Celecoxib Doc Generici: detailed information

Package leaflet: Information for the user

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

Equivalent medicine
Please read all of this leaflet carefully before you start 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, as it may 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 DOC Generici is and what it is used for
What you need to know before taking CELECOXIB DOC Generici
How to take CELECOXIB DOC Generici
Possible side effects
How to store CELECOXIB DOC Generici
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 for the treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
CELECOXIB DOC Generici belongs to a class of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and in particular to a subclass 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 higher levels of these prostaglandins. CELECOXIB DOC Generici works by reducing the production of prostaglandins, thereby reducing pain and inflammation.
This medicine is expected to start working within a few hours of taking the first dose; however, it may take several days before the full effect is achieved.

2. What you should know before taking CELECOXIB DOC Generici

CELECOXIB DOC Generici has been prescribed for you by your doctor. The following information
will help you use CELECOXIB DOC Generici correctly. If you have any doubts, please consult your
doctor or pharmacist.
Do not take CELECOXIB DOC Generici
Inform your doctor if any of the following conditions apply to you, as patients in these conditions must not take CELECOXIB DOC Generici.

if you are allergic to celecoxib or to 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 group of antibiotics used to treat infections).
if you currently have a stomach or intestinal ulcer, or stomach or intestinal bleeding.
if taking acetylsalicylic acid or any other non-steroidal anti-inflammatory and pain-relieving medicine (NSAID) has previously caused you asthma, nasal polyps, severe nasal congestion, or an allergic reaction 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, discuss contraceptive methods with your doctor.
if you are breastfeeding.
if you have severe liver disease.
if you have severe kidney disease.
if you have an inflammatory bowel disease such as ulcerative colitis or Crohn’s disease.
if you have heart failure, confirmed ischemic heart disease, or cerebrovascular disease, for example if you have been diagnosed with a heart attack, stroke, transient ischemic attack (a temporary reduction in blood flow to the brain, also known as “mini-stroke”), angina, or obstruction of blood vessels in the heart or brain.
if you have or have previously had circulatory problems (peripheral arterial disease) or have undergone surgery on the arteries in your legs.

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

if you have previously had a stomach or intestinal ulcer or gastrointestinal bleeding (do not take CELECOXIB DOC Generici if you currently have a stomach or intestinal ulcer or gastrointestinal bleeding).
if you are taking acetylsalicylic acid (even at low doses for heart protection).
if you are taking medicines to reduce blood clotting (e.g., warfarin or warfarin-like anticoagulants, or newer generation anticoagulants such as apixaban).
if you are taking corticosteroid medicines (such as, for example, prednisone).
if you are using CELECOXIB DOC Generici 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 want to schedule regular 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, diarrhoea, or use of diuretics (used to treat excess fluid in the body).
if you have previously had a severe allergic reaction or severe skin reaction to any medicine.
if you do not feel well due to an infection or suspect you have an infection, as CELECOXIB DOC Generici may mask fever or other signs of infection or inflammation.
if you are over 65 years of age, your doctor may schedule regular check-ups.
concomitant use of alcohol and NSAIDs may increase the risk of gastrointestinal problems.

Like other NSAIDs (e.g., ibuprofen or diclofenac), this medicine may cause an increase in
blood pressure, so your doctor may wish to monitor your blood pressure at regular intervals.
Severe liver reactions, including severe hepatitis, liver damage, and liver failure (some of which have been fatal or required liver transplantation), have been reported with the use of celecoxib. Among cases with known onset times, most serious liver adverse reactions occurred within one month of starting treatment.
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 (see section “Pregnancy, breastfeeding and fertility”).
Other medicines and CELECOXIB DOC Generici
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 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 agents that reduce blood clotting), including newer generation medicines 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 types of mental disorders).
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and leukaemia).
Carbamazepine (used to treat epilepsy/seizures and certain types of pain or depression).
Barbiturates (used to treat epilepsy/seizures and certain types of sleep disorders).
Cyclosporine and tacrolimus (used in immunosuppressive therapy, i.e., after organ transplants).

Celecoxib may be taken together with low-dose acetylsalicylic acid (daily dose of 75 mg or less).
Please consult your doctor before taking these two medicines together.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
CELECOXIB DOC Generici must 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 treatment. If you become pregnant while taking CELECOXIB DOC Generici,
you must stop treatment and consult your doctor to discuss an alternative therapy.
Breastfeeding
CELECOXIB DOC Generici must not be used during breastfeeding.
Fertility
NSAIDs, including CELECOXIB DOC Generici, 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 treatment with
CELECOXIB DOC Generici. If you experience dizziness or drowsiness after taking CELECOXIB
DOC Generici, do not drive 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 an intolerance to certain sugars, contact them 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. If you think or feel that the effect of CELECOXIB DOC Generici is too strong or too weak, discuss this with your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of side effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest dose that is sufficient to control pain and not to extend treatment with CELECOXIB DOC Generici beyond what is necessary to control symptoms.

Method of administration
CELECOXIB DOC Generici should be taken orally. The capsules may be taken at any time of day, with or without food. However, try to take each subsequent dose of CELECOXIB DOC Generici at the same time each day.
If you do not experience benefits within two weeks of starting treatment, consult your doctor.

Recommended dose
For osteoarthritis, the 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 daily; or
one 100 mg capsule twice daily.

For rheumatoid arthritis, the 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 daily.

For ankylosing spondylitis, the 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 daily; or
one 100 mg capsule twice daily.

Renal or hepatic impairment: ensure your doctor knows if you have kidney or liver problems, as a dose reduction may be necessary.
Elderly patients, particularly 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 wish to monitor you more closely.
Do not take more than 400 mg per day.

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

If you take more CELECOXIB DOC Generici than you should
Do not take more capsules than your doctor has prescribed. If you take too many capsules, consult your doctor, pharmacist, or go to hospital, and take the medicine pack 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
Stopping treatment with CELECOXIB DOC Generici suddenly may cause symptoms to worsen. Do not stop treatment with CELECOXIB DOC Generici unless instructed by your doctor. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any further questions 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.
The side effects listed below have been observed in patients with arthritis who have taken
celecoxib. The side effects marked with an asterisk (*) are listed according to the highest
frequencies observed in patients who took 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 conditions, stop treatment with CELECOXIB DOC Generici
and consult a doctor immediately:
If you have:

an allergic reaction presenting as skin rash, facial swelling, difficulty breathing or wheezing
heart problems presenting as chest pain
severe stomach pain or any sign of stomach or intestinal bleeding, such as dark or bloody 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)).

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, sinus pain or blockage), stuffy or runny nose, sore throat, cough, cold, flu-like symptoms
dizziness, sleep disturbances
vomiting*, stomach pain, diarrhoea, indigestion, flatulence
rash, itching
muscle stiffness
difficulty swallowing*
headache
nausea (feeling unwell)
joint pain
worsening of pre-existing allergies
accidental injury.

Uncommon: may affect up to 1 in 100 people

heart attack*
heart failure, palpitations (awareness of heartbeat), rapid heartbeat
abnormal blood test results related to liver function
abnormal blood test results related to kidney function
anaemia (abnormal red blood cells which may cause tiredness and breathlessness)
anxiety, depression, fatigue, drowsiness, tingling (pins and needles sensation)
high levels of potassium in blood tests (may cause nausea (feeling unwell), tiredness, muscle weakness or palpitations)
blurred or altered vision, ringing in the ears, mouth pain and ulcers, hearing disturbances*
constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
leg cramps
itchy rash (urticaria)
eye inflammation
difficulty breathing
skin discolouration (bruising)
chest pain (generalised 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 intestine; or intestinal injury (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction),
black or dark stools, pancreatitis (may cause stomach pain), oesophagitis
low levels of sodium in the blood (a condition called hyponatraemia)
reduction in the number of white blood cells (those that help protect the body from infections) and platelets (increased risk of bleeding and bruising)
difficulty in coordinating muscle movements
confusion, taste disturbances
increased sensitivity to light
hair loss
hallucinations
eye haemorrhage
acute reaction that may cause lung inflammation
irregular heartbeat
hot flushes
blood clots in the blood vessels of the lungs. Symptoms may include sudden breathlessness, sharp pains when breathing or fainting
bleeding in the stomach or intestine (may cause blood in stools or vomiting), inflammation of the intestine or colon
severe liver inflammation (hepatitis). Symptoms include nausea (feeling unwell), diarrhoea, jaundice (yellowish 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, 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 rash, blisters or skin peeling) and generalised exanthematous pustulosis (symptoms include red skin with swellings covered by numerous small pustules)
delayed allergic reaction with possible symptoms such as skin rash, facial swelling, fever, swollen lymph nodes, abnormal blood test results (e.g. liver function, blood count (eosinophilia, a specific increase in white blood cells))
fatal cerebral 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 include nausea (feeling unwell), diarrhoea, jaundice (yellowish 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 altered stool colour, nausea and yellowing of the skin or eyes)
kidney inflammation or 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, causing partial or complete loss of vision
inflamed blood vessels (may cause fever, pain, reddish patches on the skin)
reduction in red blood cells, 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

reduced fertility in women, generally reversible upon 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 daily for 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 cause stomach pain, diarrhoea, indigestion, flatulence)
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 clots usually in the legs, which may cause calf pain, swelling or redness, or breathing problems)
stomach disorders: stomach infection (may cause irritation and ulceration of the stomach and intestine)
lower limb fractures
shingles, skin infection, eczema (dry, itchy rash), pneumonia (chest infection (which may present with cough, fever, difficulty breathing))
floating bodies in the eye that may affect or blur vision; dizziness caused by inner ear disorders; ulceration, inflammation or bleeding of the gums; mouth ulcers
excessive need to urinate at night, haemorrhoidal bleeding, frequent bowel movements
fatty lumps on the skin or other body parts, ganglion cysts (non-painful swellings above or around joints and tendons of hands or feet), difficulty speaking, abnormal or heavy vaginal bleeding, breast pain
high levels of sodium in blood tests.

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.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 stated on the blister and the carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via 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 DOC Generici contains

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

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

100 mg capsules: PVC-PVDC/Aluminum blisters containing 10, 20, 30, 40, 50, 60, 100 capsules.
200 mg capsules: PVC-PVDC/Aluminum blisters containing 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 Milano
Italy

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

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: CELECOXIB DOC Generici 100mg/200mg hard capsules
Spain: Celecoxib Ferrer 200 mg hard capsules EFG