Perodyn Solution

PERODYN 40 contains the active substance parecoxib. PERODYN 40 is used for the short-term treatment of pain in adults. The injection is given to you by a doctor or nurse, usually in a hospital or clinic, after an operation. Following hip replacement surgery, PERODYN 40 can also be used for up to 48 hours in order to reduce the amount of opioid analgesics (such as morphine) used to achieve pain control and the side effects related with these medicines.

Parecoxib is part of a family of medicines called COX-2 inhibitors (this is short for cyclo-oxygenase-2 inhibitors). Pain and swelling are sometimes caused by substances in the body called prostaglandins. PERODYN 40 works by lowering the amount of these prostaglandins.

PERODYN 40 should not be administered to you:

• If you are hypersensitive (allergic) to parecoxib or any of the other ingredients of PERODYN 40;
• If you have a history of serious allergic reactions or if you have had an allergic reaction to a group of medicines called “sulphonamides” (e.g., some antibiotics used to treat infections);
• If you currently have a gastric or intestinal ulcer or bleeding in the stomach or gut;
• If you have had an allergic reaction to acetylsalicylic acid (aspirin) or to other Non-steroidal Anti-Inflammatory Drugs (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 suffer from severe liver or kidney disease;
• If you suffer from disorders that involve chronic inflammation of your digestive tract (e.g., ulcerative colitis or Crohn’s disease);
• 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 e.g. If you have had a heart attack, stroke, mini-stroke, blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages or have had problems with your blood circulation (peripheral arterial disease);
• If you suffer from congestive heart failure;
• If you are pregnant, think you might be pregnant or if you are currently breastfeeding;
• If you are 18 years old or younger.

Warnings and precautions

PERODYN 40 have a tendency to cause cardiovascular events, cerebrovascular events (strokes), gastrointestinal events or skin reactions which may be fatal. Serious skin reactions known as Eosinophillia and Systemic Symptoms (DRESS) has been reported in patients taking Non-steroidal Anti-Inflammatory Drugs (NSAIDs) such as PERODYN 40. Some of these events have been deadly or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, swollen lymph nodes and/or facial swelling. Other symptoms may include inflammation of the liver, inflammation of the kidneys, blood abnormalities, inflammation of the heart muscle or inflammation in your muscles. Sometimes symptoms of DRESS may resemble an acute viral infection. Higher than normal levels of eosinophils are often present in the blood. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or swollen lymph nodes may be present even though a rash is not evident. If such signs or symptoms are present, discontinue the use of PERODYN 40 and seek medical assistance immediately.

Tell your doctor or health care provider before being given PERODYN 40:

• If you suffer from heart disease risk factors e.g., hypertension, diabetes, smoking and high cholesterol;
• If you use medicines to reduce blood clotting (e.g., warfarin and other oral anticoagulants);
• If you are taking acetylsalicylic acid (aspirin) or other NSAIDs (e.g., ibuprofen);
• If you have previously had an ulcer, bleeding or perforation of the gastrointestinal tract;
• If you are prone to have severe allergic skin reactions when taking NSAIDs (ibuprofen and aspirin), including COX-2 selective inhibitors as well as other medicinal products. You should report any emergent skin condition to your health care provider immediately.
• If you have any fluid retention or swelling of the limbs (oedema);
• If you are 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. PERODYN 40 may hide fever.
• PERODYN 40, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood. This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Children

Children and adolescents under the age of 18 should not be given PERODYN 40.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself PERODYN 40. It will be given to you by a person who is qualified to do so.

Adults

PERODYN 40 will be given to you by a doctor or nurse only if alternative oral medication is not available. They will dissolve the powder before giving you the injection and will inject the solution into a vein or a muscle. You will only be given PERODYN 40 for short periods, and only for pain relief. If there are particles in the injection solution or if either the powder or solution is discoloured, PERODYN 40 will not be used. The usual dose to start with is 40 mg. You may be given another dose 6 – 12 hours after the first one. You will not be given more than 80 mg in 24 hours. Some people may be given lower doses if they have liver problems, or if they are over 65 years of age and weigh less than 50 kg.

Children

Children under 18 years should not be given PERODYN 40. Your doctor will prescribe another suitable medicine for your child.

If more PERODYN 40 is given to you than you should

Since a health care provider will administer PERODYN 40, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use PERODYN 40

Since a health care provider will administer PERODYN 40, it is unlikely that the dose will be missed.

If you stop using PERODYN 40

Since a health care provider will administer PERODYN 40, your doctor will decide you how long your treatment with PERODYN 40 will last.

PERODYN 40 can have side effects. Not all side effects reported for PERODYN 40 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while being given PERODYN 40, please inform your health care provider.

If any of the following happens while being given PERODYN 40, inform your doctor or health care provider immediately:

• If you have cardiac symptoms such as shortness of breath or difficulty breathing, sudden chest pain, cramping or tingling sensation up the left arm;
• If you experience dizziness and headache;
• If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing;
• If you have blistering or peeling of the skin;
• If you have any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood;
• If you develop a serious skin reaction, known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) characterised by an uncommon, widespread skin rash, which may occur in conjunction with high body temperature (fever) and enlarged lymph nodes (see Warnings and precautions).
• If you develop muscle weakness and light-headedness. PERODYN 40, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood. These are all very serious side effects. If you have them, you may have had a serious reaction to PERODYN 40. You may need urgent medical attention.

Tell your doctor or health care provider if you notice any of the following:

Frequent side effects:

• Blood pressure may become higher or lower
• Dizziness
• Back pain
• Ankles, legs and feet may swell (fluid retention)
• Numbness
• Abdominal pain, indigestion, bloating and wind or constipation
• Nausea and vomiting;
• Tests may show abnormal kidney function
• Feeling agitated or problems sleeping
• Low levels of iron in the blood (anaemia)
• Sore throat or difficulty breathing
• Itchy skin or rash
• Urinating less than usual
• Increased sweating

Less frequent side effects:

• Slower or irregular heartbeat and palpitations
• Blood tests may show abnormal liver function
• Bruising (or low blood platelet count)
• Low blood sugar
• Surgical wounds may become infected
• Earache or joint pain
• Risk of stroke

Frequency of side effects unknown:

• Hypersensitivity reactions
• Kidney failure

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PERODYN 40.

Store all medicines out of sight and reach of children. Store the unopened vial below or below 25 ºC (room temperature). Store the unopened vial in the original container. Do not use PERODYN 40 after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).