Nalgesin Mini

Leaflet attached to the packaging: information for the user

Nalgesin Mini, 220 mg, coated tablets
naproxen sodium

Quickly relieves pain.

You should read this leaflet carefully, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should talk to your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents:

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

1. What is Nalgesin Mini and what is it used for

Nalgesin Mini is a pain-relieving medicine that reduces inflammation.
The medicine works by inhibiting the synthesis of prostaglandins. The pain-relieving effect occurs quickly
and lasts for up to 12 hours.
Nalgesin Mini is indicated for short-term treatment of mild to moderate pain, such as: headache, toothache, painful menstruation, joint pain,
muscle pain.
If after 3 days there is no improvement or you feel worse, you must contact your doctor.

2. Important information before taking Nalgesin Mini

When not to take Nalgesin Mini

• 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 polyps, or have had serious allergic reactions which cause difficulty breathing or dizziness after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if you have or have had a stomach or intestinal ulcer or bleeding;
• if you have had bleeding or perforation in the gastrointestinal tract after taking NSAIDs;
• if you have severe liver or kidney problems;
• if you have severe heart failure;
• during the last three months of pregnancy;
• if you have had a stroke or other bleeding disorders.
• Do not give to children under 2 years of age.

Warnings and precautions

General
The frequency of side effects is dependent on the dose and duration of treatment. You should always use the smallest effective dose of Nalgesin Mini for the shortest time necessary to relieve pain.
You should avoid taking naproxen sodium at the same time as other NSAIDs (including selective COX-2 inhibitors).
During long-term use of naproxen sodium, it is necessary to check liver and kidney function, especially in patients with liver or kidney problems, heart disease, or those taking diuretics, as well as in patients over 65 years old.
You should discuss the use of Nalgesin Mini with your doctor or pharmacist before starting treatment.

• in patients over 65 years old, as there is an increased risk of serious side effects, particularly gastrointestinal, which can be fatal;
• if you have or have had bleeding, ulcers, or perforation of the gastrointestinal tract, you should be carefully monitored by your doctor. Serious gastrointestinal side effects can occur without prior symptoms, such as bleeding and perforation of the intestine (hole in the intestinal wall), which can be fatal;
• in patients with a history of gastrointestinal disease, such as ulcerative colitis and Crohn's disease, as there may be a recurrence or worsening of symptoms;
• in patients with blood clotting disorders or taking anticoagulant medications;
• if you have or have had liver or kidney problems;
• if you have or have had heart problems;
• if you have or have had high blood pressure;
• if you are trying to conceive or have problems conceiving;
• in patients who have or have had any allergic reactions, asthma, chronic respiratory diseases, or nasal polyps.

Gastrointestinal effects
Bleeding, ulcers, or perforations of the gastrointestinal tract, which can be fatal, have been reported with all NSAIDs, at any time during treatment, with or without warning symptoms.
The risk of bleeding, ulcers, or perforation of the gastrointestinal tract increases with higher doses of NSAIDs in patients who have had ulcers before and in the elderly. Treatment should be started with the lowest available dose.
Patient with a history of toxic effects on the gastrointestinal tract, especially the elderly, are advised to report any disturbing abdominal symptoms (especially gastrointestinal bleeding) to their doctor.
Concomitant use of medications used to treat pain and inflammation (corticosteroids), anticoagulant medications (warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents, such as aspirin (see section 4.5), may increase the risk of gastrointestinal ulcers or bleeding.

Effects on the cardiovascular and cerebrovascular systems
Medicines like Nalgesin Mini may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is higher in patients taking high doses or undergoing long-term treatment. You should not exceed the recommended dose or duration of treatment.
Patient with heart disease, who have had a stroke, or are suspected to be at increased risk of these conditions (e.g., patients with high blood pressure, diabetes, or high cholesterol, or smokers) should discuss their treatment with their doctor or pharmacist.

Skin reactions
Serious skin reactions, including fatal ones, have been very rarely reported, especially during the initial stages of therapy with NSAIDs. If you notice any rash, itching, mucosal lesions, or other signs of allergy/hypersensitivity, you should stop taking the medicine and consult your doctor.

Hypersensitivity reactions
Serious allergic reactions have been very rarely reported. Patients with a history of facial and throat swelling, any allergy, asthma, chronic nasal inflammation, or chronic respiratory disease are more prone to serious hypersensitivity reactions.
In case of the first symptoms of a serious allergic reaction, you should stop taking the medicine.

Fertility precautions
This medicine belongs to a group of medicines (NSAIDs) that may have a negative effect on female fertility. This effect is reversible after stopping the medicine.

Children and adolescents

Nalgesin Mini should not be used in children under 16 years of age.

Other medicines and Nalgesin Mini

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
As a result of interactions with some other medicines, the effect of Nalgesin Mini or the effect of these medicines may be increased or decreased. This is the case with:

• other pain-relieving medicines (acetylsalicylic acid and other non-steroidal anti-inflammatory drugs),
• medicines used to prevent blood clots (warfarin),
• acetylsalicylic acid used to prevent blood clots,
• medicines used to treat depression (selective serotonin reuptake inhibitors),
• 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 Mini with food, drink, and alcohol

Tablets should be swallowed with a sufficient amount of liquid, preferably during a meal.
You should not consume alcohol while taking naproxen sodium, as alcohol may increase the risk of gastrointestinal bleeding associated with NSAIDs.

Pregnancy and breastfeeding

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.
Nalgesin Mini should not be used during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. This may cause kidney and heart problems in the unborn child, as well as affect the tendency to bleeding in the mother and child, and delay or prolong delivery. You should not take Nalgesin Mini during the first six months of pregnancy, unless it is absolutely necessary and recommended by your doctor.
If treatment is necessary during this period or while trying to conceive, you should use the smallest dose for the shortest time possible. From the 20th week of pregnancy, Nalgesin Mini 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 baby (oligohydramnios).
If treatment is necessary for a longer period than a few days, your doctor may recommend additional monitoring.
You should not breastfeed while taking Nalgesin Mini.

