Apo-napro forte

Package leaflet: Information for the user

Apo-Napro Forte, 550 mg, coated tablets
Naproxenum natricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as 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 individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Apo-Napro Forte is and what it is 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. Contents of the pack and other information

1. What Apo-Napro Forte is and what it is used for

Apo-Napro Forte contains the active substance naproxen, which belongs to a group of medicines called non-steroidal 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 gouty arthritis, acute musculoskeletal pain (such as sprains and strains), and dysmenorrhoea (painful menstruation).

2. Important information before using Apo-Napro Forte

When not to use Apo-Napro Forte

• if the patient is allergic to naproxen, sodium naproxen, or any of the other ingredients of this medicine (listed in section 6).
• in patients aged over 65 years.
• if the patient has severe liver, kidney, or heart failure.
• if the patient has experienced gastrointestinal bleeding or perforation related to previous use of painkillers and anti-inflammatory drugs (NSAIDs).
• if the patient has peptic ulcer disease or bleeding from the stomach or small intestine (duodenum), or if there have been two or more such episodes in the past.
• if the patient has internal bleeding (such as stomach bleeding, intestinal bleeding, or stroke).
• if the patient has gastric or duodenal ulcer, gastritis, or abdominal pain.
• if the patient has ever had an allergic reaction such as asthma, rhinitis, or itching after taking acetylsalicylic acid, ibuprofen, or other painkillers and anti-inflammatory drugs (NSAIDs).
• if the patient has increased bleeding or is being treated with anticoagulant medicines.
• if the patient has ulcerative colitis (inflammatory bowel disease).
• if the patient is taking other medicines of this type (non-steroidal anti-inflammatory drugs).
• if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before starting to use Apo-Napro Forte, discuss this with your doctor or pharmacist.

• It is important to use the lowest effective dose for the shortest duration necessary to control symptoms.
• If the patient has impaired liver function.
• If the patient has impaired kidney function.
• If the patient has an infection.
• Taking medicines such as Apo-Napro Forte may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with higher doses and longer duration of treatment. Do not exceed the prescribed recommended dose. If the patient has heart problems, has had a stroke, or believes they may be at risk (e.g. high blood pressure, diabetes, high cholesterol, or smoking), they should discuss this with their doctor or pharmacist before taking this medicine.

Gastrointestinal ulcers or bleeding, which may be fatal, can occur at any time during NSAID treatment, even without prior symptoms.
If gastrointestinal ulcers or bleeding occur, stop taking this medicine immediately and consult a doctor. The risk increases with higher doses, previous gastrointestinal symptoms, concomitant use of other medicines that may cause ulcers or worsen bleeding (such as anticoagulants, orally administered corticosteroids, and SSRIs (selective serotonin reuptake inhibitors)), and in elderly patients. See also "Apo-Napro Forte with other medicines". Your doctor may prescribe another medicine in combination with Apo-Napro Forte to protect against gastrointestinal side effects.
If the patient has Crohn's disease or ulcerative colitis, because medicines containing sodium naproxen may worsen these conditions.
Elderly patients are particularly susceptible to adverse effects and should report any unusual gastrointestinal symptoms (especially bleeding), particularly at the beginning of treatment.
Hypersensitivity reactions may occur in sensitive individuals. Severe allergic reactions (anaphylactic reactions) may occur in patients with or without a history of allergic reactions or prior exposure to acetylsalicylic acid, naproxen, or other NSAIDs. They may also occur in patients with angioedema (swelling of the face, lips, eyes, or tongue), bronchial reactivity (e.g. asthma), rhinitis (frequent sneezing or runny nose, blocked or itchy nose), and nasal polyps. Allergic reactions such as anaphylaxis may be fatal.
If the patient has asthma or allergic conditions (such as rhinitis or nasal polyps), Apo-Napro Forte may cause breathing difficulties (bronchospasm).
If the patient experiences visual disturbances during treatment.
This medicine should be used with caution in patients on a low-salt diet and with a history of digestive disorders.
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with the use of Apo-Napro Forte, which may occasionally be fatal and usually occur early in treatment. Treatment with Apo-Napro Forte should be discontinued and medical advice sought immediately if any of the symptoms associated with these serious skin reactions, described in section 4, occur.
Naproxen inhibits platelet aggregation and may prolong bleeding time. Patients with coagulation disorders or those taking medicines affecting blood clotting 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.
Medicines such as Apo-Napro Forte may contribute to worsening varicella (chickenpox) infections.
The use of naproxen is not recommended if the patient has chickenpox.
Patients with gastrointestinal disorders or bleeding tendencies should take this medicine only 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 the patient experiences gastrointestinal symptoms (such as abdominal pain, heartburn, or bleeding) after taking sodium naproxen.
• if the patient develops fluid retention (such as swelling of the ankles and feet) after taking this medicine.

