Celecoxib 100 mg PCH, capsules, hard

2. What you need to know before you take Do NOT take

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6).
• if you have had an allergic reaction to a group of medicines called “sulfonamides” (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 (NSAIDs) 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;
• if you have severe liver disease;
• if you have severe kidney disease;
• if you have an inflammatory disease of the intestines such as ulcerative colitis or Crohn’s disease;
• if you have cardiac insufficiency
• if you have established heart disease or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction of blood flow to the brain; also known as “mini-stroke”), angina pectoris, or blockages of blood vessels to the heart or brain;
• if you have or have had problems with your blood circulation (peripheral arterial disease).

Warnings and precautions

Talk to your doctor or pharmacist before taking <Product name>

• if you have previously had an ulcer or bleeding in your stomach ot intestines.
• if you are taking acetylsalicylic acid (even at low dose for heart protective purposes). <Product name> can be taken concomitantly with acetylsalicylic acid but only in low daily doses of acetylsalicylic acid.
• if you use medicines to reduce blood clotting (e.g. warfarin).
• if you smoke.
• if you have diabetes (diabetes mellitus).
• if you have high blood pressure.
• if you have 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);
• if you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (used to treat excess fluid in the body).
• if you have had a serious allergic reaction or a serious skin reaction to any medicines.
• if you feel ill due to an infection or think you have an infection, as <Product name> may mask a fever or other signs of infection and inflammation.
• if you are over 65 years of age your doctor may want to keep a regular check on you.

You should not take <Product name> with any other pain killers or anti-inflammatory drugs (NSAIDs) not containing acetylsalicylic acid (such as ibuprofen or diclofenac).

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 and liver failure (some with fatal outcome or requiring liver transplant) have been reported with the active substance celecoxib. Of the cases that reported time to onset, these severe liver reactions occurred within one month of start of treatment.

Other medicines and <Product name>

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Interactions are possible with the following medicines:

• some medicines to treat coughs (dextrometorphan);
• medicines used for high blood pressure and heart failure (e.g. ACE inhibitors or angiotensin II antagonists);
• medicines used to treat excess fluid in the body (diuretics);
• some medicines used to treat fungal and bacterial infections (fluconazole and rifampicin);
• “blood-thinning” agents that reduce blood clotting (warfarin or other oral anticoagulants);
• medicines to treat depression (e.g. lithium):

• medicines to treat sleep disorders or an irregular heartbeat;
• medicines to treat some mental disorders (neuroleptics);
• some medicines to treat rheumatoid arthritis, psoriasis and leukemia (methotrexate);
• some medicines to treat epilepsy/seizures and some forms of pain or depression (carbamazepine);
• some medicines to treat epilepsy/seizures and some sleep disorders (barbiturates);
• some medicines used for immune system suppression e.g. after tranplants (ciclosporin and tacrolimus);
• acetylsalicylic acid. <Product name> can be taken concomitantly with acetylsalicylic acid but only in low daily doses of acetylsalicylic acid. Talk to your doctor or pharmacist before taking both medicines together.

Pregnancy and breast-feeding

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.

<Product name> 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 <Product name> you should discontinue the treatment and contact your doctor.

<Product name> must not be used during breast-feeding.

Driving and using machines

You should be aware of how you react to <Product name> before you drive or operate machinery. If you feel dizzy or drowsy after taking <Product name>, do not drive or operate machinery.

3. How to take

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

For osteoarthritis

the recommended daily dose is 200 mg (1 capsule, hard twice a day or 2 capsules, hard once a day), increased by your doctor to a maximum of 400 mg (2 capsules, hard twice a day), if needed.

For rheumatoid arthritis

the initial recommended daily dose is 200 mg (1 capsule, hard twice a day), increased by your doctor to a maximum of 400 mg (2 capsules, hard twice a day), if needed.

For ankylosing spondylitis

the recommended daily dose is 200 mg (1 capsule, hard twice a day or 2 capsules, hard once a day), increased by your doctor to a maximum of 400 mg (4 capsules, hard once a day or 2 capsules, hard twice a day), if needed.

Dosage

For osteoarthritis

the recommended daily dose is 200 mg (1 capsule, hard once a day), increased by your doctor to a maximum of 400 mg (1 capsule, hard twice a day), if needed.

