Zelsiglat

Leaflet accompanying the packaging: patient information

Zelsiglat, 100 mg, hard capsules

Zelsiglat, 200 mg, hard capsules

Celecoxib

Read the leaflet carefully before taking the medicine, 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 specifically for you. 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Zelsiglat and what is it used for

Zelsiglat belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), specifically to a subgroup of medicines called 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. Zelsiglat works by inhibiting the production of prostaglandins, thereby reducing pain and inflammation.
Zelsiglat is used in adults to treat the 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 several days.

2. Important information before taking Zelsiglat

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

When not to take Zelsiglat:

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

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with hypersensitivity to sulfonamide drugs (e.g. certain antibiotics used to treat infections);
• if you have active stomach or intestinal ulcers, or stomach or intestinal bleeding;
• if you have had asthma, nasal polyps, nasal congestion, or allergic reactions (such as itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing) after taking acetylsalicylic acid (aspirin) or other anti-inflammatory and pain-relieving medicines (NSAIDs);
• if you are pregnant. If you may become pregnant during treatment, you should discuss contraception methods with your 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, e.g. patients who have been diagnosed with myocardial infarction, stroke, or transient ischemic attack (temporary reduction of blood flow to the brain, so-called mini-stroke), angina pectoris, or blockage of the coronary arteries or cerebral vessels.
• if you have had or have circulatory problems (peripheral arterial disease), or if you have had a procedure on the arteries of the legs.

Warnings and precautions

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

• if you have had stomach or intestinal ulcers, or stomach or intestinal bleeding in the past (do not take Zelsiglat if you have active stomach or intestinal ulcers, or stomach or intestinal bleeding);
• if you are taking acetylsalicylic acid (aspirin), even in small doses for heart protection;
• if you are taking antiplatelet agents;
• if you are taking blood-thinning medicines (e.g. warfarin/anticoagulant derivatives of warfarin or new-generation anticoagulants, e.g. apixaban);
• if you are taking corticosteroids (e.g. prednisone);
• if you plan to take other NSAIDs with Zelsiglat, such as ibuprofen or diclofenac (other than acetylsalicylic acid). 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 or feet);
• if you are dehydrated due to illness, diarrhea, or taking diuretics (used to treat excess fluid in the body);
• if you have had a severe allergic reaction or severe skin reaction to any medicine;
• if you have an infection or suspect you have an infection, as Zelsiglat may mask fever or other signs of infection or inflammation;
• if you are over 65 years old; your doctor may recommend regular check-ups;

If you consume alcohol or take NSAIDs, this may increase the risk of gastrointestinal disorders.
Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may lead to increased blood pressure, so your doctor may recommend regular blood pressure check-ups.
During treatment with celecoxib, cases of severe liver disease, including severe hepatitis, liver damage, and liver failure (sometimes fatal or requiring liver transplantation), have been reported.
In cases where the period preceding the onset of the disease was known, most severe liver-related adverse events occurred within a month of starting treatment.
Zelsiglat may affect fertility. Female patients should inform their doctor if they plan to become pregnant or are having trouble becoming pregnant (see section Pregnancy and breastfeeding).

Zelsiglat and other medicines

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, 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 medicines used to prevent 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 heart rhythm disorders,
• antipsychotics (used to treat certain mental illnesses),
• 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 and tacrolimus (used to weaken the immune system, e.g. after transplants).

Zelsiglat can be taken with low doses of acetylsalicylic acid (aspirin), 75 mg or less per day. You should consult your doctor before taking both medicines at the same time.

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
Do not take Zelsiglat if you are pregnant or may become pregnant (e.g. women of childbearing age who do not use effective contraception) during treatment. If you become pregnant during treatment with Zelsiglat, stop taking Zelsiglat and consult your doctor to determine an alternative treatment method.
Breastfeeding
Do not take Zelsiglat if you are breastfeeding.
Fertility
NSAIDs, including Zelsiglat, may make it more difficult to become pregnant. Female patients should tell their doctor if they plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Before driving or operating machinery, observe how Zelsiglat affects you. If you experience dizziness or drowsiness after taking Zelsiglat, do not drive or operate machinery until these symptoms have resolved.

Zelsiglat contains lactose (a type of sugar)

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Zelsiglat contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Zelsiglat

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. If you feel that the effect of Zelsiglat is too strong or too weak, ask your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of side effects related to heart problems may increase with the dose and duration of treatment, it is essential to take Zelsiglat at the lowest effective dose that controls pain and for no longer than necessary to control symptoms.
Method of administration
Zelsiglat should be taken orally.Capsules can be taken at any time of day, with or without food. However, it is recommended that you take Zelsiglat at the same time every day.
In case of difficulty swallowing capsules: Pour the entire contents of the capsule onto a spoon containing a semi-solid food (e.g. cold or room-temperature apple sauce, rice cereal, yogurt, or mashed banana) and swallow immediately, washing it down with approximately 240 ml of water.
To open the capsule, hold it upright so that the granule contents 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.
If you do not observe any benefits within two weeks of starting treatment, contact your doctor.
Recommended dose
Osteoarthritis:the recommended dose is 200 mg per day. Your doctor may increase the dose to a maximum of 400 mg if necessary.
The recommended dose is:

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

Rheumatoid arthritis:the recommended dose is 200 mg per day. Your doctor may increase the dose to a maximum of 400 mg if necessary.
The recommended dose is:

• one 100 mg capsule twice a day.

