Leaflet: information for the user

Aceclofenac Vir 100 mg film-coated tablets EFG

Read 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they appear in this leaflet. See section 4.

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

2. What you need to know before taking Aceclofenac Vir

3. How to take Aceclofenac Vir

4. Possible side effects

5. Storage of Aceclofenac Vir

6. Contents of the pack and additional information

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

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

It is essential to use the smallest effective dose to alleviate or control pain and not to 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 breastfeeding your child.
• If you are allergic to aceclofenac or any of the other components of this medication (listed in section 6).
• If nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin have caused asthma, rhinitis, or urticaria or other allergic reactions in you.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you have bleeding or coagulation problems (bleed easily).
• If you have severe kidney failure.
• If you have severe liver failure.

-If you have established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral blood vessels, or a procedure to remove an obstruction or perform a coronary bypass.

-If you have or have had peripheral arterial disease.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take aceclofenac:

-If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as 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, especially in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

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

-If you have liver disease.

-If you have kidney problems.

-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.

Medications like aceclofenac can increase the risk of heart attacks ("myocardial infarctions"). Adverse effects can be minimized by using the lowest effective dose for the shortest possible period. Do not exceed the recommended dose or treatment duration.

Additionally, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

• If you have blood disorders
• If you are taking anticoagulant medications like warfarin, or antiplatelet medications like aspirin, inform your doctor. You should also mention the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

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

-If you are recovering from a significant surgical procedure.

• If you have had or still suffer from asthma.
• In the case of chickenpox, avoid using this medication because, in rare cases, it can cause severe skin infections related to its use.
• May cause hypersensitivity reactions and, very rarely, severe allergic reactions (see section 4. Possible adverse effects). The risk is higher during the first month of treatment. Discontinue 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 previously mentioned circumstances have occurred at some point.

Taking Aceclofenac VIR with other medications

-Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications can interact with aceclofenac. In these cases, it may be necessary to adjust the dose or discontinue treatment with one of the medications.

This is especially important when taking lithium, digoxin, diuretics, antihypertensives, anticoagulants, antiplatelet medications, hypoglycemic agents, methotrexate, aspirin, or other NSAIDs, selective serotonin reuptake inhibitors (SSRIs), cyclosporines, tacrolimus, or zidovudine.

Taking Aceclofenac Vir with food and beverages

Aceclofenac can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Oral formulations (e.g., tablets) of aceclofenac can cause adverse effects in the fetus. The risk is unknown for aceclofenac.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not use aceclofenac if you are in the third trimester of pregnancy. Do not use aceclofenac during the first and second trimesters of pregnancy, unless it is clearly necessary and your doctor recommends it. 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 may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong delivery more than expected. Do not take aceclofenac during the first six months of pregnancy unless it is clearly necessary and as your doctor indicates. 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 week 20 of pregnancy, aceclofenac may cause kidney problems in your fetus if taken for more than a few days, which can cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it is essential to consider that medications like aceclofenac have been associated with a decrease in fertility.

Breastfeeding

Aceclofenac should not be taken if you are breastfeeding.

Driving and operating machinery

If you experience dizziness, fainting, vertigo, or other central nervous system alterations while taking aceclofenac, do not drive or use any hazardous tools or machinery.

This medication contains sodium

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

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Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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, that is, one tablet in the morning and another at night (1 tablet every 12 hours).

The duration of treatment will be established by your doctor. Do not discontinue treatment before the indicated time, even if you feel well.

If you estimate that the action of this medication 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 indicate the dose to take and should perform regular checks.

Use in patients with renal insufficiency or heart failure

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

Use in patients with liver insufficiency

The dose should be reduced to 1 tablet/day

Long-term treatment

If you take aceclofenaco for a long period of time, your doctor should

perform quarterly checks, for example, kidney, liver, and blood tests.

If you take more Aceclofenaco Vir than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital, or

consult the Toxicological Information Service. Phone 915 620 420. Bring this leaflet with you.

If you forgot to take Aceclofenaco Vir

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

Like all medications, this medication may have adverse effects, although not all people may experience them. The adverse effects that may appear with aceclofenac include:

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

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

Infrequent (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 stool, digestive bleeding, digestive ulcer
• Face inflammation,
• Heart failure, high blood pressure
• Anemia
• Severe allergic reaction, allergies,
• Vision anomalies
• Difficulty breathing.

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

• Mouth mucosa inflammation, pancreas inflammation, intestinal perforation, vomiting with blood.

Also, worsening of ulcerative colitis and Crohn's disease has been observed.

• Violaceous skin spots, severe skin reactions.

Medications like Airtal may be associated, in very rare cases, with severe mucocutaneous reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

• Palpitations, redness, heat, inflammation of blood vessels (vasculitis).
• Liver damage (including hepatitis), increased alkaline phosphatase.

Medications like Airtal may be associated with liver disorders that cause yellow skin and eye discoloration, sometimes with high fever or swelling and abdominal tenderness. If any of the following reactions occur: yellow skin or eye discoloration, discontinue treatment and IMMEDIATELY report to your doctor.

• Decreased white blood cells, decreased platelets, bone marrow depression, hemolytic anemia.
• Increased potassium in the blood.
• Depression, sleep disturbances, difficulty falling asleep.
• Tickling, drowsiness, headache, taste disturbances, tremors.
• Dizziness, tinnitus (ringing in the ears).
• Respiratory noise, bronchospasm.
• Leg cramps.
• Renal function alteration (nephrotic syndrome), renal 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, pharmacist, or

nurse even if it is about possible adverse effects that do not appear in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of

this medication..

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

Do not store at a temperature above 30°C.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask

your pharmacist how to dispose of the packaging and medications you no longer need. By doing

so, you will help protect the environment.

Composition of Aceclofenaco Vir

- The active ingredient is aceclofenac. Each tablet contains 100 mg of aceclofenac.

- The other components (excipients) are:

Core excipients: microcrystalline cellulose 101, microcrystalline cellulose 102,

Povidone K 25, sodium croscarmellose, glyceryl distearate.

Coating excipients:hydroxypropylmethylcellulose, microcrystalline cellulose,

polyethylene glycol 40, titanium dioxide (E171).

Appearance of the product and content of the packaging

Aceclofenaco Vir arefilm-coatedround, biconvex, smooth on both sides, white or off-whitetabletsand are presented in carton 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

Responsible for manufacturing:

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

Last review date of this leaflet: February 2024

The detailed and updated information on this medication is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/