Package Insert: Information for the Patient

Celenib 200mg Hard EFG Capsules

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Celenib is indicated in adults to alleviate the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celenib contains celecoxib as the active ingredient andbelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), specifically the subgroup known as cyclooxygenase-2 (COX-2) inhibitors.

Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in greater quantities. Celenib acts by reducing the production of prostaglandins, thereby reducing

pain and inflammation.

Your doctor has prescribed Celenib. The following information will help you get better results with Celenib. If you have any other questions, please ask your doctor or pharmacist.

Do not take Celenib

Inform your doctor if any of the following circumstances affect you, as patients with these conditions should not take Celenib:

• If you are allergic to celecoxib or any of the other components of this medication (listed in section 6)
• If you have had any allergic reaction to any medication 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 as a result of taking acetylsalicylic acid or any other anti-inflammatory medication: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy skin rash, facial swelling, lip, tongue, or throat swelling, difficulty breathing, or wheezing
• If you are pregnant. If you can 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 problems such as heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, for example, you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as "mini-stroke"), angina pectoris, or obstruction of the blood vessels that supply the heart or brain
• If you have or have had circulation problems (peripheral arterial disease) or if you have been operated on on the arteries of your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celenib

• If you have previously had a stomach or intestinal ulcer or bleeding. (Do not take Celenib if you currently have a stomach or intestinal ulcer or bleeding).
• If you are taking acetylsalicylic acid (even low doses as a heart protector)
• If you are receiving medications to reduce blood clotting (e.g. warfarin)
• If you are taking Celenib at the same time as other non-acetylsalicylic acid anti-inflammatory medications such as ibuprofen or diclofenac. You should avoid using these medications together
• If you are a smoker, have diabetes, high blood pressure, or high cholesterol
• If your heart, liver, or kidneys are not functioning well, your doctor may want to monitor you regularly
• If you have fluid retention (e.g. swollen feet or ankles)
• If you are dehydrated, for example, due to a disease with vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body)
• If you have had a severe allergic reaction or a severe skin reaction to any medication
• If you feel unwell due to an infection or think you have an infection, as taking Celenib 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.

Like other anti-inflammatory medications (e.g. ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor can perform regular checks.

During treatment with celecoxib, some cases of severe liver reactions have been reported, including severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplantation).Most of the severe liver reactions occurred in the first month of treatment.

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

Taking Celenib with other medications

Some medications may modify the effect of other medications.Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists (medications used to treat hypertension and heart failure)
• Diuretics (used to eliminate excess fluid from the body)
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
• Warfarin or other oral anticoagulants (agents that reduce blood clotting)
• Lithium (used to treat some types of depression)
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat
• Neuroleptics (used to treat some mental disorders)
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia)
• Carbamazepine (used to treat epilepsy/convulsions and some types of pain or depression)
• Barbiturates (used to treat epilepsy/convulsions and some sleep disorders)
• Ciclosporin and tacrolimus (used to suppress the immune system, e.g. after transplants)

Celenib can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Consult your doctor before taking both medications 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 medication

Celenib should not be used by pregnant women or women who may become pregnant (i.e. women of childbearing age who do not use an adequate contraceptive method) during treatment. If you become pregnant during treatment with Celenib, you should discontinue treatment and contact your doctor for alternative treatment.

Celenib should not be taken during breastfeeding.

Driving and operating machinery

You should know how you react to Celenib before driving or operating machinery. If you feel dizzy or drowsy after taking Celenib, do not drive or operate machinery until these effects pass.

Celenib contains lactose(a type of sugar).

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication is indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

If you think or believe that the action of Celenib is too strong or weak, inform your doctor or pharmacist.

Your doctor will indicate the dose you should take. Since the risk of adverse effects associated with heart problems may increase with the dose and duration of treatment, it is essential to use the lowest dose that controls your pain and do not take Celenib for longer than necessary to control your symptoms.

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

Recommended dose:

Celenib is available in hard capsules of 200mg. Depending on the medication prescribed by your doctor, the recommended dose is:

For the treatment of arthritis

The usual dose is 200mg per day, which can be taken as:

• 1 capsule of 200mgonce a day

If necessary, your doctor may increase the dose up to a maximum of 400 mg as:

• 1 capsule of 200mgtwice a day.

For the treatment of rheumatoid arthritis

The initial recommended dose is 200mg per day:

• 1 capsule of100mgtwice a day(This recommended dose of100mg twice a daycannot be administered with this medication. There are other medications with a concentration of 100mg of celecoxib).

If necessary, your doctor may increase the dose up to a maximum of 400mg:

• 1 capsule of 200mgtwice a day

For the treatment of ankylosing spondylitis

The initial recommended dose is 200mg per day:

• 1 capsule of 200mgonce a day

If necessary, your doctor may increase the dose up to a maximum of 400mg:

• 1 capsule of 200mgtwice a dayor 2 capsules of 200mgonce a day.

Maximum daily dose:

You should not take more than 400mg of celecoxib per day.

Problems with the kidneys or liver:Make sure your doctor knows if you have problems with your liver or kidneys, as you may need a lower dose.

Patients over 65 years old, especially those with a weight of less than 50 kg:Your doctor may want to monitor you more closely if you are over 65 years old and especially if you weigh less than 50 kg.

