PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NIMESULIDE ALMUS 100 mg tablets, granules for oral suspension

Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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 you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

NIMESULIDE ALMUS contains the active substance nimesulide and belongs to the class of medicines known as NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), which have analgesic properties.
NIMESULIDE ALMUS is indicated for the treatment of acute pain and menstrual pain.
Before prescribing NIMESULIDE ALMUS, your doctor will evaluate the potential benefits this medicine may provide against the risk of developing adverse effects.

2. What you need to know before taking NIMESULIDE ALMUS

Do not take NIMESULIDE ALMUS

if you are allergic to nimesulide or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced any of the following symptoms after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs):
wheezing (noisy breathing), chest tightness, breathlessness (asthma)
nasal congestion due to growths on 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 treatment with NSAIDs such as:
gastric or intestinal bleeding
stomach or intestinal ulcers (perforations)
if you have recently had or have previously had gastric or duodenal ulcer or bleeding (at least two episodes of ulcer or bleeding);
if you have had a cerebral haemorrhage (stroke);
if you have any other bleeding disorder or a condition caused by a blood coagulation defect;
if you suffer from hepatic insufficiency (liver dysfunction);
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 drug or other substance dependence;
if you are a heavy habitual drinker (of alcohol);
if you have previously had a reaction to nimesulide that caused liver problems;
if you have severe renal insufficiency (kidney dysfunction) not requiring dialysis;
if you have severe heart failure;
if you have fever or influenza (generalised aches, malaise, chills or tremors, 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 especially careful with NIMESULIDE ALMUS:

if during treatment you develop a severe, potentially life-threatening skin reaction. You must stop taking NIMESULIDE ALMUS at the first sign of skin rash, skin peeling, blisters, or bleeding of the lips, eyes, mouth, nose or genitals, or any other symptom of an allergic reaction.
if during treatment with NIMESULIDE ALMUS you develop symptoms indicating liver problems. These symptoms include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine. You must stop taking NIMESULIDE ALMUS and contact your doctor immediately.
if during treatment with NIMESULIDE ALMUS you develop fever and/or flu-like symptoms (generalised aches, malaise, chills or tremors). You must stop taking the medicine and contact your doctor.
if during treatment with NIMESULIDE ALMUS you experience stomach or intestinal problems such as black stools or abdominal pain (peptic ulcer or bleeding). You must stop taking the medicine and contact your doctor.
if you have previously suffered from peptic ulcer, gastric or intestinal bleeding, ulcerative colitis or Crohn's disease. You must inform your doctor before taking NIMESULIDE ALMUS.
if you are elderly. Your doctor may carry out regular checks to ensure that NIMESULIDE ALMUS is not causing problems to your stomach, kidneys, heart or liver.
if you have kidney problems. You must inform your doctor before taking NIMESULIDE ALMUS, as kidney function may worsen during treatment with NIMESULIDE ALMUS.
if you have heart or circulatory 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 previously developed fixed drug eruption (round or oval patches with redness and swelling of the skin, blistering skin rash, urticaria and itching) after taking nimesulide.
Children
NIMESULIDE ALMUS is not recommended for 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, inform your doctor as they may interact with NIMESULIDE ALMUS:

corticosteroids (medicines used to treat inflammatory conditions);
medicines to thin the blood (anticoagulants, e.g. warfarin, antiplatelet agents, acetylsalicylic acid (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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take NIMESULIDE ALMUS during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour.
You should not take NIMESULIDE ALMUS during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used.
From the 20th week of pregnancy onwards, NIMESULIDE ALMUS may cause kidney problems in the unborn baby if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause 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.
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, as NIMESULIDE ALMUS may reduce fertility.

Driving and using machines
NIMESULIDE ALMUS may cause dizziness or drowsiness. If this occurs, avoid driving or operating machinery.
NIMESULIDE ALMUS tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
NIMESULIDE ALMUS oral suspension granules contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take NIMESULIDE ALMUS

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. To reduce unwanted side effects, the lowest effective dose for the shortest duration necessary to control symptoms should be used.
The recommended dose is one 100 mg tablet or one sachet twice daily, taken after meals.

Elderly:
In elderly patients, there is no need to reduce the daily dose.

Take NIMESULIDE ALMUS for the shortest possible duration and for no longer than 15 days in a single treatment cycle.

If you take more NIMESULIDE ALMUS than you should
If you (or someone else) have taken an excessive dose of NIMESULIDE ALMUS, or if you suspect that a child has taken an excessive dose, contact your doctor immediately or go to the nearest hospital Emergency Department.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so they know which medicine has been taken.
Symptoms of acute NSAID overdose are usually limited to drowsiness, lethargy, nausea, vomiting, and stomach problems (pain), which are generally reversible with appropriate treatment. Bleeding from the stomach and intestines may also occur. Rarely, high blood pressure, kidney problems, breathing difficulties, and coma may occur.
After ingestion of NSAIDs at therapeutic doses, severe, rapidly occurring allergic reactions (anaphylaxis) have been reported, which could also manifest following overdose.

If you forget to take NIMESULIDE ALMUS
Do not take a double dose to make up for the forgotten 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 everyone experiences them.
If any of the following symptoms occur, stop taking NIMESULIDE ALMUS 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 bleeding, or black stools, worsening of colitis or Crohn's disease;
Skin reactions such as rashes or redness, severe blistering reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis);
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 fatigue.

The use of some NSAIDs may be associated with a small increased risk of heart problems (occlusion of arterial vessels (thrombosis), myocardial infarction or stroke), particularly at high doses and with long-term treatment.
Fluid retention (oedema), high blood pressure (hypertension) and reduced heart function (heart failure) have been reported during treatment with NSAIDs.
The most commonly observed side effects with NSAIDs involve the gastrointestinal tract (gastrointestinal effects):

Formation of lesions in the stomach and intestine (gastric and duodenal ulcers);
Perforation of intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Side effects that may occur with NIMESULIDE ALMUS are:
Common (may affect up to 1 in 10 people)
Diarrhoea, nausea, vomiting, increased liver enzymes in the blood (indicating liver function).
Uncommon (may affect up to 1 in 100 people)
Dizziness, increased blood pressure, shortness of breath, constipation, bloating (gas in the intestine), itching, skin rash, increased sweating, swelling (oedema), stomach or intestinal bleeding, duodenal or gastric ulcer and perforation.
Rare (may affect up to 1 in 1,000 people)
Decrease in red blood cells in the blood (anaemia), 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, rapid heartbeat, hot flushes, 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 characterised by red skin spots), sudden potentially life-threatening allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disease), visual disturbances, dizziness, breathlessness (asthma), breathing difficulties (bronchospasm), inflammation of the stomach (gastritis), abdominal pain, indigestion (dyspepsia), inflammation of the mouth (stomatitis), blood in the stools, liver disorders (hepatitis, fulminant hepatitis including fatal cases, jaundice, blockage of bile flow), urticaria, swelling of the face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioedema), facial swelling (oedema), severe skin and/or mucous membrane reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), inability of the bladder to empty (urinary retention), altered kidney function (renal failure), reduced urinary excretion, interstitial nephritis (a kidney disease), lowering of body temperature.
Not known (frequency cannot be estimated from the available data)
Drug-induced fixed eruption (may appear as round or oval patches with redness and swelling of the skin), blistering skin rash (urticaria), itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 stated on the packaging after "Expiry". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIMESULIDE ALMUS contains
NIMESULIDE ALMUS 100 mg tablets

The active substance is nimesulide. Each tablet contains 100 mg of nimesulide.
The other components are: lactose, maize starch, magnesium stearate.

NIMESULIDE ALMUS 100 mg granules for oral suspension

The active substance is nimesulide. Each sachet contains 100 mg of nimesulide.
The other components are: methylcellulose, citric acid, lemon flavour, orange flavour, sucrose.

Description of the appearance of NIMESULIDE ALMUS and contents of the pack
NIMESULIDE ALMUS tablets: pack containing 30 tablets of 100 mg.
NIMESULIDE ALMUS granules for oral suspension: pack containing 30 sachets.
Marketing Authorization Holder
Almus s.r.l. - Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]
Manufacturers
Tablets:
Francia Farmaceutici Industria Farmaco Biologica S.r.l. – Via dei Pestagalli, 7 – 20138 Milan
Granules for oral suspension:
Fine Foods NTM S.p.A. – Via Grignano 43 – 24041 Brembate (BG)