100 mg and 200 mg hard capsules 
celecoxib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Celecoxib Orion is and what it is used for 
2. What you need to know before you use Celecoxib Orion 
3. How to take Celecoxib Orion 
4. Possible side effects 
5. How to store Celecoxib Orion 
6. Contents of the pack and other information 

What Celecoxib Orion is and what it is used for

Celecoxib Orion is used in adults for symptom relief in the treatment of chronicrheumatoid arthritis , osteoarthritis and pelvic pondylitis (Mb. Bechterews, rheumatic back disease). 

Celecoxib Orion belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ), and more specifically to the subgroup COX-2inhibitors. Your body produces prostaglandins that can cause pain and inflammationand in conditions such as rheumatoid arthritis and osteoarthritis , your body produces more of them. Celecoxib Orion works by reducing the production of prostaglandins and thus reducing pain and inflammation .

You can expect the medicine to start working within a few hours after taking the first dose, but it may take several days before it takes full effect.

Celecoxib contained in Celecoxib Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you use Celecoxib Orion

Do not use Celecoxib Orion

  • 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 ulcers or bleeding in the stomach / intestines
  • if you have had asthma , nasal polyps, severe nasal congestion or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing after taking acetylsalicylic acid or any other anti-inflammatory and analgesic medicine ( NSAID )
  • if you are pregnant. If you are likely to become pregnant during treatment, you should discuss appropriate contraceptive methods with your doctor.
  • if you are breast-feeding
  • 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 or known ischemic heart disease or disease of the blood vessels of the brain, e.g. if you have had a heart attack, stroke , temporary decrease in blood flow to the brain (also known as “mini-stroke”), angina or narrowing of the blood vessels to the heart or brain
  • if you have or have had problems with blood circulation ( peripheral vascular disease) or if you have had surgery on the blood vessels in your legs.

Warnings and cautions

Talk to your doctor or pharmacist before taking Celecoxib Orion:

  • if you have a history of ulcers or bleeding in the stomach or intestines ( Do not take Celecoxib Orion if you currently have ulcers or bleeding in the stomach or intestines.)
  • if you are taking acetylsalicylic acid (even at low doses in order to protect your heart)
  • if you are taking medicines to reduce blood clots (eg warfarin / warfarin-like blood thinners or new blood thinners, eg apixaban by mouth)
  • if you are taking medicines called corticosteroids (eg prednisone)
  • if you are taking Celecoxib Orion at the same time as other NSAIDs (besides acetylsalicylic acid ), such as ibuprofen or diclofenac . Concomitant use of these drugs should be avoided.
  • if you smoke, have diabetes , high blood pressure or high cholesterol
  • If your heart, liver, or kidneys are not working properly, your doctor may want to check you regularly
  • if you have fluid retention in your body (such as swollen ankles and feet)
  • if you are dehydrated, e.g. due to vomiting, diarrhea or if you are taking diuretics (to treat fluid retention in the body)
  • if you have had a severe allergic reaction or a severe skin reaction to any medicine
  • if you have an infection , or suspect you have an infection , as Celecoxib Orion may mask fever or other signs of infection and inflammation
  • if you are over 65, your doctor will check you regularly
  • Intake of alcohol and NSAIDs may increase the risk of gastrointestinal upset.

Like other NSAIDs (eg ibuprofen or diclofenac ), this medicine may cause high blood pressure , so your doctor may ask you to have your blood pressure checked regularly.

Some cases of severe hepatic reaction have been reported following the use of celecoxib, such as severe hepatitis, liver damage, liver failure (some cases fatal, or requiring liver transplantation). In cases where the onset of symptoms was reported, most severe liver reactions were seen within one month of starting treatment.

Celecoxib Orion may make it harder to get pregnant. You should tell your doctor if you are planning to become pregnant or if you are having difficulty getting pregnant (see the section on Pregnancy, breast-feeding and fertility ).

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

Other medicines and Celecoxib Orion

Tell 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 inhibitors, 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 warfarin-like medicines (blood thinners that reduce blood clotting) including newer medicines like apixaban
  • lithium (used to treat certain types of depression)
  • Other medicines for depression, sleep disorders, high blood pressure or irregular heartbeat
  • neuroleptics (used to treat certain mental illnesses)
  • methotrexate (used to treat rheumatic joint disease, psoriasis and leukemia )
  • carbamazepine (used to treat epilepsy / seizures and certain forms of pain or depression)
  • barbiturates (used to treat epilepsy / seizures and certain sleep disorders)
  • ciclosporin and tacrolimus (used to suppress the immune system, eg after transplants)

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Celecoxib Orion must not be used by women who are pregnant or may become pregnant during treatment (ie women of childbearing potential not using adequate contraception). If you become pregnant during treatment with Celecoxib Orion, you should stop treatment and contact your doctor for other treatment.

Breast-feeding

Celecoxib Orion must not be used during breast-feeding.

Fertility

NSAIDs including Celecoxib Orion may make it harder to get pregnant. Tell your doctor if you are planning to become pregnant or have problems getting pregnant.