Driving and using machines

Nalgesin Mini has no or negligible influence on the ability to drive and use machines. Dizziness, drowsiness, fatigue, and vision disturbances are possible side effects of NSAIDs. If you experience such symptoms, you should not drive or operate machinery.
Nalgesin Mini contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "sodium-free".

3. How to take Nalgesin Mini

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should talk to your doctor or pharmacist.
The recommended dose for adults and adolescents over 16 years old with a weight over 50 kg is 1 tablet every 8-12 hours.
Alternatively, you can take two tablets at once and, if necessary, one additional tablet after 8-12 hours.
Tablets should be swallowed with a sufficient amount of liquid, during or after a meal.
In patients with stomach sensitivity, it is beneficial to take the medicine during a meal. Tablets should not be chewed.
The maximum daily dose is 3 tablets (equivalent to 660 mg of naproxen sodium).
You should not take Nalgesin Mini for more than 7 days. If after 3 days of treatment the pain persists, and if the symptoms worsen, you should consult your doctor.

Use in children and adolescents

The dosage for children over 16 years old with a weight over 50 kg is the same as for adults.
Nalgesin Mini is not intended for use in children and adolescents under 16 years of age.

Elderly patients

The maximum recommended daily dose of Nalgesin Mini is 2 tablets divided into two doses.
You should use the smallest effective dose.

Patients with renal impairment

The maximum recommended daily dose of Nalgesin Mini is 2 tablets divided into two doses.
You should use the smallest effective dose.
You should not take Nalgesin Mini if you have severe renal impairment (see "When not to take Nalgesin Mini").

Patients with liver disorders

The maximum recommended daily dose of Nalgesin Mini is 2 tablets divided into two doses.
You should use the smallest effective dose.
You should not take Nalgesin Mini if you have severe liver impairment (see "When not to take Nalgesin Mini").

Taking a higher dose of Nalgesin Mini than recommended

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, seizures, and kidney failure.
If you think that the effect of Nalgesin Mini is too strong or too weak, you should talk to your doctor or pharmacist.

Missing a dose of Nalgesin Mini

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

Stopping treatment with Nalgesin Mini

During short-term use of naproxen sodium to relieve pain, you can safely stop taking the medicine if it is no longer needed.
If you have any further doubts about the use of this medicine, you should talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):

• nausea, indigestion, heartburn, vomiting, stomach pain, bloating, abdominal pain, restlessness,
• headache, dizziness, drowsiness,

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

• hypersensitivity reactions (including facial swelling (facial edema), facial and throat swelling (angioedema),
• sleep disturbances, agitation,
• ringing in the ears (tinnitus), hearing disturbances,
• vision disturbances,
• bruises,
• diarrhea, constipation
• skin rash, itching
• kidney problems
• chills,
• swelling of the ankles, feet, or fingers (peripheral edema)

Rare (may affect up to 1 in 1,000 people):

• bleeding and/or perforation in the stomach, vomiting blood from the stomach or esophagus, blood in the stool, vomiting, inflammation of the mouth (stomatitis), worsening of inflammation, which causes stomach pain and diarrhea (acute colitis) worsening of Crohn's disease,
• hypersensitivity reactions to light, hair loss (alopecia), serious skin diseases with blistering of the skin, eyes, and genitals (blistering skin diseases, such as Stevens-Johnson syndrome and toxic epidermal necrolysis).

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

• blood changes (such as granulocytopenia, thrombocytopenia, aplastic anemia, hemolytic anemia),
• symptoms similar to meningitis
• rapid heartbeat (tachycardia), swelling, high blood pressure (hypertension), congestive heart failure,
• breathing difficulties (dyspnea), asthma,
• inflammation of the colon, inflammation of the mouth (stomatitis),
• yellowing of the skin and whites of the eyes due to liver or blood problems (jaundice), liver inflammation, changes in liver enzyme activity (abnormal liver function tests).

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

• gastritis (gastric inflammation).

Nalgesin Mini may slightly increase the risk of heart attack (myocardial infarction) or stroke.
You should stop taking Nalgesin Mini immediately and consult your doctor if you experience any of the following symptoms:

• severe and sudden low blood pressure,
• accelerated or slowed heart rate,
• unusual feeling of tiredness or weakness,
• restlessness, agitation, loss of consciousness,
• difficulty breathing or swallowing,
• skin reactions, such as itching, rash, facial and throat swelling, redness of the skin,
• extensive rash, high body temperature, increased 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 syndrome).
• a characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) after re-administration of the medicine and may appear as round or oval red patches and skin swelling, blisters (hives), itching,
• severe nausea, vomiting, stomach pain, diarrhea.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Mini

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.
Do not store above 25°C.
Store in the original packaging to protect from light.
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 pack and other information

What Nalgesin Mini contains

• The active substance of the medicine is naproxen sodium. Each tablet contains 220 mg of naproxen sodium, equivalent to 200 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, consisting of hypromellose, titanium dioxide (E 171), macrogol 8000, and indigo carmine (E 132), hypromellose 6cp, macrogol 8000, candurin silver lustre, consisting of titanium dioxide (E 171), aluminum-potassium silicate (E 555).

What Nalgesin Mini looks like and contents of the pack

Coated tablets; oval, slightly convex on both sides, light blue-gray with a metallic sheen: tablet thickness: 4.2 mm - 4.6 mm, tablet length: 13.5 mm - 13.8 mm.
Packaging: 10, 20, or 30 tablets in PVC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and 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
Detailed information on this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl