ARACENAC 100 mg FILM-COATED TABLETS

2. What you need to know before you take Aracenac

It is important that you use the lowest effective dose that relieves your pain and do not take this medicine for longer than necessary to control your symptoms.

Do not takeAracenac:

• If you are allergic (hypersensitive) to aceclofenac or any of the other ingredients of this medicine (listed in section 6).
• If you are in the last 3 months of pregnancy or if you are breastfeeding, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed and make delivery delayed or longer than expected. You should not take Aracenac during the first 6 months of pregnancy unless it is absolutely necessary and your doctor indicates it. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, Aracenac may cause kidney problems in the fetus that can lead to 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 monitoring.
• If you have had asthma, rhinitis, or urticaria or other allergic reactions caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• 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 (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, mini-stroke (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 or 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, or even without previous warning symptoms.

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

Elderly patients suffer from 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 (stroke, hemorrhage),
• If you smoke,
• If you have diabetes,
• If you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides,
• If you are recovering from major surgery (surgical),
• 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 aceclofenac may worsen these conditions.
• If you have had bronchial asthma in the past or still suffer from it,
• In case of chickenpox, you should avoid using this medicine because, in rare cases, serious skin infections related to its use can occur.
• Hyposensitivity reactions may occur, and very rarely, very serious allergic reactions (see section 4) 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.

It is essential that you use the lowest effective dose that relieves your pain and do not take this medicine for longer than necessary to control your symptoms.

Medicines like aceclofenac may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when using high doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment.

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

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.

Other medicines and Aracenac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interact with aceclofenac. In these cases, it may be necessary to change the dose or interrupt treatment with one of the medicines.

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), cyclosporins, tacrolimus, or zidovudine.

Taking Aracenac with food and drinks

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Because the administration of medicines like aceclofenac has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of this medicine is contraindicated.

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

This medicine should not be taken if you are breastfeeding.

Driving and using machines

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

3. How to take Aracenac

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 administered 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 "Taking Aracenac 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 aceclofenac for a long time, your doctor should perform periodic checks (e.g., kidney, liver, and blood tests) every 3 months.

If you take more Aracenac than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or go to the nearest hospital immediately, or call the Toxicological Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Aracenac:

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 forgotten doses. Take the next dose according to your usual schedule.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may appear, classified by frequency of occurrence.

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):

• Inflammation of the mouth mucosa, pancreatitis, intestinal perforation, vomiting blood
• Worsening of ulcerative colitis and Crohn's disease has also been observed
• Purple spots on the skin, severe skin reactions
• Medicines like aceclofenac may be associated with very rare, severe mucocutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis
• Palpitations, flushing, feeling hot, inflammation of blood vessels (vasculitis)
• Liver damage (including hepatitis), increased alkaline phosphatase
• Medicines like aceclofenac 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 any of the following reactions occur: 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 disorders (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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aracenac

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 stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition ofAracenac

• The active substance of this medicine is aceclofenac. Each tablet contains 100 mg of aceclofenac.
• The other ingredients (excipients) are: Tablet core: microcrystalline cellulose, sodium croscarmellose, povidone, and glyceryl palmitostearate. Coating: hypromellose, microcrystalline cellulose, polyoxyethylene stearate 40, and titanium dioxide (E-171).

Appearance ofAracenacand contents of the pack

White, biconvex, film-coated tablets.

Available in packs of 20 or 40 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio 6-10

19180 Marchamalo (Guadalajara), Spain.

Tel. 949 22 56 22

Fax: 949 22 82 25

e-mail: [email protected]

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 Health Products (AEMPS) http://www.aemps.gob.es/