Apo-napro

Package Leaflet: Information for the Patient

Apo-Napro,250 mg, tablets
Apo-Napro,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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Apo-Napro and what is it used for
• 2. Important information before taking Apo-Napro
• 3. How to take Apo-Napro
• 4. Possible side effects
• 5. How to store Apo-Napro
• 6. Contents of the pack and other information

Apo-Napro belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs).
Apo-Napro is used to treat:
rheumatoid arthritis and other rheumatic diseases
musculoskeletal and bone problems (acute musculoskeletal disorders)
painful menstruation
acute gouty arthritis
fever of various origins.

2. Important Information Before Taking Apo-Napro

When Not to Take Apo-Napro:

if you are allergic to naproxen, naproxen sodium, or any of the other ingredients of this medicine (listed in section 6)
if you have or have had stomach or intestinal disorders, such as ulcers or bleeding
if you have severe heart, liver, or kidney failure
if you are allergic to NSAIDs or other painkillers, such as acetylsalicylic acid (aspirin)
if you are in the last three months of pregnancy.
If any of the above situations apply to you, stop taking the medicine and consult your doctor.

Warnings and Precautions

Before taking Apo-Napro, discuss with your doctor or pharmacist:

if you have any allergic reactions
if you have kidney, liver, or heart disease
if you have stomach or intestinal disease (gastrointestinal disease), including ulcers, ulcerative colitis, Crohn's disease
if you have asthma
if you have any blood disorders
if you have had liver or adrenal function tests
if you have systemic lupus erythematosus or mixed connective tissue disease, which are immune system disorders with symptoms of joint pain, fatigue, and rash
if you are planning to become pregnant, have difficulty becoming pregnant, or are undergoing fertility tests
if you are elderly.
Risk of Heart Attack:medicines like Apo-Napro may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose or prolong treatment.
If you have heart problems, have had a stroke, or suspect you are at risk of these problems (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke), discuss your treatment with your doctor or pharmacist.

Children and Adolescents

Apo-Napro is not recommended for use in children under 16 years of age in any indication, except for juvenile rheumatoid arthritis.

Apo-Napro and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. This is important because naproxen may affect the action of other medicines. Inform your doctor, especially if you are taking:
medicines used to treat acute gouty arthritis, such as probenecid
medicines used to treat epilepsy, such as hydantoin derivatives
medicines used to treat or prevent blood clotting, such as anticoagulants or antiplatelet agents
medicines used to treat infections, such as sulfonamides or fluoroquinolones
medicines used to treat heart failure, such as furosemide, other diuretics, or cardiac glycosides
medicines used to treat depression, such as lithium salts or selective serotonin reuptake inhibitors, such as fluoxetine
medicines used to treat high blood pressure, such as propranolol and other beta-blockers, as well as angiotensin-converting enzyme (ACE) inhibitors
medicines used to treat psoriasis, such as methotrexate
medicines used to treat arthritis, such as corticosteroids
medicines used to prevent transplant rejection, such as cyclosporine and tacrolimus
other NSAIDs or painkillers, such as acetylsalicylic acid
mifepristone, which is usually used in hospital treatment. After taking mifepristone, at least 8 to 12 days should pass before starting naproxen treatment.
zidovudine, an antiviral medicine used to treat HIV infection
acetylsalicylic acid used to prevent blood clots.
If any of the above situations apply to you, or if you are in doubt, consult your doctor or pharmacist before taking Apo-Napro.

Apo-Napro with Food, Drink, and Alcohol

Taking Apo-Napro with food or drink does not affect its action.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Apo-Napro during the last three months of pregnancy, as it may harm the baby.
Do not take Apo-Napro while breast-feeding.
Naproxen may cause difficulty in becoming pregnant. Inform your doctor if you are planning to become pregnant or are having difficulty becoming pregnant.

Driving and Using Machines

While taking Apo-Napro, you may have difficulty concentrating. The medicine may cause dizziness, drowsiness, vision disturbances, or depression. If you experience such symptoms, do not drive or operate machinery.

Apo-Napro Contains Sodium

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

3. How to Take Apo-Napro

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the tablets as instructed. Swallow the medicine with a glass of water, with or after food.

Recommended Daily Dose:

In Rheumatic Diseases:

The dose is 500 mg to 1 g in two divided doses, every 12 hours.
If you have severe night pain or morning stiffness, your doctor may recommend a change in dose.

In Musculoskeletal Disorders and Painful Menstruation:

The first dose is 500 mg (two 250 mg tablets).
Then, take one tablet (250 mg) every 6 to 8 hours, as needed.

