NAPROSSENE 500 mg Tablet

Зміст інструкції

1. NAPROSSENE EG 500 mg tablets
   1. What is NAPROSSENE EG and what is it used for
   2. What you need to know before taking NAPROSSENE EG
   3. How to take NAPROSSENE EG
   4. Possible side effects
   5. How to store NAPROSSENE EG
   6. Contents of the pack and other information

NAPROSSENE EG 500 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as 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 NAPROSSENE EG is and what it is used for
• 2. What you need to know before you take NAPROSSENE EG
• 3. How to take NAPROSSENE EG
• 4. Possible side effects
• 5. How to store NAPROSSENE EG
• 6. Contents of the pack and other information

1. What is NAPROSSENE EG and what is it used for

NAPROSSENE EG contains the active ingredient naproxene, belonging to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”).
NAPROSSENE EG is indicated to reduce pain of mild to moderate intensity caused by inflammation
of the bones and muscles (osteoarticular origin), in particular for the treatment of:

• an autoimmune disease that affects the joints, called rheumatoid arthritis, including juvenile idiopathic arthritis;
• inflammatory diseases of the joints (degenerative osteoarthritis, ankylosing spondylitis, gout);
• acute muscle and bone pain (sprains, strains, trauma, lower back pain, neck pain, tenosynovitis and fibrositis);
• menstrual pain (dysmenorrhea);
• inflammation that occurs after a trauma or after surgical operations (post-traumatic and post-operative).

2. What you need to know before taking NAPROSSENE EG

Do not take NAPROSSENE EG

• if you are allergic to naproxene, similar substances or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid, other medicines used to reduce pain (analgesics), medicines used to lower fever (antipyretics) and non-steroidal anti-inflammatory drugs; or if you have experienced allergic reactions to these medicines, such as asthma, skin irritation (urticaria), nasal inflammation (rhinitis);
• if you have a problem with your stomach or intestines (active peptic ulcer, gastrointestinal inflammation);
• if you have had bleeding or perforation of the stomach or intestines in the past following the use of this medicine;
• if you have had two or more separate episodes of bleeding or lesions in the stomach or intestines in the past (recurrent bleeding/peptic ulcer);
• if you have a serious heart problem (severe heart failure);
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before taking NAPROSSENE EG.
Take this medicine at the lowest doses and for short periods of time to reduce the occurrence of side effects.

Inform your doctor before taking this medicine in the following cases:

• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), including the specific type of NSAIDs called COX-2 inhibitors. In this case, taking NAPROSSENE EG should be avoided;
• if you suffer from or have suffered from an inflammatory disease of the bronchi called bronchial asthma or allergic diseases, as respiratory crises (bronchospasm) may occur;
• if you suffer from or have suffered from disorders of the stomach or intestines (ulcer, bleeding or perforations of the gastrointestinal tract, ulcerative colitis, Crohn's disease);
• if you are elderly, as this increases the possibility of injury or bleeding in the stomach or intestines. In this case, your doctor may decide to reduce the daily dose;
• if you are taking medicines that can cause problems with the stomach or intestines or medicines used to prevent blood clots in the vessels (anticoagulants) (see section “Other medicines and NAPROSSENE EG);
• if you suffer from heart problems (heart failure), high blood pressure (hypertension), problems with blood flow to the legs (peripheral arterial disease) or to the brain (cerebrovascular disease, stroke) or think you may be at risk of these conditions (e.g. if you have high blood pressure, high cholesterol levels, diabetes or if you smoke). Inform your doctor before using NAPROSSENE EG as it may increase the risk of heart attack or stroke;
• if you suffer from blood clotting disorders, as this medicine may increase the risk of bleeding;
• if you suffer from kidney problems;
• if you suffer from liver problems: liver failure, jaundice, hepatic necrosis, fulminant hepatitis (potentially fatal) may occur;
• if you experience a change in vision, in these cases your doctor will prescribe an eye examination.

Stop treatment with this medicine and consult your doctor immediately in the following cases:

• if you experience allergic reactions (hypersensitivity, anaphylaxis). This risk increases if you have already experienced allergic reactions following the use of medicines used to reduce pain (analgesics), medicines used to lower fever (antipyretics) or non-steroidal anti-inflammatory drugs;
• if you experience any unusual symptoms in the stomach or intestines, in particular bleeding (hemorrhage) or lesions (ulcers) of the stomach or intestines;
• if you experience a skin disorder characterized by irritation, lesions or blisters.

During the use of this medicine, pay attention to the following conditions:

• this medicine may interfere with some urine tests (determination of 17-ketosteroids and 5-hydroxyindoleacetic acid). Your doctor will inform you about the need to stop using this medicine 48 hours before undergoing tests of adrenal gland function.

Children
This medicine is not recommended for children under 5 years of age.

Other medicines and NAPROSSENE EG
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
If you are taking any of the following medicines, inform your doctor because these may interact with NAPROSSENE EG:

• acetylsalicylic acid or other NSAIDs(including selective cyclooxygenase-2: COX-2 inhibitors);
• aspirin/acetylsalicylic acidto prevent blood clot formation;
• hydantoic medicines, used for the treatment of epilepsy, barbiturates, used as sedatives, or sulfonamides, used for the treatment of infections caused by bacteria;
• propranolol and other beta-blockers, medicines used for the treatment of some heart disorders, because their effect may decrease;
• lithium, used for the treatment of depression and similar disorders;
• probenecid, a medicine used to promote the elimination of uric acid with urine;
• methotrexate, a chemotherapeutic agent, because its toxicity may increase;
• corticosteroids, medicines used for the treatment of inflammatory states, because they increase the risk of toxic effects of NAPROSSENE EG on the stomach and intestines;
• anticoagulants (e.g. warfarin)or antiplatelet agents, medicines used to prevent blood clot formation in the vessels, or selective serotonin reuptake inhibitors, medicines used in the treatment of depression, because they may increase the risk of bleeding in the stomach or intestines;
• ACE inhibitors, angiotensin II antagonists or diuretics, medicines used for the control of blood pressure or heart disorders, because NAPROSSENE EG may reduce their effects. In this case, the risk of developing kidney problems (acute renal failure) may increase if you already have impaired kidney function (e.g. if you are elderly or dehydrated). In this case, consult your doctor, as it is necessary to drink water and monitor kidney function;
• other medicines containing naproxen sodium;
• immunosuppressants (e.g. cyclosporine and tacrolimus), medicines used to prevent organ rejection after transplantation: NSAIDs increase the risk of renal toxicity of this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take NAPROSSENE EG in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.
You should not take NAPROSSENE EG in the first 6 months of pregnancy unless absolutely necessary and under the advice of your doctor. If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy onwards, NAPROSSENE EG may cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing the 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.
Breastfeeding
Do not take this medicine if you are breastfeeding, as it passes into breast milk.
Fertility
NAPROSSENE EG may cause fertility problems in women. Therefore, if you are planning to become pregnant, you should inform your doctor because this medicine may reduce fertility.

Driving and using machines
No data are available to establish the effects on the ability to alter driving of vehicles or using machines.

NAPROSSENE EG contains lactose
If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take NAPROSSENE EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the tablets whole, with some liquid and preferably after meals.

Adults
The recommended dose is between 500 and 1000 mg (1-2 tablets) per day, to be taken in one or two
administrations.
The recommended dose, in patients with normal weight, for the treatment of rheumatoid arthritis or mild joint
pain, is 1000 mg (2 tablets) per day, to be taken in one or two administrations.

Use in children under 5 years of age
The use of this medicine in children under 5 years of age is not recommended.

Use in children from 5 to 12 years of age
The recommended initial dose is 20 mg of naproxen per kg of body weight per day, to be taken in one
or two administrations.

Use in the elderly
The doctor will determine the dose and assess whether to reduce the dosage in this case.

If you take more NAPROSSENE EG than you should
Following the intake of an excessive dose of this medicine, drowsiness, heartburn, difficulty digesting (dyspepsia), nausea or vomiting may occur.
In case of accidental intake/ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital Emergency Room.

If you forget to take NAPROSSENE EG
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people):

• feeling of thirst;
• increased awareness of heartbeats (palpitations).

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

• severe allergic reactions (anaphylactic reactions) which can manifest with: sudden drop in blood pressure (severe hypotension), acceleration or slowing of the heartbeat, unusual fatigue or weakness, feeling of fear or worry (anxiety), agitation, dizziness, loss of consciousness, difficulty breathing (due to laryngeal obstruction or bronchospasm) or difficulty swallowing (dysphagia), generalized itching especially on the soles of the feet or palms of the hands, skin irritation (urticaria) with or without swollen areas of skin and itching localized more frequently to the extremities, external genitalia and face, especially in the region of the eyes and lips (angioedema), redness of the skin especially around the ears, bluish discoloration of the skin (cyanosis), profuse sweating, nausea, vomiting, pains due to abdominal cramps, diarrhea;
• fever;
• hair loss (alopecia), skin inflammation exposed to light (photosensitivity dermatitis), skin lesions (Lyell's syndrome or toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome), appearance of red and swollen nodules under the skin (erythema nodosum);
• alteration of liver function tests, yellowing of the skin (jaundice);
• mood disturbance (depression), difficulty concentrating, feeling unwell, muscle pain (myalgia), muscle weakness, nervous system infections (aseptic meningitis), cognitive disorders;
• alterations in the number of white blood cells in the blood (agranulocytosis, leukopenia, granulocytopenia), increased number of eosinophils (eosinophilia), reduction in the number of platelets (thrombocytopenia), reduction in the number of all blood cells (aplastic anemia), destruction of red blood cells (hemolytic anemia);
• severe heart problem (congestive heart failure), inflammation of blood vessels (vasculitis), increased heart rate (tachycardia);
• inflammation of the lungs with accumulation of eosinophils (eosinophilic pneumonia), contraction of the bronchial muscles (bronchospasm), inflammation of the lung alveoli (alveolitis), swelling of the throat (laryngeal edema), asthma;
• increased glucose in the blood (hyperglycemia), decreased glucose in the blood (hypoglycemia).

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

• liver inflammation (severe hepatitis) (potentially fatal).

Frequency not known(frequency cannot be estimated from the available data):

• increased blood pressure (hypertension);
• vision disorders (visual disturbances, papillitis, papilledema), impaired vision, corneal opacity.

Other side effects:

• vomiting, diarrhea, emission of gas from the intestine (flatulence), digestive disorders (dyspepsia), burning sensation from the stomach to the throat (pyrosis), inflammation of the esophagus (esophagitis), constipation (constipation), heartburn (gastric pyrosis), abdominal pain, nausea;
• inflammation of the mouth (stomatitis), pain in the upper part of the stomach (epigastric pain);
• headache, dizziness, drowsiness, itching, ringing in the ears (tinnitus), decreased hearing, swelling in different parts of the body due to fluid accumulation in the body (edema), difficulty breathing (dyspnea);
• inflammations and lesions of the mouth (ulcerative stomatitis), inflammation of the pancreas (pancreatitis);
• bleeding with vomiting (hematemesis), emission of dark stools (melena), ulcers, perforations or bleeding in the stomach or intestine, toxicity to the kidneys and liver (nephrotoxicity, hepatotoxicity), allergic reactions (hypersensitivity reactions) such as skin irritation (skin rashes);
• worsening of inflammation of the intestine (colitis and Crohn's disease);
• inflammation of the stomach (gastritis);
• heart problem (heart failure);
• appearance of blisters on the skin (bullous reactions);
• heart attack, stroke;
• bleeding in the stomach or intestine (gastrointestinal bleeding), colitis. Stomach disorders can be reduced by taking the medicine with food;
• skin irritation (skin rashes, urticaria), bruising (ecchymosis), sweating, rupture of capillaries under the skin (purpura);
• darkening of the skin (skin necrosis), increased sensitivity of the skin to light following application of a substance (photosensitization, including pseudoporphyria or blistering epidermolysis);
• inflammation of the kidneys (glomerular nephritis, interstitial nephritis), loss of protein in the urine (nephrotic syndrome), presence of blood in the urine (hematuria), kidney injury (papillary necrosis), fluid accumulation in different parts of the body (fluid retention), excess potassium in the blood (hyperpotassemia), kidney problems (renal failure);
• feeling of emptiness in the head, sleep disorders (insomnia), convulsions, difficulty concentrating, confusion and dizziness.

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 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 NAPROSSENE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store the medicine at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NAPROSSENE EG contains

• The active ingredient is naproxene: 1 tablet contains 500 mg of naproxene.
• The other ingredients are: lactose, corn starch, polyethylene glycol, sodium croscarmellose, magnesium stearate.

Description of the appearance of NAPROSSENE EG and contents of the pack
Pack containing 30 tablets

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan

Manufacturer
Industria Farmaceutica Nova Argentia S.r.l. - Via G. Pascoli 1 - 20064 Gorgonzola (MI)