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.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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

Elecoxel is used in adults for the treatment of symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
Celecoxib belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup of 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, thus reducing pain and inflammation.
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 help you use this medicine correctly and effectively. If you have any further questions, you should ask your 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 medicines(e.g. certain antibiotics used to treat infections);
• If you have active stomach or intestinal ulcers or bleeding;
• If you have taken aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs) and have experienced asthma, nasal polyps, severe nasal congestion

or allergic reactions such as hives, facial swelling, 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 inflammatory bowel disease, such as ulcerative colitis or Crohn's disease;
• If you have heart failure, ischemic heart disease, or cerebrovascular disease, such as myocardial infarction, 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 vessels;
• If you have had or have had circulatory problems(peripheral arterial disease) or 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 aspirin(even in small doses for heart protection);
• If you are taking blood-thinning medicines(e.g. warfarin or anticoagulant medicines, warfarin derivatives, or new-generation anticoagulant medicines such as apixaban);
• If you are taking corticosteroids(e.g. prednisone);
• If you plan to take Elecoxel with other NSAIDs that do not contain aspirin, such as ibuprofen or diclofenac. You should avoid taking these medicines at the same time;
• If you smoke, have diabetes, high blood pressure, or high cholesterol levels;
• If you have heart, liver, or kidney problems, your doctor may recommend regular check-ups;
• If you have fluid retention(such as swelling of the ankles and feet);
• If you are dehydrated, e.g. due to illness, diarrhea, or taking diuretic medicines (used to treat excess fluid in the body);
• If you have ever had a severe allergic reaction or severe skin reaction to any medicine;
• If you feel unwell due to an infection or suspect that you have an infection, as Elecoxel may mask fever or other signs of infection or inflammation;
• If you are over 65 years old, 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 your doctor may recommend regular blood pressure checks.
Severe liver damage, including severe hepatitis, liver failure (sometimes fatal or requiring liver transplantation), has been reported during treatment with celecoxib.
In cases where the time to onset was determined, most severe liver reactions occurred within one month of starting treatment.
Elecoxel may affect fertility in women.You should tell your doctor if you plan to become pregnant or if you are having trouble becoming pregnant (see section Pregnancy, breastfeeding, and fertility).

Elecoxel and other medicines

You should tell your doctor or pharmacist about all medicines you are 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)
• Warfarin or 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 medicines used to treat depression, sleep disorders, high blood pressure, or heart rhythm disorders
• Antipsychotics(used to treat mental disorders)
• Methotrexate(used to treat rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine(used to treat epilepsy, seizures, and certain types of pain or depression)
• Barbiturates(used to treat epilepsy, seizures, and certain sleep disorders)
• Cyclosporine, tacrolimus(medicines that suppress the immune system, e.g. after transplants)

Elecoxel can be taken with low doses of aspirin (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 ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Elecoxel should not be used in pregnant women who 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 contact your doctor to determine alternative treatment.
Breastfeeding
Elecoxel should not be used by women who are breastfeeding.
Fertility
NSAIDs, including Elecoxel, may affect fertility in women.If you plan to become pregnant or are having trouble 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, so it is essentially 'sodium-free'.

3. How to take Elecoxel

You should always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, you should ask your doctor or pharmacist.
If you think that the effect of Elecoxel is too strong or too weak, you should consult your doctor or pharmacist.
Your doctor will tell you what dose to take.Because the risk of side effects related to heart problems may increase with dose and duration of treatment, it is important to use the smallest effective dose of Elecoxel for the shortest duration necessary to control symptoms.
Method of administration
Elecoxel should be taken orally.Capsules can be taken at any time of day, with or without food.However, you should try to take your 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 spoonful of soft food (e.g. cold or room-temperature apple sauce, rice porridge, yogurt, or mashed banana) and swallowed immediately, followed by a glass of water (about 240 ml).
To open the capsule, hold it upright so that the contents in the form of granules are at the bottom.Then gently squeeze the cap and twist it to remove it, being careful not to spill the contents.Do not chew or crush the granules.
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 once daily or
• one 100 mg capsule twice daily.

