Elecoxel

Leaflet included in the packaging: patient information

Elecoxel, 100 mg, hard capsules

Elecoxel, 200 mg, hard capsules

Celecoxib
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific condition. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Elecoxel and what is it used for

Celecoxib belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup of cyclooxygenase-2 (COX-2) inhibitors. The human body produces prostaglandins, which can cause pain and inflammation. In diseases such as rheumatoid arthritis and osteoarthritis, the amount of prostaglandins produced increases. Celecoxib works by inhibiting the production of prostaglandins, thereby reducing pain and inflammation. Elecoxel is used in adults 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 felt after a few days.

2. Important information before taking Elecoxel

Elecoxel is prescribed by a doctor. The following information will facilitate the proper and effective use of this medicine. If you have any further questions, you should consult a doctor or pharmacist.

When not to take Elecoxel

You should inform your doctor if you have any of the following conditions that are contraindications to taking Elecoxel

• If you are allergic to celecoxib or any of the other ingredients of this medicine(listed in section 6);
• If you have ever had an allergic reaction to sulfonamide drugs(e.g. certain antibiotics used to treat infections);
• If you have active stomach or intestinal ulcers or bleeding;
• If you have taken acetylsalicylic acid or other non-steroidal anti-inflammatory and analgesic drugs (NSAIDs) and have experiencedasthma, nasal polyps, severe nasal congestionor allergic reactionssuch as hives, facial swelling, lip, tongue or throat swelling, or difficulty breathing or wheezing;
• If you are pregnant. Women who may become pregnant during treatment should discuss effective contraception with their doctor;
• If you are breastfeeding;
• If you have severe liver disease;
• If you have severe kidney disease;
• If you have intestinal inflammation, e.g. ulcerative colitis or Crohn's disease;
• If you have heart failure, ischemic heart diseaseor cerebrovascular disease, e.g. patients who have been diagnosed with heart attack, stroke or transient ischemic attack (temporary reduction of blood flow to the brain, so-called mini-stroke), angina pectoris or blockage of coronary arteries, or cerebral blood vessels;
• If you have or have had circulation disorders(peripheral artery disease), or if you have had surgery on the arteries of the legs.

Warnings and precautions

Before starting to take Elecoxel, you should discuss the following with your doctor or pharmacist:

• If you have ever had stomach ulcers or bleeding from the stomach or intestines(do not take Elecoxel if you have active stomach ulcers or bleeding);
• If you are taking acetylsalicylic acid(even in small doses for heart protection);
• when taking antiplatelet agents;
• (e.g. warfarin and anticoagulant medicines, warfarin derivatives or new-generation anticoagulant medicines, e.g. apixaban);
• (e.g. prednisone);
• , such as ibuprofen or diclofenac. You should avoid taking these medicines at the same time;
• ;
• , your doctor may recommend regular check-ups;
• (such as swelling of the ankles and feet);
• , e.g. due to illness, diarrhea or taking diuretic medicines (used to treat excess fluid in the body);
• or severe skin reaction to any medicine;
• or suspect that you have an infection, as Elecoxel may mask fever or other symptoms of infection or inflammation;
• , your doctor may recommend regular check-ups;
• consuming alcohol while taking NSAIDs may increase the risk of gastrointestinal disorders.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may increase blood pressure and therefore your doctor may recommend regular blood pressure checks. During treatment with celecoxib, cases of severe liver damagehave been reported, including severe liver inflammation, liver damage, liver failure(sometimes fatal or requiring liver transplantation). In cases where the time of onset was determined, most severe liver reactions occurred within one month of starting treatment.Elecoxel may cause difficulty in becoming pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Elecoxel and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take:

• Dextromethorphan(used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, diuretics(used to treat high blood pressure and heart failure)
• Fluconazole, rifampicin(used to treat fungal and bacterial infections)
• Warfarinor warfarin derivatives(blood-thinning medicines that inhibit blood clotting), including new-generation medicines such as apixaban
• Lithium(used to treat certain types of depression)
• Other medicinesused to treat depression, sleep disorders, high blood pressure or heart rhythm disorders
• Neuroleptics(used to treat mental disorders)
• Methotrexate(used to treat rheumatoid arthritis, psoriasis and leukemia)
• Carbamazepine(used to treat epilepsy and seizures, as well as certain types of pain or depression)
• Barbiturates(used to treat epilepsy and seizures, as well as certain sleep disorders)
• Cyclosporine, tacrolimus(medicines that suppress the immune system, e.g. after transplants)

Elecoxel may be taken with low doses of acetylsalicylic acid(75 mg per day or less). You should consult your doctor before taking these medicines together.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. Pregnancy Elecoxel should not be taken by women who are pregnant or may become pregnant (women of childbearing age who do not use adequate contraception). If you become pregnant while taking Elecoxel, you should stop taking the medicine and consult your doctor to determine alternative treatment. Breastfeeding Elecoxel should not be taken by women who are breastfeeding. Fertility NSAIDs, including Elecoxel, may cause difficulty in becoming pregnant. If you plan to become pregnant or have difficulty becoming pregnant, you should consult your doctor.

Driving and using machines

You should observe how you react to Elecoxel before driving or operating machinery. If you experience dizziness or drowsiness after taking Elecoxel, you should not drive or operate machinery until these symptoms have resolved.

Elecoxel contains lactose

Elecoxel contains lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Elecoxel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, and is therefore considered to be "sodium-free".

3. How to take Elecoxel

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. If you feel that the effect of Elecoxel is too strong or too weak, you should consult your doctor or pharmacist. Your doctor will inform you about the dose you should take. Since the risk of side effects related to heart problems may increase with the dose and duration of treatment, it is important to use the smallest effective dose of Elecoxel for the shortest possible time necessary to control symptoms. Method of administration Elecoxel should be taken orally. The capsules can be taken at any time of day, with or without food. However, you should try to take the dose of Elecoxel at the same time every day. If you have difficulty swallowing the capsule: The entire contents of the capsule should be carefully poured onto a spoon containing a semi-solid food (e.g. cold or room temperature apple sauce, rice porridge, yogurt or mashed banana) and swallowed immediately, followed by about 240 ml of water. To open the capsule, it should be held upright so that the contents in the form of granules are at the bottom. Then, the cap should be gently squeezed and twisted to remove it, taking care not to spill the contents. The granules should not be chewed or crushed.You should consult your doctor if, within two weeks of starting treatment, you do not feel any improvement. Recommended dose: In the case of osteoarthritis, the recommended dose is 200 mg per day and may be increased by your doctor if necessary to a maximum of 400 mg. The recommended dose is:

• one 200 mg capsule per day or
• one 100 mg capsule twice a day.

In the case of rheumatoid arthritis, the recommended dose is 200 mg per day and may be increased by your doctor if necessary to a maximum of 400 mg. Elecoxel 100 mg The recommended dose:

• one 100 mg capsule twice a day Elecoxel 200 mg
• It is not possible to achieve a dose of 200 mg (taken as one 100 mg capsule twice a day) using 200 mg capsules. Please consult your doctor.

In the case of ankylosing spondylitis, the recommended dose is 200 mg per day and may be increased by your doctor if necessary to a maximum of 400 mg. The recommended dose:

• one 200 mg capsule per day or
• one 100 mg capsule twice a day.

Kidney or liver disorders:you should ensure that your doctor is aware of any kidney or liver disorders you have, as you may need to have your dose reduced. Elderly patients, particularly those with a body weight below 50 kg:in the case of patients over 65 years old, and especially those with a body weight below 50 kg, your doctor may recommend more frequent check-ups. You should not exceed the dose of 400 mg per day. Use in children and adolescents:Elecoxel is intended for adult patients and should not be used in children.

Taking a higher dose of Elecoxel than recommended

You should not take more than the dose of Elecoxel recommended by your doctor. If you have taken too many capsules, you should consult your doctor or pharmacist or go to the hospital, taking the packaging of the medicine with you.

Missing a dose of Elecoxel

If you forget to take a capsule, you should take it as soon as possible. You should not take a double dose to make up for the missed dose.

Stopping treatment with Elecoxel

Suddenly stopping treatment with Elecoxel may lead to worsening of symptoms. You should not stop taking Elecoxel unless your doctor recommends it. Your doctor may recommend gradually reducing the dose over several days before completely stopping the medicine. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in patients with arthritis taking Elecoxel. The side effects marked with an asterisk (*) occurred more frequently in patients taking Elecoxel for the prevention of colon polyps. In this study, patients took Elecoxel in high doses and for a long time.

If you experience any of the following side effects, you should stop taking Elecoxel and immediately consult your doctor:

• allergic reaction such as skin rash, facial swelling, wheezing or difficulty breathing
• heart problems such as 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 such as rash, blistering or peeling of the skin
• liver failure (symptoms may include nausea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, bleeding or bruising, or fever)

Very common(may affect more than 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
• Upper respiratory tract infections (such as sinusitis, infection of the sinuses, or blockage or pain in the sinuses), stuffy nose or cold, sore throat, cough, influenza-like symptoms
• Dizziness, difficulty sleeping
• Vomiting, stomach pain, diarrhea, indigestion, bloating
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea
• Joint pain
• Worsening of existing allergies
• Accidental injuries

Uncommon(may affect up to 1 in 100 people)

• Stroke*
• Heart failure, palpitations (feeling of strong heartbeat), rapid heartbeat
• Abnormal liver function tests
• Abnormal kidney function tests
• 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 (which can cause nausea, fatigue, weakness, or palpitations)
• Visual or hearing disturbances, ringing in the ears, mouth ulcers, hearing disorders*
• Constipation, flatulence, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Hives (urticaria)
• Conjunctivitis
• Breathing difficulties
• Discoloration of the skin (bruising)
• Chest pain (general chest pain not related to the heart)
• Facial swelling

