ACECLOFENAC CINFA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

aceclofenaco cinfa 100 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is aceclofenaco cinfa and what is it used for

aceclofenaco cinfa is a film-coated tablet for oral administration.

Aceclofenaco has analgesic, anti-inflammatory, and antirheumatic activity.

Your doctor will prescribe this medication for the treatment of inflammatory and painful conditions such as lower back pain (lumbalgia), toothache (odontalgia), and joint pain (periarthritis of the shoulder and extra-articular rheumatism). aceclofenaco cinfa is also indicated for the chronic treatment of pain and inflammation associated with chronic joint conditions: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. What you need to know before taking aceclofenaco cinfa

It is essential to use the smallest dose that relieves/control the pain, and you should not take aceclofenaco cinfa for longer than necessary to control your symptoms.

Do not take aceclofenaco cinfa:

• If you are in the third trimester of pregnancy or breastfeeding.
• If you are allergic to aceclofenaco or any of the other components of this medication (listed in section 6).
• 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 kidney failure.
• If you have severe liver failure.
• 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 problems with blood circulation (peripheral arterial disease).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take aceclofenaco cinfa

• 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 ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

Elderly patients suffer from a higher incidence of side 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 suffered 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.

Medications like aceclofenaco cinfa may be associated with an increased risk of suffering heart attacks ("myocardial infarctions"). Side effects can be minimized by using the lowest effective dose for the shortest possible time. 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).

• 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 bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications like aceclofenaco cinfa may worsen these conditions.
• If you are recovering from major surgery.
• If you have had or still have bronchial asthma.
• In case of chickenpox, you should avoid using this medication because, in rare cases, it can cause severe skin infections related to its use.
• 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 any symptoms of skin rash, mucosal lesions, or other signs of hypersensitivity.

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

Taking aceclofenaco cinfa with other medications

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 medications, selective serotonin reuptake inhibitors (SSRIs), cyclosporine, tacrolimus, or zidovudine.

Taking aceclofenaco cinfa with food and drinks

aceclofenaco cinfa 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.

Pregnancy and women of childbearing age:

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 strictly 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 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.

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

Breastfeeding

Aceclofenaco 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 aceclofenaco, do not drive or use any tools or machinery.

aceclofenaco cinfa contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take aceclofenaco cinfa

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 200 mg per day, which is one tablet in the morning and one in the evening (1 tablet every 12 hours).

The tablets should be swallowed whole with a little water.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

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 effect of aceclofenaco is too strong or too weak, inform your doctor or pharmacist.

Use in children:

Not recommended.

Use in elderly patients:

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

Use in patients with kidney 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 will perform quarterly checks, for example, of the kidneys, liver, and blood tests.

If you take more aceclofenaco cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicology Information Service (telephone: 915 620 420), indicating the medication and the amount taken.

If you forget to take aceclofenaco cinfa

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

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

4. Possible side effects

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

The side effects that may occur with aceclofenaco consist of:

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• 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 patients)

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

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

• 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.
• Medications like aceclofenaco may be associated with severe mucocutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Palpitations, flushing, warmth, inflammation of blood vessels (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.
• Vertigo, ringing in the ears (tinnitus).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Kidney function disorders (nephrotic syndrome), kidney failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of aceclofenaco cinfa

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

Do not store above 30°C.

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of aceclofenaco cinfa

The active ingredient is aceclofenaco. Each tablet contains 100 mg of aceclofenaco.

The other ingredients are:

• Core of the tablet: microcrystalline cellulose (E-460i), povidone, sodium croscarmellose, polysorbate 80, glycerol distearate, and anhydrous colloidal silica.
• Coating of the tablet: Opadry Y-5-7068 (hypromellose, hydroxypropylcellulose (E-463), titanium dioxide (E-171), and macrogol 400).

Appearance of the product and packaging contents

aceclofenaco cinfa is presented in the form of white, cylindrical, biconvex, scored film-coated tablets. Each pack contains 20, 40, or 500 (clinical pack) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Date of last revision of this package leaflet:March 2023.

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69223/P_69223.html

QR code to: https://cima.aemps.es/cima/dochtml/p/69223/P_69223.html