APONAPRO 250 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. ApoNapro ACTIVE, 250 mg, effervescent tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What ApoNapro ACTIVE is and what it is used for
4. Important information before taking ApoNapro ACTIVE
   1. When not to take ApoNapro ACTIVE:
   2. Warnings and precautions
   3. When to be particularly careful when taking ApoNapro ACTIVE
   4. Children and adolescents
   5. ApoNapro ACTIVE and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Breastfeeding
   8. Fertility
   9. Driving and using machines
   10. ApoNapro ACTIVE contains sodium
   11. ApoNapro ACTIVE contains sorbitol (E 420)
5. How to take ApoNapro ACTIVE
   1. Recommended dose for adults
   2. Arthritis and ankylosing spondylitis
   3. Gout
   4. Use in children and adolescents
   5. Elderly patients with liver and kidney problems
   6. Taking more than the recommended dose of ApoNapro ACTIVE
   7. Missing a dose of ApoNapro ACTIVE
6. Possible side effects
   1. Important side effects to look out for:
   2. STOP TAKING the medicine and tell your doctor immediately if you experience any of the following side effects. You may need urgent medical attention.
   3. Other possible side effects:
   4. Stomach and intestines
   5. Blood
   6. Psychiatric disorders
   7. Nervous system
   8. Eyes and ears
   9. Heart and circulation
   10. Chest
   11. Skin and hair
   12. Urinary system
   13. Other
   14. Reporting side effects
7. How to store ApoNapro ACTIVE
8. Contents of the packaging and other information
   1. What ApoNapro ACTIVE contains
   2. What ApoNapro ACTIVE looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: information for the user

ApoNapro ACTIVE, 250 mg, effervescent tablets

Naproxen

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, talk to a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What ApoNapro ACTIVE is and what it is used for

ApoNapro ACTIVE contains naproxen, which is an anti-inflammatory, analgesic, and antipyretic medicine. It belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). ApoNapro ACTIVE is used in adults and adolescents from 16 years of age for short-term treatment of pain and fever. ApoNapro ACTIVE can relieve pain and inflammation (swelling, redness, and heat) and is used to treat adults in cases of:

• Muscle, joint, and tendon pain, such as sprains, gout, arthritis, and ankylosing spondylitis.
• Painful menstruation.

2. Important information before taking ApoNapro ACTIVE

When not to take ApoNapro ACTIVE:

• If you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid (aspirin), other NSAIDs, or any other painkillers (such as ibuprofen or diclofenac).
• If you have stomach ulcers (stomach or duodenal ulcers) or stomach bleeding, or if you have had two or more episodes of stomach ulcers, stomach bleeding, or perforation.
• If you have previously had stomach bleeding or perforation while taking NSAIDs.
• If you have severe kidney, liver, or heart problems.
• If you are in the last three months of pregnancy.
• In children and adolescents under 16 years of age, as the active substance content is too high.

Do not take this medicine if any of the above situations apply to you. If in doubt, talk to a doctor or pharmacist before taking this medicine. If at any time during treatment you experience any of the following symptoms, STOP TAKING the medicine and seek medical help immediately:

• Passing black, tarry stools.
• Vomiting blood or dark particles that look like coffee grounds.

STOP TAKING the medicine and tell your doctor if you experience:

• Indigestion or heartburn.
• Stomach pain or other abnormal stomach symptoms.

Warnings and precautions

When to be particularly careful when taking ApoNapro ACTIVE

If you have heart problems, have had a stroke, or think you may be at risk of these conditions (for example, due to high blood pressure, diabetes, high cholesterol, or smoking), you should discuss your treatment with a doctor or pharmacist. Before taking this medicine, you should talk to a doctor or pharmacist if you have any of the following:

• Asthma or allergies (such as hay fever).
• Previous swelling of the face, lips, eyes, or tongue.
• A feeling of weakness (possibly due to illness) or if you are elderly.
• Nasal polyps or frequent sneezing or runny nose, stuffy or itchy nose.
• Local swelling, high blood pressure, or heart failure.
• Kidney or liver problems.
• An autoimmune disease, such as systemic lupus erythematosus (SLE, causing joint pain, skin rashes, and fever) and ulcerative colitis or Crohn's disease (conditions causing inflammation of the intestines, abdominal pain, diarrhea, vomiting, and weight loss).
• Blood clotting disorders.
• Too much fat in the blood (hyperlipidemia).
• Vascular disorders (arteries) anywhere in the body.

Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of ApoNapro ACTIVE. STOP TAKING ApoNapro ACTIVE and seek medical help immediately if you experience any symptoms related to these severe skin reactions described in section 4. Elderly people may have an increased risk of side effects. You should tell your doctor immediately if you experience any unusual symptoms related to the stomach or intestines. If any of the above situations apply to you or if you are unsure, talk to a doctor or pharmacist before taking this medicine.

Children and adolescents

This medicine should not be taken by children and adolescents under 16 years of age.

ApoNapro ACTIVE and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those available without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

• Other painkillers, such as ibuprofen, diclofenac, and paracetamol.
• Blood-thinning medicines, such as acetylsalicylic acid (aspirin), warfarin, heparin, or clopidogrel.
• Hydantoin medicines (used to treat epilepsy), such as phenytoin.
• Sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide, including sulfonamide antibiotics (used to treat infections).
• Sulfonylurea derivatives (used to treat diabetes), such as glimepiride or glipizide.
• ACE inhibitors or any other medicine used to treat high blood pressure, such as cilazapril, enalapril, or propranolol.
• Angiotensin II receptor antagonists, such as candesartan, eprosartan, or losartan (used to treat high blood pressure).
• Diuretics (water tablets) (used to treat high blood pressure), such as furosemide.
• Cardiac glycosides (used to treat heart conditions), such as digoxin.
• Steroids (used to treat swelling and inflammation), such as hydrocortisone, prednisolone, and dexamethasone.
• Quinolone antibiotics (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 (used to treat gout).
• Methotrexate (used to treat skin disorders, arthritis, or cancer).
• Cyclosporin or tacrolimus (used in skin disorders or after organ transplantation).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used for medical termination of pregnancy or to induce labor in case of fetal death).
• Cholestyramine, a medicine used to lower cholesterol levels.
• Antacids (medicines that neutralize stomach acid).

If any of the above situations apply to you or if you are unsure, talk to a doctor or pharmacist before taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 ApoNapro ACTIVE if you are in the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. ApoNapro ACTIVE may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first six months of pregnancy, do not take ApoNapro ACTIVE 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, ApoNapro ACTIVE may cause kidney problems in the unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

Naproxen passes into breast milk. ApoNapro ACTIVE is not recommended for use in breastfeeding women.

Fertility

Naproxen may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or are having trouble becoming pregnant.

Driving and using machines

This medicine may cause drowsiness, dizziness, or blurred vision, as well as depression or disorientation. It may also cause disturbances in vision and balance. If you experience any of these symptoms, talk to a doctor, and do not drive or operate any tools or machines.

ApoNapro ACTIVE contains sodium

This medicine contains 345 mg (15 mmol) of sodium (the main component of common salt) per effervescent tablet. This corresponds to 17.2% of the maximum recommended daily intake of sodium in the diet for adults.

ApoNapro ACTIVE contains sorbitol (E 420)

Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body does not break down fructose, you should talk to a doctor before taking this medicine.

3. How to take ApoNapro ACTIVE

Taking medicines containing naproxen may be associated with a small increased risk of heart attack or stroke. The risk is higher with higher doses and longer treatment. DO NOT EXCEED THE RECOMMENDED DOSE OR DURATION OF TREATMENT. This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, talk to a doctor or pharmacist. Dissolve 1 to 2 tablets in a glass (150 mL) of water and drink, 3 tablets should be dissolved in 300 mL. To ensure that no medicine remains, rinse the empty glass with a small amount (10 mL) of water and drink. Take with food or after food. If you have a sensitive stomach, take ApoNapro ACTIVE with food. You should make sure you drink enough fluids and are well-hydrated while taking this medicine. This is especially important if you have kidney problems. While taking this medicine, your doctor will want to see you to check that you are taking the right dose and that no side effects occur. This is especially important for elderly patients.

Recommended dose for adults

Muscle, joint, or tendon pain, painful menstruation, and fever

• The recommended dose is 2 tablets, followed by one tablet every 6 to 8 hours if needed.

Arthritis and ankylosing spondylitis

• The recommended dose is 2 to 4 tablets.
• The dose should be divided into two parts and taken twice a day.

Gout

• The usual initial dose is 3 tablets, followed by one tablet every 8 hours if needed.

Use in children and adolescents

ApoNapro ACTIVE should not be taken by children and adolescents under 16 years of age, as the active substance content is too high. In adolescents aged 16 and over, the recommended daily dose is 20 mg/kg body weight per day. Do not exceed the daily dose of 1000 mg per day.

Elderly patients with liver and kidney problems

Your doctor will decide on the dose, which will usually be lower than for other adults.

Taking more than the recommended dose of ApoNapro ACTIVE

Overdose symptoms may include stomach pain, nausea, and vomiting. Headaches, dizziness, drowsiness, vision disturbances, and ringing in the ears may occur, as well as loss of consciousness. High blood pressure, respiratory depression, and coma may occur after taking NSAIDs, but are rare. If you suspect an overdose of ApoNapro ACTIVE, seek medical help immediately. Take the medicine packaging with you. If you feel that the medicine is not providing sufficient pain relief, do not increase the dose yourself; talk to a doctor immediately.

