EFRIDOL

PACKAGE LEAFLET: INFORMATION FOR THE USER

EFRIDOL 100 mg tablets, 100 mg granules for oral suspension

Nimesulide
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. This medicine 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 effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What EFRIDOL is and what it is used for
2. Before you take EFRIDOL
3. How to take EFRIDOL
4. Possible side effects
5. How to store EFRIDOL
6. Further information

1. WHAT EFRIDOL IS AND WHAT IT IS USED FOR

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

2. BEFORE TAKING EFRIDOL

Do not use EFRIDOL if:

• you are hypersensitive (allergic) to nimesulide or to any of the excipients of EFRIDOL (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 polyps)
• skin rashes / itchy skin (urticaria)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may cause breathing difficulties (angioedema)
• you have previously had reactions following treatment with NSAIDs such as:
• gastrointestinal or intestinal bleeding
• gastric 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 a cerebral haemorrhage (stroke);
• you have any other bleeding disorder or a condition due to 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 influenza (general malaise, discomfort, chills or shivering, or high temperature);
• you are in the last trimester of pregnancy;
• you are breastfeeding.

Do not give EFRIDOL to a child under 12 years of age.
Warnings
Do not take Efridol or inform your doctor before taking Efridol

• if you have previously developed fixed drug eruptions (round or oval patches with redness and swelling of the skin, skin eruptions with blisters, urticaria and itching) after taking nimesulide. Medicines such as EFRIDOL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher 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), you should discuss your treatment with your doctor or pharmacist. If severe allergic reactions occur during treatment, stop taking EFRIDOL and inform your doctor at the first sign of skin rashes, soft tissue lesions (mucous membranes) or any other allergic symptoms. Immediately discontinue treatment with EFRIDOL in the presence of gastrointestinal bleeding (black stools) or ulceration of the digestive tract (causing abdominal pain).

Exercise particular caution with EFRIDOL
If, during treatment with nimesulide, symptoms indicating liver disorder occur, you must
discontinue 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 EFRIDOL.
If, during treatment with EFRIDOL, fever and/or flu-like symptoms (general malaise, discomfort, chills or
tremors) occur, discontinue treatment and inform your doctor.
If you suffer from mild heart conditions, high blood pressure, circulatory or kidney problems, inform your
doctor before taking EFRIDOL.
If you are elderly, your doctor may carry out regular checks to ensure that EFRIDOL does not cause
problems with your stomach, kidneys, heart or liver.
If you plan to become pregnant, inform your doctor, as EFRIDOL 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 EFRIDOL:

• 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 taking EFRIDOL.

Taking EFRIDOL with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking EFRIDOL or any other medicine.

• If you are planning a pregnancy, inform your doctor, as EFRIDOL may reduce fertility.
• Do not take EFRIDOL 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 may affect your tendency and that of your baby to bleed and may cause delayed or prolonged labour.
• You should not take Efridol during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, Efridol may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is necessary, your doctor may recommend additional monitoring.

EFRIDOL must not be used during breastfeeding.
Driving and using machines
Do not drive or operate machinery if EFRIDOL causes dizziness or drowsiness.
Important information about some excipients in EFRIDOL
EFRIDOL tablets and oral suspension granules contain sugars. If your doctor has informed you that you have an intolerance to certain sugars, contact him before using this medicine.

3. HOW TO TAKE EFRIDOL

Always take EFRIDOL exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist.
To reduce unwanted 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 EFRIDOL for the shortest possible duration and no longer than 15 days in a single treatment cycle.
If you take more EFRIDOL than you should
If you take or think you have taken more EFRIDOL than prescribed (overdose), contact your doctor or hospital immediately. Bring with you any remaining medicine. 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 EFRIDOL
Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, EFRIDOL 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 could indicate a rare but serious adverse reaction requiring 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 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 tiredness.

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 (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.
The most commonly observed adverse effects with NSAIDs involve the gastrointestinal tract (gastrointestinal effects):

• Gastric and duodenal ulcers
• Perforation of the intestinal wall or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Other adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs) include:

• Common (may affect more than 1 in 100 patients): diarrhoea, nausea, vomiting, mild changes in blood liver function test results.
• 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); gastrointestinal bleeding; duodenal or gastric ulcers and perforated ulcers.
• Rare (may affect up to 1 in 1,000 patients): anaemia, decreased white blood cells in the blood, 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 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 in the blood, leading to subcutaneous bleeding or bleeding elsewhere in the body, black stools due to bleeding, liver inflammation (hepatitis), sometimes very severe, causing jaundice and blockage of 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.
• Frequency not known: Drug-induced fixed eruption (may appear as round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), sensation of itching.

If any of the adverse reactions worsen, or if you notice any adverse reactions 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 or pharmacist. You can also report adverse reactions directly via the national reporting system at: www.aifa.gov.it/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 EFRIDOL

EFRIDOL does not require any special storage conditions.
Keep EFRIDOL out of the reach and sight of children.
Do not use EFRIDOL 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 EFRIDOL contains
The active substance is Nimesulide.
One tablet contains 100 mg of nimesulide.
The tablet excipients are: sodium dioctyl sulfosuccinate, hydroxypropylcellulose, lactose, sodium starch glycolate, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate.
One sachet contains 100 mg of nimesulide.
The sachet excipients are: cetomacrogol 1000, sucrose, maltodextrins, citric acid, orange flavour.

Description of the appearance of EFRIDOL and the contents of the pack
The pack of EFRIDOL 100 mg tablets contains 30 tablets.
The pack of EFRIDOL 100 mg granules for oral suspension contains 30 sachets.

Marketing Authorization Holder
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia

Manufacturer responsible for batch release

• MITIM S.r.l. - Via Cacciamali 34-36-38 - 25125 Brescia
• Fine Foods & Pharmaceuticals NTM S.p.A. - Via Grignano, 43 - 24041 Brembate (BG)

This summary of product characteristics was last approved on