NAPROXENE 550 mg Коированная Таблетка

Содержание инструкции

1. NAPROXENE SODICO DOC Generici 550 mg coated tablets
   1. What NAPROXENE SODICO DOC Generici is and what it is used for
   2. What you need to know before taking NAPROXENE SODICO DOC Generici
   3. How to take NAPROXENE SODICO DOC Generici
   4. Possible side effects
   5. How to store NAPROXENE SODICO DOC Generici
   6. Contents of the pack and other information

NAPROXENE SODICO DOC Generici 550 mg coated 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 they have the same symptoms as you, as it may 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 NAPROXENE SODICO DOC Generici is and what it is used for
• 2. What you need to know before you take NAPROXENE SODICO DOC Generici
• 3. How to take NAPROXENE SODICO DOC Generici
• 4. Possible side effects
• 5. How to store NAPROXENE SODICO DOC Generici
• 6. Contents of the pack and other information

1. What NAPROXENE SODICO DOC Generici is and what it is used for

This medicine contains the active ingredient naproxen, belonging to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used to reduce pain caused by inflammation.
NAPROXENE SODICO DOC Generici is indicated to reduce mild to moderate pain caused by
inflammation of the bones and muscles, particularly for the treatment of:

• an autoimmune disease that affects the joints, called rheumatoid arthritis, including juvenile rheumatoid 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 trauma or after surgery (post-traumatic and post-operative).

2. What you need to know before taking NAPROXENE SODICO DOC Generici

Do not take NAPROXENE SODICO DOC Generici

• if you are allergic to naproxen, to similar substances or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid, to other medicines used to reduce pain (analgesics), to other non-steroidal anti-inflammatory drugs (NSAIDs) or rheumatic drugs; or if you have experienced allergic reactions, such as asthma, skin irritation (urticaria), nasal inflammation (rhinitis), a nasal disorder characterized by the presence of nodules (nasal polyposis), swelling of tissues due to fluid accumulation (angioedema) following the use of these medicines;
• if you have had bleeding or perforation of the stomach or intestine in the past following the use of this medicine;
• if you have or have had bleeding, perforation or lesion (ulcer) of the stomach or intestine;
• if you suffer from chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• if you have a serious heart problem (severe heart failure), liver (severe hepatic insufficiency) or kidney (severe renal insufficiency);
• if you suffer from swelling due to fluid accumulation (angioedema);
• if you are taking medicines used to promote urination (diuretics);
• if you are experiencing blood loss (hemorrhage), or are at risk for this condition and are taking medicines used to thin the blood (anticoagulants);
• if you suffer from asthma;
• if you are in the last 3 months of pregnancy or if you are breastfeeding.

NAPROXENE SODICO DOC Generici should not be used in children and adolescents under the age of 18.

Warnings and precautions
Consult your doctor or pharmacist before taking NAPROXENE SODICO DOC Generici.
Take this medicine at the lowest doses and for short periods of time to reduce the occurrence of adverse effects.

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

• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from or have suffered from allergic reactions, because this medicine may cause asthma, difficulty breathing (bronchospasm) or other allergic manifestations;
• if you suffer from or have suffered from disorders of the stomach or intestine (ulcer, bleeding or perforations of the gastrointestinal tract, chronic inflammatory bowel diseases such as ulcerative colitis, Crohn's disease);
• if you are elderly, as this increases the possibility of injury or bleeding in the stomach or intestine. In this case, the doctor may decide to reduce the daily dose;
• if you are taking medicines that can cause problems with the stomach or intestine or medicines used to prevent the formation of blood clots in the vessels (anticoagulants) (see section “Other medicines and NAPROXENE SODICO DOC Generici”);
• 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 for these conditions (e.g. if you have high blood pressure, high cholesterol levels, diabetes or if you smoke). Inform your doctor before using NAPROXENE SODICO DOC Generici 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;
• if you are using an intrauterine contraceptive device, as its effectiveness may decrease;
• if you are to undergo a urine test, because the use of this medicine may interfere with the results of the analysis; the doctor will inform you if it is necessary to stop using this medicine 48 hours before undergoing the urine test.

