Celebrex Consumer Medicine Information

Celecoxib
100mg and 200mg capsules

What is in this leaflet

This leaflet answers some common questions about Celebrex. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Celebrex against the benefits it is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What Celebrex is used for

Celebrex is used to treat joint pain, tenderness, swelling and stiffness:

  • in osteoarthritis and
  • in rheumatoid arthritis

Celebrex is also used to relieve short-term pain, in cases such as:

  • menstrual cramps (period pain)
  • following surgery
  • dental pain

Celebrex belongs to a group of medicines called Coxibs. Although Celebrex can relieve the symptoms of pain and inflammation, it will not cure your condition.

CELEBREX is also used to treat a rare disease called familial adenomatous polyposis (FAP).

CELEBREX has been shown to reduce the number of polyps in the colon of patients with FAP.

If you are taking CELEBREX for FAP, it is important that you continue with the other usual treatments (like surgery and regular check ups).

Your doctor, however, may have prescribed Celebrex for another purpose.

Ask your doctor if you have any questions about why Celebrex has been prescribed for you.

Celebrex has not been studied in children or adolescents under 18 years of age.

This medicine is only available with a doctor's prescription.

Before you take Celebrex

When you must not take it

Do not take Celebrex if:

  1. you have an allergy to:
    • Celebrex
    • any of the ingredients listed at the end of this leaflet
    • sulphonamides, a group of medicines which include, for example, certain antibiotics (If you are not sure if you are taking one of these medicines ask your Pharmacist).

    Symptoms of an allergic reaction to these medicines may include:

    • asthma, wheezing or shortness of breath
    • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
    • hives, itching or skin rash
    • fainting

    If you are allergic to sulphonamides or any of the capsule ingredients and take Celebrex, these symptoms may be severe.

    Ask your doctor or pharmacist if any of this applies to you.

  2. you have had an attack of asthma, hives, itching, skin rash or a runny nose after taking aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to treat pain and inflammation)

    Many medicines used to treat headache, period pain and other aches and pains contain aspirin or an NSAID.

    If you are allergic to aspirin or NSAIDs and use Celebrex, these symptoms may be severe.
  3. you are already taking an NSAID
  4. the expiry date printed on the packaging has passed, even though the capsules may look alright.
    If you take this medicine after the expiry date has passed, it may not work as well.
  5. the packaging is torn or shows signs of tampering

If you are not sure if you should be taking Celebrex, talk to your doctor.

Before you start to take it

You must tell your doctor if:

  1. you have any allergies to
    • any other medicines
    • any other substances such as foods, dyes or preservatives
  2. you are pregnant or intend to become pregnant

    There is no information on the use of Celebrex during pregnancy.

    Celebrex may affect your developing baby if taken in the last 3 months of pregnancy.
    Celebrex use is not recommended in pregnancy unless your doctor considers it essential.
    Discuss this with your doctor.
  3. you are breastfeeding or intend to breast-feed
    Since it is not known whether Celebrex passes into breast milk or whether your baby might be affected, Celebrex should not be used during breastfeeding.
  4. you have any other health problems including
    • liver or kidney problems
    • asthma, hives, itching, skin rash or a runny nose
    • high blood pressure, heart failure or fluid retention
    • peptic ulcer (ie stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
    • vomiting blood or material that looks like coffee grounds
    • bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea.
  5. you drink large amounts of alcohol
  6. you are a smoker

If you have not told your doctor or pharmacist about these things, tell them before you start taking Celebrex.

Taking other medicines

Tell your doctor or your pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Celebrex may interfere with each other. These include:

  • certain medicines used to treat high blood pressure called ACE inhibitors
  • diuretics or water tablets
  • fluconazole, an antifungal agent
  • lithium, a medicine used to treat some type of depression
  • warfarin, a medicine used to stop blood clots.
  • certain medicines used to treat pain and inflammation called non steroidal anti-inflammatories (NSAIDs) or (cortico) steroids.

Your doctor may need to adjust the dosage of these medicines, or provide additional advice if you are also taking Celebrex.

How to take Celebrex

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

Osteoarthritis: 200 mg once daily or 100 mg twice daily, or as directed by your doctor.

Rheumatoid arthritis: 100 mg twice daily or 200 mg twice daily.

Management of short-term pain and menstrual cramps (period pain): 400 mg on the first day and 200 mg once daily on following days.

Familial adenomatous polyposis: 400 mg twice daily

How to take it

Swallow the capsules whole with a glass of fluid. Celebrex can be taken with or without food.

How long to take it

Depending on your condition, you may need Celebrex for a few weeks or longer periods.

Celebrex will not cure your condition but should help control arthritic pain, swelling and stiffness.

Celebrex has not been used in FAP patients beyond six months. Please check with your doctor.

Keep taking Celebrex for as long as your doctor advises.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking your capsules as you would normally.

Do not take a double dose to make up for the dose you missed.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Celebrex. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Celebrex, you may feel tired, drowsy, sick, vomit, and have stomach pain. You may also have difficulty breathing and feel faint.

While you are using it

Things you must do

If you become pregnant while taking Celebrex, tell your doctor immediately.

If you are about to start any new medicines, tell your doctor and pharmacist that you are taking Celebrex.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Celebrex.

Things you must not do

Do not give Celebrex to anyone else, even if they have the same symptoms or condition as you.

Do not use Celebrex to treat any other complaints unless your doctor tells you to.

Side effects

Check with your doctor as soon as possible if you have any problems while taking Celebrex, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, Celebrex can cause some side effects. If they occur, most are likely to be minor and temporary.

Ask your doctor or pharmacist any questions you may have.

Tell your doctor if you notice any of the following:

  • stomach pain, diarrhoea, indigestion, wind
  • swollen hands, ankles and feet
  • dizziness
  • sore throat, runny nose, sinusitis, upper respiratory tract infection
  • rash

Tell your doctor immediately if you notice any of the following:

  • collapse or fainting, shortness of breath or tiredness, irregular heart beat, chest pain, swollen or sore leg veins
  • severe stomach or throat pain, vomiting blood or black sticky bowel motions
  • bleeding or bruising more than usual, reddish or purple blotches under the skin
  • yellowing of the skin or eyes (jaundice)
  • signs of anaemia such as tiredness, being short of breath and looking pale

Not all of these side effects have been reported with Celebrex but have been seen with similar medicines.

Other side effects not listed above may occur in some people.

Do not be alarmed by this list of possible side effects.

You may not get any of them.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

After Using Celebrex

Storage

Keep your capsules where young children cannot reach them.

A locked cupboard at least 1 metres above the ground is a good place to store medicines.

Keep Celebrex in a cool, dry place where the temperature stays at or below 25C. Do not store it, or any other medicine, in the bathroom or near a sink. Do not leave it in the car or on window- sills.

Heat and dampness can destroy some medicines.

Keep your capsules in their blister pack until it is time to take them.

If you take the capsules out of their container they may not keep well.

Disposal

If your doctor tells you to stop taking Celebrex, or the capsules have passed their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

  • Celebrex 100 mg - opaque, white capsules with a blue band marked 7767 and 100.
  • The 100 mg capsules come in blister packs of 60.
  • Celebrex 200 mg - opaque, white capsules with a gold band marked 7767 and 200.
  • The 200 mg capsules come in blister packs 30.

Ingredients

The active ingredient in Celebrex is celecoxib.

Other ingredients:

  • lactose
  • sodium lauryl sulphate
  • povidone
  • croscarmellose sodium
  • magnesium stearate
  • gelatin
  • titanium dioxide
  • iron oxide yellow CI 77492 /200 mg capsule
  • indigo carmine CI 73015 /100 mg capsule

Celebrex does not contain sucrose, gluten, tartrazine or other azo dyes.

This leaflet was prepared 28 April 2004