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Celecocid

Celecocid is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.


Generic Name

Celecocid


Packing

10&100


Therapeutic Category

NSAIDs


Storage

Do not store Celecocid above 30°C.


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adobe-pdf-logoPrescribing Information(SPC)


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Product Description

Product Overview


What Celecocid is and what it is used for

Celecocid is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Celecocid belongs to a group of medicinal products called no steroidal anti-inflammatory drugs (NSAID), and specifically a sub-group known as (COX-2) inhibitors. Your body makes prostaglandins that may cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these. Celecocid acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation.

What you need to know before you take Celecocid

You have been prescribed Celecocid by your doctor. The following information will help you get the best results with Celecocid.
If you have any further questions please ask your doctor or pharmacist.

Do not take Celecocid

Tell your doctor if any of the following are true for you as patients with these conditions should not take Celecocid.
•If you are allergic to celecocid or any of the other ingredients of this medicine
•If you have had an allergic reaction to a group of medicines called “sulphonamides” (e.g. some antibiotics used to treat infections)
•If you currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines
•If as a result of taking acetylsalicylic acid or any other anti-inflammatory and pain-relieving medicine (NSAID) you have had asthma, nose polyps, severe nose congestion, or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
•If you are pregnant. If you can become pregnant during ongoing treatment you should discuss methods of contraception with your doctor
•If you are breast-feeding

Warnings and precautions

Talk to your doctor before taking Celecocid:
•If you have previously had an ulcer or bleeding in your stomach or intestines.

(Do not take Celecocid if you currently have an ulcer or bleeding in your stomach or intestine).

•If you are taking acetylsalicylic acid (even at low dose for heart protective purposes)
•If you use medicines to reduce blood clotting (e.g. warfarin)
•If you are using Celecocid at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The use of these medicines together should be avoided
•If you smoke, have diabetes, raised blood pressure or raised cholesterol
•If your heart, liver or kidneys are not working well your doctor may want to keep a regular check on you
•If you have fluid retention (such as swollen ankles and feet)

As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.
Some cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant), have been reported with celecocid. Of the cases that reported time to onset, most severe liver reactions occurred within one month of start of treatment.

Celecocid may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant (see section on Pregnancy and breast-feeding).

Other medicines and Celecocid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

•Dextromethorphan (used to treat coughs)
•ACE inhibitors or angiotensin II antagonists (used for high blood pressure and heart failure)
•Diuretics (used to treat excess fluid in the body)
•Fluconazole and rifampicin (used to treat fungal and bacterial infections)
•Warfarin or other oral anticoagulants (“blood-thinning” agents that reduce blood clotting)
•Lithium (used to treat some types of depression)

Pregnancy, breast-feeding 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
Celecocid must not be used by women who are pregnant or can become pregnant (i.e. women of child bearing potential who are not using adequate contraception) during ongoing treatment. If you
become pregnant during treatment with Celecocid you should discontinue the treatment and contact your doctor for alternative treatment.

Breast-feeding
Celecocid must not be used during breast-feeding.

Fertility
NSAIDs, including Celecocid, may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines
You should be aware of how you react to Celecocid before you drive or operate machinery. If you feel dizzy or drowsy after taking Celecocid, do not drive or operate machinery until these effects wear off.

Celecocid contains
Celecocid contains lactose (a type of sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Celecocid

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you think or feel that the effect of Celecocid is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will tell you what dose you should take. As the risk of side effects associated with heart problems may increase with dose and duration of use, it is important that you use the lowest dose that controls your pain and you should not take Celecocid for longer than necessary to control symptoms.

Celecocid should be swallowed whole with a drink of water.
The capsules can be taken at any time of the day, with or without food. However, try to take each dose of Celecocid at the same time each day.

Contact your doctor within two weeks of starting treatment if you do not experience any benefit.

For osteoarthritis the usual dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

For rheumatoid arthritis the usual dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 100 mg capsule twice a day.

For ankylosing spondylitis the usual dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually:
• one 200 mg capsule once a day; or
• one 100 mg capsule twice a day.

Kidney or liver problems: make sure your doctor knows if you have liver or kidney problems as you may need a lower dose.

The elderly, especially those with a weight less than 50 kg: if you are over 65 years of age and especially if you weigh less than 50 kg, your doctor may want to monitor you more closely.
You should not take more than 400 mg per day.

Use in children: Contact your doctor within two weeks of starting treatment if you do not experience any benefit.

If you take more Celecocid than you should:
You should not take more capsules than your doctor tells you to. If you take too many capsules contact your doctor, pharmacist or hospital and take your medicine with you.

If you forget to take Celecocid:
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 Celecocid:
Suddenly stopping your treatment with Celecocid may lead to your symptoms getting worse. Do not stop taking Celecocid unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely. Is for adults only, it is not for use in children.

Possible side effects

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

The side effects listed below were observed in arthritis patients who took Celecocid.
Side effects marked with an asterisk (*) are listed below at the higher frequencies that occurred in patients who took Celecocid to prevent colon polyps.
Patients in these studies took Celecocid at high doses and for a long duration.

If any of the following happen, stop taking Celecocid and tell your doctor immediately:
If you have:

•An allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing
•Heart problems such as pain in the chest
•Severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood.
•A skin reaction such as rash, blistering or peeling of the skin
•Liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow)).

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 buildup with swollen ankles, legs and/or hands
•Urinary infections
•Shortness of breath*, sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses),blocked or runny nose, sore throat, coughs, colds, flu-like symptoms
•Dizziness, difficulty sleeping
•Vomiting*, stomach ache, diarrhoea, indigestion, wind
•Rash, itching

Uncommon: may affect up to 1 in 100 people
•Stroke*
•Heart failure, palpitations (awareness of heart beat), fast heart rate
•Abnormalities in liver-related blood tests
•Abnormalities in kidney-related blood tests
•Anaemia (changes in red blood cells that can cause fatigue and breathlessness)
•Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles)
•High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle weakness or palpitations)

Rare: may affect up to 1 in 1,000 people
•Ulcers (bleeding) in the stomach, gullet or intestines; or rupture of the intestine (can cause stomach ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the pancreas (can lead to stomach pain), inflammation of the gullet (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 infection) or blood platelets (increased chance of bleeding or bruising)
•Difficulty coordinating muscular movements
•Feeling confused, changes in the way things taste
•Increased sensitivity to light

Very rare: may affect up to 1 in 10,000 people
•Serious allergic reactions (including potentially fatal anaphylactic shock)
•Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include the skin becoming red with swollen areas covered in numerous small pustules)
•A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands, and abnormal test results (e.g., liver, blood cell (eosinophilia, a type of raised white blood cell count))
•Bleeding within the brain causing death
•Meningitis (inflammation of the membrane around the brain and spinal cord)
•Blockage of an artery or vein in the eye leading to partial or complete loss of vision

Not known: frequency cannot be estimated from the available data
•Decreased fertility in females, which is usually reversible on discontinuation of the medicine

In clinical studies not associated with arthritis or other arthritic conditions, where Celecocid was taken at doses of 400 mg per day for up 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 (can include stomach ache, diarrhoea, indigestion, wind)
•Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine
•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 of the calf or breathing problems)
•Stomach problems: stomach infection (which can cause irritation and ulcers of the stomach and intestines)
•Lower limb fracture
•Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing))
•Floaters in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, sore, inflamed or bleeding gums, mouth sores
•Excessive urination at night, bleeding from piles/haemorrhoids, frequent bowel movements

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Celecocid

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 carton. The expiry date refers to the last day of that month.
Do not store Celecocid above 30 C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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