Naproxen Evolan 500 mg Naproxen Tablets
What Naproxen Evolan Is And What It Is Used For?
Naproxen Evolan is an anti-inflammatory and analgesic medicine. Naproxen Evolan belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
These reduce the formation of so-called prostaglandins that cause pain and inflammation. Naproxen Evolan is used for rheumatic diseases, menstrual cramps, acute migraine attacks, and mild to moderate acute pain.
Naproxen contained in Naproxen Evolan may also be approved for treating other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have further questions, and always follow their instructions.
What You Need To Know Before Using Naproxen Evolan?
Do Not Use Naproxen Evolan
- If you are allergic to naproxen or any other ingredients of naproxen evolan (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 Evolan.
| Never use several different painkillers simultaneously 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 combining several NSAIDs at the same dose should be avoided.
- Talk to your doctor before using Naproxen Evolan 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 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 Evolan 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 Evolan and talk to a doctor if you get a rash or damage to the mucous membranes.
- For chickenpox, naproxen evolan 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 Evolan 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 Evolan).
- 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 50 kg should not be treated with Naproxen Evolan, as doses of less than 250 mg are impossible. Naproxen Evolan is not recommended for children under 12 in acute pain conditions.
Other Medicines And Naproxen Evolan:
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 simultaneously without consulting a doctor or pharmacist. Some medicines may affect or be affected by treatment with Naproxen Evolan, 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, e.g., cyclosporine, tacrolimus)
- Gout (probenecid)
- Depression (so-called SSRIs , e.g., fluoxetine , sertraline , paroxetine ecitalopram, citalopram )
- Pain such as acetylsalicylic acid , ibuprofen and diclofenac
- Swelling and inflammation such as prednisolone and dexamethasone
Naproxen Evolan With Food And Drink:
The effect is not reduced but can be delayed slightly if Naproxen Evolan is taken with food.
Pregnancy, Breastfeeding And Fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking naproxen evolan.
Treatment during any part of the pregnancy should only be done after a doctor’s prescription. Pregnant women should not use Naproxen Evolan during the last three months of pregnancy. Taking Naproxen Evolan 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 Evolan, some people may be less able to react. This should be considered when sharper attention is required, e.g., 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 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 Evolan Contains Lactose Monohydrate And Sodium:
The drug contains lactose monohydrates. If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking naproxen evolan.
Naproxen evolan contains less than 1 mmol (23 mg) sodium per dose, i.e., essentially ‘sodium-free.’ It is next to “sodium-free.”
How To Use Naproxen Evolan?
Naproxen evolan uses
- Always take naproxen evolan precisely as your doctor or pharmacist 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. Do not exceed the prescribed dose, as the risk of side effects increases.
- The recommended dose is:
- The usual dose for adults with rheumatic diseases and acute pain is 250-500 mg morning and evening, no more than 1000 mg/day. In case of pronounced night and morning symptoms, taking a dose of 500 mg in the evening is advantageous. Some patients may benefit from taking 750-1000 mg once a day. In these cases, it is recommended that the tablets be taken in the evening.
- For menstrual pain, 250–500 mg if needed, but not more than 1250 mg/day. Treatment is started at the first sign of menstruation.
- In acute migraine, 750 mg at the first sign of a migraine attack. Afterward, 250 mg if needed, but not more than 1250 mg/day.
- The tablet can be divided into two equal doses.
Use For Children:
For children over 50 kg, an adult dose is given. It cannot be given to children under 50 kg, as doses of less than 250 mg are impossible. Naproxen Evolan is not recommended for children under 12 in acute pain conditions.
Elderly And People With Liver And Kidney Problems:
- A lower dose is recommended due to the increased risk of side effects. Your doctor will decide on a dose to suit you.
- If you have the impression that the effect of Naproxen Evolanär is too strong or too weak, talk to your doctor or pharmacist.
If You Take More Naproxen Evolan 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 for risk assessment and advice.
If You Forget To Take Naproxen Evolan:
Do not take a double dose to make up for a forgotten tablet.
Ask your doctor or pharmacist for further questions about using this product.
Possible Side Effects Of Naproxen Evolan:
Naproxen Evolan can cause side effects like all medicines, although not everybody gets them.
Stop taking Naproxen Evolan and see a doctor or emergency room 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 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 local symptoms of infection such as sore throat / throat / mouth or difficulty urinating.
These are rare side effects but may affect up to 1 in 1,000 people. Common (may affect up to 1 in 10 people):
- Abdominal pain
- Heartburn
- Nausea
- Diarrhea
- 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 (may affect up to 1 in 1,000 people):
- Cramps
- Muscle weakness
- Blood count changes
- “Ruptured gastric ulcer”
- Inflammation of the colon
- Vomiting
- Inflammation of the esophagus
- 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 feces
- 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 Evolan prolongs bleeding time.
In rare cases, severe skin infections are associated with chickenpox. Medicines such as Naproxen Evolan may cause a small increased risk of heart attack or stroke.
How To Store Naproxen Evolan?
- Keep naproxen evolan out of sight and reach of children.
- No special storage instructions.
- Do not use naproxen evolan 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 500 mg.
- The other ingredients are hydroxypropyl cellulose, microcrystalline cellulose, magnesium trisilicate, croscarmellose sodium, colloidal anhydrous silica, lactose monohydrate, magnesium stearate, and yellow iron oxide (E172).
What The Medicine Looks Like And Contents Of The Pack?
- Capsule-shaped, biconvex yellow, flat tablet 18 mm long, marked “500” on one side and a notch on the other. The tablet can be divided into two equal doses.
- Pack sizes: 10, 20, 30, 40, 50, 100, 105, 200, 300, 400 and 500 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
Manufacturer
Santa SA
Size Panselelor No. 25/27/29
Brasov, Jud. Brasov, 500419
Romania