Celecoxib Cinfa 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

celecoxib cinfa 200 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, 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 must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What celecoxib cinfa is and what it is used for

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

celecoxib cinfa belongs to a class of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs), and more 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 cinfa works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

The medicine will begin to take effect a few hours after taking the first dose, but a full effect may not be felt until several days have passed.

2. What you need to know before starting to take celecoxib cinfa

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

Do not take celecoxib cinfa

Inform your doctor if any of the following 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 medicine: 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 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 blood vessels to the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take celecoxib cinfa

• if you have previously had a stomach or intestinal ulcer or bleeding. (Do not take celecoxib if you currently have a stomach or intestinal ulcer or bleeding).
• if you are taking acetylsalicylic acid (even at low doses used as a cardioprotective agent)
• if you are taking antiplatelet therapies
• if you are taking medicines to reduce blood clotting (e.g., warfarin/warfarin analogues or newer oral anticoagulants, e.g., apixaban)
• if you are taking corticosteroids (e.g., prednisone)
• if you are taking celecoxib at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided
• if you are a smoker, or 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 previously experienced a severe allergic reaction or a severe 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 old, your doctor may want to monitor you regularly.
• alcohol consumption and NSAIDs may increase the risk of gastrointestinal problems

Like other anti-inflammatory medicines (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may periodically monitor it.

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 onset was reported, most serious liver reactions occurred within the first month of treatment.

Celecoxib may make it harder to get 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).

Other medicines and celecoxib cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

• Dextromethorphan (used to treat cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure)
• Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
• Warfarin or other warfarin analogues (agents that reduce blood clot formation), including newer agents such as apixaban
• 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). 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.

Pregnancy

Celecoxib 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 and contact your doctor for an alternative treatment.

Breastfeeding

Celecoxib must not be taken during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it harder to become pregnant. You should inform your doctor if you plan to become pregnant or if you are experiencing difficulty becoming pregnant.

Driving and using machines

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

celecoxib cinfa 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.

celecoxib cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially "sodium-free".

3. How to take celecoxib cinfa

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. 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 tell you 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 not to take celecoxib longer than necessary to control symptoms.

Method of administration:

Celecoxib must be taken orally. Capsules may be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time each day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a teaspoon of soft food (such as applesauce, rice, cold or room temperature mashed banana, or yogurt) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it vertically to keep the granules at the bottom; then press the top and twist to remove it, taking care not to spill the contents. Do not chew or crush the granules.

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

Recommended dose:

For the treatment of osteoarthritis

The recommended 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 recommended initial 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 recommended initial 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 2 capsules of 200 mg once daily.

Maximum daily dose:

Do 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.

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.

If you take more celecoxib cinfa than you should

Do not take more capsules than prescribed by your doctor. If you take more celecoxib than prescribed, 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 cinfa

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 cinfa

Stopping treatment with celecoxib abruptly may cause worsening of symptoms. 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 will experience them.

The adverse effects listed below were observed in patients with arthritis who were taking celecoxib. The adverse effects marked with an asterisk (*) were reported 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.

If you experience any of the following adverse effects, stop treatment with celecoxib and inform your doctor immediately if you have:

• 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, blistering or peeling of the skin.
• 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 patients):

• Increase in blood pressure, including worsening of existing high 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 infections
• Difficulty breathing*, sinusitis (inflammation and infection of the sinuses, sinus blockage or pain), stuffy 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*
• Headache
• Nausea (feeling unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

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

• Stroke*
• Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidney
• Anaemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, tiredness, 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, difficulty hearing*
• Constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Itchy, raised rash (urticarial wheals)
• Eye inflammation
• Difficulty breathing
• Skin discoloration (bruising)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

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 pancreas (may lead to stomach pain), inflammation of the throat (oesophagus)
• Low levels of sodium in the blood (a condition known as hyponatraemia)
• 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
• Hallucinations
• Eye haemorrhage
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
• Bleeding from the stomach or intestine (may lead to blood in stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Severe allergic reactions (including potentially life-threatening anaphylactic shock)
• 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 (symptoms include reddening of the skin with swollen areas and numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen glands and abnormalities in laboratory test results [e.g. liver, blood cells (eosinophilia, a type of increased blood cell count)]
• Bleeding in the brain leading to death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (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
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea and yellowing of the skin or eyes)
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibly more frequent and/or severe seizures)
• Blockage of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (may cause fever, pain, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of taste sensation
• Loss of taste

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

• Decreased fertility in women, which is usually reversible if the medicine is discontinued

Adverse effects reported in clinical trials where celecoxib was administered at a dose of 400 mg daily for up to 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, diarrhoea, indigestion, 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 clots usually in the leg, which may cause pain, swelling or redness of 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, bleeding from haemorrhoids, frequent bowel movements
• Fatty lumps in the skin or other sites, ganglion cyst (non-painful swelling in or around joints or tendons, usually 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 cinfa

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of celecoxib cinfa

• The active substance is celecoxib. Each hard capsule contains 200 mg of celecoxib.
• The other components (excipients) are: monohydrate lactose, sodium lauryl sulfate, povidone K-29/32, sodium croscarmellose and magnesium stearate. The capsule shell contains: gelatin, yellow iron oxide (E-172), quinoline yellow (E-104), titanium dioxide (E-171) and sodium lauryl sulfate. The printing ink contains: shellac glaze, black iron oxide (E-172), propylene glycol, concentrated ammonium solution and potassium hydroxide.

Appearance of the product and contents of the container

Celecoxib cinfa are capsules with a white body, printed with "200 mg", and a yellow cap, printed with "A001". The capsule contents are a white to off-white granule.

Presented in PVC/PVDC/Aluminum blisters. Each pack contains 20, 30 or 100 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: November 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78565/P_78565.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78565/P_78565.html