PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NIMESULIDE ALTER 100 mg granules for oral solution

Nimesulide
Generic Medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NIMESULIDE ALTER is and what it is used for
What you need to know before taking NIMESULIDE ALTER
How to take NIMESULIDE ALTER
Possible side effects
How to store NIMESULIDE ALTER
Contents of the pack and other information

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

NIMESULIDE ALTER contains the active substance 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 NIMESULIDE ALTER, your doctor will evaluate the potential benefits this medicine may provide you against the risk of developing adverse effects.

2. What you should know before taking NIMESULIDE ALTER

Do not take NIMESULIDE ALTER

if you are allergic to nimesulide or to any of the other ingredients of this medicine (listed in section 6);
if you have experienced 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 in the nasal mucosa (nasal polyps)
itchy skin rashes (urticaria)
sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may cause breathing difficulties (angioedema)
if you have previously had reactions to NSAID treatment such as:
stomach or intestinal bleeding
stomach or intestinal ulcers (perforations)
if you have recently had, or have previously had, stomach or intestinal ulcers or bleeding (at least two episodes of ulcer or bleeding)
if you have previously had a reaction to nimesulide causing liver problems;
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 using drugs or have developed drug or substance dependence;
if you are a heavy, regular drinker (alcohol);
if you have hepatic insufficiency (impaired liver function);
if you have had a cerebral haemorrhage (stroke);
if you have any other bleeding disorder or a condition due to a blood coagulation defect;
if you have severe heart failure;
if you have severe renal insufficiency (impaired kidney function);
if you have fever or influenza (general malaise, chills or tremors, 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 especially careful with NIMESULIDE ALTER:

if you have heart or circulatory problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol levels, or if you smoke). In this case, you must inform your doctor before taking NIMESULIDE ALTER;
if you have previously suffered from peptic ulcer, gastrointestinal bleeding, or inflammatory bowel diseases such as ulcerative colitis or Crohn's disease. You must inform your doctor before taking NIMESULIDE ALTER;
if you develop a severe, potentially life-threatening skin reaction during treatment. You must stop taking NIMESULIDE ALTER and contact your doctor immediately if you notice a skin rash, lesions of soft tissues (mucous membranes), skin peeling, blisters, or bleeding of the lips, eyes, mouth, nose, or genitals, or any other symptom of an allergic reaction;
if symptoms indicating liver problems occur during treatment with NIMESULIDE ALTER. These symptoms include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, and dark urine. You must stop taking NIMESULIDE ALTER and contact your doctor immediately;
if fever and/or flu-like symptoms (general malaise, chills or tremors) occur during treatment with NIMESULIDE ALTER. You must stop taking the medicine and contact your doctor;
if you experience stomach or intestinal problems during treatment with NIMESULIDE ALTER, such as gastrointestinal bleeding (black stools) or peptic ulcer (gastric or duodenal ulcer), causing abdominal pain. You must stop taking the medicine and contact your doctor;
if you are elderly. Your doctor may carry out regular checks to ensure that NIMESULIDE ALTER is not causing problems to your stomach, kidneys, heart, or liver;
if you have kidney problems. You must inform your doctor before taking NIMESULIDE ALTER, as kidney function may worsen during treatment with NIMESULIDE ALTER.

Children
NIMESULIDE ALTER is not recommended for children under 12 years of age.
Other medicines and NIMESULIDE ALTER
Inform 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, as they may interact with NIMESULIDE ALTER:

corticosteroids (medicines used to treat inflammatory conditions);
medicines to thin the blood (anticoagulants, e.g. warfarin, antiplatelet agents, aspirin or other salicylates);
antihypertensive or diuretic medicines (for controlling blood pressure or heart conditions);
lithium, used to treat depression or similar disorders;
medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs);
methotrexate (a medicine used to treat rheumatoid arthritis and cancer);
cyclosporine (a medicine used after organ transplantation or to treat immune system disorders).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take NIMESULIDE ALTER during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect your and your baby's tendency to bleed and may result in delayed or prolonged labour. Do not take NIMESULIDE ALTER during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, NIMESULIDE ALTER may cause kidney problems in the unborn child, leading 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 require 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, inform your doctor, as NIMESULIDE ALTER may reduce fertility.

