Elecoxel

Package leaflet: Information for the patient

Elecoxel, 100 mg, hard capsules
Elecoxel, 200 mg, hard capsules
Celecoxibum
Please read carefully the entire leaflet before using the medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Elecoxel is and what it is used for

Celecoxib belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and more 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 production of prostaglandins increases.
Celecoxib works by inhibiting the production of prostaglandins, thereby reducing pain and inflammation.
Elecoxel is used in adults for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
You should feel the effect of the medicine within a few hours after the first dose, but full effect may not be noticeable until after several days.

2. Information before using Elecoxel

Elecoxel is a prescription medicine. The following information will help ensure its proper and effective use. If you have any further questions, please consult your doctor or pharmacist.

When not to use Elecoxel

You must inform your doctor if the patient has any of the following conditions, which are contraindications for the use of Elecoxel:

• if the patient is allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had an allergic reaction to sulfonamides (e.g. certain antibiotics used to treat infections);
• if the patient has active peptic ulcer disease or gastrointestinal bleeding;
• if the patient has previously experienced asthma, nasal polyps, severe inflammation of the nasal mucosa, or allergic reactions such as itchy skin rash, facial swelling, swelling of lips, tongue or throat, breathing difficulties or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient is pregnant. Women who may become pregnant during treatment should discuss effective contraceptive methods with their doctor;
• if the patient is breastfeeding;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• if the patient has inflammatory bowel disease, such as ulcerative colitis or Crohn's disease;
• if the patient has heart failure, ischemic heart disease, or cerebrovascular disease, e.g. patients who have had a heart attack, stroke, transient ischemic attack (temporary reduction in blood flow to the brain, so-called mini-stroke), angina pectoris, or blockage of blood vessels in the heart or brain;
• if the patient has current or past circulatory disorders (peripheral vascular disease), or has had surgery on the arteries of the legs.

Warnings and precautions

Before starting Elecoxel, discuss the following with your doctor or pharmacist:

• if the patient has previously had peptic ulcer disease or gastrointestinal bleeding. (Do not use Elecoxel in patients with active peptic ulcer or gastrointestinal bleeding);
• if the patient is taking acetylsalicylic acid (even in low doses for cardiovascular protection);
• when taking antiplatelet drugs;
• if the patient is taking anticoagulant drugs (e.g. warfarin and anticoagulants, warfarin derivatives, or new-generation anticoagulants such as apixaban);
• if the patient is taking corticosteroids (e.g. prednisone);
• if the patient intends to use Elecoxel 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 the patient has heart, liver, or kidney dysfunction – the doctor may recommend regular monitoring tests;
• if the patient has fluid retention (e.g. swelling of ankles and feet);
• if the patient is dehydrated, e.g. due to illness, diarrhea, or use of diuretics (medicines used to treat fluid overload);
• if the patient has ever experienced a severe allergic reaction or severe skin reaction to any medicine;
• if the patient feels unwell due to infection or suspects an infection, as Elecoxel may mask fever or other signs of infection or inflammation;
• if the patient is over 65 years of age – the doctor may recommend regular check-ups;
• alcohol consumption during NSAID use may increase the risk of gastrointestinal disorders.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may lead to increased blood pressure, and therefore your doctor may recommend regular blood pressure monitoring.

During treatment with celecoxib, cases of severe liver disorders, including severe hepatitis, liver damage, and liver failure (sometimes fatal or requiring liver transplantation) have been reported. In cases where the onset time was determined, most severe liver reactions occurred within one month of starting treatment.

Elecoxel may cause difficulty in becoming pregnant. Inform your doctor if the patient plans to become pregnant or has difficulty conceiving (see section Pregnancy and breastfeeding).

Elecoxel and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans 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 and rifampicin (used to treat fungal and bacterial infections)
• Warfarin or warfarin derivatives (anticoagulant drugs that inhibit blood clotting), including new-generation anticoagulants such as apixaban
• Lithium (used to treat certain types of depression)
• Other medicines used to treat depression, sleep disorders, high blood pressure, or cardiac arrhythmias
• Neuroleptics (used to treat psychiatric disorders)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy and seizures, and certain types of pain or depression)
• Barbiturates (used to treat epilepsy, seizures, and certain sleep disorders)
• Cyclosporine and tacrolimus (immunosuppressive drugs, e.g. after organ transplantation)

Elecoxel may be used together with low-dose acetylsalicylic acid (75 mg daily or less). Consult your doctor before combining these medicines.

Pregnancy, breastfeeding, and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Elecoxel must not be used in women who are pregnant or who may become pregnant (women of childbearing potential who are not using adequate contraception). If a patient becomes pregnant while taking Elecoxel, the medicine should be discontinued and the patient should contact her doctor to discuss alternative treatment.

Breastfeeding

Elecoxel must not be used by women who are breastfeeding.

Fertility

NSAIDs, including Elecoxel, may cause difficulties in becoming pregnant. If the patient plans pregnancy or has difficulty conceiving, she should consult her doctor.

