Nalgesin mini

Package leaflet: Information for the user

Nalgesin Mini, 220 mg, coated tablets
naproxenum natricum
Provides fast pain relief.
Please read the entire leaflet carefully as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as prescribed by the
physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents:

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

Nalgesin Mini is a pain-relieving and anti-inflammatory medicine.
It works by inhibiting the synthesis of prostaglandins. The analgesic effect occurs rapidly and lasts up to 12 hours.
Nalgesin Mini is indicated for the short-term treatment of mild to moderate pain, such as: headache, toothache, painful menstruation, joint pain, and muscle pain.
If there is no improvement after 3 days or if your condition worsens, the patient must consult a doctor.

2. Important information before using Nalgesin Mini

When not to take Nalgesin Mini

• if the patient is allergic to naproxen sodium or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced breathing difficulties (bronchial asthma), urticaria, nasal mucosa inflammation, nasal polyps, or severe allergic reactions causing breathing difficulties or dizziness after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has or has had a stomach or intestinal ulcer or bleeding;
• if the patient has experienced gastrointestinal bleeding or perforation after using NSAIDs;
• if the patient has severe liver or kidney function disorders;
• if the patient has severe heart failure;
• during the last three months of pregnancy;
• if the patient has cerebral hemorrhage or any other active bleeding.
• Do not administer to children under 2 years of age.

Warnings and precautions
General
The frequency of adverse effects depends on the dose and duration of treatment. Therefore, always use the lowest effective dose of Nalgesin Mini for the shortest period necessary to relieve pain.
Avoid using naproxen sodium simultaneously with other NSAIDs (including selective COX-2 inhibitors).
Liver and kidney function should be monitored during prolonged use of naproxen sodium, especially in patients with liver or kidney dysfunction, heart disease, those taking diuretics, and in patients over 65 years of age.
Before starting Nalgesin Mini, consult a doctor or pharmacist.

• in patients over 65 years of age, due to increased risk of serious adverse effects, particularly involving the stomach, which may be fatal;
• if the patient has or has had gastrointestinal bleeding, ulcers, or perforation, careful medical monitoring is required. Serious gastrointestinal adverse effects may occur without prior symptoms, such as intestinal bleeding and perforation (a hole in the intestinal wall), which may be fatal;
• in patients with a history of gastrointestinal disorders, such as ulcerative colitis or Crohn's disease, as symptoms may recur or worsen;
• in patients with blood clotting disorders or those taking anticoagulant medications;
• if the patient has or has had liver or kidney function disorders;
• if the patient has or has had heart problems;
• if the patient has or has had high blood pressure;
• if the woman is trying to conceive or has difficulty conceiving;
• in patients who have experienced or are experiencing any allergic reactions, asthma, chronic respiratory diseases, or nasal polyps.

Effect on the gastrointestinal tract
Bleeding, ulceration, or perforation of the gastrointestinal tract, potentially fatal, have been reported with all NSAIDs, at any time during treatment, with or without preceding warning symptoms.
The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of ulcers, and in elderly patients. Treatment should be initiated with the lowest available dose.
Patients with a history of gastrointestinal toxicity, especially elderly individuals, should report any concerning abdominal symptoms (particularly gastrointestinal bleeding) to their doctor.
Concomitant use of drugs used to treat pain and joint inflammation (corticosteroids), anticoagulants (warfarin), selective serotonin reuptake inhibitors, or antiplatelet drugs such as aspirin (see section 4.5) may increase the risk of gastrointestinal ulceration or bleeding.

Effect on the cardiovascular and cerebrovascular system
Medicines such as Nalgesin Mini may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is greater when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.
Patients with heart disease, those who have had a stroke, or those who believe they are at increased risk for these conditions (e.g., individuals with high blood pressure, diabetes, elevated cholesterol levels, or smokers) should discuss treatment options with their doctor or pharmacist.

