Celecoxib Teva 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Teva 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

This medicine contains celecoxib as the active substance and belongs to a group 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 and osteoarthritis, the body produces increased amounts. Celecoxib works by reducing the production of prostaglandins and thereby decreases pain and inflammation.

The medicine will start to work several hours after taking the first dose, but you may not experience the full effect until several days have passed.

2. What you need to know before taking Celecoxib Teva

Do NOT take Celecoxib Teva

• if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to the group of medicines known as “sulphonamides” (e.g., certain antibiotics used to treat infections).
• if you currently have a stomach or intestinal ulcer or gastrointestinal bleeding.
• if you have previously experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction (such as skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing) after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory and pain-relieving drug (NSAID).
• 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 an inflammatory bowel disease such as ulcerative colitis or Crohn’s disease.
• if you have heart failure, diagnosed ischaemic heart disease, or cerebrovascular disease (e.g., you have been diagnosed with a heart attack, stroke, transient ischaemic attack [temporary reduction in blood flow to the brain, also known as a “mini-stroke”], angina, or blockage of blood vessels supplying 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 taking Celecoxib Teva

• if you have previously had a stomach or intestinal ulcer or gastrointestinal bleeding. Do not take Celecoxib Teva if you currently have a stomach or intestinal ulcer or bleeding.
• if you are currently taking acetylsalicylic acid (even at low doses for cardioprotection).
• if you are taking antiplatelet treatments.
• if you are taking blood-thinning medicines (e.g., warfarin/anticoagulants such as warfarin or newer anticoagulant medicines such as apixaban).
• if you are taking corticosteroid medicines (such as prednisone).
• if you are taking Celecoxib Teva together with 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 if you 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 ankles or feet).
• if you are dehydrated due to vomiting, diarrhoea, or use of diuretics (used to treat excess fluid in the body).
• if you have previously had a severe allergic reaction or serious skin reaction to any medicine.
• if you feel unwell due to an infection or suspect you have an infection, as taking Celecoxib Teva may mask fever or other symptoms of infection or inflammation.
• if you are over 65 years of age, your doctor will want to monitor you regularly.
• alcohol consumption together with NSAIDs may increase the risk of gastrointestinal problems.

Like other NSAIDs (e.g., ibuprofen or diclofenac), this medicine may increase blood pressure, and your doctor may therefore monitor your blood pressure periodically.

Serious liver-related reactions, such as severe hepatitis, liver damage, and liver failure (some of which have been fatal or required liver transplantation), have been reported during treatment with celecoxib. Among cases where the onset was specified, most serious hepatic reactions occurred within the first month of treatment.

Celecoxib Teva 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 on Pregnancy, breastfeeding, and fertility).

Taking Celecoxib Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• some cough medicines (dextromethorphan);
• medicines used to treat high blood pressure and heart failure (e.g., ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics);
• some medicines used to treat fungal or bacterial infections (fluconazole and rifampicin);
• agents that reduce blood clotting (warfarin or other warfarin-type medicines, including newer agents such as apixaban);
• medicines used to treat depression (e.g., lithium);
• medicines used to treat sleep disorders or cardiac arrhythmias;
• medicines used to treat mental disorders (neuroleptics);
• some medicines used to treat rheumatoid arthritis, psoriasis, and leukaemia (methotrexate);
• some medicines used to treat epilepsy/seizures and certain types of pain or depression (carbamazepine);
• some medicines used to treat epilepsy/seizures and certain sleep disorders (barbiturates);
• some medicines used to suppress the immune system, e.g., after organ transplants (cyclosporine and tacrolimus);
• acetylsalicylic acid. Celecoxib Teva may be taken concomitantly with low-dose acetylsalicylic acid. Consult your doctor or pharmacist before starting to take both medicines together.

Celecoxib Teva 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 Teva must not be used by pregnant women or women who may become pregnant (i.e., women of childbearing potential who are not using adequate contraceptive methods) during treatment. If you become pregnant while taking Celecoxib Teva, stop treatment immediately and contact your doctor to discuss alternative treatment.

Breastfeeding

Celecoxib Teva must not be taken during breastfeeding.

Fertility

NSAIDs, including Celecoxib Teva, may make it more difficult to become pregnant. You should inform your doctor if you are planning 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 Teva before driving or operating machinery. If you feel dizzy or drowsy after taking Celecoxib Teva, do not drive or operate machinery until these effects have passed.

Celecoxib Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, it is “sodium-free”.

3. How to take Celecoxib Teva

Follow exactly the administration instructions given to you by your doctor or pharmacist for this medicine. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will tell you what dose to take. Since the risk of adverse effects related to heart problems increases with dose and duration of treatment, it is important that you take the lowest dose needed to control your pain and that you do not use celecoxib for longer than necessary to control your symptoms.

Method of administration

Celecoxib is for oral use. The capsules can be taken at any time of day, with or without food. However, try to take all doses of celecoxib at the same time each day.

If you have difficulty swallowing capsules: The entire contents of the capsule may be sprinkled onto a tablespoon of soft food (such as apple sauce, rice porridge, yogurt, or cold or room temperature banana puree) and swallowed immediately with a glass of approximately 240 ml of water.

To open the capsule, hold it vertically to keep the powder at the bottom, then gently squeeze the top and twist it off, taking care not to spill the contents.

Contact your doctor if you do not notice improvement within two weeks of starting treatment.

Recommended dose:

For osteoarthritis

The recommended dose is 200 mg daily; if necessary, your doctor may increase the dose up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice daily.

For rheumatoid arthritis

The recommended dose is 200 mg daily (taken in two divided doses); if necessary, your doctor may increase the dose up to a maximum of 400 mg (taken in two divided doses).

The dose is usually:

• one 100 mg capsule twice daily.

For ankylosing spondylitis

The recommended dose is 200 mg daily; if necessary, your doctor may increase the dose up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once daily, or
• one 100 mg capsule twice 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 kidney or liver problems, as you may require a lower dose.

Patients over 65 years of age, especially those weighing less than 50 kg

If you are over 65 years of age and especially weigh less than 50 kg, your doctor may wish to monitor you more closely.

Use in children

Celecoxib is for adults only; it is not indicated for use in children.

If you take more Celecoxib Teva than you should

Do not take more capsules than prescribed by your doctor. If you take too many capsules, contact your doctor, pharmacist, or hospital 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), stating the medicine and the amount taken.

If you forget to take Celecoxib Teva

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

If you stop taking Celecoxib Teva

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

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 Teva can cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed in patients with arthritis. Some adverse effects are marked with an asterisk (*). These adverse effects occurred at the frequency indicated only in patients taking Celecoxib Teva at high doses and for a prolonged period of time to treat other symptoms. They occurred less frequently in patients with arthritic diseases.

Stop taking Celecoxib Teva and contact your doctor immediately if you experience:

• an allergic reaction such as skin rash, facial swelling, wheezing or difficulty breathing.
• skin reactions such as rash, blistering or peeling of the skin.
• heart problems such as chest pain.
• severe stomach pain or any sign of bleeding in the stomach or intestine, such as dark or bloody stools, or blood in vomit.
• liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (skin or whites of the eyes appear yellow)).

Very common (may affect more than 1 in 10 people):

• Increased blood pressure, including worsening of pre-existing hypertension*.

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

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Breathing difficulties*, 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, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon (may affect up to 1 in 100 people):

• 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
• Anemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, tiredness, 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 difficulties*
• Constipation, burping, stomach inflammation (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)
• Facial swelling

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

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), black or tarry stools, pancreatitis (may cause stomach pain), inflammation of the throat (esophagus)
• Low levels of sodium in the blood (a condition known as hyponatremia)
• 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 bleeding
• 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 result in blood in stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty swallowing

Very rare (may affect up to 1 in 10,000 people):

• 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 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 rash, 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))
• 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), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or 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 (edema), 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, aches, 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
• Impairment of the sense of smell
• Impairment of the sense of taste

Frequency not known (cannot be estimated from available data):

Decreased fertility in women, which is usually reversible upon discontinuation of the medication

In clinical trials not related to arthritis or other arthritic conditions, where celecoxib was taken at a dose of 400 mg per day for up to 3 years, the following adverse effects were observed:

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

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

Uncommon (may affect up to 1 in 100 people):

• Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness in the calf or breathing difficulties)
• 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 (chest infection (possible cough, fever, difficulty breathing))
• Eye floaters causing visual disturbance or blurred vision, conjunctival hemorrhage, vertigo due to inner ear problems, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, hemorrhoid/anal bleeding, frequent bowel movements
• Fatty lumps under the skin or elsewhere, 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
• Elevated 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 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 Teva

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

Do not use this medicine after the expiry date stated on the label, blister pack, or cardboard box, following "EXP". The expiry date refers to the last day of the month indicated.

ALU/ALU Blister

This medicine does not require any special storage conditions.

PVC/PVDC/ALU Blister

Do not store above 30 °C.

Tablet container (bottle)

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Teva

• The active substance is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other components (excipients) are: calcium hydrogen phosphate dihydrate, sodium lauryl sulfate, crospovidone (type B), povidone (K30), povidone (K90), magnesium stearate, gelatin, shellac, propylene glycol, purified water, titanium dioxide (E171), yellow iron oxide (E172).

What Celecoxib Teva looks like and contents of the pack

Celecoxib Teva is a hard gelatin capsule, opaque, white in colour, with a yellow "200" mark.

Celecoxib Teva may be available in packs containing 5, 10, 20, 30, 50, 60, 90 and 100 hard capsules in blister packs, 30 x 1 and 50 x 1 hard capsules in perforated unit dose blisters, and 100 hard capsules in tablet containers.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80,

31-546 Krakow

Poland

or

HBM Pharma s.r.o.

03680 Martin,

Slabinská 30

Slovakia

This medicinal product is authorised in EEA Member States under the following names:

Belgium: Celecoxib Teva 200 mg capsules, hard

France: Celecoxib TEVA 200 mg, gélules

Germany: Celecoxib AbZ 200 mg Hartkapseln

Italy: Celecoxib Teva

The Netherlands: Celecoxib Teva 200 mg, capsules, hard

Spain: Celecoxib Teva 200 mg hard capsules EFG

Date of the most recent review of this leaflet: July 2024

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76749/P_76749.html

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