Naproxen Aflofarm

Package Leaflet: Information for the Patient

Naproxen Aflofarm, 200 mg, Tablets

Naproxenum

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

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 10 days, they should contact their doctor.

Table of Contents of the Package Leaflet

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

1. What is Naproxen Aflofarm and what is it used for

Naproxen Aflofarm is a medicine with analgesic and antipyretic effects. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine contains the active substance naproxen, a derivative of propionic acid.

Indications for Use

Treatment of mild to moderate pain, such as:

• pain associated with muscle and joint diseases, such as mild forms of sprains, overuse injuries, and lower back pain;
• menstrual cramps.

2. Important information before taking Naproxen Aflofarm

When not to take Naproxen Aflofarm

• if the patient is allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced shortness of breath, asthma, rhinitis, or urticaria after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, as Naproxen Aflofarm may cause similar side effects in these patients;
• if the patient has ever had or currently has gastrointestinal bleeding;
• if the patient has ever had or currently has perforation of the stomach or intestinal wall associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has or has had stomach or duodenal ulcers or gastrointestinal bleeding;
• if the patient has a bleeding disorder (coagulation disorders);
• if the patient has severe heart failure;
• if the patient has severe renal or hepatic impairment;
• if the patient is in the last three months of pregnancy.

Warnings and Precautions

Before starting to take Naproxen Aflofarm, the patient should discuss it with their doctor or pharmacist:

• if the patient has stomach or intestinal diseases (such as chronic enteritis, ulcerative colitis, Crohn's disease characterized by chronic diarrhea), diseases of the rectum and anus, as the risk of gastrointestinal bleeding increases;
• if the patient has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease). In patients with systemic lupus erythematosus and mixed connective tissue disease, the risk of aseptic meningitis may increase;
• if the patient has hypertension and/or heart function disorders due to fluid retention;
• if the patient has renal or hepatic impairment;
• if the patient has coagulation disorders (naproxen may prolong bleeding time);
• if the patient has heart disorders;
• if the patient is using an intrauterine device;
• if the patient has asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies (current or past), as taking the medicine may cause bronchospasm;
• if the patient has heart failure, renal or hepatic impairment, is taking diuretics, or has lost a lot of fluid (e.g., due to major surgery) - in such cases, the doctor may order regular monitoring of kidney function;
• if the patient is over 65 years old, as the risk of adverse reactions to the medicine increases, especially gastrointestinal bleeding and perforation of the stomach or duodenal wall, which can be fatal. The patient should inform their doctor about any unusual symptoms related to the gastrointestinal tract (especially bleeding, pain), especially at the beginning of treatment;
• if vision disturbances occur, the patient should contact an ophthalmologist;
• the medicine may mask (hide) symptoms of an existing infection;
• the medicine may adversely affect female fertility (see section: Pregnancy, breastfeeding, and fertility).

Taking the medicine in the smallest effective dose for the shortest necessary period to alleviate symptoms reduces the risk of side effects.
Taking medicines like naproxen 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 take higher doses or use the medicine for longer than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss treatment with their doctor or pharmacist.
Do not take Naproxen Aflofarm if taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib) and corticosteroids (see section: Naproxen Aflofarm and other medicines).
Gastrointestinal pain is not an indication for the use of naproxen.
Effect on laboratory tests
Before performing laboratory tests, the patient should tell their doctor that they are taking Naproxen Aflofarm, as it may affect the results of some tests (e.g., urine tests for 17-ketogenic steroids and 5-hydroxyindoleacetic acid (5 HIAA)).
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Naproxen Aflofarm. The patient should stop taking Naproxen Aflofarm and immediately consult their doctor if they experience any symptoms associated with these severe skin reactions, described in section 4.

Children and Adolescents

The safety of use in children has not been established. The medicine should not be used in children under 16 years of age.

Naproxen Aflofarm and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Do not take the following medicines with Naproxen Aflofarm. Naproxen Aflofarm may affect the action of other medicines, and vice versa. The patient should inform their doctor if they are taking any of the following medicines.

Medicines that may increase gastrointestinal bleeding:

• acetylsalicylic acid (used to relieve pain and reduce fever, as well as to prevent blood clots);
• other nonsteroidal anti-inflammatory drugs (NSAIDs);
• corticosteroids (steroid medicines used to treat, among other things, asthma);
• antiplatelet agents (medicines that reduce the risk of blood clots);
• selective serotonin reuptake inhibitors (medicines used to treat depression).

Medicines that may cause kidney damage:

• tacrolimus (a medicine used to treat, among other things, atopic dermatitis);
• cyclosporin (a medicine used in patients after organ transplantation).

Naproxen Aflofarm may enhance the effect of:

• anticoagulant medicines (medicines that prevent blood clotting, such as acenocoumarol);
• lithium (a medicine used to treat depression);
• methotrexate (a medicine used to treat certain cancers and rheumatoid arthritis);
• phenytoin, hydantoin (medicines used to treat epilepsy);
• sulfonamides (used to treat bacterial infections);
• oral hypoglycemic agents (sulfonylurea derivatives);
• baclofen (a medicine that reduces muscle tension).

Naproxen Aflofarm may reduce the effect of:

• medicines that lower blood pressure (e.g., propranolol);
• diuretics (medicines that increase urine production, such as furosemide), as there is an increased risk of kidney function disorders, such as hyperkalemia (elevated potassium levels in the blood). If such a disorder occurs, the patient should drink plenty of fluids.

Do not take Naproxen Aflofarm with:

• zydovudine (a medicine used to treat HIV infection), as it may prolong bleeding time;
• cardiac glycosides (used to treat heart failure and heart rhythm disorders), as naproxen may exacerbate heart failure symptoms and increase cardiac glycoside levels in the blood;
• quinolone antibiotics, as this may increase the risk of seizures;
• ranitidine, sucralfate, magnesium oxide, and aluminum hydroxide, as these medicines may reduce the absorption of Naproxen Aflofarm;
• probenecid (used to treat gout), as it may enhance the effect of Naproxen Aflofarm.

Naproxen Aflofarm should not be taken for 8 to 12 days after the end of treatment with mifepristone (used for medical abortion).

Naproxen Aflofarm with Food

Food may slightly delay the absorption of the medicine.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Naproxen Aflofarm should not be taken if the patient is in 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 also affect the patient's and their child's tendency to bleed and may cause prolonged or delayed delivery. Naproxen Aflofarm should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. Taking Naproxen Aflofarm 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 low amniotic fluid levels or narrowing of the ductus arteriosus in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
The medicine should not be used during breastfeeding, as naproxen passes into breast milk.
Fertility
The medicine may adversely affect female fertility. If the patient plans to become pregnant or is having difficulty conceiving, they should stop taking the medicine.

Driving and Using Machines

The medicine may affect the ability to drive and use machines. If drowsiness, dizziness, insomnia, or depression occur, the patient should not drive or operate machinery.

Naproxen Aflofarm Contains Lactose Monohydrate, Orange Yellow S, and Sodium

Lactose Monohydrate

The medicine contains 38.9 mg of lactose monohydrate per tablet.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Orange Yellow S

The medicine may cause allergic reactions.

Sodium

The medicine contains 0.026 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Naproxen Aflofarm

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
Adults
For acute pain relief, 2 tablets (400 mg) should be taken once, and then 1 tablet every 6 to 8 hours if necessary. The daily dose should not exceed 600 mg.
The medicine should not be used for pain relief for more than 10 days without explicit advice from a doctor.
Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to alleviate symptoms.
Use in the Elderly (Over 65 Years Old)
The doctor will decide whether to use the medicine in these patients and determine the appropriate dose. In these patients, there is a higher risk of side effects, so the use of smaller doses should be considered.
Use in Children
The safety of use in children has not been established. The medicine should not be used in children under 16 years of age.
Dosage in Patients with Renal, Hepatic, or Heart Impairment
In patients with renal, hepatic, or heart impairment, a dose reduction may be necessary.

Taking a Higher Than Recommended Dose of Naproxen Aflofarm

In case of taking a higher dose than recommended, the patient should immediately consult their doctor or pharmacist.
Overdose symptoms may include: drowsiness, nausea, vomiting, dizziness, heartburn, apnea, agitation, seizures.

Missing a Dose of Naproxen Aflofarm

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Naproxen Aflofarm can cause side effects, although not everybody gets them.

