NIMESULIDE 100 mg Tabletka

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

NIMESULIDE ALMUS 100 mg tablets

NIMESULIDE ALMUS 100 mg granules for oral suspension
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

NIMESULIDE ALMUS contains the active ingredient nimesulide and is a drug belonging to the class of
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), with analgesic properties.
NIMESULIDE ALMUS is indicated for the treatment of acute pain and menstrual pain.
Before prescribing NIMESULIDE ALMUS, the doctor will assess the potential benefits this medicine
can provide you with compared to the risk of developing undesirable effects.

2. What you need to know before taking NIMESULIDE ALMUS

Do not take NIMESULIDE ALMUS

• 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 (noise) in breathing, feeling of 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:
• gastric or intestinal bleeding
• ulcers (perforations) in the stomach or intestine
• if you have recently had a stomach or duodenal ulcer or have had them in the past (at least two episodes of ulcer or bleeding);
• if you have had a brain hemorrhage (stroke);
• if you have any other bleeding problems or problems due to a blood clotting defect;
• if you suffer from liver failure (malfunctioning liver);
• if you are taking other medicines known to be harmful to the liver, for example 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 (of alcohol);
• if you have had a reaction to nimesulide in the past that caused liver problems;
• if you have severe kidney failure (malfunctioning kidneys) that does not require dialysis;
• if you have severe heart failure;
• if you have a fever or flu (feeling of general malaise, discomfort, chills or shivering or fever);
• if you are in the last trimester of pregnancy (see “Pregnancy, breastfeeding and fertility”);
• if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”).

Do not give NIMESULIDE ALMUS to a child under 12 years of age (see “Children”).

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

• if you develop a severe skin reaction that may be life-threatening during treatment. You should stop taking NIMESULIDE ALMUS at the first sign of skin rash, skin peeling, blisters and bleeding of the lips, eyes, mouth, nose and genitals or any other symptom of an allergic reaction.
• if symptoms indicative of a liver disorder appear during treatment with NIMESULIDE ALMUS. These symptoms are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine. You should stop taking NIMESULIDE ALMUS and inform your doctor immediately.
• if fever and/or flu-like symptoms (feeling of general malaise, discomfort, chills or shivering) appear during treatment with NIMESULIDE ALMUS. You should stop taking the medicine and inform your doctor.
• if you experience problems with your stomach or intestines during treatment with NIMESULIDE ALMUS, such as black stools or abdominal pain (bleeding or peptic ulcer). You should stop taking the medicine and inform your doctor.
• if you have suffered from peptic ulcer, gastric bleeding or intestinal bleeding, ulcerative colitis or Crohn's disease. You should inform your doctor before taking NIMESULIDE ALMUS.
• if you are elderly. Your doctor may subject you to regular checks to ensure that NIMESULIDE ALMUS does not cause problems with your stomach, kidneys, heart or liver.
• if you have kidney problems. You should inform your doctor before taking NIMESULIDE ALMUS as kidney function may worsen with treatment with NIMESULIDE ALMUS.
• 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). Do not take NIMESULIDE ALMUS or inform your doctor before taking NIMESULIDE ALMUS:
• 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. ChildrenNIMESULIDE ALMUS is not recommended in children under 12 years of age.

Other medicines and NIMESULIDE ALMUS
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, tell your doctor because these may interact with
NIMESULIDE ALMUS:

• corticosteroids (medicines used to treat inflammatory states);
• medicines to thin the blood (anticoagulants, for example warfarin, antiplatelet agents, acetylsalicylic acid (aspirin) or other salicylates);
• medicines for high blood pressure or diuretics (for controlling blood pressure or heart disorders);
• lithium, used to treat depression or similar disorders;
• medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs);
• methotrexate (medicine used to treat rheumatoid arthritis and cancer treatment);
• cyclosporine (medicine used after a transplant or for the treatment of immune system disorders).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are 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 ALMUS in the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect
your and your baby's tendency to bleed and delay or prolong labor more than expected.
You should not take NIMESULIDE ALMUS in the first 6 months of pregnancy unless absolutely
necessary and under the advice of your doctor. If treatment is needed during this period or during attempts
to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy onwards, NIMESULIDE ALMUS 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 a narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is needed for more than a few days, your doctor may advise additional monitoring.
Breastfeeding
Do not take NIMESULIDE ALMUS while breastfeeding.
Fertility
NIMESULIDE ALMUS may cause fertility problems in women. Therefore, if you are planning to become
pregnant, you should inform your doctor because NIMESULIDE ALMUS may reduce fertility.

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

NIMESULIDE ALMUS tablets contains lactose. If you have been diagnosed with an intolerance to
some sugars, contact your doctor before taking this medicine.

NIMESULIDE ALMUS oral suspension granules contains sucroseIf you have been
diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take NIMESULIDE ALMUS

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. To reduce undesirable effects, the minimum effective dose must be used for the
shortest time necessary to control the symptoms.
The recommended dose is one 100 mg tablet or sachet twice a day, after meals.
Elderly:
In elderly patients, it is not necessary to reduce the daily dose.
Take NIMESULIDE ALMUS for the shortest possible period and for no more than 15 days in a single
treatment cycle.

If you take more NIMESULIDE ALMUS than you should
If you (or someone else) have swallowed an excessive dose of NIMESULIDE ALMUS, or if you think a
child has swallowed an excessive dose, inform your doctor immediately or go to the nearest hospital’s
Emergency Room.
Bring this leaflet, the remaining medicine and its container with you to the hospital or doctor so that
they know which medicine was taken.
The symptoms of an acute NSAID overdose are usually limited to drowsiness, lethargy, nausea, vomiting,
stomach problems (pain) generally reversible with appropriate therapy. Bleeding from the stomach and
intestines may occur. High blood pressure, kidney problems, difficulty breathing and coma may also occur,
although rarely.
Severe allergic-type reactions with rapid onset (anaphylaxis) have been reported after ingestion of NSAIDs
at therapeutic doses, and these may also occur after overdose.

If you forget to take NIMESULIDE ALMUS
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 NIMESULIDE ALMUS and tell your
doctor immediately as it may indicate a rare, serious side effect that requires
urgent medical attention:

• discomfort or pain in the stomach, loss of appetite, nausea (feeling sick), vomiting, bleeding from the stomach or intestines, or black stools, worsening of colitis and Crohn's disease;
• skin reactions such as rashes or redness, severe blistering reactions (Stevens-Johnson Syndrome, toxic epidermal necrolysis);
• wheezing (noisy) breathing 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 use of some NSAIDs may be associated with a modest increase in the risk of heart problems
(blockage of the arteries (thrombosis), myocardial infarction or stroke, especially
with high doses and long-term treatment.
In association with NSAID treatment, fluid retention (edema), high blood pressure (hypertension) and reduced heart function (heart failure) have been reported.
The most commonly observed side effects with NSAIDs concern the gastrointestinal tract (gastrointestinal effects):

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

The side effects that may occur with NIMESULIDE ALMUS are:

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

Uncommon(may affect up to 1 in 100 people)
Dizziness, increased blood pressure, shortness of breath, constipation, presence of gas in the intestines,
itching, rash, increased sweating, swelling (edema), bleeding from the stomach or
intestines, ulcer and perforation of the duodenum or stomach.

Rare(may affect up to 1 in 1,000 people)
Decrease in red blood cells in the blood (anemia), increase in a type of white blood cells in the blood
(eosinophilia), changes in blood pressure, bleeding, difficulty urinating, blood in the urine,
increased potassium levels in the blood, anxiety, nervousness, nightmares, blurred vision, fast heartbeat
increased, hot flashes, hypersensitivity, skin redness (erythema), skin inflammation
(dermatitis), malaise, fatigue.

Very rare(may affect up to 1 in 10,000 people)
Decrease in platelets in the blood (thrombocytopenia), decrease in all blood cells
(pancytopenia), purpura (diseases characterized by reddish skin spots), sudden, potentially fatal allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a disease of the
brain), visual disturbances, dizziness, shortness of breath (asthma), difficulty breathing (bronchospasm),
inflammation of the stomach (gastritis), abdominal pain, indigestion (dyspepsia), inflammation of the
mouth (stomatitis), blood in the stool, liver disorders (hepatitis, including fulminant hepatitis, jaundice,
blockage of bile flow), hives, swelling of the face, lips, mouth, tongue or throat that can cause difficulty
swallowing and breathing (angioedema), swelling (edema) of the face, severe
reactions of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema
multiforme), inability of the bladder to empty (urinary retention), altered kidney function (renal insufficiency), decreased
urine excretion, interstitial nephritis (a kidney disease), lowering of the
body temperature.

Not known (frequency cannot be estimated from available data)
Fixed drug eruption (may manifest with round or oval patches with redness and swelling of the
skin), skin eruption with blisters (urticaria), sensation of itching.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at http://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 ALMUS

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 “Expiry”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 ALMUS contains
NIMESULIDE ALMUS 100 mg tablets

• The active ingredient is nimesulide. Each tablet contains 100 mg of nimesulide.
• The other ingredients are: lactose, corn starch, magnesium stearate.

NIMESULIDE ALMUS 100 mg granules for oral suspension

• The active ingredient is nimesulide. Each sachet contains 100 mg of nimesulide.
• The other ingredients are: methylcellulose, citric acid, lemon essence, orange flavour, sucrose.

Description of the appearance of NIMESULIDE ALMUS and contents of the pack
NIMESULIDE ALMUS tablets: pack of 30 tablets of 100 mg.
NIMESULIDE ALMUS granules for oral suspension: pack of 30 sachets.

Marketing Authorisation Holder
Almus s.r.l. - Via Cesarea, 11/10 - 16121 Genova
E-mail: [email protected]

Manufacturers
Tablets:
Francia Farmaceutici Industria Farmaco Biologica S.r.l. – Via dei Pestagalli, 7 – 20138 Milano

Granules for oral suspension:
Fine Foods NTM S.p.A. – Via Grignano 43 – 24041 Brembate (BG)