Celecoxib Mabo 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib MABO 200 mg Hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

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

Celecoxib MABO 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 MABO works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

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

Your doctor has prescribed Celecoxib MABO. The following information will help you achieve the best results with Celecoxib MABO. If you have any further questions, please ask your doctor or pharmacist.

Do not take Celecoxib MABO

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

• 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 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, or blockage of the blood vessels supplying 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

Talk to your doctor or pharmacist before starting to take Celecoxib MABO

• if you have previously had an ulcer or bleeding in your stomach or intestine. (Do not take Celecoxib MABO if you currently have a stomach or intestinal ulcer or bleeding).
• 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 MABO 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 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 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 think you have an infection, as taking Celecoxib MABO 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 periodically monitor it.

During treatment with celecoxib, there have been reports of rare cases of serious liver reactions, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the timing was specified, most serious liver reactions occurred within the first month of treatment.

Celecoxib MABO may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Taking Celecoxib MABO 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 organ transplants).

Celecoxib MABO may be taken with low-dose 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.

Celecoxib MABO should 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 MABO, you must stop treatment and contact your doctor to discuss alternative treatment.

Celecoxib MABO should not be taken during breastfeeding.

Driving and using machines

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

Celecoxib MABO contains lactose

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

3. How to take Celecoxib MABO

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

If you think or believe that the effect of Celecoxib MABO 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 dose that controls your pain and not to take Celecoxib MABO longer than necessary to control symptoms.

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

Recommended dose:

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

For the treatment of osteoarthritis

The usual dose is 200 mg once daily, which may be taken as:

• 1 capsule of 200 mg once daily

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

• 1 capsule of 200 mg twice daily

For the treatment of rheumatoid arthritis

The recommended initial dose is 200 mg daily:

• 1 capsule of 100 mg twice daily (This recommended dose of 100 mg twice daily cannot be administered with this medicine. Other medicines with a concentration of 100 mg of celecoxib are available.)

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 recommended initial dose is 200 mg daily:

• 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 2 capsules of 200 mg once daily

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 require a lower dose.

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 MABO is for adults only and 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 Celecoxib MABO at the same time each day.

If you take more Celecoxib MABO 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 (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Celecoxib MABO

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

If you stop taking Celecoxib MABO

Stopping treatment with Celecoxib MABO abruptly may cause worsening of symptoms. Do not stop taking Celecoxib MABO 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, Celecoxib MABO may cause adverse effects, although not everyone experiences them.

The adverse effects listed below were observed in patients with arthritis who were taking celecoxib. 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 MABO and contact 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, blood-stained stools, or blood in vomit.
• A skin reaction such as rash, blistering or peeling of the skin.
• Liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or whites of the eyes)).

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 sinuses, sinus blockage or pain), nasal congestion 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 (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
• Anemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• Elevated 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 wheal)

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (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 with 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):

• Brain hemorrhage leading to death
• Severe 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 bloody stools or vomit), inflammation of the intestine or colon, nausea (feeling unwell)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may 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 fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellow discoloration of skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Kidney problems (possible kidney failure, kidney inflammation)
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse (pulmonary vascular obstruction)
• 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, aches, purple spots on the skin)
• Blockage of an artery or vein in the eye leading to partial or complete vision loss, conjunctivitis, eye hemorrhage
• 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
• Alteration of taste
• Skin discoloration (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 observed in clinical trials in which Celecoxib was administered at a dose of 400 mg daily 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 patients):

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

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

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness in the calf or breathing problems)
• Stomach problems: stomach infection (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, hemorrhoid bleeding, frequent bowel movements
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in joints, tendons or around them, usually in hand or foot), difficulty speaking, abnormal or heavy vaginal bleeding, chest pain
• Elevated levels of sodium in blood test results

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect 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 MABO

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer carton after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib MABO

• The active substance 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 printing ink contains: black iron oxide (E172), shellac-NF-E904, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonium hydroxide solution, potassium hydroxide, and purified water.

Nature of the product and pack contents

Celecoxib MABO is presented as hard capsules.

Capsules with a white body printed with "200 mg" and a yellow cap printed with "A001".

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

Celecoxib MABO may be available in packs containing 30 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

or

Laboratorios Cinfa S.A.

Ctra. Olaz-Chipi, 10.

Poligono Industrial Areta - Huarte - Navarra

31620 – Spain

Date of latest review of this leaflet: May 2021

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