Ankylosing spondylitis:the recommended dose is 200 mg per day. Your doctor may increase the dose to a maximum of 400 mg if necessary.
The recommended dose is:

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

Impaired renal or hepatic function:ensure that your doctor knows about any kidney or liver function disorders, as a lower dose may be necessary.
Elderly patients, particularly those with a body weight of less than 50 kg:in patients over 65 years old, particularly those with a body weight of less than 50 kg, your doctor may recommend regular monitoring. Do not take more than 400 mg of celecoxib per day.

Use in children

Zelsiglat should only be used in adults; it should not be used in children.

Taking more than the recommended dose of Zelsiglat:

Do not take more capsules than recommended by your doctor. If you have taken too many capsules, contact your doctor or pharmacist or go to the hospital. Take the medicine with you.

Missing a dose of Zelsiglat

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

Stopping treatment with Zelsiglat

Suddenly stopping treatment with Zelsiglat may worsen existing symptoms. Do not stop taking Zelsiglat unless your doctor tells you to. Your doctor may recommend gradually reducing the dose over several days before stopping treatment completely.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

In the event of any of the following symptoms, stop taking Zelsiglat and inform your doctor:

• allergic reaction, such as rash, swelling of the face, wheezing, or difficulty breathing,
• heart problems, such as chest pain,
• severe stomach pain or signs of stomach or intestinal bleeding, 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, diarrhea, jaundice (yellowing of the skin or whites of the eyes)).

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, legs, and (or) hands
• urinary tract infections
• respiratory tract infections, sinusitis (sinus infection, infection of the sinuses, feeling of blocked or painful sinuses), stuffy nose or runny 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), rapid heartbeat
• abnormal liver function test results
• abnormal kidney function test results
• anemia (changes in red blood cell count; may cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling sensation
• high potassium levels in the blood (may cause nausea, fatigue, weakness, or palpitations)
• vision disturbances or blurred vision, ringing in the ears, mouth ulcers, hearing disturbances*
• constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• leg cramps
• hives (itchy, raised rash)
• eye inflammation
• 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, intestinal obstruction), black or tarry stools, pancreatitis (which can cause stomach pain), esophagitis
• low sodium levels in the blood (a condition called hyponatremia)
• reduced white blood cell or platelet count (which can increase the risk of infection or bleeding)
• coordination disorders
• disorientation, taste disturbances
• increased sensitivity to light
• hair loss
• hallucinations
• bleeding into the eye
• severe reaction that can lead to pneumonia
• irregular heartbeat
• hot flashes
• blood clots in the lungs. Symptoms may include sudden shortness of breath, stabbing pain while breathing, or collapse
• bleeding from the stomach or intestines (which can lead to black or bloody stools or vomiting blood), intestinal or colon inflammation
• severe liver disease. Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or whites of the eyes), dark urine, pale stools, bleeding, itching, or chills
• acute kidney failure
• menstrual disorders
• facial swelling, lip swelling, mouth swelling, tongue swelling, 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 reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormal test results (e.g. liver, blood (eosinophilia, a type of increased white blood cell count))
• intracranial hemorrhage leading to 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 whites of the eyes), dark urine, pale stools, bleeding, itching, or chills
• liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellowing of the skin or whites of the eyes)
• kidney problems (such as nephrotic syndrome and submicroscopic glomerulonephritis, which may be accompanied by symptoms such as fluid retention, foamy urine, fatigue, and loss of appetite)
• worsening of epilepsy (may cause more frequent and/or severe seizures)
• closure of the retinal artery or vein, leading to partial or complete loss of vision
• inflammation of blood vessels (which can cause fever, pain, purpura)
• reduced red, 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 not related to arthritis or other joint diseases, in which celecoxib was administered 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 difficulties)
• stomach problems: stomach inflammation (which can cause stomach upset and ulcers)
• lower limb fractures
• shingles, skin inflammation, eczema (dry, itchy rash), pneumonia (chest infection, which may cause cough, fever, difficulty breathing)
• eye clouding causing blurred vision or visual impairment, dizziness caused by middle ear disorders, painful, inflamed, or bleeding gums, mouth ulcers
• nocturnal urination, bleeding hemorrhoids (bleeding piles), frequent bowel movements
• fat deposits in the skin or other locations, ganglion cysts (harmless lumps in the wrist or foot joints and tendons), 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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.
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zelsiglat

Keep this medicine out of the sight and reach of children.
Do not take 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.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Zelsiglat contains

The active substance is celecoxib.
Each Zelsiglat 100 mg capsule contains 100 mg of celecoxib.
Each Zelsiglat 200 mg capsule contains 200 mg of celecoxib.
The other ingredients (excipients) are sodium lauryl sulfate, lactose monohydrate, crospovidone (type A), povidone K29-32, magnesium stearate.
The capsule shell contains titanium dioxide (E 171), gelatin, sodium lauryl sulfate.
The ink contains:

• 100 mg capsules: shellac, indigo carmine (E 132), lacquer,
• 200 mg capsules: shellac, yellow iron oxide (E 172).

What Zelsiglat looks like and contents of the pack

Zelsiglat 100 mg, hard capsules: hard, gelatin capsules consisting of a white, opaque cap with a blue stripe and a white, opaque body with a blue stripe marked with "100", containing a white, granular powder.
Zelsiglat 200 mg, hard capsules: hard, gelatin capsules consisting of a white, opaque cap with a yellow stripe and a white, opaque body with a yellow stripe marked with "200", containing a white, granular powder.
Zelsiglat 100 mg capsules are packed in white, transparent PVC/Aluminum blisters.
Pack sizes: 10 and 30 capsules.
Zelsiglat 200 mg capsules are packed in white, transparent PVC/Aluminum blisters.
Pack sizes: 10 and 30 capsules.

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer:

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitza 2600
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Polska

Zelsiglat

Date of last revision of the leaflet: 09.2021