Driving and using machines
NIMESULIDE ALTER may cause dizziness or drowsiness. If this occurs, avoid driving or operating machinery.

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

3. How to take NIMESULIDE ALTER

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet of 100 mg twice daily, after meals.
Take NIMESULIDE ALTER for the shortest possible duration and for no longer than 15 days in a single
treatment cycle.
If you take more NIMESULIDE ALTER than you should
If you accidentally take/ingest too much of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Symptoms of overdose include: drowsiness, lethargy, nausea, vomiting, stomach pain, gastrointestinal bleeding, high blood pressure, kidney problems, breathing difficulties, and coma.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take NIMESULIDE ALTER
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If any of the following symptoms occur, stop taking the medicine and inform your doctor immediately, as they may indicate a rare but serious side effect requiring 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 rash or redness;
wheezing or shortness of breath;
yellowing of the skin or eyes (jaundice);
unexpected change in the amount or colour of urine;
swelling of the face, feet or legs;
persistent tiredness.

The side effects that may occur with NIMESULIDE ALTER are:
Common (may affect up to 1 in 10 people)
Diarrhoea, nausea, vomiting, increased liver enzymes.
Uncommon (may affect up to 1 in 100 people)
Dizziness, high blood pressure, breathlessness, constipation, intestinal gas, stomach or intestinal bleeding, duodenal or gastric ulcer, perforated ulcers, itching, skin rash, increased sweating, fluid accumulation in the body (oedema).
Rare (may affect up to 1 in 1,000 people)
Decrease in red blood cells (anaemia), increase in a type of white blood cells (eosinophilia), hypersensitivity reactions, increased blood potassium levels, anxiety, nervousness, nightmares, blurred vision, rapid heartbeat, haemorrhage, changes in blood pressure, hot flushes, skin redness, skin inflammation (dermatitis), difficulty urinating (dysuria), blood in urine, malaise, unusual weakness (asthenia).
Very rare (may affect up to 1 in 10,000 people)
Decrease in platelets (thrombocytopenia), decrease in all blood cells (pancytopenia), purpura (diseases characterised by red skin spots), sudden potentially life-threatening allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disorder), visual disturbances, asthma, breathing difficulties (bronchospasm), inflammation of the stomach (gastritis), abdominal pain, indigestion or difficulty digesting (dyspepsia), inflammation of the mouth (stomatitis), blood in stools, liver disorders (hepatitis, sometimes severe, jaundice, bile flow obstruction), urticaria, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (angioedema), facial swelling, severe skin condition affecting the mouth and other body parts (erythema multiforme), rare skin condition with blisters and bleeding of 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 failure), reduced urinary excretion, interstitial nephritis (a kidney disease), lowered body temperature.
Not known (frequency cannot be estimated from the available data)
Bleeding from the stomach, oesophagus or duodenum with vomiting (haematemesis), worsening of inflammation of the colon and Crohn’s disease (a chronic inflammatory bowel disease).

When using 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), particularly with high doses and prolonged treatment;
reduced cardiac function (heart failure).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What NIMESULIDE ALTER contains

The active substance is nimesulide. Each sachet contains 100 mg of nimesulide.
The other components are: sucrose, sodium saccharin, polyethylene glycol 1000 monostearyl 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 Authorization Holder
Laboratori Alter S.r.l. - Via Egadi, 7 – 20144 Milan, Italy
Manufacturers
Officina Farmaceutica Fine Foods ntm s.p.a. - Via Dell’Artigianato, 8/10 - Brembate (BG), Italy