NIMESULIDE 100 mg Tablet

Зміст інструкції

1. NIMESULIDE DOC Generici 100 mg tablets, oral suspension granules
   1. WHAT IS NIMESULIDE DOC Generici AND WHAT IT IS USED FOR
   2. BEFORE TAKING NIMESULIDE DOC Generici
   3. HOW TO USE NIMESULIDE DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. How to store NIMESULIDE DOC Generici
   6. FURTHER INFORMATION

NIMESULIDE DOC Generici 100 mg tablets, oral suspension granules

Equivalent Medicine
Read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, this medicine may be dangerous to other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What NIMESULIDE DOC Generici is and what it is used for
• 2. Before taking NIMESULIDE DOC Generici
• 3. How to take NIMESULIDE DOC Generici
• 4. Possible side effects
• 5. How to store NIMESULIDE DOC Generici
• 6. Further information

1. WHAT IS NIMESULIDE DOC Generici AND WHAT IT IS USED FOR

NIMESULIDE DOC Generici is a non-steroidal anti-inflammatory drug (“NSAID”), with
pain-relieving properties .It is used for the treatment of acute pain and menstrual pain.
Before prescribing NIMESULIDE DOC Generici, the doctor will assess the potential benefits that
this medicine can give you compared to the risk of developing side effects.

2. BEFORE TAKING NIMESULIDE DOC Generici

Do not use NIMESULIDE DOC Generici if

• you are hypersensitive (allergic) to nimesulide or any of the excipients of NIMESULIDE DOC Generici (listed in section 6, at the end of this leaflet);
• you have had any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs:
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to growths of the internal nasal mucosa (nasal polyps)
• skin rashes/itchy skin (urticaria)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may cause difficulty breathing (angioedema);
• you have had reactions in the past following treatment with NSAIDs such as:
• gastric or intestinal bleeding
• ulcers (perforations) in the stomach or intestine;
• you have recently had a stomach or duodenal ulcer or have had them in the past (at least two episodes of ulcer or bleeding);
• you have had a cerebral haemorrhage (stroke);
• you have any other bleeding problem or problem due to a blood clotting defect;
• you suffer from liver failure;
• you are taking other medicines known to have an effect on the liver, e.g. paracetamol or any other analgesic or NSAID treatment;
• you are taking drugs or have developed a dependence on drugs or other substances;
• you are a heavy habitual drinker (of alcohol);
• you have had a reaction to nimesulide in the past that affected the liver;
• you suffer from severe kidney failure that does not require dialysis;
• you suffer from severe heart failure;
• you have a fever or flu (general feeling of malaise, discomfort, chills or tremors or high temperature);
• you are in the last trimester of pregnancy;
• you are breastfeeding.

Do not give NIMESULIDE DOC Generici to a child under 12 years of age.

Warnings
Medicines like NIMESULIDE DOC Generici may be associated with a modest increase
in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with
high doses and prolonged treatments. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, a history of stroke, or think you may be at risk of these conditions
(e.g. if you have high blood pressure, diabetes or high cholesterol or if you smoke), you should discuss your
therapy with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking
NIMESULIDE DOC Generici and inform your doctor at the first sign of skin rashes, soft tissue lesions (mucous membranes) or any other symptom of allergy.
Do not take NIMESULIDE DOC Generici or inform your doctor before taking NIMESULIDE DOC
Generici if you have developed a fixed drug eruption (round or oval patches with redness and
swelling of the skin, skin rash with blisters, urticaria and itching) after taking
nimesulide.
Immediately stop treatment with NIMESULIDE DOC Generici in the presence of
bleeding (with black stools) or ulceration of the digestive tract (causing abdominal pain).

