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DYNASTAT® (die-na-stat) parecoxib Consumer Medicine Information

What is in this leaflet  asthma, wheezing or shortness of How Dynastat works breath This leaflet answers some common This medicine belongs to a group of  swelling of the face, lips or questions about Dynastat powder for medicines called Coxibs. tongue which may cause injection. These medicines work by relieving difficulty in swallowing or It does not contain all the available pain and inflammation. breathing information.  hives, itching or skin rash Using Dynastat It does not take the place of talking to  swelling, blistering or peeling of your doctor or nurse. Dynastat is an injection. Only a the skin. All medicines have risks and doctor or nurse can give the These symptoms may be severe if benefits. Your doctor has weighed injection. you are allergic to sulphonamides or the risks of you being given Dynastat This medicine is available only with to any of the ingredients listed at the against the benefits they expect it a doctor's prescription. end of this leaflet and you are given will have for you. This medicine is not addictive. Dynastat. If you have any concerns about Ask your doctor or nurse if any of using this medicine, ask your Use in children this applies to you. doctor or nurse. There is not enough information to You must not be given Dynastat if Keep this leaflet with the medicine. recommend the use of this medicine you have had an attack of asthma, You may need to read it again. in children. hives, itching, skin rash or a runny nose after taking or Non- Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to What Dynastat is used Before you are given treat pain and inflammation), for Dynastat including other Coxib medicines. Many medicines used to treat headache, period pain and other What Dynastat is for When it must not be used aches and pains contain aspirin or an This medicine is used for the You must not be given Dynastat if NSAID. prevention and treatment of pain. It you have an to: If you are not sure if you are can be used to relieve pain and  parecoxib sodium or taking any of these medicines, ask reduce inflammation (swelling and  any of the ingredients listed at the your doctor or nurse. soreness) which may occur after end of this leaflet surgery. If you are allergic to aspirin or  sulphonamides, a group of NSAIDs, including other Coxib Although Dynastat can relieve the medicines which include, for medicines and use Dynastat, these symptoms of pain and inflammation, example, certain antibiotics (if symptoms may be severe. it will not cure your condition. you are not sure whether you are You must not be given Dynastat if Ask your doctor if you have any taking one of these medicines ask you are about to undergo heart or questions about why this medicine your doctor or nurse). blood vessel surgery. has been prescribed for you. Some of the symptoms of an allergic You should not be given Dynastat Your doctor may have prescribed it reaction to Dynastat may include: if you have had any of the for another reason.

DYNASTAT® 1 following medical conditions. Your Use of NSAIDs in early pregnancy pressure or other heart problems. doctor or nurse need to know if can increase the risk of spontaneous These include ACE inhibitors, you have ever had: abortion. angiotensin receptor antagonists,  heart disease Use of Dynastat during pregnancy is beta blockers and diuretics (also called fluid or water tablets).  a heart attack not recommended as it may affect your developing baby. Your doctor These medicines can cause kidney  a stroke will discuss with you the benefits and problems if taken at the same time as  severe liver problems. risks of using it. you receive Dynastat. If you are not sure whether you Your doctor and nurse need to Your doctor and nurse need to should be given this medicine, talk know if you are breastfeeding or know if you are taking any of the to your doctor. intend to breastfeed. following: Dynastat passes into breast milk,  aspirin, salicylates or other Before you are given it therefore, breastfeeding should be NSAID medicines used to treat Your doctor and nurse need to discontinued during treatment with pain, inflammation or swelling know if you have any to: Dynastat.  corticosteroids, medicines used to  any other medicines including Your doctor and nurse need to suppress the immune system or aspirin or other NSAID know if you are a smoker or drink reduce inflammation medicines, including other Coxib .  selective serotonin reuptake medicines Your doctor and nurse need to inhibitors, medicines used for  any other substances, such as know if you currently have an depression foods, preservatives or dyes. infection.  warfarin or similar medicines Your doctor and nurse need to If you are given Dynastat while you including Eliquis (apixaban), know about all your medical have an infection, it may hide some Xarelto (rivaroxaban), Pradaxa conditions, especially if you have of the signs of an infection. (dabigatran) or antiplatelet ever had any of the following: If you have not told your doctor medicines that are used to prevent  kidney or liver problems and nurse about any of the above, or stop blood clots from forming tell them before you are given  lithium, a medicine used to treat  heart problems, heart surgery, heart failure, heart attack or other Dynastat. some types of depression blood vessel disease  some medicines used to treat Taking other medicines  stroke diabetes Some medicines may be affected by  methotrexate, a medicine used to  diabetes Dynastat or may affect how well it treat arthritis and some cancers  high cholesterol levels works. Your doctor may need to give  ciclosporin, a medicine used to you different amounts of your  high blood pressure suppress the immune system medicine, or you may need to take  fluid retention or if you are different medicines. Your doctor will  fluconazole and ketoconazole receiving diuretic treatment advise you. used to treat fungal infections.  dehydration Your doctor and nurse need to Your doctor and nurse have more  asthma or other allergic know if you are taking any other information on medicines to be conditions medicines, including: careful with or avoid while using Dynastat.  skin problems with symptoms  all prescription medicines such as swelling, blistering,  all medicine bought over-the- peeling, itching, reddening or counter from a pharmacy or some other abnormality supermarket How Dynastat is given  peptic ulcer i.e. stomach or  all complementary and alternative duodenal ulcer. therapies Your doctor will decide how much Your doctor and nurse need to Dynastat you need. The usual  any supplements or herbal know if you are pregnant or intend recommended dose is a single 40 mg remedies bought from a health to become pregnant. food shop. injection. Your doctor may adjust the Related medicines, NSAIDs, have dosage you are given depending on Your doctor and nurse need to been associated with reversible your condition. know if you are taking any infertility in some women. medicines used to treat high blood

DYNASTAT® 2 Dynastat will be given to you by This medicine has been prescribed to Tell your doctor immediately your doctor. It is diluted and given by help you, but it may have unwanted if... injection into a vein through an side effects in some people. All intravenous line or into a muscle. medicines can have side effects. The following list includes serious side effects which may require Sometimes they are serious, most of Ask your doctor if you want more medical attention. information about the dose of the time they are not. You may need Do not be alarmed as you may not Dynastat and how it is given. medical attention if you get some of the side effects. experience any of them. If you are receive too much Do not be alarmed by the following Tell your doctor or nurse (overdose) list of side effects. immediately if you notice: As your doctor will supervise how You may not experience any of them.  a skin rash, including hives, raised red, itchy spots much Dynastat you are given, you Tell your doctor or nurse if you are unlikely to have an overdose. notice anything else that is making  blistering and bleeding in the lips, If you are given too much Dynastat, you feel unwell. eyes, mouth, nose and genitals you may feel tired, drowsy or sick, or Other side effects not listed below  swelling, blistering or peeling of you may be sick, have stomach pains may also occur in some people. the skin, which may be or other abdominal problems. accompanied by fever, chills, If you think you have been given Tell your doctor... headache, sore throat, diarrhoea, aching joints and muscles too much Dynastat: The following list shows common  tell your doctor or nurse side effects of Dynastat.  swollen glands e.g. under armpit or neck immediately, or Tell your doctor or nurse if you  telephone the Poisons notice any of the following physical  any other signs of allergic Information Centre (telephone problems and they worry you: reaction such as wheezing, swelling of the face, lips, mouth, 0800 POISON or 0800 764 766).  changes in blood pressure tongue or throat which may cause  dizziness or light-headedness due difficulty in swallowing or to low blood pressure breathing While you are  back pain  a slow heart beat receiving Dynastat  ear ache  a severe or persistent headache,  feeling numb (your skin may lose fever, stiff neck, sensitivity to Things you must not do sensitivity to pain and touch) light and vomiting Do not take any other medication  stomach upset including nausea  bleeding or bruising more easily unless your doctor is aware of it. (feeling sick), vomiting, than normal, reddish or purplish heartburn, indigestion, cramps blotches under the skin Things to be careful of  constipation, diarrhoea, pain in  any signs of anaemia, such as tiredness, being short of breath, Be careful driving or operating the stomach, wind, bloating and looking pale machinery after your surgery in  dizziness  an unusual weight gain or loss of case Dynastat has affected you.  sore throat appetite This medicine may cause dizziness  swollen and sore gums or light-headedness in some people.  unusual stomach sounds  increased sweating If you have any of these symptoms,  swelling of lips and tongue do not drive, operate machinery or do  passing less urine than normal  severe stomach or throat pain anything else that could be  inflammation and pain after a  joint pain, muscle weakness dangerous. tooth extraction.  you are vomiting blood or having Tell your doctor or nurse if you black sticky bowel motions notice any of the following mental or emotional problems and they  any infection of, or discharge Side Effects worry you: from, any wounds Tell your doctor or nurse as soon  trouble sleeping  complications with skin healing after operations as possible if you do not feel well  irritability, agitation. while you are receiving Dynastat.  injection site pain or reaction

DYNASTAT® 3  yellowing of the skin or eyes (jaundice)  a dry mouth, feeling of thirst and needing to urinate more often  feeling faint or collapse, have shortness of breath, feel tired  have irregular heartbeat, chest pain or discomfort, swollen or sore leg veins.

Product Description

What it looks like Dynastat is supplied to the hospital in single-use glass vials, and requires dilution with normal saline before use. It is a white to off-white powder. Dynastat may also be supplied along with normal saline in glass ampoules for dilution. When diluted, Dynastat is a clear and colourless solution.

Ingredients The active ingredient in Dynastat is parecoxib (as parecoxib sodium). Dynastat contains 40 mg parecoxib per vial. Dynastat also contains dibasic sodium phosphate, phosphoric acid and sodium hydroxide.

Supplier Dynastat is supplied in New Zealand by: Pfizer New Zealand Limited PO Box 3998 Auckland, New Zealand Toll Free Number: 0800 736 363 Website: www.pfizer.co.nz

This leaflet was prepared in February 2020. ® Registered trademark © Pfizer Australia Pty Ltd 2020.

DYNASTAT® 4