In Fever of Various Origins:

The recommended dose is:
250 mg (1 tablet of 250 mg), every 8 hours, as needed. The duration of treatment should not exceed 3-5 days.

In Acute Gouty Arthritis:

The first dose is 750 mg (three 250 mg tablets).
Then, take one tablet (250 mg) every 8 hours until the attack subsides.

Children (Over 5 Years Old) with Juvenile Rheumatoid Arthritis:

The dose is 10 mg/kg body weight per day in two divided doses.
Ask your doctor or pharmacist to help you calculate the dose for your child.
Your doctor will recommend the most suitable pharmaceutical form and strength, depending on the child's age, weight, and dosage.

Elderly Patients

The patient may receive a lower dose of the medicine. The doctor will decide what dose is best for the patient.

Use in Children and Adolescents

Apo-Napro is not recommended for use in children under 16 years of age in any indication, except for juvenile rheumatoid arthritis.

Patients with Kidney or Liver Impairment

The patient may receive a lower dose of the medicine. The doctor will decide what dose is best for the patient.

Overdose of Apo-Napro

If you accidentally take more than the recommended dose, go to the nearest hospital emergency department or consult your doctor immediately. Take the medicine package and any remaining tablets with you.
Overdose symptoms may include: headache, drowsiness, heartburn, indigestion, nausea, or vomiting.

Missed Dose of Apo-Napro

If you forget to take a dose, take it as soon as possible, and then take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping Apo-Napro Treatment

Take Apo-Napro for as long as your doctor has prescribed. Stopping the medicine without consulting your doctor may be dangerous.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Apo-Napro can cause side effects, although not everybody gets them.
Stop taking Apo-Napro and contact your doctor immediately if you experience any of the following side effects:
vomiting blood or black, tarry stools
passing black, tarry stools or blood in the stool
stomach ulcers
severe diarrhea
abdominal pain (colitis)
mouth ulcers
worsening of ulcerative colitis or Crohn's disease, such as severe abdominal pain, diarrhea, or vomiting
rash
symptoms of an allergic reaction, such as difficulty breathing, wheezing, tightness in the chest, swelling of the eyelids, face, lips, throat, or tongue, rash, or itching.
Other possible side effects include:
seizures, headache, drowsiness, dizziness, feeling of emptiness in the head, sleep disturbances, nightmares, inability to concentrate, and memory problems, tingling, disorientation, hallucinations, non-infectious meningitis (aseptic meningitis).
feeling of depression.
vision disturbances.
If you experience vision disturbances, inform your doctor, who may recommend an eye examination.
balance and hearing disturbances, ringing in the ears.
high blood pressure, heart attack, or stroke.
Taking medicines like Apo-Napro may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
asthma, pneumonia, fluid in the lungs (pulmonary edema).
nausea, vomiting, abdominal discomfort, bloating, constipation, pancreatitis.
skin changes, including rash, itching, redness, bruising, swelling of the neck and face, swelling of the hands and feet, excessive sweating, blisters on the hands or feet (Stevens-Johnson syndrome), painful bruising, pushing out in the form of swelling, fluid-filled, skin peeling.
liver function disorders, hepatitis, jaundice causing yellowing of the skin and whites of the eyes.
kidney function disorders, including blood in the urine, kidney inflammation.
difficulty becoming pregnant.
Inform your doctor if you are planning to become pregnant or are having difficulty becoming pregnant.
increased thirst, fever, swelling, weakness, or muscle pain, allergic reactions, hair loss.
blood changes: decreased platelet count (cells involved in blood clotting) or white blood cell count, decreased hemoglobin level (anemia) due to reduced bone marrow production or increased red blood cell destruction, increased potassium levels in the blood.
blood vessel inflammation.
feeling of fatigue or general malaise.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell 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, PL-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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Apo-Napro

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date (EXP). The expiry date stated is the last day of the month.
Batch number is stated after "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Apo-Napro Contains

• The active substance is naproxen.
• The other ingredients are: methylcellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

What Apo-Napro Looks Like and Contents of the Pack

Apo-Napro, 250 mg: white, oval, biconvex tablets [12.7 mm x 7.9 mm] and smooth on both sides.
Apo-Napro, 500 mg: white, biconvex, capsule-shaped tablets [17.5 mm x 7.1 mm] with a dividing line on one side and smooth on the other. The dividing line on the tablet is only to facilitate breaking and not to divide into equal doses.
Apo-Napro is available in blisters containing 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta

Generis Farmacêutica, S.A.

Rua João de Deus, no 19
Venda Nova, 2700-487 Amadora
Portugal

Date of Last Revision of the Leaflet: 02.2023