Pay particular attention with NIMESULIDE DOC Generici
If symptoms indicative of a liver disorder appear during treatment with nimesulide, you should
stop taking nimesulide and immediately inform your doctor. Symptoms
indicative of a liver disorder are loss of appetite, nausea, vomiting, abdominal pain,
persistent fatigue and dark urine.
If you have suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory
diseases of the intestine such as ulcerative colitis or Crohn's disease, you should inform your doctor before
taking NIMESULIDE DOC Generici.
If fever and/or flu-like symptoms (general feeling of malaise, discomfort, chills or tremors) appear during treatment with NIMESULIDE DOC Generici, you should
stop taking the product and inform your doctor.
If you suffer from mild heart disorders, high blood pressure, circulatory problems or kidney problems, you should
inform your doctor before taking NIMESULIDE DOC Generici.
If you are elderly, your doctor may subject you to regular checks to ensure that NIMESULIDE
DOC Generici does not cause problems with your stomach, kidneys, heart or liver.
If you are planning a pregnancy, inform your doctor because NIMESULIDE DOC Generici
may reduce fertility.
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
If you are taking any of the following medicines, which may interact with NIMESULIDE DOC
Generici:

• corticosteroids (drugs used for the treatment of inflammatory states),
• drugs to thin the blood (anticoagulants, e.g. warfarin or antiplatelet agents, aspirin or other salicylates),
• antihypertensives or diuretics (drugs for controlling blood pressure or heart disorders),
• lithium, used for the treatment of depression and similar disorders,
• selective serotonin reuptake inhibitors (drugs used in the treatment of depression),
• methotrexate (drug used for the treatment of rheumatoid arthritis and cancer)
• cyclosporine (drug used after a transplant or for the treatment of immune system disorders), make sure your doctor or pharmacist knows that you are taking these medicines before taking NIMESULIDE DOC Generici.

Taking NIMESULIDE DOC Generici with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking NIMESULIDE DOC Generici or
any other medicine.
Do not take NIMESULIDE DOC Generici in the last 3 months of pregnancy, as it may
harm the fetus or cause problems during childbirth.
It may cause problems with the kidneys and heart of the fetus. It may affect your and your baby's
tendency to bleed and delay or prolong labour more than expected.
You should not take NIMESULIDE DOC Generici in the first 6 months of pregnancy, unless
absolutely necessary and under the advice of your doctor. If treatment is required during that
period or during attempts to conceive, the minimum dose should be used for the shortest
possible time. From the 20th week of pregnancy, NIMESULIDE DOC Generici may cause
kidney problems in the fetus if taken for more than a few days, thus reducing the levels of
amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood
vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than
a few days, your doctor may recommend additional monitoring.
NIMESULIDE DOC Generici should not be used during breastfeeding.
If you are planning a pregnancy, inform your doctor as NIMESULIDE DOC Generici can
decrease fertility.

Driving and operating machinery
Do not drive or operate machinery if NIMESULIDE DOC Generici causes you dizziness or drowsiness.

Important information about some excipients of NIMESULIDE DOC Generici
NIMESULIDE DOC Generici tablets and oral suspension granules contain sugars.
If you have been told by your doctor that you have an intolerance to some sugars, contact him before
using this medicine.

3. HOW TO USE NIMESULIDE DOC Generici

Always take NIMESULIDE DOC Generici exactly as your doctor has instructed. If you have
any doubts, ask your doctor or pharmacist.
To reduce side effects, the minimum effective dose should be used for the shortest time
necessary to control the symptoms.
The usual dose is one 100 mg tablet or one 100 mg sachet of granules for oral suspension,
twice a day after meals. Use NIMESULIDE DOC Generici for the shortest possible period
and for no more than 15 days in a single treatment cycle.

If you take more NIMESULIDE DOC Genericithan you should
If you take or think you have taken more NIMESULIDE DOC Generici than prescribed
(overdose), contact your doctor or hospital immediately. Bring all the remaining medicine with you. In
case of overdose, you will probably develop one of the following symptoms: drowsiness, nausea,
stomach pain, gastric ulcer, difficulty breathing.

If you forget to take NIMESULIDE DOC Generici
Do not take a double dose to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, NIMESULIDE DOC Generici can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, stop taking the medicine and immediately inform your
doctor as it may indicate a rare, serious side effect that requires urgent medical attention:

• stomach discomfort or pain, loss of appetite, nausea (feeling unwell), vomiting, gastric or intestinal bleeding, or black stools;
• skin reactions such as rashes or redness;
• wheezing or shortness of breath;
• yellowing of the skin or eyes (jaundice);
• unexpected change in the amount or color of urine;
• swelling of the face, feet, or legs;
• persistent fatigue.

Side effects of a general nature of non-steroidal anti-inflammatory drugs (NSAIDs):
The use of some NSAIDs may be associated with a modest increase in the risk of blockage of the
arteries (thrombosis), for example, heart attack (myocardial infarction) or stroke, particularly with high doses and long-term treatment.
In association with treatment with NSAIDs, fluid retention (edema),
high blood pressure (hypertension), and heart failure have been reported.
The most commonly observed side effects with NSAIDs concern the gastrointestinal tract (gastrointestinal effects):

• gastric and duodenal ulcers
• perforation of the intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Other side effects that may occur with NIMESULIDE DOC Generici are:

• Common (may affect more than 1 in 100 patients): diarrhea, nausea, vomiting, slight changes in blood test values of liver function.
• Uncommon (may affect up to 1 in 100 patients): shortness of breath, dizziness, increased blood pressure, constipation, flatulence, heartburn (gastritis), itching, skin rashes, increased sweating, swelling (edema), bleeding of the stomach or intestine, ulcers of the duodenum or stomach and perforated ulcers.
• Rare (may affect up to 1 in 1,000 patients): anemia, decreased white blood cells in the blood, increase in some white blood cells (eosinophils) in the blood, changes in blood pressure, bleeding, pain during urination or urinary retention, blood in the urine, increased potassium in the blood, feeling of anxiety or nervousness, nightmares, blurred vision, increased heart rate, hot flashes, skin redness, skin inflammation (dermatitis), malaise, fatigue.
• Very rare (may affect up to 1 in 10,000 patients): severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) causing skin rashes and severe discomfort; kidney failure or inflammation (nephritis); disorders of brain function (encephalopathy); reduction in the number of platelets in the blood, which causes bleeding under the skin or in other parts of the body, black stools due to bleeding; inflammation of the liver (hepatitis), sometimes very severe, causing jaundice and blockage of bile flow; allergies, including severe reactions with collapse and difficulty breathing, asthma, decreased body temperature, dizziness, headache, insomnia, stomach pains; indigestion, burning in the mouth, itching (urticaria); swelling of the face and surrounding areas, visual disturbances.
• Frequency not known: fixed drug eruption (may manifest with round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), sensation of itching.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store NIMESULIDE DOC Generici

NIMESULIDE DOC Generici does not require any particular storage conditions.
Keep NIMESULIDE DOC Generici out of the reach and sight of children.
Do not use NIMESULIDE DOC Generici after the expiry date which is stated on the package. The expiry
date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. FURTHER INFORMATION

What contains NIMESULIDE DOC Generici

NIMESULIDE DOC Generici 100 mg tablets

• The active ingredient is nimesulide. Each tablet contains 100 mg of nimesulide.
• The excipients are: microcrystalline cellulose, corn starch, lactose, sodium lauryl sulfate, magnesium stearate, compritol 888 ATO.

NIMESULIDE DOC Generici 100 mg granules for oral suspension

• The active ingredient is nimesulide. Each sachet of granules for oral suspension contains 100 mg of nimesulide.
• The excipients are: citric acid monohydrate, polyethylene glycol 4000, maltodextrin, orange aroma, sorbitol, cetomacrogol 1000.

Description of the appearance of NIMESULIDE DOC Generici and contents of the pack
NIMESULIDE DOC Generici 100 mg tablets: round tablet, cream-yellow in color, with
a fracture line on one side and smooth on the other.
One pack contains 30 tablets.
NIMESULIDE DOC Generici 100 mg granules for oral suspension: sachet containing a
powder of yellowish or cream-yellow color.
One pack contains 30 sachets.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano.

Manufacturer

Tablets:
LABORATORIO FARMACEUTICO C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM).

Granules for oral suspension:
MIPHARM S.p.A. – Via B. Quaranta, 12 – Milano.
LAMP SAN PROSPERO S.p.A. - Via della Pace, 25/A - S.Prospero S/S (MO).