ACECLOFENAC NORMON 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Aceclofenaco Normon 100 mg film-coated tablets EFG

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Aceclofenaco Normon and what is it used for

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

Your doctor will prescribe this medicine for the treatment of inflammatory and painful conditions such as lower back pain (lumbalgia), toothache (odontalgia), and joint pain (periarthritis of the shoulder and extrarticular rheumatism). Aceclofenaco 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 you take Aceclofenaco Normon

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

Do not take Aceclofenaco Normon

• If you are in the third trimester of pregnancy or if you are breastfeeding.
• If you are allergic to aceclofenaco or any of the other components of this medicine (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 problems.
• If you have severe liver problems.

• 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 had problems with blood circulation (peripheral arterial disease).

Warnings and precautions

Consult your doctor, pharmacist, or nurse 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 severe abdominal pain 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 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 problems.
• 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.

This medicine may be associated with an increased risk of heart attacks. Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration. 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).

• 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 this medicine 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, the use of this medicine should be avoided because, in rare cases, severe 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.

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

Other medicines and Aceclofenaco Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Certain medicines may interact with this medicine. 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), cyclosporine, tacrolimus, or zidovudine.

Taking Aceclofenaco Normon 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.

Pregnancy and women of childbearing age

Do not take aceclofenaco if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and that of your baby to bleed and make labor longer than expected. You should not take aceclofenaco during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. 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 this medicine for more than a few days from the 20th week of pregnancy, it may cause kidney problems in your unborn baby, which 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.

For women of childbearing age, it should be noted that this medicine has been associated with a decrease in fertility.

Breastfeeding

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.

Aceclofenaco Normon contains sodium

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

3. How to take Aceclofenaco Normon

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Aceclofenaco Normon is administered orally.

The tablets should be swallowed whole with a little water.

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

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 this medicine is too strong or too weak, tell 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/day.

Long-term treatment

If you take this medicine for a long time, your doctor will perform quarterly checks, for example, of the kidneys, liver, and blood tests.

If you take more Aceclofenaco Normon than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken. Bring this leaflet with you.

If you forget to take Aceclofenaco Normon

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

4. Possible side effects

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

The side effects that may appear with the use of this medicine 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 sores.
• 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, digestive bleeding, digestive ulcers.
• 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.

Medicines like aceclofenaco may be associated, in very rare cases, with 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 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 disorders (nephrotic syndrome), kidney failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of side effects

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

5. Storage of Aceclofenaco Normon

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. 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 of Aceclofenaco Normon

The active substance is aceclofenaco. Each film-coated tablet contains 100 mg of aceclofenaco.

The other ingredients (excipients) are: microcrystalline cellulose, sodium croscarmellose, povidone, colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E-171), talc, and macrogol 6000.

Appearance and packaging of the product

Aceclofenaco Normon is presented in the form of film-coated tablets. They are white or almost white, round, and engraved. Each pack contains 20 or 40 film-coated tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of last revision of this leaflet: September 2024

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

You can access detailed information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71437/P_71437.html