The Patient Should Immediately Consult Their Doctor if They Experience:

• rash, severe swelling of the face, lips, or throat, making it difficult to breathe, speak, or swallow, decreased blood pressure, slow or fast heart rate, pallor, anxiety, sweating, dizziness, loss of consciousness, and cessation of breathing and heart function (these are symptoms of a severe allergic reaction);
• vomiting blood or coffee ground-like material, black stools, or blood in the stool (these are symptoms of gastrointestinal bleeding).

The Following Side Effects May Occur

Frequently(occurring in 1 to 10 people in 100):

• dizziness, headache;
• feeling of emptiness in the head;
• indigestion, nausea, heartburn, abdominal pain.

Less Frequently(occurring in 1 to 10 people in 1,000):

• sluggishness;
• insomnia;
• drowsiness;
• diarrhea, constipation, vomiting;
• rash (itchy, red bumps on the skin);
• itching;
• hives (red, itchy blisters on the skin).

Rarely(occurring in 1 to 10 people in 10,000):

• gastrointestinal ulceration with bleeding or perforation;
• gastrointestinal bleeding;
• angioedema (sudden swelling of the face, limbs, or joints without itching or pain);
• kidney function disorders;
• peripheral edema (e.g., around the ankles), especially in patients with hypertension or kidney failure;
• fever (including chills and feverish illnesses).

Very Rarely(occurring in less than 1 person in 10,000):

• severe allergic reaction (anaphylaxis), anaphylactoid reactions (symptoms similar to those of an allergic reaction), including shock (a life-threatening condition caused by inadequate oxygenation of vital organs) that can be fatal;
• significant reduction in the number of all types of white and red blood cells (thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia). The first symptoms are: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, significant fatigue, nosebleeds, or subcutaneous bleeding;
• excessive white blood cell count (eosinophilia);
• mental disorders;
• depression;
• sleep disorders, inability to concentrate;
• aseptic meningitis (stiffness of the neck, headaches, nausea, vomiting, fever, disorientation);
• cognitive function disorders, seizures;
• vision disturbances, corneal clouding, optic neuritis, papilledema;
• tinnitus, hearing disorders;
• congestive heart failure, hypertension, pulmonary edema, palpitations, vasculitis;
• shortness of breath, asthma, eosinophilic pneumonia (presence of eosinophilia in the airways);
• pancreatitis, colitis;
• aphthous ulcers (mouth ulcers in the form of white patches), oral mucositis, esophagitis, gastrointestinal ulcers;
• hepatitis (including fatal cases), jaundice (yellowing of the skin and whites of the eyes);
• hair loss (usually reversible);
• photosensitivity;
• porphyria (a disease characterized by abnormal heme production);
• erythema multiforme (red-purple spots on the skin and/or mucous membranes, sometimes with fever and joint pain);
• bullous reactions, including Stevens-Johnson syndrome (blisters on the skin and/or mucous membranes that burst and turn into painful ulcers, often accompanied by fever, muscle and joint pain) and toxic epidermal necrolysis (peeling of large areas of skin and its necrosis);
• rumenal rash, persistent rash, lichen planus, skin reactions, skin discoloration;

Frequency Not Known(frequency cannot be estimated from 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). See also section 2;
• a characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) after re-administration of the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching.

Taking medicines like Naproxen Aflofarm may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In case of any of the above symptoms, the patient should stop taking the medicine and consult their doctor.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should consult their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Naproxen Aflofarm

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton after: EXP.
The expiry date refers to the last day of the month.
Lot - means batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Aflofarm Contains

• The active substance of the medicine is naproxen. One tablet contains 200 mg of naproxen.
• The other ingredients are: lactose monohydrate, corn starch, magnesium stearate, povidone 30, colloidal anhydrous silica, sodium lauryl sulfate, orange yellow S (E110).

What Naproxen Aflofarm Looks Like and What the Pack Contains

The medicine is in the form of tablets. The tablets are round, flat, and uncoated, with a light orange-pink color. The tablets are smooth, with a uniform surface, without spots or damage.
The medicine is available in blister packs of aluminum/PVC. The pack contains 10 tablets in a cardboard box.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of Last Revision of the Package Leaflet: