NIMEDEX 400 mg Tabletka

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1. Nimedex 400 mg tablets, 400 mg granules for oral suspension
   1. What is Nimedex and what is it used for
   2. What you need to know before you take Nimedex
   3. How to take Nimedex
   4. Possible side effects
   5. How to store Nimedex
   6. Contents of the pack and other information

Nimedex 400 mg tablets, 400 mg granules for oral suspension

nimesulide ß-cyclodextrin

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Nimedex and what is it 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.
The doctor will prescribe Nimedex only if other medications have not been effective.
Before prescribing Nimedex, the doctor will assess the potential benefits that this medicine can
give you compared to the risk of side effects.

2. What you need to know before you take Nimedex

Do not take Nimedex if:

• you are allergic to nimesulide or any of the other ingredients of this medicine (listed in section 6);
• you have had any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs:
• bronchospasm, a breathing problem that manifests with wheezing, chest tightness, shortness of breath (asthma);
• nasal congestion due to growths of the internal nasal mucosa (nasal polyps);
• skin rashes/itchy (urticaria);
• rhinitis;
• you have had reactions in the past following treatment with NSAIDs such as:
• gastric or intestinal bleeding;
• ulcers (perforations) in the stomach or intestine;
• if you have a recurrent active gastric or duodenal ulcer or bleeding (at least two episodes of ulcer or bleeding);
• you have had a cerebral hemorrhage (stroke);
• you have any other bleeding problem or problem due to a blood clotting defect;
• you suffer from liver failure (reduced liver function);
• you are taking other medicines known to have an effect on the liver, such as paracetamol or any other analgesic or NSAID treatment;
• you are taking drugs or have developed a dependence on drugs or other substances;
• you are a heavy habitual drinker (alcohol);
• you have had a reaction to nimesulide in the past that affected the liver;
• if you are exposed to other substances potentially harmful to the liver;
• you suffer from severe kidney failure (reduced kidney function);
• you suffer from severe heart failure (weak heart);
• you have a fever or flu (feeling of general malaise, discomfort, 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 tell your doctor before taking Nimedex

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

You must avoid taking Nimedex in conjunction with other non-steroidal anti-inflammatory drugs (NSAIDs). The use of concomitant analgesics is not recommended.
Medicines such as Nimedex may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and prolonged treatments. Do not exceed the dose or
duration of treatment recommended. The doctor will tell you to stop treatment if you do not
see any benefit.
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 therapy with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking Nimedex
and tell your doctor at the first appearance of skin rashes, soft tissue (mucous membrane) lesions or
any other symptom of allergy.
Immediately stop treatment with Nimedex in the presence of bleeding (with black stools) or ulcer in the digestive tract (causing abdominal pain).

Be particularly careful with Nimedex
If symptoms indicative of a liver disorder appear during treatment with Nimedex,
stop taking the medicine and immediately inform your doctor who may tell you to
suspend treatment. Symptoms indicative of a liver disorder are loss of appetite,
nausea, vomiting, abdominal pain, persistent fatigue and dark urine, including changes in
liver function tests.
If you have suffered from ulcers, gastric or intestinal bleeding, perforation, or inflammatory diseases
of the intestine such as ulcerative colitis or Crohn's disease, tell your doctor before taking Nimedex.
The doctor will tell you to start treatment with the lowest available dose and may recommend
drugs to protect the stomach such as misoprostol or proton pump inhibitors. Such
protectors will also be recommended if you take low doses of aspirin or other drugs that can
increase the risk of gastrointestinal events.
If you have had gastrointestinal problems in the past, you should report any unusual abdominal symptoms to your doctor, especially gastrointestinal bleeding, particularly in the early stages of
treatment.
If fever and/or flu-like symptoms (feeling of general malaise, discomfort, chills or tremors) appear during treatment with Nimedex
stop taking the medicine and inform your doctor.
If you suffer from heart disorders, high blood pressure, coagulation problems, circulatory problems
or kidney problems, or are a carrier of risk factors for cardiovascular disease (e.g.
hypertension, hyperlipidemia, diabetes mellitus, smoking) you should inform your doctor before taking
Nimedex.
If you notice the appearance of skin adverse reactions such as rash, mucous membrane lesions or
any other sign of hypersensitivity, contact your doctor immediately.
If you are planning to become pregnant, tell 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 should not be taken by children under 12 years of age (see “Do not take
Nimedex”).

Other medicines and Nimedex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Before taking Nimedex, make sure your doctor or pharmacist knows that you are taking any of
the following medicines that may interact with Nimedex:

• Other non-steroidal anti-inflammatory drugs (NSAIDs):
• Corticosteroids (medicines used to treat inflammatory conditions);
• Medicines to thin the blood (anticoagulants, for example warfarin, or antiplatelet agents, aspirin or other salicylates);
• Antihypertensives such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (AIIA) or diuretics (medicines for controlling blood pressure or heart problems);
• Lithium, used to treat depression or similar disorders;
• Selective serotonin reuptake inhibitors (medicines used to treat depression);
• Methotrexate (medicine used to treat rheumatoid arthritis and cancer);
• Cyclosporine (medicine used after a transplant or to treat immune system disorders).

Tell your doctor if you are taking other medicines such as oral corticosteroids, anticoagulants such as
warfarin, selective serotonin reuptake inhibitors or antiplatelet agents
such as aspirin.

Elderly
If you are elderly, you may have a greater number of adverse reactions with all medicines
belonging to the category of non-steroidal anti-inflammatory drugs, so before taking
Nimedex tell your doctor who may subject you to regular checks to ensure that Nimedex
does not cause problems with the stomach, kidneys, heart or liver.
The doctor will tell you to start treatment with the lowest available dose and may recommend
drugs to protect the stomach such as misoprostol or proton pump inhibitors. Such
protectors will also be recommended if you take low doses of aspirin or other drugs that can
increase the risk of gastrointestinal events.
If you have had gastrointestinal problems in the past, you should report any unusual abdominal symptoms to your doctor, especially gastrointestinal bleeding, particularly in the early stages of
treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 therapy.

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

Breastfeeding
NIMEDEX is contraindicated during breastfeeding.

Fertility
If you are planning a pregnancy, tell your doctor as Nimedex may decrease
fertility.

Driving and using machines
Do not drive or use machines if Nimedex causes dizziness or drowsiness.

Nimedex tablets contains lactose.If your doctor has diagnosed you with an intolerance to certain
sugars, contact him before taking this medicine.

Nimedex oral suspension granules contains sorbitol and aspartame.
This medicine contains 15 mg of aspartame per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you suffer from phenylketonuria, a rare
genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it
correctly.
This medicine contains 2560 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or
if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients
cannot transform fructose, talk to your doctor before taking this medicine.
This medicine may cause gastrointestinal problems and have a mild laxative effect.

3. How to take Nimedex

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
To reduce undesirable effects, use the minimum effective dose for the shortest time necessary to
control the symptoms.

The recommended dose isone Nimedex tablet or one Nimedex oral suspension granules sachet, twice a day, after meals.
The contents of a sachet should be dissolved in a glass of water.
Use Nimedex for the shortest possible period 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. Bring all the remaining medicine with you. In case of overdose
you will probably develop one of the following symptoms: drowsiness, lethargy, nausea, vomiting, stomach pain, gastric ulcer, difficulty breathing, gastrointestinal bleeding. Rarely, may
manifest hypertension, acute renal failure, respiratory failure and coma. Anaphylactic reactions may occur.

If you forget to take Nimedex
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and inform your doctor immediately as it may indicate a rare but serious side effect that requires 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 rashes or redness;
• wheezing or shortness of breath;
• yellowing of the skin or the whites of the eyes (jaundice);
• unexpected change in the amount or colour of urine;
• swelling of the face, feet or legs;
• persistent fatigue.

Side effects of a general nature of non-steroidal anti-inflammatory drugs (NSAIDs):
The use of some NSAIDs may be associated with a modest increase in the risk of blockage of the
arteries (thrombosis) for example heart attack (myocardial infarction) or stroke, particularly with high doses and long-term treatment.
In association with NSAID treatment, fluid retention (edema),
high blood pressure (hypertension) and heart failure (weak heart) have been reported. Very rare cases of blistering reactions including Stevens-Johnson Syndrome and toxic epidermal
necrosis have been reported.
The most commonly observed side effects with NSAIDs concern the gastrointestinal tract (gastrointestinal effects):

• gastric and duodenal ulcers;
• perforation of the intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Following the administration of NIMEDEX, nausea, vomiting, diarrhoea, flatulence,
constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation
of colitis and Crohn's disease have been reported. Gastritis has been observed less frequently.

Side effects that may occur with Nimedex are:
Common(may affect more than 1 in 100 patients):

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

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

• shortness of breath,
• dizziness,
• increased blood pressure,
• constipation,
• flatulence,
• bleeding of the stomach or intestine,
• ulcers of the duodenum or stomach,
• perforated ulcers,
• heartburn (gastritis),
• itching,
• skin rashes,
• increased sweating,
• swelling (edema).

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

• anaemia,
• decrease in white blood cells in the blood,
• increase in some white blood cells (eosinophils) in the blood,
• changes in blood pressure,
• haemorrhage,
• pain during urination or urinary retention,
• blood in the urine,
• increased potassium in the blood,
• feeling of 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 patients):

• severe skin reactions (known as erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrosis) causing skin rashes and severe illness;
• kidney failure or inflammation (nephritis);
• brain function disorders (encephalopathy);
• reduction in the number of all cells present in the blood (pancytopenia);
• bleeding under the skin (purpura);
• reduction in the number of platelets in the blood, which causes bleeding under the skin or in other parts of the body, black stools due to bleeding;
• liver inflammation (hepatitis including fulminant hepatitis), sometimes very serious, causing jaundice (yellowing of the skin or whites of the eyes) and blockage of the bile flow;
• allergies, including severe reactions with collapse and difficulty breathing;
• rapid swelling (edema) of the skin, mucous membranes and submucosal tissues (angioedema);
• asthma and difficulty breathing (bronchospasm);
• reduction in body temperature (hypothermia), dizziness, headache, drowsiness, stomach pains and digestive disorders (dyspepsia), inflammation of the stomach (gastritis), abdominal pains, urinary retention, reduced urine flow (oliguria);
• inflammation of the mouth (stomatitis), allergic skin reactions (urticaria);
• swelling of the face (edema) and surrounding areas, visual disturbances, indigestion, burning in the mouth, itching (urticaria).

Frequency not known

• Fixed drug eruption (may manifest with round or oval patches with redness and swelling of the skin), skin eruption with blisters (urticaria), sensation of itching

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is reported on the packaging. The expiry date
refers to the last day of the month.
Nimedex does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nimedex contains

• The active ingredient is nimesulide -cyclodextrin.

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

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

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

• The other ingredients are: sorbitol, colloidal silica, aspartame, orange flavour.

Description of Nimedex and contents of the pack
Lithographed cardboard box containing 30 tablets of 400 mg in opaque PVC/Al blisters.
Lithographed cardboard box containing 30 sachets of 400 mg made of paper/aluminium/polyethylene.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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