Aclexa

Package Leaflet: Information for the Patient

Aclexa, 100 mg, Hard Capsules

Aclexa, 200 mg, Hard Capsules

Celecoxib

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, or if any side effects get worse, tell your doctor or pharmacist.

Table of Contents of the Leaflet:

• 1. What is Aclexa and what is it used for
• 2. Important information before taking Aclexa
• 3. How to take Aclexa
• 4. Possible side effects
• 5. How to store Aclexa
• 6. Contents of the pack and other information

1. What is Aclexa and what is it used for

Aclexa is a medicine belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs), specifically the subgroup of cyclooxygenase-2 (COX-2) enzyme inhibitors. The body produces prostaglandins, which can contribute to pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces more of them. The action of Aclexa is to limit the production of prostaglandins, thereby reducing pain and inflammation. Aclexa is used to treat symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. The patient should feel the effect of the medicine within a few hours of taking the first dose, but the full effect may only be noticeable after a few days.

2. Important information before taking Aclexa

Aclexa has been prescribed by your doctor. The following information will help you get the best results from taking Aclexa. If you have any further questions, ask your doctor or pharmacist.

When not to take Aclexa:

Tell your doctor if you have any of the following conditions that are contraindications to taking Aclexa.

• if you are allergic to the active substance - celecoxib or any of the other ingredients of this medicine (listed in section 6);
• in patients with known hypersensitivity to sulfonamides (e.g., certain antibiotics used to treat infections);
• in patients with activepeptic ulcer or gastrointestinal bleeding;
• if, when taking acetylsalicylic acid or other anti-inflammatory and analgesic drugs (NSAIDs), you have experienced asthma, nasal polyps, significant nasal congestion, or an allergic reaction in the form of an itchy rash, facial swelling, lip swelling, tongue swelling, or throat swelling, difficulty breathing, or wheezing;
• in pregnant women. If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine;
• in breastfeeding women;
• in patients with severe liver disease;
• in patients with severe kidney disease;
• if you have inflammatory bowel disease, such as ulcerative colitis or Crohn's disease;
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, such as a diagnosed heart attack, stroke, or transient ischemic attack (temporary restriction of blood flow to the brain, also known as a mini-stroke), angina, or obstruction of blood vessels supplying blood to the heart or brain;
• in case of existing or previous circulation problems (peripheral arterial disease) or surgical procedures on the arteries of the lower limbs.

Warnings and precautions

Before taking Aclexa, consult your doctor or pharmacist:

• if you have a history of stomach ulcers or gastrointestinal bleeding. (Do not take Aclexaif you have activestomach ulcers or gastrointestinal bleeding);
• if you are taking acetylsalicylic acid (even in small doses for heart protection);
• if you are taking antiplatelet agents;
• if you are taking anticoagulant medications (e.g., warfarin/anticoagulant medications derived from warfarin or new-generation anticoagulants, e.g., apixaban);
• if you are taking corticosteroid medications (e.g., prednisone);
• when taking Aclexa at the same time as other NSAIDs not containing acetylsalicylic acid, such as ibuprofen or diclofenac. You should avoid taking these medications at the same time;
• if you smoke, have diabetes, high blood pressure, or high cholesterol levels;
• in case of abnormal heart, liver, or kidney function, treatment may be carried out under medical supervision;
• if you have fluid retention (e.g., swelling of the ankles and feet);
• in case of dehydration, e.g., due to illness, diarrhea, or the use of diuretic medications (used to treat excess fluid in the body);
• in case of a severe allergic reaction or severe skin reaction to any medications;
• in case of malaise due to infection or if you suspect an infection, as Aclexa may mask fever or other symptoms of infection and inflammation;
• in patients over 65 years of age, the doctor may recommend regular check-ups;
• if you consume alcohol or take NSAIDs, it may increase the risk of gastrointestinal disorders.

Like other NSAIDs (e.g., ibuprofen or diclofenac), this medicine may contribute to an increase in blood pressure, and your doctor may recommend regular blood pressure monitoring. There have been reports of severe liver-related adverse reactions, including severe liver inflammation, liver damage, liver failure (sometimes leading to death or the need for a liver transplant) associated with the use of celecoxib. In cases where the time to onset of the disease was considered, the most serious cases of liver-related adverse reactions occurred within a month of starting treatment. Aclexa may make it harder to get pregnant. If you are planning to get pregnant or are having trouble getting pregnant, you should tell your doctor (see section on Pregnancy, breastfeeding, and fertility).

Other medicines and Aclexa

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

• dextromethorphan (used as an ingredient in cough syrups);
• ACE inhibitors (angiotensin-converting enzyme inhibitors), angiotensin II receptor antagonists, beta-blockers, and diuretics (used to treat high blood pressure and heart failure);
• fluconazole and rifampicin (used to treat fungal and bacterial infections);
• warfarin or other warfarin derivatives (blood-thinning medications used to prevent blood clotting), including new-generation medications such as apixaban;
• lithium (used to treat depression);
• medications used to treat depression, insomnia, high blood pressure, or heart rhythm disorders;
• neuroleptics (used to treat psychotic conditions);
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and leukemia);
• carbamazepine (used to treat epilepsy/seizures and certain types of pain and depression);
• barbiturates (used to treat epilepsy/seizures and sleep disorders);
• cyclosporine and tacrolimus (used to weaken the immune system, e.g., after transplants)

Aclexa can be taken with low doses of acetylsalicylic acid (75 mg per day or less). Before taking both medications at the same time, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Aclexa should not be taken during pregnancy or when planning a pregnancy (e.g., in women of childbearing age who do not use adequate contraception) during treatment. If you become pregnant during treatment with Aclexa, stop treatment and consult your doctor for alternative treatment.

Breastfeeding

Aclexa should not be taken during breastfeeding.

Fertility

NSAIDs, including Aclexa, may make it harder to get pregnant. You should tell your doctor if you are planning to get pregnant or are having trouble getting pregnant.

Driving and using machines

Before driving vehicles or operating machinery, patients should know how they react to Aclexa. Patients who experience dizziness or drowsiness while taking Aclexa should not drive or operate machinery until these symptoms have stopped.

Aclexa contains lactose and sodium.

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Aclexa

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. If you feel that the effect of Aclexa is too strong or too weak, ask your doctor or pharmacist. Your doctor will recommend the appropriate dosing regimen. The dose and duration of treatment with Aclexa may increase the risk of heart-related side effects, so it is important to use the smallest effective dose of Aclexa for the shortest duration necessary to achieve control of symptoms. Administration: Swallow Aclexa whole with water.The capsules can be taken at any time of day, with or without food. However, try to take each dose of Aclexa at the same time every day. If the benefits of taking Aclexa are not noticeable within two weeks, consult your doctor.

Recommended dose: In the case of osteoarthritis, the recommended dose is usually 200 mg per day, and if necessary, your doctor may increase it to 400 mg. The usual dose is:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

In the case of rheumatoid arthritis, the recommended dose is usually 200 mg per day, and if necessary, your doctor may increase it to 400 mg. The usual dose is:

• one 100 mg capsule twice a day.

In the case of ankylosing spondylitis, the recommended dose is usually 200 mg per day, and if necessary, your doctor may increase it to 400 mg. The usual dose is:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

Kidney and liver diseases: Inform your doctor about liver or kidney diseases, as they may require a lower dose. Elderly patients, especially those weighing less than 50 kg: In patients over 65 years of age, especially those weighing less than 50 kg, your doctor may recommend close monitoring of treatment. Use in children: Aclexa is intended for adults only, so it should not be given to children. Maximum daily dose: Do not take more than 400 mg per day (4 capsules of 100 mg Aclexa or 2 capsules of 200 mg Aclexa).

Taking a higher dose of Aclexa than recommended

Do not take more capsules than your doctor has recommended. If you accidentally take too many capsules, contact your doctor or pharmacist or hospital immediately, taking the medicine packaging with you.

Missing a dose of Aclexa

If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for a missed dose.

Stopping treatment with Aclexa

Suddenly stopping treatment with Aclexa may lead to worsening of symptoms. Do not stop taking Aclexa unless your doctor tells you to. Your doctor may recommend gradually reducing the dose over a few days before completely stopping treatment. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aclexa can cause side effects, although not everybody gets them. If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Side effects listed below have been observed in patients with arthritis who took Aclexa. Side effects marked with an asterisk (*) are listed below with a higher frequency, which was observed in patients taking Aclexa to prevent the occurrence of colon polyps. Patients participating in these studies took Aclexa in high doses and for a long time.

Patients taking Aclexa for the prevention of colon polyps took the medicine in high doses and for a long time.

If you experience any of the following symptoms, stop taking Aclexa and contact your doctor immediately:

• allergic reaction, such as: rash, facial swelling, wheezing, or difficulty breathing,
• heart problems, such as chest pain,
• severe stomach pain or any signs of gastrointestinal bleeding, such as black or bloody stools, or vomiting blood,
• skin reactions, such as rash, blistering, or peeling of the skin,
• liver failure (symptoms may include nausea, diarrhea, yellowing of the skin or the whites of the eyes).

Very common: may affect up to 1 in 10 people

• high blood pressure, including worsening of existing high blood pressure*

Common: may affect up to 1 in 10 people

• heart attack*
• fluid retention with swelling of the ankles, feet, and (or) hands
• urinary tract infections
• shortness of breath*, sinusitis (sinus infection, sinusitis, feeling of blocked or painful sinuses), runny nose or stuffy nose, sore throat, cough, common cold, flu-like symptoms
• dizziness, difficulty sleeping
• vomiting*, stomach pain, diarrhea, indigestion, bloating with gas
• rash, itching
• muscle stiffness
• difficulty swallowing*
• headache
• nausea
• joint pain
• worsening of existing allergic symptoms
• accidental injuries

Uncommon: may affect up to 1 in 100 people

• stroke*
• heart failure, palpitations (feeling of heartbeat), tachycardia;
• abnormal liver function test results;
• abnormal kidney function test results;
• anemia (changes in red blood cell count, which can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensation
• high potassium levels in the blood {(may cause nausea, fatigue, weakness, or irregular heartbeat)}
• vision disturbances or blurred vision, ringing in the ears, mouth pain or inflammation, hearing disturbances*
• constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• leg cramps
• hives (raised, itchy rash)
• hives (raised, itchy rash)
• conjunctivitis
• breathing difficulties
• skin discoloration (bruising)
• chest pain (general chest pain not related to the heart)
• facial swelling

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

• ulceration (bleeding) of the stomach, esophagus, or duodenum; or perforation of the intestine (which can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), black or tarry stools, pancreatitis (which can cause stomach pain), esophagitis
• low sodium levels in the blood (a condition called hyponatremia)
• decrease in white blood cell count or platelet count (which can cause weakness, easy bruising, frequent nosebleeds, increased risk of infection)
• coordination disturbances
• disorientation, taste disturbances
• photosensitivity
• hair loss
• hallucinations
• bleeding into the eye
• severe reaction that can lead to pneumonia
• irregular heartbeat
• hot flashes

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

• severe allergic reactions (including anaphylactic shock, which can be fatal)
• severe skin conditions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (which can cause rash, blisters, or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include red, swollen areas of skin with numerous small blisters)
• delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormal test results (e.g., liver, blood {eosinophilia, increased white blood cell count})
• intracranial hemorrhage leading to death
• meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• hepatitis, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes leading to death or the need for a liver transplant). Symptoms may include nausea, diarrhea, yellowing of the skin and whites of the eyes, dark urine, pale stools, bleeding, itching, or chills
• liver disease (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as black stools, nausea, and yellowing of the skin or whites of the eyes)
• kidney disease (such as nephrotic syndrome and nephrotic lipidosis, which may be accompanied by symptoms such as fluid retention, frothy urine, fatigue, and loss of appetite)
• worsening of epilepsy (which may cause more frequent and/or severe seizures);
• closure of the retinal vein or artery, leading to partial or complete loss of vision
• vasculitis (which can cause fever, pain, purple spots on the skin)
• decrease in red and white blood cell and platelet count (which can cause weakness, easy bruising, frequent nosebleeds, increased risk of infection)
• muscle pain and weakness
• smell disturbances
• taste disturbances

Frequency not known: frequency cannot be estimated from the available data

• reduced fertility in women, which is usually reversible after treatment is stopped

In clinical trials unrelated to arthritis or other joint diseases, where Aclexa was taken at a dose of 400 mg per day for up to 3 years, the following additional side effects were observed:

Common: may affect up to 1 in 10 people

• heart problems: angina pectoris (chest pain)
• stomach problems: irritable bowel syndrome (which may include stomach pain, diarrhea, indigestion, bloating with gas)
• kidney stones (which can cause stomach or back pain, blood in the urine), difficulty urinating
• weight gain

Uncommon: may affect up to 1 in 100 people

• deep vein thrombosis (blood clots that occur most commonly in the legs, which can cause pain, swelling, or redness of the calf, or breathing problems)
• stomach problems: stomach inflammation (which can cause stomach upset and ulcers)
• lower limb fracture
• shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (chest infection, possible: cough, fever, difficulty breathing)
• eye clouding, causing blurred vision or vision loss, dizziness caused by middle ear disorders, mouth pain or inflammation, gum bleeding or inflammation
• nocturnal urination, hemorrhoid bleeding (bleeding piles), frequent bowel movements
• fat deposits in the skin or other locations, ganglion cysts (harmless thickening on the (or) in the joints and tendons of the hands or feet), speech difficulties, changed or very heavy menstrual bleeding, breast pain
• high sodium levels in the blood

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aclexa

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after (EXP). The expiry date refers to the last day of the month stated. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aclexa contains

• The active substance of Aclexa is celecoxib. Each 100 mg hard capsule contains 100 mg of celecoxib. Each 200 mg hard capsule contains 200 mg of celecoxib.
• The other ingredients in the 100 mg capsules are lactose monohydrate, povidone K30, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate in the capsule core, and gelatin, titanium dioxide (E 171) in the capsule shell.
• The other ingredients in the 200 mg capsules are lactose monohydrate, povidone K30, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate in the capsule core, and gelatin, titanium dioxide (E 171), and yellow iron oxide (E 172) in the capsule shell.

What Aclexa looks like and contents of the pack

Each 100 mg capsule is 15.4 mm - 16.2 mm in length and consists of a white body and cap; the capsules contain a white or almost white granule. Each 200 mg capsule is 18.9 mm - 19.7 mm in length and consists of a brown-yellow body and cap; the capsules contain a white or almost white granule. The 100 mg and 200 mg capsules are available in packs of 10, 20, 30, 40, 50, 60, 90, and 100 capsules in a blister pack in a cardboard box. Not all pack sizes may be available in your country.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Date of last revision of the leaflet: 01.07.2024