CELECOXIB 200 mg Hard Capsules

Зміст інструкції

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

Celecoxib Pensa Pharma 200 mg hard capsules

Celecoxib

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

1. What is Celecoxib Pensa Pharma and what it is used for

This medicine is used in adults to relieve the signs and symptoms of rheumatoid arthritis,
osteoarthritisand ankylosing spondylitis.
Celecoxib Pensa Pharma belongs to a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs) and in particular to a subgroup known as cyclooxygenase-2 (COX-2) inhibitors. The
body produces prostaglandins which can cause pain and inflammation. In conditions such as
rheumatoid arthritis and osteoarthritis the body produces more of them. Celecoxib Pensa Pharma
works by reducing the production of prostaglandins thereby also reducing pain and inflammation.
You can expect the medicine to start to have an effect within a few hours of taking the first dose
but you may not feel a complete effect for several days.

2. What you need to know before taking Celecoxib Pensa Pharma

This medicine has been prescribed to you by your doctor. The following information will help you to
obtain the best results from this medicine. If you have any further questions, ask your doctor or
pharmacist.

Do not take Celecoxib Pensa Pharma:
Tell your doctor if any of the following conditions occur, as patients with these
conditions should not take Celecoxib Pensa Pharma:

• 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” (e.g. some antibiotics used to treat infections)
• if currentlyyou have a stomach or intestinal ulcer, or bleeding in the stomach or

intestine

• if, after taking acetylsalicylic acid or any other anti-inflammatory and pain relieving medicine (NSAIDs), you have had asthma, nasal polyps, severe nasal congestion or an allergic reaction such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing
• if you are pregnant. If you could become pregnant during treatment, you should discuss methods of contraception with your doctor
• if you are breastfeeding
• if you have a severe liver disease
• if you have a severe kidney disease
• if you suffer from an inflammatory bowel disease such as ulcerative colitis or Crohn's disease
• if you suffer from heart failure, established ischaemic heart disease or cerebrovascular disease, for example you have been diagnosed with a heart attack, stroke or transient ischaemic attack (temporary reduction of blood flow to the brain; also known as “mini-stroke”), angina or blockages of blood vessels 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 or pharmacist before taking Celecoxib Pensa Pharma:

• if you have previouslyhad a stomach or intestinal ulcer or bleeding (do not take this medicineif currentlyyou have a stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (even at low doses for heart protection)
• if you are taking antiplatelet therapies
• if you are using medicines to reduce blood clotting (e.g. warfarin or warfarin-like anticoagulants or new oral anticoagulants, e.g. apixaban)
• if you are using medicines called corticosteroids (e.g. prednisone)
• if you are using Celecoxib Pensa Pharma at the same time as other NSAIDs that are not acetylsalicylic acid, such as ibuprofen or diclofenac. The concomitant use of these medicines should be avoided
• if you smoke, have diabetes, have high blood pressure or high cholesterol
• if you have heart, liver or kidneys that are not functioning properly, your doctor may subject you to periodic checks
• if you suffer from fluid retention (such as swollen ankles and feet)
• if you are dehydrated, for example due to illness, 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 feel unwell because of an infection or believe you have an infection, as this medicine may mask fever or other signs of infection and inflammation
• if you are over 65 years old your doctor will monitor you regularly
• the consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems

As with other anti-inflammatory drugs (e.g. ibuprofen or diclofenac), this medicine can
lead to an increase in blood pressure and therefore your doctor may ask you to
monitor your blood pressure on a regular basis.
During treatment with celecoxib, some cases of serious liver reactions have been reported, including
severe liver inflammation, liver damage, liver failure (some with fatal outcome or
requiring liver transplantation).
Among the cases for which the time of onset is known, the most serious liver reactions occurred
within one month of starting treatment.
This medicine 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 (see the section Pregnancy
and breastfeeding).

