Celecoxib OPKO 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celecoxib OPKO 100 mg hard capsules EFG

Celecoxib OPKO 200 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Celecoxib OPKO is and what it is used for

Celecoxib OPKO belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in higher amounts. Celecoxib OPKO works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

Celecoxib OPKO is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medicine will start to work several hours after taking the first dose, but you may not experience the full effect until several days have passed.

2. What you need to know before starting Celecoxib OPKO

Your doctor has prescribed this medicine. The following information will help you get the best results from this medicine. If you have any further questions, please ask your doctor or pharmacist.

Do not take Celecoxib OPKO

Tell your doctor if any of the following apply to you, as patients with these conditions should not take celecoxib:

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6)
• if you have had an allergic reaction to any medicine in the group called "sulfonamides" (e.g., some antibiotics used to treat infections)
• if you currently have a stomach or intestinal ulcer or bleeding, or bleeding in the stomach or intestines
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory and pain-relieving drugs (NSAIDs): asthma, nasal polyps, severe nasal congestion or rhinorrhea, or allergic symptoms such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing
• if you are pregnant. If you could become pregnant during treatment, you should discuss the use of contraceptive 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, diagnosed ischemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction in blood flow to the brain; also known as a "mini-stroke"), angina, or blockage of blood vessels to the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or if you have had surgery on the arteries in your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting Celecoxib OPKO:

• if you have previously had a stomach or intestinal ulcer or bleeding (do not take Celecoxib OPKO if you currently have a stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (even at low doses such as for heart protection)
• if you are taking antiplatelet therapies
• if you are receiving medications to reduce blood clotting (e.g., warfarin/warfarin-like anticoagulants or new oral anticoagulants, e.g., apixaban)
• if you are receiving corticosteroid medicines (e.g., prednisone)
• if you are taking Celecoxib OPKO at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol
• if your heart, liver, or kidneys do not function properly, your doctor may want to monitor you regularly
• if you have fluid retention (such as swollen feet or ankles)
• if you are dehydrated, for example, due to an illness with vomiting or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
• if you have had a severe allergic reaction or a serious skin reaction to any medicine
• if you feel unwell due to an infection or suspect you have an infection, as taking Celecoxib OPKO may mask fever or other signs of infection and inflammation
• if you are over 65 years old, your doctor may want to monitor you regularly
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems.

Like other anti-inflammatory medicines (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may monitor it periodically.

Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset was reported, most serious liver reactions occurred within the first month of treatment.

Celecoxib OPKO may make it harder to become pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celecoxib OPKO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure)
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
• Warfarin or other warfarin-like agents (medicines that reduce blood clotting), including newer agents such as apixaban
• Lithium (used to treat certain types of depression)
• Other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Neuroleptics (used to treat certain mental disorders)
• Methotrexate (used in 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 for immunosuppression, e.g., after organ transplants)

Celecoxib OPKO may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Seek advice from your doctor before taking both medicines together.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Celecoxib OPKO must not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using an adequate contraceptive method) during treatment. If you become pregnant while taking Celecoxib OPKO, you must stop treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib OPKO must not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib OPKO, may impair fertility. You should inform your doctor if you plan to become pregnant or are experiencing difficulty becoming pregnant.

Driving and using machines

You should be aware of how you react to Celecoxib OPKO before driving or operating machinery. If you feel dizzy or drowsy after taking Celecoxib OPKO, do not drive or operate machinery until these effects subside.

Celecoxib OPKO contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Celecoxib OPKO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; therefore, it is essentially "sodium-free".

3. How to take Celecoxib OPKO

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of Celecoxib OPKO is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine the dose you should take. Since the risk of adverse effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest dose that controls your pain and you should not take Celecoxib OPKO for longer than necessary to control symptoms.

Method of administration:

Celecoxib is for oral use. The capsules can be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time each day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a level teaspoon of soft food (such as applesauce, rice, yogurt, or mashed banana at room temperature or cold) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it vertically to keep the granules at the bottom; then squeeze the top and twist it off, taking care not to spill the contents. Do not chew or crush the granules.

Contact your doctor if you do not experience improvement after two weeks of starting treatment.

Recommended dose:

For osteoarthritis: the recommended dose is 200 mg per day. If necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

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

For rheumatoid arthritis: the recommended dose is 200 mg per day, taken in two divided doses. If necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 100 mg capsule twice daily.

For ankylosing spondylitis: the recommended dose is 200 mg per day. If necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

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

Kidney or liver problems: make sure your doctor knows if you have liver or kidney problems, as you may require a lower dose.

Patients over 65 years of age, especially those weighing less than 50 kg: your doctor may wish to monitor you more closely if you are over 65 years old, particularly if you weigh less than 50 kg.

Do not take more than 400 mg of celecoxib per day.

Use in children:

Celecoxib is intended for adults only and is not indicated for use in children.

If you take more Celecoxib OPKO than you should

If you accidentally take too much medicine, inform your doctor or pharmacist or contact the nearest hospital emergency department for advice.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Celecoxib OPKO

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

If you stop taking Celecoxib OPKO

Suddenly stopping treatment with Celecoxib OPKO may cause your symptoms to worsen. Do not stop taking Celecoxib OPKO unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects listed below were observed in patients with arthritis who were taking Celecoxib OPKO. The adverse effects marked with an asterisk (*) occurred in patients taking Celecoxib OPKO for the prevention of colon polyps. Patients included in these studies took Celecoxib OPKO at high doses and for a prolonged period of time.

If you experience any of the following adverse effects, stop treatment with Celecoxib OPKO and contact your doctor immediately:

If you have:

• an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing.
• heart problems such as chest pain
• severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or blood-stained stools, or blood in vomit.
• a skin reaction such as rash, blisters or peeling of the skin.
• liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (your skin or the whites of your eyes appear yellow)).

Very common adverse effects: may affect more than 1 in 10 patients:

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

Common adverse effects: may affect up to 1 in 10 patients:

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Difficulty breathing*, sinusitis (inflammation and infection of the sinuses, sinus blockage or pain), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon adverse effects: may affect up to 1 in 100 patients:

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidney
• Anaemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, tiredness, numbness, tingling sensation
• High levels of potassium in blood test results (may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, difficulty hearing*
• Constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy raised rash (urticarial rash)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (bruising)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

Rare adverse effects: may affect up to 1 in 1,000 patients:

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (oesophagus)
• Low levels of sodium in blood test results (a condition known as hyponatremia)
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)
• Difficulty with muscular coordination of movements
• Feeling confused, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
• Bleeding from the stomach or intestines (may result in bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty swallowing

Very rare adverse effects: may affect up to 1 in 10,000 patients:

• Severe allergic reactions (including potentially life-threatening anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include reddening of the skin with swollen areas and numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen glands and abnormalities in clinical test results (e.g.: liver, blood cells (eosinophilia, a type of increase in blood cell count))
• Bleeding in the brain causing death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplant). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or 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 eyes)
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibly more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye leading to partial or complete vision loss
• Inflammation of blood vessels (may cause fever, aches, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of taste sensation
• Loss of taste

Adverse effects with unknown frequency: their frequency cannot be estimated from the available data:

• Decreased fertility in women, which is normally reversible if the medication is discontinued

Adverse effects observed in clinical trials in which celecoxib was administered at a dose of 400 mg daily for up to 3 years, in patients with conditions unrelated to arthritis or other arthritic conditions, were:

Common adverse effects: may affect up to 1 in 10 patients:

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion and gas)
• Kidney stones (may lead to stomach or back pain, blood in urine), difficulty urinating
• Weight gain

Uncommon adverse effects: may affect up to 1 in 100 patients:

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems)
• Stomach problems: stomach infection (which may cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing))
• Eye floaters causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, bleeding from haemorrhoids, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (non-painful swelling in or around joints or tendons, usually in the hand or foot), difficulty speaking, abnormal or very heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Celecoxib OPKO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, bottle, and blister pack, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib OPKO

The active substance is celecoxib.

Each hard capsule contains 100 mg or 200 mg of celecoxib.

The other components (excipients) are:

monohydrate lactose, hydroxypropyl cellulose, crospovidone, povidone, sodium lauryl sulfate, magnesium stearate. The capsule shell contains titanium dioxide (E171), gelatin, and sodium lauryl sulfate. The printing ink contains shellac glaze, propylene glycol, strong ammonia solution, FD&C blue aluminum lake (100 mg strength), and yellow iron oxide (200 mg strength).

Appearance of the medicinal product and content of the container

Celecoxib OPKO 100 mg: Capsules are hard gelatin capsules of size 4, with an opaque white cap and a blue band marked "C5", and an opaque white body with a blue band bearing the inscription "100 mg", filled with white to almost white powder.

Celecoxib OPKO 200 mg: Capsules are hard gelatin capsules of size 2, with an opaque white cap and a yellow band marked "C6", and an opaque white body with a blue band bearing the inscription "200 mg", filled with white or almost white powder.

This medicine may be presented in PVC/PVDC/Aluminum blisters containing 20, 40, 50, 60, and 100 hard capsules (100 mg strength) and 10, 20, 30, 50, and 100 hard capsules (200 mg strength).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

OPKO HEALTH SPAIN, S.L.U.

Pl. Europa 13-15, 08908

L’Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB, United Kingdom

or

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15,

Swarzedz, 62-020,

Poland

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca

08040, Barcelona,

Spain.

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Celecoxib OPKO 100 mg/200 mg hard capsules EFG

Germany: Celecoxib Heumann 100 mg/200 mg Hartkapseln

Italy: Celecoxib Maxmind 100 mg/200 mg capsule rigide

United Kingdom: Celecoxib 100 mg/200 mg capsules, hard

Date of the most recent review of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/