Driving and operating machinery

Observe how the patient reacts to Elecoxel before driving or operating machinery. If the patient experiences dizziness or drowsiness after taking Elecoxel, driving and operating machinery should be avoided until these symptoms subside.

Elecoxel contains lactose

Elecoxel contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Elecoxel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it can be considered "sodium-free".

3. How to use Elecoxel

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt,
the patient should consult the doctor or pharmacist. If the patient feels that the effect of Elecoxel is too strong or too weak,
a doctor or pharmacist should be consulted.

The doctor will inform the patient what dose should be taken. Since the risk of cardiovascular adverse reactions
may increase with dose and duration of treatment, it is important to use the lowest effective dose of Elecoxel
for the shortest duration possible necessary to control symptoms.

Administration method
Elecoxel should be taken orally. The capsules may be taken at any time of day, with or without food.
However, the patient should try to take the dose of Elecoxel at the same time each day.

If the patient has difficulty swallowing the capsule: Carefully empty the entire contents of the capsule onto a spoon
containing a semi-solid food (e.g. cold or room temperature applesauce, rice porridge, yogurt, or mashed banana)
and swallow immediately, drinking about 240 ml of water.

To open the capsule, hold it upright so that the granules are at the bottom. Then gently press and twist the cap
to remove it, being careful not to spill the contents. Do not chew or crush the granules.

The patient should contact the doctor if no benefit is felt within two weeks of starting treatment.

Recommended dose:

In the case of osteoarthritis, the recommended dose is 200 mg once daily and may be increased by the doctor,
if necessary, up to a maximum of 400 mg.

Recommended dose:

• 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 once daily and may be increased by the doctor,
if necessary, up to a maximum of 400 mg.

Elecoxel 100 mg
Recommended dose:

• one 100 mg capsule twice daily.

Elecoxel 200 mg
A dose of 200 mg (taken as one 100 mg capsule twice daily) cannot be achieved using 200 mg capsules.
Please consult the doctor.

In the case of ankylosing spondylitis, the recommended dose is 200 mg once daily and may be increased by the doctor,
if necessary, up to a maximum of 400 mg.

Recommended dose:

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

Kidney or liver disorders: The patient should ensure that the doctor is aware of any existing kidney or liver disorders,
as dose adjustment may be required.

Elderly patients, particularly those weighing less than 50 kg: In patients over 65 years of age, and especially those weighing less than 50 kg,
the doctor may recommend more frequent monitoring.

Do not exceed 400 mg per day.

Use in children and adolescents: Elecoxel is intended for adult patients and should not be used in children.

Taking more Elecoxel than recommended
Do not take more than the dose recommended by the doctor. If too many capsules are taken, contact a doctor or pharmacist
or go to the hospital, taking the medicine packaging with you.

Missing a dose of Elecoxel
If the patient forgets to take a capsule, it should be taken as soon as possible. Do not take a double dose to make up for a missed dose.

Stopping Elecoxel
Suddenly stopping treatment with Elecoxel may lead to worsening of symptoms. Do not stop taking Elecoxel unless instructed by the doctor.
The doctor may recommend gradually reducing the dose over several days before completely discontinuing the medicine.

If there are any further doubts regarding the use of this medicine, the patient should consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below have been observed in patients with arthritis who were treated with Elecoxel. Adverse reactions marked with an asterisk (*) occurred more frequently in patients taking Elecoxel for prevention of colorectal polyps. In this study, patients received Elecoxel at a high dose and for a prolonged duration.
If any of the following adverse reactions occur, treatment with Elecoxel should be discontinued and a doctor should be contacted immediately:

• Allergic reaction such as skin rash, facial swelling, wheezing or difficulty breathing
• Cardiac disorders such as chest pain
• Severe stomach pain or any signs of gastrointestinal bleeding, such as black or blood-stained stools or vomiting blood
• Skin reactions such as rash, blisters or peeling of the skin
• Liver failure (symptoms may include nausea, jaundice (yellowing of the skin or whites of the eyes))

Very common (may occur in more than 1 in 10 people)

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

Common (may occur in less than 1 in 10 people)

• Myocardial infarction*
• Fluid retention with oedema of the ankles, legs and (or) hands
• Urinary tract infections
• Shortness of breath*, sinusitis (sinus inflammation, sinus infection, sinus congestion or pain), nasal congestion or runny nose, sore throat, cough, common cold, influenza-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, indigestion, bloating with gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea
• Joint pain
• Worsening of existing allergy
• Accidental injury

Uncommon (may occur in less than 1 in 100 people)

• Stroke*
• Heart failure, palpitations (sensation of strong heartbeat), rapid heart rate
• Abnormal liver function tests
• Abnormal blood tests related to kidney function
• Anaemia (changes in red blood cell count causing fatigue and breathlessness)
• Restlessness, depression, fatigue, drowsiness, tingling sensation
• High potassium levels in blood (may cause nausea, fatigue, muscle weakness or palpitations)
• Visual disturbances or blurred vision, ringing in the ears, mouth pain and inflammation, hearing disorders*
• Constipation, belching, gastritis (indigestion, stomach pain or vomiting), worsening of gastritis or intestinal inflammation
• Leg cramps
• Raised, itchy rash (urticaria)
• Conjunctivitis
• Breathing difficulties
• Skin discolouration (bruising)
• Chest pain (non-cardiac general pain)
• Facial swelling

