Naproxen Hasco

Leaflet attached to the packaging: patient information

NAPROXEN HASCO

500 mg, suppositories

Naproxen

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Naproxen Hasco and what is it used for
• 2. Important information before using Naproxen Hasco
• 3. How to use Naproxen Hasco
• 4. Possible side effects
• 5. How to store Naproxen Hasco
• 6. Package contents and other information

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

Naproxen Hasco contains the active substance - naproxen, belonging to the group of non-steroidal anti-inflammatory drugs with anti-inflammatory and analgesic effects.

Indications for use of Naproxen Hasco:

Rheumatic diseases

• rheumatoid arthritis
• juvenile rheumatoid arthritis
• ankylosing spondylitis Acute gout attack Acute musculoskeletal pain
• strains
• overuse injuries
• lower back pain
• herniated disc
• tendinitis
• bursitis
• fibromyalgia Pains of other origin (e.g. menstrual pain, headaches).

2. Important information before using Naproxen Hasco

When not to use Naproxen Hasco

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs),

1/6

• in patients who have ever had symptoms of allergy in the form of rhinitis, urticaria, or bronchial asthma during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• in patients with severe liver failure, severe kidney failure, or severe heart failure,
• in patients with active or past peptic ulcer disease and (or) duodenal ulcer, perforation, or bleeding, also occurring after the use of NSAIDs,
• during the third trimester of pregnancy,
• in patients with bleeding disorders.

Warnings and precautions

Before starting Naproxen Hasco, you should discuss it with your doctor, pharmacist, or nurse.

• Taking the medicine in the smallest effective dose and for the shortest possible time necessary to relieve symptoms reduces the risk of side effects. Patients treated with NSAIDs for a long time should undergo regular medical check-ups to detect any potential side effects of treatment.
• Taking such medicines as 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 use higher doses and longer treatment than recommended. In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, increased cholesterol levels, smoking), you should discuss treatment with your doctor or pharmacist.
• There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and do not necessarily have to be preceded by warning symptoms or may occur in patients who have had such warning symptoms.
• In case of gastrointestinal bleeding or ulceration, you should stop using naproxen. Patients with a history of gastrointestinal diseases, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
• Concomitant administration of naproxen and other non-steroidal anti-inflammatory drugs is not recommended due to the increased risk of serious side effects.
• Naproxen belongs to a group of medicines (NSAIDs) that may adversely affect female fertility. This effect is transient and disappears after the end of treatment.
• Naproxen inhibits platelet aggregation and prolongs bleeding time, especially in individuals who have previously had coagulation disorders or are taking anticoagulant medications.
• Caution should be exercised when using naproxen in patients with bronchial asthma or allergic diseases, as the medicine may contribute to the occurrence of bronchospasm.
• Severe skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the use of NSAIDs. The greatest risk of these severe reactions occurs at the beginning of therapy, in most cases within the first month of using the medicine. You should stop using the medicine after the first symptoms of skin rash, mucosal damage, other symptoms of hypersensitivity, or DRESS.
• Naproxen, due to its anti-inflammatory and antipyretic effects, may mask the symptoms of another disease, making its diagnosis more difficult.

Patient with heart failure
Naproxen should be used with caution, using the smallest effective dose, in patients with heart failure (as it may exacerbate peripheral edema).
Patient with renal and (or) hepatic impairment
Naproxen should be used with caution, using the smallest effective dose, in patients with hepatic and renal impairment.
2/6
In alcoholic liver disease and other forms of liver cirrhosis, there is a decrease in naproxen plasma concentration, with a simultaneous increase in the amount of unbound naproxen.
In patients with renal impairment, serum creatinine concentration and (or) creatinine clearance should be periodically monitored. The medicine is not recommended for patients with creatinine clearance below 20 ml/minute.
Elderly patients
Naproxen should be used with caution, using the smallest effective dose, in elderly patients, due to the increased risk of gastrointestinal complications.

Naproxen Hasco and other medicines

Please tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Before starting to take this medicine, you should talk to your doctor or pharmacist if you are taking any of the following medicines:

• Acetylsalicylic acid used to prevent blood clots.
• Concomitant administration of antacids or cholestyramine with naproxen may delay its absorption.
• Non-steroidal anti-inflammatory drugs may increase the effect of anticoagulant medications, such as warfarin.
• Naproxen may inhibit the diuretic effect of furosemide.
• Naproxen inhibits the excretion of lithium, increasing its plasma concentration.
• Probenecid increases the plasma concentration of naproxen.
• Naproxen inhibits the excretion of methotrexate, increasing its toxicity.
• Concomitant use of naproxen with digitalis glycosides may decrease their renal excretion, leading to increased plasma concentration.
• Naproxen may weaken the antihypertensive effect of propranolol and other beta-blockers, as well as increase the risk of renal impairment associated with the use of ACE inhibitors.
• Caution should be exercised when administering naproxen and cyclosporine concomitantly due to the increased risk of nephrotoxicity.
• Naproxen used concomitantly with hydantoin, oral anticoagulants, and sulfonamides enhances their effect.
• Caution should be exercised when using naproxen concomitantly with corticosteroids due to the increased risk of gastrointestinal bleeding.
• Non-steroidal anti-inflammatory drugs reduce the effect of mifepristone. Naproxen administration can be started 8 to 12 days after the last dose of mifepristone.
• Concomitant use of naproxen with fluoroquinolones increases the risk of seizures.

It is recommended to discontinue the use of naproxen 48 hours before assessing adrenal cortex function, due to the potential for falsifying the results.

Naproxen Hasco with food and drink

Naproxen Hasco can be used regardless of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not take Naproxen Hasco if you are 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 problems in the unborn child.
It may increase the risk of bleeding in you and your child and cause prolongation or prolongation of labor. During the first 6 months of pregnancy, you should not use the medicine unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period or during attempts to conceive, you should use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, Naproxen Hasco may cause kidney problems in the unborn child if taken for more than a few days - this may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
Breastfeeding
Naproxen passes into breast milk, so you should not use it during breastfeeding.
Fertility
The use of naproxen may adversely affect female fertility and is not recommended for women who plan to conceive.

Driving and using machines

In some patients, the medicine may cause drowsiness, dizziness, insomnia, depression.
You should consult your doctor about the possibility of using naproxen while driving or operating machinery.

3. How to use Naproxen Hasco

This medicine should always be used as directed by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.
Rectal administration.

Use in children

Children over 5 years old

• juvenile rheumatoid arthritis: the recommended dose is 10 mg/kg body weight 2 times a day (every 12 hours). The medicine is not recommended for use in any other indication in children under 16 years of age.

Adults

• rheumatoid arthritis and ankylosing spondylitis: 250 mg to 500 mg twice a day (morning and evening)
• acute gout attack: first dose 750 mg, subsequent doses 250 mg every 8 hours
• for temporary pain relief: first dose 500 mg, subsequent doses 250 mg every 6 to 8 hours
• acute musculoskeletal pain: initial dose 500 mg, subsequent doses 250 mg every 6 to 8 hours.

The maximum daily dose is 1250 mg.
Elderly patients
You should use the smallest effective dose, as the risk of side effects is higher than in younger individuals.

Using a higher dose of Naproxen Hasco than recommended

In case of taking a higher dose of the medicine than recommended, you should consult your doctor or pharmacist.
Dosing not in accordance with the patient leaflet may lead to the occurrence of overdose symptoms such as: gastrointestinal disorders, pain, and dizziness, changes in blood test results.

Missing a dose of Naproxen Hasco

You should not take a double dose to make up for a missed dose.
4/6

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop using Naproxen Hasco and contact your doctor immediately:
Frequency not known (frequency cannot be estimated from the available data):

• widespread rash, high body temperature, 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;
• characteristic skin allergic reaction, called fixed drug eruption, which usually recurs in the same place (places) as a result of re-exposure to the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching.

Common (in no more than 1 in 10 patients using the medicine):

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

Uncommon (in no more than 1 in 100 patients using the medicine):

• diarrhea, constipation, vomiting, rash, urticaria, itching, drowsiness, insomnia, sleepiness.

Rare (in no more than 1 in 1000 patients using the medicine):

• gastrointestinal bleeding, black stools, bloody vomiting, angioedema, impaired renal function.

Very rare (in no more than 1 in 10,000 patients using the medicine):

• ulcers of the oral mucosa, esophagitis, acute pancreatitis, colitis, gastric and intestinal ulcers;
• hepatitis (including fatal cases), jaundice;
• alopecia, erythema multiforme, exfoliative dermatitis: Stevens-Johnson syndrome, lichen planus, toxic epidermal necrolysis, and hypersensitivity to light (including cases resembling porphyria cutanea tarda), blistering detachment of the epidermis;
• glomerulonephritis, interstitial nephritis, nephrotic syndrome, hematuria, proteinuria, hyperkalemia, elevated serum creatinine, renal papillary necrosis, renal failure;
• seizures, concentration disorders, meningitis;
• dyspnea, edema, palpitations, congestive heart failure, hypertension.
• thrombocytopenia, granulocytopenia, agranulocytosis, eosinophilia, leukopenia, vasculitis, anemia (aplastic and hemolytic);
• eosinophilic pneumonia, asthma, pulmonary edema;
• tinnitus, hearing disorders;
• vision disorders, corneal clouding, optic neuritis, optic neuropathy, papilledema;
• anaphylactoid reactions (severe hypersensitivity reactions manifested by, for example, fever, edema, malaise, muscle pain, muscle weakness);
• abnormal liver function test results.

Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
5/6
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 the medicine.

5. How to store Naproxen Hasco

Store in a temperature below 25°C, in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Naproxen Hasco contains

• The active substance of the medicine is naproxen. One suppository contains 500 mg of naproxen.
• The other ingredient (excipient) is: solid fat (Witepsol).

What Naproxen Hasco looks like and what the package contains

Suppositories are white, matte, torpedo-shaped, and have a smooth surface. The package contains 10 suppositories.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

phone: 22 742 00 22
e-mail: [email protected]

Date of last update of the leaflet: 08/2024

6/6