Apo-napro

Package Leaflet: Information for the Patient

Apo-Napro,250 mg, tablets
Apo-Napro,500 mg, tablets
Naproxen

Read the 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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 the patient is allergic to naproxen, naproxen sodium, or any of the other ingredients of this medicine (listed in section 6)
if the patient has or has had stomach or intestinal disorders, such as ulcers or bleeding
if the patient has severe heart, liver, or kidney failure
if the patient is allergic to NSAIDs or other painkillers, such as acetylsalicylic acid (aspirin)
if the patient is in the last three months of pregnancy.
If any of the above situations apply to the patient, they should stop taking the medicine and consult their doctor.

Warnings and Precautions

Before starting to take Apo-Napro, the patient should discuss it with their doctor or pharmacist:

if the patient has any allergic reactions
if the patient has kidney, liver, or heart disease
if the patient has stomach or intestinal disease (gastrointestinal disease), including ulcers, ulcerative colitis, Crohn's disease
if the patient has asthma
if the patient has any blood disorders
if the patient has had liver or adrenal function tests
if the patient has systemic lupus erythematosus or mixed connective tissue disease, which are immune system disorders with symptoms of joint pain, fatigue, and rash
if the woman is planning to become pregnant, is having difficulty becoming pregnant, or is undergoing fertility tests
if the patient is 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. The patient should not exceed the recommended dose or prolong the treatment period.
If the patient has heart problems, has had a stroke, or suspects that they are at risk of these problems (for example, if they have high blood pressure, diabetes, high cholesterol, or smoke) they should discuss their treatment with their 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. This is important because naproxen may affect the way other medicines work. The patient should inform their doctor, especially if they 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-adrenergic 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. At least 8 to 12 days should pass after taking mifepristone 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 or in case of doubt, the patient should consult their 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 the patient is pregnant, breast-feeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
Apo-Napro should not be taken during the last three months of pregnancy, as it may harm the baby.
Apo-Napro should not be used during breast-feeding.
Naproxen may cause difficulty in becoming pregnant. The patient should inform their doctor if they are planning to become pregnant or are having difficulty becoming pregnant.

Driving and Using Machines

While taking Apo-Napro, the patient may have difficulty concentrating. The medicine may cause dizziness, drowsiness, vision disturbances, or depression. If such symptoms occur, the patient should 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

This medicine should always be taken exactly as advised by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The tablets should be taken as directed. The medicine should be swallowed with a glass of water, taken during or after meals.

Recommended Daily Dose:

In Rheumatic Diseases:

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

In Musculoskeletal Disorders and Painful Menstruation:

The first dose is 500 mg (two 250 mg tablets).
Then, one tablet (250 mg) is taken 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 treatment duration should not exceed 3-5 days.

In Acute Gouty Arthritis:

The first dose is 750 mg (three 250 mg tablets).
Then, one tablet (250 mg) is taken 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.
The patient should ask their doctor or pharmacist to help calculate the dose for the child.
The doctor should recommend the most suitable pharmaceutical form and strength, depending on the child's age, weight, and dosing.

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

In case of accidental overdose, the patient should immediatelygo to the nearest hospital emergency department or consult their doctor. The patient should take the medicine packaging and any remaining tablets with them.
Overdose symptoms may include: headache, drowsiness, heartburn, indigestion, nausea, or vomiting.

Missed Dose of Apo-Napro

If the patient forgets to take a dose, they should take it as soon as possible, and the next dose should be taken at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping Apo-Napro Treatment

Apo-Napro should be taken for as long as the doctor recommends. Stopping the medicine without consulting the doctor can be dangerous.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Apo-Napro can cause side effects, although not everybody gets them.
The patient should stop taking Apo-Napro and immediatelyconsult their doctor if they experience any of the following side effects:
vomiting blood or dark, coffee-ground-like vomit
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 increased pain, diarrhea, or vomiting
skin rash
symptoms of an allergic reaction, such as difficulty breathing, wheezing, chest tightness, swelling of the eyelids, face, lips, throat, or tongue, rash, or itching.
The patient may also experience:
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 the patient experiences vision disturbances, they should inform their doctor, who may recommend an eye examination.
Balance and hearing disturbances, ringing in the ears.
High blood pressure (hypertension), 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, swelling, fluid-filled blisters, skin peeling, skin reactions to light.
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.
The patient should inform their doctor if they 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 levels (anemia), caused by decreased bone marrow production or increased red blood cell breakdown (hemolysis), increased potassium levels in the blood.
Blood vessel inflammation.
Feeling of tiredness or general malaise.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, more information can be collected on the safety of the medicine.

5. How to Store Apo-Napro

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging.
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. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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, colloidal anhydrous 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 side. 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