Aceclofenac Normon 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aceclofenac Normon 100 mg film-coated tablets EFG

Read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms, as it could be harmful to them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Your doctor has prescribed this medicine for the treatment of painful inflammatory conditions such as low back pain (lumbago), toothache (odontalgia), and joint pain (shoulder periarthritis and extra-articular rheumatism). Aceclofenac is also indicated for the chronic treatment of pain and inflammation associated with chronic joint disorders: osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

2. What you need to know before taking Aceclofenac Normon

It is important that you use the smallest 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 Aceclofenac Normon

• If you are in the third trimester of pregnancy or if you are breastfeeding.

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

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

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

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

• If you have severe renal failure.

• If you have severe hepatic failure.

• 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 the blood vessels of the heart or brain, or surgery to remove an obstruction or coronary bypass.

• If you have or have had circulatory problems (peripheral arterial disease).

Warnings and precautions

Consult your doctor, pharmacist, or nurse 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, 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-protective medicine.
• Elderly patients have a higher incidence of adverse effects, particularly gastrointestinal bleeding and perforation (in some cases fatal).
• If you have liver disease.
• If you have renal 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.

This medicine may be associated with an increased risk of heart attacks ("myocardial infarction"). Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration. Do not exceed the recommended dose or treatment duration.

Also, 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 medicines that affect blood clotting, 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 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 or still suffer from bronchial asthma.
• In case of chickenpox, the use of this medicine should be avoided, as severe skin infections related to its use may rarely occur.

Hypersensitivity reactions may occur, and very rarely, severe allergic reactions may appear (see section 4. Possible side effects). 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.

Consult your doctor even if any of the above-mentioned circumstances occurred in the past.

Other medicines and Aceclofenac Normon

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

Certain medicines may interact with this medicine. In such cases, it may be necessary to adjust the dose or discontinue 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 Aceclofenac Normon with food and drinks

This medicine may 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.

Pregnancy and women of childbearing age

Do not take aceclofenac if you are in the last 3 months of pregnancy, as it may harm your unborn child or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed and may cause labor to start later or last longer than expected. You should not take aceclofenac during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days beyond 20 weeks of pregnancy, this medicine may cause kidney problems in your unborn baby, which could 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 treatment is needed 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 reduced ability to conceive.

Breastfeeding

This medicine should not be taken if you are breastfeeding.

Driving and use of 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.

Aceclofenac Normon contains sodium

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

3. How to take Aceclofenac Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Aceclofenac Normon is administered orally.

The tablets should be swallowed whole with a little water.

The recommended dose is 200 mg per day, that is, one tablet in the morning and another at night (1 tablet every 12 hours).

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

If you consider the effect of this medicine to be too strong or too weak, inform your doctor or pharmacist.

Use in children

Not recommended.

Use in elderly patients

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

Use in patients with renal insufficiency or heart failure

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

Use in patients with hepatic insufficiency

The dose should be reduced to 1 tablet/day.

Long-term treatment

If you take this medicine for a long period of time, your doctor should carry out quarterly checks, for example on kidney and liver function, and blood tests.

If you take more Aceclofenac Normon than you should

Contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested. Take this leaflet with you.

If you forget to take Aceclofenac Normon

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

4. Possible adverse effects

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

The adverse effects that may occur with the use of this medicine include:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• 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 people)

• Blood in stools, gastrointestinal bleeding, digestive ulcer.
• Facial swelling.
• Heart failure, high blood pressure.
• Anaemia.
• Severe allergic reaction, allergies.
• Vision abnormalities.
• Difficulty breathing.

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

• Inflammation of the mucosa 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, very rarely, be associated with very serious mucocutaneous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

• Palpitations, flushing, hot flushes, 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, haemolytic anaemia.
• Increased blood potassium levels.
• Depression, sleep disturbances, difficulty falling asleep.
• Tingling sensations, somnolence, headache, taste disturbances, tremors.
• Dizziness, tinnitus (ringing in the ears).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Impaired kidney function (nephrotic syndrome), renal failure.
• Fatigue, fluid retention (oedema).
• 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aceclofenac 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Aceclofenac Normon

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

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, povidone, colloidal silicon dioxide, polyethylene glycol 40 stearate, magnesium stearate, hypromellose, titanium dioxide (E-171), talc, and polyethylene glycol 6000.

Appearance of the product and pack contents

Aceclofenac Normon is presented as film-coated tablets. They are white or almost white, round tablets with printed markings. 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 the most recent review of this leaflet: September 2024

Detailed 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/)

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