Package Leaflet: Information for the User

Aracenac 100 mg Film-Coated Tablets EFG

Aceclofenac

Read this leaflet carefully before you start taking 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 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 leaflet. See section 4.

1. What is Aracenac and what it is used for

2. What you need to know before you start taking Aracenac

3. How to take Aracenac

4. Possible side effects

5. Storage of Aracenac

6. Contents of the pack and additional information

Aracenac is an effective medication for reducing pain and inflammation.

This medication is used in adults for the treatment of inflammatory and painful processes such as lower back pain (lumbalgia), toothache (odontalgia) and joint pain (periartritis escapulohumeral and extrarticular rheumatism). It is also used in 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 that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Aracenac:

• If you are allergic (hypersensitive) to aceclofenac or any of the other components of this medication (listed in section 6).
• If you are in the last 3 months of pregnancy or breastfeeding your child, as it could 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 prolonged. Do not take Aracenac during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to get pregnant, use the lowest dose for the shortest time possible. If taken for more than a few days after 20 weeks 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 follow-up.
• If the acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs have caused asthma, rhinitis, or urticaria or other allergic reactions.
• If you have had a stomach or duodenal ulcer or bleeding or have suffered a perforation of the digestive system.
• If you have bleeding or coagulation problems (bleed easily).
• If you have a 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 a surgery to remove some obstruction or 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 medication

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest 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 protector medication.

Elderly patients suffer a higher incidence of adverse effects, specifically bleeding and perforations of the gastrointestinal tract (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 are convalescing from a major surgical operation,
• If you have blood disorders,
• If you are taking other medications that alter blood coagulation, such as oral anticoagulants like warfarin, or antiplatelet agents like acetylsalicylic acid, 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 aceclofenac-type medications may worsen these conditions.
• If you have had or still suffer from bronchial asthma,
• In the case of chickenpox, avoid using this medication because in rare cases, it can cause severe skin infections related to its use.
• Severe allergic reactions may occur, and very rarely, anaphylactic reactions may appear (see section 4). The risk is higher during the first month of treatment. Discontinue treatment immediately at the first signs of skin rash, mucosal lesions, or other signs of hypersensitivity.

It is essential to use the smallest effective dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Medications 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 treatment duration.

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

The adverse effects can be minimized by using the lowest effective dose for the shortest time possible. Do not exceed the recommended dose or treatment duration.

Other medications and Aracenac

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 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, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRIs), cyclosporines, tacrolimus, or zidovudine.

Aracenac 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.

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

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

For fertile women, it should be noted that medications like aceclofenac have been associated with a decrease in the ability to conceive.

This medication should not be taken if 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 use 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 administered 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 Aracenac with food and drinks" section).

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 aceclofenac 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 Aracenac than you should:

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

If you forgot to take Aracenac:

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 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 medicinemay cause side effects, although not everyone will experience them.

The side effects that may occur are described below according to their frequency of presentation.

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 1000 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 tenderness. If any of the following reactions occur: yellow skin or eye discoloration, interrupt treatment and immediately inform your doctor.immediatelyto 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 (ringing in the ears)
• 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 for the 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 usethis medicationafter 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 pointat 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 Aracenac

- The active principle of this medication is aceclofenac. Each tablet contains 100 mg of aceclofenac.

- The other components (excipients) are: Tablet core: microcrystalline cellulose, sodium croscarmellose, povidone, and glyceryl palmitostearate. Coating: hydroxypropylmethylcellulose, microcrystalline cellulose, polyoxethylene 40 stearate, and titanium dioxide (E-171).

Appearance of Aracenac and content of the container

Coated tablets, round, white, biconvex.

It is presented in containers of 20 or 40 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

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 the last revision of this prospectus: September 2023

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