Leaflet: information for the user

Aceclofenaco Normon 100 mg film-coated tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms, 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 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 (periartritis escapulohumeral and extrarticular rheumatism). Aceclofenaco 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 this medication for longer than necessary to control your symptoms.

Do not take Aceclofenaco Normon

• If you are in the third trimester of pregnancy or breastfeeding your child.
• If you are allergic to aceclofenac 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 suffered 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 heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral blood vessels, or coronary bypass surgery.
• If you have or have had circulation problems (peripheral arterial disease).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• Patients over 65 years of age have a higher incidence of adverse effects, particularly 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.

This medication may increase the risk of heart attacks ("myocardial infarction"). 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.

Furthermore, 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 medications that alter blood coagulation, such as oral anticoagulants like 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 this medication may worsen these conditions.
• If you are recovering from a major surgical operation.
• If you have had or still suffer from bronchial asthma.
• In the case of chickenpox, avoid using this medication, as it may cause severe skin infections in rare cases.

Reactions of hypersensitivity may occur, and very rarely, severe allergic reactions may appear (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-mentioned circumstances have occurred at any time.

Other Medications and Aceclofenaco Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with this medication. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

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

Taking Aceclofenaco Normon with Food and Beverages

This medication can be taken with or without food.

Pregnancy, Lactation, 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 Fertility

Do not take aceclofenac if you are in the last 3 months of pregnancy, as it may harm your unborn child or cause complications during delivery. It may cause kidney and heart problems in your newborn. It may affect your bleeding tendency and that of your newborn, and may cause a longer or more difficult delivery. Do not take aceclofenac during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest effective dose for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, this medication may cause kidney problems in your newborn, which may lead to 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 more than a few days, your doctor may recommend additional monitoring.Pregnant women of childbearing age should be aware that this medication has been associated with a decrease in the ability to conceive.

Lactation

This medication should not be taken if you are breastfeeding.

Driving and Operating Machinery

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

Aceclofenaco Normon 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. If in doubt, consult your doctor or pharmacist again.

Aceclofenaco Normon is administered orally.

The tablets should be swallowed whole with a little water.

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

If you estimate that the action of this medication 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 regular checks.

Use in patients with renal insufficiency or heart failure

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

Use in patients with liver insufficiency

The dose should be reduced to 1 tablet/day.

Long-term treatment

If you take this medication 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 Normon than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested. Bring this leaflet with you.

If you forgot to take Aceclofenaco Normon

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

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

The side effects that may occur with the use of this medication are:

Frequent (may affect up to 1 in 10 people)

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

Infrequent (may affect up to 1 in 100 people)

• 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 people)

• 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 people)

• 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.

Medications like aceclofenac may be associated, in very rare cases, with 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.

Medications like aceclofenac may be associated with liver disorders that cause yellow discoloration of skin and eyes, sometimes with high fever or swelling and sensitivity in the upper abdomen. If any of the following reactions occur: yellow discoloration of skin or eyes, discontinue treatment and report IMMEDIATELY to the 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 disturbances, tremors.
• Dizziness, tinnitus.
• Respiratory noise, bronchospasm.
• Leg cramps.
• Renal function impairment (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, pharmacist, or nurse, 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 for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above30°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 of the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Aceclofenaco Normon

The active ingredient is aceclofenaco. Each film-coated tablet contains 100 mg of aceclofenaco.

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, povidone, colloidal silica, macrogol 40 stearate, magnesium stearate, hypromellose, titanium dioxide (E-171), talc, and macrogol 6000.

Appearance of the product and content of the packaging

Aceclofenaco Normon is presented in the form of film-coated tablets. They are white or almost white, round, and printed tablets. Each package contains 20 or 40 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Dateof the last review of this leaflet: September 2024

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