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Nimesil 100 mg. 15 sachets

Product Code: Nimesil 100 mg. 15 sachets
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What is Nimesil and what is it used for?
Nimesil, which contains nimesulide as the active substance, is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties. It is used to treat acute pain and to treat menstrual pain.
Before prescribing Nimesil, your doctor will evaluate the potential of this medicine in terms of the risk of side effects for you.

2. What you need to know before you take 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 wheezing, 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 that are known to have an effect on the liver, such as paracetamol, other painkillers or non-steroidal anti-inflammatory drugs;
if you are taking substances to which you may become addicted or if you suffer from drug addiction;
if you drink alcohol often;
if you have liver disease or elevated levels of liver enzymes; if you have now or previously had a peptic ulcer, bleeding from the stomach or intestines or chronic digestive problems (eg indigestion, heartburn); if you have had a cerebral haemorrhage (stroke);
if you have diseases accompanied by bleeding or blood clotting disorders;
if you have heart problems (heart failure) or kidney problems (impaired kidney function) or liver problems;
if you have a fever or flu-like symptoms (whole body pain, malaise, 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 include loss of appetite, nausea, vomiting, abdominal pain, prolonged fatigue and dark urine.
If you have suffered from peptic ulcer, stomach or intestinal bleeding, ulcerative colitis or Crohn's disease, you should inform your doctor before taking Nimesil.
If you develop fever and / or flu-like symptoms (whole body pain, malaise, chills or chills) during treatment with Nimesil®, 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 be impaired during treatment with Nimesil.
If you are elderly, your doctor may ask to see you at regular intervals to make sure that Nimesil® does not cause stomach, kidney, heart or liver problems.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you have any stomach problems during treatment with Nimesil, such as stomach pain, stomach bleeding 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 attack (heart attack) or stroke.

The risk is higher with high doses of Nimesil® and long-term treatment. Do not exceed the recommended dose and duration of treatment.

If you suffer from heart problems, if you have had 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 dose adjustment when given at the same time.
Always tell your doctor or pharmacist if you are using or receiving any of the following medicines in addition to Nimesil:

The following medicines 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 to treat immune system disorders.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use during the last 3 months of pregnancy. May cause problems with the fetus or at birth.
If you are in the second or third trimester of pregnancy, do not exceed the dose or duration of treatment prescribed by your doctor.

Do not take Nimesil if you are breast-feeding.

If you are planning to become pregnant, tell your doctor, as Nimesil® may reduce fertility.

Driving and working is machines
If dizziness or drowsiness occurs while taking Nimesil, do not drive or use machines.

Nimesil contains sucrose
Nimesil granules for oral suspension contain sucrose. If you have been told by your doctor 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, talk to your doctor or pharmacist.
The recommended dose is one sachet (100 mg), taken twice a day after meals. Pour the contents of the sachet into a glass of still water. Stir with a spoon to get a suspension with orange flavor. Drink the suspension immediately after preparation.
Use Nimesil for as short a time as possible, but no more than 15 days for each course of treatment.

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 a large amount of Nimesil, tell your doctor or pharmacist immediately or go to the nearest emergency department. Please be sure to take the medicine pack or this leaflet yourself.
If you take too much Nimesil, you may experience any of the following symptoms: dizziness, nausea, stomach pain, stomach ulcers or difficulty 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. This table shows how many patients can get 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: the frequency cannot be determined from the available data

If any of the following symptoms occur, stop taking Nimesil and tell your doctor immediately, as this may mean that you have an adverse reaction that requires urgent medical attention.

Stomach pain or stomach discomfort, loss of appetite, nausea, vomiting, stomach or intestinal bleeding, which may be manifested by vomiting of blood or black stools.
Skin reactions such as skin rash or redness.
Whistling when breathing or shortness of breath.
Yellowing of the skin or eyes (jaundice).
Unexpected change in the amount or color of urine excreted.
Swelling of the face, legs, ankles.
Constant fatigue.
Medicines, such as Nimesil, may be associated with a slightly increased risk of heart attack (heart attack) or stroke.

Side effects that may occur with Nimesil are:

Common: diarrhea, nausea, vomiting, slight changes in blood parameters of liver function.
Uncommon: bleeding from the stomach or intestines, duodenal or gastric ulcer and rupture of the ulcer, shortness of breath, dizziness, high blood pressure, constipation, gas, burning in the stomach (gastritis), itching, skin rash, increased sweating, edema (edema) .
Rare: anemia, decreased white blood cell count, increased white blood cell count (eosinophils), changes in blood pressure, bleeding, pain when urinating or urinary retention, blood in the urine, increased potassium in the blood, feeling anxious and nervous , nightmares, blurred vision, increased heart rate, hot flashes, redness of the skin, inflammation of the skin (dermatitis), general fatigue, fatigue.
Very rare: severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) which cause skin rash and severe tiredness; renal failure or renal inflammation (nephritis); impaired brain function (encephalopathy); decreased platelet count in the blood, leading to subcutaneous bleeding and bleeding in other parts of the body, black stools, inflammation of the liver (hepatitis), sometimes very severe, leading to jaundice and blocking bile flow, allergies, including severe reactions with fainting and difficulty breathing, asthma, low body temperature

How to store Nimesil?
Keep out of reach of children.
Protect from light, moisture and heat sources.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information
What does Nimesil contain?
The active substance is: nimesulide. One sachet contains 100 mg of nimesulide.
The other ingredients are: sucrose, orange essence, citric acid, maltodextrin, cetomacrogol.
What Nimesil looks like and contents of the pack
Nimesil sachets contain pale yellow granules with orange flavor. Nimesil is produced in packs of 9, 15 or 30 sachets. Not all pack sizes may be marketed.


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