ACECLOFENAC VIR 100 mg FILM-COATED TABLETS

2. What you need to know before you start taking Aceclofenac Vir

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

Do not take Aceclofenac Vir:

• If you are in the third trimester of pregnancy or if you are breastfeeding.
• If you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6).
• If acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have caused you asthma, rhinitis, or 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, transient ischemic attack (TIA), or blockages in the blood vessels of the heart or brain, or have had an operation to remove a blockage or perform a coronary bypass.

for example, if you have had a heart attack, stroke, transient ischemic attack (TIA), or blockages in the blood vessels of the heart or brain, or have had an operation to remove a blockage or perform a coronary bypass.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take aceclofenac:

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe and persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater 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 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 (stroke, hemorrhage)
• If you smoke.
• If you have diabetes.
• If you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Medicines like aceclofenac may be associated with an increased risk of heart attacks ("myocardial infarctions"). 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.

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 such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.

• If you have Crohn's disease or ulcerative colitis, as medications like aceclofenac may worsen these conditions.

• If you are recovering from major surgery (surgical).
• If you have had or still have bronchial asthma.
• In case of chickenpox, you should avoid using this medication because, in rare cases, severe skin infections related to its use can occur.
• Severe hypersensitivity reactions and very rarely, severe allergic reactions (see section 4. Possible side effects) may occur. The risk is greater 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.

Taking Aceclofenac VIR with other medicines

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

Certain medicines may interact with aceclofenac. 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, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRIs), cyclosporin, tacrolimus, or zidovudine.

Taking Aceclofenac Vir with food and drinks

Aceclofenac 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.

Oral formulations (e.g., tablets) of Aceclofenac may cause adverse effects in the fetus. It is not known if Aceclofenac carries the same risk.

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. Do not use Aceclofenac if you are in the third trimester of pregnancy. Do not use Aceclofenac during the first and second trimester of pregnancy, unless clearly necessary and as recommended by your doctor. If you need treatment during this period, the dose and duration should be reduced as much as possible.

Pregnancy and women of childbearing age

It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take aceclofenac during the first six months of pregnancy unless it is clearly necessary and as indicated 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, aceclofenac may cause kidney problems in your fetus if taken for more than a few days, which can cause 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 checks.

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

Breastfeeding

Aceclofenac 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 aceclofenac, do not drive or use any tools or machinery.

This medicine contains sodium

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

3. How to take Aceclofenac VIR

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed whole with a little water.

The recommended dose in adults 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 it is indicated, even if you feel well.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

It is 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 aceclofenac for a long period, your doctor will perform quarterly checks, for example, kidney, liver, and blood tests.

If you take more Aceclofenac Vir than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service. Telephone 915 620 420. Bring this leaflet with you.

If you forget to take Aceclofenac Vir

Do not worry. Do not take a double dose to make up for forgotten doses. 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 aceclofenac 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 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, gastrointestinal ulcer.
• 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)

• 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.

Medicines like Airtal can be associated, in very rare cases, 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.

Medicines like Airtal can 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 any of the following reactions occur: 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. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aceclofenac Vir

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

Do not store above 30°C.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for safe disposal.

6. Contents of the pack and other information

Composition of Aceclofenac Vir

• The active substance is aceclofenac. Each tablet contains 100 mg of aceclofenac.
• The other ingredients (excipients) are:

Core excipients: microcrystalline cellulose 101, microcrystalline cellulose 102, povidone K 25, sodium croscarmellose, glycerol distearate.

Coating excipients: hypromellose, microcrystalline cellulose, polyethylene glycol 40, titanium dioxide (E171).

Appearance and packaging of the product

Aceclofenac Vir are film-coated tablets, round, biconvex, smooth on both sides, white or almost white in color, and are presented in cardboard boxes containing 20 and 40 tablets, packaged in aluminum-aluminum blisters.

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

GENERIS FARMACEUTICA, S.A.

Rua Joao de Deus, 19

Venda Nova, Amadora (Portugal)

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of last revision of this leaflet: February 2024

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