Missing a dose of ApoNapro ACTIVE

If you miss a dose, skip it and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, ApoNapro ACTIVE can cause side effects, although not everybody gets them. Taking medicines containing naproxen may be associated with a small increased risk of heart attack or stroke.

Important side effects to look out for:

STOP TAKING the medicine and tell your doctor immediately if you experience any of the following side effects. You may need urgent medical attention.

Frequency not known: frequency cannot be estimated from the available data

• Characteristic skin allergic reaction, known as fixed 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.
• 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.

Severe stomach and intestinal problems,symptoms include:

• Vomiting blood or particles that look like coffee grounds.
• Black, tarry stools or bloody diarrhea.
• Stomach upset, stomach pain, fever, nausea, or vomiting.
• Pancreatitis. Symptoms include severe stomach pain radiating to the back.
• Worsening of ulcerative colitis or Crohn's disease, with symptoms of pain, diarrhea, vomiting, and weight loss.

Allergic reactions,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:

• Severe rash that develops quickly, with blisters or peeling of the skin and possible blisters in the mouth, throat, or eyes. This may be accompanied by fever, headache, cough, and soreness of the whole body.
• Blisters on the skin after exposure to sunlight, especially on the arms, face, and hands.

Liver problems,symptoms include:

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

Heart attack,symptoms include:

• Chest pain and feeling of tightness, which may radiate to the neck, arms, and down the left arm.

Stroke,symptoms include:

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

Meningitis,symptoms include:

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

If you notice any of the serious side effects listed above, STOP TAKING the medicine and tell your doctor immediately.

Other possible side effects:

Stomach and intestines

• Heartburn, indigestion, stomach pain, nausea, or vomiting, constipation, diarrhea, bloating, difficulty or painful swallowing.

Blood

• Blood disorders, such as anemia or changes in white blood cell count.
• High potassium levels in the blood (hyperkalemia).

Psychiatric disorders

• Severe sleep problems or sleep disturbances.
• Depression.
• Feeling confused or seeing and possibly hearing things that are not there (hallucinations).

Nervous system

• Headache.
• Seizures, dizziness, drowsiness, or sleepiness.
• Feeling of tingling or numbness in hands and feet.
• Difficulty with memory or concentration.

Eyes and ears

• Vision disturbances, eye pain.
• Hearing disturbances, including ringing in the ears (tinnitus) and hearing loss.
• Dizziness causing balance disturbances.

Heart and circulation

• Swelling of hands, feet, or ankles. This may be accompanied by chest pain, fatigue, shortness of breath (heart failure).
• Feeling of palpitations, slow heart rate, or high blood pressure.
• Disorders related to the way the heart pumps blood throughout the body or damage to blood vessels. Symptoms may include fatigue, shortness of breath, feeling of fainting, general pain.

Chest

• Difficulty breathing, including shortness of breath, wheezing, or coughing.
• Pneumonia or pulmonary edema.

Skin and hair

• Skin rash, including redness, hives, pimples, and blisters on the body and face.
• Bruising, itching, sweating, increased sensitivity of the skin to sunlight, or hair loss.

Urinary system

• Blood in urine or kidney problems.

Other

• Thirst, fever, feeling tired, or general malaise.
• Pain or ulcers in the mouth.
• Pain or weakness of muscles.
• Difficulty for women to become pregnant.
• Systemic lupus erythematosus (SLE). Symptoms include fever, rash, kidney problems, and joint pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your 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, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store ApoNapro ACTIVE

Keep this medicine out of the sight and reach of children. Do not take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. There are no special storage precautions for this medicine. Store in the original packaging to protect from moisture. 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 packaging and other information

What ApoNapro ACTIVE contains

The active substance is naproxen. Each effervescent tablet contains 250 mg of naproxen. The other ingredients are: citric acid, sodium bicarbonate, sodium carbonate, sodium cyclamate (E 952), sodium saccharin (E 954), sodium citrate, povidone (K 30), macrogol (6000), mannitol (E 421), simethicone, sodium docusate, Cassis flavor (containing maltodextrin, mannitol (E 421), gluconolactone (E 575), sorbitol (E 420), arabic gum (E 414), colloidal silica anhydrous (E 551)).

What ApoNapro ACTIVE looks like and contents of the pack

Round, white effervescent tablets (diameter 25 mm). ApoNapro ACTIVE is available in packs of 10 and 20. 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 lokal 27 01-909 Warsaw e-mail: [email protected]

Manufacturer:

HERMES PHARMA GmbH Hans-Urmiller-Ring 52 82515 Wolfratshausen Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: ApoNapro ACTIVE Date of last revision of the leaflet:04/2025