Naproxen sodium HCS

Patient Information Leaflet: Information for the User

Naproxene sodico HCS 550 mg film-coated tablets

Naproxene sodico
Generic medicine
Please read all of this leaflet carefully before you take 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. It may be harmful even if their symptoms are the same as yours.
• If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Naproxene sodico HCS is and what it is used for

Naproxene sodico HCS contains the active substance naproxen sodium, a substance belonging to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Naproxene sodico HCS is used for:

• the treatment of mild to moderate pain,
• the symptomatic treatment of rheumatoid arthritis (inflammation of the joints, including those of the hands and feet, with swelling and pain), osteoarthritis (a chronic disorder causing damage to cartilage), acute gout attacks, and ankylosing spondylitis (inflammation affecting the joints of the spine),
• relief of menstrual pain,
• relief of pain from acute migraine,
• treatment of pain due to bleeding associated with the insertion of an intrauterine device (IUD).

2. What you need to know before taking Naproxen Sodium HCS

Do not take Naproxen Sodium HCS:

• if you are allergic to naproxen sodium or to any of the excipients of this medicine (listed in section 6);
• if you have experienced difficulty breathing (bronchial asthma), rash (urticaria), or inflammation of the nasal mucosa (rhinitis) while taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal antirheumatics);
• if you currently suffer or have previously suffered more than once from: a stomach or duodenal ulcer, or gastrointestinal bleeding;
• if you have experienced episodes of gastrointestinal bleeding or perforation while taking NSAIDs;
• if you suffer from severe heart failure;
• if you are in the third trimester of pregnancy;
• if you suffer from ulcerative colitis (a bowel disease);
• if you suffer from severe liver insufficiency (liver impairment) or renal insufficiency (kidney impairment);
• if you are currently taking other medicines of this type (non-steroidal anti-inflammatory drugs).

Warnings and precautions
Inform your doctor or pharmacist before taking Naproxen Sodium HCS.

• It is important to use the lowest effective dose for the shortest duration necessary to control symptoms.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• If you have previously experienced gastric or duodenal bleeding or gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug.
• This risk increases when high doses and prolonged treatments are used in patients with a history of peptic ulcer or in elderly patients. In such cases, your doctor may consider prescribing gastroprotective agents.
• If you have or have previously had stomach problems, as Naproxen Sodium HCS may cause stomach irritation, bleeding, or ulcers. Your doctor will advise you on the most appropriate dose.
• If you suffer from Crohn's disease or ulcerative colitis, as Naproxen Sodium HCS may worsen these conditions.
• If you suffer from asthma or allergic disorders (such as rhinitis or nasal polyps), as Naproxen Sodium HCS may cause breathing difficulties (bronchospasm).
• If you have serious kidney, liver, or heart problems.
• If you are concurrently taking medications that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also consult your doctor about using other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have or suspect you have an infection, as Naproxen Sodium HCS may mask the typical signs and symptoms of infection.
• If during treatment with Naproxen Sodium HCS you experience stomach pain and/or notice black stools, you must stop taking Naproxen Sodium HCS immediately.
• If you experience vision disturbances during treatment.
• This medicine should be used with caution in patients on a low-salt diet or with a history of gastrointestinal disorders.

Naproxen Sodium HCS may make it more difficult to become pregnant. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant.
Medicines such as Naproxen Sodium HCS may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high 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 are at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or smoking), consult your doctor or pharmacist before using this medicine.
In addition, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Other medicines and Naproxen Sodium HCS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Due to interactions with certain other medicines, the effect of Naproxen Sodium HCS or of these other medicines may be increased or decreased. This may occur with:

• medicines used to neutralize stomach acidity (antacids or cholestyramine),
• medicines used to prevent blood clotting (warfarin),
• medicines used to prevent blood clot formation (aspirin/acetylsalicylic acid),
• medicines used to treat diabetes (sulfonylureas),
• medicines used to treat epilepsy (hydantoin derivatives),
• medicines used to treat high blood pressure (angiotensin receptor antagonists, beta-blockers, or diuretics),
• medicines that increase urine production (furosemide),
• medicines used to treat mental disorders (lithium),
• medicines used to treat malignant diseases (methotrexate),
• medicines used for the treatment of pain and joint inflammation (steroids and corticosteroids).

Naproxen Sodium HCS with food and drink
Take the tablets with a sufficient amount of liquid, preferably with food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Naproxen Sodium HCS must not be taken during pregnancy, childbirth, or breastfeeding.
Since administration of medicines like naproxen has been associated with an increased risk of congenital abnormalities, administration of this medicine during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, dosage and duration should be limited to the minimum possible.
Administration of Naproxen Sodium HCS is contraindicated during the third trimester of pregnancy.
Women of childbearing age should be aware that medicines such as naproxen have been associated with reduced fertility.

Driving and using machines
Naproxen Sodium HCS should be used with caution in patients whose occupation requires alertness and who have experienced dizziness or visual disturbances during treatment with this medicine.

Naproxen Sodium HCS contains sodium
This medicine contains 2.17 mmol (or 50.00 mg) of sodium per dose. This should be taken into account in patients on a low-sodium diet.

3. How to take Naproxene sodico HCS

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and children over 16 years of age
The usual daily dose is 1 or 2 tablets (550 mg or 1100 mg of naproxen sodium). The recommended
initial dose is 1 tablet (550 mg of naproxen sodium), followed by half a tablet (275 mg of naproxen
sodium) every 6–8 hours, depending on the severity of symptoms. Your doctor may adjust this dosage.

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
The recommended initial dose is 550 mg of naproxen sodium (1 tablet) twice daily (morning and
evening), or 1100 mg of naproxen sodium (2 tablets) taken once daily.

Acute gout attacks
The recommended initial dose is 825 mg of naproxen sodium (1 and a half tablets), followed by 275 mg
of naproxen sodium (half a tablet) every 8 hours until the attack subsides.

Dysmenorrhea (menstrual pain)
The recommended initial dose is 550 mg of naproxen sodium (1 tablet), followed by 275 mg of naproxen
sodium (half a tablet) every 6–8 hours as needed.

Migraine
The recommended initial dose is 825 mg of naproxen sodium (1 and a half tablets) at the first signs,
followed by 275 mg of naproxen sodium (half a tablet) after half an hour.

Menorrhagia (pain associated with excessive menstrual bleeding)
The recommended initial daily dose is between 825 mg of naproxen sodium (1 and a half tablets) and
1375 mg of naproxen sodium (2 and a half tablets), divided into two doses, followed by a daily dose
between 550 mg of naproxen sodium (1 tablet) and 1100 mg of naproxen sodium (2 tablets), divided
into two doses, for a maximum period of four days.

Children and adolescents under 16 years of age
Naproxene sodico HCS is not intended for use in children and adolescents under 16 years of age.

Elderly
The dose should be reduced in elderly patients, and the lowest effective dose for the shortest possible
duration should be used. Consult your doctor or pharmacist.

Patients with renal and/or hepatic impairment
In patients with mild to moderate renal or hepatic impairment, the dose should be reduced and the
lowest effective dose for the shortest possible duration should be used. Consult your doctor or
pharmacist.

Method of administration
This medicine is taken orally.
The tablet may be divided into two equal doses.
Swallow the tablet whole with a glass of water and preferably with food.
Always take the lowest effective dose.

If you take more Naproxene sodico HCS than you should
If you have taken more Naproxene sodico HCS than you should, contact your doctor or pharmacist
immediately. Symptoms of overdose include drowsiness, heartburn, indigestion, nausea, vomiting, and,
in some cases, seizures. In case of accidental or intentional overdose, gastric lavage should be
performed and symptomatic treatment initiated. Rapid administration of 50–100 g of activated
charcoal as an aqueous suspension reduces absorption of the medicine.

If you forget to take Naproxene sodico HCS
Do not take a double dose to make up for the missed tablet.
Take the medicine at approximately the same time each day. If you forget to take the medicine at the
scheduled time, take it as soon as you remember.

If you stop taking Naproxene sodico HCS
If you are taking naproxen sodium for short-term pain relief, you may safely stop taking it as soon as
you no longer need it. When long-term treatment has been prescribed, you must consult your doctor
before stopping the treatment.

If you have any questions 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 everyone experiences them.

Side effects may occur during treatment with this medicine, with very rare frequency (may affect up to 1 in 10,000 people):

Gastrointestinal disorders: The most common side effects observed with sodium naproxen are of a gastrointestinal nature (affecting the stomach and intestine).
Inflammation, bleeding (in some cases fatal, especially in the elderly), peptic ulcer, perforation, and obstruction of the upper or lower gastrointestinal tract (digestive tract) may occur. Cases of esophagitis (inflammation of the esophagus), gastritis (inflammation of the stomach lining), pancreatitis (inflammation of the pancreas), stomatitis (inflammation of the oral mucosa), and worsening of ulcerative colitis and Crohn's disease have been reported. There have also been cases of heartburn, dyspepsia (digestive disturbances), abdominal discomfort, nausea, vomiting, diarrhea, constipation, flatulence (gas), haematemesis (vomiting blood), and melena (black, tarry stools).

Disorders of the blood and lymphatic system: agranulocytosis (increase/decrease in certain white blood cells), aplastic and haemolytic anaemia (reduced number of red blood cells, white blood cells, and platelets in the blood), eosinophilia (increase in certain white blood cells in the blood), leucopenia (decrease in the number of white blood cells), thrombocytopenia (decrease in platelet count).

Immune system disorders: anaphylactic reactions (severe allergic reaction), angioneurotic oedema (swelling of the skin, mucosa, and internal organs).

Metabolism and nutrition disorders: hypercalcaemia (increased concentration of calcium in the blood).

Psychiatric disorders: difficulty in concentration, depression, sleep disturbances.

Nervous system disorders: dizziness, drowsiness, headache, cognitive dysfunction, aseptic meningitis (inflammation of the meninges), convulsions, insomnia.

Eye disorders: visual disturbances, corneal opacity, optic papillitis (inflammation of the optic disc), retrobulbar neuritis (inflammation of the optic nerve), and papilledema.

Ear and labyrinth disorders: hearing disturbances, tinnitus (ringing in the ears), hearing loss (decreased hearing).

Cardiac disorders: palpitations, congestive heart failure (inability of the heart to pump effectively), hypertension (high blood pressure). Medicines such as sodium naproxen may be associated with a moderately increased risk of myocardial infarction or stroke.

Vascular disorders: vasculitis (inflammation of blood vessels), oedema.

Respiratory, thoracic and mediastinal disorders: asthma, eosinophilic pneumonia, dyspnoea (shortness of breath), pulmonary oedema.

Infections and infestations: aseptic meningitis.

Hepatobiliary disorders: hepatitis (inflammation of the liver), jaundice (yellowing of the skin).

Skin and subcutaneous tissue disorders: skin bleeding, pruritus, capillary haemorrhage, skin rashes, sweating, hair loss, skin desquamation, lichen planus (a skin disease characterised by small nodules), pustular reactions, skin redness, systemic lupus erythematosus (an autoimmune disease with typical skin signs, skin rash, and redness), severe blistering reactions such as Stevens-Johnson syndrome (map-like skin rash) and toxic epidermal necrolysis, allergy, photosensitivity reactions including rare cases with skin appearance resembling that of late cutaneous porphyria, pseudoporphyria (defective liver enzymes), or epidermolysis bullosa. If skin fragility, blistering, or other symptoms suggestive of pseudoporphyria occur, treatment and patient monitoring should be discontinued.

Musculoskeletal and connective tissue disorders: muscle pain, muscle fatigue.

Renal and urinary disorders: blood in urine, interstitial nephritis (kidney inflammation with brownish-yellow discoloration), nephritic syndrome, kidney disease, renal failure, renal papillary necrosis (death of cells forming the renal papillae due to metabolic disturbances).

Reproductive system and breast disorders: infertility.

General disorders and administration site conditions: malaise, pyrexia (chills and fever), thirst, sore throat.

Investigations: abnormal liver function tests, increased serum creatinine, hyperkalaemia.

Medicines such as sodium naproxen may rarely be associated with liver damage (may affect up to 1 in 1,000 people).

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Naproxen sodium HCS

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 after EXP. The expiry
date refers to the last day of that month.
Store in the original packaging to protect from light.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Naproxene sodico HCS contains

• The active substance is naproxen sodium. Each film-coated tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• The other ingredients are povidone K30, microcrystalline cellulose, talc, magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), macrogol 8000, and indigo carmine (E132) in the tablet coating. See section 2 "Naproxene sodico HCS contains sodium".

Description of the appearance of Naproxene sodico HCS and package contents
The tablets are blue, oval, film-coated, slightly biconvex tablets, marked on one side. Size: 18 x 8 mm.
The tablet may be divided into equal parts.
Film-coated tablets are available in boxes containing 10 x 1, 16 x 1, 30 x 1, 40 x 1, and 60 x 1 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names: