PACKAGE LEAFLET: INFORMATION FOR THE USER

NIMESULIDE DOC Generici 100 mg tablets, granules for oral suspension

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, consult your doctor or pharmacist.
This medicine has been prescribed for you personally. Never give it to others. It may 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 effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT NIMESULIDE DOC Generici IS AND WHAT IT IS USED FOR

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

2. BEFORE TAKING NIMESULIDE DOC Generici

Do not use NIMESULIDE DOC Generici if

you are hypersensitive (allergic) to nimesulide or to any of the excipients in NIMESULIDE DOC Generici (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 in the chest, shortness of breath (asthma)
nasal congestion due to nasal polyps (nasal mucosal growths)
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);
you have previously had reactions to NSAID treatment 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 cerebral haemorrhage (stroke);
you have any other bleeding disorder or coagulation problems;
you suffer from hepatic insufficiency;
you are currently taking other medicines known to affect the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs;
you are using 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 influenza (general malaise, discomfort, chills or tremors, or high temperature);
you are in the last trimester of pregnancy;
you are breastfeeding.

Do not give NIMESULIDE DOC Generici to a child under 12 years of age.

Warnings
Medicines such as NIMESULIDE DOC Generici may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The 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, high cholesterol, or if you smoke), discuss your treatment with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking NIMESULIDE DOC Generici and inform your doctor immediately at the first sign of skin rash, lesions of soft tissues (mucous membranes), or any other allergy symptoms.
Do not take NIMESULIDE DOC Generici or inform your doctor before taking it 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.
Immediately discontinue treatment with NIMESULIDE DOC Generici if gastrointestinal bleeding (black stools) or ulceration of the digestive tract (causing abdominal pain) occurs.

Take special care with NIMESULIDE DOC Generici

If, during treatment with nimesulide, you experience symptoms suggestive of liver disorder, stop taking nimesulide and contact your doctor immediately. Symptoms indicating liver problems 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 DOC Generici.
If, during treatment with NIMESULIDE DOC Generici, you develop fever and/or flu-like symptoms (general malaise, discomfort, chills or tremors), stop taking the medicine and inform your doctor.
If you suffer from mild heart conditions, high blood pressure, circulatory or kidney problems, inform your doctor before taking NIMESULIDE DOC Generici.
If you are elderly, your doctor may carry out regular checks to ensure that NIMESULIDE DOC Generici is not causing problems to your stomach, kidneys, heart, or liver.
If you plan to become pregnant, inform your doctor, as NIMESULIDE DOC Generici 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 DOC Generici:

corticosteroids (medicines used to treat inflammatory conditions),
blood-thinning medicines (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates),
antihypertensives or diuretics (medicines for controlling blood pressure or heart conditions),
lithium (used to treat depression and similar disorders),
selective serotonin reuptake inhibitors (medicines used to treat depression),
methotrexate (used to treat rheumatoid arthritis and in cancer therapy),
cyclosporine (used after organ transplantation or to treat immune system disorders),

ensure that your doctor or pharmacist is aware that you are taking these medicines before starting NIMESULIDE DOC Generici.

Taking NIMESULIDE DOC Generici with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those not requiring a prescription.

Pregnancy, breastfeeding and fertility
Consult your doctor or pharmacist before taking NIMESULIDE DOC Generici or any other medicine.
Do not take NIMESULIDE DOC Generici during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth.
It may cause kidney and heart problems in the fetus. It could affect your or your baby's tendency to bleed and may delay or prolong labour beyond the expected time.
You should not take NIMESULIDE DOC Generici during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or when trying to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, NIMESULIDE DOC Generici may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction 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.
NIMESULIDE DOC Generici must not be used during breastfeeding.
If you are planning a pregnancy, inform your doctor, as NIMESULIDE DOC Generici may reduce fertility.

Driving and using machines
Do not drive or operate machinery if NIMESULIDE DOC Generici causes you dizziness or drowsiness.

Important information about some excipients in NIMESULIDE DOC Generici
NIMESULIDE DOC Generici tablets and oral suspension granules contain sugars.
If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before using this medicine.

3. HOW TO USE NIMESULIDE DOC Generici

Always take NIMESULIDE DOC Generici exactly as directed 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 NIMESULIDE DOC Generici for the shortest possible duration and for no longer than 15 days in a single treatment cycle.
If you take more NIMESULIDE DOC Generici than you should
If you take or think you have taken more NIMESULIDE DOC Generici 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 DOC Generici
Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, NIMESULIDE DOC Generici 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 rashes 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), 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 gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

Other adverse reactions that may occur with NIMESULIDE DOC Generici include:

Common (may affect more than 1 in 100 patients): diarrhoea, nausea, vomiting, slight 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, stomach burning (gastritis), itching, skin rashes, increased sweating, swelling (oedema), stomach or intestinal bleeding, gastric or duodenal ulcers, and perforated ulcers.
Rare (may affect up to 1 in 1,000 patients): anaemia, reduced white blood cell count, increased levels of certain white blood cells (eosinophils) in the blood, changes in blood pressure, haemorrhage, painful urination or urinary retention, blood in the urine, increased potassium levels in the blood, feelings of anxiety or restlessness, 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 leading to subcutaneous or other internal bleeding, black stools due to bleeding; liver inflammation (hepatitis), sometimes very 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 and surrounding area swelling, visual disturbances.
Frequency not known: drug eruption (may present as round or oval patches with redness and swelling of the skin), blistering skin rash (urticaria), sensation of itching.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 DOC Generici

NIMESULIDE DOC Generici does not require any special storage conditions.
Keep NIMESULIDE DOC Generici out of the reach and sight of children.
Do not use NIMESULIDE DOC Generici 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 NIMESULIDE DOC Generici contains
NIMESULIDE DOC Generici 100 mg tablets

The active substance is nimesulide. Each tablet contains 100 mg of nimesulide.
The excipients are: microcrystalline cellulose, corn starch, lactose, sodium lauryl sulfate, magnesium stearate, compritol 888 ATO.

NIMESULIDE DOC Generici 100 mg granules for oral suspension

The active substance is nimesulide. Each sachet of granules for oral suspension contains 100 mg of nimesulide.
The excipients are: monohydrate citric acid, polyethylene glycol 4000, maltodextrin, orange flavour, sorbitol, cetomacrogol 1000.

Description of the appearance of NIMESULIDE DOC Generici and contents of the pack
NIMESULIDE DOC Generici 100 mg tablets: round, cream-yellow tablet, with a break line on one side and smooth on the other.
One pack contains 30 tablets.
NIMESULIDE DOC Generici 100 mg granules for oral suspension: sachet containing a yellowish or cream-yellow powder.
One pack contains 30 sachets.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano.

Manufacturer
Tablets:
LABORATORIO FARMACEUTICO C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM).
Granules for oral suspension:
MIPHARM S.p.A. – Via B. Quaranta, 12 – Milano.
LAMP SAN PROSPERO S.p.A. - Via della Pace, 25/A - S.Prospero S/S (MO).

This Patient Information Leaflet was last approved on