Package Leaflet: Information for the User

Aceclofenac Kern Pharma 100 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

1. What is Aceclofenac Kern Pharma and what it is used for

2. What you need to know before taking Aceclofenac Kern Pharma

3. How to take Aceclofenac Kern Pharma

4. Possible side effects

5. Storage of Aceclofenac Kern Pharma

6. Contents of the pack and additional information

Aceclofenaco is an effective medication for reducing pain and inflammation.

Aceclofenaco Kern Pharma is used in adults for the treatment of inflammatory and painful processes such as lower back pain (lumbalgia), toothaches (odontalgia), and joint pain (periartritis escapulohumeral and extrarticular rheumatism). Aceclofenaco is also used 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 aceclofenac for longer than necessary to control your symptoms.

Do not take Aceclofenac Kern Pharma

• if you are allergic to aceclofenac or any of the other components of this medication (listed in section 6),
• if you are in the third trimester of pregnancy or breastfeeding your child,
• if nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin have caused asthma, rhinitis, urticaria, or other allergic reactions in you,
• 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 a severe liver or kidney disease,
• 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 coronary or cerebral 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 this medication

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

This risk is higher when using high doses and prolonged treatments, 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.

Elderly patients are at a higher risk of adverse effects, specifically gastrointestinal bleeding and perforation (in some cases fatal),

• if you have liver disease,
• if you have kidney insufficiency,
• 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,
• 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 aceclofenac can worsen these conditions,
• if you are recovering from a significant surgical operation,
• if you have a history of bronchial asthma,
• in case of chickenpox, avoid using this medication as it may cause severe skin infections in rare cases,
• hypersensitivity reactions may occur, and very rarely, severe allergic reactions may occur (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.

Medications like aceclofenac may increase the 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)

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

Other Medications and Aceclofenac Kern Pharma

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 aceclofenac. In these cases, it may be necessary to adjust 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 NSAIDs, selective serotonin reuptake inhibitors (SSRIs), cyclosporine, tacrolimus, or zidovudine.

Taking Aceclofenac Kern Pharma with Food and Beverages

Aceclofenac can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

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

Do not take aceclofenac 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 and your baby's predisposition to bleeding and delay or prolong delivery more than expected. Do not take aceclofenac during the first 6 months of pregnancy unless it is clearly 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, aceclofenac may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Aceclofenac film-coated tablets should not be taken if you are breastfeeding.

For fertile women, it is essential to consider that medications like aceclofenac have been associated with a decrease in the ability to conceive.

Driving and Operating Machinery

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

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

Your doctor will prescribe the most effective dose at the lowest possible level for the shortest time possible to reduce side effects.

This medication is taken orally.

The tablets should be swallowed whole with a sufficient amount of water.

The recommended dose in adults is 200 mg per day, that is, one tablet in the morning and another at night (1 tablet every 12 hours), before or after meals (see "Taking Aceclofenaco Kern Pharma with food and drinks").

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 this medication is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents:

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 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 Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested.

If you forgot to take Aceclofenaco Kern Pharma

Take your dose as soon as possible. If there is little time left to take the next dose, wait until then to take your tablet.

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

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

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

The side effects that may occur 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.
• Medications like aceclofenaco 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 aceclofenaco may be associated with liver disorders that cause yellow skin and eye discoloration, sometimes with high fever or swelling and abdominal tenderness. 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 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 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 medication.

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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aceclofenaco Kern Pharma:

• The active ingredient is aceclofenac. Each tablet contains 100 mg of aceclofenac.
• The other components (excipients) are: Tablet core: microcrystalline cellulose, povidone, stearic acid, sodium croscarmellose, magnesium stearate. Coating: OPADRY I YS-1R-7003 (titanium dioxide (E-171), 3cp hypromellose (E-464), 5cp hypromellose (E-464), macrogol 400, and polysorbate 80 (E-433)).

Appearance of the product and contents of the packaging

Coated tablets, round, white or almost white, slightly convex on both sides, packaged in Opa-Aluminio-PVC/Aluminio blisters.

It is presented in packaging of 20 or 40 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:September of 2023

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