Package leaflet: Information for the patient

NAPROXENE SODICO DOC Generici 550 mg film-coated tablets

Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NAPROXENE SODICO DOC Generici is and what it is used for
What you need to know before taking NAPROXENE SODICO DOC Generici
How to take NAPROXENE SODICO DOC Generici
Possible side effects
How to store NAPROXENE SODICO DOC Generici
Contents of the pack and other information

1. What NAPROXENE SODICUM DOC Generics is and what it is used for

This medicinal product contains the active substance naproxen, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs ("NSAIDs"), used to reduce pain caused by inflammation.
NAPROXENE SODICUM DOC Generics is indicated to relieve moderate to mild pain caused by
inflammation of bones and muscles, particularly for the treatment of:

an autoimmune disease affecting the joints, called rheumatoid arthritis, including juvenile rheumatoid arthritis;
inflammatory joint diseases (degenerative osteoarthritis, ankylosing spondylitis, gout);
acute muscle and bone pain (strains, sprains, injuries, lumbosacral pain, cervical pain, tenosynovitis and fibrositis);
menstrual pain (dysmenorrhea);
inflammations occurring after trauma or surgical procedures (post-traumatic and post-operative).

2. What you should 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 relieve pain (analgesics), to other non-steroidal anti-inflammatory drugs (NSAIDs) or anti-rheumatic drugs; or if you have experienced allergic reactions after using these medicines, such as asthma, skin irritation (urticaria), nasal inflammation (rhinitis), a nasal disorder characterized by the presence of nodules (nasal polyps), or tissue swelling due to fluid accumulation (angioedema);
if you have previously experienced gastrointestinal bleeding or perforation following the use of this medicine;
if you currently have or have previously had gastrointestinal bleeding, perforation, or injury (ulcer);
if you suffer from chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
if you have a serious heart condition (severe heart failure), liver disease (severe hepatic insufficiency), or kidney disease (severe renal insufficiency);
if you suffer from swelling due to fluid accumulation (angioedema);
if you are currently taking medicines used to promote urine excretion (diuretics);
if you are experiencing bleeding (haemorrhage), or are at risk of bleeding 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 must not be used in children and adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking NAPROXENE SODICO DOC Generici.
Take this medicine at the lowest effective dose and for the shortest possible duration to minimize the risk 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 or have suffered from allergic reactions, as this medicine may cause asthma, breathing difficulties (bronchospasm), or other allergic manifestations;
if you suffer or have suffered from stomach or intestinal disorders (ulcers, gastrointestinal bleeding or perforation, chronic inflammatory bowel diseases such as ulcerative colitis, Crohn's disease);
if you are elderly, as this increases the risk of stomach or intestinal injury or bleeding. In this case, your doctor may consider reducing the daily dose;
if you are taking medicines that may cause stomach or intestinal problems, or medicines used to prevent blood clotting in blood vessels (anticoagulants) (see section “Other medicines and NAPROXENE SODICO DOC Generici”);
if you suffer from heart problems (heart failure), high blood pressure (hypertension), impaired 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 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 scheduled for a urine test, as the use of this medicine may interfere with test results; your doctor will inform you whether it is necessary to stop taking this medicine 48 hours before the urine test.

Stop treatment with this medicine and contact your doctor immediately if:

you develop symptoms of an allergic reaction (see section 4 “Possible side effects”);
you experience any unusual stomach or intestinal symptoms, especially bleeding (haemorrhage) or injury (ulcer) of the stomach or intestine;
you develop a skin disorder characterized by irritation, lesions, or blistering. Serious 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;
you experience vision problems.

While using this medicine, pay attention to the following conditions:

this medicine may mask symptoms of certain infections;
if pain, fever, redness, or swelling in the affected area persists, or if new symptoms appear, consult your doctor;
prolonged use of this medicine may cause vision disorders. If you have been taking this medicine for a long time, periodic eye examinations are recommended;
limit your alcohol consumption, as alcohol increases the risk of adverse effects.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and NAPROXENE SODICO DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
If you are taking any of the following medicines, inform your doctor, as they may interact with NAPROXENE SODICO DOC Generici:

acetylsalicylic acid or other NSAIDs;
aspirin/acetylsalicylic acid used to prevent blood clotting;
hydantoin derivatives, used to treat epilepsy, barbiturates, used as sedatives, or sulfonamides, used to treat bacterial infections;
propranolol and other beta-blockers, medicines used to treat certain heart conditions, as their effect may be reduced;
lithium, used to treat depression and similar disorders;
probenecid, a medicine used to promote the urinary excretion of uric acid;
methotrexate, a chemotherapeutic agent, as its toxicity may increase;
corticosteroids, medicines used to treat inflammatory conditions; as they increase the risk of gastrointestinal toxicity from NAPROXENE SODICO DOC Generici;
anticoagulants (e.g. warfarin, dicoumarol) or antiplatelet agents, medicines used to prevent blood clotting, or selective serotonin reuptake inhibitors (SSRIs), medicines used to treat depression, as they may increase the risk of gastrointestinal bleeding;
ACE inhibitors, angiotensin II receptor antagonists, or diuretics (e.g. furosemide), medicines used to control blood pressure or heart conditions, as NAPROXENE SODICO DOC Generici may reduce their effectiveness. In such cases, consult your doctor, as adequate fluid intake and monitoring of kidney function may be necessary;
cyclosporine and tacrolimus, medicines used to treat immune system disorders;
sulfonylureas, medicines used to treat diabetes;
digoxin, a medicine used to treat certain heart conditions;
quinolone antibiotics, medicines used to treat bacterial infections.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take NAPROXENE SODICO DOC Generici during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour beyond the expected duration. You should not take NAPROXENE SODICO DOC Generici during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy, naproxen may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required 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 a pregnancy, inform your doctor, as this medicine may reduce fertility.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery. However, if you experience dizziness, drowsiness, vertigo, or depression, avoid driving or operating machinery.
NAPROXENE SODICO DOC Generici contains sodium
This medicine contains 50 mg of sodium (a main component of table salt) per tablet. This corresponds to 2.5% of the maximum daily dietary intake recommended for an adult.

3. How to take NAPROXENE SODICO DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended initial dose is 550 mg (1 tablet). Afterwards, treatment may continue with 550 mg (1 tablet) every 12 hours or 275 mg every 6 – 8 hours, according to your doctor's advice.
How to take NAPROXENE SODICO DOC Generici
The tablet should be swallowed whole, with a glass of water.
For people who have stomach problems, it is advisable to take the tablet during a meal.
Use in the elderly
If you are elderly, your doctor will decide whether a dose reduction is necessary.
If you take more NAPROXENE SODICO DOC Generici than you should
After taking an excessive dose of this medicine, symptoms such as numbness, drowsiness, stomach burning, indigestion (dyspepsia), nausea, vomiting, diarrhoea or seizures may occur.
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital emergency department.
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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
A distinct allergic skin reaction known as fixed drug eruption, which usually recurs at the same site or sites upon re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, skin rash with blisters (urticaria), itching sensation.

The following side effects may occur:
Common (may affect up to 1 in 10 people):

sensation of thirst;
increased awareness of heartbeat (palpitations).

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

allergic reaction (anaphylactic reaction). Some symptoms of an allergic reaction may include: sudden drop in blood pressure, rapid or slow heartbeat, unusual tiredness, anxiety, restlessness, dizziness, fainting, difficulty breathing or swallowing, itching (especially on soles of feet or palms of hands), skin irritation and redness with or without swelling (particularly in hands, feet, genitals, face, eyes, lips or ears), bluish-purple skin discoloration (cyanosis), excessive sweating, nausea, vomiting, abdominal pain, diarrhoea, fever;
inflammation of the intestine (colitis), inflammation and damage to the mouth (ulcerative stomatitis), inflammation of the pancreas (pancreatitis);
hair loss (alopecia), inflammation of skin exposed to light (photosensitivity dermatitis), skin lesions (Lyell’s syndrome or toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome), appearance of red, swollen nodules under the skin (erythema nodosum);
changes in liver function tests, yellowing of the skin (jaundice);
mood disturbance (depression), difficulty concentrating, feeling of malaise, inflammation of the brain (aseptic meningitis), cognitive disorders;
changes in white blood cell count (agranulocytosis, leucopenia, granulocytopenia, eosinophilia), reduced platelet count (thrombocytopenia), reduced count of all blood cells (aplastic anaemia), destruction of red blood cells (haemolytic anaemia);
serious heart problem (congestive heart failure), inflammation of blood vessels (vasculitis), increased heart rate (tachycardia);
lung inflammation with accumulation of eosinophils (eosinophilic pneumonia), contraction of bronchial muscles (bronchospasm), inflammation of lung alveoli (alveolitis), throat swelling (laryngeal edema), asthma, difficulty breathing (dyspnoea);
increased blood glucose (hyperglycaemia), decreased blood glucose (hypoglycaemia).

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

skin reactions characterized by irritation and blister formation (bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis);
liver inflammation (severe hepatitis).

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

nausea, vomiting, diarrhoea, passing intestinal gas (flatulence), digestive disturbances (dyspepsia), constipation (stipsis, constipation), heartburn (pyrosis), abdominal pain, headache (cephalalgia), dizziness (vertigo), inflammation of the mouth (stomatitis), stomach pain (epigastric pain);
vomiting blood (haematemesis), passing black stools (melaena), stomach or intestinal ulcers, perforations or bleeding in the stomach or intestine, kidney and liver toxicity (nephrotoxicity, hepatotoxicity), allergic reactions (hypersensitivity reactions);
worsening of intestinal inflammation (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 (oedema);
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 skin discoloration (skin necrosis), increased skin sensitivity to light (photosensitisation, including pseudoporphyria or epidermolysis bullosa);
kidney inflammation (glomerulonephritis, interstitial nephritis), protein loss in urine (nephrotic syndrome), presence of blood in urine (haematuria), kidney damage (papillary necrosis),
fluid accumulation in various parts of the body (fluid retention), high potassium levels in blood (hyperkalaemia), kidney problems (renal failure);
sensation of emptiness in the head, sleep disturbances (insomnia or drowsiness), seizures, difficulty concentrating, confusion and dizziness;
muscle pain (myalgia), muscle weakness;
vision disorders (visual disturbances), hearing disturbances, hearing loss, ringing in the ears (tinnitus), swelling in feet and legs (peripheral oedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store NAPROXEN SODIUM DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from heat and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What NAPROXENE SODICO DOC Generici contains

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

Description of the appearance of NAPROXENE SODICO DOC Generici and package contents
The package contains 30 tablets in blister packs.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 – 20121 Milan - Italy.
Manufacturer
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010 Zollino (Lecce) – Italy.