Naprocur 250 mg and Naprocur 500 mg Enteric Tablets are Naproxen
What Naprocur Is And What It Is Used For
Naprocur has analgesic, anti-inflammatory, and antipyretic properties. The Naprocur tablets are coated with a layer that protects the tablet from gastric juice so that it dissolves in the intestine instead.
Naprocur is used for non-inflammatory joint changes ( osteoarthritis ) as well as inflammatory joint diseases and spinal stiffness ( rheumatoid arthritis, Bechterew’s disease).
The Naprox contained in Naprocur may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions and follow their instructions.
What You Need To Know Before Using Naprocur
Do Not Use Naprocur
- If you are allergic to Naprocur Naproxen or any of the other ingredients of this medicine (listed in section 6).
- If you have previously had allergic reactions such as asthma, runny nose, or rash when you have taken painkillers containing acetylsalicylic acid or other ‘non-steroidal anti-inflammatory drugs ‘ ( NSAIDs ).
- If you have an increased tendency to bleed
- If you have or have had recurrent stomach ulcers or duodenal ulcers
- If you have had stomach ulcers or duodenal ulcers during treatment with naproxen or ‘non-steroidal anti-inflammatory drugs ( NSAIDs )
- If you have cirrhosis ( liver cirrhosis )
- If you have severe heart failure
- If you have severe kidney disease
- The last three months of pregnancy
Warnings And Cautions
Talk to your doctor or pharmacist before taking Naprocur.
The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects. In general, higher doses than recommended can lead to risks. This also means that the combination of several NSAIDs at the same dose should be avoided.
If you have or have had the following diseases, you should consult a doctor before starting treatment with Naprocur:
- Gastric ulcer or duodenal ulcer
- Inflammatory bowel diseases such as
- Ulcerative colitis
- Crohn’s disease
- Asthma
- Diseases with an increased tendency to bleed
- SLE (Systemic lupus erythematosus, a connective tissue disease)
- High blood pressure
- Heart failure
- Kidney or liver disease.
Naprocur Uses
- Elderly people should be aware of the increasing risk of side effects that exist in old age.
- Especially at the beginning of treatment, patients who have previously had problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of symptoms from the abdomen.
- Drugs such as Naprocur 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 (for example, if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
- Naprocur can in rare cases affect the white blood cells so that the defense of 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.
- Stop taking Naprocur and contact a doctor immediately if swelling of e.g. a. face, tongue and/or throat and/or difficulty swallowing or hives that occur together with difficulty breathing ( angioedema ).
- Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Naprocuroch and consult a doctor if you get a rash or damage to the mucous membranes.
- For chickenpox, this medicine should not be used.
- The use of Naprocur, like all medicines that inhibit cyclooxygenase/prostaglandin synthesis, may make it difficult for you to get pregnant. Tell your doctor if you are planning to become pregnant or if you have problems getting pregnant.
Other Medicines And Naprocur
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Naprocur may affect or be affected by certain medicines (containing the following substances):
- Blood clots eg
- Warfarin
- Ticlopidine
- Clopidogrel
- Acetylsalicylic acid
- Cancer
- Methotrexate
- Disorders of the immune system
- Methotrexate
- Depression (so-called SSRIs – selective serotonin reuptake inhibitors)
- Gout
- Probenecid
- High blood pressure eg
- So-called beta-receptor blockers
- Diuretics
- ACE inhibitors
- Angiotensin II inhibitors
- Inflammation
- Corticosteroids are
- Manic depression
- Lithium
- Pain
- So-called NSAIDs
- Acetylsalicylic acid
- Rejection of organs after transplantation
- Cyclosporine
- Tacrolimus
- High blood fats
- Cholestyramine
- Acid reflux
- Antacids
Naprocur With Food And Drink
The effect of Naprocur may be delayed if taken concomitantly with food.
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.
Taking Naprocur 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.
Naprocur passes into breast milk but is unlikely to affect the breastfeeding baby.
Driving And Using Machines
During treatment with Naprocur, in some patients, the ability to react may be reduced. This should be taken into account when sharper attention is required e.g. while driving.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform risky work. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Naprocur Contains Sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
3. How To Use Naprocur
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.
- Rheumatic diseases : Adults: 1 tablet of 250 or 500 mg morning and evening. The maximum dose is 1000 mg per day.
- The tablets should be swallowed whole.
- If you have the impression that the effect of Naprocur is too strong or too weak, talk to your doctor or pharmacist.
If You Use More Naprocur Than You Should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital for risk assessment and advice.
If You Forget To Use Naprocur
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Naprocur Side Effects
Like all medicines, Naprocur can cause side effects, although not everybody gets them.
Stop taking Naprocur and contact a doctor immediately if you experience:
- Swelling of i.a. a. face, tongue, and/or throat and/or difficulty swallowing or hives that occur together with difficulty breathing ( angioedema ).
- Skin rash or damage to the mucous membranes.
Common Naprocur side effects (affects more than 1 patient in 100):
- Drowsiness
- Thirst
- Dizziness
- Sweating
- Palpitations
- Headache
- Digestive problems
- Abdominal pain
- Nausea
- Constipation
- Heartburn
- Inflammation of the mouth
- Diarrhea
- Fluid retention
- Skin rash
- Superficial skin ulcers
- tinnitus
- Visual disturbances.
Uncommon (affects less than 1 patient in 100):
- Fever
- Stomach ulcer
- Gastrointestinal bleeding
- Sore inflammation of the oral mucosa
- Inflammation of the lining of the stomach
- Hives
- Photosensitivity that causes inflammation in the skin
- Liver effects
- Asthma
- Shortness of breath
- Difficulty falling asleep
- Concentration difficulties
- Kidney effects
- Hair loss
- Hearing loss
Rare (affects less than 1 patient in 1,000):
- Stretch marks in the gastrointestinal wall
- Hepatitis
- Inflammation of the esophagus
- Inflammation of the colon
- Vomiting
- Vomiting blood
- Weather voltage
- Worsening of certain inflammatory bowel diseases
- Colitis
- Crohn’s disease
- Fluid accumulation in the lungs
- Pneumonia
- Meningitis
- Pancreatitis
- Severe skin reaction with inflammation and high fever
- Hypersensitivity reaction with symptoms such as swelling of the face due to fluid retention ( angioedema see “Warnings and precautions”)
- Cramps
- Muscle weakness
- Muscle pain
- Effects on blood count (eg agranulocytosis see “Warnings and precautions”)
- Increased amount of potassium in the blood
- Inflammation of the blood vessels
- Heart failure
- High blood pressure
- Bloody stools
- Blood in the urine
- Depression
- Slight anxiety
- Nightmares
Drugs such as Naprocur may cause a small increased risk of heart attack or stroke.
In rare cases, severe skin infections are associated with chickenpox.
How To Store Naprocur
- Keep this medicine out of the sight and reach of children.
- Store in the original package. Sensitive to light. Used before the expiration date specified after the Expiration Date. on the outer carton and EXP on the blister. 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 naproxen.
- Other excipients are
- Povidone
- Crushed caramel sodium
- Magnesium stearate
- Methacrylic acid-ethyl acrylate copolymer
- Polysorbate 80
- Sodium lauryl sulfate
- Triethyl citrate
- Talc
- Simethicone
What The Medicine Looks Like And Contents Of The Pack
- Entero-tablet 250 mg: White or almost white, round, cupped tablet with a diameter of 10 mm.
- Entero-tablet 500 mg: White or almost white, round, cupped tablet with a diameter of 13 mm.
- Pack sizes, blisters: 10, 20 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400 and 500 tablets
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer
Adamed Pharma SA
5 Marszalka J.Pilsudskiego Str
95-200 Pabianice
Poland