Read all of this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.

What’s in this leaflet:

• 1. What Dynastat is and what it’s used for
• 2. Before you are given Dynastat
• 3. How the injection is given
• 4. Possible side effects
• 5. Storing Dynastat
• 6. Other information
• 7. Information for the Health Professional

You will not be given Dynastat…

• if you have heart failure
• if you are about to have heart surgery or surgery on your arteries (including any coronary artery procedure)
• if you have established heart disease and /or cerebrovascular disease eg. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
• if you have or have had problems with your blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs.
• if you are hypersensitive (allergic) to parecoxib or any of the other ingredients of Dynastat
• if you have had a serious allergic reaction (especially a serious skin reaction) to any medicines
• if you have had an allergic reaction to a group of medicines called “sulphonamides” (e.g. some antibiotics used to treat infections)
• if you have a gastric or intestinal ulcer or gastrointestinal bleeding
• if you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other NSAIDs (e.g. ibuprofen) or to COX-2 inhibitors. Reactions might include wheezing (bronchospasm), badly blocked nose, itchy skin, rash or swelling of the face, lips or tongue, other allergic reactions or nasal polyps after taking these medicines
• if you are more than 6 months pregnant
• if you are breastfeeding
• if you have severe liver disease
• if you have inflammation of the intestines (ulcerative colitis or Crohn’s disease)

If any of these applies to you, you will not be given the injection. Tell your doctor or nurse immediately.

Taking special care with Dynastat

Some people will need special care from their doctors when they are given Dynastat.

Make sure your doctor knows, before you are given Dynastat …

• If you have had an ulcer, bleeding or perforation of the gastrointestinal tract
• If you are taking acetylsalicylic acid or other NSAIDs (e.g. ibuprofen)
• if you smoke, have diabetes, angina , blood clots, raised blood pressure or raised cholesterol.
• If you are taking anti-platelet therapies (e.g. acetylsalicylic acid)
• If you have fluid retention (oedema)
• If you have liver or kidney disease
• If you might be dehydrated – this may happen if you have had diarrhoea or have been vomiting (being sick) or unable to drink fluids
• If you have an infection as it may hide a fever (which is a sign of infection)
• If you use medicines to reduce blood clotting (e.g. warfarin)
• If you are a woman trying to become pregnant

Pregnant or breast-feeding women

• If you are pregnant, tell your doctor, as Dynastat may not be right for you. You will not be given Dynastat in the last three months of pregnancy.
• If you are breast-feeding, you must not have Dynastat. Ask your doctor for advice: it may be better to stop breast-feeding altogether to take the injections.

Get advice from a doctor or pharmacist before taking any medicine if you’re pregnant or breast-feeding.

Driving or using machines

If the injection makes you feel dizzy or tired, do not drive or use machines until you feel better again.

Other medicines and Dynastat

Tell your doctor or nurse about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription. Medicines can sometimes interfere with each other. Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine. It’s especially important to mention:

• Acetylsalicylic acid or other anti-inflammatory drugs
• Fluconazole – used for fungal infections
• ACE inhibitors – used for high blood pressure and heart conditions
• Cyclosporin or Tacrolimus – used after transplants
• Warfarin – or other medicines used to prevent blood clots
• Lithium – used to treat depression.
• Rifampicin – used for bacterial infections
• Antiarrhythmics – used to treat an irregular heartbeat
• Phenytoin or Carbamazepine – used for epilepsy
• Theophylline – used for asthma
• Methotrexate – used for rheumatoid arthritis and cancer
• Antidepressants – used to treat depression
• Neuroleptics – used to treat psychoses

Dynastat can be used in combination with low dose acetylsalicylic acid

Some people may be given lower doses:

• People with liver problems
• Patients over 65 who weigh less than 50 kg
• People taking fluconazole.

Children and adolescents under the age of 18 will not be given Dynastat. People aged 18 and over will be given the adult dose.

Stop taking Dynastat and tell your doctor immediately:

• if you develop a rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or develop any other signs of an allergic reaction such as skin rash, swelling of the face, lips or tongue which may cause difficulty breathing, or wheezing
• if you have blistering or peeling of the skin
• the onset of skin reactions can occur at any time but most often occur in the first month of treatment; the reported rate of these events appears to be greater for valdecoxib as compared to other cox-2 inhibitors
• if you have jaundice (your skin or the whites of your eyes appear yellow)
• if you have any signs of bleeding in the stomach or intestine, such as passing a black or blood-stained bowel movement or vomiting blood

More common effects

These could affect between 1 and 10 in every 100 people

• Blood pressure may be made higher or lower
• You may get back pain
• Ankles, legs and feet may swell (fluid retention)
• You may feel numb
• You may get stomach ache, indigestion, bloating and wind
• Tests may show abnormal kidney function
• You may feel agitated or find it hard to sleep
• There is a risk of anaemia
• You may get a sore throat or difficulty breathing
• Your skin may be itchy
• You may pass less urine than usual.
• Dry socket (inflammation and pain after a tooth extraction)

• If any of these affects you, talk to your doctor or nurse.

Uncommon effects

These could affect less than 1 in every 100 people

• Worsening of high blood pressure
• Ulcers in the digestive system
• The heart may beat more slowly
• Blood tests may show abnormal liver function
• You may bruise easily (or have a low blood platelet count)
• Surgical wounds may become infected
• There is a risk of stroke.

• If any of these affects you, talk to your doctor or nurse.

Rare Effects

These could affect less than 1 in every 1000 people.

• Rash or ulceration in any part of your body (e.g. skin, mouth, eyes, face, lips or tongue), or any other signs of allergic reactions such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing
• Swelling, blistering or peeling of the skin.
• The onset of skin reactions can occur at any time but most often occur in the first month of treatment; the reported rate of these events appears to be greater for valdecoxib as compared to other cox-2 inhibitors
• Kidney failure and acute kidney failure
• Heart failure, heart attack
• Racing or irregularity of the heartbeat
• Breathlessness
• Hepatitis (inflamed liver)
• Abdominal pain
• Nausea (feeling sick)
• Vomiting

• If any of these affects you, tell your doctor or nurse immediately.