Parecoxib 40 mg Powder and solvent for solution for injection – patient leaflet, side effects, dosage

1. What Parecoxib is and what it is used for

Parecoxib contains the active substance parecoxib.

Parecoxib is used for the short-term treatment of pain in adults after an operation. It belongs to the group 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. Parecoxib works by lowering the amount of these prostaglandins.

2. What you need to know before you are given Parecoxib

Parecoxib must not be given:

• if you are allergic to parecoxib or

  any of the other ingredients of this medicine (listed in section 6).

• 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 “sulfonamides” (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 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 breast-feeding.
• if you have severe liver disease.

• if you have inflammation of the

  intestines (ulcerative colitis or Crohn’s disease).

• 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 e.g., 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).

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

Warnings and precautions

Talk to your doctor or nurse before Parecoxib is given:

• If you have previously 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 or drink alcohol.

• If you have diabetes.

• If you have angina, blood clots, high

  blood pressure or raised cholesterol.

• If you are taking anti-platelet therapies.
• If you have fluid retention (oedema).
• If you have liver or kidney disease.

• 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 as it may hide

  a fever (which is a sign of infection).

• If you use medicines to reduce blood

  clotting (e.g. warfarin/warfarin e.g. anticoagulants or novel oral anti-clotting medicines, e.g. apixaban, dabigatran, and rivaroxaban).

• If you use medicines called

  corticosteroids (e.g. prednisone).

• If you use a class of medicines used

  to treat depression called selective serotonin re-uptake inhibitors (e.g. sertraline).

Parecoxib can lead to an increase in blood pressure or worsening of existing high blood pressure which may result in an increase in side-effects associated with heart conditions. Your doctor may want to monitor your blood pressure during treatment with this medicine.

Children and adolescents

Parecoxib should not be used in children and adolescents under the age of 18.

Other medicines and Parecoxib

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. Medicines can sometimes interfere with each other. Your doctor may reduce the dose of Parecoxib or other medicines, or you may need to take a different medicine. It’s especially important to mention:

• Acetylsalicylic acid or other anti-inflammatory medicines

• Fluconazole - used for fungal

  infections

• ACE inhibitors, Angiotensin-II

  inhibitors, beta blockers and diuretics - used for high blood pressure and heart conditions

• Ciclosporin or Tacrolimus - used after transplants

• Warfarin - or other warfarin e.g.

  medicines used to prevent blood clots including newer medicines e.g. apixaban, dabigatran, and rivaroxaban

• Lithium - used to treat depression

• Rifampicin - used for bacterial

  infections

• Antiarrhythmics - used to treat an irregular heartbeat
• Phenytoin or Carbamazepine - used for epilepsy
• Methotrexate - used for rheumatoid arthritis and cancer
• Diazepam - used for sedation and anxiety
• Omeprazole - used for treating ulcers

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before you are given this medicine.

• If you are pregnant or trying to become pregnant, tell your doctor. Parecoxib is not recommended in the first 6 months of pregnancy and you must not receive Parecoxib in the last three months of pregnancy.
• If you are breast-feeding, you must not receive Parecoxib, as a small amount of the active substance will pass into your breast milk.
• NSAIDs, including Parecoxib, may make it more difficult to become pregnant. Tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

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

Parecoxib contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial that is to say essentially ‘sodium-free’.

3. How Parecoxib is given

Parecoxib will be given to you by a doctor or nurse.

The usual dose to start with is 40 mg.

You may be given another dose - either 20 mg or 40 mg - 6 to 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:

• People with liver problems
• People with severe kidney problems

• Patients over 65 who weigh less than

  50 kg

• People taking fluconazole.

If Parecoxib is used with strong pain killers (called opioid analgesics) such as morphine the dose of Parecoxib will be the same as explained above.

Your doctor or nurse will dissolve the powder before giving you the injection, and will inject the solution into a vein or a muscle (intravenous or intramuscular use). The injection may be given rapidly and directly into a vein or into an existing intravenous line (a thin tube running into a vein), or it can be given slowly and deeply into a muscle.

You will only be given this medicine for short periods.

If you are given more Parecoxib than you should

You may experience side-effects that have been reported with recommended doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Parecoxib and tell your doctor immediately:

• if you develop a rash or ulceration in any part of your body (for example 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 wheezing, difficulty breathing, or swallowing - this occurs rarely
• if you have blistering or peeling of the skin - this occurs rarely

Arial 10 pt 160x840 mm

The following information is intended for healthcare professionals only

Dosing. The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg / day. The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle.

There is limited clinical experience with parecoxib treatment beyond three days. As the cardiovascular risk of

cyclooxygenase-2 (COX-2) specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

Cases of severe hypotension shortly following parecoxib administration have been reported in postmarketing experience with parecoxib. Some of these cases have occurred without other signs of anaphylaxis. The physician should be prepared to treat severe hypotension.

Administration is by intramuscular (IM) or intravenous (IV) injection. The IM injection is to be given slowly and deeply into the muscle and the IV bolus injection may be given rapidly and directly into a vein or into an existing IV line.

Administration other than IV or IM

Methods of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used.

Reconstitution solvents

This medicinal product must not be mixed with other medicinal products.

Reconstitute the powder with the solvent, included in the pack (2 mL sodium chloride 9 mg / mL (0.9%) solution).

The only other acceptable solvents for reconstitution are:

• glucose 50 mg / mL (5 %) solution for infusion

• sodium chloride 4.5 mg / mL (0.45 %)

  and glucose 50 mg / mL (5 %) solution for injection / infusion

The following solutions cannot be used for reconstitution:

• Use of Ringer-Lactate solution for injection or glucose 50 mg / mL (5 %) in Ringer-Lactate solution for injection for reconstitution will cause the parecoxib to precipitate from solution and therefore is not recommended.
• Use of Sterile Water for Injection for reconstitution is not recommended, as the resulting solution is not isotonic.

Reconstitution process

Use aseptic technique to reconstitute the powder.

Remove the flip-off cap to expose the central portion of the rubber stopper of the powder vial. Withdraw with a sterile needle and syringe, 2 mL of an acceptable solvent and insert the needle through the central portion of the rubber stopper transferring the solvent into the powder vial.

Dissolve the powder completely using a gentle swirling motion. The reconstitution time is not more than 30 seconds. Inspect the reconstituted product before use.

The reconstituted solution should be a clear and colourless to almost colourless solution.

38000901-1

• 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, a medicine related to parecoxib, 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

Very common: may affect more than 1 in 10 people

• nausea (feeling sick)

Common: may affect up to 1 in 10 people

• change in your blood pressure (up or

  down)

• back pain

• swelling of the ankles, legs and feet

  (fluid retention)

• feeling numb - your skin may lose

  sensitivity to pain and touch

• vomiting, stomach ache, indigestion,

  constipation, bloating and wind

• tests may show abnormal kidney

  function

• feeling agitated or find it hard to sleep
• dizziness

• there is a risk of anaemia - changes in

  red blood cells after an operation that may cause fatigue and breathlessness

• sore throat or difficulty breathing

  (shortness of breath)

• itchy skin
• passing less urine than usual.

• dry socket (inflammation and pain after

  a tooth extraction)

• increased sweating

• low levels of potassium in blood test

  results

Uncommon: may affect up to 1 in 100 people

• heart attack

• there is a risk of cerebrovascular

  disease e.g. stroke, or transient ischaemic attack (transient reduced blood flow to the brain)/mini-stroke or angina, or blockages to blood vessels to the heart or brain

• blood clot in the lungs
• worsening of high blood pressure

• ulcers in the digestive system, chronic

  stomach acid reflux

• the heart may beat more slowly
• low blood pressure on standing

• blood tests may show abnormal liver

  function

• bruising easily due to a low blood

  platelet count

• abnormal discharge from surgical

  wounds, surgical wounds may become infected,

• skin discolouration or bruising

• complications with skin healing after

  operations

• high sugar levels in blood tests

• injection site pain or injection site

  reaction

• rash, or raised itchy rash (hives)
• anorexia (loss of appetite)
• joint pain

• high levels of blood enzymes in blood

  tests that indicate injury or stress to the heart, the brain, or muscle tissue.

• dry mouth
• muscle weakness
• ear ache
• unusual abdominal sounds

Rare: may affect up to 1 in 1,000 people

• rash or ulceration in any part of your

  body (such as 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 (potentially fatal)

• swelling, blistering or peeling of the

  skin

• acute kidney failure
• hepatitis (inflamed liver)

• inflammation of the gullet

  (oesophagus)

• inflammation of the pancreas (can lead

  to stomach pain)

Not known: frequency cannot be estimated from the available data

• collapse due to severe low blood

  pressure

• heart failure
• kidney failure
• racing or irregularity of the heartbeat
• breathlessness

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Parecoxib

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 carton and on the vial label after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

It is recommended that Parecoxib is used as soon as possible after it is mixed with solvent, although it may be stored if the instructions at the end of the leaflet are strictly followed.

The injection solution should be a clear and colourless to almost colourless solution. If there are particles in the injection solution or if either the powder or solution is discoloured, the solution will not be used.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Parecoxib contains

• The active substance is parecoxib.

  Each vial of powder contains 40 mg parecoxib (as 42.36 mg parecoxib sodium). After reconstitution with 2 mL solvent, each mL contains 20 mg of parecoxib.

• The other ingredients are:

Powder: Disodium hydrogen phosphate anhydrous, phosphoric acid, sodium hydroxide

Solvent: Sodium chloride, water for injections

What Parecoxib looks like and contents of the pack

Parecoxib is a powder and solvent for solution for injection

Powder: white to off white powder, contained in type I clear glass vials with 20 mm bromobutyl rubber stopper & aluminum flip off cap.

Solvent: 2 ml clear and colourless solution, contained in polypropylene ampoules with a twist-off top.

Pack sizes

1 powder vial and 1 solvent ampoule. 3 powder vials and 3 solvent ampoules. 5 powder vials and 5 solvent ampoules. 10 powder vials and 10 solvent ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Noridem Enterprises Limited

Evagorou and Makariou

Mitsi Building 3, Office 115,

Nicosia 1065, Cyprus

Manufacturer:

DEMO S.A. PHARMACEUTICAL INDUSTRY,

21^st Km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,

T: +30 210 8161802, F: +30 210 8161587

This leaflet was last revised in 11/2025.

The reconstituted solution must not be used if discoloured or cloudy or if particulate matter is observed.

The entire contents of the vial should be withdrawn for a single administration. If a dose lower than 40 mg is required, excess medicine should be discarded.

IV line solution compatibility

Precipitation may occur when Parecoxib is combined in solution with other medicines and therefore Parecoxib must not be mixed with any other medicine, either during reconstitution or injection. In those patients where the same IV line is to be used to inject another medicine, the line must be adequately flushed prior to and after Parecoxib injection with a solution of known compatibility.

After reconstitution with acceptable solvents, Parecoxib may only be injected IV or IM, or into IV lines delivering the following:

• sodium chloride 9 mg / mL (0.9 %)

  solution for injection/infusion

• glucose 50 mg / mL (5 %) solution for

  infusion

• sodium chloride 4.5 mg / mL (0.45 %)

  and glucose 50 mg / mL (5 %) solution for injection/infusion or

• Ringer-Lactate solution for injection

It is not recommended to inject into an IV line delivering glucose 50 mg / mL (5 %) in Ringer-Lactate solution for injection, or other IV fluids not listed in this section, as this may cause precipitation from solution.

The solution is for single use only. Chemical and physical in-use stability has been demonstrated for 12 hours at 5±3^oC or -20^oC and for 24 hours at 25±2 °C, if diluted in 2 ml of sodium chloride 9 mg / mL (0.9 %), glucose 50 mg / mL (5 %) and sodium chloride 4.5 mg / mL (0.45 %) and glucose 50 mg / mL (5 %). From a microbiological point of you, the reconstituted solution should be used immediately. If not used immediately, in use storage times and conditions prior to use are in the responsibility of the user and would normally not be longer than 24 hours at 2-8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.