Celecoxib Pensapharma: detailed information

Package leaflet: Information for the user

Celecoxib Pensa Pharma 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 other people, even if their symptoms are the same as yours, because 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 Pensa Pharma is and what it is used for
What you need to know before taking Celecoxib Pensa Pharma
How to take Celecoxib Pensa Pharma
Possible side effects
How to store Celecoxib Pensa Pharma
Contents of the pack and other information

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

This medicine is used in adults to relieve the signs and symptoms of rheumatoid arthritis,
osteoarthritis, and 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 increased levels of prostaglandins.
Celecoxib Pensa Pharma works by reducing the production of prostaglandins, thereby reducing
pain and inflammation.
You may expect the medicine to start working within a few hours of taking the first dose, but it may
take several days before you experience the full effect.

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

This medicine has been prescribed for you by your doctor. The following information will help you achieve the best results with this medicine. If you have any further questions, consult your doctor or pharmacist.

Do not take Celecoxib Pensa Pharma:

Inform your doctor if any of the following conditions apply, as patients with these conditions must not take Celecoxib Pensa Pharma:

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)
if you currently have a stomach or intestinal ulcer, or stomach or intestinal bleeding
if, after taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving medicine (NSAIDs), you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as itchy rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
if you are pregnant. If you could become pregnant during treatment, you should discuss contraceptive methods with your doctor
if you are breastfeeding
if you have severe liver disease
if you have severe kidney disease
if you suffer from an inflammatory bowel disease such as ulcerative colitis or Crohn’s disease
if you have 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 (temporary reduction in blood flow to the brain; also known as “mini-stroke”), angina, or blockages in blood vessels to the heart or brain
if you have or have had circulation problems (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 Pensa Pharma:

if you have previously had a stomach or intestinal ulcer or bleeding (do not take this medicine if you currently 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 therapy
if you are taking medicines to reduce blood clotting (e.g., warfarin or warfarin-like anticoagulants, or newer oral anticoagulants such as apixaban)
if you are taking corticosteroid medicines (e.g., prednisone)
if you are taking Celecoxib Pensa Pharma together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided
if you smoke, have diabetes, high blood pressure, or high cholesterol
if your heart, liver, or kidneys do not function properly, your doctor may perform periodic checks
if you experience fluid retention (such as swollen ankles and feet)
if you are dehydrated, for example due to illness, diarrhea, 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 feel unwell due to an infection or suspect 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
alcohol consumption together with NSAIDs may increase the risk of gastrointestinal problems

As with other anti-inflammatory medicines (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 regularly.

During treatment with celecoxib, rare cases of serious liver reactions have been reported, including severe liver inflammation, liver damage, and liver failure (some fatal or requiring liver transplantation).
Among cases with known onset times, the most severe 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 difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Other medicines and Celecoxib Pensa Pharma

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 to treat 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 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 leukemia)
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, for example after transplants)

This medicine may 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

This medicine must not be used by women who are pregnant or who could become pregnant (i.e., women of childbearing age who are not using an adequate contraceptive method) during treatment. If you become pregnant while taking this medicine, you must stop treatment and contact your doctor for alternative therapy.

Breastfeeding

This medicine must not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more difficult to become pregnant. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.

Driving and using machines

Before driving or operating machinery, you should be aware of how you react to this medicine. If you experience dizziness or drowsiness after taking this medicine, do not drive or operate machinery until these effects have subsided.

Celecoxib Pensa Pharma contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Each capsule contains less than 1 mmol of sodium (23 mg), i.e., essentially “sodium-free”.

3. How to take Celecoxib Pensa Pharma

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. If you think or feel that the effect of this medicine
is too strong or too weak, contact your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of unwanted effects related to heart problems may increase with higher doses and longer duration of use, it is important that you use
the lowest effective dose needed to control your pain and that you do not take this medicine for longer than necessary to control your symptoms.
The recommended dose is:
For osteoarthritis, the recommended dose is 200 mg per day, which your doctor may increase up to a maximum of 400 mg per day, if necessary.
The usual dose is:

one 200 mg capsule once daily

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

one 100 mg capsule twice daily

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

one 200 mg capsule once daily

You must 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 required.
Elderly patients, 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 decide to monitor you more closely.
Use in children
This medicine is intended for adults only and must not be used in children.

Instructions for administration
The capsules are for oral use. The capsules can be taken at any time of day, with or without food. However, try to take each dose at approximately the same time every day.
If you have difficulty swallowing the capsules: the entire contents of the capsule may be emptied onto a level teaspoon of soft food (such as cold or room temperature apple sauce, rice pudding, yogurt, or mashed banana) and immediately swallowed with about 240 mL of water.
To open the capsule, hold it upright to keep the granules at the bottom, then gently press and twist the top part to remove it, taking care 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 notice any benefit.

If you take more Celecoxib Pensa Pharma 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 immediately and bring 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
Stopping treatment with this medicine suddenly may cause your symptoms to worsen. Do not stop taking this medicine unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose over several days before stopping completely.

If you have any further 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 everyone will experience them.
The side effects listed below were observed in patients with arthritis who were taking this medicine. The side effects listed below marked with an asterisk (*) occurred more frequently in patients taking Celecoxib Pensa Pharma to prevent colon polyps. The patients involved in these studies took this medicine at high doses and for a long period of time.
If you experience any of the following conditions, stop taking this medicine and contact your doctor immediately:
If you have:

an allergic reaction such as rash, swelling of the face, wheezing or difficulty breathing
heart problems such as chest pain
severe stomach pain or any signs of bleeding in the stomach or intestines, 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 may 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 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 ache, diarrhoea, indigestion, gas
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 heartbeat), rapid heartbeat
Abnormal blood test results related to the liver
Abnormal blood test results related to the kidneys
Anaemia (changes in red blood cells that may cause tiredness and shortness of breath)
Anxiety, depression, fatigue, drowsiness, tingling sensations (pins and needles)
Elevated potassium levels in blood test results (may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations)
Blurred or impaired vision, ringing in the ears, mouth pain or sores, hearing difficulties*
Constipation, belching, inflammation of the stomach (indigestion, stomach ache or vomiting), worsening of stomach or intestinal inflammation
Leg cramps
Itchy raised rash (urticaria)
Eye inflammation
Difficulty breathing
Skin discolouration (bruising)
Chest pain (generalised 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 intestine; or intestinal hernia (may cause stomach pain, fever, nausea, vomiting, intestinal blockage), 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)
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 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 intestine (may lead to blood in stools or vomiting), inflammation of the intestine or colon
Severe liver inflammation (hepatitis). Symptoms may 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 or 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 rashes, blistering or peeling of the skin) and generalised exanthematous pustulosis (symptoms include red skin with swollen areas covered in numerous small pustules)
Delayed allergic reaction with possible symptoms such as rash, facial swelling, 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 liver inflammation (fulminant hepatitis) (some cases fatal or requiring liver transplant). Symptoms may 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 pale stools, nausea and yellowing of the skin or eyes)
Kidney inflammation and other kidney disorders (such as nephrotic syndrome and minimal change glomerulopathy, 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 leading to partial or complete loss of vision
Inflamed blood vessels (may cause fever, pain, purple spots on the skin)
Reduced number of red and 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

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

In clinical trials not related to arthritis or other arthritic conditions, where this medicine
was taken at doses of 400 mg daily for up to 3 years, the following additional side effects were observed:
Common: may affect up to 1 in 10 people:

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

Uncommon: may affect up to 1 in 100 people:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton/blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Celecoxib Pensa Pharma contains
The active substance is celecoxib.
Each hard capsule contains 200 mg of celecoxib.
The other ingredients are: sodium lauryl sulfate, povidone, monohydrate lactose, sodium
croscarmellose, magnesium stearate.
The capsule shell contains titanium dioxide (E171), gelatin.
Description of the appearance of Celecoxib Pensa Pharma and package contents
White opaque hard gelatin capsules size 0, with white or almost white homogeneous powder free from particles.
Available in blisters of 20 or 30 unit doses.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area countries with the
following names:
Italy Celecoxib Pensa Pharma
Spain Celecoxib pensa
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