Apo-napro Forte

Package Leaflet: Information for the User

Apo-Napro Forte, 550 mg, Coated Tablets

Naproxen Sodium

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you, 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 any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Apo-Napro Forte and What is it Used For
• 2. Important Information Before Taking Apo-Napro Forte
• 3. How to Take Apo-Napro Forte
• 4. Possible Side Effects
• 5. How to Store Apo-Napro Forte
• 6. Package Contents and Other Information

1. What is Apo-Napro Forte and What is it Used For

Apo-Napro Forte contains the active substance naproxen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Apo-Napro Forte is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (neck and back pain and stiffness), acute gout, acute musculoskeletal pain (such as sprains and strains), and painful menstruation (dysmenorrhea).

2. Important Information Before Taking Apo-Napro Forte

When Not to Take Apo-Napro Forte

• If you are allergic to naproxen, naproxen sodium, or any of the other ingredients of this medicine (listed in section 6).
• If you are over 65 years old.
• If you have severe liver, kidney, or heart failure.
• If you have had gastrointestinal bleeding or perforation related to previous use of painkillers or NSAIDs.
• If you have a history of ulcers or gastrointestinal bleeding (stomach or duodenal ulcers) or if you have had two or more episodes of this condition.
• If you have internal bleeding (such as stomach or intestinal bleeding or stroke).
• If you have stomach or duodenal ulcers, gastritis, or abdominal pain.
• If you have ever had an allergic reaction, such as asthma, rhinitis, or itching after taking acetylsalicylic acid, ibuprofen, or other painkillers or NSAIDs.
• If you have increased bleeding or are being treated with anticoagulant medications.
• If you have ulcerative colitis (inflammatory bowel disease).
• If you are taking other medications of this type (NSAIDs).
• If you are in the third trimester of pregnancy.

Warnings and Precautions

Before starting treatment with Apo-Napro Forte, discuss it with your doctor or pharmacist.

• It is important to use the smallest effective dose for the shortest duration necessary to control symptoms,
• If you have liver function disorders,
• If you have kidney function disorders,
• If you have an infection,
• Taking medications like Apo-Napro Forte may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with increasing dose and duration of treatment. Do not exceed the recommended dose. If you have heart problems, have had a stroke, or think you may be at risk (e.g., high blood pressure, diabetes, or high cholesterol or smoking), discuss it with your doctor or pharmacist before taking this medication.

Ulcers or gastrointestinal bleeding, which can be fatal, can occur at any time during NSAID treatment, without prior symptoms.
In case of ulcers or gastrointestinal bleeding, stop taking this medication immediately and consult your doctor. The risk increases with the use of higher doses, with a history of gastrointestinal symptoms, in combination with other medications that may cause ulcers or bleeding, such as anticoagulants, oral corticosteroids, and SSRI medications (selective serotonin reuptake inhibitors), as well as in the elderly. See also "Apo-Napro Forte and Other Medications". Your doctor may prescribe another medication in combination with Apo-Napro Forte to protect against gastrointestinal symptoms.
If you have Crohn's disease or ulcerative colitis, because naproxen sodium-containing medications can exacerbate these conditions.
In particular, elderly patients often experience side effects and should report any unusual gastrointestinal symptoms (especially bleeding), especially at the start of treatment.
Sensitive individuals may experience hypersensitivity reactions. Severe allergic reactions (anaphylactic reactions) can occur in individuals with a history of allergic reactions or without contact with acetylsalicylic acid, naproxen, or other NSAIDs. They can also occur in individuals with angioedema (swelling of the face, lips, eyes, or tongue), bronchial hyperreactivity (e.g., asthma), rhinitis (frequent sneezing or runny nose, stuffy or itchy nose), and nasal polyps. Allergic reactions, such as anaphylaxis, can be fatal.
If you have asthma or allergic diseases (such as rhinitis or nasal polyps), Apo-Napro Forte may cause breathing difficulties (bronchospasm).
If you experience vision disturbances during treatment.
This medication should be used with caution in patients who are on a low-sodium diet and have a history of digestive disorders.
Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which can sometimes lead to death and usually occur at the start of treatment, have been reported with the use of Apo-Napro Forte. Stop taking Apo-Napro Forte and seek medical attention immediately if you experience any symptoms related to these severe skin reactions, described in section 4.
Naproxen inhibits platelet aggregation and may prolong bleeding time. Patients with coagulation disorders or taking medications that affect blood coagulation should be closely monitored during treatment with Apo-Napro Forte.
Concomitant use of Apo-Napro Forte with other NSAIDs, including selective COX-2 inhibitors, should be avoided.
Medications like Apo-Napro Forte may contribute to the worsening of chickenpox infections. Naproxen use is not recommended if you have chickenpox.
Patients with gastrointestinal disorders and bleeding ulcers should only take this medication under medical supervision.
Consult your doctor if any of the above warnings apply to you or have occurred in the past.
Consult your doctor or pharmacist:

• if you experience gastrointestinal symptoms (such as stomach pain, heartburn, or bleeding) after taking naproxen sodium
• if you experience fluid retention (such as swelling of the ankles and feet) after taking this medication.

This medication belongs to a group of medications (NSAIDs) that may affect female fertility during treatment. This effect is temporary and reverses after stopping treatment.
Long-term use of any painkillers for headache may worsen the headache. If you think this situation applies to you, consult your doctor for advice.
Naproxen sodium is not recommended for use in cases of gastrointestinal pain.

Children and Adolescents

Apo-Napro Forte is not recommended for use in children and adolescents under 16 years of age.

Apo-Napro Forte and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those available without a prescription.
Due to interactions with certain other medications, the effect of Apo-Napro Forte or the effect of these medications may be increased or decreased. This occurs with:

• medications that neutralize stomach acid (antacids or cholestyramine)
• medications used to prevent blood clotting (warfarin)
• medications used to prevent blood clots (aspirin/acetylsalicylic acid)
• medications used to treat diabetes (sulfonylurea)
• hydantoins (medications used to treat epilepsy), such as phenytoin
• sulfonamide medications, such as hydrochlorothiazide, acetazolamide, indapamide, including sulfonamide antibiotics (used in infections)
• medications used to treat high blood pressure (beta-blockers and diuretics)
• ACE inhibitors or any other medication used to treat high blood pressure, such as cilazapril, enalapril, or propranolol
• angiotensin II receptor antagonists, such as candesartan, eprosartan, or losartan
• medications that increase urine production (furosemide)
• medications used to treat mental disorders (lithium)
• medications used to treat cancer (methotrexate)
• medications used to treat joint pain and inflammation (steroids and corticosteroids)
• SSRI medications (selective serotonin reuptake inhibitors, antidepressants)
• cyclosporine (used against autoimmune disorders)
• zidovudine (used in the treatment of AIDS and HIV infections)
• other painkillers and anti-inflammatory medications (NSAIDs, such as ibuprofen)

Concomitant use of probenecid (for gout) may increase the risk of adverse effects of naproxen sodium.
Naproxen sodium may falsely increase the level of 17-ketosteroids in urine; it may affect the results of urine tests for 5-hydroxyindoleacetic acid.
Naproxen should be discontinued at least 48 hours before adrenal function tests.

Apo-Napro Forte with Food and Drink

Tablets should be taken during or immediately after a meal, with a sufficient amount of liquid.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medication.
Pregnancy
Do not take Apo-Napro Forte during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medication may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in you and your child and cause prolongation or delay of labor. In the first and second trimesters of pregnancy, naproxen sodium should not be used unless absolutely necessary and under medical supervision. When using naproxen sodium in women planning pregnancy or in the first or second trimester of pregnancy, use the lowest possible dose and the shortest treatment duration. Apo-Napro Forte taken for more than a few days from the 20th week of pregnancy may cause constriction of the fetal ductus arteriosus or kidney problems, which can lead to low amniotic fluid levels (oligohydramnios). If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
Breastfeeding
Naproxen sodium passes into breast milk (in the form of naproxen). Therefore, naproxen sodium should not be used during breastfeeding.
Fertility
This medication belongs to a group of medications (NSAIDs) that may affect female fertility during treatment. This effect is temporary and reverses after stopping treatment.

Driving and Using Machines

Apo-Napro Forte has no or negligible influence on the ability to drive and use machines. Naproxen sodium may cause drowsiness and dizziness as a side effect. It may cause fatigue, vision problems, and balance problems, depression, or sleep disturbances, and thus affect the ability to drive and use machines.

Apo-Napro Forte Contains Sodium

This medication contains 50 mg of sodium (a major component of common salt) per coated tablet. This corresponds to 2.5% of the recommended maximum daily intake of sodium for an adult.

3. How to Take Apo-Napro Forte

This medication should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults and Adolescents Over 16 Years

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis

The recommended initial dose is 550 mg of naproxen sodium (1 tablet) twice a day (morning and evening) or 550 mg - 1100 mg of naproxen sodium (1 - 2 tablets) once a day.

Acute Gout

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 has passed.

Acute Musculoskeletal Pain and Painful Menstruation (Dysmenorrhea)

The recommended initial dose is 550 mg, followed by half a tablet every 6 to 8 hours as needed, with a maximum daily dose of 1375 mg after the first day.

Elderly Patients and Patients with Liver and Kidney Function Disorders

Your doctor will decide on a dose that will usually be lower than for other adults.

Use in Children and Adolescents Under 16 Years

Apo-Napro Forte is not recommended for use in children and adolescents under 16 years of age.
Method of Administration:
This medication is intended for oral use. Tablets should be taken preferably during or after a meal, with a large amount of water or milk. The tablet can be divided into equal doses.

Overdose of Apo-Napro Forte

In case of overdose, contact your doctor or pharmacist immediately. It is best to show them the packaging or package leaflet.
Overdose symptoms may include: nausea, vomiting, heartburn, indigestion, stomach pain, drowsiness, dizziness, and in some cases, diarrhea, convulsions. 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 in aqueous suspension reduces drug absorption.

Missed Dose of Apo-Napro Forte

In this case, you can take the usual dose at the usual time.
Do not take a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medications, Apo-Napro Forte can cause side effects, although not everybody gets them.
Stop taking Apo-Napro Forte and contact your doctor immediately if you experience any of the following side effects:
Rare: may affect up to 1 in 1,000 people
Characterized skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) upon re-administration of the medication and may take the form of round or oval red patches and skin swelling, blisters (hives), itching
Frequency not known: frequency cannot be estimated from the available data
Widespread rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
The following side effects have been observed during treatment with naproxen (sodium).
Common: may affect up to 1 in 10 people

• Bruising (ecchymoses), decreased blood clotting
• Headache, dizziness, drowsiness, feeling of emptiness in the head
• Vision disturbances
• Tinnitus
• Shortness of breath
• Heartburn and (or) gastroesophageal reflux, nausea, discomfort in the stomach, constipation
• Rash, itching
• Fluid retention in hands and feet (peripheral edema).

Uncommon: may affect up to 1 in 100 people

• Tingling or numbness of hands and feet (paresthesia)
• Blurred vision
• Balance disorders, hearing disorders
• Palpitations
• Vomiting, gastrointestinal bleeding, peptic ulcers, oral mucositis, thirst, indigestion with symptoms of fullness in the upper abdomen, stomach pain, belching, nausea, vomiting, and heartburn (indigestion), diarrhea
• Abnormal liver function test results
• Small red spots on the skin due to minor bleeding into the skin or under the skin
• Sweating.

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

• Change in blood composition, anemia, blood disorders (thrombocytopenia) with accompanying bruising and bleeding (thrombocytopenia), blood disorders (granulocytopenia) associated with increased susceptibility to infections, very severe blood disorders (agranulocytosis), which is accompanied by sudden high fever, severe sore throat, and oral ulcers (agranulocytosis), blood disorders (leukopenia) associated with increased susceptibility to infections, excessive frequency of a certain type of white blood cell in the blood (eosinophilia)
• Reactions (sudden drop in blood pressure, pallor, anxiety, weak, rapid pulse, moist skin, decreased consciousness) in the form of sudden, severe vasodilation due to severe hypersensitivity to certain substances (anaphylactic reaction)
• Infectious disease characterized by inflammation of the meninges and (or) spinal cord (aseptic meningitis), angioedema, seizures
• Corneal clouding, eye inflammation (papillitis), optic neuritis associated with pain, numbness, and sometimes impaired optic nerve function (optic neuritis), accumulation of fluid in the eye or around the eye (papilledema)
• Vasculitis
• Fluid accumulation in the lungs, pneumonia, episodic pain occurring in the form of muscle spasms and swelling of the mucous membranes of the airways, which is often accompanied by coughing and expectoration of secretions (asthma)
• Gastrointestinal perforation, ulcers, recurrent (severe) colitis, esophageal inflammation, gastrointestinal bleeding, pancreatitis with severe abdominal pain radiating to the back and vomiting (pancreatitis), dry mouth, throat irritation
• Jaundice (yellowing of the skin or eyes), liver inflammation with jaundice (yellowing of the skin or eyes), in some cases fatal, increased liver enzyme activity. Medications like naproxen sodium can rarely cause liver damage
• Alopecia, skin reddening (erythema multiforme), delicate blue-red spots on the skin (erythema nodosum), small, intensely shining, itching, pink to blue spots, occurring especially on the neck, under the arms, and in the mouth (lichen planus), pimples, hypersensitivity reaction to medications
• Muscle weakness, muscle pain
• Increased urine production, protein in urine (proteinuria), kidney inflammation (glomerulonephritis and interstitial nephritis), necrosis of part of the kidney (renal papillary necrosis), condition characterized by the presence of protein in the urine (nephrotic syndrome), kidney function disorders, blood in urine, excessively high potassium levels in the blood (hyperkalemia), sometimes manifested by muscle cramps, diarrhea, nausea, dizziness, headache. Increased creatinine levels in the blood
• Fatigue, fever
• Decreased appetite
• Insomnia, nervousness, extreme feeling of happiness (euphoria), unusual dreams, concentration disorders, memory loss, and loss of concentration (cognitive function disorders), mild depression, disorientation.

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

• Hearing loss (hearing impairment)
• Rash with blister formation (including Stevens-Johnson syndrome and toxic epidermal necrolysis)
• Female infertility.

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

• Heart failure (insufficient heart pumping power)
• High blood pressure (hypertension) After administration, reports of stomach ulcers, bloating, stomach pain, blood in stool, oral ulcers, and worsening of colitis and Crohn's disease have been made. Less frequently, gastritis has been observed.

Medications like Apo-Napro Forte may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
By reporting side effects, you can help provide more information on the safety of this medication.
Side effects can also be reported to the marketing authorization holder.

5. How to Store Apo-Napro Forte

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month stated.
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Apo-Napro Forte Contains

• The active substance of Apo-Napro Forte is naproxen sodium. Each coated tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• Other ingredients are: Tablet core: povidone, microcrystalline cellulose, anhydrous colloidal silica, talc, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 8000, indigo carmine, aluminum lake (E 132).

What Apo-Napro Forte Looks Like and Contents of the Package

Coated tablet.
Apo-Napro Forte tablets are dark blue coated tablets in the shape of a modified capsule with the inscription "T & 22" on both sides, a dividing line on one side, and a dividing line on the other side.
The tablet can be divided into equal doses.
Apo-Napro Forte tablets are available in transparent blisters of PVC/Aclar/Aluminum containing 20, 30, and 60 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer/Importer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Italy:
Naprossene Aurobindo
Poland:
Apo-Napro Forte
Portugal:
Naproxeno Generis

Date of Last Revision of the Package Leaflet: 11/2024