This medicine belongs to a group of medicines (NSAIDs) which, when used, may impair female fertility.
This effect is reversible and resolves after discontinuation of the medicine.
Prolonged use of any painkillers for headache may worsen headache.
If you think this applies to you, contact your doctor for advice.
Sodium naproxen is not recommended for stomach or intestinal pain.

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

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

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

The use of probenecid (used for gout) may increase the risk of adverse effects of sodium naproxen.
Sodium naproxen may falsely increase urinary 17-ketosteroid levels; it may affect 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 an adequate amount of liquid.

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.

Pregnancy
Do not use Apo-Napro Forte during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Naproxen sodium should not be used during the first and second trimesters of pregnancy unless absolutely necessary and prescribed by a doctor. When using naproxen sodium in women planning pregnancy or during the first or second trimester of pregnancy, the lowest possible dose and shortest duration of treatment should be used. Apo-Napro Forte taken for more than a few days after the 20th week of pregnancy may cause narrowing of the blood vessel (ductus arteriosus) in the baby's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Sodium naproxen passes into the breast milk (in the form of naproxen). Therefore, sodium naproxen should not be used during breastfeeding.

Fertility
This medicine belongs to a group of medicines (NSAIDs) which, when used, may impair female fertility. This effect is reversible and resolves after discontinuation of the medicine.

Driving and operating machinery
Apo-Napro Forte has no effect or negligible effect on the ability to drive and operate machinery. However, sodium naproxen may cause drowsiness and dizziness as side effects. It may also cause fatigue, visual disturbances, imbalance, depression, or sleep disturbances, thereby affecting the ability to drive and/or operate machinery.

Apo-Napro Forte contains sodium
This medicine contains 50 mg of sodium (the main component of table salt) in each coated tablet. This corresponds to 2.5% of the recommended maximum daily intake of sodium for an adult.

3. How to use Apo-Napro Forte

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults and adolescents aged above 16 years
Recommended dose:
Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
The recommended initial dose is 550 mg of naproxen sodium (1 tablet) twice daily (morning and
evening), or 550 mg to 1100 mg of naproxen sodium (1 to 2 tablets) once daily.
Acute gouty arthritis
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 subsides.
Acute musculoskeletal pain and painful menstruation (dysmenorrhea)
The recommended initial dose is 550 mg, followed by half a tablet as needed every 6 to 8 hours, with
a maximum daily dose on the first day of 1375 mg.
Elderly patients and patients with impaired liver or kidney function
The doctor will determine the dose, which will usually be lower than for other adults.
Use in children and adolescents under 16 years of age
Apo-Napro Forte is not recommended for use in children and adolescents under 16 years of age.
Method of administration:
This medicine is intended for oral use. Tablets should be taken preferably during or after a meal, with
a full glass of water or milk. The tablet may be divided into equal doses.
Taking more than the recommended dose of Apo-Napro Forte
If an excessive dose of naproxen sodium is taken, contact your doctor or pharmacist immediately.
It is best to show the packaging or leaflet.
Symptoms of overdose may include: nausea, vomiting, heartburn, indigestion, stomach pain, drowsiness,
dizziness, diarrhea in some cases, and seizures. In case of accidental or intentional overdose, gastric
lavage should be performed and symptomatic treatment initiated. Prompt administration of 50–100 g of
activated charcoal as an aqueous suspension reduces drug absorption.
Missed dose of Apo-Napro Forte
In this case, take the usual dose at the usual time.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Apo-Napro Forte and contact your doctor immediately if any of the following adverse reactions occur:
Rare: may affect up to 1 in 1,000 people
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 skin patches and swelling, blisters (urticaria), itching
Frequency unknown: frequency cannot be estimated from available data
Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
The following adverse reactions have been observed during use of naproxen (sodium):
Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Tingling or numbness in hands and feet (paresthesia)
• Blurred vision
• Loss of balance, hearing disturbances
• Palpitations
• Vomiting, gastrointestinal bleeding, peptic ulcers, inflammation of the oral mucosa, thirst, dyspepsia with symptoms of fullness in the upper abdomen, abdominal pain, belching, nausea, vomiting and heartburn (dyspepsia), diarrhea
• Abnormal liver function test results
• Small red spots on the skin caused by minor bleeding into or under the skin
• Sweating.

