Nalgesin pro

Package leaflet: Information for the user

Nalgesin PRO, 550 mg, coated tablets
Naproxenum natricum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Nalgesin PRO is a medicine that reduces pain, inflammation, and fever.
The medicine works by inhibiting the synthesis of prostaglandins. Nalgesin PRO contains the active substance naproxen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Nalgesin PRO is used for symptomatic treatment of:

• Rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis;
• Acute inflammatory conditions such as bursitis, tendinitis, and fasciitis;
• Acute musculoskeletal disorders (e.g. dislocations and sprains, direct injuries, lumbosacral pain);
• Acute attacks of gout;
• Dysmenorrhoea (painful menstruation);
• Acute postoperative pain and swelling (e.g. after surgical procedures, tooth extraction);
• Common cold (as an adjunctive therapy to relieve pain and reduce inflammation and fever);
• Mild to moderate acute or chronic pain such as muscle, bone, joint and spinal pain, neuralgia, toothache, headache, including migraine;
• Fever of various origins.

2. Important information before using Nalgesin PRO

When not to take Nalgesin PRO

• if the patient is allergic to sodium naproxen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced breathing difficulties (bronchial asthma), nasal polyps, swelling of the face, lips, eyes or tongue (angioedema), urticaria, or inflammation of the nasal mucosa (rhinitis) while taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has or has had stomach or intestinal ulcers, or other gastrointestinal disorders;
• if the patient has experienced gastrointestinal bleeding or perforation during previous NSAID treatment;
• if the patient has severe liver or kidney impairment;
• if the patient has severe heart failure;
• if the patient has bleeding (hemorrhagic diathesis);
• during the last three months of pregnancy.

Nalgesin PRO must not be given to children and adolescents under 16 years of age.
Warnings and precautions
Before starting treatment with Nalgesin PRO, consult your doctor or pharmacist if:

• the patient experiences hypersensitivity reactions;
• the patient has asthma;
• the patient has or has had gastrointestinal bleeding, ulceration or perforation; such patients should be closely monitored by a physician; particular caution is required in patients with ulcerative colitis or Crohn's disease, as symptoms may recur or worsen. Serious gastrointestinal adverse effects may occur without prior symptoms; intestinal bleeding and perforation (a hole in the intestinal wall) are possible;
• the patient is taking medications that may increase the risk of ulcers or bleeding, such as corticosteroids, anticoagulants (e.g. warfarin), certain antidepressants (selective serotonin reuptake inhibitors - SSRIs), or acetylsalicylic acid;
• the patient has blood clotting disorders;
• the patient has autoimmune diseases such as systemic lupus erythematosus (which causes joint pain, skin rash and fever);
• the patient has impaired liver, kidney or heart function;
• the patient has high blood pressure.

Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been reported with the use of Nalgesin PRO. Treatment with Nalgesin PRO should be discontinued immediately and medical advice sought if any symptoms related to these serious skin reactions occur, as described in section 4.
Nalgesin PRO may impair fertility. If a woman is planning pregnancy or has difficulty conceiving, she should inform her doctor.
Prolonged use of any painkillers for headache treatment may lead to worsening headaches. If the patient has or suspects such a condition, medical advice should be sought.
Medicines such as Nalgesin PRO may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is higher when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.
If the patient has heart problems, a history of stroke, or risk factors for these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), treatment should be discussed with a doctor or pharmacist.
Like all medicines used in elderly patients, sodium naproxen should be administered at the lowest effective dose.
Patients with a history of gastrointestinal adverse effects, especially elderly patients, should report any concerning abdominal symptoms (including gastrointestinal bleeding) to their doctor.
Patients who experience any visual disturbances during treatment with naproxen should seek medical advice.
Nalgesin PRO, like other NSAIDs, due to its anti-inflammatory and antipyretic effects, may mask symptoms of another illness, thereby delaying diagnosis.
Concomitant use of sodium naproxen with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
Nalgesin PRO and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription.
The effect of Nalgesin PRO or other medicines may be increased or decreased due to interactions with certain drugs, such as:

• other painkillers (acetylsalicylic acid and other NSAIDs);
• drugs that neutralize gastric acid and cholestyramine;
• drugs used to prevent blood clots (warfarin, acenocoumarol, heparin);
• aspirin (acetylsalicylic acid) used to prevent blood clots;
• drugs used in diabetes treatment (sulfonylureas);
• drugs used to treat epilepsy (hydantoin derivatives);
• drugs used to treat high blood pressure;
• drugs that increase urine output (furosemide);
• drugs used to treat heart conditions (cardiac glycosides, e.g. digoxin);
• quinolone antibiotics used to treat infections (ciprofloxacin, moxifloxacin);
• mifepristone;
• drugs used to treat psychiatric disorders (lithium, SSRIs, e.g. fluoxetine, citalopram);
• drugs that increase uric acid excretion and prevent gout attacks (probenecid);
• drugs used for weight loss in combination with diet and exercise (sibutramine);
• drugs that suppress the immune system (cyclosporine, tacrolimus);
• drugs used in cancer treatment (methotrexate);
• drugs used to treat muscle pain, spasms and stiffness (baclofen);
• drugs used in the treatment of AIDS (zidovudine);
• drugs used to treat joint pain and inflammation (corticosteroids).

Taking Nalgesin PRO with food and drink
Tablets should be swallowed with sufficient liquid, preferably during a meal.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Nalgesin PRO must not be used during the last three 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 tendency to bleeding in both the mother and the child and may delay or prolong labor.
During the first six months of pregnancy, this medicine should not be used unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Long-term use of Nalgesin PRO beyond a few days after week 20 of pregnancy may cause impaired kidney function in the unborn child, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, additional monitoring may be recommended by the doctor.
Do not take this medicine during the third trimester of pregnancy.
Naproxen passes into breast milk. Breastfeeding is not recommended during treatment with Nalgesin PRO.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Driving and operating machinery
Dizziness, drowsiness, fatigue and visual disturbances are possible adverse effects after taking this medicine. If such symptoms occur, driving and operating machinery should be avoided.
Nalgesin PRO contains sodium
This medicine contains 50 mg of sodium (the main component of table salt) per tablet. This corresponds to 2.5% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Nalgesin PRO

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Tablets should be swallowed with water, preferably during a meal. The tablet may be divided into
two equal doses.

Adults
Acute musculoskeletal disorders and other mild to moderate pain of various origins
The recommended initial dose of naproxen sodium is 550 mg, followed by 550 mg every 12
hours or 275 mg every 6–8 hours.

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
The recommended daily dose of naproxen sodium ranges from 550–1100 mg, administered
in two divided doses. The maintenance dose of naproxen sodium may be increased or decreased
depending on the patient's response to treatment. A single dose exceeding 1100 mg should not be used.

Fever of various origins, common cold
The recommended initial dose of naproxen sodium is 550 mg, followed by 275 mg every 6–8 hours, if needed.

Acute gouty arthritis attack
The recommended initial dose of naproxen sodium is 825 mg, followed by 275 mg every 8 hours.

Dysmenorrhea (menstrual pain)
The recommended initial dose of naproxen sodium is 550 mg, followed, if necessary, by 550 mg every 12 hours or 275 mg every 6–8 hours.

Acute 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.

Migraine headaches
For migraine treatment, the recommended dose is 825 mg of naproxen sodium at the first signs of an impending attack, followed, if necessary, by an additional dose of 275 mg to 550 mg after 30 minutes.

Use in children and adolescents under 16 years of age
Nalgesin PRO is contraindicated in children and adolescents under 16 years of age.

Elderly patients
The lowest effective dose of Nalgesin PRO should be used.

Patients with renal impairment
Nalgesin PRO should be used with caution in patients with impaired renal function. A reduced dose should be administered in such patients. Nalgesin PRO must not be used in patients with severe renal impairment (see: When not to use Nalgesin PRO).

Patients with hepatic impairment
Nalgesin PRO should be used with caution in patients with impaired liver function. A reduced dose should be administered in such patients. Nalgesin PRO must not be used in patients with severe hepatic impairment (see: When not to use Nalgesin PRO).

If the patient feels that the effect of Nalgesin PRO is too strong or too weak, consult a physician or pharmacist.

Use of a higher than recommended dose of Nalgesin PRO
Overdose may result in abdominal pain, nausea, vomiting, dizziness, tinnitus, irritability, and in more severe cases, bloody vomiting, tarry stools, disturbances of consciousness, respiratory disorders, seizures, and renal failure.
In case of overdose, the physician will take appropriate measures.

Missed dose of Nalgesin PRO
Do not take a double dose to make up for a missed tablet.
The medicine should be taken at the same time each day. If a dose is missed at the scheduled time, it should be taken as soon as remembered.

Discontinuation of Nalgesin PRO
When naproxen sodium is used short-term for pain relief, it is safe to discontinue the medicine when no longer needed. In cases of long-term use, consult a physician before stopping treatment.

If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with Nalgesin PRO should be stopped immediately and a doctor consulted if the patient experiences any of the following symptoms, as they may be signs of serious adverse reactions:

• severe gastrointestinal disturbances, heartburn or abdominal pain;
• vomiting blood or material resembling coffee grounds;
• black stools or blood in the urine;
• skin reactions such as itchy rash;
• difficulty breathing and (or) swelling of the face or throat;
• fatigue with loss of appetite;
• sore throat with oral ulceration, fatigue and fever;
• nosebleeds, skin hemorrhages;
• unusual tiredness and reduced urine output;
• swelling of the face, feet or hands;
• chest pain;
• disturbances of consciousness.
• 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). See also section 2.
• characteristic allergic skin reaction called fixed drug eruption, which usually recurs in the same location(s) upon re-administration of the drug and may present as round or oval red patches and swelling of the skin, blisters (urticaria), itching;

Adverse effects are most commonly associated with high doses.
Common (may occur in up to 1 in 10 patients):

• constipation, abdominal pain, nausea, indigestion, diarrhea, oral mucosal inflammation, bloating;
• headache, dizziness, balance disorders, drowsiness, paresthesia;
• itching, skin rash, bleeding within the skin or mucous membranes (petechiae), small red spots on the skin caused by minor bleeding within or under the skin (purpura), urticaria, excessive sweating;
• tinnitus, hearing disturbances;
• visual disturbances;
• edema, rapid heartbeat or palpitations;
• thirst, sweating, fatigue, peripheral edema;
• breathing difficulties (dyspnea), bronchial asthma.

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

• bleeding and (or) perforation in the stomach, gastric ulcers, vomiting blood from the stomach or esophagus, blood in the stool, vomiting;
• changes in liver enzyme activity, jaundice, hepatitis leading to death;
• sleep disorders, inability to concentrate;
• muscle pain and weakness;
• hair loss (alopecia), photoallergic dermatitis;
• hearing disturbances;
• insomnia, depression, confusion, hallucinations;
• heart failure, congestive heart failure (medicines such as Nalgesin PRO may slightly increase the risk of heart attack (myocardial infarction) or stroke);
• fever and chills;
• kidney function disorders (glomerulonephritis, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis);
• blood morphology changes (eosinophilia, granulocytopenia, leukopenia, thrombocytopenia, neutropenia);
• eosinophilic pneumonia, pulmonary edema.

Rare (may occur in up to 1 in 1000 patients):

• agranulocytosis;
• oral mucosal inflammation (ulcerative stomatitis), recurrence or exacerbation of ulcerative colitis or Crohn's disease (see section 4.4), esophagitis, gastritis, pancreatitis;
• cognitive function disorders;
• angioedema;
• malaise, weakness.

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

• seizures;
• corneal opacity, optic disc edema, optic neuritis, retrobulbar optic neuritis;
• hypertension;
• fertility disorders in women, menstrual disorders;
• increased creatinine concentration, abnormal liver function test results, prolonged bleeding time, hyperkalemia;
• photosensitivity, hypersensitivity reactions (anaphylactic and anaphylactoid reactions, including fatal anaphylactic shock).

Adverse effects for which a causal relationship with sodium naproxen use is unknown:

• blood morphology changes (aplastic anemia, hemolytic anemia);
• inflammation of the membranes surrounding the central nervous system (aseptic meningitis);
• skin hypersensitivity reactions (toxic epidermal necrolysis, erythema multiforme, photosensitivity reactions resembling late cutaneous porphyria and bullous detachment of the epidermis, Stevens-Johnson syndrome, nodular erythema, lichen planus, pustular reactions, systemic lupus erythematosus);
• vasculitis;
• high blood sugar (hyperglycemia), low blood sugar (hypoglycemia).

If any of the adverse symptoms worsen or if any adverse effects not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not mentioned in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nalgesin PRO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the specified month.
The batch number is indicated on the packaging after the abbreviation "Lot".
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 practices help
protect the environment.

6. Contents of the package and other information

What Nalgesin PRO contains

• The active substance is naproxen sodium. Each coated tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• Other ingredients: povidone K 30, microcrystalline cellulose, talc, magnesium stearate; coating composition Opadry 02F205004 blue: hypromellose, titanium dioxide (E 171), polyethylene glycol 8000, and indigo carmine (E 132). See section 2 "Nalgesin PRO contains sodium".

What Nalgesin PRO looks like and contents of the pack
Blue, oval, slightly biconvex coated tablets with a division line on one side.
The tablet can be divided into equal doses.
Pack sizes: 10, 20, 30, 40, 50 or 60 coated tablets in PVC/Aluminium blisters,
in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: + 48 22 573 75 00