Onsenal

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  • Onsenal
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Staðsetning

  • Fáanlegt í:
  • Onsenal
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antineoplastic
  • Lækningarsvæði:
  • Adenomatous Polyposis Coli
  • Ábendingar:
  • Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1)
  • Vörulýsing:
  • Revision: 13

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Withdrawn
  • Leyfisnúmer:
  • EMEA/H/C/000466
  • Leyfisdagur:
  • 16-10-2003
  • EMEA númer:
  • EMEA/H/C/000466
  • Síðasta uppfærsla:
  • 31-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

EMA/230377/2010

EMEA/H/C/466

EPAR summary for the public

Onsenal

celecoxib

This document is a summary of the European Public Assessment Report (EPAR) for Onsenal. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for Onsenal.

What is Onsenal?

Onsenal is a medicine that contains the active substance celecoxib. It is available as white capsules

(200 and 400 mg).

What is Onsenal used for?

Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).

This is a genetic disease that causes ‘adenomatous intestinal polyps’, growths that project from the

lining of the colon or rectum (large intestine). Onsenal is used in addition to surgery (to remove the

polyps) and endoscopic monitoring (to check if polyps are developing, using an endoscope, a thin tube

that allows a doctor to look inside the gut).

Because the number of patients with FAP is low, the disease is considered ‘rare’, and Onsenal was

designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 November 2001.

The medicine can only be obtained with a prescription.

How is Onsenal used?

The recommended dose of Onsenal is 400 mg twice a day with food. The usual medical care for FAP

patients should be continued.

In patients with moderate liver disease, the dose of Onsenal should be halved. Onsenal must not be

given to patients with severe liver or kidney problems. A lower starting dose may be needed in

Medicinal product no longer authorised

patients whose bodies may break Onsenal down slowly. The maximum recommended daily dose of

Onsenal is 800 mg.

How does Onsenal work?

The active substance in Onsenal, celecoxib, is a ‘non-steroidal anti-inflammatory drug’ (NSAID) that

belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors’. It blocks the COX-2 enzyme, resulting in

a reduction in the production of prostaglandins, substances that are involved in processes such as

inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the

opening and closing of blood vessels). COX-2 is found at high levels in adenomatous colorectal polyps.

By blocking the activity of COX-2, celecoxib helps to slow down the formation of polyps by stopping

them developing their own blood supply and by increasing the rate of cell death.

How has Onsenal been studied?

Onsenal has been studied in one main study involving 83 adults (aged 18 years or over) with FAP, in

which two doses of Onsenal were compared with placebo (a dummy treatment). In the study, 25

patients had an intact colon, but the remainder had had some or all of their colon removed through

surgery. The main measure of effectiveness was the reduction in the number of polyps in a defined

area of the colon or rectum wall after six months of treatment. An additional study looked at the

effects of Onsenal in 18 patients aged 10 to 14 years with FAP.

What benefit has Onsenal shown during the studies?

Onsenal at a dose of 400 mg twice a day was more effective than placebo. In adults, Onsenal had

reduced the average number of polyps by 28% after six months, while the number had fallen by 5% in

the patients taking placebo. Onsenal also reduced the number of polyps in patients aged 10 to 14

years with FAP.

What is the risk associated with Onsenal?

The most common side effects with Onsenal (seen in more than 1 patient in 10) are hypertension (high

blood pressure) and diarrhoea. For the full list of all side effects reported with Onsenal, see the

Package Leaflet.

Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the

other ingredients, or to sulphonamides (such as some antibiotics). It must not be used in patients who

have an active ulcer or bleeding in the stomach or gut, or in patients who have had allergic-type

reactions after taking aspirin or an NSAID, including another COX-2 inhibitor. Onsenal must not be

given to pregnant women or women who could become pregnant unless they are using an effective

method of contraception, or to women who are breast-feeding. It must not be given to patients with

severe liver or kidney disease, patients with a disease causing inflammation of the bowel, or patients

with certain problems affecting the heart or blood vessels. For the full list of restrictions, see the

Package Leaflet.

Why has Onsenal been approved?

The CHMP decided that Onsenal’s benefits are greater than its risks but noted that no effect of Onsenal

on the risk of developing cancer of the intestine had been shown. The Committee recommended that

Onsenal be given marketing authorisation.

TOnsenal

EMA/230377/2010

Page 2/3

Medicinal product no longer authorised

TOnsenal

EMA/230377/2010

Page 3/3

Onsenal has been authorised under ‘exceptional circumstances’. This means that because the disease

is rare, it has not been possible to obtain complete information about Onsenal. Every year, the

European Medicines Agency will review any new information that may become available and this

summary will be updated as necessary.

What information is still awaited for Onsenal?

The company that makes Onsenal has committed to carrying out a study in patients with FAP, in order

to collect more information on the medicine’s safety and effectiveness. The company will submit a

progress report on the study, including all safety information and details of how it is ensuring that

patients are being recruited quickly enough. The company will also submit a full report on the study

once it has finished.

