CELECOXIB 100 mg Hard Capsules

Зміст інструкції

1. Celecoxib Mylan 100 mg hard capsules, 200 mg hard capsules
   1. What is Celecoxib Mylan and what it is used for
   2. What you need to know before taking Celecoxib Mylan
   3. How to take Celecoxib Mylan
   4. Possible side effects
   5. How to store Celecoxib Mylan
   6. Package Contents and Other Information
2. Celecoxib Mylan 200 mg hard capsules

Celecoxib Mylan 100 mg hard capsules, 200 mg hard capsules

celecoxib

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Celecoxib Mylan is used in adults for the relief of signs and symptoms of rheumatoid arthritis,

osteoarthritisand ankylosing spondylitis.
Celecoxib Mylan belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), and more precisely to a subgroup known as cyclooxygenase-2 (COX-2) inhibitors. Your
body produces prostaglandins which can cause pain and inflammation. In some conditions
such as rheumatoid arthritis and osteoarthritis your body produces a greater quantity of them. Celecoxib
Mylan works by reducing the production of prostaglandins, thus reducing pain and inflammation.
You should expect the medicine to start to take effect after a few hours from taking the
first dose, but it may not reach a full effect for a few days.

2. What you need to know before taking Celecoxib Mylan

Celecoxib Mylan has been prescribed to you by your doctor. The following information will help you get the
best results with Celecoxib Mylan. If you have further questions, ask your doctor or pharmacist.

Do not take Celecoxib Mylan:
Tell your doctor if any of the following conditions apply to you, as patients who
are in these conditions should not take Celecoxib Mylan:

• if you are allergic to celecoxib or 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 “sulphonamides” (such as some antibiotics used to treat infections) or some diuretic tablets/water tablets
• if you currentlysuffer from an ulcer in the stomach or intestine, or bleeding in the stomach or intestine
• if, after taking acetylsalicylic acid (aspirin) or any other anti-inflammatory or pain-relieving medicine (NSAIDs), you have had 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 wheezing
• if you are pregnant. If you might become pregnant during the current treatment, you should discuss possible contraceptive methods with your doctor
• if you are breastfeeding
• if you have a severe liver disease
• if you have a 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 ischaemic heart disease or cerebrovascular disease, e.g. if you have been diagnosed with a heart attack, stroke or transient ischaemic attack (a temporary reduction in blood flow to the brain; also known as “mini-stroke”), angina or blockage of the blood vessels leading to the heart or brain
• if you have or have had problems with blood circulation (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 taking Celecoxib Mylan:

• if you have previouslyhad an ulcer or bleeding in the stomach or intestine. ( Do not takeCelecoxib Mylanif you have an ulcer or bleeding in the stomach or intestine currently)
• if you are taking acetylsalicylic acid (aspirin; even at low doses to protect the heart);
• if you are taking antiplatelet therapies;
• if you are using medicines to reduce blood clotting (e.g. warfarin or medicines similar to warfarin or new oral anticoagulants such as e.g. apixaban, dabigatran, rivaroxaban);
• if you are using medicines called corticosteroids (e.g. prednisone);
• if you are using Celecoxib Mylan at the same time as other NSAIDs other than acetylsalicylic acid such as ibuprofen or diclofenac. The simultaneous 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 are not functioning well, your doctor may subject you to regular checks;
• if you suffer from 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 severe skin reaction to any medicine;
• if you are feeling unwell due to an infection or think you have an infection, as Celecoxib Mylan may mask a fever or other signs of infection and inflammation;
• if you are over 65 years of age, your doctor will monitor you regularly;
• drinking alcohol and taking NSAIDs may increase the risk of gastrointestinal problems.

As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead to an increase in
blood pressure and therefore your doctor may ask you to monitor your blood pressure at regular
intervals.
Some cases of serious liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplantation) have been reported with celecoxib.
In cases where the time of onset was reported, the most serious liver reactions occurred within
one month of starting treatment (see Possible side effects).
Taking Celecoxib Mylan may make it more difficult to become pregnant. You should inform your
doctor if you are planning a pregnancy or if you have problems starting a pregnancy (see section
Pregnancy and breastfeeding).

Children and adolescents
Celecoxib Mylan is only for adults, use in children and adolescents is not recommended.

