Onsenal
celecoxib
Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Onsenal is and what it is used for
Before you take Onsenal
How to take Onsenal
Possible side effects
How to store Onsenal
Further information
Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.
Medicinal product no longer authorised
Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites and in abnormally growing cells. Onsenal works by inhibiting COX-2, to which such dividing cells are sensitive. As a consequence the cells die.
Onsenal is used to reduce the number of gastrointestinal polyps in patients with Familial Adenomatous Polyposis (FAP). FAP is an inherited disorder in which the rectum and colon are covered with many polyps that might develop colorectal cancer. Onsenal should be used along with the usual care for FAP patients such as surgery and endoscopic surveillance.
if you have had an allergic reaction to any of the ingredients of Onsenal
if you have had an allergic reaction to a group of medicines called “sulphfonamides”. These include some antibiotics (Bactrim and Septra used in combination of sulfamethoxazole and trimethoprim), which can be used to treat infections
if you have a stomach or duodenal ulcer, or bleeding in the stomach or intestines
if after taking aspirin or another anti-inflammatory medicine you have had nasal polyps or severe nasal congestion, or any allergic reaction such as an itchy skin rash, swelling, breathing difficulties or wheezing
women of childbearing potential unless using an effective method of contraception
if you are breast feeding
if you have inflammation of the colon (ulcerative colitis) or intestinal tract (Crohn’s disease)
if you have severe liver disease
if you have severe kidney disease
if you have heart failure, established heart disease and /or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages of blood vessels to the heart or brain
if you have had an operation to clear or bypass blockages
or if you have or have had problems with blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs
Some people will need special care from their doctors when they are taking Onsenal. Make sure that your doctor knows before you start taking Onsenal:
if you have conditions which increase your risk of heart disease such as high blood pressure,
diabetes, high cholesterol or if you smoke you should discuss with your doctor whether Onsenal is suitable for you
if you have had a stomach or duodenal (intestinal) ulcer or bleeding in the stomach or intestines
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 or feet)
if you are dehydrated, for example by sickness or diarrhoea or if you are taking diuretic treatment (water tablets)
if you have had a serious allergic reaction or a serious skin reaction to any medicines
if you are taking acetylsalicylic acid
if you are taking anticoagulants
if you have intolerance to some sugars
if you are being treated for an infection, because Onsenal may mask a fever which is a sign of an infection
if you are over 65 years of age your doctor may want to keep a regular check on you
Medicinal product no longer authorised
As with other non-steroidal, anti-inflammatory drugs (NSAIDs; eg, 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Before you start taking Onsenal make sure your doctor knows if you are taking:
ACE inhibitors or Angiotensin II receptor antagonists (used for high blood pressure and heart failure)
Acetylsalcylic acid or other anti-inflammatory medicines
Cyclosporin and tacrolimus (used for immune system suppression e.g. after transplants)
Dextromethorphan (used as an antitussive in cough mixtures)
Diuretics (used to treat fluid retention)
Fluconazole (used to treat fungal infections)
Lithium (used to treat depression)
Rifampicin (used to treat bacterial infections)
Warfarin (used to prevent blood from clotting) or other anticoagulants
Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat
Neuroleptics (used to treat some mental disorders)
Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
Barbiturates ( used to treat epilepsy/seizures and some sleep disorders)
Onsenal can be taken with low dose acetylsalicylic acid (aspirin). Ask your doctor for advice before taking both of these medicines together.
You can take Onsenal with or without food.
You must not take Onsenal if you are pregnant or if it is possible that you become pregnant. You must not take Onsenal if you are breast feeding.
If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling normal again.
Onsenal contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Onsenal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose is 400 mg twice a day. You will usually take two 200 mg capsules twice a day.
The maximum recommended daily dose is 800 mg.
If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.
Medicinal product no longer authorised
Do not take a double dose to make up for forgotten individual doses.
Like all medicines, ONSENAL can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
The side effects listed below were observed in arthritis patients who took medicines with the same active ingredient as Onsenal:
Stop taking the capsules and tell your doctor immediately
If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing
If you have heart problems such as pain in the chest
If you have liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow))
If you have blistering or peeling of the skin
If you have severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood
Fluid build up with swollen ankles, legs and/or hands
Urinary infections
Sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny
nose, sore throat, coughs, colds, flu-like symptoms
Dizziness, difficulty sleeping
stomach ache, diarrhoea, indigestion, wind
Rash, itching
Muscle stiffness
Worsening of existing allergies
Heart failure, palpitations (awareness of heart beat), fast heart rate
Worsening of existing high blood pressure
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)
Impaired or blurred vision, ringing in the ears, mouth pain and soresConstipation, burping, stomach inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine.
Leg cramps
Raised itchy rash (hives)
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 gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to stomach pain)
Reduced number of white blood cells (which help protect the body from infection) and blood platelets (increased chance of bleeding or bruising)
Difficulty coordinating muscular movements
Medicinal product no longer authorised
Feeling confused, changes in the way things taste
Increased sensitivity to light
Loss of hair
Bleeding within the brain causing death
Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing; difficulty swallowing
Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon, nausea (feeling sick)
Serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin)
Liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant). Symptoms may include nausea (feeling sick), diarrhoea, jaundice, yellow discolouration of the skin or eyes, dark urine, pale stools, bleeding easily, itching or chills
Kidney problems (possible kidney failure, inflammation of the kidneys)
Blood clot in the blood vessels in the lungs. Symptoms may include sudden breathlessness, sharp pains when you breathe or collapse
Irregular heartbeat
Meningitis (inflammation of the membrane around the brain and spinal cord)
Hallucinations
Worsening of epilepsy (possible more frequent and/or severe seizures)
Inflamed blood vessels (can cause fever, aches, purple blotches on the skin)
Blockage of an artery or vein in the eye leading to partial or complete loss of vision, conjunctivitis, eye infection (pink eye), bleeding in the eye
A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nose bleeds and increased risk of infections)
Chest pain
Impaired sense of smell
Skin discolouration (bruising), muscle pain and weakness, painful joints
Menstrual disturbances
Headache, flushing
Low levels of sodium in blood test results (can cause loss of appetite, headache, nausea (feeling sick), muscle cramps and weakness)
High blood pressure*, diarrhoea*
Heart problems: heart attack*, angina (chest pain)
Stomach problems: nausea, heartburn, diverticulum (a problem with the stomach or intestine that can become painful or infected), vomiting*, 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, increased creatinine (blood test result related to kidney function)
Difficulty breathing
Muscle spasms
Oedema (water retention that can cause swelling)
Enlarged or inflamed prostate, prostate specific antigen increased (lab test)
Infections of various types
Medicinal product no longer authorised
Weight gain
Stroke
Unstable angina (chest pain), troubles with heart valves, rhythm, or coronary arteries, or enlarged heart
Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness
of the calf or breathing problems), bruising
Stomach infection(which can cause irritation and ulcers of the stomach and intestines), bleeding from piles/haemorrhoids, frequent bowel movements, inflamed or bleeding gums/mouth sores
Lower limb fracture, tendon rupture or inflammation
Shingles, skin infection, allergic dermatitis (dry itchy rash)
Floaters or haemorrhage in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, difficulty speaking
Difficulty sleeping, excessive urination at night
Fatty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot)
Abnormal or heavy bleeding from the vagina, painful menstruation, breast pain, ovarian cyst, menopausal symptoms
High levels of sodium or haemoglobin and low levels of hematocrit or testosterone in blood test
results
Decreased hearing
Changes in blood counts
Keep out of the reach and sight of children. Do not store your capsules above 30°C.
Do not take the capsule after the ‘expiry date’ shown on the blister and carton. If your capsules are out of date, take them to your pharmacist who will get rid of them safely.
The active substance is celecoxib
The other ingredients are gelatin, lactose monohydrate, sodium lauryl sulphate, povidone K30, croscarmellose sodium, magnesium stearate and the colouring agent titanium dioxide E171.
The printing ink contains also shellac, propylene glycol and iron oxide E172.
The capsules are white with ‘7767‘ and ‘200‘ marked in gold ink. Onsenal is packed in blisters and supplied in boxes of 10 or 60 capsules.
Pfizer Limited Ramsgate Road Sandwich
Kent CT13 9NJ
Medicinal product no longer authorised
United Kingdom
Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Strasse 35
89257 Illertissen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Pfizer S.A. / N.V.
Tél/Tel: +32 (0)2 554 62 11
Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11
Pfizer HCP Corporation
Тел.: +359 2 970 4333
Pfizer Kft.
Tel.: +36-1-488-37-00
Pfizer s.r.o.
Tel.: +420-283-004-111
V.J. Salomone Pharma Ltd. Tel. +356 212201 74
Pfizer ApS
Tlf: +45 44 20 11 00
Pfizer BV
Tel: +31 (0)10 406 4301
Pfizer Pharma GmbH
Tel: +49 30 550055-51000.
Pfizer AS
Tlf: +47 67 52 61 00
Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 6 405 328
Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0
Pfizer Hellas A.E.
Τηλ: +30 210 6785 800.
Pfizer Polska Sp. z o.o Tel.:+48 22 335 61 00
Pfizer S.A.
Tel: +34 91 490 99 00
Laboratórios Pfizer, Lda. Tel: +351 21 423 5500
Pfizer
Tél: +33 (0)1 58 07 34 40
Pfizer România S.R.L. Tel: +40 21 207 28 00
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
+44 (0)1304 616161
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: + 386 1 52 11 400
Medicinal product no longer authorised
Vistor hf
Sími: +354 535 7000
Pfizer Luxembourg SARL, organizačná zložka Tel.:+ 421-2-3355 5500
Pfizer Italia S.r.l. Tel: +39 06 33 18 21
Pfizer Oy
Puh./Tel: +358 (0)9 43 00 40
Geo. Pavlides & Araouzos Ltd. Tηλ.:+ 357 22 818087
Pfizer AB
Tel: +46 (0)8 550-52000
Pfizer Luxembourg SARL filiāle Latvijā Tel.: + 371 670 35 775
Pfizer Limited,
Tel: +44 (0)1304 616161
Pfizer Luxembourg SARL filialas Lietuvoje Tel.
+ 370 52 51 4000
This medicine has been authorised under “exceptional circumstances”.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Medicinal product no longer authorised
/. There are also links to other websites about rare diseases and treatments.