PACKAGE LEAFLET: INFORMATION FOR THE USER

ISODOL 100 mg tablets, 100 mg granules for oral suspension

Nimesulide
Please 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. It could be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What ISODOL is and what it is used for
Before you take ISODOL
How to take ISODOL
Possible side effects
How to store ISODOL
Further information

1. WHAT ISODOL IS AND WHAT IT IS USED FOR

ISODOL is a non-steroidal anti-inflammatory drug ("NSAID") with analgesic properties. It is used for the
treatment of acute pain and menstrual pain.
Before prescribing ISODOL, your doctor will evaluate the potential benefits this medicine may provide you
against the risk of developing adverse effects.

2. BEFORE TAKING ISODOL

Do not use ISODOL if:

you are hypersensitive (allergic) to nimesulide or to any of the excipients of ISODOL (listed in section 6 at the end of this leaflet);
you have previously experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
- wheezing, tightness of the chest, shortness of breath (asthma)
- nasal congestion due to nasal polyps (nasal polyps)
- skin rashes / itchy rash (urticaria)
- sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may cause breathing difficulties (angioedema)
you have previously had reactions after treatment with NSAIDs such as:
- gastric or intestinal bleeding
- stomach or intestinal ulcers (perforations)
you have recently had, or have previously had, gastric or duodenal ulcer or bleeding (at least two episodes of ulcer or bleeding);
you have had a cerebral haemorrhage (stroke);
you have any other bleeding disorder or a condition due to a blood coagulation defect;
you suffer from hepatic insufficiency;
you are taking other medicines known to affect the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs;
you are taking drugs or have developed drug or other substance dependence;
you are a heavy habitual drinker (of alcohol);
you have previously had a liver-related reaction to nimesulide;
you suffer from severe renal insufficiency not requiring dialysis;
you suffer from severe heart failure;
you have fever or influenza (generalised aching, malaise, chills or tremors, or elevated temperature);
you are in the last trimester of pregnancy;
you are breastfeeding.

Do not give ISODOL to a child under 12 years of age.
Warnings
Do not take Isodol or inform your doctor before taking Isodol

if you have previously developed fixed drug eruption (round or oval patches with redness and swelling of the skin, skin eruption with blisters, urticaria and itching sensation) after taking nimesulide. Medicines such as ISODOL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or if you smoke), you should discuss your treatment with your doctor or pharmacist. If severe allergic reactions occur during treatment, stop taking ISODOL and inform your doctor at the first sign of skin rash, lesions of soft tissues (mucous membranes) or any other allergy symptoms. Immediately discontinue treatment with ISODOL in the event of gastrointestinal bleeding (black stools) or ulcer in the digestive tract (causing abdominal pain).

Take special care with ISODOL
If, during treatment with nimesulide, symptoms indicating liver disorder occur, you must
stop taking nimesulide and inform your doctor immediately. Symptoms indicating a
liver disorder include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine.
If you have previously suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory bowel diseases
such as ulcerative colitis or Crohn's disease, inform your doctor before taking ISODOL.
If fever and/or flu-like symptoms (generalised aching, malaise, chills or tremors) occur during treatment with ISODOL,
you must stop taking the product and inform your doctor.
If you suffer from mild heart disorders, high blood pressure, circulatory or kidney problems, inform your
doctor before taking ISODOL.
If you are elderly, your doctor may carry out regular checks to ensure that ISODOL does not cause problems
to your stomach, kidneys, heart or liver.
If you are planning to become pregnant, inform your doctor as ISODOL 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 ISODOL:

Corticosteroids (medicines used to treat inflammatory conditions),
Medicines to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates),
Antihypertensives or diuretics (medicines to control blood pressure or heart conditions),
Lithium, used to treat depression and similar disorders,
Selective serotonin reuptake inhibitors (medicines used to treat depression),
Methotrexate (a medicine used to treat rheumatoid arthritis and cancer),
Cyclosporine (a medicine used after organ transplantation or to treat immune system disorders),
ensure that your doctor or pharmacist knows you are taking these medicines before taking ISODOL.

Taking ISODOL with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking ISODOL or any other medicine.

ISODOL must not be used during the last trimester of pregnancy. It may cause problems for the baby and delivery.
If you are planning a pregnancy, inform your doctor as ISODOL may reduce fertility.
If you are in the first or second trimester of pregnancy, do not exceed the prescribed dose or duration of treatment.
It may cause kidney and heart problems in the fetus. It may affect the tendency of mother and baby to bleed and delay or prolong labour beyond expected limits. You must not take ISODOL during the first 6 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 week 20 of pregnancy onwards, ISODOL may cause kidney problems in the fetus leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or compression of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

ISODOL must not be used during breastfeeding.
Driving and using machines
Do not drive or operate machinery if ISODOL causes you dizziness or drowsiness.
Important information about some excipients in ISODOL
ISODOL tablets and granules for oral suspension contain sugars. If your doctor has informed you that you have an intolerance to certain sugars, contact him before using this medicine.

3. HOW TO TAKE ISODOL

Always take ISODOL exactly as instructed by your doctor. If you have any doubts, 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 usual dose is one 100 mg tablet or one 100 mg sachet of granules for oral suspension, taken twice daily after meals. Use ISODOL for the shortest possible time and for no longer than 15 days in a single treatment cycle.
If you take more ISODOL than you should:
If you take or think you have taken more ISODOL than prescribed (overdose), contact your doctor or hospital immediately. Bring with you any remaining medicine. In case of overdose, you may experience one or more of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer, breathing difficulties.
If you forget to take ISODOL
Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ISODOL may cause adverse reactions, although not everyone experiences 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 adverse reaction requiring 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 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 fatigue.

General adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs):
The use of some NSAIDs may be associated with a slight increase in the risk of arterial thrombosis (e.g. heart attack [myocardial infarction] or stroke [cerebrovascular accident]), particularly at high doses and with long-term treatment.
Fluid retention (oedema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID therapy.
The most commonly observed adverse effects with NSAIDs involve the gastrointestinal tract (gastrointestinal effects):

gastric and duodenal ulcers;
intestinal wall perforation or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Other adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs) include:

Common (may affect more than 1 in 100 patients): diarrhoea, nausea, vomiting, mild changes in blood liver function test values.
Uncommon (may affect up to 1 in 100 patients): shortness of breath, dizziness, increased blood pressure, constipation, flatulence, heartburn (gastritis), itching, skin rash, increased sweating, swelling (oedema); gastric or intestinal bleeding; duodenal or gastric ulcers and perforated ulcers.
Rare (may affect up to 1 in 1,000 patients): anaemia, decreased white blood cells in the blood, increased levels of certain white blood cells (eosinophils) in the blood, changes in blood pressure, haemorrhage, pain during urination or urinary retention, blood in the urine, increased potassium levels in the blood, feeling anxious or nervous, nightmares, blurred vision, increased heart rate, hot flushes, 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 malaise; kidney failure or inflammation (nephritis); disturbances in brain function (encephalopathy); reduced platelet count in the blood, leading to subcutaneous bleeding or bleeding elsewhere in the body, black stools due to bleeding, gastric or intestinal bleeding, duodenal or gastric ulcers, perforated ulcers; liver inflammation (hepatitis), sometimes severe, causing jaundice and bile flow obstruction; allergic reactions, including severe reactions with collapse and breathing difficulties, asthma, reduced body temperature, dizziness, headache, insomnia, stomach pain; indigestion, mouth burning, itching (urticaria); facial swelling and swelling of surrounding areas, visual disturbances.
Frequency not known: drug-induced fixed eruption (may present as round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), itching sensation. If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at: www.aifa.gov.it/en/content/adverse-reaction-reports. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ISODOL

ISODOL does not require any special storage conditions.
Keep ISODOL out of the reach and sight of children.
Do not use ISODOL after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines must 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. OTHER INFORMATION

What ISODOL contains
The active substance is Nimesulide.
The excipients are:
Tablets: sodium dioctyl sulfosuccinate, hydroxypropylcellulose, lactose, sodium starch glycolate, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate
Granules for oral suspension: cetomacrogol 1000, sucrose, citric acid, orange flavor, maltodextrins

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

Marketing Authorization Holder
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia

Manufacturer

MITIM S.r.l. - Via Cacciamali 34-36-38 - 25125 Brescia
Fine Foods & Pharmaceuticals NTM S.p.A. Via Grignano, 43 - 24041 Brembate (BG) The letter A preceding the batch number identifies the manufacturing site MITIM.

This summary of product characteristics was last approved on