DYNASTAT 40 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Dynastat 40 mg powder and solvent for solution for injection

parecoxib

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Dynastat is and what it is used for
2. What you need to know before you use Dynastat
3. How to use Dynastat
4. Possible side effects
5. Storage of Dynastat
6. Contents of the pack and other information

1. What Dynastat is and what it is used for

Dynastat contains the active substance parecoxib.

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

2. What you need to know before you use Dynastat

Do not use Dynastat

• if you are allergic to parecoxib or any of the other ingredients of this medicine (listed in section 6)
• if you have had a severe allergic reaction (especially a severe skin reaction) to any medicine
• 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 stomach or intestinal ulcer or bleeding
• if you have had an allergic reaction to acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen) or COX-2 inhibitors. Reactions can include wheezing (bronchospasm), nasal congestion, itchy skin, rash, or swelling of the face, lips, or tongue, or other allergic reactions or nasal polyps after taking any of these medicines
• if you are more than 6 months pregnant
• if you are breast-feeding
• if you have severe liver disease
• if you have inflammatory bowel disease (ulcerative colitis or Crohn's disease)
• if you have heart failure
• if you are going to have coronary artery bypass grafting (CABG) or other heart surgery
• if you have had a heart attack, stroke, transient ischaemic attack, or blockage of blood vessels to the heart or brain, or have had surgery to unblock your arteries or a bypass operation
• if you have problems with blood circulation (peripheral arterial disease)

If any of these apply to you, you will not be given the injection. 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 severe liver disease

Tell your doctor or nurse before you start using Dynastat:

• if you have had a previous ulcer, bleeding, or perforation in the gastrointestinal tract
• if you have had a skin reaction (e.g. rash, hives, itching, blistering, or peeling) with any medicine
• 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 on anti-coagulant treatment
• if you have fluid retention (oedema)
• if you have kidney or liver disease
• if you are dehydrated, this can happen if you have had diarrhoea or have been vomiting or have not been able to drink fluids
• if you have an infection, as this may mask a fever (which is a sign of infection)
• if you are taking medicines to reduce blood clotting (e.g. warfarin or similar medicines to warfarin, or new oral anti-coagulants, e.g. apixaban, dabigatran, and rivaroxaban)
• if you are using corticosteroid medicines (e.g. prednisone)
• if you are using a class of medicines used to treat depression called selective serotonin reuptake inhibitors (e.g. sertraline)

Dynastat may lead to an increase in blood pressure or worsening of existing high blood pressure, which can result in an increased risk of heart-related side effects. Your doctor may want to monitor your blood pressure during treatment with Dynastat.

Potentially life-threatening skin rashes may occur with the use of Dynastat and treatment should be discontinued at the first appearance of a skin rash, blisters, or peeling of the skin, mucosal lesions, or any other sign of hypersensitivity. If you develop a skin rash or other signs and symptoms on the skin or mucous membranes (such as the inside of the cheeks or lips), seek urgent medical attention and inform your doctor that you are taking this medicine.

Children and adolescents

Dynastat must not be given to children and adolescents under 18 years.

Other medicines and Dynastat

Tell your doctor or nurse ifyou 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 Dynastat or of other medicines, or may need to give you a different medicine. It is especially important to mention:

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

Pregnancy, breast-feeding, and fertility

• Dynastat must not be used if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. Dynastat may cause kidney or heart problems in the unborn baby. Dynastat may affect your tendency and your baby's tendency to bleed and may cause prolonged delivery. Dynastat must not be used during the first 6 months of pregnancy unless absolutely necessary and under the guidance of 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 from 20 weeks of pregnancy, Dynastat may cause kidney problems in the unborn baby, which can lead to low levels of the fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductal constriction) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
• If you are breast-feeding,you must not be given Dynastat, as a small amount of Dynastat is transferred into breast milk.
• NSAIDs, including Dynastat, may make it more difficult to become pregnant. Tell your doctor if you are planning to become pregnant or if you are having problems becoming pregnant.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Driving and using machines

If you feel dizzy or drowsy after the injection, do not drive or use machines until you feel better.

Dynastat contains sodium

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

3. How to use Dynastat

Dynastat will be given to you by a doctor or nurse. They will dissolve the powder before and then inject the solution into a vein or into a muscle. The injection can be given quickly and directly into a vein or into an existing intravenous line (a thin tube inserted into a vein), or it can be given slowly and deeply into the muscle. You will only be given Dynastat for a short period and only for pain relief.

The usual starting dose is 40 mg.

You may be given another dose - of 20 mg or 40 mg - 6 to 12 hours after the first dose.

You must 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
• Patient over 65 years with a weight below 50 kg
• People taking fluconazole

If Dynastat is used with strong pain-relieving medicines (called opioid analgesics) such as morphine, the dose of Dynastat will be the same as described above.

If you are given more Dynastat than you should, you may experience side effects that have been reported with the 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 taking Dynastat and tell your doctor immediately:

• if you develop a rash or ulceration that can appear anywhere on 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, wheezing, difficulty breathing, or swallowing - this happens rarely
• if you get blisters or peeling of the skin - this happens rarely
• the appearance of these skin reactions can occur at any time, although they usually appear during the first month of treatment; the frequency of reporting of these events seems to be higher with valdecoxib, a medicine related to parecoxib, compared to other COX-2 inhibitors
• if you get jaundice (your skin or the whites of your eyes turn yellow)
• if you have any signs of bleeding in the stomach or intestines, such as black or bloody stools, 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 blood pressure (increase or decrease)
• You may get back pain
• Your legs, ankles, and feet may swell (fluid retention)
• You may feel numbness - you may lose feeling in your skin to pain and touch
• You may be sick, have stomach pain, indigestion, constipation, bloating, and gas
• Kidney function tests may show changes
• You may feel agitated or have difficulty sleeping
• Dizziness
• There is a risk of anaemia - changes in red blood cells after an operation that can cause tiredness and difficulty breathing
• You may have a sore throat or difficulty breathing (shortness of breath)
• You may have itchy skin
• You may urinate less than usual
• Dry socket (inflammation and pain after a tooth extraction)
• Increased sweating
• Decrease in potassium levels in blood tests

Uncommon: may affect up to 1 in 100 people

• Heart attack
• There is a risk of stroke, or transient ischaemic attack, or mini-stroke, or angina, or blockage of the blood vessels that supply the heart or brain
• Blood clots in the lungs
• Worsening of high blood pressure
• Stomach ulcers, chronic acid reflux
• Your heart may beat more slowly
• Decrease in blood pressure when standing up

• Blood tests may show changes in liver function
• You may bruise easily due to a low platelet count in the blood
• Surgical wounds may become infected, may have abnormal discharge
• Discoloration of the skin (bruising)
• Complications in wound healing after an operation
• Blood tests may show high levels of sugar
• Pain or reaction at the injection site
• Rash, or increased rash with itching (urticarial rash)
• Anorexia (loss of appetite)
• Pain in the joints
• High levels of enzymes in the blood in blood tests that indicate damage or stress to the heart, brain, or muscle tissue
• Dry mouth
• Muscle weakness
• Ear pain
• Abnormal bowel sounds

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

• Rash or ulceration that can appear anywhere on 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, and tongue, wheezing, difficulty breathing, or swallowing (which can be fatal)
• Swelling, blisters, or peeling of the skin
• Acute kidney failure
• Hepatitis (inflammation of the liver)
• Inflammation of the throat (oesophagus)
• Inflammation of the pancreas (which can cause stomach pain)

Not known: frequency cannot be estimated from the available data

• Collapse due to a severe drop in blood pressure
• Heart failure
• Kidney failure
• Fast or irregular heartbeats
• Difficulty breathing

Reporting of side effects

If you experience 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 the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dynastat

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 label of the vial after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions before reconstitution.

It is recommended that Dynastat should be used as soon as possible after mixing with the solvent, although it can be stored if the instructions at the end of the leaflet are strictly followed. The injection solution should be a clear and colourless liquid. The solution must not be used if there are particlesin the injection solution or if the powder or solution is discoloured.

6. Container Content and Additional Information

Dynastat Composition

• 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 9 mg/ml (0.9%) sodium chloride solution, Dynastat contains approximately 0.44 mEq of sodium per vial.

• The other components are:

Powder

Disodium hydrogen phosphate

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

Solvent

Sodium chloride

Hydrochloric acid or sodium hydroxide (for pH adjustment)

Water for injectable preparations.

Product Appearance and Container Content

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

The powder is contained in colorless glass vials (5 ml) with a stopper, sealed with a purple flip-offcap, over the aluminum closure.

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

Marketing Authorization Holder and Manufacturer

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

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

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the last revision of this leaflet: 01/2024.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals.