Nalgesin forte

Patient Information Leaflet

Nalgesin Forte, 550 mg, coated tablets
naproxenum natricum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• 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. It 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.

Contents:

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

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

Nalgesin Forte is a medicine that relieves pain, reduces inflammation and fever.
The medicine works by inhibiting the synthesis of prostaglandins.
Nalgesin Forte is used for symptomatic treatment of:

• Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile idiopathic arthritis
• Acute inflammatory conditions of the musculoskeletal system (e.g. dislocations and sprains, direct injuries, lumbosacral back pain, bursitis, tenosynovitis)
• Acute gout attack
• Menstrual pain (dysmenorrhoea)
• Acute postoperative pain and swelling (e.g. following surgical procedures, tooth extraction).

2. Important information before using Nalgesin Forte

When not to take Nalgesin Forte

• 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, or inflammation of the nasal mucosa (rhinitis) during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal anti-rheumatic drugs);
• if the patient has or has previously had a stomach or intestinal ulcer, or other gastrointestinal disorders;
• if the patient has experienced gastrointestinal bleeding or perforation during previous use of NSAIDs;
• if the patient has severe impairment of liver or kidney function;
• if the patient has heart failure;
• during the last three months of pregnancy.

Warnings and precautions
Contact a doctor or pharmacist before taking Nalgesin Forte.

• if the patient has or has previously had gastrointestinal bleeding, ulceration, or perforation, they should be carefully monitored by a physician; particular caution is required in cases of 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.
• if the patient has impaired liver or kidney function;
• if the patient has heart failure;
• if the patient has high blood pressure.

Nalgesin Forte may impair fertility. If the patient is planning to become pregnant or has difficulty becoming pregnant, she should inform her doctor.
Medicines such as Nalgesin Forte 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.
Like all medicines used in elderly people, naproxen sodium should be taken at the lowest effective dose.
Serious skin reactions have been reported with the use of Nalgesin Forte, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Treatment with Nalgesin Forte should be discontinued immediately and medical advice sought if any of the symptoms associated with these serious skin reactions, described in section 4, occur.

Other medicines and Nalgesin Forte
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take, including those available without a prescription.
Due to interactions with certain other medicines, the effect of Nalgesin Forte or those medicines may be increased or decreased. This may occur 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 in diabetes treatment (sulfonylurea derivatives),
• medicines used in epilepsy treatment (hydantoin derivatives),
• medicines used to treat high blood pressure,
• medicines that increase urine output (furosemide),
• medicines used in the treatment of psychiatric 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 in cancer therapy (methotrexate),
• medicines used in the treatment of AIDS (zidovudine),
• medicines used for joint pain and inflammation (corticosteroids).

Taking Nalgesin Forte with food and drink
Tablets should be swallowed with sufficient liquid, preferably during a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The use of Nalgesin Forte is not recommended 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, increase the risk of bleeding in both mother and child, and delay or prolong labour. Nalgesin Forte should not be taken 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, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Nalgesin Forte may cause kidney dysfunction 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 Forte.

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

Nalgesin Forte contains sodium
This medicine contains 50 mg of sodium (the main component of table salt) in each tablet. This corresponds to 2.5% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Nalgesin Forte

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
Tablets should be swallowed with water, preferably during a meal.

Adults and adolescents aged above 16 years
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.

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.

Dysmenorrhoea (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.

Juvenile idiopathic arthritis
In adolescents aged 16 years and older with body weight of 50 kg or more, the recommended daily dose
of naproxen sodium ranges from 550–825 mg, administered in two divided doses.

Children and adolescents under 16 years of age
Nalgesin Forte is not intended for use in children and adolescents under 16 years of age.

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

Patients with renal impairment
Nalgesin Forte should be used with caution in patients with impaired kidney function.
A reduced dose should be administered in such patients. Nalgesin Forte must not be taken
by patients with severe renal impairment (see: "When not to take Nalgesin Forte").

