1. What is Nimesil® and what is it used for?
Nimesil®, which contains nimesulide as active substance, is a non-steroidal anti-inflammatory drug (NSAID) with pain relieving properties. It is used to treat acute pain and treat menstrual pain.
Before prescribing Nimesil®, your doctor will evaluate the potential of this medicine for the risk of side effects for you.
2. What do you need to know before taking Nimesil®?
Do not take Nimesil®:
if you are allergic to nimesulide or any of the other ingredients of this medicine (listed in section 6);
if you have had allergic reactions (eg breathing whizzing, runny or stuffy nose, urticaria) after taking aspirin or other non-steroidal anti-inflammatory drugs;
if you have had a reaction to nimesulide affecting the liver;
if you are taking other medicines known to have liver effects such as paracetamol, other painkillers or non-steroidal anti-inflammatory medicines;
if you are taking substances that may be addicted or if you have a drug addiction;
if you often take alcohol;
if you have liver disease or elevated liver enzymes; if you have had a peptic ulcer, bleeding from the stomach or intestines or chronic digestive problems (eg indigestion, heartburn); if you have had a cerebral hemorrhage (stroke);
if you have bleeding disorders or bleeding disorders;
if you have heart problems (heart failure) or kidney problems (impaired kidney function) or liver problems;
if you have fever or flu-like symptoms (aching the whole body, feeling unwell, chills, chills or fever);
if you are pregnant in the last three months of pregnancy;
if you are breast-feeding.
Do not use Nimesil® in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nimesil®.
If liver problems occur during treatment, stop taking nimesulide and tell your doctor. Symptoms of liver problems are dizziness, nausea, vomiting, abdominal pain, prolonged fatigue and dark urine.
If you have had peptic ulcer, stomach or intestinal bleeding, ulcerative colitis or Crohn's disease, you should tell your doctor before taking Nimesil®.
If you experience fever and / or flu-like symptoms (full-body pain, malaise, chills or chills) during treatment with Nimesulide, stop taking this medicine and tell your doctor.
If you suffer from heart or kidney disease, tell your doctor before taking Nimesil®; renal function may worsen with Nimesil®.
If you are elderly, your doctor may want to see you at regular intervals to make sure that Nimesil® does not cause stomach, kidney, heart or liver problems.
If you have an intolerance to some sugars, tell your doctor before taking this medicinal product.
If you have any stomach problems during treatment with Nimesil®, such as stomach pain, stomach hemorrhage or black stools, stop taking Nimesil® and tell your doctor immediately.
If you do not notice any benefit from taking this medicine, tell your doctor.
Medicines such as Nimesil® may be associated with a slightly increased risk of heart attacks or stroke.
The risk is greater with high doses of Nimesle® and prolonged treatment. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, if you have a stroke or think you are at risk for these problems (eg if you have high blood pressure, diabetes, high cholesterol or if you are a smoker), you should discuss this treatment with your doctor or pharmacist.
Other medicines and Nimesil®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are some medicines that should not be taken together and other medicines that may require a dose adjustment when taken together.
Always tell your doctor or pharmacist if you are using or are taking any of the following medicines in addition to Nimesil®:
The following drugs may interact with Nimesil®:
corticosteroids, e.g. cortisone (medicines used to treat inflammatory diseases);
anticoagulants, e.g. warfarin or antiplatelet agents such as aspirin (medicines that prevent blood clots);
selective serotonin reuptake inhibitors (medicines used to treat depression);
lithium used to treat certain mood disorders; methotrexate (a medicine used to treat rheumatoid arthritis and malignancies);
cyclosporine, a medicine used after transplants or for the treatment of immune system disorders.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use during the last 3 months of pregnancy. May cause fetal or nasal problems.
If you are in the second or third trimester of pregnancy, do not exceed the dose or duration of treatment prescribed by your doctor.
Breast-feeding
Do not take Nimesil® if you are breast-feeding. Fertility
If you plan to become pregnant, tell your doctor as Nimesil® may reduce fertility.
Driving and using machines
If dizziness or drowsiness occurs when taking Nimesiol, do not drive or operate machinery.
Nimesil® contains sucrose
Nimesil® granules for oral suspension contain sucrose. If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Nimesil®?
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one sachet (100 mg), taken twice a day after a meal. Pour the contents of the sachet into a glass of non-carbonated water. Stir with a spoon to get an orange flavor suspension. Drink the suspension as soon as it is prepared.
Use Nimesil® as soon as possible, but no more than 15 days for each treatment course.
Use in children and adolescents
Do not use Nimesil® in children under 12 years of age.
If you take more Nimesil® than you should
If you have taken or think you may have taken too much Nimesulide, tell your doctor or pharmacist immediately or go to the nearest emergency room. Please be sure to take the medicine pack or this leaflet yourself.
If you take too much Nimesulide, any of the following symptoms may occur: dizziness, nausea, stomach pain, stomach ulcer or difficulty in breathing.
If you forget to take Nimesil
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below according to their frequency of occurrence. This table shows how many patients can experience these side effects:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: Frequency can not be estimated from available data
If any of the following symptoms occur, stop taking Nimesil® and tell your doctor immediately as this may indicate that you have an adverse reaction that requires urgent medical attention.
Stomach pain or stomach discomfort, dizziness, nausea, vomiting, stomach or intestinal bleeding, which may be due to vomiting of blood or black stools.
Skin reactions such as skin rash or redness.
Breathing in breathing or breathlessness.
Yellow skin or eyes (jaundice).
An unexpected change in the amount or color of the urine.
Swelling of the face, feet , ankles.
Permanent fatigue (fatigue).
Medicines such as Nimesil® may be associated with a slightly increased risk of heart attacks (stroke) or stroke.
Adverse reactions that may occur with Nimesil® are:
Common: diarrhea , nausea, vomiting, mild changes in liver function blood counts.
Uncommon : stomach or intestinal bleeding, duodenal ulcer or stomach ulcer, cramping of the ulcer, shortness of breath, vertigo, increased blood pressure, constipation, gas, stomach burning (gastritis), itching, skin rash, .
Rare: anemia, decreased white blood cell count, increased number of certain white blood cells (eosinophils), changes in blood pressure, bleeding, urinary pain or urine retention, blood in the urine, increased blood potassium, anxiety and nervousness , nightmares, blurred vision, increased heart rate, hot flushes, skin redness, skin inflammation (dermatitis), common fatigue, fatigue.
Very rare : severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) that cause skin rash and severe fatigue; renal insufficiency or renal inflammation (nephritis); impaired brain function (encephalopathy); (hepatitis), sometimes very severe, resulting in jaundice and blocking the bile flow, allergies including severe seizure reactions and difficulty breathing, asthma, decreased body temperature, vertigo, headache, insomnia, stomach pain; impaired digestion, burning sensation in the mouth, hives (urticaria); swelling of the face and surrounding tissues, visual disturbances.
Acute pain: toothache, bursitis, tendinitis, back and back pain, pain syndrome due to trauma, joint dislocation or sprain; Pain syndrome in osteoarthritis; Algodismenorea. It is intended for symptomatic therapy, relief of pain and reduction of inflammation at the time of application, it does not influence the progression of the disease. The recommended dose is one sachet (100 mg), taken twice a day after a meal. Pour the contents of the sachet into a glass of non-carbonated water. Stir with a spoon to get an suspension. Drink the suspension as soon as it is prepared.