ACECLOFENAC KERN PHARMA 100 MG FILM-COATED TABLETS

2. What you need to know before you take Aceclofenaco Kern Pharma

It is important that you use the smallest dose that relieves your pain and do not take aceclofenaco for longer than necessary to control your symptoms.

Do not take Aceclofenaco Kern Pharma

• if you are allergic to aceclofenaco or any of the other ingredients of this medicine (listed in section 6),
• if you are in the third trimester of pregnancy or if you are breastfeeding,
• if acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have caused you asthma, rhinitis, urticaria, or other allergic reactions,
• if you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract,
• if you have bleeding or coagulation problems (you bleed easily),
• if you have severe liver or kidney disease,
• if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, transient ischaemic attack (TIA), or blockages in the blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass,
• if you have had problems with blood circulation (peripheral arterial disease).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• if you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor may consider the possibility of associating a stomach protective medication.

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

• if you have any liver disease,
• if you have kidney failure,
• if you have heart problems or have had a stroke,
• 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 medications that alter blood coagulation, such as oral anticoagulants like warfarin, or antiplatelet agents like acetylsalicylic acid, inform your doctor. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs),
• if you have Crohn's disease or ulcerative colitis, as medications like aceclofenaco may worsen these conditions,
• if you are recovering from major surgery,
• if you have had asthma in the past or still suffer from it,
• in case of chickenpox, you should avoid using this medication because, in rare cases, serious skin infections related to its use can occur,
• hypersensitivity reactions may occur, and very rarely, severe allergic reactions (see section 4. Possible side effects) may appear. The risk is higher during the first month of treatment. Stop treatment immediately if you experience the first symptoms of skin rash, mucosal lesions, or other signs of hypersensitivity.

Medications like aceclofenaco 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 time. Do not exceed the recommended dose or duration of treatment.

Similarly, 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 to you at any time.

Other medications and Aceclofenaco Kern Pharma

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

Certain medications may interact with aceclofenaco. In these cases, it may be necessary to change the dose or interrupt 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, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRIs), cyclosporin, tacrolimus, or zidovudine.

Taking Aceclofenaco Kern Pharma with food and drinks

Aceclofenaco 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.

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 and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take aceclofenaco 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 the 20th week of pregnancy, aceclofenaco may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid 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 checks.

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

For women of childbearing age, it should be noted that medications like aceclofenaco have been associated with a decrease in fertility.

Driving and using machines

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

3. How to take Aceclofenaco Kern Pharma

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

This medicine 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, i.e., one tablet in the morning and one in the evening (1 tablet every 12 hours), before or after meals (see section "Taking Aceclofenaco Kern Pharma with food and drinks").

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

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents:

Not recommended.

Use in elderly patients:

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

Use in patients with renal or heart failure:

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

Use in patients with liver failure:

The dose should be reduced to 1 tablet per day.

Long-term treatment:

If you take aceclofenaco for a long 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 Toxicology Information Service (telephone 91 562 04 20) indicating the medication and the amount taken.

If you forget to take Aceclofenaco Kern Pharma

Take your dose as soon as possible. If it is almost time for your next dose, wait until then to take your tablet.

Do not take a double dose to make up for a forgotten dose. Take the next dose according to your usual schedule.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that may appear are:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Blood in stools, gastrointestinal bleeding, gastrointestinal ulcer.
• Facial inflammation.
• Heart failure, high blood pressure.
• Anemia.
• Severe allergic reaction, allergies.
• Vision disturbances.
• Breathing difficulties.

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

• Mouth mucosa inflammation, pancreas inflammation, intestinal perforation, vomiting blood.
• Worsening of ulcerative colitis and Crohn's disease has also been observed.
• Purple spots on the skin, severe skin reactions.
• Medications like aceclofenaco may be associated with very rare but serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Palpitations, flushing, feeling hot, blood vessel inflammation (vasculitis).
• Liver damage (including hepatitis), increased alkaline phosphatase.
• Medications like aceclofenaco may be associated with liver disorders that cause yellowing of the skin and eyes, sometimes with high fever or swelling and sensitivity of the upper abdomen. If you experience any of the following reactions: yellowing of the skin or eyes, stop treatment and inform your doctor IMMEDIATELY.
• Decreased white blood cells, decreased platelets, bone marrow depression, hemolytic anemia.
• Increased potassium in the blood.
• Depression, sleep disturbances, difficulty falling asleep.
• Numbness, drowsiness, headache, taste disturbances, tremors.
• Dizziness, ringing in the ears (tinnitus).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Kidney function disorder (nephrotic syndrome), kidney failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, serious skin infections have been observed during chickenpox.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aceclofenaco Kern Pharma

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Aceclofenaco Kern Pharma:

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

Appearance of the product and pack contents

White or almost white, slightly convex, film-coated tablets, packaged in Opa-Alu-PVC/Alu blisters.

Available in packs of 20 or 40 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet:September 2023

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