Celecoxib Mylan: detailed information

Package leaflet: Information for the patient

Celecoxib Mylan 100 mg hard capsules, 200 mg hard capsules

celecoxib
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Celecoxib Mylan is and what it is used for
What you need to know before taking Celecoxib Mylan
How to take Celecoxib Mylan
Possible side effects
How to store Celecoxib Mylan
Contents of the pack and other information

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

Celecoxib Mylan is used in adults for the relief of signs and symptoms of rheumatoid arthritis,
osteoarthritis, and ankylosing spondylitis.
Celecoxib Mylan belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), and more specifically to a subgroup known as cyclooxygenase-2 (COX-2) inhibitors.
Your body produces prostaglandins which can cause pain and inflammation. In certain conditions
such as rheumatoid arthritis and osteoarthritis, your body produces increased amounts of these.
Celecoxib Mylan works by reducing the production of prostaglandins, thereby reducing pain and
inflammation.
You should expect the medicine to start working within a few hours of taking the first dose, although
it may take several days to achieve its full effect.

2. What you need to know before taking Celecoxib Mylan

Celecoxib Mylan has been prescribed by your doctor. The following information will help you achieve the best results with Celecoxib Mylan. If you have further questions, please consult your doctor or pharmacist.
Do not take Celecoxib Mylan:
Inform your doctor if any of the following conditions apply to you, as patients in these circumstances must not take Celecoxib Mylan:

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 a group of medicines called “sulfonamides” (for example, certain antibiotics used to treat infections) or certain diuretic tablets
if you currently have a stomach or intestinal ulcer, or bleeding in the stomach or intestines
if, after taking acetylsalicylic acid (aspirin) or any other anti-inflammatory or pain-relief medicine (NSAIDs), you have experienced asthma, nasal polyps, severe nasal congestion or runny nose, or an allergic reaction such as skin rash with itching, swelling of the face, lips, tongue or throat, difficulty breathing or shortness of breath
if you are pregnant. If you could become pregnant during treatment, discuss possible 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 had heart disease, established ischemic heart disease or cerebrovascular disease, e.g. if you have been diagnosed with a heart attack, stroke or transient ischemic attack (a temporary reduction in blood flow to the brain; also known as “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 Mylan:

if you have previously had a stomach or intestinal ulcer or gastrointestinal bleeding. (Do not take Celecoxib Mylan if you currently have a stomach or intestinal ulcer or bleeding)
if you are taking acetylsalicylic acid (aspirin: even low-dose aspirin for heart protection)
if you are taking antiplatelet therapy
if you are using medicines to reduce blood clotting (e.g. warfarin or warfarin-like anticoagulants or newer oral anticoagulants such as apixaban, dabigatran, rivaroxaban)
if you are using corticosteroids (e.g. prednisone)
if you are taking Celecoxib Mylan together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. The concomitant use of these medicines should be avoided
if you smoke, have diabetes, high blood pressure, or high cholesterol levels
if your heart, liver or kidneys do not function properly, your doctor may perform regular monitoring
if you experience fluid retention (such as swelling of the ankles and feet)
if you are dehydrated, for example due to vomiting, diarrhoea, or use of diuretics (used to treat excess fluid in the body)
if you have had a severe allergic reaction or a serious skin reaction to any medicine
if you are unwell due to an infection or suspect you have an infection, as Celecoxib Mylan may mask fever or other signs of infection and inflammation
if you are over 65 years of age, your doctor will monitor you regularly
alcohol consumption and use of NSAIDs may increase the risk of gastrointestinal problems.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in blood pressure, and therefore your doctor may ask you to monitor your blood pressure at regular intervals.
Serious liver reactions, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation), have been reported with celecoxib. In cases where the onset time was reported, the most serious liver reactions occurred within one month of starting treatment (see section Possible side effects).
Taking Celecoxib Mylan may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or have difficulty conceiving (see section Pregnancy and breastfeeding).
Children and adolescents
Celecoxib Mylan is for adults only; use in children and adolescents is not recommended.
Other medicines and Celecoxib Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

dextromethorphan (used to treat cough)
ACE inhibitors, angiotensin II antagonists, beta-blockers, and diuretics (used for high blood pressure and heart failure)
diuretics (used to treat excess fluid in the body)
fluconazole and rifampicin (used to treat fungal and bacterial infections)
warfarin and other medicines similar to warfarin (blood thinners that reduce blood clotting), 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 to treat rheumatoid arthritis, psoriasis, and leukaemia)
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 Mylan may be taken with low-dose acetylsalicylic acid (aspirin; 75 mg or less per day). Ask your doctor for advice before taking both medicines together.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Celecoxib Mylan must not be used by women who are pregnant or who could become pregnant (e.g. women of childbearing age who are not using adequate contraception) during treatment. If you become pregnant while being treated with Celecoxib Mylan, you must stop treatment and contact your doctor for alternative treatment.
Breastfeeding
Celecoxib Mylan must not be used during breastfeeding.
Fertility
NSAIDs, including Celecoxib Mylan, may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving and using machines
Before driving or operating machinery, assess how you react to Celecoxib Mylan. If you experience dizziness or drowsiness after taking Celecoxib Mylan, do not drive or operate machinery until these effects have passed.
Celecoxib Mylan contains lactose
Celecoxib Mylan contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Celecoxib Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Celecoxib Mylan

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist. If you think the effect of Celecoxib Mylan 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 unwanted side effects related to heart problems may increase with dose and duration of use, it is important that you use the lowest effective dose needed to control your pain. You should not take Celecoxib Mylan for longer than necessary to control your symptoms.
If you do not experience any benefit, contact your doctor within two weeks of starting treatment.
The recommended dose is:
For osteoarthritis, the recommended dose is 200 mg per day, which may be increased by your doctor up to a maximum of 400 mg, if necessary.
The usual dose is:

one 200 mg capsule once daily; or
one 100 mg capsule twice daily.

For rheumatoid arthritis, the recommended dose is 200 mg per day, which may be increased by your doctor up to a maximum of 400 mg, if necessary.
The usual dose is:

one 100 mg capsule twice daily.

For ankylosing spondylitis, the recommended dose is 200 mg per day, which may be increased by your doctor up to a maximum of 400 mg, if necessary.
The usual dose is:

one 200 mg capsule once daily; or
one 100 mg capsule twice daily.

Liver or kidney problems: make sure your doctor knows if you have liver or kidney problems, as you may require a lower dose.
Elderly patients, particularly those weighing less than 50 kg: if you are over 65 years of age, and especially if you weigh less than 50 kg, your doctor may decide to monitor you more closely.
Do not take more than 400 mg per day.
Use in children and adolescents
Celecoxib Mylan should only be used in adults; it must not be used in children.
Method of administration
Celecoxib Mylan is for oral use. Celecoxib Mylan capsules must be swallowed whole with a glass of water. The capsules may be taken at any time of day, with or without food. However, try always to take each dose of Celecoxib Mylan at the same time every day.
If you take more Celecoxib Mylan 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.
If you forget to take Celecoxib Mylan
If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for the missed dose.
If you stop taking Celecoxib Mylan
Stopping treatment with Celecoxib Mylan suddenly may worsen your symptoms. Do not stop taking Celecoxib Mylan unless your doctor tells you to.
Your doctor may advise you to gradually reduce the dose over a few days before stopping completely.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects listed below were observed in patients with arthritis treated with Celecoxib Mylan. Side effects marked with an asterisk (*) are listed below under the most frequent occurrence in patients treated with Celecoxib Mylan for the prevention of colon polyps. Patients in these studies took Celecoxib Mylan at high doses and for a prolonged period.
If any of the following side effects occur, stop taking Celecoxib Mylan immediately and contact your doctor immediately:
If you experience:

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 black stools or blood in the stool, or vomiting blood
a skin reaction such as rashes, blisters or peeling of the skin
liver failure (symptoms include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or whites of the eyes))

Other side effects
Very common: may affect more than 1 in 10 people:

High blood pressure, including worsening of existing high blood pressure*

Common: may affect up to 1 in 10 people:

Heart attack*
Fluid retention with swollen ankles, legs and/or hands
Urinary tract infections
Shortness of breath*, sinusitis (inflammation of the sinuses, sinus infection, blocked or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
Dizziness, difficulty sleeping
Vomiting*, stomach ache, diarrhoea, indigestion, flatulence
Skin rash, itching
Muscle stiffness
Difficulty swallowing*
Headache
Nausea (feeling unwell)
Joint pain
Worsening of existing allergies
Accidental injuries

Uncommon: may affect up to 1 in 100 people:

Stroke*
Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
Abnormal results in blood tests relating to the liver
Abnormal results in blood tests relating to the kidneys
Anaemia (changes in red blood cells that may cause tiredness and shortness of breath)
Anxiety, depression, fatigue, dizziness, tingling sensations (pins and needles)
High levels of potassium in blood test results (may cause nausea (feeling unwell), tiredness, muscle weakness or palpitations)
Impaired or blurred vision, ringing in the ears, mouth pain and sores, hearing difficulties*
Constipation, burping, inflammation of the stomach (indigestion, stomach ache or vomiting), worsening of inflammation in the stomach or intestines
Leg cramps
Raised, itchy skin rash (urticaria)
Eye inflammation
Breathing difficulties
Skin discolouration (bruising)
Chest pain (general pain not related to the heart)
Swelling of the face

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

Ulcers (bleeding) in the stomach, oesophagus or intestines; or bowel hernia (may cause stomach pain, fever, nausea, vomiting, bowel obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the oesophagus
Low levels of sodium in the blood (a condition known as hyponatraemia)
Reduction in white blood cells (which help protect the body against infections) and platelets (increased risk of bleeding or bruising)
Difficulty coordinating muscle movements
Confusion, hallucinations, taste disturbances
Increased sensitivity to light
Hair loss
Bleeding in the eye
Acute reaction that may cause lung inflammation
Irregular heartbeat
Hot flushes
Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or fainting
Bleeding in the stomach or intestines (may cause blood in stools or vomit), inflammation of the intestine or colon
Severe liver inflammation (hepatitis). Symptoms include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills
Acute kidney failure
Menstrual disorders
Swelling of the face, lips, mouth, tongue or throat, difficulty swallowing

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

Severe allergic reactions (including potentially fatal anaphylactic shock)
Serious skin diseases such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blisters or peeling of the skin) and generalised exanthematous pustulosis (symptoms include reddened skin with swellings covered by numerous small pustules)
Delayed allergic reaction with possible symptoms such as skin rash, facial swelling, fever, swollen lymph nodes, abnormal blood test results (e.g. liver function, full blood count (eosinophilia, a specific increase in white blood cells)).
Fatal cerebral haemorrhage
Meningitis (inflammation of the membrane covering the brain and spinal cord)
Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (some cases have been fatal or required liver transplantation). Symptoms include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills
Liver disorders (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as altered stool colour, nausea and yellowing of the skin or eyes)
Kidney inflammation or other kidney disorders (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 (increased frequency and/or severity of seizures)
Blockage of an artery or vein in the eye, causing partial or complete loss of vision
Inflamed blood vessels (may cause fever, pain, red patches on the skin)
Reduction in red blood cells, white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds and increased risk of infections)
Muscle pain and weakness
Impaired sense of smell
Loss of taste

Not known: frequency cannot be estimated from the available data

Reduced fertility in women, generally reversible upon discontinuation of the medicine.

In clinical studies not related to arthritis or other arthritis-related conditions, in which Celecoxib Mylan was taken at doses of 400 mg daily for a maximum period of 3 years, the following side effects were observed:
Common: affects up to 1 in 10 people:

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

Uncommon: affects 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 (may cause irritation and ulcers in the stomach and intestines)
Fracture of the lower limbs
Herpes zoster, skin infections, eczema (dry, itchy rash), pneumonia (chest infection (possible cough, fever, breathing difficulties))
Floaters in the eye causing impaired or blurred vision, vertigo due to inner ear disorders, painful, inflamed or bleeding gums, mouth sores
Excessive urination at night, bleeding haemorrhoids, frequent bowel movements
Fatty deposits under the skin or elsewhere, ganglion cyst (harmless swelling on joints and around tendons of hands and feet or near them), difficulty speaking, abnormal or heavy vaginal bleeding, breast pain
High levels of sodium in blood test results

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celecoxib Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/blister pack/bottle after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Celecoxib Mylan contains

The active substance is celecoxib. Each hard capsule contains 100 mg of celecoxib. Each hard capsule contains 200 mg of celecoxib.
The other components are: sodium lauryl sulfate, povidone K29-32, monohydrate lactose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica. The capsule shell contains titanium dioxide (E171), gelatin, indigotine (E132), titanium dioxide (E171), gelatin, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172). The ink contains: shellac, black iron oxide (E172), propylene glycol.

Description of the appearance of Celecoxib Mylan and contents of the pack
Celecoxib Mylan is available as hard capsules.
Celecoxib Mylan 100 mg are hard gelatin capsules consisting of an opaque blue cap and an opaque white body, containing white to almost white powder. The capsule is printed with black ink with the inscription "MYLAN" above "CE 100" around the cap and body.
Celecoxib Mylan 200 mg are hard gelatin capsules consisting of an opaque light brown cap and an opaque white body, containing white to almost white powder. The capsule is printed with black ink with the inscription "MYLAN" above "CE 200" around the cap and body.
Celecoxib Mylan 100 mg hard capsules are available in unit dose blisters of 10, 20, 30, 40, 50, 60, 100, 1 x 30, 1 x 60 capsules or in bottles of 500 capsules.
Celecoxib Mylan 200 mg hard capsules are available in unit dose blisters of 10, 20, 30, 50, 60, 100, 1 x 30, 1 x 60 capsules or in bottles of 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Mylan Hungary Kft., H-2900 Komárom Mylan útca 1, Hungary

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
France CELECOXIB VIATRIS 200 mg, gélule
Germany Celecoxib Mylan 100 mg Hartkapseln
Celecoxib Mylan 200 mg Hartkapseln
Italy Celecoxib Mylan
Spain Celecoxib Viatris 200 mg cápsulas duras
United Kingdom Celecoxib 100 mg hard capsules
(Northern Ireland) Celecoxib 200 mg hard capsules