CELENIB 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Celenib 200mg 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

1. What is Celenib and what is it used for

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

Celenib contains celecoxib as the active substance and belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), specifically to the subgroup known as selective 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 larger quantities. Celenib acts by reducing the production of prostaglandins, thus decreasing pain and inflammation.

2. What you need to know before you take Celenib

Your doctor has prescribed Celenib for you. 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

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

• If you are allergic to celecoxib or 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 any other anti-inflammatory medicine: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as skin rash with itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing
• If you are pregnant. If you may 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, 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 pectoris, or obstruction of the blood vessels that supply the heart or brain
• If you have or have had blood circulation problems (peripheral arterial disease) or if you have undergone surgery on the arteries in 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 Celenibif you currently have a stomach or intestinal ulcer or bleeding).
• If you are taking acetylsalicylic acid (even at low doses as a heart protector)
• If you are receiving medicines to reduce blood clotting (e.g., warfarin)
• If you are taking Celenib at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The 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, 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 medicine
• 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.

As with other anti-inflammatory medicines (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

During treatment with celecoxib, some cases of severe liver reactions have been reported, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases where it was specified when the event occurred, most 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 problems becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celenib with other medicines

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

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists (medicines used to treat hypertension and heart failure)
• Diuretics (used to eliminate excess fluid from the body)
• Fluconazole and rifampicin (used to treat bacterial and fungal infections)
• Warfarin or other oral anticoagulants (agents that reduce blood clot formation)
• Lithium (used to treat some types of depression)
• Other medicines 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/seizures and some forms of pain or depression)
• Barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• Cyclosporine 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). Ask your doctor for advice 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

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 stop treatment and contact your doctor for alternative treatment.

Celenib should not be taken during breastfeeding.

Driving and using machines

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

Celenib contains lactose(a type of sugar).

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine

3. How to take Celenib

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

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

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

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

Recommended dose:

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

For the treatment of osteoarthritis

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

• 1 capsule of 200 mg once a day

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

• 1 capsule of 200 mg twice a day

For the treatment of rheumatoid arthritis

The initial recommended dose is 200 mg per day:

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

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

• 1 capsule of 200 mg twice a day

For the treatment of ankylosing spondylitis

The initial recommended dose is 200 mg per day:

• 1 capsule of 200 mg once a day

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

• 1 capsule of 200 mg twice a dayor 2 capsules of 200 mg once a day

Maximum daily dose:

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

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

Patient over 65 years old, especially those weighing 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; it is not indicated in children.

Method of administration:

This medicine is taken orally.

The capsules should be swallowed whole with a glass of water and can be taken at any time of 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

Do not take more capsules than indicated by your doctor. If you take more capsules than prescribed, consult your doctor, pharmacist, or hospital immediately and take the medicine with you.

In case of overdose or accidental ingestion, consult 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 Celenib

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

If you stop taking Celenib

Sudden interruption of treatment with Celenib may cause worsening of symptoms. Do not stop taking Celenib unless your doctor tells you to. Your doctor will indicate that you should decrease the dose for a few days before stopping treatment completely.

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

4. Possible Adverse Effects

Like all medicines, Celenib can cause adverse effects, although not all people suffer from them.

The adverse effects mentioned below were observed in patients with arthritis who took celecoxib. The adverse effects marked with an asterisk (*) occurred in patients who took celecoxib for the prevention of colon polyps and have been classified taking into account the highest frequency of occurrence. The patients included in these studies took celecoxib at high doses and for a prolonged period.

Discontinue treatment with Celenib and inform your doctor immediately if you experience any of the following adverse effects:

• 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 stools stained with blood, or blood in vomit.
• A skin reaction such as rash, blisters, or peeling of the skin.
• Liver failure (symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, easy bruising, or chills).

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

• Increased 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 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

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

• Stroke*
• Heart failure, palpitations (perception of heartbeat), accelerated heartbeat
• Worsening of high blood pressure
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• High levels of potassium in blood test results (can cause nausea, fatigue, muscle weakness, or palpitations)
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain, or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Rash with itching and relief (urticarial habon)

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

• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, throat inflammation (can cause difficulty swallowing), pancreatitis (can cause stomach pain)
• Decreased number of white blood cells and platelets (increases the risk of bleeding and bruising)
• Difficulty in muscle coordination of movements
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss

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

• Bleeding in the brain that causes death
• Severe allergic reactions (including potentially fatal anaphylactic shock) that can cause skin rash, swelling of the face, lips, mouth, tongue, or throat, wheezing, or difficulty breathing; difficulty swallowing
• Bleeding in the stomach or intestine (can cause bloody stools or vomit), intestinal or colon inflammation, nausea
• Severe skin disorders such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (can cause rash, blistering, or peeling of the skin) and acute generalized exanthematous pustulosis (swollen and red area with numerous small pustules)
• Liver failure, liver damage, and severe liver inflammation (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice, dark urine, pale stools, easy bruising, or chills
• Kidney problems (possible kidney failure, kidney inflammation)
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp 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 (possibly more frequent and/or severe seizures)
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin)
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision, conjunctivitis, eye bleeding
• Reduction in the number of red and white blood cells and platelets (can cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Chest pain
• Taste disturbance
• Discoloration of the skin (bruising), muscle pain and weakness, joint pain
• Menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (can cause loss of appetite, headache, nausea, cramps, and muscle weakness)

The adverse 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 diseases unrelated to Arthritis or other arthritic conditions, were:

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

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

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

• Deep vein thrombosis (blood clotting usually in the leg, which can cause pain, swelling, or redness of the calf or breathing problems)
• Stomach problems: stomach infection (can cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia (infection in the chest, possibility of cough, fever, difficulty breathing)
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, ulcers, inflammation, or bleeding of the gums, mouth ulcers
• Excessive urination at night, bleeding hemorrhoids, frequent bowel movement
• Fat lumps on the skin or other areas, ganglion cyst (painless inflammation in the 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

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

5. Storage of Celenib

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

Do not use this medicine after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Celenib Composition

• 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, sodium croscarmellose, magnesium stearate.

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

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

Product Appearance and Package Contents

Celenib is presented in the form of hard capsules.

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

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Date of the Last Revision of this Prospectus: August 2013

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