CELECOXIB 100 mg Kapsułka Twarda

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

CELECOXIB DOC Generici 100 mg hard capsules, 200 mg hard capsules

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may 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 DOC Generici is and what it is used for
• 2. What you need to know before you take CELECOXIB DOC Generici
• 3. How to take CELECOXIB DOC Generici
• 4. Possible side effects
• 5. How to store CELECOXIB DOC Generici
• 6. Contents of the pack and other information

1. What CELECOXIB DOC Generici is and what it is used for

CELECOXIB DOC Generici is used, in adults, in the treatment of signs and symptoms of rheumatoid arthritis
, osteoarthritisand ankylosing spondylitis.
CELECOXIB DOC Generici belongs to a class of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and in particular to a sub-classification known as
COX-2 Inhibitors. Your body produces prostaglandins which can cause pain and
inflammation. In diseases such as rheumatoid arthritis and osteoarthritis your body produces them in
greater quantities. CELECOXIB DOC Generici works by reducing the production of prostaglandins,
thus reducing pain and inflammation.
It is expected that this medicine will start to take effect within a few hours of taking the
first dose, however it may take several days before it takes effect completely.

2. What you need to know before taking CELECOXIB DOC Generici

CELECOXIB DOC Generici has been prescribed for you by your doctor. The following information will help you to use CELECOXIB DOC Generici in the best way. If you have any doubts, ask your doctor or pharmacist.

Do not take CELECOXIB DOC Generici
Tell your doctor if any of the following conditions apply to you, as patients who are in these conditions should not take CELECOXIB DOC Generici.

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to a class of medicines called “sulfonamides” (a class of antibiotics used to treat infections).
• if currentlyyou have a stomach or intestinal ulcer, or bleeding from the stomach or intestine.
• if taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving medicine (NSAID) has caused you asthma, nasal polyps, severe nasal congestion, or an allergic reaction manifested with skin rash and itching, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing.
• if you are pregnant. If you think you may become pregnant during treatment, you should discuss contraception 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 suffer from heart failure, established ischemic heart disease, or cerebrovascular disease, for example if you have been diagnosed with a heart attack, stroke, or transient ischemic attack (a temporary reduction in blood flow to the brain, also called a “mini-stroke”), angina, or blockage of the blood vessels of the heart or brain.
• if you have or have had problems with blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs.

Warnings and precautions
Talk to your doctor or pharmacist before taking CELECOXIB DOC Generici

• if you have had in the pasta stomach or intestinal ulcer or bleeding (do not takeCELECOXIB DOC Genericiif you have at this timea stomach 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 or similar anticoagulants to warfarin, or newer generation anticoagulants such as apixaban).
• if you are using corticosteroids (such as, for example, prednisone).
• if you are using CELECOXIB DOC Generici at the same time as other NSAIDs that are not 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.
• if your heart, liver or kidneys are not functioning properly; your doctor may want to schedule periodic check-ups.
• if you suffer from fluid retention (such as, for example, swollen ankles and feet).
• if you are dehydrated, for example due to illness, diarrhea, or the 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 do not feel well because of an infection or think you have an infection, as CELECOXIB DOC Generici may mask fever or other signs of infection or inflammation.
• if you are over 65 years old your doctor will schedule periodic check-ups.
• the simultaneous intake of alcohol and NSAIDs can increase the risk of gastrointestinal problems.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine can cause an increase in blood pressure, and therefore your doctor may want to check your blood pressure at regular intervals.
Some cases of severe liver reactions have been reported with the use of celecoxib, including severe liver inflammation, liver damage, liver failure (some of which were fatal or required a liver transplant). Among the cases for which the time of onset is known, most serious adverse hepatic reactions developed within one month of the start of therapy.
Celecoxib may make it more difficult to get pregnant. You should inform your doctor if you are planning a pregnancy or have difficulty getting pregnant (see section “Pregnancy, breastfeeding and fertility”).

Other medicines and CELECOXIB DOC Generici
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, beta-blockers and diuretics (used for high blood pressure and heart failure).
• Fluconazole and rifampicin (used to treat fungal and bacterial infections).
• Warfarin or other medicines similar to warfarin (“blood-thinning” substances that reduce blood clotting), including newer generation medicines such as apixaban.
• Lithium (used to treat some types of depression).
• Other medicines used to treat depression, sleep disorders, high blood pressure or irregular heartbeat.
• Neuroleptics (used to treat some types of 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 types of sleep disorders).
• Cyclosporine and tacrolimus (used in immunosuppressive therapy, i.e. after transplants).

Celecoxib can be taken at the same time as low doses of acetylsalicylic acid (daily dose of 75 mg or less). Consult your doctor before taking these two medicines at the same time.

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 DOC Generici should not be used by women who are pregnant or who may become pregnant (i.e. women of childbearing potential who are not using adequate contraceptive measures) during the course of therapy. If you become pregnant during therapy with CELECOXIB DOC Generici, you should stop therapy and consult your doctor to agree on alternative therapy.
Breastfeeding
CELECOXIB DOC Generici should not be used during breastfeeding.
Fertility
NSAIDs, including CELECOXIB DOC Generici, can make it more difficult to get pregnant. You should inform your doctor if you are planning a pregnancy or have difficulty getting pregnant.

Driving and operating machinery
Before driving vehicles or operating machinery, you must be aware of how you react to treatment with CELECOXIB DOC Generici. If you experience dizziness or drowsiness after taking CELECOXIB DOC Generici, do not drive vehicles or operate machinery until these effects have disappeared.

CELECOXIB DOC Generici contains lactose and sodium

• This medicine contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take CELECOXIB DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist. If you believe or feel that the effect of CELECOXIB DOC Generici
is too strong or too weak, talk to your doctor or pharmacist.
Your 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 therapy, it is important to use the lowest
dose that is sufficient to control the pain and not prolong the therapy with CELECOXIB DOC
Generici beyond what is necessary to control the symptoms.
Method of administration
CELECOXIB DOC Generici must be taken orally. The capsules can be taken, in
any time of the day, with or without food. In any case, try to take each subsequent
dose of CELECOXIB DOC Generici at the same time of day.
If within two weeks of starting treatment you do not feel any benefit, consult your doctor.
The recommended dose is:

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

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

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

• one 100 mg capsule twice a day.

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

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

Kidney or liver problems:make sure your doctor is aware that you suffer from kidney or liver
problems, as it may be necessary to reduce the dose.

Elderly, especially if 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 want to keep you under closer control.
You should not take more than 400 mg per day.

Use in children
CELECOXIB DOC Generici is only for adults and should not be used in children.

If you take more CELECOXIB DOC Generici than you should
Do not take a number of capsules greater than that prescribed by your doctor. If you take a
excessive number of capsules, consult your doctor, pharmacist or hospital, and bring the
package of the medicine with you.

If you forget to take CELECOXIB DOC Generici
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 forgotten dose.

If you stop taking CELECOXIB DOC Generici
Sudden interruption of treatment with CELECOXIB DOC Generici may cause a
worsening of symptoms. Do not stop treatment with CELECOXIB DOC Generici unless
you have been told to do so by your doctor. The doctor may tell you to reduce the dose for a few
days before stopping treatment definitively.
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.

The following side effects listed below have been observed in patients with arthritis who have
taken celecoxib. Side effects indicated by an asterisk (*) are listed reporting the highest
frequencies that have been observed in patients who have taken celecoxib to
prevent colon polyps. In these studies, patients took celecoxib at high doses and
for a long period.
If you experience any of the following situations, stop treatment with
CELECOXIB DOC Generici and consult your doctor immediately:
If you:

• have an allergic reaction that manifests with skin rash, facial swelling, difficulty breathing or wheezing
• have heart problems that manifest with chest pain
• have severe stomach pain or any sign of bleeding from the stomach or intestines, such as dark or tarry stools, or vomiting blood
• have a skin reaction such as rash, blistering or peeling of the skin
• have liver failure (symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or the 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, pain or blockage of the sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• dizziness, sleep disorders
• vomiting*, stomach pain, diarrhea, indigestion, flatulence
• skin rash, itching
• muscle stiffness,
• difficulty swallowing*
• headache
• nausea (feeling sick)
• joint pain
• worsening of pre-existing allergies
• accidental injury.