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

• Changes in blood composition, anaemia, blood disorders (low platelet count) with associated bruising and bleeding (thrombocytopenia), blood disorders (lack of white blood cells) associated with increased susceptibility to infections (granulocytopenia), very severe blood disorders (absence of white blood cells) accompanied by sudden high fever, severe sore throat and oral ulcers (agranulocytosis), blood disorders (lack of white blood cells) with associated increased susceptibility to infections (leukopenia), excessive presence of a certain type of white blood cells in the blood (eosinophilia)
• Reactions (sudden drop in blood pressure, pallor, restlessness, weak and rapid pulse, cold and clammy skin, reduced consciousness) due to sudden, severe blood vessel dilation caused by severe hypersensitivity to certain substances (anaphylactic reaction)
• Infectious disease characterized by inflammation of the meninges and/or spinal cord (aseptic meningitis), mucosal swelling (angioedema), seizures
• Corneal clouding, eye inflammation (phlyctenular conjunctivitis), nerve inflammation associated with pain, numbness and sometimes impaired nerve function behind the eye (retrobulbar optic neuritis), fluid accumulation in or around the eye (optic disc edema)
• Inflammation of blood vessels (vasculitis)
• Fluid accumulation in the lungs, pneumonia, episodic pain occurring as muscle spasms and swelling of the mucous membranes of the airways, often accompanied by cough and sputum production (asthma)
• Gastrointestinal perforation, ulcers, recurrent (severe) colitis, esophageal wall inflammation, vomiting blood, pancreatitis with severe upper abdominal pain radiating to the back and vomiting (pancreatitis), dry mouth, throat irritation
• Jaundice (yellowing of the skin or eyes), hepatitis with accompanying jaundice (yellowing of the skin or eyes), in some cases fatal, increased liver enzyme activity. Medicines such as sodium naproxen may rarely cause liver damage
• Hair loss (alopecia), skin redness (erythema multiforme), small, tender bluish-red nodules on the skin (nodular erythema), small, intensely bright, itchy, pink to bluish nodules, especially on the neck, under the arms and in the mouth (lichen planus), blisters, hypersensitivity reaction following drug administration
• Muscle weakness, muscle pain
• Increased urination, protein in urine (proteinuria), kidney inflammation (glomerular and interstitial nephritis), necrosis of part of the kidney (renal papillary necrosis), condition characterized by presence of protein in urine (nephrotic syndrome), kidney function disorders, blood in urine, abnormally high potassium levels in blood (hyperkalemia), sometimes manifesting as muscle cramps, diarrhea, nausea, dizziness, headache. Increased blood creatinine levels
• Fatigue, fever
• Loss of appetite
• Insomnia, nervousness, extreme feelings of happiness (euphoria), unusual dreams, difficulty concentrating, forgetfulness and loss of concentration (cognitive disturbances), 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)
• Infertility in women.

Frequency unknown: frequency cannot be estimated from available data

• Heart failure (inadequate pumping function of the heart)
• Increased blood pressure (hypertension)
  After administration, gastric ulcers, bloating, abdominal pain, blood in stool, ulcerative stomatitis, exacerbation of colitis, and Crohn's disease have been reported. Gastritis (inflammation of the stomach mucosa) has been observed less frequently.

Medicines such as Apo-Napro Forte may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Apo-Napro Forte

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Napro Forte contains

• The active substance 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 silicon dioxide, talc, and magnesium stearate.
  Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 8000, indigo carmine, aluminium lake (E 132).

What Apo-Napro Forte looks like and contents of the pack
Film-coated tablet.
Apo-Napro Forte tablets are dark blue, film-coated, modified capsule-shaped tablets, embossed with the code "T & 22" on both sides, with a division line on one side and a division line on the other side.
The tablet can be divided into equal doses.
Apo-Napro Forte tablets are available in transparent PVC/Aclar/Aluminium blisters containing 20, 30 or 60 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Naprossene Aurobindo
Poland: Apo-Napro Forte
Portugal: Naproxeno Generis