Naproxen Apofri 250 mg Naproxen tablets
What Naproxen Apofri Is And What Naproxen Apofri Used For
Naproxen Apofri is an anti-inflammatory and analgesic medicine. Naproxen Apofri belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). These work by reducing the formation of so-called prostaglandins that cause pain and inflammation in the body.
Naproxen Apofri is used for temporary mild to moderate acute pain, e.g.
- Headache
- Toothache
- Muscle and joint pain
- Back pain
- Menstrual pain in adults and adolescents from 12 years.
Naproxen Apofri can also be used in acute migraine attacks in adults. Naproxen in Naproxen Apofri may also be approved for treating other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before You Use Naproxen Apofri
Do Not Use Naproxen Apofri
- If you are allergic to naproxen or any other ingredients of naproxen Apofri (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 pain/inflammation medicines in the NSAID group
- 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 severe liver or kidney disease
- If you have severe heart failure
- During the last three months of pregnancy
Warnings And Cautions
Talk to your doctor or pharmacist before using Naproxen Apofri.
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
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 the combination of several NSAIDs at the same dose should be avoided.
Talk to your doctor before using Naproxen Apofri 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
- Impaired renal function or liver function
- Heart failure
- High blood pressure
- Gastric ulcer or duodenal ulcer
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.
Naproxen Apofri can, in rare cases, affect the white blood cells so that the immune system deteriorates. 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.
Severe skin reactions when using NSAIDs have been reported in very rare cases. Stop taking Naproxen Apofri and consult a doctor if you get a rash or damage to the mucous membranes.
For chickenpox, naproxen apofri should not be used.
Naproxen may temporarily make it difficult for you to get pregnant during use. Talk to your doctor if you are planning to become pregnant or have problems getting pregnant (see Pregnancy, breastfeeding, and fertility ).
Medicines such as Naproxen Apofri 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 How to use Naproxen Apofri).
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
Children under 12 years of age or weighing less than 50 kg should not be treated with Naproxen Apofri.
Other Medicines And Naproxen Apofri
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 Apofri, for example, medicines for:
- Blood clots (eg ticlopidine, warfarin , clopidogrel, acetylsalicylic acid )
- Bipolar disorder (lithium)
- Cancer and disorders of the immune system (methotrexate)
- High blood pressure and heart failure (so-called beta-receptor blockers, ACE inhibitors, angiotensin II antagonists, diuretics )
- Organ rejection after transplantation (immunosuppressive drugs eg cyclosporine, tacrolimus)
- Gout (probenecid)
- Depression (so-called SSRIs, eg fluoxetine, sertraline, paroxetine ecitalopram, citalopram )
- Pain such as acetylsalicylic acid , ibuprofen and diclofenac
- Swelling and inflammation such as prednisolone and dexamethasone
Naproxen Apofri With Food, Drink And Alcohol
The effect is not reduced but can be delayed somewhat if Naproxen Apofri is taken 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.
Treatment during any part of the pregnancy should only be given as prescribed by a doctor. Pregnant women should not use Naproxen Apofri during the last three months of pregnancy. Taking Naproxen Apofri should be avoided by women who are planning to become pregnant or are pregnant. Naproxen can make it harder to get pregnant. You should inform your doctor if you are planning to become pregnant or have problems getting pregnant.
Naproxen passes into breast milk and should not be used during breastfeeding.
Driving And Using Machines
During treatment with Naproxen Apofri, some people may be less able to react. This should be considered when sharper attention is required, eg when driving a car.
You are responsible for assessing whether you can 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 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 Apofri Contains Lactose Monohydrate And Sodium
The drug contains lactose monohydrates. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Naproxen apofri contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. It is next to “sodium-free”.
How To Use Naproxen Apofri
- Always use this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Adults and adolescents from 12 years weighing over 50 kg:
- Temporary pain
- 1 tablet (250 mg) as needed, but not more than 2 tablets (500 mg) per day. Contact a doctor if Naproxen Apofri has not helped your pain within 5 days.
- Adults:
- 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. Contact a doctor if Naproxen Apofri has not helped your migraine within 3 days.
- In case of acute migraine attacks
- The notch is not intended for splitting the tablet.
If You Use More Naproxen Apofri Than You Should
If you have ingested too much medicine or if, e.g. a child ingested the medicine accidentally, contact a doctor or hospital.
If You Forget To Use Naproxen Apofri
- Do not take a double dose to make up for a forgotten tablet.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Naproxen Apofri Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop taking Naproxen Apofri and see a doctor or emergency department immediately if you experience the following symptoms:
- Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing.
- Extremely severe allergic reaction with skin rash is usually in the form of blisters or sores in the oral cavity, eyes, and other mucous membranes such as genitals.
- Fever with severe general deterioration or fever with local symptoms of infection such as sore throat/throat/mouth or difficulty urinating.
These rare side effects may affect up to 1 in 1,000 people.
Common naproxen Apofri side effects (may affect up to 1 in 10 people):
- Abdominal pain
- Heartburn
- Nausea
- Diarrhoea
- Constipation
- Inflammation of the mouth
- Rash
- Superficial wounds in the skin
- Drowsiness
- Headache
- Dizziness
- Thirst
- Sweating
- Tinnitus
- Visual disturbances
- Fluid retention in the body ( edema )
- Palpitation
Uncommon (may affect up to 1 in 100 people):
- Respiratory distress
- Asthma
- Hives
- Skin changes (increased pigmentation or blisters) due to increased photosensitivity
- Inflammation and sores in the mouth
- Inflammation of the lining of the stomach
- Gastric bleeding and gastric ulcer
- Fever
- Hair loss
- Liver effects
- Renal impact
- Hearing loss
- Insomnia
- Concentration difficulties
Rare naproxen apofri side effects (may affect up to 1 in 1,000 people):
- Cramps
- Muscle weakness
- Blood count changes
- “Broken stomach ulcer”
- Inflammation of the colon
- Vomiting
- Inflammation of the oesophagus
- Gas formation
- Inflammation of the lining of the stomach
- Inflammation of the pancreas
- Severe skin reactions with inflammation and high fever
- Pneumonia
- Inflammation of the liver
- Blood in the urine or faeces
- Memory disorders
- Depression
- Nightmares
- Muscle pain
- Slight anxiety
- Meningitis
- Vascular wall inflammation
- Heart failure
- High blood pressure
- Fluid accumulation in the lungs
- Elevated levels of potassium in the blood
- Worsening of colitis and Chron´s disease
A few isolated cases of elevated liver enzyme levels are known.
Naproxen Apofri prolongs bleeding time.
In rare cases, severe skin infections are associated with chickenpox.
Medicines such as Naproxen Apofri may cause a small increased risk of heart attack or stroke.
How To Store Naproxen Apofri
- Keep this medicine out of sight and reach of children.
- No special storage instructions.
- Do not use this medicine after the expiry date stated on the carton after EXP. and after 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 that are 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 hydroxypropyl cellulose, microcrystalline cellulose, magnesium trisilicate, croscarmellose sodium, anhydrous colloidal silica, lactose monohydrate, magnesium stearate, and yellow iron oxide.
What The Medicine Looks Like And Contents Of The Pack
- The tablets are round, yellow, and flat with a bevelled edge. Diameter 10 mm and marked “250” on one side and a notch on the other. The notch is not intended for splitting the tablet.
- Pack sizes: 10 and 20 tablets (pressure packs).
- Not all packaging may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
182 12 Danderyd
Information is provided by
Apofri AB
Box 120
182 12 Danderyd
Phone: 08-544 960 30
Email: info@apofri.se
Manufacturer
Santa SA
Size Panselelor No. 25/27/29
Brasov, Jud. Brasov, 500419
Romania