Package leaflet: Information for the user

Naproxen Genoptim, 250 mg, tablets
Naproxen Genoptim, 500 mg, tablets
Naproxenum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

What is Naproxen Genoptim and what is it used for
Important information before taking Naproxen Genoptim
How to take Naproxen Genoptim
Possible side effects
How to store Naproxen Genoptim
Contents of the pack and other information

1. What is Naproxen Genoptim and what is it used for

Naproxen Genoptim belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) which have analgesic and antipyretic properties.
Naproxen Genoptim is indicated for use in:
adults:

rheumatoid arthritis;
ankylosing spondylitis;
osteoarthritis;
acute musculoskeletal pain;
acute gouty arthritis;
painful menstruation.

in children:

treatment of juvenile idiopathic arthritis.

2. Important information before using Naproxen Genoptim

When not to use Naproxen Genoptim:

if the patient is allergic to the active substance, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
if use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs has previously caused allergic symptoms: asthma attack, rhinitis, urticaria;
if the patient has or has had gastric or duodenal ulcer disease,

perforation or bleeding, including events occurring after use of NSAIDs;

if the patient has a bleeding disorder;
if the patient has severe heart, liver, or kidney failure;
if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Naproxen Genoptim, discuss this with your doctor or pharmacist.
Naproxen should be administered cautiously, using the lowest effective dose, in patients
with cardiac insufficiency (due to the possibility of increased peripheral edema).
To detect potential adverse effects, patients on long-term NSAID therapy should undergo regular medical check-ups.
Naproxen should be used with particular caution in patients with risk factors for cardiovascular complications – such as hypertension,
hyperlipidemia, impaired peripheral circulation, diabetes, or in smokers.
Use of naproxen carries a risk of gastrointestinal ulceration, perforation, or bleeding.
These adverse effects may be fatal and may occur without warning symptoms. Treatment with Naproxen Genoptim should
be discontinued if gastrointestinal bleeding or ulceration occurs. Patients
with gastrointestinal disorders, particularly elderly patients, should be informed of the need to report any unusual
gastrointestinal symptoms, especially bleeding, to their doctor. This is particularly important
during the initial period of treatment. In such patients, it is recommended to use the lowest effective
dose of the medicine.
Concomitant use of Naproxen Genoptim and other non-steroidal anti-inflammatory drugs (including selective COX-2 inhibitors) should be avoided due to increased
risk of severe adverse effects.
Concomitant use of Naproxen Genoptim with heparin or warfarin should be conducted under
medical supervision. Naproxen inhibits platelet aggregation and prolongs bleeding time. In patients
receiving anticoagulants (e.g., dicumarol) or those with pre-existing coagulation disorders, the risk of bleeding is increased.
In patients with impaired liver function, such as chronic alcoholic liver disease
or other forms of cirrhosis, use of the lowest effective dose is recommended.
In patients with bronchial asthma or other allergic diseases, Naproxen Genoptim increases
the risk of bronchospasm.
Naproxen Genoptim should be used cautiously in patients with impaired kidney function.
In such patients, the physician may recommend periodic kidney function tests: monitoring of serum creatinine
levels and/or creatinine clearance. Naproxen Genoptim is contraindicated in patients whose creatinine clearance is below
20 ml/minute.
Due to its anti-inflammatory and antipyretic effects, Naproxen Genoptim may mask symptoms
of other diseases and complicate diagnosis.
Due to the increased risk of adverse effects, long-term NSAID therapy is not recommended
in elderly patients. They should receive the medicine at the lowest effective dose.
Elderly patients on long-term NSAID therapy should undergo regular medical examinations.
Use of non-steroidal anti-inflammatory drugs carries a risk of severe
gastrointestinal adverse effects. This risk is independent of the duration
of NSAID use. Most adverse events occur in elderly and debilitated patients, who tolerate gastric and intestinal ulcers and bleeding less well.
Very rarely, severe skin reactions (some fatal), such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been observed in patients using NSAIDs.
The highest risk of the above-mentioned reactions occurs at the beginning of naproxen treatment, most commonly within the first month of use. If early symptoms such as rash, oral mucosal lesions, or other signs of hypersensitivity occur, treatment with Naproxen Genoptim should be discontinued immediately and medical advice sought without delay.
Hypersensitivity reactions may occur in patients with hypersensitivity to acetylsalicylic acid or other
NSAIDs, as well as in patients without known hypersensitivity, particularly in those with angioedema,
bronchial asthma, rhinitis, or nasal polyps. Hypersensitivity reactions may be fatal.
Rarely, use of non-steroidal anti-inflammatory drugs may lead to eye disorders: optic neuritis;
optic disc edema. A causal relationship has not been established. Ophthalmological examination is recommended if eye disorders occur.
During therapy with Naproxen Genoptim, steroid dose reduction or discontinuation should be gradual. Due to the risk of adverse effects such as adrenal insufficiency or worsening of joint inflammation symptoms, the patient should remain under medical supervision.
Use of medicines such as Naproxen Genoptim may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Doses higher than recommended or longer treatment duration than advised should not be used.
If the patient has heart problems, a history of stroke, or suspected risk of such conditions (e.g., high blood pressure, diabetes, elevated cholesterol, smoking), treatment should be discussed with a doctor or pharmacist.

Naproxen Genoptim and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Before starting treatment with this medicine, talk to your doctor or pharmacist if the patient is taking any of the following medicines, including acetylsalicylic acid used for prevention of blood clots.
Acetylsalicylic acid may increase renal clearance of naproxen and reduce its serum concentration.
Concomitant administration of antacids or cholestyramine with Naproxen Genoptim may delay its absorption. Naproxen Genoptim may enhance the effect of anticoagulants, such as warfarin and heparin.
Naproxen Genoptim may inhibit the diuretic effect of furosemide and reduce lithium excretion (decreased renal clearance of lithium ions), leading to increased blood lithium levels.
Probenecid increases naproxen blood concentration and prolongs its half-life.
Concomitant use of Naproxen Genoptim with cardiac glycosides may inhibit renal excretion of glycosides, resulting in increased blood levels.
Naproxen reduces urinary excretion of methotrexate, which may lead to increased methotrexate toxicity.
Naproxen reduces the blood pressure-lowering effect of propranolol and other β-adrenergic receptor blockers. Naproxen increases the risk of renal dysfunction associated with ACE inhibitors.
Concomitant use of Naproxen Genoptim with cyclosporine may increase cyclosporine serum levels, potentially leading to nephrotoxic effects.
Concomitant use of NSAIDs with tacrolimus may also have nephrotoxic effects.
Naproxen Genoptim enhances the effects of hydantoins, sulfonamides, and oral anticoagulants by displacing them from protein binding sites.
Concomitant use of Naproxen Genoptim with corticosteroids increases the risk of gastrointestinal disorders, including gastrointestinal bleeding.
Naproxen Genoptim reduces the efficacy of mifepristone. Naproxen treatment should not be initiated until at least 8 to 12 days after the last dose of mifepristone.
Concomitant use of Naproxen Genoptim with fluoroquinolones increases the risk of seizures.
Use of Naproxen Genoptim within 48 hours before adrenal cortex function testing may interfere with the measurement of 17-ketosteroids and 5-hydroxyindoleacetic acid in urine.
Concomitant use of Naproxen Genoptim with antiplatelet agents and non-selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding.
Zidovudine (a medicine used in the treatment of AIDS and HIV infection) increases the risk of hematotoxic effects.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Naproxen Genoptim should not be used during the first and second trimesters of pregnancy, except in cases recommended and supervised by a doctor, after careful consideration of potential benefits to the mother and fetus. Naproxen Genoptim should not be used during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both mother and child and may result in delayed or prolonged labor. Naproxen Genoptim should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. Naproxen Genoptim taken for longer than a few days after the 20th week of pregnancy may cause impaired kidney function in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.
Naproxen passes into breast milk; therefore, it should not be used in breastfeeding women.
Naproxen Genoptim may impair fertility. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
During treatment with Naproxen Genoptim, caution should be exercised. Some patients may experience: drowsiness, dizziness, balance disturbances, insomnia, fatigue, visual disturbances, or depression.
If any of these adverse effects occur, the patient should not drive or operate machinery.

Naproxen Genoptim contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Naproxen Genoptim contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Naproxen Genoptim

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. The doctor will individually adjust the dose for the patient.
Adults:
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
The recommended initial dose is usually 500 mg to 1000 mg daily, divided into two doses
given 12 hours apart or as a single dose.
In acute conditions, the dose may be increased (short-term, under strict medical supervision) to 750 mg
to 1000 mg daily (loading dose):

in patients experiencing severe night pain or morning stiffness;
in patients switched to naproxen from other NSAIDs previously taken in high doses;
in osteoarthritis with painful symptoms.

Acute gout attack
Initially 750 mg, then 500 mg after 8 hours, followed by 250 mg every 8 hours until the attack subsides.
Acute musculoskeletal disorders and dysmenorrhea
The initial dose is 500 mg as a single dose, then 250 mg every 6 to 8 hours as needed, with a maximum daily dose of 1250 mg on the first day of treatment.
Elderly patients
As with other medicines, elderly patients are at increased risk of adverse effects, including gastrointestinal bleeding. This medicine should be administered at the lowest effective dose for the shortest possible duration. Patients in this group should be monitored periodically by a physician.
Children:
Juvenile rheumatoid arthritis (children over 5 years of age weighing more than 25 kg)
The recommended daily dose is 10 mg/kg body weight daily, divided into two doses given 12 hours apart (morning and evening). Naproxen is not recommended for children under 16 years of age for indications other than juvenile arthritis.
Patients with renal or hepatic impairment
In patients with impaired renal and/or hepatic function, lower doses of naproxen should be considered. This medicine is contraindicated in patients with creatinine clearance below 30 ml/minute, as accumulation of naproxen metabolites has been observed in patients with severe renal impairment or those on dialysis, as well as in patients with severe hepatic impairment.
Naproxen Genoptim should be taken during or after meals.
Taking the medicine at the lowest effective dose and for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
The doctor will assess treatment outcomes at regular intervals; if no improvement is observed, naproxen use should be discontinued.
Use of a higher than recommended dose of Naproxen Genoptim
Symptoms of overdose: drowsiness, vomiting, heartburn, nausea, epigastric pain, renal dysfunction. If any of these symptoms occur, contact a doctor immediately.
In case of naproxen overdose, empty the stomach and then administer appropriate supportive treatment. Prompt administration of an appropriate amount of activated charcoal reduces the amount of drug absorbed.
In case of renal failure, hemodialysis may be necessary.
Missed dose of Naproxen Genoptim
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Gastrointestinal disorders:
The most commonly reported adverse effects involve the gastrointestinal tract. These include heartburn,
nausea, vomiting, constipation, diarrhoea, bloating, indigestion, discomfort in the abdominal cavity,
and epigastric pain. More serious reactions that may occur include gastrointestinal bleeding,
sometimes leading to death, particularly in elderly patients, inflammatory states, ulcers, perforations and
obstructions of the upper and lower gastrointestinal tract, tarry stools, bloody vomiting, stomatitis,
exacerbation of ulcerative colitis and Crohn's disease, oesophagitis, gastric and pancreatic mucositis.
Blood and lymphatic system disorders:
neutropenia (reduced number of neutrophils), thrombocytopenia (deficiency of blood platelets),
granulocytopenia (reduced number of granulocytes below normal levels in blood) with agranulocytosis
(life-threatening drop in neutrophil count), leukopenia (low white blood cell count), eosinophilia (increased number of eosinophils), aplastic anaemia (bone marrow failure), and haemolytic anaemia (accelerated breakdown of red blood cells).
Immune system disorders:
Hypersensitivity reactions have been reported during NSAID therapy in patients with or without
known NSAID hypersensitivity. These may include (a) non-specific allergic and anaphylactic reactions, (b) respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea, or (c) mixed skin reactions including various types of rashes, pruritus, urticaria, purpura, angioedema, and less frequently exfoliative and bullous dermatoses (including necrolysis of the epidermis and erythema multiforme).
Metabolism and nutrition disorders:
hyperkalaemia.
Psychiatric disorders:
depression, insomnia, sleep disturbances, disorientation, hallucinations.
Nervous system disorders:
Seizures, dizziness, headache, somnolence, paraesthesia, optic neuritis, papilloedema, concentration disturbances and cognitive dysfunction have been reported. Aseptic meningitis (particularly in patients with autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever and disorientation.
Eye disorders:
visual disturbances, corneal clouding, optic neuritis, optic disc oedema.
Ear and labyrinth disorders:
tinnitus, hearing disturbances and dizziness.
Cardiac disorders:
palpitations, oedema, cardiac failure and congestive heart failure.
Clinical studies and epidemiological data suggest that the use of coxibs and certain NSAIDs, particularly long-term and at high doses, may be associated with a small increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Vascular disorders:
hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders:
dyspnoea, asthma; eosinophilic pneumonia (accumulation of eosinophils in lung alveoli and interstitium); pulmonary oedema.
Hepatobiliary and biliary disorders:
jaundice, hepatitis (including fatal cases), abnormal liver function test results.
Skin and subcutaneous tissue disorders:
skin rashes, including drug eruption, pruritus, urticaria, petechiae, purpura, sweating, alopecia, erythema multiforme, Stevens-Johnson syndrome, nodular erythema, lichen planus, bullous reactions, systemic lupus erythematosus, epidermal necrosis, very rarely toxic epidermal necrolysis, photosensitivity, including pseudoporphyria (late cutaneous porphyria), or rarely bullous detachment of the epidermis.
If skin fragility, skin blisters or other symptoms suggestive of pseudoporphyria occur, the medicine should be discontinued and the patient monitored.
If any of the following adverse effects occur, stop taking
Naproxen Genoptim and contact your doctor immediately:
Widespread rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
A characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same location(s) upon re-exposure to the drug and may present as round or oval red spots and swelling of the skin, blisters (urticaria), itching; a characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same location(s) upon re-exposure to the drug and may present as round or oval red spots and swelling of the skin, blisters (urticaria), itching;
Musculoskeletal and connective tissue disorders:
muscle pain and weakness.
Renal and urinary disorders:
glomerulonephritis, interstitial nephritis, nephrotic syndrome, haematuria, increased serum creatinine concentration, necrosis of renal papillae and renal failure.
Reproductive system and breast disorders:
impaired fertility in women.
General disorders and administration site conditions:
increased thirst, fever, fatigue, malaise.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Naproxen Genoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after EXP and on the
carton after: Expiry date (EXP). The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Naproxen Genoptim contains

The active substance is naproxen. Each tablet contains 250 or 500 mg of naproxen.
The other ingredients are: lactose monohydrate, maize starch, yellow iron oxide (E 172), povidone (K-29/32), sodium carboxymethyl starch (type A), magnesium stearate.

What Naproxen Genoptim looks like and contents of the pack
Naproxen Genoptim 250 mg, tablets
A yellow, mottled, biconvex, round tablet with bevelled edges, uncoated, with the imprint "T" and "18" on both sides of the break line on one side of the tablet and smooth on the other side, with a diameter of 10.5 mm.
The tablet can be divided into equal doses.
Naproxen Genoptim 500 mg, tablets
A yellow, mottled, biconvex, uncoated, capsule-shaped tablet with the imprint "T" and "20" on both sides of the break line on one side of the tablet and smooth on the other side, with a length of 18.5 mm and a width of 8 mm.
The tablet can be divided into equal doses.
PVC/PE/PVDC/Aluminium blister pack in a cardboard box.
Pack sizes:
Blister: 20, 30, 50, 60, 90 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel. 607 696 231
e-mail: [email protected]

Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia,
BBG 3000 Malta

Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz