Anapran Ec

Package Leaflet: Information for the User

Anapran EC, 250 mg, enteric-coated tablets

Anapran EC, 500 mg, enteric-coated tablets

Naproxen

Read the package leaflet carefully before taking the medicine, 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 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 package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What Anapran EC is and what it is used for

Anapran EC contains the active substance naproxen, which belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are used to reduce inflammation and pain in the joints and muscles.
Anapran EC is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis (neck and back pain and stiffness), acute musculoskeletal disorders (e.g. sprains and overuse injuries) and painful menstruation (dysmenorrhea), in patients over 16 years of age.

2. Important information before taking Anapran EC

When not to take Anapran EC:

• if you are allergic to naproxen, naproxen sodium or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to acetylsalicylic acid (aspirin), other NSAIDs (e.g. ibuprofen or diclofenac) or other painkillers, with symptoms such as asthma, rhinitis, nasal polyps or urticaria,
• if you have had nasal polyps, frequent sneezing, rhinitis, stuffy or itchy nose,
• if you have asthma or allergies (such as hay fever) or have had facial swelling, lip swelling, eye swelling or tongue swelling in the past,
• if you have had stomach or intestinal disorders, such as ulcers or bleeding,
• if you have had gastrointestinal bleeding or perforation after taking NSAIDs,
• if you have severe liver, kidney or heart failure,
• if you are in the last three months of pregnancy. 1/8

Do not take Anapran EC if any of the above points apply to you. If you have any further doubts, before taking Anapran EC, consult your doctor or pharmacist.

Warnings and precautions

If you have heart problems, have had a stroke or suspect you may be at risk of these problems (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker), discuss your treatment with your doctor or pharmacist.
Before starting to take Anapran EC, discuss it with your doctor or pharmacist if any of the following conditions apply to you:

• Asthma or allergy (such as hay fever) or facial swelling, lip swelling, eye swelling or tongue swelling in the past.
• Feeling weak (possibly due to illness) or if you are elderly.
• Nasal polyps or frequent sneezing, rhinitis, stuffy or itchy nose (rhinitis).
• Kidney or liver problems.
• Blood clotting disorders.
• Vascular disorders (arteries) anywhere in the body.
• High levels of lipids (fats) in the blood (hyperlipidaemia).
• Autoimmune disease, such as systemic lupus erythematosus (SLE, causing joint pain, rash and fever), ulcerative colitis or Crohn's disease (conditions causing intestinal inflammation, abdominal pain, diarrhea, vomiting and weight loss).

Taking such medicines as Anapran EC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of higher doses of the medicine. Do not exceed the recommended dose and duration of treatment.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with the use of Anapran EC. Stop taking Anapran EC and contact your doctor immediately if you experience any of the following symptoms (see section 4).
Naproxen may cause increased sensitivity to sunlight. Sunlight or sunlamps may cause sunburn, blisters (including porphyria cutanea tarda), rash, redness, itching or skin discoloration. If you experience a reaction to sunlight, contact your doctor.
If any of the above points apply to you or if you have any further doubts, before taking this medicine, consult your doctor or pharmacist.

Children and adolescents

Anapran EC is not recommended for use in children under 16 years of age.

Anapran EC and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription and herbal medicines. In particular, inform your doctor or pharmacist if you are taking:

• Other painkillers (such as acetylsalicylic acid, ibuprofen, diclofenac and paracetamol).
• Medicines used to prevent blood clots, such as acetylsalicylic acid, warfarin, heparin or clopidogrel. 2/8
• Hydantoin medicines (antiepileptic drugs) such as phenytoin.
• Sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide, including sulfonamide antibiotics (medicines used to treat infections).
• Sulfonylurea medicines (used to treat diabetes) such as glimepiride and glipizide.
• ACE inhibitors and other medicines used to treat high blood pressure, such as cilazapril, enalapril or propranolol.
• Angiotensin II receptor antagonists, such as candesartan, eprosartan or losartan.
• Diuretics (medicines used to treat high blood pressure) such as furosemide.
• Cardiac glycosides (medicines used to treat heart conditions) such as digoxin.
• Steroids (medicines used to treat swelling and inflammation) such as hydrocortisone, prednisolone and dexamethasone.
• Quinolone antibiotics (medicines used to treat infections) such as ciprofloxacin or moxifloxacin.
• Certain medicines used to treat mental disorders, such as lithium or selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine or citalopram.
• Probenecid (a medicine used to treat acute gout).
• Methotrexate (a medicine used to treat skin disorders, arthritis and cancer).
• Cyclosporin or tacrolimus (medicines used to treat skin disorders or after organ transplantation).
• Zidovudine (a medicine used to treat AIDS and HIV infections).
• Mifepristone (a medicine used to terminate pregnancy or induce labor in case of fetal death).