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

• if you develop symptoms of an allergic reaction (see section 4 “Possible side effects”);
• if you experience any unusual symptoms in the stomach or intestine, in particular bleeding (hemorrhage) or lesions (ulcers) of the stomach or intestine;
• if you experience a skin disorder characterized by irritation, lesions or the appearance of blisters. Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with NAPROXENE SODICO DOC Generici;
• if you experience vision problems.

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

• this medicine can mask the symptoms of some infections;
• in case of persistent pain or fever, redness or swelling of the painful area, or the onset of new symptoms, ask your doctor for advice;
• prolonged use of this medicine can cause visual disturbances. If you have been taking this medicine for a long time, periodic eye exams are recommended;
• limit your alcohol consumption, as alcohol increases the risk of side effects.

Children and adolescents
This medicine is not recommended for children and adolescents under the age of 18.

Other medicines and NAPROXENE SODICO DOC Generici
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 NAPROXENE SODICO DOC Generici:

• acetylsalicylic acid or other NSAIDs;
• aspirin/acetylsalicylic acidto prevent the formation of blood clots;
• hydantoic medicines, used for the treatment of epilepsy, barbiturates, used as sedatives, or sulfonamides, used for the treatment of infections caused by bacteria;
• propanolol and other beta-blockers, medicines used for the treatment of certain 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 NAPROXENE SODICO DOC Generici on the stomach and intestine;
• anticoagulants (e.g. warfarin, dicoumarol)or antiplatelet agents, medicines used to prevent the formation of blood clots 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 intestine;
• ACE inhibitors, angiotensin II antagonists or diuretics (e.g. furosemide), medicines used for the control of blood pressure or heart disorders, because NAPROXENE SODICO DOC Generici may reduce their effects. In this case, consult your doctor, as it is necessary to take water and monitor kidney function;
• cyclosporine and tacrolimus, medicines used for the treatment of immune system diseases;
• sulfonylureas, medicines used for the treatment of diabetes;
• digoxin, a medicine used to treat some heart problems;
• quinolone antibiotics, medicines used for the treatment of infections caused by bacteria.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant 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 NAPROXENE SODICO DOC Generici 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 NAPROXENE SODICO DOC Generici in the first 6 months of pregnancy unless absolutely necessary and under the advice of a 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, naproxen can cause kidney problems in the fetus if taken for more than a few days, thus reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing 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 naproxen passes into breast milk.

Fertility
NAPROXENE SODICO DOC Generici 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 operating machinery
This medicine does not impair the ability to drive or operate machinery. However, if you experience dizziness, drowsiness, vertigo or depression, avoid driving vehicles or operating machinery.

NAPROXENE SODICO DOC Generici contains sodium
This medicine contains 50 mg of sodium (the main component of table salt) per tablet. This is equivalent to 2.5% of the recommended maximum daily intake of salt with the diet of an adult.

3. How to take NAPROXENE SODICO DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended initial dose is 550 mg (1 tablet). Afterwards, you can continue the therapy
by taking 550 mg (1 tablet) every 12 hours or 275 mg every 6 – 8 hours, as advised by your doctor.

How to take NAPROXENE SODICO DOC Generici
The tablet must be swallowed whole, with a glass of water.
People who have stomach problems are advised to take the tablet during meals.

Use in the elderly
If you are an elderly person, your doctor will determine if it is necessary to reduce the dose.

If you take more NAPROXENE SODICO DOC Generici than you should
Following the intake of an excessive dose of this medicine, drowsiness, somnolence,
heartburn, difficulty digesting (dyspepsia), nausea, vomiting, diarrhea or convulsions may occur.
In case of accidental intake of an excessive dose of this medicine, immediately inform your doctor
or go to the Emergency Room of the nearest hospital.

If you forget to take NAPROXENE SODICO DOC Generici
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.
Stop taking NAPROXENE SODICO DOC Generici and contact your doctor immediately if
you notice any of the following side effects:

Not known:frequency cannot be estimated from the available data

• Widespread skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• a distinctive allergic skin reaction known as fixed drug eruption, which usually reappears in the same place or places upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, rash with blisters (urticaria), sensation of itching.

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):

• allergic reaction (anaphylactic reaction). Some of the symptoms of an allergic reaction may be: sudden drop in blood pressure, acceleration or slowing of the heartbeat, unusual tiredness, anxiety, agitation, dizziness, fainting, difficulty breathing or swallowing, itching (especially on the soles of the feet or palms of the hands), irritation and redness of the skin with or without swelling (especially on hands, feet, genitals, face, eyes, lips or ears), bluish discoloration of the skin (cyanosis), profuse sweating, nausea, vomiting, abdominal pain, diarrhea, fever;
• inflammation of the intestine (colitis), inflammation and injury of the mouth (ulcerative stomatitis), inflammation of the pancreas (pancreatitis);
• hair loss (alopecia), skin inflammation exposed to light (photosensitivity dermatitis), skin lesions (toxic epidermal necrolysis or Lyell's syndrome, 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 disorder (depression), difficulty concentrating, feeling unwell, inflammation of the brain (aseptic meningitis), cognitive disorders;
• alterations in the number of white blood cells in the blood (agranulocytosis, leukopenia, granulocytopenia, 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), constriction of the bronchial muscles (bronchospasm), inflammation of the lung alveoli (alveolitis), swelling of the throat (laryngeal edema), asthma, difficulty breathing (dyspnea);
• increased glucose in the blood (hyperglycemia), decreased glucose in the blood (hypoglycemia).

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

• skin reactions characterized by irritation and the appearance of blisters (bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis);
• inflammation of the liver (severe hepatitis).

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

• nausea, vomiting, diarrhea, passage of gas from the intestine (flatulence), digestive disorders (dyspepsia), constipation (stipsi, costipazione), heartburn (pyrosis), abdominal pain, headache (cephalalgia), dizziness (vertigini), inflammation of the mouth (stomatitis), stomach pain (epigastric pain);
• vomiting of blood (hematemesis), passing 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);
• worsening of inflammation of the intestine (colitis and Crohn's disease);
• inflammation of the stomach (gastritis).
• increased blood pressure (hypertension), heart problems (heart failure);
• swelling due to fluid accumulation in the body (edema);
• heart attack, stroke;
• skin irritations (rash, urticaria), bruising (ecchymosis), sweating, rupture of capillaries under the skin (purpura), itching;
• swelling due to fluid accumulation (angioedema);
• dark discoloration of the skin (cutaneous necrosis), increased sensitivity of the skin to light (photosensitization, including pseudoporphyria or bullous 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),

accumulation of fluids 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 or drowsiness), convulsions, difficulty concentrating, confusion and disorientation;
• muscle pain (myalgia), muscle weakness;
• visual disturbances (visual impairment), hearing disturbances, decreased hearing, ringing in the ears (tinnitus), swelling of the feet and legs (peripheral edema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 NAPROXENE SODICO DOC Generici

Keep this medicine out of 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.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from heat and humidity.
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 NAPROXENE SODICO DOC Generici contains

• The active ingredient is naproxen sodium. Each tablet contains 550 mg of naproxen sodium (equivalent to 500 mg of naproxene).
• The other ingredients are: stearic acid, magnesium stearate, hydroxypropylcellulose type LF, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, indigo carmine.

Description of the appearance of NAPROXENE SODICO DOC Generici and pack contents
The pack contains 30 tablets in blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milano - Italy.

Manufacturer
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010 Zollino
(Lecce) – Italy.