Aceclofenac Vir 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aceclofenac Vir 100 mg film-coated tablets EFG

Read the 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 other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects listed in this leaflet. See section 4.

Leaflet contents:

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

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

Aceclofenaco Vir 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 used 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 starting to take Aceclofenac Vir

It is important that you use the lowest dose that relieves/controls your pain and that you 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 your child.

• 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 previously caused you asthma, rhinitis, urticaria, or another allergic reaction.

• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal 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:

Talk to 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 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 such cases, your doctor may consider prescribing a stomach-protecting 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 suffered 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.

Medicines such as aceclofenac 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 time. Do not exceed the recommended dose or duration of treatment.

Also, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

• If you have blood disorders.

• If you are taking medications that affect blood coagulation, 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 inhibitor (SSRI) antidepressants.

• If you have Crohn's disease or ulcerative colitis, as medicines like aceclofenac 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, 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 (see section 4. Possible adverse 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 circumstances mentioned above have occurred in the past.

Taking Aceclofenac Vir with other medicines

• 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 aceclofenac. 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, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRI antidepressants), cyclosporine, tacrolimus, or zidovudine.

Taking Aceclofenac Vir with food and drinks

Aceclofenac 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.

Oral formulations (e.g., tablets) of Aceclofenac may cause adverse effects in the fetus. It is unknown whether Aceclofenac carries the same risk.

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. Do not use Aceclofenac if you are in the third trimester of pregnancy. You should not use Aceclofenac during the first and second trimesters of pregnancy unless clearly necessary and recommended by your doctor. If treatment is needed 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 unborn baby. It may affect your ability and your baby's ability to bleed and may delay or prolong labor more than expected. You should not take aceclofenac during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, aceclofenac may cause kidney problems in your unborn baby if taken for more than a few days, 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 you need treatment for longer than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like aceclofenac have been associated with a reduced ability to conceive.

Breastfeeding

Aceclofenac must not be taken if you are breastfeeding.

Driving and using machines

If you experience dizziness, fainting, vertigo, or other central nervous system disturbances while taking aceclofenac, do not drive or operate any tools or machinery that could be dangerous.

This medicine contains sodium

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

3. How to take Aceclofenac VIR

Follow exactly the instructions for use of this medicine as given 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 for adults is 200 mg per day, that is, one tablet in the morning and one 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 better.

If you think that the effect of this medicine 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 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 aceclofenac 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 VIR than you should

Contact your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service. Telephone 915 620 420. Take 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 the usual schedule.

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone will experience them. The adverse effects that may occur with aceclofenac 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 faeces, gastrointestinal haemorrhage, peptic 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 mucous membranes of the mouth, inflammation of the pancreas, 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 such as Airtal may, in very rare cases, be associated with severe mucocutaneous reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

• Palpitations, flushing, feeling of warmth, inflammation of blood vessels (vasculitis).
• Liver injury (including hepatitis), increased alkaline phosphatase.

Medicines such as Airtal 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 and inform your doctor IMMEDIATELY.

• Decrease in white blood cells, decrease in platelets, bone marrow suppression, hemolytic anemia.
• Increased blood potassium levels.
• Depression, sleep disturbances, difficulty falling asleep.
• Tingling sensations, drowsiness, headache, taste disturbances, tremors.
• Dizziness, ringing in the ears (tinnitus).
• Noisy breathing, bronchospasm.
• Leg cramps.
• Impaired kidney function (nephrotic syndrome), renal failure.
• Fatigue, fluid retention (edema).
• Weight gain.

Exceptionally, severe skin infections have been observed during chickenpox.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, 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 container.

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 collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

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 components (excipients) are:

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

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

Nature of the product and contents of the pack

Aceclofenac Vir are round, biconvex, film-coated tablets, smooth on both sides, white or almost white in colour. They are available in cardboard boxes containing 20 or 40 tablets, packed in aluminium-aluminium 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 the most recent revision of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/