Package Leaflet: Information for the User

Aceclofenaco Stada 100 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine.

• Keep this package 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. Do 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 are not listed in this package leaflet. See section 4.

Aceclofenaco Stada contains aceclofenac. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Aceclofenac is used to relieve pain and inflammation in patients who suffer from:

-Osteoarthritis of the joints. This typically occurs in patients over 50 years old and causes the loss of cartilage and bone tissue next to the joint.

-Chronic inflammatory joint disease (rheumatoid arthritis) caused by an autoimmune disorder.

-Spinal arthritis that can lead to the fusion of vertebrae (ankylosing spondylitis).

Do not take Aceclofenaco Stada:

• if you are allergic to aceclofenaco or any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen, naproxen, or diclofenac.
• if you have taken acetylsalicylic acid or any other NSAID and have experienced any of the following symptoms:

-asthma attack

-nasal secretion, itching, and/or sneezing (nasal irritation)

-appearance of a rash of red, circular, irregular patches on the skin with possible itching or burning sensation

-severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, abnormal pain, and vomiting

• if you have had, have, or suspect you have a stomach or duodenal ulcer, bleeding, or perforation of the digestive system.
• if you have a severe kidney disease
• if you have severe liver disease
• if you are in the third trimester of pregnancy (from the sixth month of pregnancy).
• if you have bleeding or coagulation problems (bleed easily)
• 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 coronary or cerebral blood vessels, or a surgery to remove an obstruction or bypass the coronary artery
• if you have or have had circulation problems (peripheral arterial disease)

Do not recommend the use of aceclofenaco in children.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aceclofenaco Stada:

• if you have any other kidney or liver disease.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatment, 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 protector medication.

• if you have Crohn's disease (or ulcerative colitis), this type of medication may worsen these conditions.
• if you have had or still have bronchial asthma
• if you have porphyria hepatica, aceclofenaco may trigger an attack.
• if you have systemic lupus erythematosus, a chronic skin and connective tissue disease with a typical rash on the edge of the nose and cheeks.
• if varicella occurs, avoid using this medication because in rare cases, severe skin infections related to its use may occur
• if you are recovering from major surgery
• if you are an elderly patient (your doctor will prescribe the lowest effective dose for the shortest possible time).

May cause hypersensitivity reactions, including angioedema (may cause swelling mainly around the eyes and lips, without previous exposure to the medication. Severe skin reactions, including exfoliative dermatitis (skin irritation with peeling), Stevens-Johnson syndrome (skin and mucous membrane lesions), and toxic epidermal necrolysis. Rarely, cases of necrolysis (a severe skin disease in which the epidermis peels off in sheets) associated with the use of NSAIDs (see section 4. Possible adverse reactions). The risk is higher during the first month of treatment. Discontinue treatment with aceclofenaco immediately at the first signs of skin rash, mucous membrane lesions, or other signs of hypersensitivity.

Medications such as aceclofenaco may be associated with a higher risk of heart attack ("myocardial infarction") or stroke. In addition, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Make sure to inform your doctor before starting to take aceclofenaco:

All patients receiving an anti-inflammatory medication (the group to which aceclofenaco belongs) must be monitored with caution regarding, among other things, liver and kidney function, as well as blood counts.

Elderly patients experience a higher incidence of adverse effects, specifically bleeding and perforation of the gastrointestinal tract (in some cases fatal).

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.

Children and adolescents

Currently, there are no clinical data available on the use of aceclofenaco in children, so it is not recommended for administration.

Other medications and Aceclofenaco Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Your doctor must decide if you can take aceclofenaco with other medications. Do not start or stop taking any medication, including those purchased without a prescription and herbal remedies, before consulting with your doctor.

Please inform your doctor if you are taking:

• Lithium (a mood stabilizer used in the treatment of depression and bipolar disorder) and digoxin (a medication used in heart failure). Several NSAIDs inhibit the elimination of lithium and digoxin, causing an increase in blood levels. Therefore, combination should be avoided unless frequent monitoring of lithium and digoxin levels is possible.

• Antihypertensives (used to reduce blood pressure). NSAIDs may reduce the effect of antihypertensives. If your renal function is altered (e.g., if you have lost a lot of fluid or are an elderly patient), the coadministration of antihypertensives such as ACE inhibitors or angiotensin II antagonists and NSAIDs may increase the risk of acute renal failure, usually reversible. In these cases, adequate hydration and monitoring of renal function after initiating concomitant therapy and subsequently at regular intervals are essential.

• Quinolone antibiotics. Due to the interaction between quinolone antibiotics and NSAIDs, seizures may occur. This can occur in patients with or without a history of seizures.

• Diuretics (medications used to increase the rate of urine excretion). Aceclofenaco, like other NSAIDs, may inhibit the activity of diuretics. Therefore, blood pressure should be monitored. In the case of concomitant administration with potassium-sparing diuretics, your doctor will monitor potassium levels in the blood at regular intervals.

