EFRIDOL 100 mg Таблетки

Содержание инструкции

1. EFRIDOL 100 mg tablets
   1. WHAT EFRIDOL IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING EFRIDOL
   3. HOW TO TAKE EFRIDOL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE EFRIDOL
   6. FURTHER INFORMATION

EFRIDOL 100 mg tablets

EFRIDOL 100 mg granules for oral suspension
Nimesulide

Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What EFRIDOL is and what it is used for
• 2. Before taking 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, the doctor will assess the potential benefits this medicine can give you
compared to the risk of developing side effects.

2. BEFORE TAKING EFRIDOL

Do not use EFRIDOL if:

• you are hypersensitive (allergic) to nimesulide or any of the excipients of EFRIDOL (listed in section 6 at the end of this leaflet);
• you have experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs:
• wheezing, tightness in the chest, shortness of breath (asthma)
• nasal congestion due to growths of the mucous membrane inside the nose (nasal polyps)
• skin rashes / itchy (urticaria)
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which can cause difficulty breathing (angioedema)
• you have had reactions in the past following treatment with NSAIDs such as:
• gastric or intestinal bleeding
• ulcers (perforations) in the stomach or intestine
• you have recently had a stomach or duodenal ulcer or have had them in the past (at least two episodes of ulcer or bleeding);
• you have had a cerebral haemorrhage (stroke);
• you have any other bleeding problems or problems due to a blood clotting defect;
• you suffer from liver failure;
• you are taking other medicines known to have an effect on the liver, e.g. 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 (of alcohol);
• you have had a reaction to nimesulide in the past that affected the liver;
• you suffer from severe renal failure that does not require dialysis;
• you suffer from severe heart failure;
• 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 EFRIDOL to a child under 12 years of age.

Warnings
Do not take Efridol or tell your doctor before taking Efridol

• if you have developed a fixed drug eruption in the past (round or oval patches with redness and swelling of the skin, skin rash with blisters, urticaria and a feeling of itching) after taking nimesulide. Medicines like EFRIDOL 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 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 (e.g. 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 EFRIDOL and inform your doctor at the first sign of skin rashes, soft tissue (mucous membrane) lesions or any other symptom of allergy. Stop treatment with EFRIDOL immediately in the presence of bleeding (with black stools) or ulcer in the digestive tract (causing abdominal pain).

Pay particular attention with EFRIDOL
If symptoms indicative of a liver disorder appear during treatment with nimesulide, you should
stop taking nimesulide and immediately inform your doctor. Symptoms indicative of
a liver disorder are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and
dark urine.
If you have suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory bowel diseases
such as ulcerative colitis or Crohn's disease, you should inform your doctor before taking EFRIDOL.
If fever and/or flu-like symptoms (feeling
of general malaise, discomfort, chills or tremors) appear during treatment with EFRIDOL, you should stop taking the product and
inform your doctor.
If you suffer from mild heart problems, high blood pressure, circulatory or kidney problems, you should inform
your doctor before taking EFRIDOL.
If you are elderly, your doctor may subject you to regular checks to ensure that EFRIDOL does not cause
problems with your stomach, kidneys, heart or liver.
If you are planning a pregnancy, inform your doctor because 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 (drugs used for the treatment of inflammatory states),
• Drugs to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates),
• Antihypertensives or diuretics (drugs for controlling blood pressure or heart disorders),
• Lithium, used for the treatment of depression and similar disorders,
• Selective serotonin reuptake inhibitors (drugs used in the treatment of depression),
• Methotrexate (drug used for the treatment of rheumatoid arthritis and cancer care),
• Cyclosporine (drug used after a transplant or for the treatment of immune system disorders), make sure your doctor or pharmacist knows that you are taking these drugs before taking EFRIDOL.

Taking EFRIDOL with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without 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 because EFRIDOL can decrease fertility.
• Do not take EFRIDOL in the last 3 months of pregnancy as it may harm the fetus or cause problems during childbirth. It can cause problems with the fetus's kidneys and heart. It can affect your and your baby's tendency to bleed and cause a delay or prolongation of labour.
• You should not take Efridol during the first 6 months of pregnancy unless it is absolutely necessary and recommended by your doctor. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy onwards, Efridol can cause kidney problems in the fetus that can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or can cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.

EFRIDOL should not be used during breastfeeding.

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

Important information about some excipients of EFRIDOL
EFRIDOL tablets and oral suspension granules contain sugars. If you have been told by
your doctor 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 undesirable effects, the minimum effective dose should be used for the shortest time necessary to
control the symptoms.
The usual dose is one 100 mg tablet or one 100 mg sachet of oral suspension granules, twice
a day after meals. Use EFRIDOL for the shortest possible period and for no more 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 all remaining medicine with you. In case of overdose, you will probably develop
one of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer, difficulty breathing.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, EFRIDOL can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and immediately inform your
doctor 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 rash or redness;
• wheezing or shortness of breath;
• yellowing of the skin or eyes (jaundice);
• unexpected change in the amount or color 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.
Fluid retention (edema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID treatment.
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).

Other side effects of non-steroidal anti-inflammatory drugs (NSAIDs) are:

• Common (may affect more than 1 in 100 people): diarrhea, nausea, vomiting, slight changes in blood test values of liver function.
• Uncommon (may affect up to 1 in 100 people): shortness of breath, dizziness, increased blood pressure, constipation, flatulence, heartburn (gastritis), itching, rash, increased sweating, swelling (edema); bleeding from the stomach or intestines; ulcers of the duodenum or stomach and perforated ulcers.
• Rare (may affect up to 1 in 1,000 people): anemia, decreased white blood cells in the blood, increase in some white blood cells (eosinophils) in the blood, changes in blood pressure, bleeding, pain during urination or urinary retention, blood in the urine, increased potassium in the blood, feeling of anxiety or nervousness, nightmares, blurred vision, increased heart rate, hot flashes, skin redness, skin inflammation (dermatitis), malaise, fatigue.
• Very rare (may affect up to 1 in 10,000 people): severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) that cause skin rashes and severe discomfort; kidney failure or inflammation (nephritis); brain function disorders (encephalopathy); 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, inflammation of the liver (hepatitis), sometimes very serious, causing jaundice and blockage of the bile flow; allergies, including severe reactions with collapse and difficulty breathing, asthma, decreased body temperature, dizziness, headache, insomnia, stomach pains; indigestion, burning in the mouth, itching (urticaria); swelling of the face and surrounding areas, visual disturbances.
• Frequency not known: Fixed drug eruption (may manifest with round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), feeling of itching

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: www.aifa.gov.it/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 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 which is reported on the packaging. The expiry date refers
to the last day of the month.
Medicines should 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. FURTHER INFORMATION

What EFRIDOL contains
The active ingredient is Nimesulide
One tablet contains 100 mg of nimesulide.
The excipients of the tablet are: dioctyl sodium sulfosuccinate, hydroxypropylcellulose, lactose, sodium starch
glycolate, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate.
One sachet contains 100 mg of nimesulide.
The excipients of the sachet are: cetomacrogol 1000, sucrose, maltodextrins, citric acid, orange flavour.

Description of the appearance of EFRIDOL and 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 Authorisation 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)