Other medicines and Celecoxib Mylan
Tell 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 receptor antagonists and 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-thinning agents that reduce blood clotting) including newer medicines such as apixaban
• lithium (used to treat some types of depression)
• other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
• neuroleptics (used to treat some mental disorders)
• methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
• barbiturates (used to treat epilepsy/seizures and some sleep disorders)
• cyclosporine and tacrolimus (used for suppression of the immune system e.g. after transplants).

Celecoxib Mylan can be taken with low-dose acetylsalicylic acid (aspirin; 75 mg or less per
day). Ask your doctor for advice before taking the two medicines together.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you might be pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Celecoxib Mylan should not be used by women who are pregnant or who may become pregnant
(e.g. women of childbearing potential who are not using adequate contraception) during the treatment. If
you become pregnant during treatment with Celecoxib Mylan, you should stop treatment and
contact your doctor for alternative treatment.

Breastfeeding
Celecoxib Mylan should not be used during breastfeeding.

Fertility
NSAIDs, including Celecoxib Mylan, may make it more difficult to become pregnant. You should inform your
doctor if you are planning a pregnancy or if you have problems getting pregnant.

Driving and using machines
Before driving or using machines you should see how you react to Celecoxib Mylan. If you experience
dizziness or drowsiness after taking Celecoxib Mylan, do not drive or use machines until these
effects have worn off.

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 him/her before taking this medicine.

Celecoxib Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodiumper capsule, that is to say essentially “sodium-free”.

3. How to take Celecoxib Mylan

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist. If you think that the effect of Celecoxib Mylan is too strong or too weak, contact your
doctor or pharmacist.
The doctor will tell you which dose to take. Because the risk of side effects associated with heart problems
may increase with the dose and duration of use, it is important that you use the lowest dose necessary to
control the pain. You should not take Celecoxib Mylan for longer than necessary to control the
symptoms.
If you do not experience any benefit, contact your doctor within two weeks of starting treatment.
The recommended dose is:

For osteoarthritisthe recommended dose is 200 mg per day, increased by your doctor up to a maximum
of 400 mg, if necessary.
The usual dose is as follows:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

For rheumatoid arthritisthe recommended dose is 200 mg per day, increased by your doctor up to a
maximum of 400 mg, if necessary.
The usual dose is as follows:

• one 100 mg capsule twice a day.

For ankylosing spondylitisthe recommended dose is 200 mg per day, increased by your doctor up to
a maximum of 400 mg, if necessary.
The usual dose is as follows:

• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

Liver or kidney problems: make sure your doctor knows if you have liver or kidney problems as you may
need a lower dose.

Elderly patients, especially 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.
You should not take more than 400 mg per day.

Use in children and adolescents
Celecoxib Mylan should only be used in adults; it should not be used in children.

Method of administration
Celecoxib Mylan is for oral use. Celecoxib Mylan should be swallowed whole with a glass of
water.The capsules can be taken at any time of the day, with or without food. However,
always try to take each dose of Celecoxib Mylan at the same time each day.

If you take more Celecoxib Mylanthan you should
You should not take more capsules than indicated by your doctor. If you take too many capsules, contact your
doctor, pharmacist or hospital and take 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
Suddenly stopping treatment with Celecoxib Mylan may worsen your symptoms. Do not
stop taking Celecoxib Mylan unless your doctor has told you to.
The doctor may tell you to reduce the dose for a few days before stopping completely.
If you have any doubts about the use of 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.
manifest.

The side effects listed below have been observed in patients with arthritis treated
with Celecoxib Mylan. The side effects marked with an asterisk (*) are listed below in the
highest frequency observed 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
long period.
If any of the following side effects occur, stop taking
Celecoxib Mylan immediately and inform your doctor immediately:
If you experience:

• an allergic reaction, such as skin rash, facial swelling, 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 stools, or vomiting blood
• a skin reaction such as rashes, blisters or peeling skin
• liver failure (symptoms include nausea (feeling unwell), diarrhea, 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 swelling of ankles, legs and/or arms
• 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 pain, diarrhea, indigestion, gas
• 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 (feeling of a racing heartbeat), fast heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and shortness of breath)
• Anxiety, depression, fatigue, dizziness, tingling sensations (pins and needles)
• High levels of potassium in blood test results (can cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
• Impaired or blurred vision, ringing in the ears, pain and sores in the mouth, difficulty hearing*
• Constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of inflammation in the stomach or intestines
• Leg cramps
• Raised, itchy skin rash (hives)
• Inflammation of the eye
• Difficulty breathing
• Skin discoloration (bruising)
• Chest pain (general pain not related to the heart)
• Facial swelling.

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

• Ulcers (bleeding) in the stomach, esophagus or intestines; or intestinal hernia (can cause stomach pain, fever, nausea, vomiting, bowel obstruction), dark or black stools, inflammation of the pancreas (can cause stomach pain), inflammation of the esophagus
• Low levels of sodium in the blood (a condition known as hyponatremia)
• Reduction in white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding or bruising)
• Difficulty coordinating muscle movements
• Feeling confused, hallucinations, changes in taste
• Increased sensitivity to light
• Hair loss
• Bleeding in the eye
• Acute reaction that can cause inflammation of the lungs
• Irregular heartbeat
• Hot flashes
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pains during breathing or fainting
• Bleeding in the stomach or intestines (can cause blood in the stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising, 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 life-threatening anaphylactic shock)
• Severe skin diseases such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blisters or peeling skin) and acute generalized exanthematous pustulosis (symptoms include reddened skin with bumps covered with numerous small pustules)
• Delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, altered blood test values (e.g. liver function, blood count (eosinophilia, a specific increase in white blood cells)).
• Fatal brain hemorrhage
• Meningitis (inflammation of the membrane covering the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (cases sometimes fatal or requiring liver transplantation). Symptoms include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bruising, itching or chills
• Liver disorders (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as altered stool color, nausea and yellowing of the skin or eyes)
• Inflammation of the kidneys or other kidney disorders (such as nephrotic syndrome and minimal change lesions, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibility of more frequent and/or more severe seizures)
• Blockage of an artery or vein in the eye, causing partial or total loss of vision
• Inflamed blood vessels (can cause fever, pain, reddish patches on the skin)
• Reduction in red blood cells, white blood cells and platelets (can cause fatigue, easy bruising, frequent nosebleeds and increased risk of infection)
• Muscle pain and weakness
• Impaired sense of smell
• Loss of taste

Not known: frequency cannot be estimated based on available data

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

In clinical studies not related to arthritis or other arthritis-related conditions, in which Celecoxib
Mylan was taken at doses of 400 mg per day for a maximum 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 (can include stomach pain, diarrhea, indigestion, gas)
• Kidney stones (which can cause back pain or stomach pain, blood in the urine), difficulty urinating
• Weight gain

Uncommon: affects up to 1 in 100 people:

• Deep vein thrombosis (blood clot usually in the leg, which can cause pain, swelling or redness in the calf or breathing problems)
• Stomach problems: stomach infection (which can cause irritation and ulcers in the stomach and intestines)
• Fractures of the lower limbs
• Herpes zoster, skin infections, eczema (dry, itchy rash), pneumonia (infection in the chest (possible cough, fever, difficulty breathing))
• Floaters in the eye causing impaired or blurred vision, dizziness due to inner ear disorders, sore, inflamed or bleeding gums, mouth sores
• Excessive urination at night, bleeding hemorrhoids, frequent bowel movements
• Fat deposits on the skin or elsewhere, ganglion cysts (benign swelling on the joints and around the tendons of the hands and feet or around them), difficulty speaking, abnormal or very heavy vaginal bleeding, breast pain
• High levels of sodium in blood test results

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through 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 package/ blister/ 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 any medicine in 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 ingredient is celecoxib. Each hard capsule contains 100 mg of celecoxib. Each hard capsule contains 200 mg of celecoxib.
• The other ingredients are: sodium lauryl sulfate, povidone K29-32, lactose monohydrate, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica. The capsule shell contains titanium dioxide (E171), gelatin, indigotin (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 Package Contents
Celecoxib Mylan is available in hard capsules.
Celecoxib Mylan 100 mg are hard gelatin capsules consisting of an opaque blue cap and an opaque white body containing white to off-white powder. The capsule is marked 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 off-white powder. The capsule is marked 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 Authorisation Holder
Mylan S.p.A. Via Vittor Pisani 20, 20124 Milan Italy

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

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
France CELECOXIB VIATRIS 200 mg, capsule
Germany Celecoxib Mylan 100 mg Hartkapseln

Celecoxib Mylan 200 mg hard capsules

Italy Celecoxib Mylan
Spain Celecoxib Viatris 200 mg hard capsules
United Kingdom Celecoxib 100 mg hard capsules
(Northern Ireland) Celecoxib 200 mg hard capsules