Driving and using machines

You should know how to react to Celecoxib Orion before driving or using machines. If you feel dizzy or drowsy after taking Celecoxib Orion, do not drive or use machines until these effects have subsided.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Celecoxib Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will tell you which dose to take. As the risk of heart side effects may increase with high doses and long-term treatment, it is important that you do not take a higher dose or use Celecoxib Orion for longer than you need to control your symptoms.

Method of administration

Celecoxib Orion is for oral use Your dose can be taken at any time of the day, with or without food.

Try to take each dose at the same time of day.

If you have difficulty swallowing capsules: All the contents of the capsule can be sprinkled on a teaspoon of semi-solid food (eg cold or room-warm apple puree, rice gruel, yoghurt or mashed banana) and swallowed immediately with about 240 ml of water.

Open the capsule by holding it upright so that the granules collect at the bottom, then gently squeeze the upper part and remove it with a twisting motion. Be careful not to spill any of the contents.

Granules must not be chewed or crushed.

Contact your doctor if you do not experience any improvement after two weeks of treatment.

The recommended dose is:

In osteoarthritis , the usual dose is 200 mg daily, which can be increased to a maximum of 400 mg if your doctor deems it necessary.

The usual dose is:

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

In chronic rheumatoid arthritis , the usual dose is 200 mg daily, which can be increased to a maximum of 400 mg if your doctor deems it necessary.

The usual dose is:

  • one capsule of 100 mg twice a day.

For Celecoxib Orion 200 mg only:

Contact your doctor if the prescribed dose is not available in this strength of the medicine. Other strengths of the drug are available to achieve dose one.

In the case of pelvic spondylitis , the usual dose is 200 mg daily, which can be increased to a maximum of 400 mg if your doctor deems it necessary.

The usual dose is:

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

Kidney or liver failure: If you have kidney or liver failure, tell your doctor as you may need to take a lower dose .

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

You should not take more than 400 mg per day.

Use in children: Celecoxib Orion is for adults only and should not be used in children.

If you forget to use Celecoxib Orion

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

If you stop using Celecoxib Orion

If you suddenly stop taking Celecoxib Orion, your symptoms may get worse. Do not stop taking Celecoxib Orion unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping treatment altogether.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The adverse reactions listed below have been observed in patients with osteoarthritisusing celecoxib. Side effects marked with an asterisk (*) are indicated with the higher frequency seen in patients using celecoxib to prevent colon polyps. These patients took celecoxib in high doses and for a long time.

If any of the following occur, stop taking Celecoxib Orion and contact your doctor immediately:

If you experience:

  • 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 signs of bleeding in the stomach or intestines, e.g. black or blood – stained stools or vomiting with blood in
  • a skin reaction such as rash, blistering, or flaking
  • liver failure with symptoms that may include nausea, diarrhea, jaundice (your skin or whites of the eyes look yellowish).

Very common (may affect more than 1 user in 10):

  • high blood pressure including increase in already high blood pressure . *

Common (may affect up to 1 in 10 people):

  • myocardial infarction*
  • fluid accumulation in the body that can cause swelling in the ankles, legs, and/or hands
  • urinary tract infection
  • difficulty breathing *, sinusitis, nasal congestion or runny nose, sore throat, cough, cold, flu-like symptoms
  • dizziness, difficulty sleeping
  • vomiting *, stomach pain, diarrhea, digestive problems, flatulence
  • rash, itching
  • uuskel tensions
  • difficulty swallowing *
  • headache
  • nausea
  • joint pain
  • deterioration of existing allergy s
  • damage in the event of an accident.

Uncommon (may affect up to 1 in 100 people):

  • stroke*
  • heart failure , palpitations, rapid heartbeat
  • changes in liver values ​​during blood tests
  • changes in kidney values ​​during blood tests
  • anemia (decreased number of red blood cells , which can cause weakness and shortness of breath)
  • anxiety, depression, fatigue, drowsiness, ant crawling
  • increased amount of potassium in the blood (may cause nausea, fatigue, muscle weakness or palpitations)
  • impaired vision or blurred vision, tinnitus , soreness in the mouth, cold sores, hearing loss *
  • constipation, belching, gastritis (indigestion, stomach pain or vomiting), worsening inflammation of the stomach or intestines
  • leg cramps
  • raised, itchy rash ( hives )
  • eye inflammation
  • breathing difficulties
  • discolored skin (bruises)
  • chest pain (general pain not related to the heart)
  • facial swelling.

Rare (may affect up to 1 in 1,000 people):

  • ulcers (bleeding) in the stomach, esophagus and intestines, ruptured intestines (may cause abdominal pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause abdominal pain), inflammation of the esophagus ( esophagitis )
  • decreased amount of sodium in the blood (a condition known as hyponatremia )
  • decreased white blood cell count (which helps protect the body against infection ) and platelets (increased risk of bleeding or bruising)
  • difficulty coordinating muscle movements
  • confusion, taste changes
  • increased photosensitivity
  • hair loss
  • hallucinations
  • bleeding in the eye
  • the acute reaction that can lead to pneumonia
  • irregular heartbeats
  • herds
  • blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse
  • bleeding in the stomach or intestines (may cause bloody stools or vomiting), intestinal inflammation
  • serious liver inflammation ( hepatitis ). Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed, itching or chills.
  • acute renal failure
  • menstrual disorders
  • swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty swallowing.

Very rare (may affect up to 1 in 10,000 people):

  • severe skin reactions (including anaphylactic shock , which may be life-threatening)
  • severe skin conditions such as Stevens-Johnson syndrome , exfoliative dermatitisand toxic epidermal necrolysis (which may cause rash, blistering or flaking of the skin) and acute skin rash-like generalized pustulosis (red, swollen area with many small blisters)
  • a delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormal test results in e.g. liver tests and blood cell tests ( eosinophilia , a type of increased white blood cell count )
  • cerebral hemorrhage, which can be life-threatening
  • meningitis ( inflammation of the meninges )
  • liver failure, liver damage and severe hepatitis ( fulminant hepatitis ) which in some cases had a fatal outcome or required liver transplantation. Symptoms may include nausea, diarrhea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, increased tendency to bleed, itching or chills.
  • liver problems (eg cholestasis and cholestatic hepatitis , which may be accompanied by symptoms such as discolored stools, nausea and yellow skin or yellow eyes)
  • nephritis and other kidney problems (eg nephrotic syndrome and minimal change disease which may be accompanied by symptoms such as fluid retention ( edema), frothy urine, fatigue and loss of appetite)
  • worsening epilepsy (possibly increased number of seizures and / or increased severity)
  • partial or complete loss of vision, caused by blockage of a blood vessel in the eye
  • inflammation of the blood vessels (may cause fever, aches, dark purple spots on the skin)
  • deficiency of all blood cells (may cause fatigue, increase the tendency to get bruises, frequent nosebleeds and increased risk of infection)
  • muscle aches and weakness
  • impaired sense of smell
  • loss of taste.

Has been reported (occurs in an unknown number of users):

  • Decreased fertility in women, which is usually transient at the end of treatment.

In clinical trials of conditions other than osteoarthritis or joint pain, which Celecoxib Orion was taken in dose you about 400 mg daily for up to 3 years, the following additional adverse reactions are observed:

Common (may affect up to 1 in 10 people):

  • angina (chest pain)
  • irritated colon (may include abdominal pain, diarrhea, digestive problems, flatulence)
  • kidney stones (may cause abdominal or back pain, blood in the urine), urinary incontinence
  • weight gain.

Uncommon (may affect up to 1 in 100 people):

  • deep vein thrombosis (blood clot, usually in the legs, which may cause pain, swelling or redness in the calf or difficulty breathing)
  • stomach infection (which can cause irritation and ulcers in the stomach and intestines)
  • fracture of forearm / lower leg
  • shingles , skin infection, eczema (dry itchy rash), pneumonia (cough, fever, difficulty breathing)
  • visual impairment caused by small spots in the visual field , dizziness caused by problems in the inner ear, tender, inflamed or bleeding gums, cold sores
  • need to urinate frequently at night, bleeding from hemorrhoids , upset bowel
  • lumps of fat in the subcutaneous tissue, ganglion (harmless swelling of the wrist and ankle tendons), speech difficulties, abdominal bleeding, tenderness in the breasts
  • increased amount of sodium in the blood.

Reporting of side effects is if you get side effects are, speak with your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase drug safety information. 

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Celecoxib Orion

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 label, carton and container after EXP. The expiration date is the last day of the specified month. 

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is celecoxib. 
    Each capsule contains 100 mg of celecoxib. 
    Each capsule contains 200 mg of celecoxib.
  • Other ingredients are: Capsule contents:  lactose monohydrate, hydroxypropylcellulose, Crospovidone (Type B) (E1202), sodium (E487), povidone (K-30) (E1201), sodium Capsule shells: titanium dioxide (E171), gelatin (E441) Capsule labeling: shellac (E904), indigo carmine E132 (only 100 mg), yellow iron oxide (E172) (only 200 mg) 


What the medicine looks like and contents of the pack

Celecoxib Orion is available as hard capsules.

Celecoxib Orion 100 mg hard capsules

White, hard gelatin capsule in size ‘4’, filled with a white to off-white powder, marked with ‘Y’ and ‘100’ in blue.

Celecoxib Orion 200 mg hard capsules

White, hard gelatin capsule in size ‘2’, filled with a white to off-white powder, marked with ‘Y’ and ‘200’ with a golden color.

Celecoxib Orion capsules are supplied in blisters and in HDPE cans.

Pack sizes:

Blister packs : 10, 20, 30, 50, 60, 90 and 100 capsules

HDPE cans: 

100 mg: 60, 100, 250 and 500 capsules

200 mg: 30, 100, 250 and 500 capsules

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913

Malta

Manufacturer:

APL Swift Services (Malta) Limited,

HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB

medinfo@orionpharma.com

Muhammad Nadeem

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