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Celebra

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Document: Celebra capsule hard ENG PL change

Package leaflet: Information for the user


Celebra100 mg hard capsules
Celebra 200 mg hard capsules

celecoxib


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


What is in this leaflet:

1. What Celebrais and what it is used for

2. What you need to know before you take Celebra

3. How to take Celebra

4. Possible side effects

5. How to store Celebra

6. Contents of the pack and other information


1. What Celebra is and what it is used for


Celebra is usedin adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritisand ankylosing spondylitis.


Celebra belongs to a group of medicinal products called nonsteroidal 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. Celebraacts by reducing the production of prostaglandins, thereby reducing the pain and inflammation.


You should expect your medicine to start working within hours of taking the first dose, but you may not experience a full effect for several days.


2. What you need to know before you take Celebra


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


Do not take Celebra


Tell your doctor if any of the following are true for you as patients with these conditions should not take Celebra.



Warnings and precautions


Talk to your doctor or pharmacist before taking Celebra:



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 celecoxib. Of the cases that reported time to onset, most severe liver reactions occurred within one month of start of treatment.


Celebra 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 Celebra


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



Celebra can be taken with low dose acetylsalicylic acid (75 mg or less daily). Ask your doctor for advice before taking both medicines together.


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

Celebra 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 Celebra you should discontinue the treatment and contact your doctor for alternative treatment.


Breast-feeding

Celebra must not be used during breast-feeding.


Fertility

NSAIDs, including Celebra, 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 Celebra before you drive or operate machinery. If you feel dizzy or drowsy after taking Celebra, do not drive or operate machinery until these effects wear off.


Celebra contains lactose

Celebra 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 Celebra


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. If you think or feel that the effect of Celebra 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 Celebra for longer than necessary to control symptoms.


Method of administration:


Celebra is for oral use.The capsules can be taken at any time of the day, with or without food. However, try to take each dose of Celebra at the same time each day.


If you have difficulty swallowing capsules: The entire capsule contents can be sprinkled onto a level teaspoon of semi-solid food (such as cool or room temperature applesauce, rice gruel, yogurt or mashed banana) and swallowed immediately with a drink approximately 240 ml of water.


To open the capsule, hold upright to contain the granules at the bottom then gently squeeze the top and twist to remove, taking care not to spill the contents. Do not chew or crush the granules.


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


The recommended dose is:


For osteoarthritisthe recommendeddose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.

The dose is usually:


Forrheumatoid arthritisthe recommendeddose 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.


Forankylosing spondylitisthe recommendeddose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.

The dose is usually:


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

Celebra is for adults only, it is not for use in children.


If you take more Celebrathan 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 Celebra

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 Celebra

Suddenly stopping your treatment with Celebra may lead to your symptoms getting worse. Do not stop taking Celebra unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.


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


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


If any of the following happen, stop taking Celebraand tell your doctor immediately:

If you have:



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



Uncommon: may affect up to 1 in 100 people



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


Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills


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



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 Celebra 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



Uncommon: may affect up to 1 in 100 people



Reporting of side effects

If you get any 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 national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Celebra


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 Celebra above 30o 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.


6. Contents of the pack and other information


What Celebracontains


The active substance is celecoxib.

1 capsule contains 100 mg or 200 mg celecoxib.


The other ingredients are:

Lactose monohydrate, sodium laurilsulfate, povidone, croscarmellose sodium, magnesium stearate. Capsule shells contain gelatin, titanium dioxide E171, sodium laurilsulfate and sorbitan monolaurate. Printing ink contains shellac, propylene glycol, indigotine E132 (100 mg capsule), iron oxide E172 (200 mg capsule).


What Celebra looks like and contents of the pack


Celebrais available as hard capsules.


Opaque, white with two blue bands marked 7767 and 100 (Celebra100 mg).

Opaque, white with two gold bands marked 7767 and 200 (Celebra200 mg).


The capsules are packaged in clear or opaque PVC/aluminium blisters.


Celebrais contained in packs of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose, 5x(10x10).


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder


For SE:


Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

E-mail: medinfo.sweden@pfizer.com


Manufacturer


For SE:


R Pharm Germany GmbH

Heinrich-Mack-Str. 35,

89257 Illertissen

Germany


For any information about this medicine, please contact:


<Local representative to be completed nationally>


This medicinal product is authorized in the Member States of the EEA under the following names:


Name

Country

Celebra

Denmark, Finland, Iceland, Norway, Sweden

Celebrex

Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, UK


This leaflet was last revisedin

2016-03-18


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