Patients with hepatic dysfunction
Nalgesin Forte should be used with caution in patients with impaired liver function.
A reduced dose should be administered in such patients. Nalgesin Forte must not be taken
by patients with severe hepatic impairment (see: "When not to take Nalgesin Forte").

If a patient feels that the effect of Nalgesin Forte is too strong or too weak, they should consult
a doctor or pharmacist.

Overdose of Nalgesin Forte
Overdose may cause abdominal pain, nausea, vomiting, dizziness, tinnitus, irritability, and in more severe cases,
hematemesis (vomiting blood), melena (black 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 Forte
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, it should be taken
as soon as the patient remembers.

Discontinuation of Nalgesin Forte
When naproxen sodium is used short-term for pain relief, the medicine can be safely discontinued
when no longer needed. In cases of long-term use, consult a doctor before stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
You should stop taking Nalgesin Forte immediately and consult a doctor if any of the following symptoms occur in the patient, 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 ulcers, fatigue and fever
• nosebleeds, skin hemorrhages
• unusual tiredness and reduced urine output
• swelling of the face, feet or legs
• chest pain
• disturbances of consciousness
• widespread rash, high body temperature, increased 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). 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.

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

• constipation, abdominal pain, nausea, dyspepsia, diarrhoea, inflammation of the oral mucosa,
• headache, dizziness, balance disorders, drowsiness,
• itching, skin rash, bleeding within the skin or mucous membranes (purpura), small red spots on the skin caused by minor bleeding into or under the skin (petechiae),
• tinnitus, hearing disturbances,
• visual disturbances,
• oedema, rapid heartbeat or palpitations,
• thirst, sweating,
• breathing difficulties (dyspnoea).

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

• bleeding and (or) perforation in the stomach, vomiting blood from the stomach or oesophagus, blood in the stool, vomiting,
• changes in liver enzyme activity, jaundice,
• depression, sleep disorders, difficulty concentrating, insomnia, malaise,
• muscle pain and weakness,
• hair loss (alopecia), photoallergic dermatitis,
• hearing disturbances,
• congestive heart failure (medicines such as Nalgesin Forte may slightly increase the risk of heart attack (myocardial infarction) or stroke),
• hypersensitivity reactions,
• fever and chills,
• menstrual disorders,
• kidney function disorders (glomerulonephritis, haematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis),
• blood morphology changes (eosinophilia, granulocytopenia, leukopenia, thrombocytopenia),
• eosinophilic pneumonia.

Adverse reactions for which a causal relationship to sodium naproxen use is unknown:

• blood morphology changes (aplastic anaemia, haemolytic anaemia),
• inflammation of the membranes surrounding the central nervous system (aseptic meningitis), cognitive or psychiatric disorders,
• skin hypersensitivity reactions (epidermal necrolysis, erythema multiforme, photosensitivity reactions resembling late cutaneous porphyria and bullous detachment of the epidermis, Stevens-Johnson syndrome, urticaria),
• inflammation of the oral mucosa (ulcerative stomatitis),
• vasculitis,
• hypersensitivity reactions (angioedema), high blood sugar levels (hyperglycaemia), low blood sugar levels (hypoglycaemia).

If any of the adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nalgesin Forte

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicinal product.
Medicines must 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 Forte contains

• The active substance is naproxen sodium. Each tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• Other ingredients are: in the tablet core: povidone K 30, microcrystalline cellulose, talc, magnesium stearate; in the tablet coating Opadry 02F205004 blue, E 132** : hypromellose, titanium dioxide (E 171), polyethylene glycol 8000, and indigo carmine (E 132).

What Nalgesin Forte looks like and contents of the pack
Film-coated tablets, oval-shaped, slightly biconvex, blue, with a division groove on one side.
The tablet can be divided into equal doses.
Pack sizes: 10, 20, 30, 40, 50 or 60 tablets in PVC/Aluminium blisters, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
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:

For more detailed information about the medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500