Celecoxib Combix 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Combix 200 mg hard capsules EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Celecoxib Combix is indicated in adults for the relief of the 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 known as non-steroidal anti-inflammatory drugs (NSAIDs), specifically to 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 them in higher amounts. Celecoxib Combix works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

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

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

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

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously 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 drug: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy skin 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 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 “mini-stroke”), angina pectoris, or blockage of blood vessels to the heart or brain.
• if you have or have had 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 CelecoxibCombix:

• if you have previously had an ulcer or bleeding in your stomach or intestine (Do not take celecoxib if you currently have an ulcer or bleeding in your stomach or intestine).
• if you are taking acetylsalicylic acid (even at low doses such as for heart protection).
• if you are taking medications to reduce blood clotting (e.g., warfarin).
• if you are taking celecoxib at the same time as other non-acetylated 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 are not functioning 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 experienced 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 may mask fever or other signs of infection and inflammation.
• if you are over 65 years of age, your doctor may want to monitor you regularly.

Like other anti-inflammatory drugs (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may monitor it periodically. Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where timing was specified, most serious 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 difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Children and adolescents

Celecoxib is intended for adults only and is not indicated for use in children.

Taking CelecoxibCombix with other medicines

Some medicines can affect the action of other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 infections caused by bacteria and fungi).
• Warfarin or other oral anticoagulants (agents that reduce blood clot formation).
• 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 transplants).

Celecoxib may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Please seek advice from your doctor 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. Celecoxib Combix 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, you must stop treatment immediately and contact your doctor to discuss alternative treatment. Celecoxib Combix must not be taken during breastfeeding.

Driving and using machines

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

CelecoxibCombix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

3. How to take Celecoxib Combix

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 is too strong or too weak, inform your doctor or pharmacist. Your doctor will determine 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 effective dose that controls your pain, and you should not take celecoxib longer than necessary to control your symptoms.

Contact your doctor if you do not experience improvement within two weeks after starting treatment.

The recommended dose is:

For the treatment of osteoarthritis

The usual dose is 200 mg per day (1 capsule of 200 mg once daily).

If necessary, your doctor may increase the dose up to a maximum of 400 mg (1 capsule of 200 mg twice daily).

For the treatment of rheumatoid arthritis

The usual dose is 200 mg per day (1 capsule of 100 mg twice daily. This recommended initial dose of 100 mg twice daily 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 daily).

For the treatment of ankylosing spondylitis

The usual dose is 200 mg per day (1 capsule of 200 mg once daily). If necessary, your doctor may increase the dose up to a maximum of 400 mg (1 capsule of 200 mg twice daily or two capsules of 200 mg once daily).

Maximum daily dose

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

Patients with kidney or liver problems

Make sure your doctor knows if you have liver or kidney problems, as you may require a lower dose.

Elderly patients over 65 years of age, 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.

Use in children

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

Method of administration

This medicine is taken orally. The capsules should be swallowed whole with a glass of water. The capsules may be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Combix at the same time each day.

If you take more Celecoxib Combix than you should

Do not take more capsules than prescribed by your doctor. If you take more capsules than directed, 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Celecoxib Combix

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 Celecoxib Combix

Stopping treatment with celecoxib abruptly may cause your symptoms to worsen. Do not stop taking celecoxib unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before stopping treatment completely.

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 experiences 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. The patients included in these studies took celecoxib at high doses and for a prolonged period of time.

Stop 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 blood-stained stools, or blood in vomit.
• a skin reaction such as rash, blisters or skin peeling.
• liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (your skin or the whites of your eyes appear yellow)).

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
• Difficulty breathing*, sinusitis (inflammation and infection of the sinuses, sinus blockage or pain), nasal congestion or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, 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 (awareness of heartbeat), rapid heartbeat
• Worsening of high blood pressure
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidney
• Anaemia (changes in red blood cells that may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, 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, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial wheals)

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

• (Bleeding) ulcers 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)
• Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)
• Difficulty in muscular coordination of movements
• Feeling confused, taste disturbances
• Increased sensitivity to light
• Hair loss

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Bleeding in the brain leading to death
• Serious allergic reactions (including potentially life-threatening anaphylactic shock) which may cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing
• Bleeding from the stomach or intestines (may result in blood in stools or vomit), inflammation of the intestine or colon, nausea (feeling unwell)
• Serious skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or skin peeling) and acute generalized exanthematous pustulosis (swollen and red area with numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rashes, facial swelling, 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 fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bleeding, itching or chills
• Kidney problems (possible kidney failure, inflammation of the kidneys)
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse (circulatory obstruction of the pulmonary pathways)
• 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 (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, conjunctivitis, eye haemorrhage
• Reduction in the number of red and white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
• Chest pain – altered sense of taste
• Skin discolouration (bruising), muscle pain and weakness, joint pain
• Menstrual disorders
• Headache, flushing
• Low levels of sodium in blood test results (may cause loss of appetite, headache, nausea (feeling unwell), muscle cramps and weakness)

Adverse effects reported in clinical trials where celecoxib was administered at a dose of 400 mg per day for more than 3 years, in patients with conditions unrelated to arthritis or other arthritic conditions, were:

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

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion and gas)
• Kidney stones (which may lead to stomach or back pain, blood in 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 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 (infection in the chest (possible cough, fever, difficulty breathing))
• Eye floaters 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, haemorrhoid/anal fissure bleeding, frequent bowel movements
• Fatty lumps in the skin or other areas, 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of CelecoxibCombix

• The active substance is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other components (excipients) are: monohydrate lactose, 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 (E904), black iron oxide (E172), dehydrated alcohol, propylene glycol, isopropyl alcohol, butyl alcohol, and potassium hydroxide (E525).

Appearance of the product and contents of the pack

Opaque white hard capsules, marked with "200" printed on the body of the capsule in black ink.

Blister packs made of OPA/AL/PVC-Aluminum (standard and perforated) and PVC/PVDC-Aluminum (standard and perforated).

Packages containing 20 and 30 capsules.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible for production

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 the most recent revision of this leaflet: March 2014

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