Other medicines and Celecoxib Pensa Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines:

• Dextromethorphan (used in the treatment of cough)
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers and diuretics (used for the treatment of 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” agents that reduce blood clotting), including newer medicines such as apixaban
• Lithium (used to treat some types of depression)
• Other medicines for the treatment of depression, sleep disorders, high blood pressure or 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 immunosuppression, e.g. after transplants)

This medicine can be taken with low-dose acetylsalicylic acid (75 mg or less
per day). Ask your doctor for advice before taking both 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
This medicine should not be used by women who are pregnant or who could become
pregnant (i.e. women of childbearing potential who are not using adequate contraception) during
treatment. If you become pregnant during treatment with this medicine, you should
stop treatment and contact your doctor for alternative therapy.
Breastfeeding
This medicine should not be used during breastfeeding.
Fertility
NSAIDs, including celecoxib, can 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 operating machinery, you need to be aware of how you may react to
this medicine. If you feel dizzy or sleepy after taking this medicine, do not drive
or use machines until these effects have worn off.

Celecoxib Pensa Pharma contains lactose and sodium
This medicine contains lactose(a type of sugar). If your doctor has diagnosed you with
intolerance to some sugars, contact him/her before taking this medicine.
Each capsule contains less than 1 mmol sodium(23 mg), which is essentially “sodium-free”.

3. How to take Celecoxib Pensa Pharma

Take this medicine following the instructions of your doctor or pharmacist exactly.
If you have doubts, consult your doctor or pharmacist. If you think or feel that the effect of this medicine
is too strong or too weak, consult 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 increasing dose and duration of use, it is important that you use
the lowest possible dose to control the pain and you should not take this medicine for a
longer time than necessary to control the symptoms.
The recommended dose is:

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

• one 200 mg capsule once a day

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

• one 100 mg capsule twice a day

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

• one 200 mg capsule once a day

You should not take more than 400 mg per day.

Kidney or liver problems: make sure your doctor knows if you have liver or kidney problems as
a lower dose may be necessary.

Elderly, especially those weighing less than 50 kg: if you are over 65 years old and especially if
you weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children
This medicine is only for adults, it should not be used in children.
Method of administration

The capsules are for oral use.The capsules can be taken at any time of the
day, with or without food. However, try to take each dose of this medicine every day
at the same time.
If you have difficulty swallowing the capsules: the entire contents of the capsule can be poured onto a
teaspoon of semi-solid food (such as cold or room temperature applesauce, rice pudding, yogurt or banana puree) and swallowed immediately with about 240 mL of water.
To open the capsule, hold it upright to keep the granules at the bottom then press and
gently rotate the top to remove it, being careful not to spill the
contents. Do not chew or crush the granules.
Contact your doctor within two weeks of starting treatment if you do not experience any benefit.

If you take more Celecoxib Pensa Pharma than you should
You should not take more capsules than your doctor has prescribed. If you take too many capsules
contact your doctor, pharmacist or hospital and take the medicine with you.

If you forget to take Celecoxib Pensa Pharma
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 Pensa Pharma
Suddenly stopping treatment with this medicine can lead to a worsening
of symptoms. Do not stop taking this medicine unless your doctor has told you to. The
doctor may tell you to reduce the dose for a few days before stopping it completely.
If you have further questions 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 side effects listed below have been observed in patients with arthritis who were taking this medicine. The side effects listed below marked with an asterisk (*) occurred more frequently in patients who were taking Celecoxib Pensa Pharma to prevent colon polyps. The patients involved in these studies were taking this medicine at high doses and for a long period.

If any of the following occurs, stop taking this medicine and tell your doctor immediately:

• 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 intestine, such as black stools or blood in the stools, or vomiting blood
• a skin reaction such as rash, blistering or peeling of the skin
• liver failure. Symptoms can include nausea (feeling unwell), diarrhoea, jaundice (the skin or whites of the eyes appear yellow)

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 hands
• Urinary tract infections
• Shortness of breath*, sinusitis (inflammation or infection of the sinuses, blocked or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhoea, indigestion, wind
• Skin 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 your heartbeat), fast heartbeat
• Abnormal blood tests for liver values
• Abnormal blood tests for kidney values
• Anaemia (alterations in red blood cells that can cause fatigue and shortness of breath)
• Anxiety, depression, fatigue, drowsiness, 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 of the stomach or intestine
• Leg cramps
• Itchy raised skin rash (hives)
• Inflammation of the eye
• Difficulty breathing
• 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, esophagus or intestine; 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)
• Reduced number of white blood cells (which help protect the body from infections) or platelets (increased risk of bleeding or bruising)
• Difficulty coordinating muscle movements
• Feeling confused, altered taste
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Bleeding of the eye
• Acute reaction that can cause inflammation of the lungs
• Irregular heartbeat
• Hot flushes
• Blood clots in the blood vessels of the lungs. Symptoms can include sudden shortness of breath, sharp pains during breathing or fainting
• Bleeding of the stomach or intestine (can lead to blood in the stools or vomit), inflammation of the intestine or colon
• Severe inflammation of the liver (hepatitis). Symptoms can include nausea (feeling unwell), diarrhoea, 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 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 diseases such as Stevens Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause skin rash, blisters or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include reddened skin with areas swollen covered with numerous small pustules)
• 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)
• Fatal brain haemorrhage
• Meningitis (inflammation of the membrane covering the brain and spinal cord)
• Liver failure, liver damage and severe inflammation of the liver (fulminant hepatitis) (cases sometimes fatal or requiring a liver transplant). Symptoms can include nausea (feeling unwell), diarrhoea, 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 can be accompanied by symptoms such as pale stools, nausea and yellowing of the skin or eyes)
• Inflammation of the kidneys and other kidney disorders (such as nephrotic syndrome and minimal change glomerulopathy, which can 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 severe seizures)
• Blockage of an artery or vein in the eye resulting in partial or total loss of vision
• Inflamed blood vessels (can cause fever, pain, purple spots on the skin)
• Reduction in the number of 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

• Decreased fertility in women, generally reversible with discontinuation of the medicine.

In clinical studies not associated with arthritis or other arthritic conditions, in which this medicine was taken at doses of 400 mg per day for a maximum of 3 years, the following additional side effects were observed:

Common: may affect up to 1 in 10 people:

• Cardiac disorders: angina (chest pain)
• Stomach disorders: irritable bowel syndrome (can include stomach pain, diarrhoea, indigestion, wind)
• Kidney stones (which can cause stomach pain or back pain, blood in the urine), difficulty urinating
• Weight gain

Uncommon: may affect up to 1 in 100 people:

• Deep vein thrombosis (blood clot usually in the leg, which can cause pain, swelling or redness of the calf or breathing problems)
• Stomach disorders: stomach infection (which can cause irritation and ulcers in the stomach and intestine)
• Fractures of the lower limbs
• Herpes zoster, skin infection, eczema (dry and itchy skin rash), pneumonia (infection of the chest (possible cough, fever, difficulty breathing))
• Floaters in the eye causing blurred or impaired vision, dizziness due to inner ear problems, painful, inflamed or bleeding gums, sores in the mouth
• Excessive urination at night, bleeding from hemorrhoids/piles, frequent bowel movements
• Fatty lumps on the skin or elsewhere, ganglionic cysts (benign swelling above or around the joints and tendons of the hands or feet), difficulty speaking, abnormal or very heavy vaginal bleeding, breast pain
• Elevated 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 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 Pensa Pharma

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 after Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30ºC.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Celecoxib Pensa Pharma contains
The active ingredient is celecoxib.
Each hard capsule contains 200 mg of celecoxib.
The other ingredients are: sodium lauryl sulfate, povidone, lactose monohydrate, croscarmellose
sodium, magnesium stearate.
The capsule shell contains titanium dioxide (E171), gelatin.

Description of the appearance of Celecoxib Pensa Pharma and contents of the pack
Size 0 hard gelatin capsules, opaque, white body and cap, containing a white or almost white
homogeneous powder free of particles.
Available in blisters of 20 or 30 unit doses.
Not all pack sizes may be marketed

Marketing Authorisation Holder
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturer
Laboratorios Alter SA
C/ Mateo Inurria, 30.
28036 MADRID - SPAIN

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy Celecoxib Pensa Pharma
Spain Celecoxib pensa
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