Rare (may occur in less than 1 in 1000 people)

• Stomach, oesophagus or intestinal ulcer (with bleeding); or intestinal perforation (which may cause stomach pain, fever, nausea, vomiting, gastrointestinal obstruction), black or dark stools, pancreatitis (may lead to stomach pain), oesophagitis
• Low sodium levels in blood (so-called hyponatraemia)
• Decreased white blood cell count (which help protect the body against infections) or platelet count (increased risk of bleeding and bruising)
• Impaired muscle coordination
• Feeling disoriented, disturbances in taste perception
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Intraocular haemorrhage
• Acute reaction which may lead to lung inflammation
• Irregular heartbeat
• Hot flushes
• Blood clots in blood vessels of the lungs. Symptoms may include sudden breathlessness, sharp pain when breathing or collapse
• Bleeding from stomach or intestines (may lead to bloody stools or vomiting), intestinal inflammation or colitis
• Severe liver inflammation. Symptoms may include nausea, diarrhoea, jaundice (yellowing of skin or eyes), dark-coloured urine, pale stools, easy bleeding, itching, chills
• Acute kidney failure
• Menstrual disorders
• Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

Very rare (may occur in less than 1 in 10,000 people)

• Severe allergic reactions (including anaphylactic shock, which may result in death). Severe skin diseases 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, lymph node enlargement and abnormal test results (e.g. liver, blood (eosinophilia, increased white blood cell count))
• Intracranial haemorrhage leading to death
• Meningitis (inflammation of the membranes surrounding the brain and spinal cord)
• Liver failure, liver damage and severe hepatitis (fulminant hepatitis, sometimes fatal or requiring liver transplantation). Symptoms may include: nausea, diarrhoea, jaundice (yellowing of skin or 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 pale stools, nausea and yellowing of the skin or eyes
• Kidney inflammation and other kidney disorders (such as nephrotic syndrome, minimal change disease (MCD)), which may be accompanied by symptoms such as fluid retention (oedema), frothy urine, fatigue and loss of appetite
• Exacerbation of epilepsy (increased frequency and/or severity of seizures)
• Occlusion of retinal artery or vein leading to partial or complete vision loss
• Vasculitis (may cause fever, pain, purple skin spots)
• Decreased red and white blood cell counts and platelet count (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Smell disturbances
• Loss of taste

Frequency unknown: cannot be estimated from available data

• Reduced fertility in women, which is usually reversible after discontinuation of the drug.

In clinical trials not related to arthritis or other joint diseases,
where Elecoxel was administered at a dose of 400 mg daily for up to 3 years, the following additional adverse reactions were observed:
Common (may occur in less than 1 in 10 people)

• Cardiac disorders: angina (chest pain)
• Gastrointestinal disorders: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion, bloating with gas)
• Kidney stones (which may lead to abdominal or back pain, haematuria)
• Weight gain

Uncommon (may occur in less than 1 in 100 people)

• Deep vein thrombosis (blood clots most commonly occurring in the legs, which may cause pain, swelling or redness in the calf, or breathing problems)
• Gastrointestinal disorders: gastritis (which may cause irritation and ulceration of the stomach and intestines)
• Fracture of the lower limb
• Shingles, dermatitis, eczema (dry, itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing))
• Eye fatigue causing blurred or reduced vision, dizziness caused by middle ear disturbances, pain, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, haemorrhoidal bleeding (haemorrhoids), frequent bowel movements
• Lipomas in the skin or other locations, cysts, ganglion cysts (benign swellings in joints (or) around joints and tendons of the hand or foot), difficulty speaking, altered or very heavy vaginal bleeding, breast pain
• High sodium levels in blood

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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]
Adverse reactions may also be reported to the representative of the marketing authorisation holder.
By reporting adverse reactions, more information can be gathered about the safety of the medicine.

5. How to store Elecoxel

Keep the 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 stated month.
No special precautions for storage of the medicine are required.
Medicines should not be disposed of via wastewater or household waste. You should ask
your pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the package 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: monohydrate lactose, povidone (K-29/32), sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (granulate); gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (capsule).

Ink ingredients:
Elecoxel 100 mg: shellac, propylene glycol, indigo carmine, aluminium lake (E132)
Elecoxel 200 mg: shellac, propylene glycol, yellow iron oxide (E172)

What Elecoxel looks like and contents of the pack
An opaque, white, hard gelatin capsule. The body of the capsule has a blue band with the white printed text "C9OX-100".
An opaque, white, hard gelatin capsule. The body of the capsule has a yellow band with the white printed text "C9OX-200".
Pack size: 30 hard capsules.

Marketing Authorisation 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
The 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

For further information and information on the medicinal product names in other EEA countries, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]