Patient Information Leaflet

Nimesulide ratiopharm 100 mg 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What Nimesulide ratiopharm is and what it is used for
What you need to know before taking Nimesulide ratiopharm
How to take Nimesulide ratiopharm
Possible side effects
How to store Nimesulide ratiopharm
Package contents and other information

1. What Nimesulide ratiopharm is and what it is used for

Nimesulide ratiopharm 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 ratiopharm, 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 ratiopharm

Do not use Nimesulide ratiopharm

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 or other non-steroidal anti-inflammatory drugs (NSAIDs):
- difficulty breathing (bronchospasm), runny or stuffy nose (rhinitis);
- nasal congestion due to nasal polyps (nasal polyps);
- itchy skin rash (urticaria);
if you have previously had the following reactions to treatment with NSAIDs:
- gastric or intestinal bleeding;
- stomach or intestinal ulcers (perforations);
if you have recently had, or have had in the past, 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 blood coagulation disorder;
if you suffer from hepatic failure;
if you are taking other medicines known to affect the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs;
if you are taking drugs or have developed drug or substance dependence;
if you are a heavy habitual drinker (of alcohol);
if you have previously had a liver-related reaction to nimesulide;
if you suffer from severe renal failure;
if you suffer from severe heart failure;
if you have fever or influenza (general malaise, chills or tremors, or fever, high temperature);
if you are in the last three months of pregnancy;
if you are breastfeeding.

Do not give Nimesulide ratiopharm to a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nimesulide ratiopharm.
Do not take Nimesulide ratiopharm or inform your doctor before taking Nimesulide ratiopharm if you have
previously developed a fixed drug eruption (round or oval red, swollen skin patches, skin rash with blisters, urticaria and itching) after taking nimesulide.
Medicines such as Nimesulide ratiopharm may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.
If you have heart problems, circulatory 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), discuss your treatment with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking Nimesulide ratiopharm and inform your doctor at the first sign of skin rash, lesions of soft tissues (mucous membranes), or any other symptoms of allergy.
Stop treatment with Nimesulide ratiopharm immediately if you experience gastrointestinal bleeding (black stools) or gastrointestinal ulcer (causing abdominal pain).
Stop treatment with Nimesulide ratiopharm immediately and inform your doctor if you experience worsening headache, as prolonged use of medicines to relieve headache may in some cases worsen it.
Take special care with Nimesulide ratiopharm
If symptoms indicating liver disorder occur during treatment with nimesulide, stop taking nimesulide and inform 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 ratiopharm.
If fever and/or flu-like symptoms (general malaise, chills or tremors) occur during treatment with Nimesulide ratiopharm, stop taking the product and inform your doctor.
If you suffer from kidney problems, inform your doctor before taking Nimesulide ratiopharm.
If you are elderly, your doctor may carry out regular checks to ensure that Nimesulide ratiopharm is not causing problems with your stomach, kidneys, heart or liver.
If you plan to become pregnant, inform your doctor, as Nimesulide ratiopharm may reduce fertility.
Other medicines and Nimesulide ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, inform your doctor as they may interact with Nimesulide ratiopharm:

corticosteroids (medicines used to treat inflammatory conditions);
blood-thinning medicines (anticoagulants, e.g. warfarin, or antiplatelet agents, acetylsalicylic acid 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 (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 or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Nimesulide ratiopharm 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 more than expected.
You should not take Nimesulide ratiopharm during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy onwards, Nimesulide ratiopharm may cause kidney problems in the unborn baby if taken for more than a few days, reducing the level of amniotic fluid surrounding the baby (oligohydramnios), or cause 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 recommend additional monitoring.
Nimesulide ratiopharm must not be used during breastfeeding.
If you are planning a pregnancy, inform your doctor, as Nimesulide ratiopharm may reduce fertility.
Driving and using machines
Do not drive or operate machinery if Nimesulide ratiopharm causes dizziness, vertigo or drowsiness.
Nimesulide ratiopharm oral suspension granules contain sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Nimesulide ratiopharm

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
To reduce the risk of unwanted effects, the lowest effective dose should be used for the shortest duration necessary to control symptoms.
The recommended dose is one sachet containing 100 mg of granules for oral suspension, taken twice daily after meals.
Instructions for using the sachet: dissolve the contents of the sachet in a glass of water.
Use Nimesulide ratiopharm for the shortest possible time and for no longer than 15 days in a single treatment cycle.
If you take more Nimesulide ratiopharm than you should
If you take or think you have taken more Nimesulide ratiopharm than prescribed (overdose), contact your doctor or go to a hospital immediately. Bring with you any remaining medicine. In case of overdose, you may experience one or more of the following symptoms: drowsiness, numbness, nausea, vomiting, stomach pain, gastrointestinal bleeding, high blood pressure, kidney problems, breathing difficulties, and coma.
If you forget to take Nimesulide ratiopharm
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following symptoms occur, stop taking the medicine and inform your doctor immediately, as they may indicate a rare serious side effect requiring urgent medical attention:

abdominal pain, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, gastrointestinal or intestinal bleeding, blood in the stools, vomiting blood, mouth sores or burning sensation inside the mouth, worsening of certain inflammatory bowel conditions such as colitis or Crohn's disease;
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 (oedema);
fatigue.

General side 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. Very rare cases of blistering skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
The most commonly observed side 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 side effects that may occur with Nimesulide ratiopharm

Common (may affect more than 1 in 100 patients):
- diarrhoea, nausea, vomiting;
- increased blood levels of liver enzymes.
Uncommon (may affect up to 1 in 100 patients):
- shortness of breath (dyspnoea);
- dizziness;
- increased blood pressure;
- constipation (stipsis), presence of gas in the intestine (flatulence), stomach or intestinal bleeding, ulcers and perforations of the duodenum or stomach;
- itching, skin rashes, increased sweating;
- swelling (oedema).
Rare (may affect up to 1 in 1,000 patients):
- anaemia, increased levels of certain white blood cells (eosinophils) in the blood;
- hypersensitivity reactions;
- changes in blood pressure;
- haemorrhage, hot flushes;
- difficulty and pain during urination (dysuria), blood in the urine;
- increased potassium levels in the blood;
- anxiety, nervousness, nightmares;
- blurred vision;
- increased heart rate;
- skin redness (erythema), skin inflammation (dermatitis);
- malaise, fatigue.
Very rare (may affect up to 1 in 10,000 patients):
- severe skin reaction affecting the mouth and other parts of the body (erythema multiforme); severe skin reaction characterised by blisters and bleeding of the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome); severe skin reaction (toxic epidermal necrolysis); itching (urticaria); facial swelling; swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing and breathing (angioedema);
- inability of the bladder to empty (urinary retention);
- decreased urine output (oliguria);
- renal failure, inflammation of the kidney tubules and surrounding tissues (tubulo-interstitial nephritis);
- reduced platelet count in the blood (thrombocytopenia), reduced number of all blood cells (pancytopenia), skin or mucosal lesions, purplish in colour, caused by bleeding (purpura);
- inflammation of the liver (hepatitis), sometimes very severe (fulminant hepatitis), including fatal cases; jaundice; blockage of bile flow;
- allergic reactions, including severe reactions with collapse and breathing difficulties (anaphylactic reactions);
- asthma, breathing difficulties (bronchospasm);
- reduced body temperature;
- vertigo;
- headache, drowsiness, disturbances in brain function (encephalopathy, including Reye's syndrome);
inflammation of the stomach (gastritis), abdominal pain, indigestion (dyspepsia), inflammation of the mouth (stomatitis), black stools due to bleeding (melena);
visual disturbances.
- Not known (frequency cannot be determined from the available data): drug-induced fixed eruption (may present as round or oval patches with redness and swelling of the skin), skin eruption with blisters (urticaria), itching sensation.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 ratiopharm

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton. 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 ratiopharm contains
Active substance: nimesulide 100 mg.
Excipients: cetomacrogol 1000, sucrose, maltodextrin, citric acid, orange flavour.
Description of the appearance of Nimesulide ratiopharm and contents of the pack
30 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco Strasse 3, Ulm (Germany)
Manufacturer
ITC Production S.r.l. - Via Pontina Km 29 - 00071 Pomezia (RM)