ACECLOFENAC STADA 100 mg FILM-COATED TABLETS

2. What you need to know before you take Aceclofenac Stada

Do not take Aceclofenac Stada:

• if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen, naproxen or diclofenac.
• if you have taken acetylsalicylic acid or any other NSAID and have suffered any of the following symptoms:

• asthma attack
• nasal secretion, itching and/or sneezing (irritation of the nose)
• appearance of a rash of red, irregular, circular patches on the skin with possible itching, or with a 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 (the duodenum is the top part of the small intestine), bleeding or perforation of the digestive system.
• if you have severe kidney disease
• if you have severe liver failure
• if you are in the third trimester of pregnancy (from the start of 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 blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass
• if you have or have had problems with blood circulation (peripheral arterial disease)

Aceclofenac is not recommended for use in children.

Warnings and precautions

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

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

This risk is higher when high doses and prolonged treatments are used, 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.

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

Reactions of hypersensitivity may occur, including angioedema (swelling can occur mainly around the eyes and lips, without previous exposure to the medication). Severe skin reactions, including exfoliative dermatitis (skin irritation with scaling), Stevens-Johnson syndrome (lesions on the skin and mucous membranes) and toxic epidermal necrolysis. Very rarely, cases of necrolysis (severe skin disease in which the epidermis peels off in sheets) associated with the use of NSAIDs have been reported (see section 4. Possible side effects). The risk is higher during the first month of treatment. Stop treatment with aceclofenac immediately upon the first symptoms of skin rash, mucosal lesions or other signs of hypersensitivity.

Medications such as aceclofenac may be associated with a higher risk of heart attack ("myocardial infarction") or stroke. Additionally, 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 aceclofenac:

• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, high cholesterol or high triglycerides

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

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

Side effects can be minimized if the minimum effective dose is used for the shortest possible time. Do not exceed the recommended dose or treatment duration.

Children and Adolescents

There are currently no clinical data available on the use of aceclofenac in children, so its administration is not recommended.

Other medications and Aceclofenac Stada

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

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

Please inform your doctor if you are taking:

• Lithium (mood stabilizer medication used in the treatment of depression and bipolar disorder) and digoxin (medication used in heart failure). Several NSAIDs inhibit the elimination of lithium and digoxin, causing an increase in blood concentration. Therefore, the 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 kidney function is altered (for example, if you have lost a lot of fluids or are an elderly person), the co-administration of antihypertensives such as ACE inhibitors or angiotensin II antagonists and NSAIDs may increase the risk of acute kidney failure, usually reversible. In these cases, adequate hydration is important and kidney function monitoring should be considered after starting concomitant therapy and periodically thereafter.

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

• Diuretics (medications used to increase urine excretion rate). Aceclofenac, 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 periodically monitor potassium levels in the blood.

• Anticoagulants (medications that stop blood clotting) such as warfarin, heparin. Like other NSAIDs, aceclofenac may increase the activity of anticoagulants. Therefore, it is recommended that you remain under the supervision of your doctor when receiving simultaneous treatment with aceclofenac 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). The possible interaction between NSAIDs and methotrexate should also be considered when low doses of methotrexate are administered, especially in patients with reduced kidney function. NSAIDs and methotrexate should not be taken during the same 24-hour period, as the amount of methotrexate retained in the blood may increase, representing a risk of toxic effects.

• Mifepristone, which is used to induce abortions

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

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

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

• Zidovudine (medication used to treat HIV). When NSAIDs are administered with zidovudine, there may be a higher risk of hematological toxicity, hemarthrosis (bleeding into the joint) and hematoma (bruises).

• Antidiabetics (medications used to reduce blood sugar levels). Isolated cases of hypoglycemic (decrease in blood sugar level) and hyperglycemic (increase in blood sugar level) effects have been reported. Therefore, it is recommended to consider the possibility of adjusting the dose of antidiabetics when administered concomitantly with aceclofenac.

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

Taking Aceclofenac Stada with food and drinks

Aceclofenac should be taken preferably with or after meals.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take aceclofenac if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and that of your baby to bleed and make labor longer than expected.

Do not take aceclofenac during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, aceclofenac may cause kidney problems in your unborn baby, which may 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 more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

There is no information available on the secretion of aceclofenac in human breast milk. However, in rats, it was observed that only a very small amount of the medication passes into the rat's breast milk, so it is not recommended to use aceclofenac.

Fertility

NSAIDs may negatively affect female fertility and, therefore, the use of aceclofenac is not recommended in women who intend to become pregnant. The administration of aceclofenac should be suspended in women who have difficulty conceiving or who are undergoing fertility tests.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

If you are taking aceclofenac and suffer from dizziness, drowsiness, fatigue, visual disturbances, or any other nervous disorder, do not drive or use machinery.

If you have taken other anti-inflammatory medications (non-steroidal anti-inflammatory drugs) with the same effects, you should be especially careful when taking aceclofenac for the first time.

3. How to take Aceclofenac Stada

Follow the instructions for taking aceclofenac indicated by your doctor exactly. You will be prescribed the lowest effective dose for the shortest possible 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.

The 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 patient, you are more likely to suffer from serious side effects (listed in section 4 "Possible side effects").

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

Use in patients with kidney or heart failure

Your doctor will indicate the dose you should take. Caution is recommended and periodic checks should be performed.

Use in patients with liver failure

The dose should be reduced to 1 tablet of 100 mg 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 tests.

If you have osteoarthritis, you should not take aceclofenac continuously. You should only take aceclofenac when inflammation starts. You can use pain relievers between these episodes. Your doctor will tell you which pain relievers to take and how to take them.

If you take more Aceclofenac Stada than you should

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

Treatment, if necessary, consists of gastric lavage and administration of repeated doses of activated charcoal and antacids as necessary 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 their 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 forget to take Aceclofenac 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 make up for forgotten doses.

If you stop taking Aceclofenac Stada

Do not stop taking aceclofenac unless your doctor tells you to do so.

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

Aceclofenac Stada contains sodium

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

4. Possible Adverse Effects

Like all medicines, aceclofenaco can cause adverse effects, although not all people suffer from them.

Stop taking the medicine and consult a doctor IMMEDIATELY, if you experience any of the following adverse 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 already 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)
• bloody vomiting
• shedding of the skin or mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis, which manifests as red blisters and eroded, bleeding, or crusted skin, and bullous necrolysis, a disease with blisters and peeling 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
• increase in liver enzymes in blood

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

• wind (flatulence)
• inflammation or irritation of the stomach lining (gastritis)
• constipation
• vomiting
• mouth ulcers
• itching
• rash
• skin inflammation (dermatitis)
• red, circular, raised patches that itch, burn, or sting the skin (urticaria)
• increase in blood urea levels
• increase in blood creatinine levels

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

• anemia (low red blood cell levels 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):

• decrease in platelet count in blood (thrombocytopenia)
• decrease in hemoglobin concentration in blood caused by destruction of red blood cells (hemolytic anemia)
• severe decrease in the number of granulocytes in the blood (granulocytopenia)
• decrease in bone marrow function that produces blood cells (bone marrow depression)
• depression
• strange dreams
• inability to sleep
• tingling, pinching, or numbness of the skin
• uncontrollable trembling (tremor)
• drowsiness
• headaches
• abnormal taste in the mouth
• feeling of spinning when standing
• ringing in the ears (tinnitus)
• palpitations or rapid heartbeat
• flushing
• hot flashes
• inflammation of the veins (vasculitis)
• difficult breathing
• high-pitched noise when breathing
• inflammation of the mouth
• stomach ulcers
• intestinal perforation
• exacerbation of ulcerative colitis and Crohn's disease
• spontaneous bleeding on the skin (appearing as a rash), severe skin reactions
• skin irritation (eczema)
• kidney failure
• water retention and swelling
• fatigue
• leg cramps
• increase in blood alkaline phosphatase levels
• weight gain

Other side effects that have been reported with this type of medicine (NSAIDs) are:

• hallucinations
• confusion
• blurred, partial, or complete loss of vision
• painful eye movement
• worsening of asthma
• skin reaction to sunlight
• kidney inflammation
• general malaise

Exceptionally, severe skin infections have been observed during chickenpox.

Medicines like aceclofenaco may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aceclofenaco Stada

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Aceclofenaco Stada

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

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

Appearance of the Product and Package Contents

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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 under the following names:

BE: Aceclofenac EG 100 mg film-coated tablets

ES: Aceclofenaco Stada 100 mg film-coated tablets EFG

FR: ACECLOFENAC EG LABO 100 mg film-coated tablets

IT: ACECLOFENAC EG 100 mg film-coated tablets

LU: Aceclofenac EG 100 mg film-coated tablets

Date of the last revision of this leaflet: February 2023

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/