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What Celicoxib is and what it is used for
Celecoxib is used in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.
Celecoxib belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to the Cyclooxygenase-2 (COX-2) subgroup of inhibitors. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, the body produces them in greater quantities. Celecoxib Ecofarm works by reducing the production of prostaglandins, thus reducing pain and inflammation.
You may expect the drug to start acting within a few hours of taking the first dose, but you may not experience its full effect within a few days.
2. What you need to know before taking Celucoxib
Celecoxib Ecofarm has been prescribed for you by your doctor. The following information will help you get the best results from celecoxib ecofarm. If you have any further questions, ask your doctor or pharmacist.
Do not take Celucoxib
Talk to your doctor if any of the following applies to you because patients with these conditions should not take Celecoxib Ekofarm:
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" (eg some antibiotics used to treat infections);
if you currently have stomach or intestinal ulcer or bleeding from the stomach and intestines;
if you have suffered from asthma, nasal polyps, severe swelling of the nasal mucosa, or have had an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue, or tongue, as a result of taking acetylsalicylic acid or other anti-inflammatory and pain killers (NSAIDs) throat, difficulty in breathing or wheezing;
if you are pregnant. If there is a possibility of becoming pregnant during treatment, it is necessary to discuss methods of contraception with your doctor;
if you are breastfeeding;
if you suffer from severe liver disease;
if you suffer from severe kidney disease;
if you suffer from 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, you have had a diagnosed heart attack, stroke, or transient ischemic attack (a temporary loss of blood flow to the brain, also known as a microinstance), angina or blockage of the blood vessels to the heart or the brain;
if you have or have had circulatory problems (peripheral arterial disease) or if you have undergone an operation of the lower limb arteries.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Celucoxib Ekofarm:
if you have had ulcers or bleeding from the stomach or intestine (do not take Celucoxib if you currently have ulcers or bleeding from the stomach or intestines);
if you are taking acetylsalicylic acid (even in a low dose for cardiac prophylaxis);
if you take blood thinning medicines (eg warfarin / warfarin-like anticoagulants or new oral anticoagulants such as apixaban);
if you are taking medicines called corticosteroids (for example, prednisone);
if you take Celecoxib Ecofarm with other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided;
if you smoke, you have diabetes, high blood pressure or elevated cholesterol;
if your heart, liver or kidneys do not work well, so your doctor may decide to periodically review you;
if you keep fluid (you have swollen knees or feet);
if you are dehydrated, for example due to illness, diarrhea or diuretic use (used to reduce excess fluid in the body);
if you have had a serious allergic reaction or serious skin reaction due to the use of medicinal products;
if you feel unwell because of an infection or think you may have an infection because Celecoxib Ekofarm may mask fever or other signs of infection and inflammation;
if you are over 65 years of age because your doctor may decide to monitor your condition regularly;
you use alcohol and NSAIDs, which may increase the risk of gastrointestinal disorders.
As with other NSAIDs (eg ibuprofen or diclofenac), this medicine may cause an increase in blood pressure, so your doctor may start to monitor your blood pressure periodically.
Cases of severe liver reactions, including severe liver inflammation, hepatic impairment, hepatic failure (some fatal or requiring liver transplantation), have been reported
If any of the following occurs, stop taking Celecoxib and tell your doctor immediately:
an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty in breathing;
heart problems, such as chest pain;
severe stomach pain or any sign of bleeding from the stomach or intestine, for example, the onset of black or blood-mixed stools, or vomiting of blood;
skin reactions such as rash, blistering or scaling of the skin;
hepatic insufficiency (symptoms may include nausea, diarrhea, jaundice (yellow skin and white 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:
fluid retention by swelling of the ankles, lower and / or upper limbs;
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, sleep problems;
vomiting *, stomach pain, diarrhea, indigestion, gas;
difficulty swallowing *;
soreness of the joints;
worsening of existing allergies;
Uncommon: may affect up to 1 in 100 people:
haemorrhage in the brain (stroke);
heart failure, palpitations (heart beat sensation), increased heart rhythm;
deviations in liver tests;
deviations in kidney research;
anemia (changes in red blood cells leading to tiredness and shortness of breath);
anxiety, depression, tiredness, drowsiness, tingling sensation (tingling);
high levels of potassium in your blood (may cause nausea, tiredness, muscle weakness or palpitations);
impaired or blurred vision, tinnitus, pain and throat inflammation, hearing disorder *;
constipation, belching, stomach inflammation (indigestion, stomach ache or vomiting), worsening of existing inflammation of the stomach or intestines;
cramps in the lower limbs;
embossed skin rash (urticaria);
changes in skin color (bruises);
chest pain (generalized 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 intestines; (may cause stomach pain, fever, nausea, vomiting, bowel obstruction), dark or black stools, inflammation of the pancreas (may lead to stomach ache), inflammation of the esophagus (esophagus);
decreased blood sodium (a condition called hyponatraemia);
decreased amount of white blood cells (which help the body protect against infections) or blood platelets (increased risk of bleeding or bruising);
difficulty coordinating muscular movements;
feeling of confusion, changes in taste;
increased sensitivity to light;
an acute reaction that can lead to pulmonary inflammation;
irregular heart rhythm;
blood clot in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, severe breathing pain or collapse;
bleeding from the stomach or intestines (may lead to bloody stools or vomiting), inflammation of the small or large intestine;
severe liver inflammation (hepatitis). Symptoms may include nausea (feeling sick), diarrhea, jaundice (yellow skin and white eyes), darkening of the urine, pale faeces, easy bleeding, itching or chills;
acute renal failure;
swelling of the face, lips, mouth, tongue or throat or difficulty in swallowing
Very rare: may affect up to 1 in 10,000 people:
severe allergic reactions (including potentially fatal anaphylactic shock);
severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis (may cause rash, blistering or scaling) and acute generalized exanthemous pustulosis (symptoms include reddening of the skin accompanied by swollen areas covered with numerous small purulent pimples);
delayed allergic reactions with possible symptoms such as rash, facial swelling, fever, enlarged glands and abnormalities in laboratory tests (eg liver, blood (eosinophilia - increased number of certain white blood cells));
brain haemorrhage that can lead to death;
meningitis (inflammation of the lining of the spinal cord and the spinal cord);
hepatic failure, hepatic impairment and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling sick), diarrhea, jaundice (yellow skin and white eyes), darkening of the urine, pale faeces, easy bleeding, itching or chills;
hepatic disorders (eg cholestasis or cholestatic hepatitis, which may be accompanied by symptoms such as faecal discolouration, nausea and yellowing of the skin and whites of the eyes);
kidney inflammation or other kidney problems (such as nephrotic syndrome or minimal changes of illness that may be accompanied by symptoms such as water retention, urine fatigue, tiredness and loss of appetite);
worsening of epilepsy (possible more frequent and / or more severe seizures);
blockage of an artery or vein in the eye resulting in partial or complete loss of vision;
inflammation of the blood vessels (can cause fever, pain, purple spots on the skin;
decrease in red blood cell count, white blood cells or blood platelets (may cause tiredness, bruising, often bleeding from the nose and increased risk of infection);
muscle aches and weakness;
loss of taste.
Not known: available data can not be estimated
decreased fertility in women, usually reversible when discontinuing the drug.
In clinical trials that were not associated with arthritis or other arthritic conditions and in which Celecoxib was taken at doses of 400 mg daily to 3 years, the following additional side effects have been observed:
Common: may affect up to 1 in 10 people:
• heart problems: angina (chest pain);
• stomach problems: irritable bowel syndrome (which may include stomach pain, diarrhea, indigestion, gas);
• 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 (a blood clot usually forming in a lower limb that can cause pain, swelling or redness of the calf, and difficulty in breathing);
• stomach problems: gastric infection (can cause inflammation and ulcers in the stomach or intestines);
• lower limb fracture;
• shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection with possible cough, fever, difficulty in breathing);
• Floating mumps in the eye causing blurred or disturbed vision, dizziness caused by problems with the inner ear, sore, painful or bleeding gums, inflammation in the oral cavity;
• excessive nighttime urination, bleeding hemorrhoids, accelerated intestinal peristalsis;
• fatty lumps on the skin or other areas of the body, ganglion cyst (innocuous swelling of or around the joints and tendons of the wrists or feet), difficulty speaking, abnormal or very strong vaginal bleeding, chest pain;
• high levels of sodium in the blood.
How to store Celecoxib
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister or carton. The expiry date refers to the last day of that month.
Store below 30 ° C.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Celecoxib contains
The active substance is celecoxib. Each capsule contains 100 mg or 200 mg celecoxib.
The other ingredients are:
Capsule contents: lactose monohydrate, hydroxypropyl cellulose, crospovidone, povidone, sodium lauryl sulfate, purified water, magnesium stearate.
Capsule shell content: titanium dioxide E171, gelatin, water, sodium lauryl sulfate.
Printing ink: shellac E904, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, FD & C blue 2 aluminum lake El32 (100 mg capsules) or yellow iron oxide E172 (200 mg capsules).
What Celecoxib looks like and contents of the pack
Celecoxib 100 mg capsules: Solid 4-size hard capsules containing white to off-white powder with a white opaque cap, white opaque body, marked "C5" on a blue stripe on the cap and "100 mg" on a blue stripe on the body capsule.
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