Nalgesin

Package Leaflet: Information for the Patient

Nalgesin, 275 mg, coated tablets
naproxen sodium

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

• Keep this 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nalgesin and what is it used for

Nalgesin is a pain-relieving, anti-inflammatory, and antipyretic medicine.
The medicine works by inhibiting the synthesis of prostaglandins.
Nalgesin is used for symptomatic treatment of:

• rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis, juvenile idiopathic arthritis
• acute musculoskeletal disorders (e.g., sprains and strains, direct injuries, lower back pain, bursitis, tendon sheath inflammation)
• acute gout attack
• menstrual pain (dysmenorrhea)
• postoperative pain and swelling (e.g., after surgery, after tooth extraction).

2. Important information before taking Nalgesin

When not to take Nalgesin

• if you are allergic to naproxen sodium or any of the other ingredients of this medicine (listed in section 6);
• if you have had breathing difficulties (asthma), hives, or nasal inflammation (rhinitis) when taking acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs, nonsteroidal anti-rheumatic drugs);
• if you have or have had stomach or intestinal ulcers, or other gastrointestinal disorders;
• if you have had bleeding or perforation in the gastrointestinal tract when taking NSAIDs;
• if you have severe liver or kidney dysfunction;
• if you have severe heart failure;
• during the last three months of pregnancy.

Warnings and precautions

Before taking Nalgesin, discuss it with your doctor or pharmacist.

• if you have or have had bleeding, ulcers, or perforation of the gastrointestinal tract, you should be carefully monitored by your doctor; special caution should be exercised in cases of ulcerative colitis and Crohn's disease, as it may lead to recurrence or worsening of symptoms. Serious gastrointestinal side effects can occur without prior symptoms; bleeding and perforation of the intestine (hole in the intestinal wall) are possible.
• if you have liver or kidney dysfunction;
• if you have heart failure;
• if you have high blood pressure.

Nalgesin may make it difficult to become pregnant. If you are planning to become pregnant or are having trouble becoming pregnant, you should inform your doctor.
Medicines like Nalgesin may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is higher when taking high doses or long-term treatment. Do not exceed the recommended dose and duration of treatment.
As with all medicines used in the elderly, naproxen sodium should be taken in the smallest effective doses.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with the use of Nalgesin Forte. You should stop taking Nalgesin Forte and consult your doctor immediately if you experience any symptoms associated with these severe skin reactions, described in section 4.

Nalgesin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
As a result of interactions with some other medicines, the effect of Nalgesin or the effect of these medicines may be enhanced or weakened. This is the case with:

• other painkillers (acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs),
• medicines used to prevent blood clots (warfarin),
• acetylsalicylic acid used to prevent blood clots,
• medicines used to treat diabetes (sulfonylurea derivatives),
• medicines used to treat epilepsy (hydantoin derivatives),
• medicines used to treat high blood pressure,
• medicines that increase urine production (furosemide),
• medicines used to treat mental disorders (lithium),
• medicines that increase the excretion of uric acid from the body and prevent gout attacks (probenecid),
• medicines that suppress the immune system (cyclosporine),
• medicines used to treat cancer (methotrexate),
• medicines used to treat AIDS (zidovudine),
• medicines used to treat pain and inflammation of the joints (corticosteroids).

Nalgesin with food and drink

Tablets should be swallowed with a sufficient amount of liquid, preferably during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice.
Nalgesin should not be used during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. This can cause problems with the kidneys and heart of the unborn child, as well as affect the tendency to bleed in the mother and child, and delay or prolong delivery. You should not take Nalgesin during the first 6 months of pregnancy, unless it is absolutely necessary and advised by your doctor. If treatment is necessary during this period or during attempts to become pregnant, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Nalgesin 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 baby (oligohydramnios). If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
During treatment with Nalgesin, breastfeeding is not recommended.

Driving and using machines

Nalgesin has no or negligible influence on the ability to drive and use machines. Dizziness, drowsiness, fatigue, and vision disturbances are possible side effects after taking NSAIDs. If you experience such symptoms, do not drive or operate machinery.

Nalgesin contains sodium

The medicine contains 25 mg of sodium (the main component of common salt) in each tablet. This corresponds to 1.25% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Nalgesin

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Tablets should be swallowed with water, preferably during meals.
Adults and adolescents over 16 years of age
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
The recommended daily dose of naproxen sodium is between 550-1100 mg, given in two divided doses. The maintenance dose of naproxen sodium may be increased or decreased depending on the patient's response to treatment. Do not exceed a single dose of 1100 mg.
Acute musculoskeletal disorders
The recommended initial dose of naproxen sodium is 550 mg, followed by 550 mg every 12 hours or 275 mg every 6-8 hours.
Acute gout attack
The recommended initial dose of naproxen sodium is 825 mg, followed by 275 mg every 8 hours.
Menstrual pain
The recommended initial dose of naproxen sodium is 550 mg, followed by 550 mg every 12 hours or 275 mg every 6-8 hours if necessary.
Postoperative pain
The recommended initial dose of naproxen sodium is 550 mg, followed by 550 mg every 12 hours or 275 mg every 6-8 hours.
Juvenile idiopathic arthritis
In adolescents over 16 years of age and with a body weight of 50 kg or more, the recommended daily dose of naproxen sodium is between 550-825 mg, given in two divided doses.
Children and adolescents under 16 years of age
Nalgesin is not intended for use in children and adolescents under 16 years of age.
Elderly patients
The smallest effective dose of Nalgesin should be used.
Patients with renal impairment
Nalgesin should be used with caution in patients with renal impairment. A reduced dose should be given to such patients. Do not take Nalgesin if you have severe renal impairment (see "When not to take Nalgesin").
Patients with liver dysfunction
Nalgesin should be used with caution in patients with liver dysfunction. A reduced dose should be given to such patients. Do not take Nalgesin if you have severe liver dysfunction (see "When not to take Nalgesin").
If you feel that the effect of Nalgesin is too strong or too weak, talk to your doctor or pharmacist.

Overdose of Nalgesin

Overdose may cause stomach pain, nausea, vomiting, dizziness, ringing in the ears, irritability, and in severe cases, bleeding vomiting, black stools, disturbances of consciousness, breathing difficulties, convulsions, and kidney failure.
In case of overdose, your doctor will take appropriate measures.

Missed dose of Nalgesin

Do not take a double dose to make up for a forgotten tablet.
Take the medicine at the same time every day. If you forget to take your medicine at the scheduled time, take it as soon as you remember.

Stopping treatment with Nalgesin

During short-term use of naproxen sodium to relieve pain, you can safely stop taking the medicine when it is no longer needed. In case of long-term use, consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nalgesin can cause side effects, although not everybody gets them.
Stop taking Nalgesin and consult your doctor immediately if you experience any of the following symptoms, as they may be signs of serious side effects:

• severe stomach disorders, heartburn, or stomach pain
• vomiting with blood or coffee grounds-like vomit
• black stools or blood in urine
• skin reactions, such as itchy rash
• breathing difficulties and (or) swelling of the face or throat
• fatigue with loss of appetite
• throat pain with mouth ulcers, fatigue, and fever
• nosebleeds, skin bruising
• unusual fatigue and decreased urine output
• swelling of the face, feet, or ankles
• chest pain
• disturbances of consciousness
• widespread rash, high body temperature, elevated liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
• characteristic skin allergic reaction, known as 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 swelling, blisters (hives), itching.

Side effects are most commonly associated with high doses.
Common (may affect up to 1 in 10 people):

• constipation, stomach pain, nausea, indigestion, diarrhea, mouth ulcers,
• headache, dizziness, balance disorders, drowsiness,
• itching, skin rash, bleeding in the skin or mucous membranes (bruising), small red spots on the skin caused by minor bleeding in the skin or under the skin (petechiae),
• ringing in the ears, hearing disturbances,
• vision disturbances,
• swelling, rapid heartbeat or palpitations,
• thirst, sweating,
• breathing difficulties (dyspnea).

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

• bleeding and (or) perforation in the stomach, vomiting with blood from the stomach or esophagus, blood in stool, vomiting,
• changes in liver enzyme activity, jaundice,
• depression, sleep disorders, inability to concentrate, insomnia, malaise,
• muscle pain and weakness,
• hair loss (alopecia), photoallergic skin inflammation,
• hearing disturbances,
• congestive heart failure (medicines like Nalgesin may slightly increase the risk of heart attack (myocardial infarction) or stroke,
• allergic reactions,
• fever and chills,
• menstrual disorders,
• kidney problems (interstitial nephritis, hematuria, interstitial nephritis, nephrotic syndrome, kidney failure, renal papillary necrosis),
• blood changes (eosinophilia, granulocytopenia, leukopenia, thrombocytopenia),
• eosinophilic pneumonia,

Side effects for which a causal relationship with naproxen sodium is not known (frequency cannot be estimated from available data):

• blood changes (aplastic anemia, hemolytic anemia),
• inflammation of the membranes surrounding the central nervous system (aseptic meningitis), mental disorders (cognitive),
• skin allergic reactions (toxic epidermal necrolysis, erythema multiforme, allergic reactions to light resembling late porphyria cutanea and blistering detachment of the skin, Stevens-Johnson syndrome, urticaria),
• inflammation of the mouth (ulcerative stomatitis),
• inflammation of the blood vessels,
• allergic reactions (angioedema), high blood sugar (hyperglycemia), low blood sugar (hypoglycemia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nalgesin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect from light.
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 Nalgesin contains

• The active substance of Nalgesin is naproxen sodium. Each tablet contains 275 mg of naproxen sodium, equivalent to 250 mg of naproxen.
• The other ingredients of the medicine are: in the tablet core: povidone K 30, microcrystalline cellulose, talc, magnesium stearate, and in the tablet coating Opadry YS-1R-4215, E 132**: hypromellose, titanium dioxide (E 171), macrogol 8000, and indigo carmine (E 132).

What Nalgesin looks like and contents of the pack

Coated tablets, oval, slightly convex on both sides, light blue.
Packaging: 10, 20, 30, 40, or 60 tablets in PVC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

Date of last revision of the leaflet: 08.08.2024