CELECOXIB 100 mg Hard Capsule

Содержание инструкции

1. Celecoxib Maxmind 100 mg capsule, 200 mg capsule
   1. What is Celecoxib Maxmind and what it is used for
   2. What you need to know before taking Celecoxib Maxmind
   3. How to take Celecoxib Maxmind
   4. Possible side effects
   5. How to store Celecoxib Maxmind
   6. Contents of the pack and other information

Celecoxib Maxmind 100 mg capsule, 200 mg capsule

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

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

Celecoxib Maxmind belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and specifically a subgroup known as “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 Maxmind works by reducing the production of prostaglandins, thereby reducing pain and inflammation. Celecoxib Maxmind is used in adults for the relief of signs and symptoms of rheumatoid arthritis,

osteoarthritisand ankylosing spondylitis.

2. What you need to know before taking Celecoxib Maxmind

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

Do not take Celecoxib Maxmind
Tell your doctor if any of the following applies to you as patients with these conditions
should not take Celecoxib Maxmind:

• 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 “sulfonamides” (e.g. some antibiotics used to treat infections);
• if you currentlysuffer from stomach or intestinal ulcers, 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 experienced asthma, nasal polyps, severe nasal congestion, 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 could 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 heart failure, proven 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 a “mini-stroke”), angina or blockage of the vessels carrying blood 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 of the legs.

Warnings and precautions
Talk to your doctor before taking Celecoxib Maxmind:

• if you have had previouslya stomach or intestinal ulcer or bleeding. ( Do not takeCelecoxib Maxmindif you have an ongoingstomach or intestinal ulcer or bleeding );
• if you are taking acetylsalicylic acid (even at low doses to protect the heart);
• if you are using medicines to reduce blood clotting (e.g. warfarin);
• if you are using Celecoxib Maxmind at the same time as other NSAIDs other than acetylsalicylic acid such as ibuprofen or diclofenac. The concurrent 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 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, diarrhea 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 unwell due to an infection or think you have an infection, as Celecoxib Maxmind may mask a fever or other signs of infection and inflammation;
• if you are over 65 years of age your doctor may subject you to regular checks.

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 has been reported, the most serious liver reactions occurred within one month of starting treatment.
Taking Celecoxib Maxmind may make it more difficult to get 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).

Other medicines and Celecoxib Maxmind
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 or angiotensin II receptor blockers (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 oral anticoagulants (blood-thinning agents that reduce blood clotting)
• lithium (used to treat some types of depression)
• other medicines for treating depression, sleep disorders, high blood pressure or irregular heartbeat
• neuroleptics (used to treat some mental disorders)
• methotrexate (used to treat rheumatoid arthritis, psoriasis and leukemia)
• 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 Maxmind can be taken with acetylsalicylic acid at low doses (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 may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Celecoxib Maxmind 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 current treatment.
If you become pregnant during treatment with Celecoxib Maxmind, you should stop the
treatment and contact your doctor for alternative treatment.

Breastfeeding
Celecoxib Maxmind should not be used during breastfeeding.

Fertility
NSAIDs, including Celecoxib Maxmind, may make it more difficult to get 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 Maxmind. If you experience
dizziness or drowsiness after taking Celecoxib Maxmind, do not drive or use machines until
these effects have worn off.

Celecoxib Maxmind contains lactose
Celecoxib Maxmind contains lactose(a type of sugar). If your doctor has told you that you have an
intolerance to some sugars, contact him/her before taking this medicine.

3. How to take Celecoxib Maxmind

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. If you think or feel that the effect of Celecoxib Maxmind is too strong or too
weak, consult your doctor or pharmacist.
Your doctor will tell you which dose you should 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 Maxmind for longer than necessary to
control the symptoms.

Celecoxib Maxmind capsules must be swallowed whole with a glass of water.
The capsules can be taken at any time of day, with or without food. However, always try to
take each dose of Celecoxib Maxmind at the same time each day.
If you do not experience any benefit, contact your doctor within two weeks of starting treatment.

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

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

For rheumatoid arthritis:the recommended starting dose is 200 mg per day to be taken in two divided
doses. The dose may be subsequently increased to a maximum of 200 mg twice a day,
if necessary.
The dose is usually:

• one 100 mg capsule twice a day.

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

• one 200 mg capsule per 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 because
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:Celecoxib Maxmind should only be used in adults; it should not be used in
children.

If you take more Celecoxib Maxmindthan you should
Do not take more capsules than those 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 Maxmind
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 Maxmind
Suddenly stopping treatment with Celecoxib Maxmind may lead to a worsening
of your symptoms. Do not stop taking Celecoxib Maxmind unless your doctor tells you to do so.
Your doctor may tell you to reduce the dose over a few days before stopping treatment completely.
If you have any doubts about the use of this medicine, consult 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 Maxmind. Side effects marked with an asterisk (*)
are listed below with the highest frequency observed in patients treated with
Celecoxib Maxmindfor the prevention of colon polyps. Patients in these studies have
taken Celecoxib Maxmindat high doses and for a long period.
Stop taking Celecoxib Maxmindimmediately and inform your doctor immediately
if you experience any of the following effects:
If you have:

• an allergic reaction such as skin rash, swelling of the face, shortness of breath 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 stools or stools containing blood, or vomiting blood;
• a skin reaction such as rash, blisters or peeling skin;
• liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or whites of the eyes).

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 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 pain, diarrhea, indigestion, gas
• rash, itching
• muscle stiffness
• difficulty swallowing*
• headache
• nausea (feeling unwell)
• painful joints
• worsening of pre-existing allergies
• accidental injury

Uncommon: may affect up to 1 in 100 people

• stroke*
• heart failure, palpitations (feeling of a racing heartbeat), fast heartbeat
• abnormalities in blood test values related to the liver
• abnormalities in blood test values related to the kidneys
• anemia (changes in red blood cells that can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, dizziness, tingling sensations
• 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
• itchy, raised rash (urticaria)
• eye inflammation
• difficulty breathing
• skin discoloration (bruising)
• chest pain (generalized pain not related to the heart)

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

• ulcers (bleeding) in the stomach, esophagus or intestine; or damage to the intestine (can cause pain, fever, nausea, vomiting, bowel obstruction), dark or black stools, inflammation of the pancreas (can lead to stomach pain), inflammation of the esophagus
• low levels of sodium in the blood (a condition known as hyponatremia)
• reduced number of white blood cells (which help protect the body from infections) and platelets in the blood (increased risk of bleeding or bruising)
• difficulty coordinating muscle movements
• feeling confused, altered taste
• increased sensitivity to light
• hair loss
• hallucinations
• bleeding from the eye
• irregular heartbeat
• hot flashes
• blood clots in the blood vessels of the lungs. Symptoms may include shortness of breath, sharp pain when breathing or collapse
• bleeding from the stomach or intestines (can lead to blood in the stool or vomit), inflammation of the intestine or colon
• severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching and chills
• acute kidney failure
• menstrual disorders
• swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing

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

• severe allergic reactions (including potentially life-threatening anaphylactic shock)
• serious skin conditions 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 redness of the skin with swollen areas covered with numerous small pustules)
• a delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormal test results (e.g. liver, blood cells (eosinophilia, a type of increase in white blood cells))
• bleeding inside the brain causing death
• meningitis (inflammation of the membrane around the brain and spinal cord)
• liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring a liver transplant). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching or chills.
• problems with the liver (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discoloration of the stool, nausea and yellowing of the skin or eyes)
• inflammation of the kidneys or other kidney problems (such as nephrotic syndrome, minimal change glomerulopathy which can be accompanied by symptoms such as fluid retention, (edema), foamy urine, fatigue and loss of appetite)
• worsening of epilepsy (possible more frequent and/or severe seizures)
• blockage of an artery or vein in the eye which can lead to partial or complete loss of vision
• inflamed blood vessels (can cause fever, pain, red spots on the skin)
• a reduction in the number of white blood cells and red blood cells and platelets (can cause fatigue, bruising more easily, frequent nosebleeds and increased risk of infection)
• muscle pain and weakness
• impaired sense of smell

Frequency not known: the frequency cannot be estimated from the available data

• Reduced fertility in women, usually reversible with discontinuation of the drug.

In clinical studies not associated with arthritis or other arthritic conditions, in which Celecoxib
Maxmind was taken at doses of 400 mg per day for up to 3 years, the following side 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 (which can lead to stomach or back pain, blood in the urine), difficulty passing urine
• weight gain

Uncommon: may affect up to 1 in 100 people

• deep vein thrombosis (blood clots, usually in the legs, which can cause pain or redness of the calf or problems breathing)
• stomach problems: stomach infection (which can cause irritation and ulcers in the stomach and intestines)
• fractures of the lower limbs
• herpes, skin infection, eczema (rash with dry and itchy skin), pneumonia (inflammation of the chest (possible cough, fever, difficulty breathing))
• corpuscles in the eye causing blurred or impaired vision, dizziness due to problems with the inner ear, injury, inflamed or bleeding gums, mouth sores
• excessive urination at night, blood from hemorrhoids, frequent bowel movements
• fatty lumps on the skin or elsewhere, ganglion cysts (benign swellings on the joints and tendons of the hands and feet or around them), difficulty speaking, abnormal or very heavy vaginal bleeding, breast pain
• elevated levels of sodium in blood test results

Reporting of side effects
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 Italian Medicines Agency at the address www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Celecoxib Maxmind

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 blister and the carton. The expiry date
refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Celecoxib Maxmind contains

• The active ingredient is celecoxib. Each capsule contains 100 mg or 200 mg of celecoxib.
• The other ingredients are: Anhydrous lactose, hydroxypropylcellulose, crospovidone, povidone, sodium lauryl sulfate, magnesium stearate. The capsule shell contains: titanium dioxide E171, gelatin, sodium lauryl sulfate. The printing ink contains: shellac, propylene glycol, strong ammonia solution, aluminium lake indigo carmine E132 (100 mg capsules) and yellow iron oxide E172 (200 mg capsules).

Description of the appearance of Celecoxib Maxmind and contents of the pack
Celecoxib Maxmind100 mg:size “4” capsules, containing powder from white to almost
white, with an opaque white cap, opaque white body with “C5” printed on a blue band on the
cap and “100mg” on a blue band on the body.

Celecoxib Maxmind 200 mg:size “2” capsules, containing powder from white to almost
white, with an opaque white cap, opaque white body with “C6” printed on a yellow band on the
cap and “200mg” on a yellow band on the body.
The capsules are packaged in blisters made of transparent PVC/PVdC and aluminium and are available in
packs of 20, 40, 50, 60, 100 capsules (100 mg dosage) and 10, 20, 30, 50, 100 capsules (200 mg
dosage).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Maxmind Pharmaceutical S.L.
Calle Copenhague 12, Oficina 205, Edificio Tifán,
28232 Las Rozas,
Madrid,
Spain

Manufacturer
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park,
Wheatley Hall Road,
Doncaster,
DN2 4LT, United Kingdom.