250 mg naproxen tablets
What Pronaxen is and what it is used for
Pronaxen is a painkiller, antipyretic and anti-inflammatory drug. Pronaxen belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These work by reducing the formation of so-called prostaglandins (painkillers) in the body. The full effect is achieved after about 2 hours.
Pronaxen is used in adults and children over 12 years of age for temporary mild to moderate acute pain, such as headaches, acute attacks of migraine, toothache, muscle, and joint pain, back pain, and for colds, and menstrual pains. Pronaxen 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. You must talk to a doctor if you do not feel better or if you feel worse after 3 days with fever or migraine and after 5 days with pain.
Naproxen, which is found in Pronaxen, may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pronaxen
Do not use Pronaxen
- if you are allergic to naproxen, sodium naproxen, or any of the other ingredients of this medicine
- if you have previously had allergic reactions such as asthma, runny nose, or rash after taking painkillers containing acetylsalicylic acid or other pain/inflammation medicines in the NSAID group (non-steroidal anti-inflammatory drugs)
- 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 severe liver or kidney disease, severe heart failure, or an increased tendency to bleed
- during the last 3 months of pregnancy.
Warnings and cautions
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Talk to your doctor or pharmacist before taking Pronaxen.
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.
If you have or have had the following diseases, you should consult a doctor before starting treatment with Pronaxen:
- gastric ulcer or duodenal ulcer
- inflammatory bowel diseases or other gastrointestinal diseases (e.g.
- ulcerative colitis, Crohn’s disease )
- asthma
- heart failure
- high blood pressure
- kidney or liver disease
- diseases with an increased tendency to bleed
- SLE (connective tissue disease).
Children under 12 years of age should not be treated with Pronaxen.
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 problems with the gastrointestinal tract, especially elderly patients, should contact a doctor in case of symptoms from the abdomen.
Pronaxen 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 Pronaxen and contact a doctor immediately if swelling e.g. face, tongue, and/or throat and/or difficulty swallowing or hives that occur with difficulty breathing ( angioedema ).
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Pronaxen 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. Talk to your doctor if you are planning a pregnancy or if you have problems getting pregnant.
Medicines such as Pronaxen 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 (see section 3 How to take Pronaxen).
Talk to your doctor or pharmacist about your treatment if you have heart problems, if you have had a stroke before, or if you have an increased risk of these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or if you smoke).
Other medicines and Pronaxen
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.
Pronaxen may affect or be affected by certain medicines. Avoid taking Pronaxen at the same time as medicines containing any of the following active substances:
- high-dose methotrexate (anti-cancer and anti-inflammatory drugs)
- warfarin and ticlopidine ( anticoagulants (liver), corticosteroids (anti-inflammatory drugs)
- other agents for fever and pain (eg acetylsalicylic acid, other NSAIDs )
Talk to your doctor before using Pronaxen at the same time as medicines containing any of the following active substances. Dosage one of these may then need to be changed:
- ACE inhibitors, angiotensin II antagonists, beta -blocker blockers, loop diuretics, and thiazide derivatives (antihypertensive agents and certain diuretics)
- acetylsalicylic acid to prevent blood clots
- ciclosporin and tacrolimus (lowers the immune system)
- lithium (for manic depression / bipolar disorder)
- low-dose methotrexate (anti-cancer and anti-inflammatory drugs)
- probenecid (anti-gout)
- clopidogrel (for blood clots)
- SSRIs (so-called selective serotonin reuptake inhibitors, used for depression, among other things)
The effect of Pronaxen can be delayed if you take it at the same time as cholestyramine (lowers blood fats) or antacids (anti-acidic agents).
Pronaxen with food, drink, and alcohol
The effect of Pronaxen may be delayed if you take it 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.
Pregnant women should not use Pronaxen during the last three months of pregnancy. Taking Pronaxen 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.
Promax passes into breast milk but is unlikely to affect the breast-fed baby.
Driving and using machines
During treatment with Pronaxen, the ability to react may be reduced in some patients. 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 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.
Pronaxen contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pronaxen.
How to use Pronaxen
Adults
In case of fever or pain: 1 tablet (250 mg) if needed, but not more than 2 tablets (500 mg) per day (24 hours).
Without a doctor’s prescription, Pronaxen should be used for a maximum of 5 consecutive days in case of pain and 3 consecutive days in case of fever. Contact a doctor if symptoms worsen or do not improve.
In case of acute migraine attacks: 3 tablets (750 mg) in case of the onset of seizures, then 1 tablet (250 mg) if necessary, but not more than 5 tablets (1250 mg) on the first day, then no more than 4 tablets (1000 mg) per day. Contact a doctor if Pronaxen has not helped with your migraine within 3 days.
Children over 12 years
In case of fever or pain: 1 tablet (250 mg) if needed, but not more than 2 tablets (500 mg) per day (24 hours).
Without a doctor’s prescription, Pronaxen should be used for a maximum of 5 consecutive days in case of pain and 3 consecutive days in case of fever. Contact a doctor if symptoms worsen or do not improve.
Do not exceed the recommended dose or treatment time, as the risk of side effects increases. Ask your doctor or pharmacist if you are unsure.
Swallow the tablet together with the liquid. The tablet can be divided into two equal doses.
If you use more Pronaxen than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- Drowsiness, dizziness, headache,
- Thirst,
- Fluid retention ( edema ),
- Palpitation. Acid reflux, abdominal pain, nausea, diarrhea, constipation, heartburn, and inflammation of the mouth.
- Sweating, rash, superficial skin ulcers.
- Visual disturbances.
- Tinnitus.
Uncommon (may affect up to 1 in 100 people):
- Fever.
- Bleeding, rupture, inflammation, or ulcers in the gastrointestinal tract.
- Hair loss, hives, and photosensitivity cause inflammation in the skin.
- Liver effects.
- Asthma, shortness of breath.
- Difficulty sleeping, difficulty concentrating.
- Kidney impact.
- Hearing loss.
Rare (may affect up to 1 in 1,000 people):
- Allergic reactions (from the skin, mucous membranes, and respiratory tract) such as angioedema (see Take special care with Pronaxen).
- Cramps, muscle weakness, muscle pain,
- Blood count changes e.g. agranulocytosis (see Take special care with Pronaxen)
- Vascular inflammation, high blood pressure,
- Heart failure, fluid accumulation in the lungs
- Meningitis
- Severe skin reaction with inflammation and high fever
- Liver inflammation
- Allergic pneumonia
- An elevated amount of potassium or sugar in the blood
- Mental disorders such as mild anxiety, depression, nightmares
- Blood in the urine
- Inflammation of the colon, rupture of the gastrointestinal wall, vomiting, black stools, inflammation of the esophagus, flatulence, inflammation of the lining of the stomach, vomiting of blood, worsening of colitis, and Crohn’s disease.
Very rare (may affect up to 1 in 10,000 users):
- Severe hypersensitivity reactions including anaphylaxis
- Inflammation of the pancreas
- Severe skin reactions, e.g. Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis.
In rare cases, severe skin infections are associated with chickenpox.
Medicines such as Pronaxen may cause a small increased risk of heart attack or stroke.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Pronaxen
Keep this medicine out of the sight and reach of children.
Blister: Do not store above 30 ° C. Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton (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. 1 tablet contains 250 mg.
The other ingredients are lactose monohydrate, corn starch, gelatin, talc, magnesium stearate, and sodium starch glycolate.
What the medicine looks like and the contents of the pack
The tablets are white, round, cupped with a notch, diameter of 11 mm.
Pack sizes: 10 tablets and 20 tablets (print packs)
Not all pack sizes may be marketed
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com