Label: Information for the User

Dynastat 40 mg Powder and Diluent for Injectable Solution

Parecoxib

Read this label carefully before you start taking this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

Dynastat contains the active ingredient parecoxib.

Dynastat is used for the short-term treatment of pain in adults after surgery. It belongs to a group of medicines called COX-2 inhibitors (short forciclo-oxigenase-2). Sometimes pain and inflammation are caused by substances in the body calledprostaglandins. Dynastat works by reducing the amount of these prostaglandins.

No use Dynastat

• If you are allergic to parecoxib or any of the other components of this medication (listed in section 6)
• If you have had a severe allergic reaction (especially a severe skin reaction) to any medication
• If you have had an allergic reaction to a group of medications called “sulfonamides” (e.g. some antibiotics used to treat infections)
• If you currently have a stomach or intestinal ulcer or gastrointestinal bleeding
• If you have had an allergic reaction to acetylsalicylic acid (aspirin), or to other nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen) or to COX-2 inhibitors. Reactions may include wheezing (bronchospasm), nasal obstruction, skin itching, rash, or facial, lip, or tongue swelling, or other allergic reactions or nasal polyps after taking any of these medications
• If you are more than 6 months pregnant
• If you are breastfeeding
• If you have a severe liver disease
• If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease)
• If you have heart failure
• If you are undergoing cardiac surgery (bypass) or vascular surgery (including any coronary artery procedure)
• If you have a diagnosed heart or cerebrovascular disease, e.g. if you have had a heart attack, or a stroke, or a transient ischemic attack, or any blockage of blood vessels that has prevented circulation to the heart or brain, or if you have undergone surgery to unblock your arteries or to perform a bypass
• If you have or have had circulation problems (peripheral arterial disease)

If any of these things happen, the injection will not be administered to you.Tell your doctor or nurse immediately.

Warnings and precautions

Do not use Dynastatif you currently have a stomach or intestinal ulcer or gastrointestinal bleeding

Do not use Dynastatif you have a severe liver disease

Consult your doctor or nurse before starting to use Dynastat:

• If you have had a previous stomach or intestinal ulcer, bleeding, or perforation
• If you have had a skin reaction (e.g. rashes, hives, blisters, red streaks) with any medication
• If you are taking acetylsalicylic acid (aspirin) 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 high cholesterol
• If you are undergoing antiplatelet treatment
• If you have fluid retention (edema)
• If you have kidney or liver disease
• If you are dehydrated, this may occur if you have had diarrhea or have been vomiting or unable to take liquids
• If you have an infection, as it may mask fever (a sign of infection)
• If you are taking medications to reduce blood clotting (e.g. warfarin/anticoagulants similar to warfarin or new oral anticoagulants, e.g. apixaban, dabigatran, and rivaroxaban)
• If you are taking corticosteroids (e.g. prednisone)
• If you are taking a class of medications used to treat depression called selective serotonin reuptake inhibitors (e.g. sertraline)

Dynastat may cause an increase in blood pressure or worsening of existing high blood pressure, which may result in increased side effects associated with heart disease. Your doctor may want to monitor your blood pressure during treatment with Dynastat.

Severe skin reactions, including potentially life-threatening skin reactions, may occur with the use of Dynastat. Treatment should be discontinued at the first sign of a skin reaction, blisters, or peeling of the skin, mucosal lesions, or any other sign of hypersensitivity. If you experience a skin reaction, other skin or mucosal symptoms (such as the inside of the cheeks or lips), seek urgent medical attention and inform your doctor that you are taking this medication.

Children and adolescents

Dynastat should not be administered to children and adolescents under 18 years old.

Other medications and Dynastat

Inform your doctor or nurse ifyou are taking, have taken recently, or may need to take any other medication. Medications sometimes interfere with each other. Your doctor may reduce the dose of Dynastat or other medications, or may need to prescribe a different medication.It is especially important to mention:

• Acetylsalicylic acid (aspirin) or other anti-inflammatory medications
• Fluconazole - used to treat fungal infections
• Inhibitors of the ECA, angiotensin II inhibitors, beta blockers, and diuretics - used to treat high blood pressure and heart problems
• Ciclosporin or tacrolimus - used after transplants
• Warfarin - or other medications similar to warfarin used to prevent blood clots, including new medications, such as apixaban, dabigatran, and rivaroxaban
• Lithium - used to treat depression
• Rifampicin - used to treat bacterial infections
• Antiarrhythmics - used to treat irregular heartbeats
• Phenobarbital or carbamazepine - used to treat epilepsy
• Methotrexate - used to treat rheumatoid arthritis and cancer
• Diazepam - used for sedation and anxiety
• Omeprazole - used to treat ulcers

Pregnancy, breastfeeding, and fertility

• Dynastat should not be used if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. Dynastat may cause kidney and heart problems in the fetus. Dynastat may affect your tendency and that of your baby to bleed and make delivery delayed or prolonged. Dynastat should not be used during the first 6 months of pregnancy unless absolutely necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If used for more than a few days after 20 weeks of pregnancy, Dynastat may cause kidney problems in the fetus that may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (arterial duct) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
• If you are breastfeeding,Dynastat should not be administered, as a small amount of Dynastat will be transferred to breast milk.
• NSAIDs, including Dynastat, may make it difficult to become pregnant. Inform your doctor if you are planning to become pregnant or have difficulty conceiving.

If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to become pregnant, consult your doctor or nurse before using this medication.

Driving and operating machinery

If you feel dizzy or tired after the injection, do not drive or operate machinery until you feel better again.

Dynastat contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially “sodium-free”.

