CELECOXIB COMBIX 200 mg HARD CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

CelecoxibCombix200 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 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. See section 4.

Contents of the pack and other information:

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

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

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

Celecoxib Combix contains celecoxib as the active substance and belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), specifically 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. Celecoxib Combix works by reducing the production of prostaglandins, thus reducing pain and inflammation.

2. What you need to know before you take Celecoxib Combix

Your doctor has prescribed celecoxib for you. The following information will help you get the best results with celecoxib. If you have any other questions, please ask your doctor or pharmacist.Do not take CelecoxibCombix

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

• 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 of 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 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, 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 to the heart or brain.
• if you have had problems with blood circulation (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 CelecoxibCombix:

• if you have previously had a stomach or intestinal ulcer or bleeding (Do not take celecoxibif 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 taking medicines to reduce blood clotting (e.g. warfarin)
• if you are taking celecoxib 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 celecoxib 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. Some cases of severe liver reactions have been reported with celecoxib, 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 within the first month of treatment.Celecoxib Combix may make it more 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).Children and adolescents

Celecoxib is only for adults, it is not indicated in children.

Taking CelecoxibCombixwith other medicines

Some medicines may affect the way other medicines work. Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• Dextromethorphan (used to treat cough)
• ACE inhibitors or angiotensin II receptor antagonists (medicines used to treat high blood pressure and heart failure)
• Diuretics (used to remove 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)
• Cyclosporin and tacrolimus (used to suppress the immune system, e.g. after transplants).

Celecoxib 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.Celecoxib Combix should not be used by women who are pregnant or may become pregnant (i.e. women of childbearing potential who do not use an effective contraceptive method) during treatment. If you become pregnant during treatment with celecoxib, you should stop treatment and contact your doctor for alternative treatment.Celecoxib Combix should not be taken during breastfeeding.

Driving and using machines

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

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

3. How to take Celecoxib Combix

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

If you think that the effect of celecoxib is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose to 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 celecoxib for longer than necessary to control the symptoms.

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

The recommended dose is:

For the treatment of osteoarthritis

The usual 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 day).

For the treatment of rheumatoid arthritis

The usual dose is 200 mg per day (1 capsule of 100 mg twice a day. This initial recommended dose of 100 mg twice a day cannot be administered with this medicine. Please consult your doctor).

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 usual 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 onceaday).

Maximum daily dose

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

Patient with 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 kgYour 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 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. The capsules can be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Combix at the same time every day.

If you take more CelecoxibCombixthan you should

Do not take more capsules than your doctor has told you. If you take more capsules than you should, contact your doctor, pharmacist, or hospital immediately and take the medicine with you. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take CelecoxibCombix

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 CelecoxibCombix

Sudden stopping of treatment with celecoxib may cause worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will tell you to reduce the dose over 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, this medicine 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 celecoxib 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 skin peeling.
• Liver failure (symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes)).

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Increased blood pressure*

Common Adverse Effects (may affect up to 1 in 10 people):

• Heart attack*
• Fluid retention with swelling of ankles, legs, and/or hands
• Urinary tract infection
• Difficult 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 people):

• Stroke*
• Heart failure, palpitations (perception of heartbeat), rapid 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 people):

• 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)
• Decrease in the number of white blood cells and platelets (increases the possibility of bleeding and bruising)
• Difficulty in muscle coordination
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss

Adverse Effects of Unknown Frequency (frequency cannot be estimated from 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 skin peeling) and acute generalized exanthematous pustulosis (red and swollen area with numerous small pustules)
• A late allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands, and abnormalities in 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 (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching, 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 heartbeat
• 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, ease of bruising, frequent nosebleeds, and increased risk of infections)
• Chest pain - Alteration of taste
• Discoloration of the skin (bruises), 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)

Adverse Effects Reported 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 people):

• 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 people):

• 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 intestines)
• 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 disorder 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 from 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 heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results

Reporting of Adverse Effects

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

5. Storage of Celecoxib Combix

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Celecoxib Combix Composition

• The active ingredient is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other ingredients (excipients) are: lactose monohydrate, sodium lauryl sulfate, povidone K-30, sodium croscarmellose, and magnesium stearate. The capsule shell contains: gelatin, titanium dioxide (E171), sodium lauryl sulfate, and water. The printing ink contains: shellac lacquer (E904), black iron oxide (E172), dehydrated alcohol, propylene glycol, isopropyl alcohol, butyl alcohol, and potassium hydroxide (E525).

Product Appearance and Packaging Contents

Hard, opaque, white capsules with "200" printed on the body of the capsule in black ink.

OPA/AL/PVC-Aluminum (standard and perforated) and PVC/PVDC-Aluminum (standard and perforated) blisters.

Packaging containing 20 and 30 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of Last Revision of this Leaflet:March 2014

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.