Nalgesin Forte

Leaflet attached to the packaging: information for the user

Nalgesin Forte, 550 mg, coated tablets

naproxen sodium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents:

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

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

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

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

2. Important information before using Nalgesin Forte

When not to use Nalgesin Forte

• 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 (bronchial asthma), hives, or nasal inflammation (rhinitis) when using acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal 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 using NSAIDs;
• if you have severe liver or kidney dysfunction;
• if you have heart failure;
• during the last three months of pregnancy.

Warnings and precautions

You should consult your doctor or pharmacist before using Nalgesin Forte.

• if you have or have had bleeding, ulcers, or perforation of the gastrointestinal tract, you should be carefully monitored by your doctor; special caution is required in the case 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 Forte may make it more 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 Forte 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 reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Nalgesin Forte. You should stop using Nalgesin Forte and consult your doctor immediately if you experience any symptoms associated with these severe skin reactions, as described in section 4.

Other medicines and Nalgesin Forte

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
As a result of interactions with some other medicines, the effect of Nalgesin Forte or the effect of these medicines may be enhanced or weakened. 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 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).

Using Nalgesin Forte with food and drink

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

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 using this medicine.
Nalgesin Forte 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 bleed in the mother and child, and delay or prolong delivery. You should not take Nalgesin Forte during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor.
If treatment is necessary during this period or when trying to become pregnant, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Nalgesin Forte may cause kidney dysfunction 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 child (oligohydramnios).
If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
You should not breastfeed while using Nalgesin Forte.

Driving and using machines

Nalgesin Forte 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 machines.

Nalgesin Forte contains sodium

The medicine contains 50 mg of sodium (the main component of common salt) in each tablet. This corresponds to 2.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Nalgesin Forte

This medicine should always be used according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult your doctor or pharmacist.
Tablets should be swallowed with water, preferably during a meal.
Adults and adolescents over 16 years old
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.
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 over 16 years old 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 old
Nalgesin Forte is not intended for use in children and adolescents under 16 years old.
Elderly patients
The smallest effective dose of Nalgesin Forte should be used.
Patients with renal impairment
Nalgesin Forte should be used with caution in patients with renal impairment.
Such patients should receive a reduced dose. Do not take Nalgesin Forte if you have severe renal impairment (see "When not to use Nalgesin Forte").
Patients with liver dysfunction
Nalgesin Forte should be used with caution in patients with liver dysfunction.
Such patients should receive a reduced dose. Do not take Nalgesin Forte if you have severe liver dysfunction (see "When not to use Nalgesin Forte").
If you feel that the effect of Nalgesin Forte is too strong or too weak, you should talk to your doctor or pharmacist.

Using a higher than recommended dose of Nalgesin Forte

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.
In case of overdose, your doctor will take appropriate action.

Missing a 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 every day. If you miss a dose, take it as soon as you remember.

Stopping the use of Nalgesin Forte

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Nalgesin Forte 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 resembling coffee grounds
• black stools or blood in the urine
• skin reactions, such as itchy rash
• breathing difficulties and (or) swelling of the face or throat
• fatigue with loss of appetite
• sore throat with oral 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 reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• 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 take the form of round or oval red patches and skin swelling, blisters (hives), itching.

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

• constipation, stomach pain, nausea, indigestion, diarrhea, oral inflammation,
• headache, dizziness, balance disturbances, 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).

Less frequently(may occur in up to 1 in 100 patients):

• bleeding and (or) perforation in the stomach, vomiting with blood from the stomach or esophagus, blood in the stool, vomiting,
• changes in liver enzyme activity, jaundice,
• depression, sleep disturbances, inability to concentrate, insomnia, malaise,
• muscle pain and weakness,
• hair loss (alopecia), photoallergic skin inflammation,
• hearing disturbances,
• congestive heart failure (medicines like Nalgesin Forte may slightly increase the risk of heart attack (myocardial infarction) or stroke,
• allergic reactions,
• fever and chills,
• menstrual disorders,
• kidney dysfunction (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:

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

If any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 Forte

Keep 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 the month.
There are no special storage conditions for the medicinal product.
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 packaging and other information

What Nalgesin Forte contains

• The active substance of the medicine is naproxen sodium. Each tablet contains 550 mg of naproxen sodium, which corresponds to 500 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 02F205004 blue, E 132**: hypromellose, titanium dioxide (E 171), macrogol 8000, and indigo carmine (E 132).

What Nalgesin Forte looks like and what the packaging contains

Coated tablets, oval, slightly convex on both sides, blue, with a dividing line on one side.
The tablet can be divided into equal doses.
Packaging: 10, 20, 30, 40, 50, or 60 tablets in PVC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

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:

In order to obtain more detailed information on the medicine, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of the last revision of the leaflet: