250 mg
naproxen
What Naprosyn Entero is and what it is used for
Naprosyn Entero has analgesic, anti-inflammatory and antipyretic properties. Naprosyn Entero tablets are coated with a layer that protects the tablet from gastric juice so that it dissolves in the intestine instead.
Naprosyn Entero is used for non-inflammatory joint changes ( osteoarthritis ) as well as inflammatory joint diseases and spinal stiffness ( rheumatoid arthritis, Bechterew’s disease).
What you need to know before using Naprosyn Entero
Do not take Naprosyn Entero
– if you are allergic to 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 similar preparations.
– 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 similar preparations
– 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
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 Naprosyn Entero:
gastric ulcer or duodenal ulcer
– inflammatory bowel diseases (such as ulcerative colitis, Crohn’s disease )
asthma – diseases with an increased tendency to bleed
– SLE (connective tissue disease)
– high blood pressure
– heart failure
– kidney or liver disease
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 gastrointestinal problems, especially elderly patients, should contact a doctor in case of abdominal symptoms.
Medicines such as Naprosyn Entero may cause a slight increase in the 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).
Naprosyn Entero 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 information about your medication.
Stop taking Naprosyn Entero 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 Naprosyn Entero 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 naproxen, 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.
Naprosyn Entero with food and drink
The effect of Naprosyn Entero may be delayed if taken concomitantly with food
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Taking Naprosyn Entero 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.
Naproxen passes into breast milk but is unlikely to affect the breast-fed baby.
Driving and using machines
During treatment with Naprosyn Entero, in some patients, the reactivity may be reduced. This should be taken into account when sharper attention is required, for example when driving a car.
Other drugs and Naprosyn Entero
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
– Acetylsalicylic acid to prevent blood clots
Naprosyn Entero may affect or be affected by certain medicines (containing the following substances):
– blood clots (eg warfarin, ticlopidine, acetylsalicylic acid )
– cancer (methotrexate)
– disorders of the immune system (methotrexate)
– depression (so-called SSRIs )
– 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)
How to take Naprosyn Entero
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: 250-500 mg morning and evening. The maximum dose is 1000 mg per day.
If you have the impression that the effect of Naprosyn Entero is too strong or too weak, talk to your doctor or pharmacist.
If you take more Naprosyn Entero than you should
If you have taken too much Naprosyn Entero, always contact a doctor, hospital.
If you forget to use Naprosyn Entero
Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (more than 1 in 100 patients): Drowsiness, thirst, dizziness, sweating, palpitations, headache, digestive problems, abdominal pain, nausea, constipation, heartburn, inflammation of the mouth, diarrhea, fluid retention, rash or superficial skin ulcers, tinnitus, visual disturbances.
Uncommon (less than 1 in 100 patients): Fever, gastric ulcer, gastrointestinal bleeding, inflammation of the lining of the stomach, hives , photosensitivity that causes inflammation of the skin, liver effects, asthma, shortness of breath, difficulty falling asleep, difficulty concentrating, kidney effects, hair loss, hearing loss.
Rare (less than 1 in 1000 patients): Flatulence, gastritis, inflammation of the esophagus, inflammation of the colon, vomiting, vomiting, flatulence, worsening of certain inflammatory bowel diseases ( colitis and Crohn’s disease ), accumulation of fluid 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 Take special care with Naprosyn Entero), cramps, muscle weakness, muscle pain, blood clots (eg agranulocytosis see Take special care with Naprosyn Entero), increased amount of potassium in the blood, inflammation of the blood vessels, heart failure, high blood pressure, bloody stools, blood in the urine, depression, mild anxiety, nightmares,
Medicines such as Naprosyn Entero may cause a slight increase in the risk of heart attack or stroke.
In rare cases, severe skin infections are associated with chickenpox.
Inflammation, bleeding (sometimes fatal, especially in the elderly), gastric ulcer, rupture, and obstruction of the upper or lower gastrointestinal tract may occur during treatment with Naprosyn Entero.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below).
By reporting side effects, you can help increase drug safety information.
Läkemedelsverket Box 26
751 03 Uppsala
www.lakemedelsverket.se
How to store Naprosyn Entero
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton.
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 250 mg and 500 mg per tablet respectively.
The other ingredients are croscarmellose sodium, magnesium stearate, povidone, talc, sodium hydroxide, triethyl citrate, eudragit L (anionic copolymer of ethyl acrylate, methacrylic acid, sodium lauryl sulfate (0.7%), polysorbate 80 (2.3%)), and Op labeling blue -17823 (shellac, black iron oxide, propylene glycol).
What the medicine looks like and contents of the pack
Naprosyn Entero 250 mg are white, round, cupped, marked “NPR EC 250” in black on one side.
Naprosyn Entero 500 mg are white, oval, marked “NPR EC 500” in black on one side.
The 250 mg enteric tablets are supplied in blisters containing 100 tablets.
The 500 mg enteric tablets are supplied in blisters containing 100 tablets.
Marketing Authorisation Holder
Atnahs Pharma Netherlands BV
Strawinskylaan 3127
1077 ZX Amsterdam
The Netherlands
Local representative
Pharmanovia A / S
Copenhagen Towers,
Ørestads Boulevard 108
DK-2300 Copenhagen S
Denmark