If any of the above points apply to you or if you have any further doubts, before taking this medicine, consult your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

• Do not take naproxen in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor.
• During the first six months of pregnancy, do not take naproxen unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
• From the 20th week of pregnancy, Anapran EC may cause kidney problems in the unborn child if taken for more than a few days, which may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct in the child's heart. If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
• If you are breastfeeding (or plan to breastfeed in the near future), do not take naproxen.
• If you are pregnant, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medicine.
• Anapran EC may make it harder to get pregnant. Tell your doctor if you are planning to get pregnant or if you are having trouble getting pregnant.

Driving and using machines

Anapran EC may cause drowsiness, dizziness, blurred vision and balance disorders, depression or sleep disorders. Talk to your doctor if you experience any of these symptoms and do not drive or operate machinery.

Anapran EC contains sodium

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

3. How to take Anapran EC

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
During treatment with Anapran EC, your doctor will recommend regular check-ups to detect possible side effects and to confirm that you are taking the correct dose of the medicine.
This is especially important if you are elderly.
The recommended dose is:

Adults

Osteoarthritis and ankylosing spondylitis

The recommended daily dose is 500 mg to 1000 mg in two divided doses, every 12 hours. If the prescribed dose is 1000 mg per day, you can take one 500 mg tablet twice a day or two 500 mg tablets in a single dose (in the morning or evening).
In some patients, to relieve pain, a higher initial dose of 750 mg to 1000 mg per day may be taken. This applies to patients:

• with increased night pain or morning stiffness,
• who have changed treatment from a high dose of another painkiller,
• with osteoarthritis, where the main symptom is pain.

Musculoskeletal disorders (e.g. sprains and overuse injuries) or painful menstruation

The initial dose is usually 500 mg per day, followed by 250 mg every 6 to 8 hours if necessary. Do not exceed the dose of 1250 mg per day after the first day of treatment.

Elderly patients and patients with kidney or liver problems

The dose will be decided by your doctor. It is usually lower than for other adult patients.

Use in children and adolescents

Due to the inappropriate strength of the medicine, Anapran EC is not recommended for use in children under 16 years of age.
How to take it:
Swallow the tablets whole with a small amount of water, during or after a meal.
Do not crush or chew the tablets.
You should make sure you drink enough fluids (are well-hydrated) while taking Anapran EC. This is especially important if you have kidney problems. During treatment with Anapran EC, your doctor will want to check that you are taking the correct dose and that you are not experiencing any side effects. This is especially important if you are elderly.

Overdose of Anapran EC

If you accidentally take a higher dose than recommended, contact your doctor or go to the nearest hospital immediately. Take the medicine packaging with you.

Missed dose of Anapran EC

If you miss a dose, skip the missed dose. Then continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping treatment with Anapran EC

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Anapran EC can cause side effects, although not everybody gets them.
Taking such medicines as Anapran EC may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Important side effects to look out for:

Stop taking Anapran EC and contact your doctor immediately if you experience any of the following side effects. You may need urgent medical attention:

Severe gastrointestinal disorders occur uncommonly (may affect up to 1 in 100 people) or rarely (may affect up to 1 in 1000 people),

symptoms include:

• Gastrointestinal bleeding, observed as vomiting blood or dark, coffee-ground-like vomit.
• Rectal bleeding, observed as passing black, tarry stools or bloody diarrhea.
• Ulcers or perforation of the stomach or intestines. Symptoms may include indigestion, stomach pain, fever, nausea or vomiting.
• Pancreatitis. Symptoms may include severe stomach pain radiating to the back.
• Worsening of ulcerative colitis or Crohn's disease, with symptoms such as abdominal pain, diarrhea, vomiting and weight loss.

Allergic reactions occur rarely (may affect up to 1 in 1000 people),symptoms include:

• Sudden swelling of the throat, face, hands or feet.
• Difficulty breathing, feeling of tightness in the chest.
• Skin rash, blisters or itching.

Severe skin reactions, symptoms include:

• A severe rash that develops quickly, with blisters or peeling of the skin, possibly with blisters in the mouth, throat or eyes, and possibly with fever, headache, cough and sensitivity of the whole body. The frequency is unknown, i.e. it cannot be estimated from the available data.
• Blisters on the skin after exposure to sunlight (porphyria cutanea tarda), especially on the arms, face and hands. Occurs uncommonly (may affect up to 1 in 100 people).
• Widespread rash, high fever, elevated liver enzymes, blood disorders (eosinophilia), lymph node enlargement and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). The frequency is unknown, i.e. it cannot be estimated from the available data.
• A characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) after re-exposure to the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching. The frequency is unknown, i.e. it cannot be estimated from the available data.

Liver disorders occur rarely (may affect up to 1 in 1000 people),symptoms include:

• Yellowing of the skin or whites of the eyes (jaundice).
• Feeling tired, loss of appetite, nausea or vomiting, pale stools (hepatitis) and abnormalities visible in blood test results (including hepatitis).

Myocardial infarction occurs rarely (may affect up to 1 in 1000 people),symptoms include:

• Chest pain that may radiate to the neck, shoulders and down the left arm.

Stroke occurs rarely (may affect up to 1 in 1000 people),symptoms include:

• Weakness and numbness. May occur only on one side of the body.
• Sudden change in smell, taste, hearing or vision, confusion.

Meningitis (frequency unknown, i.e. it cannot be estimated from the available data),

symptoms include:

• Fever, nausea or vomiting, stiff neck, headache, sensitivity to light and confusion (more likely in people with immune system disorders such as systemic lupus erythematosus).

If you experience any of the above side effects, stop taking the medicine and contact your doctor immediately.

Other side effects:

Common (may affect up to 1 in 10 people):

• Heartburn,
• Diarrhea,
• Constipation,
• Abdominal discomfort,
• Oral inflammation,
• Indigestion,
• Bruising,
• Itching,
• Sweating,
• Headache,
• Dizziness, drowsiness, feeling dizzy,
• Visual disturbances,
• Ringing in the ears (tinnitus),
• Nausea or vomiting.

Uncommon (may affect up to 1 in 100 people):

• Palpitations,
• Shortness of breath, asthma,
• Memory or concentration problems, drowsiness,
• Sleep disorders,
• Hearing loss,
• Sensitivity to sunlight,
• Hives, skin rash, including redness of the skin,
• Kidney problems.

Rare (may affect up to 1 in 1000 people):

• Blood disorders, such as anemia or changes in white blood cell count,
• Swelling of the hands, feet or ankles (edema). May be accompanied by chest pain, fatigue, shortness of breath (heart failure),
• High levels of potassium in the blood,
• Disorders of blood circulation in the body. Symptoms may include fatigue, shortness of breath, feeling faint, general pain,
• Slow heart rate,
• High blood pressure,
• Vascular damage (vasculitis), symptoms may include fever, headache, fatigue, weight loss and pain.
• Pneumonia or pulmonary edema,
• Hematuria,
• Changes in sleep patterns,
• Depression,
• Disorientation or seeing and hearing things that are not there (hallucinations),
• Memory and concentration problems.

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

• Eye pain, visual disturbances, scarring of the cornea,
• Hearing disorders, hearing loss,
• Dizziness causing balance disorders,
• Hives, rash, blisters on the body and face,
• Increased thirst, fever, feeling tired or general malaise,
• Pain, muscle weakness,
• Systemic lupus erythematosus (SLE). Symptoms may include fever, rash, kidney problems, fatigue and joint pain,
• Kidney problems.

Frequency unknown (frequency cannot be estimated from the available data):

• Seizures or convulsions,
• Optic neuritis, which causes pain and blurred vision, and other symptoms,
• Numbness or tingling of the hands and feet,
• Difficulty getting pregnant in women;

If you experience any worsening of the above symptoms or any other side effects not listed in this package leaflet, tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anapran EC

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
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 Anapran EC contains

• The active substance of the medicine is naproxen. Each tablet contains 250 mg or 500 mg of naproxen.
• The other ingredients are: povidone K 90, sodium croscarmellose, magnesium stearate in the tablet core and methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, talc, simethicone emulsion in the tablet coating.

What Anapran EC looks like and contents of the pack

Anapran EC, 250 mg, enteric-coated tablets:
White or almost white, round, biconvex, film-coated tablets with a diameter of about 10 mm.
Anapran EC, 500 mg, enteric-coated tablets:
White or almost white, round, biconvex, film-coated tablets with a diameter of about 13 mm.
Blister pack with PVC/Aluminum foil in a cardboard box. Each blister pack contains 10 enteric-coated tablets.
The pack of Anapran EC, 250 mg contains: 20, 30 or 60 enteric-coated tablets.
The pack of Anapran EC, 500 mg contains: 20 or 60 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Phone: 22 732 77 00

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the package leaflet:

April 2025