Orudis Retard 200 mg Prolonged Release Ketoprofen Hard Capsule
What Orudis Retard Is And What Orudis Retard Used For
Orudis Retard is used in rheumatic diseases. Orudis Retard is anti-inflammatory, analgesic, and antipyretic. Orudis Retard belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory / anti-rheumatic medicines).
Orudis Retard relieves symptoms such as pain, swelling, tenderness, and stiffness by reducing the level of a group of substances in the body called prostaglandins.
Orudis Retard prolonged-release capsule contains the active substance in the form of many small grains that are not affected by gastric juice.
During the passage through the gastrointestinal tract, the drug is gradually released from the grains, which means that the effect remains for 24 hours.
The ketoprofen contained in Orudis Retard may also be approved for the treatment of other diseases not mentioned in this product information.
Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What You Need To Know Before Using Orudis Retard
Do Not Use Orudis Retard
- If you are allergic to Orudis Retard Ketoprofen or any of the other ingredients of this medicine (listed in section 6).
- If you have had a hypersensitivity reaction (eg symptoms such as bronchospasm ( bronchospasm ), asthma attacks, hay fever, hives or similar allergic reactions) when you have taken ketoprofen , acetylsalicylic acid or other anti- inflammatory drugs.
- If you have ongoing stomach ulcers or if you have previously had bleeding, ulcers or ruptured ulcers in the gastrointestinal tract.
- If you have an increased tendency to bleed, ongoing stomach ulcers or duodenal ulcers (or if you have previously had problems with stomach ulcers / bleeding) in connection with treatment with non-steroidal anti-inflammatory drugs).
- If you have severe liver function, severe heart failure or severe kidney disease.
- During the last three months of a pregnancy.
- Orudis Retard should not be given to children under 16 years of age.
Warnings And Cautions
Talk to your doctor or pharmacist before starting treatment with Orudis Retard if
you have:
- Gastric ulcer
- Asthma
- Disease with increased bleeding tendency
- Inflammatory bowel disease
- Heart failure
- Kidney disease
- Liver disease
- High blood pressure
- An infection – see the heading “Infections” below.
if you have previously had:
- Gastric ulcer
- SLE ( inflammatory connective tissue disease)
- If you are being treated with diuretics.
The risk of serious gastrointestinal side effects may be higher for Orudis Retard than for other NSAIDs, especially at high doses.
Medicines such as Orudis Retard may cause a small increased risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time.
Talk to your doctor or pharmacist about your treatment if you have heart problems, if you have had a stroke before, or if you think you have an increased risk of these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
In connection with the treatment of perioperative pain with NSAIDs in coronary artery surgery, an increased risk of cardiovascular side effects has been reported.
If you have problems with asthma combined with chronic inflammation of the nasal mucosa and sinuses and/or nasal polyps, you are more sensitive to acetylsalicylic acid or other anti-inflammatory drugs. Taking this medicine can cause an asthma attack or spasm of the trachea, especially if you are allergic to these substances.
If you have previously had problems with side effects from the gastrointestinal tract, you should be aware of unusual symptoms from the gastrointestinal tract when taking this medicine, especially at the beginning of treatment, in which case contact your healthcare provider.
The use of Orudis Retard (as well as all medicines that inhibit cyclooxygenase/prostaglandin synthesis) may make it difficult for you to get pregnant. Talk to your doctor if you are planning to become pregnant or if you have problems getting pregnant.
In general, higher doses of painkillers than recommended can lead to serious risks. The risk of side effects increases with increasing age.
Therefore, do not take a higher dose than your doctor prescribed and do not use different types of painkillers at the same time without asking a doctor.
Contact your doctor if visual disturbances, such as blurred vision, occur.
Infection is
Orudis Retard can hide signs of infection such as fever and pain. Therefore, Orudis Retard may delay the appropriate treatment of infection and increase the risk of complications.
This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox.
If you are taking this medicine while you have an infection and the symptoms of infection persist or worsen, you should contact your doctor immediately.
Children And Young People
Safety and efficacy have not been established for use in children under 16 years of age.
Other Medicines And Orudis Retard
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Orudis Retard may affect or be affected by certain medicines, or groups of medicines such as:
- Acetylsalicylic acid (used as a blood-thinning drug or for pain and inflammation ). May increase the risk of bleeding, the combination should be avoided.
- Other NSAIDs including selective cyclooxygenase -2 inhibitors (painkillers and anti- inflammatory drugs ). The combination should be avoided as these drugs may increase the risk of bleeding and may contribute to the occurrence of excessive levels of potassium in the blood.
- Warfarin , heparin , ticlopidine, clopidogrel, dabigatran, apixaban, rivaroxaban, edoxaban (blood thinners). May increase the risk of bleeding, the combination should be avoided. Heparin can also contribute to the formation of excessive levels of potassium in the blood.
- Lithium (used to treat certain mental conditions). Concomitant treatment may lead to elevated lithium levels in the blood.
- Methotrexate (used to treat cancer and disorders of the immune system). Concomitant treatment may lead to an increased risk of blood side effects.
- Corticosteroids (used for inflammation , among other things ). Concomitant treatment may increase the risk of bleeding.
- ACE inhibitors and angiotensin II inhibitors (used, for example, to treat high blood pressure or heart failure ). May contribute to the formation of excessive levels of potassium in the blood and affect kidney function.
- Some diuretics (eg furosemide , thiazides , potassium-sparing diuretics ). Concomitant treatment can, for example, affect kidney function, the diuretic effect or contribute to high levels of potassium in the blood.
- Potassium salts (used in the absence of potassium in the blood). May contribute to excessive levels of potassium in the blood.
- Ciclosporin and tacrolimus (used to suppress the immune system, eg after transplants). Concomitant treatment can contribute to the formation of excessive levels of potassium in the blood and affect kidney function.
- Pentoxifylline (used in circulatory disorders). Concomitant treatment may increase the risk of bleeding.
- Nikorandil (vasodilator). Concomitant treatment may increase the risk of, for example, bleeding.
- Cardiac glycosides such as digoxin (used in certain heart diseases).
- Tenofovir (used to treat HIV infections). Concomitant treatment may increase the risk of kidney problems.
- Trimethoprim (medicines used to treat infections ). May contribute to excessive levels of potassium in the blood.
- Selective serotonin reuptake inhibitors ( SSRIs , used for example in various types of depressive disorders). Concomitant treatment may increase the risk of bleeding.
- Beta-blockers (used for example for the treatment of high blood pressure or angina).
- Probenecid (used for gout ).
- Drugs used to dissolve blood clots ( thrombolytics ).
As certain other medicines may also affect or be affected by the treatment with Orudis Retard, the treating physician needs to know of other concomitant treatments. Therefore, tell your doctor if you are taking other medicines.
Pregnancy, Breastfeeding And Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Ketoprofen should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Breast-feeding
It is not known whether the active substance in Orudis Retard passes into breast milk. Always consult a doctor before using Orudis Retard during breastfeeding.
Fertility
Using Orudis Retard may impair fertility and is not recommended if you wish to become pregnant.
Driving And Using Machines
Some people may have impaired reactivity from Orudis Retard. This should be borne in mind at times when sharper attention is required, for example when driving a car and precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.
One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Orudis Retard Contains Sucrose
Orudis Retard contains sugar spheres that contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How To Use Orudis Retard
- Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor immediately if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2).
- Dose one is determined by the doctor who adjusts it individually for you. The size of the dose depends on the nature and severity of the disease.
- The usual dose is 1 prolonged-release capsule daily. The capsules should be swallowed whole. Can be emptied but must not be chewed.
If You Use More Orudis Retard Than You Should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If You Forget To Take Orudis Retard
Do not take a double dose to make up for a forgotten capsule. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible Orudis Retard Side Effects
Like all medicines, Orudis Retard can cause side effects, although not everybody gets them.
Stop taking Orudis Retard and contact your doctor immediately or see your nearest emergency department you experience any of the following rare side effects:
- Swelling of the face, tongue, or throat; difficulty swallowing;
- Hives
- Difficulty breathing ( angioedema )
- Severe anaphylactic reaction including shock
- Tracheal spasm ( bronchospasm )
- Severe skin reactions such as:
- Skin effect with blisters
- Mucosa – and dermatitis
- Tissue loss
- Acute general rash with blisters
Orudis Retard can in rare cases affect the white blood cells so that the defense against infection deteriorates.
If you get an infection with symptoms such as fever with severe general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ).
It is important that you then have information about your medication.
Other side effects that may occur:
Common (may affect up to 1 in 10 people ) :
- Gastrointestinal disorders such as
- Heartburn
- Nausea
- Vomiting
- Abdominal pain
Uncommon (may affect up to 1 in 100 people):
- Headache
- Dizziness
- Fatigue and drowsiness
- Gastric ulcer
- Flatulence
- Inflammation of the lining of the stomach
- Diarrhea
- Constipation
- Itching
- Rash
- Edema
- Mild anxiety
Rare (may affect up to 1 in 1,000 people ) :
- Anemia due to bleeding, anemia due to reduced blood formation in the bone marrow
- Asthma , hives and severe skin reaction with inflammation and high fever
- Liver effects, increase in liver enzymes
- Weight gain
- Ant crawls
- Visual disturbances, blurred vision
- Tinnitus
- Inflammation of the oral mucosa, gastric ulcer , blood in the stool
Has been reported (occurs in an unknown number of users) :
- Blood effects and bone marrow failure. Decreased platelet production ( thrombocytopenia ) . Anemia due to increased degradation of red blood cells . Low white blood cell count
- Heart effect; worsening of heart failure
- Taste change
- Cramps
- Meningitis (not caused by bacteria)
- Hay fever
- Exacerbation of inflammation of the colon and of Crohn’s disease
- Bleeding in the stomach and intestines and possible perforation
- Inflammation of the pancreas
- Cases of worsening of previous renal impairment, abnormal renal function tests, acute renal failure , nephritis (nephritis)
- Occasional cases of skin reactions caused by sunlight have occurred
- Hair loss ( alopecia )
- High blood pressure
- Vasodilation. Vascular inflammation (even in the small blood vessels)
- Mood influence
- Depression
- Hallucination
- Confusion
- Decreased amount of sodium in the blood
Medicines such as Orudis may have a small increased risk of heart attack or stroke. Note that Orudis may prolong the bleeding time in case of injury.
How To Store Orudis Retard
- 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 can after EXP.
- The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content declaration
- The active substance is ketoprofen . One capsule contains 200 mg of ketoprofen .
- The other ingredients are sugar spheres (contains sucrose, see section 2 “Orudis Retard contains sucrose” for further information), colloidal silica, shellac, ethylcellulose, talc, erythrosine (dye E 127), titanium dioxide (dye E 171), gelatin (capsule shell).
What The Medicine Looks Like And Contents Of The Pack
- Orudis prolonged-release capsules are gelatin capsules and are available in the following pack sizes:
- 30 or 100 depot capsules in a plastic jar.
Marketing Authorisation Holder
Sanofi AB
Box 30052
104 25 Stockholm