Skin reactions
Serious skin reactions, including fatal ones, have been very rarely reported and primarily occurred during the initial phase of treatment with NSAIDs. If the patient notices any rash, itching, mucosal changes, or other signs of allergy/hypersensitivity, they should immediately stop taking the medicine and consult a doctor.

Hypersensitivity reactions
Severe allergic reactions have been very rarely observed. Individuals with facial or throat swelling, known allergies, asthma, chronic nasal mucosa inflammation, or chronic respiratory disease are more susceptible to serious hypersensitivity reactions. If the first signs of a serious allergic reaction occur, discontinue the medicine immediately.

Precautions related to fertility
This medicine belongs to a group of drugs (NSAIDs) that may adversely affect fertility in women. This effect reverses upon discontinuation of the drug.

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

Other medicines and Nalgesin Mini
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Due to interactions with certain other medicines, the effect of Nalgesin Mini or the effect of those medicines may be enhanced or weakened. This occurs with:

• other painkillers (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 in diabetes therapy (sulfonylurea derivatives);
• medicines used in epilepsy treatment (hydantoin derivatives);
• medicines used to treat high blood pressure;
• diuretics (furosemide);
• medicines used in psychiatric disorders (lithium);
• medicines that increase uric acid excretion and prevent gout attacks (probenecid);
• immunosuppressive medicines (cyclosporine);
• medicines used in cancer therapy (methotrexate);
• medicines used in AIDS treatment (zidovudine);
• medicines used to treat pain and joint inflammation (corticosteroids).

Nalgesin Mini with food, drink, and alcohol
Tablets should be swallowed with sufficient liquid, preferably during a meal.
Do not consume alcohol while taking naproxen sodium, as alcohol may increase the risk of gastrointestinal bleeding associated with NSAIDs.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Nalgesin Mini is not recommended during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child, increase the risk of bleeding in both mother and child, and delay or prolong labor. Do not take Nalgesin Mini during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor.
If treatment is necessary during this period or when trying to conceive, use the lowest dose for the shortest possible time. From the 20th week of pregnancy, Nalgesin Mini may cause kidney function disturbances in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios).
If treatment is required for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding is not recommended while taking Nalgesin Mini.

Driving and operating machinery
Nalgesin Mini has no effect or has a negligible effect on the ability to drive or operate machinery. Dizziness, drowsiness, fatigue, and visual disturbances are possible adverse effects after using NSAIDs. If such symptoms occur, do not drive or operate machinery.

Nalgesin Mini contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet and can therefore be considered "essentially sodium-free."

3. How to use Nalgesin Mini

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
contact your doctor or pharmacist.
The recommended dose for adults and adolescents over 16 years of age weighing more than 50 kg is
1 tablet every 8–12 hours.
Alternatively, two tablets may be taken at once, followed by one additional tablet if needed after 8–
12 hours.
Tablets should be swallowed with sufficient fluid, during or after a meal.
For patients with gastric sensitivity, it is beneficial to take the medicine during a meal. Tablets must
not be chewed.
The maximum daily dose is 3 tablets (corresponding to 660 mg of sodium naproxen).
Do not use Nalgesin Mini for longer than 7 days. If pain persists after 3 days of treatment, or if
symptoms worsen, consult your doctor.
Use in children and adolescents
The dosage for children over 16 years of age weighing more than 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.
It is recommended to use the lowest effective dose.
Patients with renal impairment
The maximum recommended daily dose of Nalgesin Mini is 2 tablets, divided into two doses.
It is recommended to use the lowest effective dose.
Nalgesin Mini must not be taken by patients with severe renal impairment (see: "When not to take Nalgesin Mini").
Patients with hepatic dysfunction
The maximum recommended daily dose of Nalgesin Mini is 2 tablets, divided into two doses.
It is recommended to use the lowest effective dose.
Nalgesin Mini must not be taken by patients with severe hepatic impairment (see:
"When not to take Nalgesin Mini").
Use of a higher than recommended dose of Nalgesin Mini
Overdose may cause abdominal pain, nausea, vomiting, dizziness, tinnitus, irritability, and in more severe cases, bloody vomiting, tarry stools, disturbances of consciousness, breathing problems, seizures, and renal failure.
If the patient feels that the effect of Nalgesin Mini is too strong or too weak, consult your doctor or pharmacist.
Missed dose of Nalgesin Mini
Do not take a double dose to make up for a missed dose.
Discontinuation of Nalgesin Mini
When sodium naproxen is used short-term to relieve pain, it is safe to discontinue the medicine if it is no longer needed.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common (may occur in up to 1 in 10 patients):

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

Uncommon (may occur in up to 1 in 100 patients):

• hypersensitivity reactions (including facial swelling (angioedema), swelling of the face and throat (angioedema)),
• sleep disturbances, restlessness,
• ringing in the ears (tinnitus), hearing disturbances,
• visual disturbances,
• bruising,
• diarrhoea, constipation,
• skin rash, itching,
• kidney function disorders,
• chills,
• swelling of ankles, feet or fingers (peripheral oedema)

Rare (may occur in up to 1 in 1,000 patients):

• bleeding and/or perforation in the stomach, vomiting blood originating from the stomach or oesophagus, blood in stool, vomiting, inflammation of the oral mucosa (ulcerative stomatitis), worsening of inflammatory condition causing abdominal pain and diarrhoea (acute colitis), exacerbation of Crohn's disease,
• photosensitivity reactions, hair loss (alopecia), serious skin disorders with blistering detachment of the skin at the lips, eyes and genital organs (bullous skin eruptions such as Stevens-Johnson syndrome and toxic epidermal necrolysis).

Very rare (may occur in up to 1 in 10,000 patients):

• blood morphology changes such as granulocytopenia, thrombocytopenia, aplastic anaemia, haemolytic anaemia,
• symptoms resembling meningitis,
• rapid heartbeat (tachycardia), oedema, elevated blood pressure (hypertension), congestive heart failure,
• breathing difficulties (dyspnoea), asthma,
• inflammation of the large intestine, inflammation of the oral mucosa (stomatitis),
• yellowing of the skin and whites of the eyes due to liver or blood problems (jaundice), hepatitis, changes in liver enzyme activity (abnormal liver function test results).

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

• inflammation of the stomach (gastritis).

Nalgesin Mini may slightly increase the risk of heart attack (myocardial infarction) or stroke.

Treatment with Nalgesin Mini should be stopped immediately and medical advice sought if any of the following symptoms occur:

• severe and sudden hypotension,
• increased or slowed heart rate,
• unusual feeling of tiredness or weakness,
• restlessness, agitation, loss of consciousness,
• breathing or swallowing difficulties,
• skin reactions such as itching, rash, facial and throat swelling, skin redness,
• widespread rash, high body temperature, elevated liver enzyme activity, blood disorders (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome),
• a characteristic allergic skin reaction called fixed drug eruption, which typically recurs in the same location(s) upon re-administration of the drug and may present as round or oval red patches and skin swelling, blisters (urticaria), itching,
• severe nausea, vomiting, abdominal pain, diarrhoea.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Nalgesin Mini

Keep the medicine out of the 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 stated month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nalgesin Mini contains

• The active substance is naproxen sodium. Each tablet contains 220 mg of naproxen sodium, equivalent to 200 mg of naproxen.
• The other ingredients are: in the tablet core: povidone K 30, microcrystalline cellulose, talc, magnesium stearate; in the tablet coating: Opadry YS-1R-4215, E 132, containing hypromellose, titanium dioxide (E 171), polyethylene glycol 8000, and indigo carmine (E 132), hypromellose 6cp, polyethylene glycol 8000, Candurin Silver Lustre containing titanium dioxide (E 171), potassium aluminium silicate (E 555).

What Nalgesin Mini looks like and contents of the pack
Film-coated tablets; oval, slightly biconvex, light grey-blue 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/Aluminium blisters, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the European Economic Area countries under the following names:

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl