Naproxen Genoptim

Package Leaflet: Information for the User

Naproxen Genoptim, 250 mg, tablets

Naproxen Genoptim, 500 mg, tablets

Naproxen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Naproxen Genoptim and what is it used for
• 2. Important information before taking Naproxen Genoptim
• 3. How to take Naproxen Genoptim
• 4. Possible side effects
• 5. How to store Naproxen Genoptim
• 6. 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 with analgesic and antipyretic properties.
Naproxen Genoptim is indicated for use in:
adults:

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

in children:

• treatment of juvenile rheumatoid arthritis.

2. Important information before taking Naproxen Genoptim

When not to take Naproxen Genoptim:

• if the patient is hypersensitive 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 the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs has caused symptoms of allergy: bronchial asthma, rhinitis, urticaria;
• if the patient has or has had gastric or duodenal ulcer, perforation or bleeding, also occurring after the use of NSAIDs;

gastrointestinal disorders such as ulcerative colitis, Crohn's disease;

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

Warnings and precautions

Before starting treatment with Naproxen Genoptim, discuss it with your doctor or pharmacist.
Naproxen should be administered with caution, using the smallest effective dose, to patients with heart failure (due to the possibility of increasing peripheral edema).
In order to detect possible side effects, patients taking non-steroidal anti-inflammatory drugs for a long time should undergo regular medical check-ups.
In people with a risk factor for cardiovascular complications - hypertension, hyperlipidemia, peripheral circulation disorders, diabetes, and smokers, naproxen should be used with extreme caution.
Taking naproxen carries the risk of developing ulcers, perforations or bleeding in the gastrointestinal tract. These side effects, which can be fatal, may be preceded by warning signs, but do not have to be. The use of Naproxen Genoptim should be discontinued in case of bleeding or gastrointestinal ulcers. Patients who have had gastrointestinal diseases, especially the elderly, should be informed about the need to report any unusual gastrointestinal symptoms to their doctor, especially bleeding. This is especially important during the initial treatment period. In such patients, the use of the smallest effective dose of the medicine is recommended.
It is recommended to avoid concomitant use of Naproxen Genoptim and other non-steroidal anti-inflammatory drugs (including selective COX-2 inhibitors) due to the increased risk of serious side effects.
Concomitant use of Naproxen Genoptim with heparin or warfarin should be carried out under medical supervision. Naproxen inhibits platelet aggregation and prolongs bleeding time. In patients taking anticoagulant drugs (e.g. dicumarol) or in whom coagulation disorders have already occurred, the risk of bleeding increases.
In patients with liver function disorders, such as chronic alcoholic liver disease and other forms of liver cirrhosis, the use of the smallest 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 with caution in patients with impaired renal function.
In these patients, the doctor will prescribe periodic renal function tests: monitoring serum creatinine levels and (or) creatinine clearance. In patients with a creatinine clearance of less than 20 ml/minute, the medicine is contraindicated.
Due to its anti-inflammatory and antipyretic effects, the use of the medicine may mask the symptoms of another disease and make diagnosis difficult.
Due to the increased risk of side effects, long-term therapy with NSAIDs is not recommended in elderly patients. They should take the medicine in the smallest effective dose.
Elderly patients taking non-steroidal anti-inflammatory drugs for a long time should undergo regular medical check-ups.
Taking non-steroidal anti-inflammatory drugs carries the risk of serious side effects related to the gastrointestinal system. This risk is independent of the duration of NSAID use. Most side effects occur in the elderly and frail, who are less tolerant of ulcers and bleeding in the stomach and intestines.
Very rarely, serious skin reactions (some fatal) such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome) have been observed in patients taking NSAIDs.
The greatest risk of the above reactions occurs at the beginning of treatment with naproxen, most often in the first month of taking the medicine. After the first symptoms of a rash, oral mucosa damage or other signs of hypersensitivity appear, the use of Naproxen Genoptim should be discontinued and medical attention should be sought immediately.
Hypersensitivity reactions may occur in people with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, as well as in people with hypersensitivity, patients with angioedema, bronchial asthma, nasal inflammation, and nasal polyps. Hypersensitivity reactions can be fatal.
Rarely, non-steroidal anti-inflammatory drugs can cause eye diseases: optic neuritis; papillitis. The causal relationship of this mechanism is not known. If eye diseases occur, ophthalmological examinations are recommended.
During treatment with Naproxen Genoptim, the dose of steroids or their withdrawal should be gradual. Due to the possibility of side effects such as adrenal insufficiency or worsening of arthritis symptoms, the patient should be under medical supervision.
Taking such medicines 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 of the medicine. Do not use higher doses and longer treatment than recommended.
In case of heart problems, a history of stroke or suspected risk of these disorders (e.g. high blood pressure, diabetes, increased cholesterol levels, smoking), consult your doctor or pharmacist.

Naproxen Genoptim and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Before starting treatment with this medicine, talk to your doctor or pharmacist if you are taking any of the following medicines, including acetylsalicylic acid used to prevent blood clots.
Acetylsalicylic acid may increase the renal clearance of naproxen and decrease its serum concentration.
Concomitant administration of antacids or cholestyramine with Naproxen Genoptim may delay its absorption. Naproxen Genoptim may increase the effect of anticoagulant drugs, e.g. warfarin and heparin.
Naproxen Genoptim may inhibit the diuretic effect of furosemide and lithium excretion (decrease in renal clearance of lithium ions), leading to increased lithium levels in the blood.
Probenecid increases the concentration of naproxen in the blood and prolongs its half-life.
Concomitant use of Naproxen Genoptim with digitalis glycosides may inhibit the renal excretion of glycosides, leading to an increase in their blood levels.
Naproxen decreases the excretion of methotrexate in the urine, which may lead to increased methotrexate toxicity.
Naproxen reduces the blood pressure-lowering effect of propranolol and other beta-adrenergic receptor blockers. Naproxen increases the risk of renal function disorders associated with the use of ACE inhibitors.
Concomitant use of Naproxen Genoptim with cyclosporin may increase the concentration of cyclosporin in the serum, which may lead to toxic effects on the kidneys.
Concomitant use of NSAIDs with tacrolimus may also have a toxic effect on the kidneys.
Naproxen Genoptim enhances the effect of hydantoin, sulfonamides, and oral anticoagulants by displacing their binding to proteins.
Concomitant use of Naproxen Genoptim with corticosteroids increases the risk of gastrointestinal disorders: gastrointestinal bleeding.
Naproxen Genoptim reduces the effect of mifepristone. Naproxen treatment can only be started 8 to 12 days after the last dose of mifepristone.
Taking Naproxen Genoptim at the same time as fluoroquinolones increases the risk of seizures.
Taking Naproxen Genoptim within 48 hours before an adrenal function test may lead to false results of 17-ketosteroid and 5-hydroxyindoleacetic acid measurements 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 to treat AIDS and HIV infections) increases the risk of toxic effects on the hematopoietic system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Naproxen Genoptim should not be used during the first and second trimester of pregnancy, except in cases recommended and supervised by a doctor, after careful consideration of the potential benefits to the mother and the fetus. Naproxen Genoptim should not be used during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart disorders in the unborn child. It may affect the tendency to bleed in the mother and child and cause the delivery to be later or longer than expected. Naproxen Genoptim should not be taken during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during attempts to conceive, the smallest dose should be used for the shortest possible time. Naproxen Genoptim taken for more than a few days from the 20th week of pregnancy may cause kidney function disorders in the unborn child, which can lead to a low level of amniotic fluid surrounding the child (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for a period longer than a few days, the doctor may recommend additional monitoring.
Naproxen passes into breast milk, so it should not be used in breastfeeding women.
Naproxen Genoptim may make it difficult to become pregnant. If you are planning to become pregnant or are having trouble becoming pregnant, tell your doctor.

Driving and using machines

Be careful when taking Naproxen Genoptim. Some patients may experience: drowsiness, dizziness, balance disorders, insomnia, fatigue, vision disorders, depression.
If you experience any of the above side effects, do not drive or operate machinery.

Naproxen Genoptim contains lactose.

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Naproxen Genoptim contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Naproxen Genoptim

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The doctor will adjust the dose individually for you.

Adults:

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
The recommended initial dose is usually 500 mg to 1000 mg per day in two divided doses every 12 hours or in a single dose.
In acute conditions, the dose can be increased (short-term, under strict medical supervision) from 750 mg to 1000 mg per day (loading dose):

• in patients reporting severe night pain or morning stiffness;
• in patients in whom naproxen has replaced other NSAIDs taken in high doses;
• in osteoarthritis with painful symptoms.

Acute gouty attack
Initially 750 mg, then 500 mg after 8 hours, then 250 mg every 8 hours until the attack subsides.
Acute musculoskeletal disorders and painful menstruation
The initial dose is 500 mg once, then 250 mg every 6 to 8 hours as needed, with a maximum daily dose of 1250 mg after the first day of administration.

Elderly patients

Similarly, as with other medicines, elderly patients are at increased risk of side effects, including gastrointestinal bleeding. This medicine should be administered in the smallest effective dose for the shortest possible period. The doctor will periodically monitor these patients.

Children:

Juvenile rheumatoid arthritis (children over 5 years old and weighing over 25 kg)
The recommended daily dose is 10 mg/kg body weight per day in 2 divided doses every 12 hours (morning and evening). Naproxen is not recommended for children under 16 years of age for indications other than juvenile rheumatoid arthritis.

Patients with renal or hepatic impairment

In patients with renal or hepatic impairment, the use of lower doses of naproxen should be considered. The medicine is contraindicated in patients with a creatinine clearance of less than 30 ml/minute, as naproxen metabolites have been observed to accumulate in patients with severe renal impairment or those undergoing dialysis, as well as in patients with severe liver impairment.
Naproxen Genoptim should be taken with food or after eating.
Taking the medicine in the smallest effective dose and for the shortest possible period necessary to alleviate symptoms reduces the risk of side effects.
The treatment results will be assessed by the doctor at regular intervals, and if there is no improvement, the use of naproxen should be discontinued.

Overdose of Naproxen Genoptim

Symptoms of overdose: drowsiness, vomiting, heartburn, nausea, abdominal pain, kidney function disorders. If you experience any of the above symptoms, contact your doctor immediately.
In case of overdose, the stomach should be emptied, and then appropriate supportive treatment should be applied. Rapid administration of a sufficient amount of activated carbon reduces the amount of absorbed medicine.
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 side effects