Use in children:Celenib is only for adults, not indicated for children.

Administration form:

This medication is taken orally.

The capsules should be swallowed whole with a glass of water, and can be taken at any time of the day, with or without food. However, try to take each dose of Celenib at the same time every day.

If you take more Celenib than you should

You should not take more capsules than indicated by your doctor. If you take more capsules than you have been told, consult your doctor, pharmacist, or hospital immediately and bring the medication with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount taken.

If you forget to take Celenib

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

If you interrupt treatment with Celenib

Stopping treatment with Celenib abruptly may cause a worsening of symptoms. Do not stop taking Celenib unless your doctor tells you to. Your doctor will indicate that you reduce the dose over a few days before stopping treatment completely.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

Like all medicines, Celenib may cause side effects, although not everyone will experience them.

The side effects listed below were observed in patients with arthritis who took celecoxib. The side 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.

Stop taking Celenib and tell your doctor immediately if you experience any of the following side effects:

• A hypersensitivity reaction such as skin rash, facial swelling, 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 stools stained with blood, or blood in the vomit.
• A skin reaction such as rash, blisters, or peeling of the skin.
• Liver failure (symptoms may include nausea, diarrhea, jaundice (your skin or the white of your eyes appears yellow).

Very common side effects (may affect more than 1 in 10 patients):

• Increased blood pressure*.

Common side effects (may affect up to 1 in 10 patients):

• Myocardial infarction*.
• Fluid retention with swelling of ankles, legs, and/or hands
• Urinary tract infection
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), stuffy nose 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

Rare side effects (may affect up to 1 in 1,000 patients):

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the throat (may cause difficulty swallowing), inflammation of the pancreas (may cause stomach pain)
• Decreased white blood cell count (which helps protect the body from infections) and platelet count (increases the risk of bleeding and petechiae)
• Difficulty in coordinating muscle movements
• Feeling of confusion, alterations in taste
• Increased sensitivity to light
• Hair loss

Side effects of unknown frequency (their frequency cannot be estimated from the available data):

• Cerebral hemorrhage leading to death
• Severe allergic reactions (including potential fatal anaphylactic shock) that may cause skin rash, facial swelling, lips, mouth, tongue, or throat, wheezing, or difficulty breathing; difficulty swallowing
• Gastrointestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation, nausea (sensation of discomfort)
• Severe skin alterations such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or peeling of the skin) and acute generalized pustular psoriasis (swollen and red area with numerous small pustules)
• Liver failure, severe liver damage, and severe liver inflammation (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (sensation of discomfort), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bleeding, itching, or chills
• Renal problems (possible renal insufficiency, renal inflammation)
• Pulmonary embolism (blood clots in the pulmonary vessels). Symptoms may include sudden difficulty breathing, acute chest pain, or collapse (circulatory obstruction of the pulmonary vessels)
• Irregular heart rhythm
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Hallucinations
• Worsening of epilepsy (seizures possibly more frequent and/or severe)
• Inflammation of blood vessels (may cause fever, pain, and purplish spots on the skin)
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision, conjunctival inflammation, hemorrhage
• Decreased red and white blood cell count and platelet count (may cause fatigue, frequent nosebleeds, and increased risk of infections)
• Chest pain
• Alteration of taste
• Decoloration of the skin (petechiae), muscle pain and weakness, joint pain
• M menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (may cause loss of appetite, headache, nausea (sensation of discomfort), cramps, and muscle weakness)

The side effects observed in clinical trials in which celecoxib was administered at a dose of 400 mg per day for more than 3 years in patients with non-arthritis-related diseases or other arthritic conditions were:

Common side effects (may affect up to 1 in 10 patients):

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

Rare side effects (may affect up to 1 in 100 patients):

• Deep vein thrombosis (blood clotting generally in the leg, which may cause pain, swelling, or redness of the calf or problems breathing)
• Gastrointestinal problems: stomach infection (which may cause irritation or ulcers in the stomach and intestines)
• Lower limb fractures
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (chest infection (possibility of cough, fever, difficulty breathing))
• Flies 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 nighttime urination, heavy menstrual bleeding, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (non-painful inflammation in the joints or tendons or around them, in the hand or foot) difficulty speaking, abnormal or severe vaginal bleeding, chest pain
• High sodium levels in blood test results

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack and the boxafter CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Celenib

• The active ingredient is celecoxib. Each hard capsule contains 200 mg of celecoxib.

• The other components (excipients) are: lactose monohydrate, sodium lauryl sulfate, povidone K-29/32, croscarmellose sodium, magnesium stearate.

The capsule coating contains: gelatin, sodium lauryl sulfate, titanium dioxide (E171), yellow iron oxide (E172), water.

The ink contains: black iron oxide (E172), shellac-NF-E904, anhydrous ethanol, isopropanol, butyl alcohol, propylene glycol, concentrated ammonium solution, potassium hydroxide, and purified water.

Appearance of the product and content of the packaging

Celenib is presented in the form of hard capsules.

The capsules are opaque, with a white body bearing the imprint 200 and a yellow cap bearing the imprint CLX.

The capsules are presented in aluminum/PVC-PVDC blisters.

Celenib may be presented in packaging of 30 and 100 hard capsules.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for Manufacturing

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet: August 2013

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/