Dynastat will be administered by a doctor or nurse. They will dissolve the powder first, and then inject the solution into a vein or muscle. The injection can be administered quickly and directly into a vein or existing intravenous route (a thin tube inserted into a vein), or it can be administered slowly and deeply into the muscle. Only Dynastat will be injected for a short period and only for pain relief.

The usual starting dose is 40 mg.

Another dose of 20 mg or 40 mg may be administered 6 to 12 hours after the first dose.

Do not administer more than 80 mg in 24 hours.

Lower doses may be administered to some individuals:

• Individuals with liver problems
• Individuals with severe kidney problems
• Patients over 65 years old with a weight less than 50 kg
• Individuals taking fluconazol

If Dynastat is used with strong pain medications (opioid analgesics) such as morphine, the Dynastat dose will be the same as previously described.

If more Dynastat is administered than recommended, you may experience adverse effects that have been reported with the recommended doses.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment with Dynastat and inform your doctor immediately:

• if you develop a rash or ulceration that could appear on any part of your body (e.g. skin, mouth, eyes, face, lips, or tongue), or develop any other sign of an allergic reaction such as skin rash, swelling of the face, lips, or tongue, which may cause ringing, difficulty breathing, or swallowing – this occursin rare cases
• if you develop blisters or have skin peeling – this occursin rare cases
• the appearance of these skin reactions may occur at any time, although they usually appear during the first month of treatment; the frequency of reporting of these events appears to be higher with valdecoxib, a related medication to parecoxib, compared to other COX-2 inhibitors
• if you have jaundice (your skin or the white of your eyes turns yellow)
• if you have any sign of bleeding in the stomach or intestines, such as black or bloody stools, or vomiting with blood

Very common: may affect more than 1 in 10 people

• Nausea (feeling unwell)

Common: may affect up to 1 in 10 people

• Change in blood pressure (rise or fall)
• You may have back pain
• You may experience swelling of the legs, ankles, and feet (fluid retention)
• You may feel numbness – you may lose sensitivity to pain and touch in your skin
• You may have vomiting, stomach pain, indigestion, constipation, swelling, and gas
• Renal function tests may show abnormalities
• You may feel agitation or have difficulty sleeping
• Dizziness
• There is a risk of anemia – changes in red blood cells after surgery that may cause fatigue and difficulty breathing
• You may have a sore throat or difficulty breathing (feeling of lack of air)
• You may have skin itching
• You may urinate less than usual
• Dry alveolus (inflammation and pain after a dental extraction)
• Increased sweating
• Decreased potassium levels in blood tests

Rare: may affect up to 1 in 100 people

• Heart attack
• There is a risk of suffering a cerebrovascular disease, for example stroke, or transient ischemic attack (temporary decrease in blood flow to the brain) / mini-stroke or angina, or blockage of blood vessels leading to the heart or brain
• Clots in the lungs
• Worsening of high blood pressure
• Ulcers in the digestive tract, chronic acid reflux
• The heart may beat slower
• Decrease in blood pressure when standing up

• Blood tests may show abnormalities in liver function
• You may bruise easily due to low platelet count in the blood
• Wounds from surgery may become infected, may have abnormal discharge
• Discolored skin (cardenales)
• Complications in skin healing after surgery
• Blood tests may show high sugar levels
• Pain or reaction at the injection site
• Rash, or increased rash with itching (urticarial hives)
• Loss of appetite
• Joint pain
• High levels of enzymes in blood tests indicating the presence of a heart, brain, or muscle tissue injury or stress
• Dry mouth
• Muscle weakness
• Ear pain
• Abnormal abdominal sounds

Very rare: may affect up to 1 in 1,000 people

• Rash or ulceration that may appear on any part of your body (e.g. skin, mouth, eyes, face, lips, or tongue), or other signs of allergic reactions such as skin rash, swelling of the face, lips, or tongue, ringing, difficulty breathing, or swallowing (which may be fatal)
• Swelling, blisters, or skin peeling
• Acute renal insufficiency
• Hepatitis (inflammation of the liver)
• Pharyngitis (inflammation of the throat)
• Pancreatitis (may cause stomach pain)

Unknown: the frequency cannot be estimated from available data

• Shock due to severe drop in blood pressure
• Heart failure
• Renal insufficiency
• Irregular or rapid heartbeats
• Difficulty breathing

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the vial label after CAD.The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions before reconstitution.

It is recommended that Dynastat be used as soon as possible once mixed with the solvent, although it can be conserved if the instructions at the end of the prospectus are strictly followed.

The injectable solution must be a transparent and colorless liquid.Do not use the solutionif there are particles in the injectable solution or if the powder or solution are discolored.

Composition of Dynastat

• The active ingredient is parecoxib (as parecoxib sodium). Each vial contains 40 mg of parecoxib as parecoxib sodium 42.36 mg. When reconstituted with 2 ml of solvent, 20 mg/ml of parecoxib is obtained. When reconstituted in a 0.9% sodium chloride solution, Dynastat contains approximately 0.44 mEq of sodium per vial.

• The other components are:

Dry powder

Sodium dihydrogen phosphate

Phosphoric acid and/or sodium hydroxide (for pH adjustment).

Solvent

Sodium chloride

Hydrochloric acid or sodium hydroxide (for pH adjustment)

Water for injection preparations.

Appearance of the product and contents of the package

Dynastat is available as a white to off-white powder.

The powder is contained in colourless glass vials (5 ml) with a stopper, sealed with a purple flip-off capsule, over an aluminium closure.

The solvent is contained in neutral, colourless glass ampoules (2 ml).

Marketing authorization holder and responsible manufacturer

Marketing authorization holder: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium.

Responsible manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium.

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Spain

Pfizer, S.L.

Phone: +34 91 490 99 00

Last review date of this leaflet: 01/2024.

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals