Naproxen Hasco

Leaflet attached to the packaging: patient information

NAPROXEN HASCO

250 mg, suppositories

Naproxen

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

• You should 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 taking Naproxen Hasco
• 3. How to take Naproxen Hasco
• 4. Possible side effects
• 5. How to store Naproxen Hasco
• 6. Contents of the packaging 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 taking Naproxen Hasco

When not to take 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),

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• 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 of the stomach and/or duodenum, perforation, or bleeding, also occurring after the use of NSAIDs,
• in 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 alleviate symptoms reduces the risk of side effects. Patients taking 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 slight increase in the risk of a heart attack ("heart attack") or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or 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 taking 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 people who have had bleeding disorders or are taking anticoagulant medications.
• Caution should be exercised when taking 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 taking the medicine. You should stop taking 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 administered with caution, using the smallest effective dose, to patients with heart failure (as it may exacerbate peripheral edema).
Patient with renal and/or hepatic impairment
Naproxen should be administered with caution, using the smallest effective dose, to patients with hepatic and renal impairment.
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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 administered with caution, using the smallest effective dose, to elderly patients, due to the increased risk of gastrointestinal complications.

Naproxen Hasco and other medicines

You should 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 medicines, 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 impaired renal function associated with the use of ACE inhibitors.
• Caution should be exercised when taking naproxen and cyclosporin 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 taking naproxen and corticosteroids concomitantly 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 naproxen 48 hours before assessing adrenal cortex function, due to the possibility of falsifying the results.

Naproxen Hasco with food and drink

Naproxen Hasco can be taken 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 taking 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 take the medicine unless it is absolutely necessary and prescribed 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 can lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) 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 take it during breastfeeding.
Fertility
Taking 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 taking naproxen while driving or operating machinery.

3. How to take Naproxen Hasco

This medicine should always be taken as directed by your doctor or pharmacist. If you have any 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 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 people.

Taking a higher dose of Naproxen Hasco than recommended

If you have taken 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 count.

Missing a dose of Naproxen Hasco

You should not take a double dose to make up for a missed dose.
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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 taking Naproxen Hasco and contact your doctor immediately:
Frequency not known (frequency cannot be estimated from the available data):

• widespread rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymphadenopathy, 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-administration of the medicine and may take the form of round or oval red patches and skin edema, blisters (hives), itching.

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

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

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

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

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

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

Very rare (in no more than 1 in 10,000 patients taking 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, impaired concentration, meningitis;
• dyspnea, edema, palpitations, congestive heart failure, hypertension.
• thrombocytopenia, granulocytopenia, agranulocytosis, eosinophilia, leukopenia, vasculitis, anemia (aplastic and hemolytic anemia);
• eosinophilic pneumonia, asthma, pulmonary edema;
• tinnitus, hearing impairment;
• vision disturbances, corneal clouding, optic neuritis, optic neuropathy, papilledema;
• anaphylactoid reactions (severe hypersensitivity reactions manifesting as 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 Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
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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 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. Contents of the packaging and other information

What Naproxen Hasco contains

• The active substance of the medicine is naproxen. One suppository contains 250 mg of naproxen.
• The other ingredient (excipient) is: solid fat (Witepsol).

What Naproxen Hasco looks like and what the pack contains

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

Marketing authorization holder and manufacturer

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

Medicine information

tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: 08/2024

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