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

• Stomach or intestinal ulcers (bleeding) or perforation of the intestine(which can cause stomach pain, fever, nausea, vomiting, or constipation), dark or black stools, intestinal inflammation
• Low sodium levels in the blood (hyponatremia)
• Decreased white blood cell or platelet count(which can cause fatigue, increased risk of bruising and bleeding)
• Coordination disorders
• Disorientation, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Bleeding in the eye
• Acute reaction, which can lead to pneumonia
• Irregular heartbeat
• Hot flashes
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, stabbing pain when breathing, or coughing up blood
• Bleeding from the stomach or intestines(which can lead to bloody stools or vomiting blood), intestinal inflammation or colitis
• Severe liver inflammation. Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, bleeding, or fever
• Acute kidney failure
• Menstrual disorders
• Facial swelling, lip, tongue or throat swelling, or difficulty swallowing

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

• Severe allergic reactions(including anaphylactic shock, which can be fatal) Severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis(which can cause rash, blistering, or peeling of the skin) and acute generalized exanthematous pustulosis(symptoms include red, swollen areas of skin with numerous small blisters)
• Delayed allergic reactionwith possible symptoms such as rash, facial swelling, fever, increased lymph node size, and abnormal test results (e.g. liver, blood (eosinophilia, increased white blood cell count))
• Bleeding in the brain, which can be fatal
• Meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• Liver failure, liver damage, and severe liver inflammation(sometimes fatal or requiring liver transplantation). Symptoms may include: nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, bleeding, or fever
• Liver diseases (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellowing of the skin or eyes)
• Kidney inflammation and other kidney disorders (such as nephrotic syndrome, which may be accompanied by symptoms such as fluid retention, foamy urine, fatigue, and loss of appetite)
• Worsening of epilepsy (increased number and/or severity of seizures)
• Blockage of the artery or vein of the retina, leading to partial or complete loss of vision
• Vasculitis (inflammation of blood vessels, which can cause fever, pain, and purple spots on the skin)
• Decreased red and white blood cell and platelet count(which can cause fatigue, increased risk of bruising and bleeding)
• Muscle pain and weakness
• Taste disorders
• Loss of taste

Frequency not known, cannot be estimated from the available data

• Decreased fertility in women, which is usually reversible after stopping the medicine.

In clinical trials not related to arthritis or other joint diseases, in which Elecoxel 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)
• Kidney stones (which can lead to abdominal or back pain, blood in the urine)
• 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 ulceration)
• Fractures of the lower end of the bone
• Shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (lung infection, which may cause cough, fever, or difficulty breathing)
• Eye problems, blurred vision, dizziness caused by inner ear disorders, ear pain, mouth ulcers, or bleeding gums
• Nocturnal urination, hemorrhoid bleeding (bleeding from hemorrhoids), frequent urination
• Fatty tumors on the skin or in other locations, cysts, ganglion cysts (non-cancerous thickening of the joints (and/or) tendons of the hands or feet), difficulty speaking, changes in menstrual bleeding, breast pain
• High sodium levels in the blood

Reporting side effects

If you experience any side effects, including any side effects not mentioned in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported 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, e-mail: [email protected]. Side effects can also be reported to the representative of the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elecoxel

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Elecoxel contains

• The active substance is celecoxib. Each capsule contains 100 mg of celecoxib.
• The active substance is celecoxib. Each capsule contains 200 mg of celecoxib. The other ingredients are: lactose monohydrate, povidone (K-29/32), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (granule); gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (capsule).

The ingredients of the ink are: Elecoxel 100 mg: shellac, propylene glycol, and indigo carmine, aluminum lake (E132) Elecoxel 200 mg: shellac, propylene glycol, and yellow iron oxide (E172)

What Elecoxel looks like and contents of the pack

Opaque, white, hard gelatin capsule. The body of the capsule has a blue band with the inscription "C9OX-100" printed in white Opaque, white, hard gelatin capsule. The body of the capsule has a yellow band with the inscription "C9OX-200" printed in white The pack contains 30 hard capsules.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Manufacturer

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria Synthon BV, Microweg 22, 6545 CM, Nijmegen, Netherlands Synthon Hispania S.L., C/ Castelló, n 1, Polígono Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain Industria Química y Farmacèutica VIR, S.A., C/Laguna 66-68-70, Pol. Industrial Urtinsa II, Alcorcón, 28923 Madrid, Spain

To obtain more detailed information and information on the names of the medicinal product in other EEA countries, you should contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, Tel: 022/ 636 52 23; 636 53 02, [email protected], Date of last revision of the leaflet:24.07.2023