Other information about Onsenal:

The European Commission granted a marketing authorisation valid throughout the European Union for

Onsenal on 17 October 2003. The marketing authorisation holder is Pfizer Limited. After five years, the

marketing authorisation was renewed for a further five years.

The full EPAR for Onsenal can be found here

. For more information about treatment with Onsenal, read

the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Onsenal is available

here

This summary was last updated in 05-2010.

Medicinal product no longer authorised

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Onsenal 200 mg hard capsules

celecoxib

Read all of this leaflet carefully before you start taking this medicine.

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.

In this leaflet

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

1.

WHAT ONSENAL IS AND WHAT IT IS USED FOR

Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.

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.

2.

BEFORE YOU TAKE ONSENAL

Do not take ONSENAL

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

Medicinal product no longer authorised

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

Take special care with ONSENAL

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

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.

Taking other medicines

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 acety

lsalicylic acid (aspirin). Ask your doctor for advice before

taking both of these medicines together.

Taking ONSENAL with food and drink

You can take Onsenal with or without food.

Medicinal product no longer authorised

Pregnancy and breast-feeding

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.

Driving and using machines

If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling

normal again.

Important information about some of the ingredients of Onsenal:

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.

3.

HOW TO TAKE ONSENAL

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 take more ONSENAL than you should

If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.

If you forget to take ONSENAL

Do not take a double dose to make up for forgotten individual doses.

4.

POSSIBLE SIDE EFFECTS

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

Common side effects which may affect more than 1 person in 100, are listed below

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

Medicinal product no longer authorised

Muscle stiffness

Worsening of existing allergies

Uncommon side effects which may affect more than 1 person in a 1000, are listed below

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)

Rare side effects which may affect more than 1 person in a 10,000, are listed below

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

Feeling confused, changes in the way things taste

Increased sensitivity to light

Loss of hair

Additional reactions have been reported from actual use of the active ingredient of Onsenal (in

post-marketing experience). The frequencies of these reactions are difficult to determine but are

generally considered to be very rare (affecting less than 1 person in every 10,000)

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

Medicinal product no longer authorised

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)

In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon

polyps, the following additional side effects have been observed (side effects marked with an

asterisk were more common in these studies than in arthritis studies):

Very Common side-effects (affecting more than 1 person in every 10):

High blood pressure*, diarrhoea*

Common

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

Weight gain

Uncommon

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

5.

HOW TO STORE ONSENAL

Keep out of the reach and sight of children.

Do not store your capsules above 30°C.

Medicinal product no longer authorised

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.

6.

FURTHER INFORMATION

What ONSENAL contains

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.

What ONSENAL looks like and contents of the pack

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.

Marketing Authrisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Manufacturer

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.

Belgique / België /Belgien

Pfizer S.A. / N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Pfizer HCP Corporation

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: +36-1-488-37-00

Česká republika

Pfizer s.r.o.

Tel.: +420-283-004-111

Malta

V.J. Salomone Pharma Ltd.

Tel. +356 212201 74

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer BV

Tel: +31 (0)10 406 4301

Medicinal product no longer authorised

Deutschland

Pfizer Pharma GmbH

Tel: +49 30 550055-51000.

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel.: +372 6 405 328

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Pfizer Hellas A.E.

λ: +30 210 6785 800.

Polska

Pfizer Polska Sp. z o.o

Tel.:+48 22 335 61 00

España

Pfizer S.A.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 21 207 28 00

Ireland

Pfizer Healthcare Ireland

Tel: +1800 633 363 (toll free)

+44 (0)1304 616161

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja

farmacevtske dejavnosti, Ljubljana

Tel.: + 386 1 52 11 400

Ísland

Vistor hf

Sími: +354 535 7000

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel.:+ 421-2-3355 5500

Italia

Pfizer Italia S.r.l.

Tel: +39 06 33 18 21

Suomi/Finland

Pfizer Oy

Puh./Tel: +358 (0)9 43 00 40

Kύπρος

Geo. Pavlides & Araouzos Ltd.

Tηλ.:+ 357 22 818087

Sverige

Pfizer AB

Tel: +46 (0)8 550-52000

Latvija

Pfizer Luxembourg SARL filiāle Latvijā

Tel.: + 371 670 35 775

United Kingdom

Pfizer Limited,

Tel: +44 (0)1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje Tel.

+ 370 52 51 4000

This leaflet was last approved in

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

Detailed information on this medicine is available on the European Medicines Agency (EMA) web

site: http://www.ema.europa.eu

/. There are also links to other websites about rare diseases and

treatments.

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Onsenal 400 mg hard capsules

celecoxib

Read all of this leaflet carefully before you start taking this medicine.

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.

In this leaflet

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

1.

WHAT ONSENAL IS AND WHAT IT IS USED FOR

Onsenal belongs to a group of medicines called cyclo-oxygenase-2 (COX-2) inhibitors.

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.

2.

BEFORE YOU TAKE ONSENAL

Do not take ONSENAL

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 “sulphonamides”. These

include some antibiotics (Bactrim and Septra used in combination with sulfamethoxole 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

Medicinal product no longer authorised

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

Take special care with ONSENAL

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

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.

Taking other medicines

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.

Taking ONSENAL with food and drink

You can take Onsenal with or without food.

Medicinal product no longer authorised

Pregnancy and breast-feeding

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.

Driving and using machines

If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling

normal again.

Important information about some of the ingredients of Onsenal:

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.

3.

HOW TO TAKE ONSENAL

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 one 400 mg

capsule twice a day.

The maximum recommended daily dose is 800 mg.

If you take more ONSENAL than you should

If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.

If you forget to take ONSENAL

Do not take a double dose to make up for forgotten individual doses.

4.

POSSIBLE SIDE EFFECTS

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

Common side effects which may affect more than 1 person in 100, are listed below

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

Medicinal product no longer authorised

Muscle stiffness

Worsening of existing allergies

Uncommon side effects which may affect more than 1 person in a 1000, are listed below

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 sores

Constipation, burping, stomach inflammation (indigestion, stomach ache or vomiting),

worsening of inflammation of the stomach or intestine.

Leg cramps

Raised itchy rash (hives)

Rare side effects which may affect more than 1 person in a 10,000, are listed below

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

Feeling confused, changes in the way things taste

Increased sensitivity to light

Loss of hair

Additional reactions have been reported from actual use of the active ingredient of Onsenal (in

post-marketing experience). The frequencies of these reactions are difficult to determine but are

generally considered to be very rare (affecting less than 1 person in every 10,000)

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, inflammation of the pancreas, 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

Medicinal product no longer authorised

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)

In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon

polyps, the following additional side effects have been observed (side effects marked with an

asterisk were more common in these studies than in arthritis studies):

Very Common side-effects (affecting more than 1 person in every 10):

High blood pressure*, diarrhoea*

Common

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

Weight gain

Uncommon

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

5.

HOW TO STORE ONSENAL

Keep out of the reach and sight of children.

Do not store your capsules above 30°C.

Medicinal product no longer authorised

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.

6.

FURTHER INFORMATION

What ONSENAL contains

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, Brilliant Blue FCF

E 133.

What ONSENAL looks like and contents of the pack

The capsules are white with ‘7767‘ and ‘400‘ marked in green ink. Onsenal is packed in blisters and

supplied in boxes of 10 or 60 capsules.

Marketing Authrisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Manufacturer

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:

Belgique / België /Belgien

Pfizer S.A. / N.V.

Tél/Tel: +32 (0)2 554 62 11

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

България

Pfizer HCP Corporation

Тел.: +359 2 970 4333

Magyarország

Pfizer Kft.

Tel.: +36-1-488-37-00

Česká republika

Pfizer s.r.o.

Tel.: +420-283-004-111

Malta

V.J. Salomone Pharma Ltd.

Tel. +356 212201 74

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Nederland

Pfizer BV

Tel: +31 (0)10 406 4301

Medicinal product no longer authorised

Deutschland

Pfizer Pharma GmbH

Tel: +49 30 550055-51000.

Norge

Pfizer AS

Tlf: +47 67 52 61 00

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel.: +372 6 405 328

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

Ελλάδα

Pfizer Hellas A.E.

λ: +30 210 6785 800.

Polska

Pfizer Polska Sp. z o.o

Tel.:+48 22 335 61 00

España

Pfizer S.A.

Tel: +34 91 490 99 00

Portugal

Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500

France

Pfizer

Tél: +33 (0)1 58 07 34 40

România

Pfizer România S.R.L.

Tel: +40 21 207 28 00

Ireland

Pfizer Healthcare Ireland

Tel: +1800 633 363 (toll free)

+44 (0)1304 616161

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja

farmacevtske dejavnosti, Ljubljana

Tel.: + 386 1 52 11 400

Ísland

Vistor hf

Sími: +354 535 7000

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel.:+ 421-2-3355 5500

Italia

Pfizer Italia S.r.l.

Tel: +39 06 33 18 21

Suomi/Finland

Pfizer Oy

Puh./Tel: +358 (0)9 43 00 40

Kύπρος

Geo. Pavlides & Araouzos Ltd.

Tηλ.:+ 357 22 818087

Sverige

Pfizer AB

Tel: +46 (0)8 550-52000

Latvija

Pfizer Luxembourg SARL filiāle Latvijā

Tel.: + 371 670 35 775

United Kingdom

Pfizer Limited,

Tel: +44 (0)1304 616161

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje Tel.

+ 370 52 51 4000

This leaflet was last approved in

{MM/YYYY}.

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

Detailed information on this medicine is available on the European Medicines Agency (EMA) web

site: http://www.ema.europa.eu

/. There are also links to other websites about rare diseases and

treatments.

Medicinal product no longer authorised