Buy Celebrex Malaysia

Package insert: Information for the user

Celebrex 100 mg hard capsules Celebrex 200 mg hard capsules Celecoxib

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this brochure. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has only been prescribed for you. Do not pass it on to others, even if the symptoms of the disease are the same as yours, as this can be dangerous.
• If side effects occur, including those not listed in this leaflet, yes

Talk to your doctor or pharmacist. See paragraph 4.

What is in this brochure

11. What Celebrex is and what it is used for

22. What you need to know before you get Celebrex

33. How to take Celebrex

44. Possible side effects

55. How to store Celebrex

66. Contents of the pack and other information

1. What Celebrex is and what it is used for

   Celebrex is used in adults for the symptomatic treatment of rheumatoid arthritis, and osteoarthritis

   Ankylosing spondylitis.

   Celebrex belongs to a class of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), and in particular to a subset known as COX-2 inhibitors. The body produces prostaglandins, which can cause pain and inflammation. Under certain conditions, such as rheumatoid arthritis and osteoarthritis, the body produces more. Celebrex reduces the production of prostaglandins and thus also pain and inflammation.

   The medicine is expected to work within a few hours of taking the first dose, but it may not feel fully effective for several days.

2. What you need to know before you get Celebrex

   Your doctor has prescribed Celebrex for you. The following information will help you get the best results from Celebrex. If you have any further questions, ask your doctor or pharmacist.

   Do not take Celebrex

   Tell your doctor if any of the following conditions apply to you, as patients with these conditions should not take Celebrex.
   • if you are allergic to celecoxib or any of the other ingredients in this medicine (see section 6)
   • if you have an allergic reaction to a class of medicines called "sulfonamides" (e.g. some antibiotics to treat infections)
   • if you currently have a stomach or intestinal ulcer or bleed in the stomach or intestines
   • if you have asthma, nasal polyps, severe stuffy nose or an allergic reaction such as an itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or hissing
   • if you are pregnant. If you can become pregnant during treatment, you should talk to your doctor about contraception
   • 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
   • For example, if you have heart failure or known ischemic heart disease or cerebrovascular disease, you have been diagnosed with a heart attack, stroke or transient ischemic attack (stroke "), angina pectoris, or blockage of the blood vessels to the heart or brain
   • if you have or have had circulatory problems (peripheral arterial disease) or if you have had an operation on the arteries of your legs

   Warnings and precautions

   Talk to your doctor or pharmacist before taking Celebrex:
   • If you have previously had an ulcer or bleeding in the stomach or intestines (do not take Celebrex if you currently have an ulcer or bleeding in the stomach or intestines).
   • 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 / warfarin-like anticoagulants or new oral anticoagulants such as apixaban)
   • if you use medicines called corticosteroids (such as prednisone)
   • if you use Celebrex with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concomitant use of these medicines should be avoided
   • If you smoke, you have diabetes, high blood pressure, or high cholesterol
   • If you have a heart, liver, or kidney that is not working properly, your doctor may have you examined regularly
   • if you have fluid retention (such as swollen ankles and feet)
   • if you are dehydrated, for example due to illness, diarrhea or using diuretics (to treat excess fluids in the body)
   • if you have had a severe allergic or skin reaction to someone medicine
   • If you feel bad or think you may have an infection due to an infection, Celebrex may mask fever or other signs of infection and inflammation
   • Your doctor will monitor you regularly if you are over 65 years of age

   Drinking alcohol and NSAIDs could increase your risk of gastrointestinal problems. As with other NSAIDs (e.g. ibuprofen or diclofenac), this medicine can cause an increase in blood pressure. Your doctor may ask you to check your pressure regularly. Some cases of severe liver reactions have been reported during treatment with celecoxib, including severe inflammation of the liver, liver damage, liver failure (some cases had poor results or required liver transplantation). Among the cases for which the time of onset is known, most serious liver reactions occurred within a month of starting treatment. Celebrex can make it difficult to get pregnant. You must tell your doctor if you are planning to become pregnant, or if you are having trouble getting pregnant (see the section on pregnancy and lactation).

   Other drugs and Celebrex

   Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking 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 warfarin-like medicines (medicines that reduce blood clotting), including newer medicines such as apixaban
   • Lithium (used to treat some types of depression)
   • Other medications used to treat depression, sleep disorders, high blood pressure or irregular heartbeat
   • Neuroleptics (used to treat some mental disorders)
   • Metrotressate (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 sleep disorders)
   • Cyclosporin and tracrolimus (to suppress the immune system, e.g. after transplants)

   Celebrex can be taken with a low dose of acetylsalicylic acid (75 mg per day or less). Ask your doctor for advice before taking the two medicines at the same time.

   Pregnancy, lactation and fertility

   If you are pregnant, breast-feeding, planning to become pregnant, or plan to breast-feed, ask your doctor or pharmacist for advice before taking this medicine.

   pregnancy

   Celebrex should not be used during treatment by pregnant women or women who may become pregnant (e.g. women of childbearing age who do not use appropriate methods of contraception). If you become pregnant while taking Celebrex, you must stop treatment and contact your doctor for alternative therapy.

   lactation

   Celebrex should not be used while breastfeeding.

   fertility

   NSAIDs, including Celebrex, can make it difficult to get pregnant. You must tell your doctor if you are planning to become pregnant or if you are having trouble getting pregnant.

   Drive and use machines

   Before you drive or operate machines, you should know how they can react to Celebrex. If you feel dizzy or sleepy after taking Celebrex, do not drive or use machines until these effects have disappeared.

   Celebrex contains lactose

   Celebrex contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Celebrex

   Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, contact your doctor or pharmacist. If you think or think that Celebrex is too strong or too weak, talk to your doctor or pharmacist.

   Your doctor will tell you what dose to take. Because the risk of side effects related to heart problems may increase with increasing dose and duration of therapy, it is important that you use the lowest possible dose to relieve pain and do not take Celebrex longer than necessary to control symptoms.

   Method of administration:

   Celebrex is for oral use. The capsules can be taken at any time of the day with or without food. However, always try to take every dose of Celebrex at the same time each day. If you have trouble swallowing the capsules

   The entire contents of the capsule can be poured onto a flat spoon of semi-solid food (such as apple mousse, rice cream, yoghurt or mashed banana, cold or at room temperature) and swallowed immediately with about 240 ml of water.

   To open the capsule, hold it vertically to keep the granules at the bottom, and then pull out the top part by rotating it with light pressure. Make sure that the contents are not spilled.

   Do not chew or crush the granules.

   If you see no benefit, contact your doctor within two weeks of starting treatment. The recommended dose is:

   For osteoarthritis, the recommended dose is 200 mg per day, which the doctor can increase to a maximum of 400 mg if necessary.

   The usual dose is the following:

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

   In rheumatoid arthritis, the recommended dose is 200 mg per day, which the doctor can increase to a maximum of 400 mg if necessary.

   • The usual dose is the following:
   • one 100 mg capsule twice a day.

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

   The usual dose is the following:

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

   Kidney or liver disease: Make sure your doctor knows if you have liver or kidney problems, as a lower dose may be required.

   Elderly people, especially 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 have you examined more closely.

   You must not take more than 400 mg a day.

   Use in children: Celebrex is only for adults. It should not be used for children.

   If you take more Celebrex 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 Celebrex:

   If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

   If you stop taking Celebrex:

   Stopping Celebrex suddenly can make the symptoms worse. Do not stop taking Celebrex unless your doctor tells you to. Your doctor will likely tell you to reduce the dose for a few days before you stop completely.

   If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

   Like all medications, this medication can cause side effects, although not everyone gets them.

   The side effects listed below have been observed in arthritis patients taking Celebrex. The side effects marked with an asterisk (*) have been seen more often in patients taking Celebrex to prevent colon polyps. The patients in these studies took Celebrex in high doses and over a long period of time. If any of the following occur, stop taking Celebrex and tell your doctor straight away: If you have:
   • an allergic reaction such as a rash, swelling of the face, wheezing or difficulty breathing
   • Heart problems such as chest pain
   • Severe pain in the stomach or signs of bleeding in the stomach or intestines, such as black stool or blood in the stool or vomiting of blood
   • a skin reaction such as a rash, blistering or peeling of the skin
   • Liver failure (symptoms include nausea, diarrhea, jaundice (yellowing of the skin or eyeball))

   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:

   • Myocardial *
   • Fluid retention with swollen ankles, legs and / or hands
   • Urinary tract infections
   • Shortness of breath *, sinusitis (inflammation or infection of the sinuses, stuffy or painful sinuses), stuffy or runny nose, sore throat, cough, cold, flu symptoms
   • Dizziness, trouble sleeping
   • Vomiting *, stomach pain, diarrhea, indigestion, air
   • Itchy rash
   • Muscle stiffness
   • Difficulties swallowing *
   • a headache
   • nausea
   • Joint pain
   • Deterioration of existing allergies
   • Accident injury
   Uncommon: may affect up to 1 in 100 people:
   • Stroke *
   • Heart failure, palpitations, high heart rate
   • Blood test abnormalities for liver-related values
   • Blood test abnormalities for kidney-related values
   • Anemia (changes in red blood cells that can cause tiredness and shortness of breath)
   • Anxiety, depression, fatigue, sleepiness, tingling
   • High levels of potassium in blood test results (may cause nausea, fatigue, muscle weakness, or palpitations)
   • Blurred or impaired vision, buzzing in the ears, pain and sores in the mouth, difficulty Listen *
   • Constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of inflammation of the stomach or intestines
   • Leg cramps
   • Increased itchy rash (hives)
   • Inflammation of the eye
   • Difficulty breathing
   • Skin discoloration (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 intestines; or bowel hernia (may cause stomach pain, fever, nausea, vomiting, bowel blockage), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the esophagus
   • Low levels of sodium in the blood (a condition called hyponatremia)
   • Reduction of white blood cells (which protect the body from infections) and platelets (more likely to bleed or bruise)
   • Difficulty coordinating muscle movements
   • Feeling confused, changes in taste
   • Higher sensitivity to light
   • Hair loss
   • Hallucinations
   • Bleeding of the eye
   • Acute reaction that can cause pneumonia
   • Irregular heartbeat
   • Flushes
   • Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, severe pain when breathing, or fainting.
   • Bleeding in the stomach or intestines (may cause blood in the stool or vomiting), inflammation Intestine or colon
   • Severe inflammation of the liver (hepatitis). Symptoms include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, light 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:

   • Serious allergic reactions (including a potentially fatal anaphylactic shock)
   • Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (which can cause a rash, blistering or peeling of the skin) and pustulosis

   acute generalized and exanthematic (symptoms are red skin with swelling covered with numerous small pustules)

   • Delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, enlarged lymph glands, impaired blood test values (e.g. liver function, blood count (eosinophilia, 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 that are sometimes fatal or require a liver transplant). Symptoms include nausea (feeling sick), diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, light bleeding, itching or chills
   • Liver disease (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as changes in stool color, nausea, and yellowing of the skin or eyes)
   • Inflammation of the kidneys or other kidney diseases (such as nephrotic syndrome and glomerulopathy a minimal lesions, which may be accompanied by symptoms such as water retention (edema), frothy urine, fatigue and loss of appetite)
   • Worsening of epilepsy (possibility of more frequent and / or more severe attacks)
   • Blockage of an artery or vein in the eye causing partial or complete loss of vision
   • Inflamed blood vessels (can cause fever, pain, and reddish spots on the skin)
   • Reduction of red blood cells, white blood cells and platelets (can lead to tiredness, bruising, frequent nosebleeds and an increased risk of infection)
   • 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 with discontinuation of the drug
   The following side effects have been observed in clinical trials not related to arthritis or other arthritis-related diseases and in which Celebrex has been taken in doses of 400 mg per day for a maximum of 3 years:

   Common: may affect up to 1 in 10 people:

   • Heart disease: angina (chest pain)
   • Stomach discomfort: irritable bowel syndrome (may include stomach pain, diarrhea, indigestion, air)
   • Kidney stones (which may cause back or stomach pain, blood in the urine), Difficulty urinating
   • Weight gain

   Uncommon: may affect up to 1 in 100 people:

   • Deep vein thrombosis (blood clotting in general in the leg that can cause pain, swelling or redness in the calf or breathing problems)
   • Stomach discomfort: gastric infection (which can cause stomach irritation and ulcers intestine)
   • Fracture in the lower limbs
   • Herpes zoster (fire of St. Anthony), skin infection, eczema (dry and itchy rash), pneumonia (breast infection (possible cough, fever, difficulty breathing))
   • Flying flies in the eye cause visual disturbances or dizziness due to internal ear disorders, painful, inflamed or bleeding gums, mouth pain
   • Excessive urination at night, bleeding hemorrhoids, frequent bowel movements
   • Accumulation of fat on the skin or elsewhere, ganglion cyst (harmless swelling on the joints and around the tendons of the hands or feet), difficulty speaking, abnormal or very heavy bleeding from the vagina, chest pain
   • High levels of sodium in blood test results

   Reporting of side effects

   If you experience side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-. By reporting side effects you can provide more information on the safety of this medicine.

5. How to store Celebrex

   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 on the carton. The expiry date refers to the last day of this month.

   Do not store Celebrex above 30 ° C.

   Do not throw medication into wastewater or household waste. Ask your pharmacist how you can get rid of medicines you no longer use. This helps protect the environment.

6. Contents of the pack and other information What Celebrex contains

The active substance is celecoxib.

1 capsule contains 100 mg or 200 mg Celecoxib.

Advertising The other components are:

Lactose monohydrate, sodium lauryl sulfate, povidone, croscarmellose sodium and magnesium stearate. The capsule shells contain: gelatin, titanium dioxide E171, sodium lauryl sulfate and sorbitan monolaurate. The ink contains shellac, propylene glycol, indigo carmine E132 (100 mg capsules) and yellow iron oxide E172 (200 mg capsules).

Description of the appearance of Celebrex and the contents of the pack

Celebrex is available in the form of hard capsules.

Opaque white capsules with blue bands marked 7767 and 100 (Celebrex 100 mg). Opaque white capsules with gold bands marked 7767 and 200 (Celebrex 200 mg).

The capsules are packed in transparent or opaque aluminum / PVC blisters.

Celebrex is contained in packs of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10 x 10, 10 x 30, 10 x 50, 1 x 50

in separable units, 1 x 100 in separable units, 5 x (10 x 10) capsules. It is possible that not all pack sizes will be marketed.