Uncommon: may affect up to 1 in 100 people

• myocardial infarction*
• heart failure, palpitations (feeling of heartbeat), fast heartbeat
• abnormalities in blood tests related to liver function
• abnormalities in blood tests related to kidney function
• anemia (abnormality of red blood cells that can cause fatigue and shortness of breath)
• anxiety, depression, fatigue, drowsiness, tingling (pins and needles sensation)
• high levels of potassium in blood tests (can cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
• altered or blurred vision, ringing in the ears, pain and ulcers in the mouth, hearing impairment*
• constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of inflammation of the stomach or intestines
• leg cramps
• itchy skin rash (urticaria)
• 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) of the stomach, throat/esophagus or intestines; or perforation

of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction),
black or tarry stools, inflammation of the pancreas (can cause stomach pain), inflammation
of the esophagus

• low levels of sodium in the blood (a condition called hyponatremia)
• reduction in the number of white blood cells (those that help protect the body from infections) and platelets (increased possibility of bleeding and bruising)
• difficulty coordinating muscle movements
• confusion, altered taste
• increased sensitivity to light
• hair loss
• hallucinations
• eye bleeding
• 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 from the stomach or intestines (can cause blood in the stool 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 fatal anaphylactic shock)
• severe skin diseases such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blisters or peeling of the skin) and acute generalized 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 cerebral 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 glomerulopathy, 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, aches, 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 from available data

• reduced fertility in women, usually reversible with discontinuation of the medicine.

In clinical studies not related to arthritis or other arthritic conditions, in which celecoxib
was taken at doses of 400 mg per day for 3 years, the following additional side effects
were observed:
Common: may affect up to 1 in 10 people

• heart problems: angina (chest pain)
• stomach problems: irritable bowel syndrome (can cause stomach pain, diarrhea, indigestion, flatulence)
• kidney stones (which can cause stomach or back pain, blood in the urine), difficulty urinating
• weight gain.

Uncommon: may affect up to 1 in 100 people

• deep vein thrombosis (blood clots usually located in the legs, which can cause pain, swelling or redness of the calf, or breathing problems)
• stomach problems: stomach infection (which can cause irritation and ulcers of the stomach and intestines)
• lower limb fractures
• herpes zoster, skin infection, eczema (dry, itchy rash), pneumonia (chest infection (which can manifest with cough, fever, difficulty breathing))
• floating bodies in the eye that can alter or blur vision; dizziness caused by inner ear disorders; ulceration, inflammation or bleeding of the gums; mouth ulcers
• excessive need to urinate at night, hemorrhoidal bleeding, frequent bowel movements
• fatty lumps on the skin or in other parts of the body, ganglion cysts (non-painful bumps above or around the joints and tendons of the hands or feet), difficulty speaking, abnormal vaginal bleeding or heavy bleeding, breast pain
• high levels of sodium in blood tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store CELECOXIB DOC Generici

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 packaging. 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 DOC Generici contains

• The active ingredient is celecoxib.
• A 100 mg capsule contains 100 mg of celecoxib. The other components are: lactose monohydrate, sodium lauryl sulfate, povidone K-29/32, croscarmellose sodium, magnesium stearate. The capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide E171, indigotine E132. The edible printing ink contains black iron oxide.
• A 200 mg capsule contains 200 mg of celecoxib. The other components are: lactose monohydrate, sodium lauryl sulfate, povidone K-29/32, croscarmellose sodium, magnesium stearate. The capsule shell contains: gelatin, sodium lauryl sulfate, titanium dioxide E171, yellow iron oxide E172. The edible printing ink contains black iron oxide.

Description of the appearance of CELECOXIB DOC Generici and contents of the pack
CELECOXIB DOC Generici is available in hard capsules.
CELECOXIB DOC Generici 100 mg capsules: opaque capsules, with a white body
marked with 100 and a blue cap marked with CLX.
CELECOXIB DOC Generici 200 mg capsules: opaque capsules, with a white body
marked with 200 and a yellow cap marked with CLX.
CELECOXIB DOC Generici is available in the following packs:

• 100 mg capsules: PVC-PVDC/Aluminum blister packs of 10, 20, 30, 40, 50, 60, 100 capsules.
• 200 mg capsules: PVC-PVDC/Aluminum blister packs of 6, 10, 20, 30, 50, 60, 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder:
DOC Generici S.r.l.
Via Turati 40 – 20121 Milan
Italy

Manufacturer:
Ferrer Internacional, S.A.
Joan Buscallà, 1-9, 08173 Sant Cugat del Vallés (Barcelona)
Spain

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Italy: CELECOXIB DOC Generici 100mg/200mg hard capsules
Spain: Celecoxib Ferrer 200 mg hard capsules EFG