For rheumatoid arthritis

the initial recommended daily dose is 200 mg (as one 100 mg capsule, hard twice a day), increased by your doctor to a maximum of 400 mg (1 capsule, hard twice a day), if needed.

For ankylosing spondylitis

the recommended daily dose is 200 mg (1 capsule, hard once a day), increased by your doctor to a maximum of 400 mg (2 capsules, hard once a day or 1 capsule, hard twice a day), if needed.

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 <Product name> for longer than necessary to control symptoms. If you think that the effect of <Product name> is too strong or too weak, talk to your doctor or pharmacist.

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

Maximum daily dose:

You should not take more than 400 mg (4 capsules, hard) of Celecoxib per day. You should not take more than 400 mg (2 capsules, hard) of Celecoxib per day.

Kidney or liver problems

Make sure that your doctor knows if you have liver or kidney problems as you may need a lower dose.

Elderly, especially those with a weight less than 50 kg

If you are over 65 years of age and if you weigh less than 50 kg, your doctor may want to monitor you more closely.

Use in children

<Product name> is for adults only and not for use in children.

How to take <Product name>

The capsules can be taken at any time of the day, with or without food. However, try to take each dose of <Product name> at the same time each day.

<Product name> should be swallowed with a sufficient amount of water (e.g. one glass [200 ml]).

If you take more <Product name> than you should

You should not take more hard capsules than your doctor tells you to. If you take too many hard capsules contact your doctor, pharmacist or hospital and take your medicines with you so that your doctor can see what you are taking.

If you forget to take <Product name>

If you forget to take <Product name>, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose.

If you stop taking <Product name>

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

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

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 celecoxib.

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

Stop taking <Product name> and tell your doctor immediately if you have:

• an allergic reaction such as skin rash, swelling of the face, wheezing or difficult breathing;
• skin reactions such as rash, blistering or peeling of the skin;
• 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;
• liver failure with such symptoms as nausea, diarrhoea or jaundice (your skin or the whites of your eyes look yellow).

Very common side effects (may affect more than 1 in 10 people):

High blood pressure*.

Common side effects (may affect up to 1 in 10 people):

• sinus inflammation, sinus infection, blocked or painful sinuses (sinusitis), colds, urinary infections;
• worsening of existing allergies;
• difficulty sleeping;
• dizziness, muscle stiffness;
• heart attack*;
• blocked or runny nose, coughs, sore throat, shortness of breath*;
• stomach ache, diarrhoea, indigestion, wind, vomiting*, difficulty swallowing*;
• rash, itching;
• flue-like symptoms, fluid build up in the body with swollen ankles, legs and/or hands.

Uncommon side effects (may affect up to 1 in 100 people):

• Changes in red blood cells that can cause pale skin, fatigue and breathlessness;
• increased levels of potassium in the blood that can cause nausea, fatigue, muscle weakness or palpitations;
• Anxiety, depression, tiredness;
• tingling sensations, drowsiness, stroke*;
• blurred vision;
• ringing in the ears, difficulty hearing*;
• heart failure, palpitations, fast heart rate;
• worsening of existing high blood pressure;
• constipation, burping, stomach inflammation (with symptoms such as indigestion, stomach ache or vomiting), stomatitis, worsening of inflammation of the stomach or intestine;
• abnormalities in liver values;
• hives;
• leg cramps;
• abnormalities in certain kidney values.

Rare side effects (may affect up to 1 in 1,000 people):

• reduced number of white blood cells which can increase the risk for infections and reduced number of blood platelets which can increase the risk for bleeding or bruising;
• feeling confused;
• difficulty coordinating muscular movements, changes in the way things taste;
• ulcers in the duodenum-, stomach-, gullet-, intestines, rupture of the intestine (can cause stomach ache, pain, fever, nausea or blockage), inflammation of the gullet (can cause difficulty in swallowing), dark or black stools, inflammation of the pancreas (can lead to stomach pain);
• increased liver values;
• loss of hair, increased sensitivity to light.

Further side effects were reported during the widespread use <Product name> (experiences after market launch). The frequency of these side effects cannot be estimated from the available data:

• serious reduction in the number of blood cells which may cause fatigue and bruising and increase the risk of infections;
• serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of the face, lips, mouth, tongue or air tube, wheezing or difficulty breathing;
• hallucinations;
• headache, worsening of epilepsy with possible more frequent and/or severe seizures, inflammation of membrane around the brain and spinal cord (meningitis), impaired sense of taste, impaired sense of smell, bleeding within the brain causing death;
• inflammation of the conjunctiva, bleeding in the eye, blockage of an artery or vein in the eye leading to partial or complete loss of vision;
• irregular heartbeat;
• erythema with sensation of heat, inflammed blood vessels (can cause fever, aches and purple blotches on the skin), blot clot in the lungs which causes chest pain and breathlessness;
• spasm in the air passages with shortness of breath;
• nausea, bleeding of the stomach or intestines (can lead to bloody stools or vomiting), occurrence or worsening of an inflammation of the intestine or colon;
• liver failure (sometimes fatal or requiring liver transplant); severe liver inflammation (sometimes fatal), liver inflammation, liver damage, jaundice;
• skin discolouration (bruising), serious skin conditions (such as Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis [can cause rash, blistering or peeling of the skin]), swelling of the face, lips, mouth, tongue, red swollen area with numerous small pustules (acute generalised exanthematous pustulosis);
• kidney failure, inflammation of the kidneys, decreased levels of sodium in the blood which can cause loss of appetite, headache, nausea, muscle cramps and weakness;
• painful joints, muscle pain and weakness;
• menstrual disturbances;
• chest pain.

In clinical studies not associated with arthritis (inflammation of the joints) or other arthritic conditions, where celecoxib was taken at doses of 400 mg per day for up to 3 years, the following additional side effects have been observed:

Common side effects (may affect up to 1 in 10 people):

• angina pectoris;
• irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion and wind);
• kidney stones (which may lead to stomach or back pain or blood in urine), abnormalities in the kidney values, difficulty passing urine;
• weight gain;

Uncommon side effects (may affect up to 1 in 100 people):

• stomach infection (which can cause irritation and ulcers of the stomach and intestinal mucosa), shingles, skin infection, inflamed gums, bronchitis and pneumonia;
• conjunctival haemorrhage, vision disorders causing blurred or impaired vision;
• vertigo due to inner ear troubles;
• deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems);
• ulceration in the mouth, speech disorder;
• bleeding from haemorrhoids (hemorrhoidal bleeding), frequent bowel movements;
• fatty lumps in skin or elsewhere, harmless swellings on or around joints and tendons in the hand or foot (ganglion), allergic eczema (dry itchy rash);
• lower limb fracture;
• excessive urination at night, increased levels of sodium in the blood;
• bleeding from the vagina, breast pain.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store

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 label, the blister and the outer carton after “EXP”. The expiry date refers to the last day of that month.

ALU/ALU-blister

This medicinal product does not require any special storage conditions.

PVC/PVDC/ALU-blister

Do not store above 30 °C.

Tablet container

This medicinal product does not require any special storage conditions.

Tablet containers:

Shelf life after first opening: 6 months.

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 to protect the environment.

6. Contents of the pack and other information What contains

• The active substance is celecoxib. Each capsule, hard contains 100 mg celecoxib.
• The other ingredients are: Calcium hydrogen phosphate dihydrate, sodium laurilsulfate, crospovidone (type B), povidone (K30), povidone (K90), magnesium stearate, gelatine, shellac, propylene glycol, purified water, titanium dioxide (E171), indigo carmine aluminium lake (E132).

What <Product name> contains

• The active substance is celecoxib. Each capsule, hard contains 200 mg celecoxib.
• The other ingredients are: Calcium hydrogen phosphate dihydrate, sodium laurilsulfate, crospovidone (type B), povidone (K30), povidone (K90), magnesium stearate, gelatine, shellac, propylene glycol, purified water, titanium dioxide (E171), yellow iron oxide (E172).

What <Product name> looks like and contents of the pack

<Product name> are white, opaque hard gelatine capsules with a blue imprint “100”.

<Product name> is available in packs of 5, 10, 20, 30, 50, 60, 90 and 100 capsules, hard in blister, 50 x 1 capsules, hard in perforated unit dose blister and 100 capsules, hard in tablet container.

Not all pack sizes may be marketed.

What <Product name> looks like and contents of the pack

<Product name> are white, opaque hard gelatine capsules with a yellow imprint “200”.

<Product name> is available in packs of 5, 10, 20, 30, 50, 60, 90 and 100 capsules, hard in blister, 50 x 1 capsules, hard in perforated unit dose blister and 100 capsules, hard in tablet container.

Not all pack sizes may be marketed.

In het register ingeschreven onder nummer:

100 mg: RVG 108780

200 mg: RVG 108794

Marketing Authorisation Holder

Pharmachemie BV

Swensweg 5

2031 GA Haarlem

Nederland

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Duitsland

TEVA Pharmaceutical Works Private Limited Company Pallagi út 13,

4042 Debrecen Hongarije

TEVA UK Ltd

Brampton Road, Hampden Park,

Eastbourne, East Sussex, BN22 9AG

Groot-Brittannië

Pharmachemie BV

Swensweg 5

2031 GA Haarlem

Nederland

TEVA Santé

Rue Bellocier,

89107 Sens

Frankrijk

Teva Czech Industries s.r.o. Ostravska 29, c.p. 305, 74770 Opava-Komarov Tsjechië

PLIVA Krakow Zakłady Farmaceutyczne S.A. ul. Mogilska 80. 31-546,

Krakow

Polen

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

DE/H/3057

Austria:		Celecoxib-ratiopharm 100 mg Hartkapseln
France		Celecoxib ratiopharm 100 mg gélule
Germany		Celecoxib-ratiopharm 100 mg Hartkapseln
Luxembourg		Celecoxib-ratiopharm 100 mg Hartkapseln
Portugal		Celecoxib ratiopharm
DE/H/3058		Celecoxib Teva 100 mg capsules, hard
Belgium:
Bulgaria:		TevaCoxib 100 mg capsules, hard
Cyprus:		Celecoxib Teva 100mg Hard Capsules
France:		Celecoxib TEVA 100 mg, gélules
Germany:		Celecoxib AbZ 100 mg Hartkapseln
Greece:		Celecoxib Teva 100 mg Καψάκια, σκληρά
Hungary:		Celecoxib-Teva 100 mg kemény kapszula
Iceland:		Celecoxib Teva
Italy:		Celecoxib Teva
Netherlands:Celecoxib 100 mg PCH, capsule, hard
Norway:		Celecoxib Teva
Portugal:		Celecoxib Teva
Romania:		Celecoxib Teva 100 mg capsule
Sweden:		Celecoxib Teva 100 mg, kapsel hård
United Kingdom:	Celecoxib 100 mg capsules, hard
DE/H/3057
Austria:		Celecoxib-ratiopharm 200 mg Hartkapseln
France		Celecoxib ratiopharm 200 mg gélule
Germany		Celecoxib-ratiopharm 200 mg Hartkapseln
Italy		Celecoxib ratiopharm 200 mg capsule
Luxembourg		Celecoxib-ratiopharm 200 mg Hartkapseln
Portugal		Celecoxib ratiopharm
Spain		Celecoxib ratiopharm 200 mg cápsulas duras EFG
DE/H/3058
Belgium:		Celecoxib Teva 200 mg capsules, hard
Bulgaria:		TevaCoxib 200 mg capsules, hard
Cyprus:		Celecoxib Teva 200mg Hard Capsules
France:		Celecoxib TEVA 200 mg, gélules
Germany:		Celecoxib AbZ 200 mg Hartkapseln
Greece:		Celecoxib Teva 200 mg Καψάκια, σκληρά
Hungary:		Celecoxib-Teva 200 mg kemény kapszula
Iceland:		Celecoxib Teva
Italy:		Celecoxib Teva
Netherlands:Celecoxib 200 mg PCH, capsule, hard
Norway:		Celecoxib Teva
Portugal:		Celecoxib Teva
Romania:		Celecoxib Teva 200 mg capsule
Slovakia:		Celecoxib Teva 200 mg
Spain:	Celecoxib Teva 200 mg cápsulas duras EFG
Sweden:		Celecoxib Teva 200 mg, kapsel hård
United Kingdom:	Celecoxib 200 mg capsules, hard

This leaflet was last revised in juli 2012