Aclexa

Package leaflet: Information for the patient

Aclexa, 100 mg, hard capsules
Aclexa, 200 mg, hard capsules
Celecoxib
Read the entire leaflet carefully before using this medicine, as it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• This medicine may harm others, even if their symptoms are the same.
• If any of the side effects worsens, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist.

Table of contents of the leaflet:

1. What is Aclexa and what is it used for
2. What you need to know 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 non-steroidal anti-inflammatory drugs (NSAIDs), specifically within the subgroup of cyclooxygenase-2 (COX-2) enzyme inhibitors. The body produces prostaglandins, which may contribute to pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, the body produces increased levels of prostaglandins. Aclexa works by reducing the production of prostaglandins, thereby decreasing 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 after the first dose, but the full effect may not be noticeable until after several days.

2. Important information before using Aclexa

Aclexa has been prescribed by your doctor. The following information will help you achieve the best results from using Aclexa. If you have any further questions, please consult your doctor or pharmacist.

When not to use Aclexa: Please inform your doctor if the patient has any of the following conditions, which are contraindications for the use of Aclexa.

• If the patient is allergic to the active substance – celecoxib, or to 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 active gastric or duodenal ulcer, or gastrointestinal bleeding;
• If asthma, nasal polyps, significant nasal mucosal congestion, or an allergic reaction such as itchy rash, facial swelling, swelling of the lips, tongue or throat, difficulty breathing, or wheezing occurred after taking acetylsalicylic acid or other non-steroidal anti-inflammatory and pain-relieving drugs (NSAIDs);
• In pregnant women. If the patient may become pregnant during treatment, discuss contraceptive methods with the doctor;
• In breastfeeding women;
• In patients with severe liver disease;
• In patients with severe kidney disease;
• If the patient has inflammatory bowel disease, such as ulcerative colitis or Crohn's disease;
• If the patient has heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g. myocardial infarction, stroke, or transient ischemic attack (temporary reduction in blood supply to the brain, also known as a mini-stroke), angina, or obstruction of blood vessels supplying the heart or brain;
• In case of current or previous circulatory problems (peripheral arterial disease) or prior surgical procedures on the lower limb arteries.

Warnings and precautions Before taking Aclexa, consult your doctor or pharmacist:

• If the patient has had in the past gastric or duodenal ulcer or gastrointestinal bleeding. (Do not take Aclexa in case of active gastric or duodenal ulcer or gastrointestinal bleeding);
• If the patient is taking acetylsalicylic acid (even in low doses for heart protection);
• If the patient is taking antiplatelet drugs;
• If the patient is taking anticoagulant drugs (e.g. warfarin, warfarin derivatives, or newer generation anticoagulants such as apixaban);
• If the patient is taking corticosteroids (e.g. prednisone);
• When taking Aclexa together with other NSAIDs not containing acetylsalicylic acid, such as ibuprofen or diclofenac. Concomitant use of these drugs should be avoided;
• If the patient smokes, has diabetes, high blood pressure, or elevated cholesterol levels;
• If there is impaired function of the heart, liver, or kidneys, treatment should be under medical supervision;
• If fluid retention occurs (e.g. swelling of ankles and legs);
• In case of dehydration, for example due to illness, diarrhea, or use of diuretics (used in the treatment of excess body fluids);
• In case of severe allergic reaction or severe skin reaction to any medication;
• If the patient feels unwell due to infection or suspects an infection, because Aclexa may mask fever or other signs of infection and inflammation;
• For patients over 65 years of age, the doctor may recommend regular check-ups;
• If the patient consumes alcohol or uses NSAIDs, this may increase the risk of gastrointestinal disorders.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may contribute to increased blood pressure, therefore the doctor may recommend regular blood pressure monitoring. Severe adverse reactions affecting the liver, including severe hepatitis, liver damage, and liver failure (sometimes leading to death or the need for liver transplantation) have been reported with celecoxib use. In cases where the time to onset of disease was considered, the most serious liver-related adverse reactions occurred within one month of starting therapy. Aclexa may impair fertility. If the patient plans pregnancy or has difficulty conceiving, she should inform her doctor (see section: Pregnancy, breastfeeding and effects on fertility).

Other medicines and Aclexa Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

• 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 drugs used to prevent blood clotting), including newer generation anticoagulants such as apixaban;
• Lithium (used to treat depression);
• Medicines used to treat depression, sleep disorders, high blood pressure, or cardiac arrhythmias;
• 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 suppress the immune system, e.g. after organ transplants).

Aclexa may be taken with low-dose acetylsalicylic acid (75 mg per day or less). Before taking both medicines together, consult your doctor.

Pregnancy, breastfeeding and effects on fertility If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy Aclexa must not be used in pregnant women or in women planning pregnancy (e.g. women of childbearing age who are not using appropriate contraception) during treatment. If pregnancy occurs while taking Aclexa, treatment should be discontinued and the patient should contact her doctor to discuss alternative treatment.

Breastfeeding Aclexa must not be used during breastfeeding.

Fertility NSAIDs, including Aclexa, may impair fertility. The patient should inform her doctor if she plans to become pregnant or has difficulty conceiving.

Driving and operating machinery Patients should be aware of how they react to Aclexa before driving or operating machinery. Patients who experience dizziness or drowsiness while taking Aclexa should not drive or operate machinery until these symptoms resolve.

Aclexa contains lactose and sodium. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Aclexa

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist. If you feel that the effect of Aclexa is too strong or too weak,
consult a physician or pharmacist.
Your doctor will recommend an appropriate dosing regimen. The dose and duration of treatment may increase
the risk of adverse effects on the heart; therefore, it is important to use the lowest effective dose
of Aclexa for no longer than necessary to control symptoms.

Method of administration
Aclexa capsules should be swallowed whole with water. The capsules may be taken at any time
of day, with or without food. However, it is advisable to take each dose at approximately the same time
every day.
If no benefit is observed within two weeks, medical advice should be sought.

Recommended dose:
In osteoarthritis, the usual recommended dose is 200 mg daily; if necessary, the doctor may increase
the dose to 400 mg.
The commonly used dose is:

• one 200 mg capsule once daily; or
• one 100 mg capsule twice daily.

In rheumatoid arthritis, the usual recommended dose is 200 mg daily; if needed, the doctor may increase
the dose to 400 mg.
The commonly used dose is:

• one 100 mg capsule twice daily.

In ankylosing spondylitis, the usual recommended dose is 200 mg daily; if needed, the doctor may increase
the dose to 400 mg.
The commonly used dose is:

• one 200 mg capsule once daily; or
• one 100 mg capsule twice daily.

Kidney and liver disorders: Inform your doctor if you have liver or kidney disease, as these
conditions may require a lower dose.
Elderly patients, especially those weighing less than 50 kg: In patients over 65 years of age, particularly those weighing less than 50 kg, the doctor may recommend close monitoring of treatment.
Use in children: Aclexa is intended for adults only and must not be used in children.

Maximum daily dose:
Do not exceed 400 mg per day (4 capsules of 100 mg Aclexa or 2 capsules of 200 mg Aclexa).

Taking more Aclexa than recommended
Do not take more capsules than prescribed by your doctor. If you accidentally take too many capsules,
seek immediate medical advice from a doctor, pharmacist, or hospital, and bring the medicine packaging with you.

Missed dose of Aclexa
If a patient forgets to take a capsule, they should take it as soon as they remember.
Do not take a double dose to make up for a missed dose.

Stopping Aclexa
Suddenly stopping Aclexa may lead to worsening of disease symptoms.
Do not stop taking Aclexa unless advised by your doctor. Your doctor may recommend gradually reducing the dose over several days before completely stopping the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the side effects worsen, or if you experience any side effects not listed in this leaflet,
you should inform your doctor or pharmacist.
The side effects listed below were observed in patients with arthritis
who took the medicine Aclexa. Side effects marked with an asterisk (*) are listed
below with a higher frequency observed in patients taking Aclexa to
prevent the occurrence of colorectal polyps. Patients participating in these studies
took Aclexa at high doses and for prolonged periods.
If any of the symptoms listed below occur, stop taking Aclexa immediately
and contact your doctor without delay:

• allergic reaction such as: rash, facial swelling, wheezing or difficulty breathing,
• heart problems, e.g. chest pain,
• severe stomach pain or any signs of bleeding from the stomach or intestines, such as black or blood-stained stools, or vomiting blood,
• skin reactions, e.g. rash, blistering or peeling of the skin,
• liver failure {symptoms may include: nausea (feeling sick), diarrhoea, jaundice (yellowing of the skin or whites of the eyes)}.

Very common: may affect more than 1 in 10 people

• hypertension, including worsening of pre-existing high blood pressure*

Common: may affect up to 1 in 10 people

• heart attack*
• fluid retention with oedema of ankles, legs and (or) hands
• urinary tract infections
• dyspnoea*, sinusitis (inflammation of the sinuses, sinus infection, feeling of blocked or painful sinuses), stuffy nose or runny nose, sore throat, cough, common cold, influenza-like symptoms
• dizziness, difficulty sleeping
• vomiting*, abdominal pain, diarrhoea, indigestion, bloating with flatulence
• 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 (awareness of heartbeat), tachycardia
• abnormal blood test results indicating liver function abnormalities
• abnormal blood test results indicating kidney function abnormalities
• anaemia (changes in red blood cell count, which may cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensation
• elevated potassium levels in the blood {(may cause nausea (feeling sick), fatigue, muscle weakness or palpitations)}
• blurred or impaired vision, tinnitus, mouth pain and inflammation, hearing disturbances*
• constipation, belching, gastritis (indigestion, stomach pain or vomiting), worsening of gastritis or enteritis
• leg cramps
• raised itchy rash (urticaria)
• raised itchy rash (urticaria)
• conjunctivitis
• difficulty breathing
• skin discolouration (bruising)
• chest pain (general pain not related to the heart)
• facial swelling

Rare (may affect fewer than 1 in 10,000 people)

• ulceration (bleeding) of the stomach, oesophagus, or duodenum; or intestinal perforation (which may cause stomach pain, fever, nausea, vomiting, gastrointestinal obstruction), tarry or black stools, pancreatitis (which may cause stomach pain), oesophagitis
• hyponatraemia (a condition known as low sodium levels in the blood)
• decreased white blood cell count (which helps protect the body against infections) or thrombocytopenia (increased risk of bleeding or bruising)
• movement coordination disorders
• disorientation, taste disturbances
• photophobia (sensitivity to light)
• hair loss
• hallucinations
• intraocular haemorrhage
• severe reaction which may lead to lung inflammation
• irregular heartbeat
• hot flushes
• blood clots in the blood vessels of the lungs. Symptoms may include sudden breathlessness, sharp pain when breathing or collapse
• bleeding from the stomach or intestines (which may lead to bloody stools or vomiting), inflammation of the intestine or colon
• severe hepatitis. Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellowing of the skin and whites of the eyes), dark urine, pale stools, bleeding, itching or chills
• severe kidney failure
• menstrual disorders
• swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

Very rare (may affect fewer than 1 in 10,000 people)

• severe allergic reactions (including anaphylactic shock, which may be fatal)
• severe skin disorders such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (which may cause rash, blistering or peeling of the skin), and acute generalised exanthematous pustulosis (symptoms include red, swollen areas of skin with numerous small pustules)
• delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, enlarged lymph nodes and abnormal test results (e.g. liver, blood {eosinophilia, increased white blood cell count})
• fatal intracranial haemorrhage
• meningitis (inflammation of the membranes covering the brain and spinal cord)
• hepatitis, liver damage and severe hepatitis (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include: nausea, diarrhoea, jaundice (yellowing of the skin and whites of the eyes), dark urine, pale stools, bleeding, itching or chills
• liver disorders (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as tarry stools, nausea and yellowing of the skin or whites of the eyes)
• nephritis and other kidney disorders (such as nephrotic syndrome and lipid nephrosis, which may be accompanied by symptoms such as fluid retention (oedema), frothy urine, fatigue and loss of appetite)
• worsening of epilepsy (possibly more frequent and/or severe epileptic seizures)
• occlusion of retinal artery or vein, leading to partial or complete loss of vision
• vasculitis (inflammation of blood vessels) (may cause fever, pain, purple skin spots)
• decreased red and white blood cells and platelets (may cause weakness, easy bruising, frequent nosebleeds, increased risk of infection)
• muscle pain and weakness
• smell disturbances
• loss of taste

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

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

In clinical trials not related to arthritis or other joint diseases,
where Aclexa was administered at a dose of 400 mg per day for up to 3 years, the following additional adverse reactions were observed:
Common: may affect up to 1 in 10 people

• heart-related problems: angina (chest pain)
• stomach-related problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion, bloating with flatulence)
• kidney stones (may lead to abdominal or back pain, blood in urine), difficulty passing urine through the urinary tract
• weight gain

Uncommon: may affect up to 1 in 100 people

• deep vein thrombosis (blood clots most commonly in the legs, which may cause pain, swelling or redness in the calf, or breathing problems)
• stomach-related problems: inflammation within the stomach (which may cause irritation and ulceration of the stomach and intestines)
• lower limb fracture
• shingles, dermatitis, eczema (dry, itchy rash), pneumonia (infection in the chest cavity, possible symptoms: cough, fever, difficulty breathing)
• eye opacities causing blurred or reduced vision, dizziness caused by middle ear disturbances, pain, inflammation or bleeding of gums, oral ulceration
• excessive urination at night, haemorrhoidal bleeding (haemorrhoids), frequent bowel movements
• lipomas in the skin or other locations, ganglion cysts of tendon sheaths (harmless swellings on or near joints and tendons of the hand or foot), speech difficulties, altered or very heavy bleeding from the genital tract, breast pain
• high sodium levels in the blood

Reporting of side effects
If you experience any side effects, including any possible side effects not listed
in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Aclexa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
(EXP). The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must 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 packaging and other information

What Aclexa contains

• The active substance is celecoxib. Each hard capsule, 100 mg, contains 100 mg of celecoxib. Each hard capsule, 200 mg, contains 200 mg of celecoxib.
• The other ingredients in the 100 mg capsules are lactose monohydrate, povidone K30, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate in the capsule core; gelatin and 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, and magnesium stearate in the capsule core; 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, 15.4 mm – 16.2 mm in length, consists of a white body and cap;
the capsules contain white or almost white granules.
Each 200 mg capsule, 18.9 mm – 19.7 mm in length, consists of a brown-yellow body and cap;
the capsules contain white or almost white granules.
The 100 mg and 200 mg capsules are available in packs of 10, 20, 30, 40, 50, 60, 90 and 100 capsules in blister packs within a cardboard box.
Not all pack sizes may be available on the market.

Marketing Authorisation 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

For more detailed information on the product names available in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500