Celecoxib Vir-Pharma 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Celecoxib Vir-Pharma 200 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Celecoxib Vir-Pharma is and what it is used for

Celecoxib belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), specifically within 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 higher levels of prostaglandins. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

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

The medicine will begin 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 taking Celecoxib Vir-Pharma

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

Do not take Celecoxib Vir-Pharma

Inform your doctor if any of the following apply to you, as patients with these conditions should not take Celecoxib Vir-Pharma:

• 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.
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs): asthma, nasal polyps, severe nasal congestion, or an allergic reaction 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., if 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 circulatory problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before starting Celecoxib Vir-Pharma:

• if you have previously had a stomach or intestinal ulcer or bleeding (Do not take Celecoxib Vir-Pharma 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 analogues, or newer oral anticoagulants, e.g., apixaban).

• if you are taking corticosteroid medicines (e.g., prednisone).

• if you are taking Celecoxib Vir-Pharma together with other non-acetylsalicylic acid NSAIDs, such as ibuprofen or diclofenac. The combined 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 Vir-Pharma 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 can increase the risk of gastrointestinal problems.

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

There have been reports of serious liver reactions 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 Vir-Pharma may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celecoxib Vir-Pharma with other medicines

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

• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat high blood pressure and heart failure).
• Fluconazole and rifampicin (used to treat bacterial and fungal infections).
• Warfarin or other warfarin analogues (agents that reduce blood clot formation), 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 Vir-Pharma may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medicines together.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Celecoxib Vir-Pharma 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 Vir-Pharma, you must stop treatment immediately and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib Vir-Pharma must not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Vir-Pharma, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are experiencing difficulty conceiving.

Driving and using machines

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

Celecoxib Vir-Pharma contains lactose

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

Celecoxib Vir-Pharma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Celecoxib Vir-Pharma

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

Your doctor will tell you 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 Vir-Pharma for longer than necessary to control your symptoms.

Method of administration:

Celecoxib Vir-Pharma is taken orally. The capsules can be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Vir-Pharma 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 semisolid food (such as apple sauce, 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 within two weeks of starting treatment.

Recommended dose:

The recommended dose for the treatment of osteoarthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.

The usual dose is:

• one 200 mg capsule once daily.

The recommended dose for the treatment of rheumatoid arthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.

• The initial recommended dose of 200 mg (administered as two doses of 100 mg daily) is not available with this medicine. Please consult your doctor.

The recommended dose for the treatment of ankylosing spondylitis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.

The usual dose is:

• one 200 mg capsule once daily.

Patients with kidney or liver problems: ensure your doctor knows if you have liver or kidney problems, as you may require a lower dose.

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

Do not take more than 400 mg per day.

Use in children

Celecoxib Vir-Pharma is for adults only and is not indicated for use in children.

If you take more Celecoxib Vir-Pharma than you should

Do not take more capsules than prescribed by your doctor. If you take more Celecoxib Vir-Pharma than prescribed, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

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

If you forget to take Celecoxib Vir-Pharma

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 Vir-Pharma

Abruptly stopping treatment with Celecoxib Vir-Pharma may cause worsening of symptoms. Do not stop taking this medicine unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before completely stopping treatment.

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. The adverse effects marked with an asterisk (*) occurred in patients taking Celecoxib for the prevention of colon polyps and have been classified according to the highest frequency of occurrence. Patients included in these studies took Celecoxib at high doses and for a prolonged period of time.

If you experience any of the following adverse effects, stop treatment with Celecoxib Vir-Pharma and inform 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), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)].

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

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

Common (may affect up to 1 in 10 people)

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infections
• 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, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Worsening of existing allergies
• Headache
• Nausea (feeling unwell)
• Joint pain
• Accidental injury

Uncommon (may affect up to 1 in 100 people)

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• Abnormal blood test results related to the liver
• Abnormal blood test results 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, hearing difficulty*
• Constipation, burping, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial wheals)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (bruising)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), oesophagitis (inflammation of the oesophagus)
• Low levels of sodium in the blood (a condition known as hyponatremia)
• Decrease in the number of white blood cells (which help protect the body from infections) or platelets (increased risk of bleeding and bruising)
• Difficulty in 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 chest pain or collapse
• Bleeding from the stomach or intestine (may result in bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, 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, or difficulty swallowing

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

• Brain hemorrhage leading to death.
• 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 abnormal clinical test results [e.g.: liver, blood cells (eosinophilia, a type of increase in blood cell count)].
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhea, 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)
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Worsening of epilepsy (possibly more frequent and/or severe seizures).
• Inflammation of blood vessels (may cause fever, pain, purple spots on the skin).
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision,
• Reduction in the number of red and white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections).
• Disturbance of the sense of smell.
• Muscle pain and weakness
• Ageusia (loss of taste)

Frequency not known (cannot be estimated from available data):

• Decreased fertility in women, which is usually reversible if the medicine is discontinued.

Adverse effects reported 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 (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Deep vein thrombosis (blood clots 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)].
• Floaters in the eye 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 hemorrhoids, frequent bowel movements.
• Fatty lumps under the skin or elsewhere, ganglion cyst (non-painful swelling in joints or tendons or around them, 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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Celecoxib Vir-Pharma

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 packaging, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Vir-Pharma

The active substance is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are: the granulate contains lactose monohydrate, povidone, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E572). The capsule shell contains gelatin (E441), titanium dioxide (E171), and yellow iron oxide (E172). The printing ink contains shellac (E904), propylene glycol (E1520), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

White, opaque hard capsules. The body features a yellow band with the white text “C9OX-200”.

Celecoxib Vir-Pharma may be available in packs containing 1, 10, 20, 30, 40, 50, 60 or 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

Synthon BV

Microweg 22

6545 CM, Nijmegen

The Netherlands

or

Synthon Hispania S.L

Castelló, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

or

G.L. Pharma GmbH

Schlossplatz 1,

8502 Lannach,

Austria

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

Netherlands: Licebril 200 mg, capsules, hard
Spain: Celecoxib Vir-Pharma 200 mg hard capsules EFG

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

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