Package leaflet: Information for the patient

Nimesulide Sandoz 100 mg oral solution granules

Generic medicine
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 only. Do not give it to other people, 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.

Contents of this leaflet:

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

1. WHAT NIMESULIDE SANDOZ IS AND WHAT IT IS USED FOR

Nimesulide Sandoz 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 Nimesulide Sandoz, your doctor will evaluate the potential benefits this medicine may provide you against the risk of developing adverse effects.

2. WHAT YOU NEED TO KNOW BEFORE TAKING NIMESULIDE SANDOZ

Do not use Nimesulide Sandoz if

you are hypersensitive (allergic) to nimesulide or to any of the excipients of Nimesulide Sandoz (listed in section 6, at the end of this leaflet);
you have experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
- wheezing, tightness in the chest, breathlessness (asthma)
- nasal congestion due to nasal polyps (growths in the nasal mucosa)
- skin rash / itching (urticaria)
- sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may cause difficulty in breathing (angioedema)
you have previously had reactions following treatment with NSAIDs such as:
- gastrointestinal bleeding
- stomach or intestinal ulcers (perforations)
you have recently had, or have had in the past, 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 caused by 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 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 flu (general malaise, chills or tremor, or high temperature);
you are in the last trimester of pregnancy;
you are breastfeeding;
you have previously developed drug-induced fixed eruption (round or oval patches with redness and swelling of the skin, blistering skin rash, urticaria and itching) after taking nimesulide.

Do not give Nimesulide Sandoz to a child under 12 years of age.
Warnings and precautions
Medicines such as Nimesulide Sandoz may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is more likely with higher 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, high cholesterol or if you smoke), discuss your treatment with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking Nimesulide Sandoz and inform your doctor at the first sign of skin rash, lesions of soft tissues (mucous membranes) or any other symptoms of allergy.
Immediately discontinue treatment with Nimesulide Sandoz if gastrointestinal bleeding (black stools) or ulceration of the digestive tract (causing abdominal pain) occurs.
Take special care with Nimesulide Sandoz
If symptoms indicating liver disorder occur during treatment with nimesulide, you must stop taking nimesulide and contact your doctor immediately. Symptoms indicating 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 Nimesulide Sandoz.
If fever and/or flu-like symptoms (general malaise, chills or tremor) occur during treatment with Nimesulide Sandoz, stop taking the product and inform your doctor.
If you have mild heart conditions, high blood pressure, circulatory or kidney problems, inform your doctor before taking Nimesulide Sandoz.
If you are elderly, your doctor may carry out regular checks to ensure that Nimesulide Sandoz does not cause problems with your stomach, kidneys, heart or liver.
If you are planning to become pregnant, inform your doctor, as Nimesulide Sandoz 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 Nimesulide Sandoz:

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 starting Nimesulide Sandoz.
Other medicines and Nimesulide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking Nimesulide Sandoz or any other medicine.

Nimesulide Sandoz 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 Nimesulide Sandoz may reduce fertility.
If you are in the first or second trimester of pregnancy, do not exceed the dose or duration of treatment prescribed by your doctor.

Nimesulide Sandoz must not be used during breastfeeding.
Driving and using machines
Do not drive or operate machinery if Nimesulide Sandoz causes dizziness or drowsiness.
Important information about some excipients of Nimesulide Sandoz
This medicine contains sucrose (sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE NIMESULIDE SANDOZ

Always take Nimesulide Sandoz exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
To reduce the risk of adverse effects, the lowest effective dose for the shortest duration necessary to control symptoms should be used.
The recommended dose is one sachet containing 100 mg of granules for oral suspension, taken twice daily after meals. Use Nimesulide Sandoz for the shortest possible duration and for no longer than 15 days in a single treatment cycle.

If you take more Nimesulide Sandoz than you should
If you take or think you have taken more Nimesulide Sandoz than prescribed (overdose), contact your doctor or hospital immediately. Take any remaining medicine with you. 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 Nimesulide Sandoz
Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Nimesulide Sandoz 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, gastrointestinal 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 reactions associated with non-steroidal anti-inflammatory drugs (NSAIDs):
The use of some NSAIDs may be associated with a modest increase in the risk of arterial thrombosis (e.g. heart attack [myocardial infarction] or stroke), 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
perforation of the intestinal wall or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

Other adverse reactions associated with non-steroidal anti-inflammatory drugs (NSAIDs) include:
Common (may affect more than 1 in 100 patients)
Diarrhoea, nausea, vomiting, slight changes in blood test values indicating liver function abnormalities.
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), bleeding from the stomach or intestine; duodenal or gastric ulcers and perforated ulcers.
Rare (may affect up to 1 in 1,000 patients)
Anaemia, decreased white blood cell count, 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, feelings of anxiety or nervousness, 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 gastrointestinal bleeding; liver inflammation (hepatitis), sometimes severe, causing jaundice and impaired bile flow; 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.
Not known (frequency cannot be estimated from available data)
Drug-induced fixed drug eruption (may present as round or oval spots with redness and swelling of the skin), blistering skin rash (urticaria), sensation of itching.

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, pharmacist, or nurse. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NIMESULIDE SANDOZ

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Nimesulide Sandoz after the expiry date stated on the carton 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 you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Nimesulide Sandoz contains
Nimesulide Sandoz 100 mg granules for oral solution
Each sachet contains: Active substance: nimesulide 100 mg. Excipients: sucrose, citric acid monohydrate,
orange flavour, cetomacrogol 1000.
Description of the appearance of Nimesulide Sandoz and contents of the pack
Each pack of Nimesulide Sandoz 100 mg granules for oral solution contains: 30 sachets.
Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Manufacturer
Nimesulide Sandoz 100 mg granules for oral solution:
MIPHARM S.p.A. – Via B. Quaranta, 12 – 20141 Milano