• Anticoagulants (medications that prevent blood clotting) such as warfarin, heparin. Like other NSAIDs, aceclofenaco may increase the activity of anticoagulants. Therefore, it is recommended that you remain under the supervision of your doctor when receiving simultaneous treatment with aceclofenaco and anticoagulants.

• Antiplatelet agents. Concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding.

• Selective serotonin reuptake inhibitors (SSRIs, medications used to treat depression). Concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding.

• Methotrexate (used to treat cancers such as leukemia, lymphoma, and autoimmune disorders such as rheumatoid arthritis, lupus, and psoriasis). Also, consider the possible interaction between NSAIDs and methotrexate when administering low doses of methotrexate, especially in patients with reduced renal function. NSAIDs and methotrexate should not be taken during the same 24-hour period because the amount of methotrexate retained in the blood may increase, representing a risk of toxic effects.

• Mifepristone used to induce abortion

• Some types of steroids (estrogens, androgens, or glucocorticoids). Concomitant administration of corticosteroids may increase the risk of stomach or intestinal ulcers or bleeding.

• Ciclosporin (a medication used in autoimmune diseases, rheumatoid arthritis, nephrotic syndrome, chronic glomerulonephritis, and organ transplantation). Concomitant administration of NSAIDs with ciclosporin may increase the risk of renal toxicity. Therefore, during combination therapy, it is essential to monitor renal function.

• Tacrolimus (a medication used in organ transplantation). Concomitant administration of NSAIDs with tacrolimus may increase the risk of renal toxicity. Therefore, during combination therapy, it is essential to monitor renal function.

• Zidovudine (a medication used to treat HIV). When NSAIDs are administered with zidovudine, there may be an increased risk of hematologic toxicity, hemorrhrosis (bleeding in the joint), and hematoma (hematoma).

• Antidiabetics (medications used to reduce blood sugar levels). Cases of isolated hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) effects have been reported. Therefore, consider the possibility of adjusting the dose of antidiabetics when administered concomitantly with aceclofenaco.

• Any other NSAID (acetylsalicylic acid, ibuprofen, naproxen), including COX-2 inhibitors. Concomitant use of two anti-inflammatory medications increases the likelihood of unwanted effects.

Taking Aceclofenaco Stada with food and drinks

Aceclofenaco should be taken preferably with or after meals.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take aceclofenaco 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 newborn. It may affect your tendency and that of your newborn to bleed and make labor longer or more difficult than expected.

Do not take aceclofenaco during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, aceclofenaco may cause kidney problems in your newborn that may lead to low amniotic fluid levels 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.

Breastfeeding

No information is available on the secretion of aceclofenaco in human breast milk. However, in rats, only a very small amount of the drug was found in the milk of the rat, so it is not recommended to use aceclofenaco.

Fertility

NSAIDs may negatively affect female fertility, and therefore, it is not recommended to use aceclofenaco in women who intend to become pregnant. Administration of aceclofenaco should be discontinued in women who have difficulty conceiving or are undergoing fertility tests.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

If you are taking aceclofenaco and experience dizziness, drowsiness, fatigue, visual disturbances, or any other nervous disorder, do not drive or operate machinery.

If you have taken other anti-inflammatory medications (nonsteroidal anti-inflammatory drugs) with similar effects, you should exercise special caution when taking aceclofenaco for the first time.

Follow exactly the administration instructions for aceclofenac indicated by your doctor. You will be prescribed the most effective dose at the lowest possible dose for the shortest time to reduce side effects. In case of doubt, consult your doctor or pharmacist again.

The recommended daily dose in adults is 200 mg (2 aceclofenac tablets). You should take one 100 mg tablet in the morning and another at night.

Tablets should be taken whole with a sufficient amount of water and should be taken during or after meals. Do not crush or chew the tablets.

Do not exceed the indicated daily dose.

Use in children and adolescents

Aceclofenac is not recommended for use in children.

Use in elderly patients

If you are an elderly person, you are more likely to experience severe side effects (listed in section 4 "Possible adverse effects").

If your doctor prescribes aceclofenac for you, you will be given the most effective dose at the lowest possible dose for the shortest time.

Use in patients with renal or cardiac insufficiency

Your doctor will indicate the dose you should take. Precautions are recommended and regular checks should be performed.

Use in patients with liver insufficiency

The dose should be reduced to 1 100 mg tablet per day.

Long-term treatment

If you take aceclofenac for a prolonged period, your doctor should perform quarterly checks, such as kidney, liver, and blood analyses.

If you have osteoarthritis, do not take aceclofenac continuously. Only take aceclofenac when inflammation begins. You can use analgesics between these conditions. Your doctor will tell you which analgesics to take and how to take them.

If you take more Aceclofenaco Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The treatment, if necessary, consists of gastric lavage and repeated doses of activated charcoal and antacids as needed, or other symptomatic treatment.

Specific therapies, such as forced diuresis, dialysis, or hemoperfusion, do not allow the elimination of non-steroidal anti-inflammatory drugs due to the high percentage of binding to blood proteins and extensive metabolism.

The symptoms of an overdose may include nausea, vomiting, stomach pain, dizziness, drowsiness, and headache.

If you forgot to take Aceclofenaco Stada

If you forget a dose, do not worry, simply take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Aceclofenaco Stada

Do not stop taking aceclofenac unless your doctor tells you otherwise.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Aceclofenaco Stada contains sodium

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

Like all medicines, aceclofenac may cause side effects, although not everyone will experience them.

Stop taking the medicine and consult a doctorIMMEDIATELY, if you experience any of the following side effects:

Rare (may affect up to 1 in 1,000 people):

• Swelling of the face, tongue, or throat, difficulty swallowing, irritating rash, and bronchospasm (angioedema), visual disturbances, high blood pressure, worsening of existing high blood pressure, heart failure, difficulty breathing
• Severe stomach pain or any sign of bleeding in the stomach or intestines, blood in the gastrointestinal tract (blood in the stool or black stool color)

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

• Yellowing of the skin and eyes, sometimes with high fever or swelling and sensitivity in the upper abdomen (hepatitis and/or pancreatitis)
• Vomiting blood
• Peeling of the skin or mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis, which manifests as red blisters, eroded, bloody, or crusted skin, and epidermolysis bullosa, a disease with blisters and shedding of the upper layers of the skin)

STOP TAKINGthe medicine and seek medical attention if you experience:

• Indigestion or stomach acid.
• Abdominal pain (stomach pain) or other abnormal stomach symptoms.

The following side effects have also been reported:

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

• Dizziness
• Abdominal pain, nausea
• Diarrhea
• Increased liver enzymes in the blood

Occasional (may affect up to 1 in 100 people):

• Gas (flatulence)
• Inflammation or irritation of the stomach lining (gastritis)
• Constipation
• Vomiting
• Mouth ulcers
• Craving
• Rash
• Inflammation of the skin (dermatitis)
• Red, elevated, itchy, burning, or burning patches on the skin (urticaria)
• Increased urea levels in the blood
• Increased creatinine levels in the blood

Rare (may affect up to 1 in 1,000 people):

• Anemia (low red blood cell count in the blood)
• Hyperkalemia (high potassium levels in the blood)
• Hypersensitivity (allergic reaction)
• Severe allergic reaction, including anaphylactic shock

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

• Decreased platelet count in the blood (thrombocytopenia)
• Decreased hemoglobin concentration in the blood caused by the destruction of red blood cells (hemolytic anemia)
• Severe decrease in the number of granulocytes in the blood (granulocytopenia)
• Severe depression of the bone marrow that produces blood cells (bone marrow depression)
• Depression
• Strange dreams
• Inability to sleep
• Itching, pinching, or numbness of the skin
• Uncontrollable tremor (tremor)
• Drowsiness
• Headaches
• Abnormal taste in the mouth
• Sensation of spinning when standing
• Tinnitus (ringing in the ears)
• Palpitations or rapid heartbeat
• Redness
• Flushes
• Inflammation of the veins (vasculitis)
• Difficulty breathing
• Sharp sound while breathing
• Inflammation of the mouth
• Stomach ulcer
• Intestinal perforation
• Exacerbation of ulcerative colitis and Crohn's disease
• Spontaneous bleeding in the skin (appears as a rash), severe skin reactions
• Irritation of the skin (eczema)
• Renal insufficiency
• Water retention and swelling
• Fatigue
• Leg cramps
• Increased alkaline phosphatase levels in the blood
• Weight gain

Other side effects reported with this type of medication (NSAIDs) are:

• Hallucinations
• Confusion
• Blurred, partial, or complete loss of vision
• Painful eye movement
• Worsening of asthma
• Sunlight reaction of the skin
• Inflammation of the kidneys
• General malaise

Exceptionally, severe skin infections have been observed during chickenpox.

Medicines like aceclofenac may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects

If you experience any type of side effect, consult your doctor orpharmacist even if it is a side effect that does 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 side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack (after CAD). The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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 pointat 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 Stada

• The active ingredient is aceclofenac. Each tablet contains 100 mg of the active ingredient aceclofenac.
• The other components are: microcrystalline cellulose (E460i), sodium croscarmellose, copovidone, talc (E553b), anhydrous colloidal silica, diestearoyl glycerol.

The coating contains: HPMC 2910/hypromellose, microcrystalline cellulose, titanium dioxide (E171), poloxyl 40 (macrogol) stearate.

Appearance of the product and content of the packaging

Aceclofenaco Stada 100 mg is presented in film-coated tablets of white color, round, and biconvex.

They are available in aluminum/aluminum blisters in packaging containing 20, 30, 40, 60, 90, 100, or 180 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Holsten Pharma GmbH

Hanstrasse 31-35

Frankfurt am Main

60528 Hessen

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

BE: Aceclofenac EG 100 mg filmomhulde tabletten

ES: Aceclofenaco Stada 100 mg comprimidos recubiertos con película EFG

FR: ACECLOFENAC EG LABO 100 mg comprimés pelliculés

IT: ACECLOFENAC EG 100 mg compresse rivestite con film

LU: Aceclofenac EG 100 mg comprimés pelliculés

Last review date of this leaflet: February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/