Nimedex

Patient Information Leaflet: Information for the User

Nimedex 400 mg tablets, 400 mg granules for oral suspension

nimesulide ß-cyclodextrin
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 yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Nimedex is and what it is used for
2. What you need to know before taking Nimedex
3. How to take Nimedex
4. Possible side effects
5. How to store Nimedex
6. Contents of the pack and other information

1. What Nimedex is and what it is used for

Nimedex is a non-steroidal anti-inflammatory drug ("NSAID") with analgesic properties. It is used for the treatment of acute pain and menstrual pain.
Your doctor will prescribe Nimedex only if other medications have not been effective.
Before prescribing Nimedex, your doctor will evaluate the potential benefits this medicine may provide you against the risk of developing unwanted side effects.

2. What you should know before taking Nimedex

Do not take Nimedex if:

• you are allergic to nimesulide or to any of the other ingredients of this medicine (listed in section 6);
• you have previously experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
• bronchospasm, a breathing problem causing wheezing, tightness in the chest, or shortness of breath (asthma);
• nasal congestion due to growths in the nasal mucosa (nasal polyps);
• itchy skin rash (urticaria);
• rhinitis;
• you have previously had reactions to NSAID treatment such as:
• gastrointestinal or intestinal bleeding;
• stomach or intestinal ulcers (perforations);
• you currently have or have previously had recurrent active gastric or duodenal ulcers or bleeding (at least two episodes of ulcer or bleeding);
• you have previously had a cerebral haemorrhage (stroke);
• you have any other bleeding disorder or a blood clotting disorder;
• you suffer from hepatic insufficiency (reduced liver function);
• you are taking other medicines known to affect the liver, for example 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 (alcohol);
• you have previously had a liver-related reaction to nimesulide;
• you are exposed to other substances potentially harmful to the liver;
• you suffer from severe renal insufficiency (reduced kidney function);
• you suffer from severe heart failure;
• you have fever or flu-like symptoms (general malaise, chills or tremors, or high temperature);
• you are in the last trimester of pregnancy;
• you are breastfeeding.

Do not give Nimedex to a child under 12 years of age (see “Children and adolescents”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Nimedex.
Do not take Nimedex or consult your doctor before taking Nimedex

• If you have previously developed fixed drug eruption (round or oval patches with redness and swelling of the skin, skin rash with blisters, urticaria, and itching) after taking nimesulide.

You should avoid taking Nimedex together with other non-steroidal anti-inflammatory drugs (NSAIDs). Concomitant use of analgesics is not recommended.
Medicines such as Nimedex 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. Your doctor will tell you to stop treatment if no benefit is observed.
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 Nimedex 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 Nimedex immediately if you experience gastrointestinal bleeding (black stools) or ulcers in the digestive tract (causing abdominal pain).
Take special care with Nimedex
If symptoms indicating liver problems occur during treatment with Nimedex, stop taking the medicine and inform your doctor immediately, who may advise you to discontinue treatment. Symptoms indicating liver problems include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, dark urine, and abnormal liver function tests.
If you have previously suffered from ulcers, gastric or intestinal bleeding, perforation, or inflammatory bowel diseases such as ulcerative colitis or Crohn’s disease, inform your doctor before taking Nimedex.
Your doctor may advise starting treatment with the lowest available dose and may recommend gastroprotective agents such as misoprostol or proton pump inhibitors. These protective agents may also be recommended if you are taking low-dose aspirin or other medicines that may increase the risk of gastrointestinal events.
If you have previously had gastrointestinal problems, inform your doctor of any unusual abdominal symptoms, especially gastrointestinal bleeding, particularly in the early stages of treatment.
If fever and/or flu-like symptoms (general malaise, chills or tremors) occur during treatment with Nimedex, stop taking the medicine and inform your doctor.
If you suffer from heart conditions, high blood pressure, blood clotting disorders, circulatory or kidney problems, or are at risk of cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), inform your doctor before taking Nimedex.
If you notice the onset of skin-related adverse reactions such as rash, mucosal lesions, or any other signs of hypersensitivity, contact your doctor immediately.
If you are planning a pregnancy, inform your doctor, as Nimedex may reduce fertility (see “Pregnancy, breastfeeding and fertility”).
If you have an intolerance to certain sugars, consult your doctor before taking this medicine (see “Nimedex contains sugars”).
Children and adolescents
Nimedex must not be taken by children under 12 years of age (see “Do not take Nimedex”).
Other medicines and Nimedex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Before taking Nimedex, ensure that your doctor or pharmacist knows if you are taking any of the following medicines, which may interact with Nimedex:

• Other non-steroidal anti-inflammatory drugs (NSAIDs);
• Corticosteroids (medicines used to treat inflammatory conditions);
• Medicines to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates);
• Antihypertensives such as angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists (AIIAs), or diuretics (medicines for controlling blood pressure or heart conditions);
• Lithium, used to treat depression or 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).

Inform your doctor if you are taking other medicines such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin.
Elderly
If you are elderly, you may be at increased risk of adverse reactions with all medicines belonging to the non-steroidal anti-inflammatory drug (NSAID) class. Before taking Nimedex, inform your doctor, who may recommend regular monitoring to ensure that Nimedex does not cause problems to your stomach, kidneys, heart, or liver.
Your doctor may advise starting treatment with the lowest available dose and may recommend gastroprotective agents such as misoprostol or proton pump inhibitors. These protective agents may also be recommended if you are taking low-dose aspirin or other medicines that may increase the risk of gastrointestinal events.
If you have previously had gastrointestinal problems, inform your doctor of any unusual abdominal symptoms, especially gastrointestinal bleeding, particularly in the early stages of treatment.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Nimedex may have a negative effect on pregnancy, and the risk is believed to increase with dose and duration of treatment.

• Do not use Nimedex during the last trimester of pregnancy. It may cause problems for the baby and for delivery.
• If you are in the first or second trimester of pregnancy, your doctor will prescribe NIMEDEX only if strictly necessary.

Breastfeeding
NIMEDEX is contraindicated during breastfeeding.
Fertility
If you are planning a pregnancy, inform your doctor, as Nimedex may reduce fertility.
Driving and using machines
Do not drive or operate machinery if Nimedex causes you dizziness or drowsiness.
Nimedex tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Nimedex oral suspension granules contain sorbitol and aspartame.
This medicine contains 15 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body’s inability to properly metabolize it.
This medicine contains 2560 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
This medicine may cause gastrointestinal disturbances and has a mild laxative effect.

3. How to take Nimedex

Take this medicine exactly as your doctor or pharmacist has told you.
If you are in doubt, consult your doctor or pharmacist.
To reduce unwanted effects, use the lowest effective dose for the shortest time needed to control your symptoms.
The recommended dose is one Nimedex tablet or one sachet of Nimedex granules for oral suspension, twice daily, after meals.
The contents of one sachet should be dissolved in a glass of water.
Use Nimedex for the shortest possible duration and for no more than 15 days in a single treatment cycle.
If you take more Nimedex than you should
If you take or think you have taken more Nimedex than prescribed (overdose), contact your doctor or the nearest hospital immediately. Take with you any remaining medicine. In case of overdose, you may experience one of the following symptoms: drowsiness, lethargy, nausea, vomiting, stomach pain, gastric ulcer, breathing difficulties, gastrointestinal bleeding. Rarely, hypertension, acute renal failure, respiratory failure, and coma may occur. Anaphylactic reactions may also occur.
If you forget to take Nimedex
Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following symptoms, stop taking the medicine 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 or intestinal bleeding, or black stools;
• skin reactions such as rashes or redness;
• wheezing or shortness of breath;
• yellowing of the skin or whites of the eyes (jaundice);
• unexpected change in the amount or colour of urine;
• swelling of the face, feet or legs;
• persistent fatigue.

General side effects of non-steroidal anti-inflammatory drugs (NSAIDs):
The use of some NSAIDs may be associated with a small increased risk of arterial thrombotic events (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 (weakened heart) have been reported in association with NSAID therapy. Very rare cases of blistering skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
The most commonly observed side 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).

Following administration of NIMEDEX, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastritis has been observed less frequently.
The side effects that may occur with Nimedex are:
Common (may affect more than 1 in 100 people):

• diarrhoea,
• nausea,
• vomiting,
• slight changes in blood test values indicating liver function.

Uncommon (may affect up to 1 in 100 people):

• shortness of breath,
• dizziness,
• increased blood pressure,
• constipation,
• flatulence,
• bleeding of the stomach or intestines,
• duodenal or gastric ulcers,
• perforated ulcers,
• heartburn (gastritis),
• pruritus,
• skin rashes,
• increased sweating,
• swelling (oedema).

Rare (may affect up to 1 in 1,000 people):

• anaemia,
• decrease in white blood cells in the blood,
• increase in 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,
• anxiety,
• nervousness,
• nightmares,
• blurred vision,
• increased heart rate,
• hot flushes,
• redness of the skin,
• skin inflammation (dermatitis),
• malaise,
• fatigue,
• hypersensitivity.

Very rare (may affect up to 1 in 10,000 people):

• 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);
• reduction in the number of all blood cells (pancytopenia);
• subcutaneous bleeding (purpura);
• reduction in the number of platelets in the blood, causing subcutaneous bleeding or bleeding in other parts of the body, black stools due to bleeding;
• liver inflammation (hepatitis, including fulminant hepatitis), sometimes very severe, causing jaundice (yellowing of the skin or whites of the eyes) and bile flow obstruction;
• allergic reactions, including severe reactions with collapse and breathing difficulties;
• rapid swelling (oedema) of the skin, mucosa and submucosal tissues (angioneurotic oedema);
• asthma and breathing difficulties (bronchospasm);
• reduction in body temperature (hypothermia), dizziness, headache, somnolence, stomach pain and digestive disturbances (dyspepsia), stomach inflammation (gastritis), abdominal pain, urinary retention, reduced urine output (oliguria);
• inflammation of the mouth (stomatitis), skin allergic reactions (urticaria);
• swelling of the face (oedema) and surrounding areas, visual disturbances, indigestion, mouth burning, pruritus (urticaria).

Frequency not known

• Fixed drug eruption (may appear as round or oval patches with redness and swelling of the skin), skin rash with blisters (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 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 Nimedex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Nimedex does not require any special storage conditions.
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. Package contents and other information

What Nimedex contains

• The active substance is nimesulide-cyclodextrin.

Tablets: Each tablet contains 400 mg of nimesulide-cyclodextrin, equivalent to 100 mg of nimesulide.

• The other components are: lactose, calcium hydrogen phosphate, cross-linked polyvinylpyrrolidone, magnesium stearate.

Granules for oral suspension: Each sachet of granules for oral suspension contains 400 mg of nimesulide-cyclodextrin, equivalent to 100 mg of nimesulide.

• The other components are: sorbitol, colloidal silicon dioxide, aspartame, orange flavouring.

Description of the appearance of Nimedex and contents of the pack
Carton box containing 30 tablets of 400 mg in opaque PVC/Al blister packs.
Carton box containing 30 sachets of 400 mg granules in paper/aluminum/polyethylene packaging.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Italfarmaco S.p.A. – Viale F. Testi, 330 – Milan
Tel.: +39.02.64431
Fax: +39.02.644346
e-mail: [email protected]

Manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330 – 20126 Milan, Italy
and/or
Italfarmaco S.A.
San Rafael 3
28108 Alcobendas, Madrid, Spain