Aracenac 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Aracenac 100 mg film-coated tablets EFG

Aceclofenac

Read all of this leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Aracenac is and what it is used for
2. What you need to know before taking Aracenac
3. How to take Aracenac
4. Possible side effects
5. How to store Aracenac
6. Contents of the pack and other information

1. What Aracenac is and what it is used for

Aracenac is a medicine effective in reducing pain and inflammation.

This medicine is used in adults for the treatment of inflammatory and painful conditions such as low back pain (lumbago), toothache (odontalgia), and joint pain (shoulder periarthritis and extra-articular rheumatism). It is also used for the long-term treatment of pain and inflammation associated with chronic joint disorders: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. What you need to know before starting to take Aracenac

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

Do not take Aracenac:

• If you are allergic (hypersensitive) to aceclofenac or to any of the other components of this medicine (listed in section 6).

• If you are in the last 3 months of pregnancy or if you are breastfeeding, 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 may delay or prolong labor. You should not take Aracenac during the first 6 months of pregnancy unless absolutely necessary and prescribed by your doctor. If treatment is needed during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, Aracenac may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohidramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is needed, your doctor may recommend additional monitoring.

• If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) have previously caused you asthma, rhinitis, urticaria, or another allergic reaction.

• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.

• If you have bleeding disorders or coagulation problems (you bleed easily).

• If you suffer from 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), blockages in blood vessels of the heart or brain, or surgery to remove an obstruction or coronary bypass.

- If you have or have had circulation problems (peripheral arterial disease).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine

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

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protecting medicine.

Elderly patients have a higher incidence of adverse effects, particularly gastrointestinal bleeding and perforation (in some cases fatal).

• If you suffer from liver disease,
• If you have kidney insufficiency,
• If you have heart problems or have suffered 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 recovering from major surgery,
• If you have blood disorders,
• If you are taking medications that affect blood coagulation such as oral anticoagulants like warfarin, or antiplatelet agents such as acetylsalicylic acid, inform your doctor. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs),
• If you suffer from Crohn’s disease or ulcerative colitis, as medicines like aceclofenac may worsen these conditions.
• If you have previously or currently suffer from bronchial asthma,
• In case of chickenpox, the use of this medicine should be avoided, as serious skin infections related to its use may rarely occur.
• Hypersensitivity reactions may occur and, very rarely, severe allergic reactions (see section 4). The risk is higher during the first month of treatment. Immediately discontinue treatment at the first signs of skin rash, mucosal lesions, or other signs of hypersensitivity.

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

Medicines like aceclofenac may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or strokes. This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.

Also, 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 need to take any other medicine.

Certain medicines may interact with aceclofenac. In such cases, it may be necessary to adjust the dose or stop treatment with one of the medicines.

This is especially important if you are taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, antiplatelet agents, hypoglycemics, methotrexate, corticosteroids, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRIs), cyclosporine, 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Because the use of medicines like aceclofenac has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of this medicine during the third trimester is contraindicated.

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

This medicine should not be taken during breastfeeding.

Driving and using machines:

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

3. How to take Aracenac

Follow exactly the administration instructions for this medicine as given 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 duration in order 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 at night (1 tablet every 12 hours), taken either before or after meals (see section "Taking Aracenac with food and drink").

The duration of treatment will be determined by your doctor. Do not stop treatment earlier than instructed, even if you feel well.

If you feel that the effect of this medicine 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 determine the dose to be taken and should carry out periodic monitoring.

Use in patients with renal impairment or heart failure:

Your doctor will determine the dose to be taken and should carry out periodic monitoring.

Use in patients with hepatic impairment:

The dose should be reduced to 1 tablet per day.

Long-term treatment:

If you take aceclofenac for a prolonged period, your doctor should perform quarterly check-ups, for example on kidney and liver function, as well as blood tests.

If you take more Aracenac than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The adverse effects that may occur are described below, classified according to their frequency of occurrence.

Frequent (may affect up to 1 in 10 patients):

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

Uncommon (may affect up to 1 in 100 patients):

• Gas (flatulence), 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 patients):

• Blood in stool, gastrointestinal bleeding, gastrointestinal ulcer
• Facial swelling
• Heart failure, high blood pressure
• Anemia
• Severe allergic reaction, allergies
• Vision disturbances
• Difficulty breathing

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

• Inflammation of the mucous membrane of the mouth, pancreatitis, intestinal perforation, vomiting with blood
• Worsening of ulcerative colitis and Crohn's disease has also been observed
• Purple spots on the skin, severe skin reactions
• Medicines such as aceclofenac may, in very rare cases, be associated with very serious mucocutaneous reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
• Palpitations, redness, flushing, inflammation of blood vessels (vasculitis)
• Liver injury (including hepatitis), increased alkaline phosphatase
• Medicines such as aceclofenac may be associated with liver disorders causing yellowing of the skin and eyes, sometimes accompanied by high fever or swelling and tenderness in the upper abdomen. If any of the following reactions occur—yellowing of the skin or eyes—discontinue treatment immediately and inform your doctor without delay.
• Decrease in white blood cells, decrease in platelets, bone marrow suppression, hemolytic anemia
• Increased blood potassium levels
• Depression, sleep disturbances, difficulty falling asleep
• Tingling, drowsiness, headache, taste disturbances, tremors
• Dizziness, ringing in the ears (tinnitus)
• Noisy breathing, bronchospasm
• Leg cramps
• Impaired kidney function (nephrotic syndrome), kidney failure
• Fatigue, fluid retention (edema)
• Weight gain

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aracenac

Keep this medicine out of 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 must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Aracenac

• The active substance in this medicine 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: hypromellose, microcrystalline cellulose, polyethylene stearate 40, and titanium dioxide (E-171).

Appearance of the medicine and contents of the container

Film-coated tablets, round, white, biconvex.

Available in packs of 20 or 40 tablets.

Only certain 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 the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/