NIMESULIDE 100 mg Гранулы

Содержание инструкции

1. NIMESULIDE ALTER 100 mg granules for oral solution
   1. What is NIMESULIDE ALTER and what is it used for
   2. What you need to know before taking NIMESULIDE ALTER
   3. How to take NIMESULIDE ALTER
   4. Possible side effects
   5. How to store NIMESULIDE ALTER
   6. Contents of the pack and other information

NIMESULIDE ALTER 100 mg granules for oral solution

Nimesulide

Equivalent Medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• 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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What NIMESULIDE ALTER is and what it is used for
• 2. What you need to know before you take NIMESULIDE ALTER
• 3. How to take NIMESULIDE ALTER
• 4. Possible side effects
• 5. How to store NIMESULIDE ALTER
• 6. Contents of the pack and other information

1. What is NIMESULIDE ALTER and what is it used for

NIMESULIDE ALTER contains the active ingredient nimesulide.
NIMESULIDE ALTER is a non-steroidal anti-inflammatory drug (“NSAID”), with analgesic properties.
NIMESULIDE ALTER is indicated for the treatment of acute pain and menstrual pain.
Before prescribing, your doctor will assess the potential benefits this medicine can provide you compared to the risk of developing undesirable effects.

2. What you need to know before taking NIMESULIDE ALTER

Do not take NIMESULIDE ALTER

• if you are allergic to nimesulide or any of the other ingredients of this medicine (listed in section 6);
• if you have had any of the following symptoms after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs):
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to growths of the mucous membrane inside the nose (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)
• if you have had reactions in the past following treatment with NSAIDs such as
• bleeding in the stomach or intestine
• ulcers (perforations) in the stomach or intestine
• if you have recently had an ulcer or bleeding in the stomach or intestine or have had them in the past (at least two episodes of ulcer or bleeding)
• if you have had a reaction in the past to nimesulide that caused problems with the liver;
• if you are taking other medicines known to be harmful to the liver, e.g. paracetamol, other painkillers or other non-steroidal anti-inflammatory drugs;
• if you are taking drugs or have developed a dependence on drugs or other substances;
• if you are a heavy habitual drinker (alcohol);
• if you have hepatic insufficiency (poor liver function);
• if you have had a cerebral haemorrhage (stroke);
• if you have any other bleeding problem or problem due to a defect in blood coagulation;
• if you have severe heart failure;
• if you have severe renal insufficiency (poor kidney function);
• if you have fever or flu (feeling of general malaise, discomfort, chills or shivering or fever);
• if you are in the last trimester of pregnancy;
• if you are breastfeeding. Do not give NIMESULIDE ALTER to a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking NIMESULIDE ALTER.
Be particularly careful with NIMESULIDE ALTER:

• if you have heart problems, blood circulation problems, a history of stroke, or think you may be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels or if you smoke). In this case you should inform your doctor before taking NIMESULIDE ALTER;
• if you have suffered from peptic ulcer, gastric or intestinal bleeding or inflammatory bowel diseases such as ulcerative colitis or Crohn's disease. You should inform your doctor before taking NIMESULIDE ALTER;
• if during treatment you develop a severe skin reaction that may be life-threatening. You should stop taking NIMESULIDE ALTER and inform your doctor at the first sign of rash, soft tissue (mucous membrane) lesions, skin peeling, blisters and bleeding of the lips, eyes, mouth, nose and genitals or any other symptom of an allergic reaction;
• if during treatment with NIMESULIDE ALTER symptoms indicative of a liver disorder appear. These symptoms are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine. You should stop taking NIMESULIDE ALTER and inform your doctor immediately;
• if during treatment with NIMESULIDE ALTER you experience fever and/or flu-like symptoms (feeling of general malaise, discomfort, chills or shivering). You should stop taking the medicine and inform your doctor;
• if during treatment with NIMESULIDE ALTER you experience problems with the stomach or intestine such as bleeding from the stomach or intestine (with black stools) or peptic ulcer (gastric or duodenal ulcer), which causes abdominal pain. You should stop taking the medicine and inform your doctor;
• if you are elderly. Your doctor may subject you to regular checks to ensure that NIMESULIDE ALTER does not cause problems with the stomach, kidneys, heart or liver;
• if you have kidney problems. You should inform your doctor before taking NIMESULIDE ALTER as kidney function may worsen with treatment with NIMESULIDE ALTER.

Children
NIMESULIDE ALTER is not recommended in children under 12 years of age.

Other medicines and NIMESULIDE ALTER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
If you are taking any of the following medicines, inform your doctor because these may interact with
NIMESULIDE ALTER:

• corticosteroids (medicines used for the treatment of inflammatory states);
• medicines to thin the blood (anticoagulants, e.g. warfarin, antiplatelet agents, aspirin or other salicylates);
• medicines for high blood pressure or diuretics (for controlling blood pressure or heart disorders);
• lithium, used for the treatment of depression or similar disorders;
• medicines used in the treatment of depression, known as selective serotonin reuptake inhibitors (SSRIs);
• methotrexate (medicine used for the treatment of rheumatoid arthritis and cancer);
• cyclosporine (medicine used after a transplant or for the treatment of disorders of the immune system). Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take NIMESULIDE ALTER if you are in the last 3 months of pregnancy as it may harm the
foetus or cause problems with labour. It may cause problems with the kidneys and heart in the unborn baby. It may affect
your and your baby's tendency to bleed and cause labour to be later or longer than expected. You should not take
NIMESULIDE ALTER during the first 6 months of pregnancy unless it is
absolutely necessary and recommended by your doctor. If you need treatment during this period or
while trying to become pregnant, the lowest dose should be used for the shortest possible time. If
taken for more than a few days from the twentieth week of pregnancy onwards, NIMESULIDE ALTER may
cause problems with the kidneys in the unborn baby which may lead to low levels of amniotic fluid surrounding the
baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If
you need treatment for more than a few days, your doctor may recommend additional monitoring

Breastfeeding
Do not take NIMESULIDE ALTER while breastfeeding.

Fertility
If you are planning to become pregnant, you should inform your doctor because NIMESULIDE ALTER may
reduce fertility.

Driving and using machines
NIMESULIDE ALTER may cause dizziness or drowsiness. If this happens to you, do not drive vehicles or
use machines.

NIMESULIDE ALTER contains sucrose
This medicine contains sucrose, a type of sugar. If you have been diagnosed with an intolerance
to certain sugars, contact your doctor before taking this medicine.

3. How to take NIMESULIDE ALTER

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet of 100 mg 2 times a day, after meals.
Take NIMESULIDE ALTER for the shortest possible period and for no more than 15 days in a single
treatment cycle.

If you take more NIMESULIDE ALTER than you should
In case of accidental intake/ingestion of an excessive dose of this medicine, immediately
inform your doctor or go to the nearest hospital emergency room.
The symptoms of an overdose are as follows: drowsiness, lethargy, nausea, vomiting, stomach pain,
gastrointestinal bleeding, high blood pressure, kidney problems, difficulty breathing and coma.
Bring this leaflet, the remaining medicine and its container with you to the hospital or doctor so
they know which medicine was taken.

If you forget to take NIMESULIDE ALTER
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and tell your doctor immediately as it may indicate a rare but serious side effect that requires urgent medical attention:

• stomach discomfort or pain, loss of appetite, nausea (feeling unwell), vomiting, gastrointestinal 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.

The side effects that may occur with NIMESULIDE ALTER are:

Common(may affect up to 1 in 10 people)
Diarrhea, nausea, vomiting, increased liver enzymes (of the liver).

Uncommon(may affect up to 1 in 100 people)
Dizziness, high blood pressure, shortness of breath, constipation, presence of gas in the intestines, bleeding from the stomach or intestines, duodenal or gastric ulcer and perforated ulcers, itching, skin rash, increased sweating, fluid retention in the body (edema).

Rare(may affect up to 1 in 1,000 people)
Decreased red blood cells in the blood (anemia), increased type of white blood cells in the blood (eosinophilia), hypersensitivity reactions, increased potassium levels in the blood, anxiety, nervousness, nightmares, blurred vision, rapid heartbeat, hemorrhage, changes in blood pressure, hot flashes, skin redness, skin inflammation (dermatitis, difficulty urinating (dysuria), blood in the urine, malaise, unusual weakness (asthenia).

Very rare(may affect up to 1 in 10,000 people)
Decreased platelets (thrombocytopenia), decreased of all blood cells (pancytopenia), purpura (diseases characterized by red spots on the skin), a sudden and potentially life-threatening allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disease), visual disturbances, asthma, difficulty breathing (bronchospasm), inflammation of the stomach (gastritis), abdominal pain, indigestion or difficulty digesting (dyspepsia), inflammation of the mouth (stomatitis), blood in the stool, liver disorders (hepatitis, sometimes very serious, jaundice, blockage of the bile flow), hives, swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema), facial swelling, severe skin condition affecting the mouth and other parts of the body (erythema multiforme), a rare skin condition with blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin reaction (toxic epidermal necrolysis), inability of the bladder to empty (urinary retention), altered kidney function (renal insufficiency), decreased urinary excretion, interstitial nephritis (a kidney disease), lowering of body temperature.

Not known(the frequency of which cannot be estimated on the basis of available data)
Bleeding from the stomach, esophagus or duodenum with vomiting (hematemesis), worsening of inflammation of the colon and Crohn's disease (a chronic inflammatory bowel disease).
With the use of non-steroidal anti-inflammatory drugs (NSAIDs), the following side effects may also occur:

• a modest increase in the risk of myocardial infarction or stroke (cerebrovascular accident), especially with high doses and for prolonged treatments;
• reduced heart function (heart failure).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NIMESULIDE ALTER

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NIMESULIDE ALTER contains

• The active ingredient is nimesulide. Each sachet contains 100 mg of nimesulide.
• The other ingredients are: sucrose, sodium saccharin, polyethylene glycol 1000 monoethyl ether, citric acid, orange flavour.

Description of the appearance of NIMESULIDE ALTER and contents of the pack
Pack of 30 sachets of 100 mg.

Marketing Authorisation Holder
Laboratori Alter S.r.l. - Via Egadi, 7 – 20144 Milano

Manufacturers
Officina Farmaceutica Fine Foods ntm s.p.a. - Via Dell’Artigianato, 8/10 - Brembate (BG)