Like all medicines, Naproxen Genoptim can cause side effects, although not everybody gets them.
Gastrointestinal disorders:
The most commonly reported side effects are related to the gastrointestinal tract. Heartburn, nausea, vomiting, constipation, diarrhea, bloating, indigestion, discomfort in the abdominal cavity, and abdominal pain. More serious reactions that may occur are gastrointestinal bleeding, sometimes fatal, especially in the elderly, inflammation, ulcers, perforations, and obstruction of the upper and lower gastrointestinal tract, melena, hematemesis, oral mucosal inflammation, exacerbation of ulcerative colitis and Crohn's disease, esophagitis, gastric mucosal inflammation, and pancreatitis.
Blood and lymphatic system disorders:
neutropenia (decreased granulocyte count), thrombocytopenia (low platelet count), granulocytopenia (decreased granulocyte count) with agranulocytosis (life-threatening decrease in neutrophil count), leukopenia (low white blood cell count), eosinophilia (increased eosinophil count), aplastic anemia (bone marrow failure) and hemolytic anemia (faster breakdown of red blood cells).
Immune system disorders:
hypersensitivity reactions have been reported during treatment with NSAIDs in patients with or without hypersensitivity to NSAIDs. They may include (a) non-specific allergic and anaphylactic reactions and (b) respiratory tract reactions, including asthma, asthma exacerbation, bronchospasm, or dyspnea, or (c) mixed skin reactions, including various types of rashes, itching, urticaria, angioedema, and rare cases of exfoliative and bullous dermatoses (including toxic epidermal necrolysis and Stevens-Johnson syndrome).
Metabolic and nutritional disorders:
hyperkalemia.
Psychiatric disorders:
depression, insomnia, sleep disorders, disorientation, hallucinations.
Nervous system disorders:
seizures, dizziness, headache, drowsiness, paresthesia, optic neuritis, concentration disorders, and cognitive function disorders, aseptic meningitis (especially in patients with autoimmune disorders such as systemic lupus erythematosus, mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.
Eye disorders:
vision disorders, corneal clouding, optic neuritis, papillitis.
Ear and labyrinth disorders:
tinnitus, hearing disorders, and dizziness.
Cardiac disorders:
palpitations, edema, heart failure, and congestive heart failure.
Based on clinical trials and epidemiological data, the use of coxibs and some NSAIDs, especially long-term and in high doses, may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Vascular disorders:
hypertension, vasculitis.
Respiratory, thoracic, and mediastinal disorders:
dyspnea, asthma; eosinophilic pneumonia (accumulation of eosinophils in the alveoli and lung interstitium); pulmonary edema.
Hepatobiliary disorders:
jaundice, hepatitis (including fatal cases), abnormal liver function tests.
Skin and subcutaneous tissue disorders:
skin rashes, including drug rash, itching, urticaria, purpura, petechiae, sweating, alopecia, Stevens-Johnson syndrome, toxic epidermal necrolysis, and very rarely drug-induced pseudoporphyria or bullous dermatosis.
If skin fragility, blisters, or other symptoms suggesting pseudoporphyria appear, the use of the medicine should be discontinued and the patient monitored.
If you experience any of the following side effects, stop taking Naproxen Genoptim and contact your doctor immediately:
extensive rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymphadenopathy, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
A characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) as a result of re-exposure to the medicine and may take the form of round or oval red patches and skin edema, blisters (urticaria), itching;
a characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) as a result of re-exposure to the medicine and may take the form of round or oval red patches and skin edema, blisters (urticaria), itching;
Musculoskeletal and connective tissue disorders:
muscle pain and weakness.
Renal and urinary disorders:
glomerulonephritis, interstitial nephritis, nephrotic syndrome, hematuria, increased serum creatinine levels, and renal failure.
Reproductive system and breast disorders:
female fertility disorders.
General disorders and administration site conditions:
increased thirst, fever, fatigue, malaise.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Naproxen Genoptim

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

6. Contents of the pack and other information

What Naproxen Genoptim contains

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

What Naproxen Genoptim looks like and contents of the pack

Naproxen Genoptim, 250 mg, tablets
Yellow, scored, biconvex, round with beveled edges, uncoated tablet with the inscription "T" and "18" on either side of the break line, on one side of the tablet and smooth on the other, with a diameter of 10.5 mm.
The tablet can be divided into equal doses.
Naproxen Genoptim, 500 mg, tablets
Yellow, scored, biconvex, capsule-shaped, uncoated tablet with the inscription "T" and "20" on either side of the break line, on one side of the tablet and smooth on the other, with a length of 18.5 mm and a width of 8 mm.
The tablet can be divided into equal doses.
PVC/PE/PVDC/Aluminum blister pack in a cardboard box.
Package sizes:
Blister pack: 20, 30, 50, 60, 90 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
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

Date of last revision of the package leaflet: