Prospect:Information for the Patient

Celecoxib Tarbis Farma 200 mg Hard Capsules EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they 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 prospect.

1.What is Celecoxib Tarbis Farma and what is it used for

2.What you need to know before starting to take Celecoxib Tarbis Farma

3.How to take Celecoxib Tarbis Farma

4.Possible adverse effects

5Storage of Celecoxib Tarbis Farma

6.Contents of the package and additional information

Celecoxib Tarbis Farma is indicated in adults to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib Tarbis Farma 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.Celecoxib Tarbis Farmaacts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

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

Do not take Celecoxib Tarbis Farma

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

• 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 hemorrhage
• 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, 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 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 to repair the arteries in your legs

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Tarbis Farma

• if you have previously had a stomach or intestinal ulcer or hemorrhage. (Do not take Celecoxib Tarbis Farma if you currently have a stomach or intestinal ulcer or hemorrhage).
• 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 Celecoxib Tarbis Farma at the same time as other non-acetylsalicylic acid anti-inflammatory medications such as ibuprofen or diclofenac. The concurrent use of these medications should be avoided
• 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 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 medication
• if you feel unwell due to an infection or think you have an infection, as taking Celecoxib Tarbis Farma 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.

Celecoxib Tarbis Farma may make it difficult to become pregnant. Inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celecoxib Tarbis Farma 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)

Celecoxib Tarbis Farma 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

Celecoxib Tarbis Farma 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 Celecoxib Tarbis Farma, you should discontinue treatment and contact your doctor for alternative treatment.

Celecoxib Tarbis Farma should not be taken during breastfeeding.

Driving and operating machinery

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

Celecoxib Tarbis Farma 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 medication

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

If you think or believe that the action of Celecoxib Tarbis Farma is too strong or too 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 Celecoxib Tarbis Farma for longer than necessary to control your symptoms.

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

Recommended dose:

Celecoxib Tarbis Farma is available in hard capsules of 200 mg. Depending on the medication prescribed by your doctor, 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 dayonce 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 daytwice a day.

For the treatment of rheumatoid arthritis

The initial recommended dose is 200 mg per day:

• 1 capsule of 100 mg twice a daytwice a day(This recommended dose of 100 mg twice a day cannot be administered with this medication. There are other medications 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 daytwice a day

For the treatment of ankylosing spondylitis

The initial recommended dose is 200 mg per day:

• 1 capsule of 200 mg once a dayonce a day

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

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

Maximum daily dose:

You should not take more than 400 mg 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:Celecoxib Tarbis Farma 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 Celecoxib Tarbis Farma at the same time every day.

If you take more Celecoxib Tarbis Farma than you should

You should not take more capsules than indicated by your doctor. If you take more capsules than prescribed, 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 Celecoxib Tarbis Farma

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 Celecoxib Tarbis Farma

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

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

Like all medications, Celecoxib Tarbis Farma 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 who took 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 treatment with Celecoxib Tarbis Farma and immediately inform your doctor 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 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, or yellowing of the skin or eyes).

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 the 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, esophagus, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the esophagus (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
• Confusion, altered sense of 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 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
• 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, diarrhea, jaundice, dark urine, pale stools, easy bruising, itching, or chills
• Renal problems (possible renal insufficiency, kidney inflammation)
• Pulmonary embolism (blood clots in the pulmonary vessels). Symptoms may include sudden difficulty breathing, acute chest pain, or collapse (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)
• Vascular inflammation (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
• Reduced red and white blood cell count and platelet count (may cause fatigue, frequent nosebleeds, and increased risk of infections)
• Chest pain
• Altered sense of taste
• Decoloration of the skin (petechiae), muscle pain and weakness, joint pain
• Menstrual disorders
• Headache, flushing
• Low sodium levels in blood test results (may cause loss of appetite, headache, nausea, muscle cramps, and weakness)

The side effects observed in clinical trials in which celecoxib was administered at a dose of 400mg 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 difficulty breathing)
• Gastrointestinal problems: stomach infection (which may cause stomach irritation or ulcers)
• Lower limb fractures
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia (chest infection, possibility of cough, fever, difficulty breathing)
• Flies in the eye causing vision 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 on the boxafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Celecoxib Tarbis Farma

• 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 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 Container

Celecoxib Tarbis Farma 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.

Celecoxib Tarbis Farma may be presented in containers of 30 and 100 hard capsules.

Only some container sizes may be commercially marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028, 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:

September 2013

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/