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 is:

• one 100 mg capsule twice dailyElecoxel 200 mg
• It is not possible to achieve a dose of 200 mg (taken as one 100 mg capsule twice daily) 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 is:

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

Kidney or liver problems:you should make sure that your doctor knows about any kidney or liver problems you have, as you may need to have your dose reduced.
Elderly patients, especially those with a body weight below 50 kg:in patients over 65 years of age, especially those with a body weight below 50 kg, your doctor may recommend more frequent check-ups.
Do not exceed the dose of 400 mg per day.
Use in children and adolescents:Elecoxel is intended for use in adult patients only and should not be used in children.

Taking too much Elecoxel

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

Missing a dose of Elecoxel

If you miss a dose, you should take it as soon as possible.Do not take a double dose to make up for a missed dose.

Stopping treatment with Elecoxel

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

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 at a high dose and for a long time.

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

• allergic reaction such as skin rash, facial swelling, wheezing, or difficulty breathing
• heart problems such as chest pain
• severe stomach pain or 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, vomiting, jaundice (yellowing of the skin or eyes), dark urine, pale stools, bleeding, or itching)

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)

• Myocardial infarction*
• Fluid retention with swelling of the ankles, feet, and (or) hands
• Urinary tract infections
• Respiratory tract infections, sinusitis (sinus infection, sinus congestion, or sinus pain), stuffy nose or cold, sore throat, cough, bronchitis, 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 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)
• Restlessness, depression, fatigue, drowsiness, tingling sensation
• High potassium levels in the blood (can cause nausea, fatigue, weakness, or palpitations)
• Visual disturbances or blurred vision, 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
• 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)

• 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 (which can lead to stomach pain)
• Low sodium levels in the blood (hyponatremia)
• Decreased white blood cell count or platelet count (which can increase the risk of infection or bleeding and bruising)
• Coordination disorders
• Disorientation, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Bleeding in the eye
• Severe allergic reaction that can lead to pneumonia inflammation
• Irregular heartbeat
• Hot flashes
• Blood clots in the lungs.Symptoms may include sudden shortness of breath, stabbing pain when breathing, or coughing.
• Bleeding from the stomach or intestines (which can lead to bloody stools or vomiting), intestinal or colon inflammation
• Severe liver damage.Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, bleeding, or itching.
• Acute kidney failure
• Menstrual disorders
• Facial swelling, mouth, throat, or tongue 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 reaction with possible symptoms such as rash, facial swelling, fever, lymph node enlargement, and abnormal test results (e.g. liver, blood (eosinophilia, increased white blood cell count))
• Bleeding in the brain that can cause death
• Meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• Liver failure, liver damage, and severe hepatitis (sometimes fatal or requiring liver transplantation).Symptoms may include: nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, bleeding, or itching.
• 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 diseases (such as nephrotic syndrome, minimal change disease), which may be accompanied by symptoms such as fluid retention (swelling), foamy urine, fatigue, and loss of appetite.
• Worsening of epilepsy (increased number and/or severity of seizures)
• Closure of the retinal artery or vein leading to partial or complete loss of vision
• Vasculitis (inflammation of blood vessels, which can cause fever, pain, purple spots on the skin)
• Decreased red and white blood cell count and platelet count (which can cause fatigue, increased risk of bleeding and bruising, and increased risk of infection)
• 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 used 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 (may include stomach pain, diarrhea, indigestion, bloating with gas)
• Kidney stones (which can cause 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 ulcers)
• Fractures of the lower end of the radius (forearm bone)
• Shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (lung infection, which may cause cough, fever, difficulty breathing)
• Eye problems, blurred vision, or decreased vision, dizziness due to inner ear disorders, ear pain, or mouth ulcers
• Increased urination at night, bleeding from hemorrhoids (piles), frequent urination
• Fatty growths on the skin or in other locations, cysts, ganglion cysts (non-cancerous swellings of the joints and tendons of the hands or feet), speech difficulties, changes in menstrual bleeding, breast pain
• High sodium levels in the blood

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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: ndl@urpl.gov.pl.
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

You should keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing this 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.Other ingredients are lactose monohydrate, povidone (K-29/32), croscarmellose sodium, 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