250 mg naproxen tablets
What Naproxen Orifarm is and what it is used for
Naproxen Orifarm belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). They are anti-inflammatory, analgesic, and antipyretic. The anti-inflammatory effect is because naproxen reduces the formation of harmful substances ( prostaglandins ), which are formed during inflammation and in tissue damage. The analgesic effect is considered to be due to a similar mechanism. The full effect is achieved after about 2 hours.
Adults and adolescents from 12 years (over 50 kg):
Naproxen Orifarm 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 Orifarm can also be used in acute migraine attacks in adults.
Naproxen Orifarm can be used for short-term use for up to 5 days for the pain and 3 days for fever or migraine without a doctor’s consultation.
Naproxen contained in Naproxen Orifarm may also be approved for the treatment of other conditions 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 you use Naproxen Orifarm
Do not use Naproxen Orifarm
- 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 while taking painkillers containing acetylsalicylic acid or other pain / inflammation medicines in the NSAID group (non-steroidal anti-inflammatory drugs)
- if you have an increased tendency to bleed
- if you have stomach ulcers or duodenal ulcers
- 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
Talk to your doctor, pharmacist, or nurse before taking Naproxen Orifarm.
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. Do not use different types of painkillers at the same time without a doctor’s prescription.
Elderly people should be aware of the increased risk of side effects that exist in old age. A lower dose is recommended due to the increased risk of side effects.
Talk to your doctor before using Naproxen Orifarm if you have or have had any of the following conditions:
- inflammatory bowel diseases (such as ulcerative colitis , Crohn’s disease )
- diseases with an increased tendency to bleed
- SLE (connective tissue disease)
- asthma
- kidney or liver disease
- high blood pressure
- heart failure
- gastric ulcer or duodenal ulcer
- vigorous dehydration
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 Orifarm 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.
Stop taking Naproxen Orifarm 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 Orifarm and consult a doctor if you get a rash or damage to the mucous membranes.
The use of naproxen (like all medicines that inhibit cyclooxygenase/prostaglandin synthesis) may make it difficult to get pregnant. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant.
If you experience allergic reactions ( asthma, rash, swelling of the skin, mucous membranes or throat, photosensitivity reactions, etc.), treatment should be stopped and the treating physician should be contacted as soon as possible.
Medicines such as Naproxen Orifarm may increase 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).
For chickenpox, this medicine should not be used.
Children and young people
Do not use in children under 12 years of age without a doctor’s prescription.
Do not use in adolescents over 12 years of age weighing less than 50 kg without a doctor’s prescription.
Other medicines and Naproxen Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Some medicines may affect or be affected by treatment with Naproxen Orifarm, for example, some medicines:
- against blood clots (eg clopidogrel, ticlopidine, warfarin )
- to prevent blood clots ( acetylsalicylic acid )
- against manic-depressive illness (lithium)
- against tumors and disorders of the immune system (methotrexate)
- for high blood pressure and heart failure (beta-blocker drugs, diuretics , ACE inhibitors and angiotensin II receptor antagonists)
- against organ rejection (immunosuppressive drugs such as cyclosporine, tacrolimus)
- against gout (probenecid)
- for depression (so-called SSRIs )
- against inflammation and pain (other NSAIDs and acetylsalicylic acid )
- against inflammation ( corticosteroids are)
- which lowers blood fats (cholestyramine)
- mot sur mage (antacida).
Certain other medicines may also affect or be affected by treatment with Naproxen Orifarm.
Naproxen Orifarm with food and drink
The effect of Naproxen Orifarm may be delayed if you take it with food at the same time.
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.
Pregnancy
There is a risk of fetal harm. Pregnant women should not use Naproxen Orifarm during the last three months of pregnancy. Intake 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
Naproxen passes into breast milk but is unlikely to affect the breast-fed baby. Consult a physician if you need more than temporary use during breastfeeding.
Driving and using machines
Naproxen Orifarm can cause side effects (eg dizziness) that impair your ability to react. 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.
How to use Naproxen Orifarm
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Occasional mild to moderate pain and fever with cold
Adults and adolescents from 12 years (over 50 kg):
1 tablet if needed, however, no more than 2 tablets 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:
3 tablets in case of signs of incipient seizure, then 1 tablet if necessary, but not more than 5 tablets per day. Contact a doctor if Naproxen Orifarm 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.
Without a doctor’s prescription, Naproxen Orifarm should be used for a maximum of 5 consecutive days for the pain and 3 consecutive days for fever and migraine.
If you use more Naproxen Orifarm than you should
If you have taken too large a dose of medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Naproxen Orifarm
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Naproxen Orifarm and contact your doctor immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):
- Severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic shock )
- Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing ( angioedema , see Warnings and Precautions ).
- Serious skin reactions such as:
- an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes, as well as other mucous membranes such as genitals
- severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes)
- severe skin rash
- Blood count changes, i.a. agranulocytosis (see Warnings and Precautions )
Other side effects include:
Common (may affect up to 1 in 10 people ):
- Gastrointestinal side effects (stomach pain, heartburn, nausea, diarrhea, constipation, inflammation of the mouth)
- Skin rash, superficial sores on the skin
- Drowsiness, headache, dizziness
- Whisper in the ears
- Visual disturbances
- Fluid retention in the body, swelling ( edema ), thirst, sweating
- Palpitation
Uncommon (may affect up to 1 in 100 people):
- Allergic reactions ( hives , photosensitivity reaction)
- Bleeding from the stomach and intestines (possibly gastric ulcer ), sore inflammation of the oral mucosa
- Fever, hair loss
- Liver effects
- Kidney impact
- Asthma , shortness of breath
- Hearing loss
- Difficulty falling asleep and concentrating
Rare (may affect up to 1 in 1,000 people ):
- Cramps
- Muscle weakness, muscle pain
- “Broken stomach ulcer”, inflammation of the colon, vomiting, black stools, flatulence, inflammation of the lining of the stomach , worsening of ulcerative colitis or Crohn’s disease , inflammation of the pancreas
- Pneumonia
- Inflammation of the liver
- Blood in the urine
- Depression, nightmares, mild anxiety
- Meningitis
- Vascular inflammation, high blood pressure , fluid accumulation in the lungs
- Heart failure
- Elevated levels of potassium or sugar in the blood
In rare cases, severe skin infections are associated with chickenpox.
A few isolated cases of elevated liver enzyme levels are known.
Note that naproxen may prolong bleeding time.
Medicines such as Naproxen Orifarm may increase the risk of heart attack or stroke.
How to store Naproxen Orifarm
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 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 naproxen 250 mg per tablet.
- The other ingredients are povidone, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, croscarmellose sodium.
What the medicine looks like and contents of the pack
Naproxen Orifarm 250 mg tablets:
White, cylindrical, biplanar tablet with beveled edges. Break notch on one side and N250 embossed on the other, about 10 mm in diameter and 3.5 mm thick.
Pack sizes: Blister pack: 10, 20 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com