.

The other components are:

• Tablet core: microcrystalline cellulose (E-460i), povidone, sodium croscarmellose, polisorbate 80, glyceryl distearate, and anhydrous colloidal silica.
• Tablet coating: Opadry Y-5-7068 (hypromellose, hydroxypropylcellulose (E-463), titanium dioxide (E-171), and macrogol 400).

Appearance of the product and contents of the packaging

aceclofenac cinfa is presented in the form of coated, cylindrical, biconvex, scored tablets on one side and white in color. Each package contains 20, 40, or 500 (clinical package) tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra)-Spain

Last review date of this leaflet:March 2023.

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69223/P_69223.html

QR code to:https://cima.aemps.es/cima/dochtml/p/69223/P_69223.html