250 mg naproxen tablets
What Naproxen Mylan is and what it is used for
Naproxen Mylan is a painkiller, antipyretic and anti-inflammatory drug. Naproxen Mylan belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
Adults and adolescents from 12 years (over 50 kg):
Naproxen Mylan is used for temporary, mild to moderate pain conditions, e.g. headache, toothache, muscle and joint pain, back pain. Period pain. Fever with a cold.
Adults from 18 years:
Naproxen Mylan can also be used in acute migraine attacks in adults.
Naproxen contained in Naproxen Mylan may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Naproxen Mylan
Do not take Naproxen Mylan:
- if you are allergic to naproxen , sodium 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 medicines for pain / inflammation within the group NSAIDs (non-steroidal anti-inflammatory drugs).
- If you have an increased tendency to bleed, active stomach ulcer or duodenal ulcer.
- If you have had stomach ulcers or duodenal ulcers during treatment with naproxen or similar preparations
- If you have had recurrent stomach ulcers or duodenal ulcers
- If you have severe hepatic impairment, severe heart failure or severe kidney disease.
- During the last three months of pregnancy.
Warnings and cautions
| Higher doses than those recommended can lead to serious risks. Do not use different types of painkillers at the same time without a doctor’s prescription. |
The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects. Higher doses than those recommended can lead to serious 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 Naproxen Mylan:
- Gastric ulcer or inflammatory bowel disease ( ulcerative colitis , Crohn’s disease ), asthma , diseases with increased bleeding tendency, SLE (connective tissue disease), heart failure , high blood pressure , kidney disease or liver disease.
For chickenpox, this medicine should not be used.
Elderly people should be aware of the increased 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 consult a doctor in case of abdominal symptoms.
Naproxen Mylan 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 Naproxen Mylan 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 Naproxen Mylan and consult a doctor if you get a rash or damage to the mucous membranes.
Using naproxen may make it difficult for you to get pregnant. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant.
Medicines such as Naproxen Mylan may have 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 (see section 3 How to take Naproxen Mylan).
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).
Children and young people
Naproxen Mylan should not be used by children under 12 years of age without a doctor’s prescription.
Naproxen Mylan should not be used in adolescents over 12 years of age who weigh less than 50 kg without a doctor’s prescription.
Other medicines and Naproxen Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not use several different painkillers at the same time without a doctor’s prescription.
Naproxen Mylan 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 )
- organ rejection after transplantation (cyclosporine, tacrolimus)
- high blood fats (cholestyramine)
- acid reflux (antacids)
Naproxen Mylan with food and drink:
The effect is not reduced but can be delayed slightly if Naproxen Mylan is taken with food.
Pregnancy and breastfeeding
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.
Pregnant women should not use Naproxen Mylan during the last three months of pregnancy. Taking Naproxen Mylan 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 Mylan passes into breast milk but is unlikely to affect the breast-feeding baby. Talk to your doctor if you need more than temporary use of Naproxen Mylan while breastfeeding.
Driving and using machines
During treatment with Naproxen Mylan, some people may be less able to react. This should be taken into account when sharper attention is required, eg when driving a car.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Naproxen Mylan contains lactose and sodium
The drug contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Naproxen Mylan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Occasional mild to moderate pain and fever in case of cold
Adults and adolescents from 12 years (over 50 kg): 1 tablet if needed, but not more than 2 tablets (500 mg) per day.
Contact a doctor if the symptoms worsen or do not improve within 3 days in case of fever and 5 days in case of pain.
In case of acute migraine attacks
Adults from 18 years of age: 3 tablets at the onset of seizures, then 1 tablet if necessary, but not more than 5 tablets per day. Contact a doctor if Naproxen Mylan has not helped with your migraine within 3 days.
Adolescents from 12 years (over 50 kg):
If you think you have a migraine headache, consult a doctor.
If you take more Naproxen Mylan than you should:
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital by mistake for assessment of the risk and advice.
If you forget to take Naproxen Mylan:
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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects from the gastrointestinal tract such as dyspepsia, abdominal pain, and nausea are the most common side effects.
Common (more than 1 in 100 patients): Drowsiness, thirst, dizziness, sweating, palpitations, headache, indigestion, 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, hepatitis, inflammation of the esophagus, inflammation of the colon, vomiting, vomiting, flatulence, worsening of certain inflammatory bowel diseases ( colitis and 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 facial swelling due to fluid retention ( angioedema see Take special care with NaproxenMylan), seizures, muscle weakness, muscle aches, blood clots (eg agranulocytosis see Take special care with Naproxen Mylan), increased potassium in the blood, inflammation of the blood vessels, heart failure, high blood pressure, bloody stools, blood in the urine, depression, mild anxiety, nightmares.
Naproxen Mylan prolongs bleeding time.
Medicines such as Naproxen Mylan may have a small increased risk of heart attack or stroke.
In rare cases, severe skin infections are associated with chickenpox.
Inflammation, bleeding (sometimes fatal, especially in the elderly), stomach ulcers, rupture, and obstruction of the upper or lower gastrointestinal tract may occur during treatment with Naproxen Mylan.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Naproxen Mylan
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 after EXP. dat.:. 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 250 mg.
- The other ingredients are lactose monohydrate , corn starch, povidone, sodium starch glycolate, talc, magnesium stearate and polysorbate.
What the medicine looks like and contents of the pack:
Tablet 250 mg: a white, round, faceted tablet with a scoreline, diameter 10 mm, marked “Naproxen 250” on one side.
Pack sizes: 10 x 1 and 20 x 1 tablets in pressure pack (single dose). 10 and 20 tablets in a pressure pack.
Marketing Authorisation Holder:
Mylan AB
Box 23033
104 35 Stockholm
08-555 227 50
inform@mylan.se