Nalgesin Pro

Leaflet attached to the packaging: information for the user

Nalgesin PRO, 550 mg, coated tablets

Naproxen sodium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

Nalgesin PRO is a pain-relieving, anti-inflammatory, and antipyretic medicine.
The medicine works by inhibiting prostaglandin synthesis. Nalgesin PRO contains the active substance naproxen,
which belongs to nonsteroidal 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, tendonitis, and synovitis;
• acute musculoskeletal disorders (e.g., sprains and strains, direct injuries, lower back pain);
• acute gout attack;
• menstrual pain (dysmenorrhea);
• postoperative pain and swelling (e.g., after surgery, after tooth extraction);
• common cold (as an adjunct to therapy to alleviate pain and reduce inflammation and fever);
• mild to moderate pain, acute or chronic, such as muscle, bone, joint, and back pain, neuralgia, toothache, headache, including migraine;
• fever of various origins.

2. Important information before taking Nalgesin PRO

When not to take Nalgesin PRO

• 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), nasal polyps, facial, lip, tongue, or throat swelling (angioedema), hives, or nasal congestion (rhinitis) when taking acetylsalicylic acid and other nonsteroidal anti-inflammatory 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 taking NSAIDs;
• if you have severe liver or kidney failure;
• if you have severe heart failure;
• if you have bleeding disorders (hemorrhagic diathesis);
• during the last three months of pregnancy.

Nalgesin PRO should not be given to children and adolescents under 16 years of age.

Warnings and precautions

Before taking Nalgesin PRO, discuss it with your doctor or pharmacist:

• if you have hypersensitivity reactions;
• if you have asthma;
• 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 cases 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 are taking medicines that may increase the risk of ulcers or bleeding, such as corticosteroids, anticoagulants (e.g., warfarin), or certain antidepressants (selective serotonin reuptake inhibitors);
• if you have blood clotting disorders;
• if you have autoimmune diseases, such as systemic lupus erythematosus (which causes joint pain, skin rashes, and fever);
• if you have liver, kidney, or heart function disorders;
• if you have high blood pressure.

With the use of Nalgesin PRO, severe skin reactions have been reported, including (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS)). You should stop taking Nalgesin PRO and consult your doctor immediately if you experience any symptoms related to these severe skin reactions, described in section 4.
Nalgesin PRO may make it harder to get pregnant. If you are planning to get pregnant or have problems getting pregnant, you should tell your doctor.
Long-term use of any painkillers for headache treatment may lead to worsening of the headache. If you experience or suspect this, you should consult your doctor.
Medicines like Nalgesin PRO may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is higher when taking high doses or for long-term treatment. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, have had a stroke, or suspect that you are at risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss your treatment with your doctor or pharmacist.
As with all medicines used in the elderly, naproxen sodium should be taken at the lowest effective dose.
Patients who have had gastrointestinal side effects in the past, especially the elderly, should report any worrying abdominal symptoms (including gastrointestinal bleeding) to their doctor.
Patients who experience vision disturbances during naproxen treatment should consult their doctor.
Nalgesin PRO, like other NSAIDs, due to its anti-inflammatory and antipyretic effects, may mask the symptoms of another disease, making its diagnosis more difficult.
Avoid concurrent use of naproxen sodium with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

Nalgesin PRO and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, 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 PRO or the effect of these medicines may be increased or decreased. This is the case with:

• other painkillers (acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs);
• antacids and cholestyramine;
• medicines used to prevent blood clots (warfarin, acenocoumarol, heparin);
• aspirin (acetylsalicylic acid) to prevent blood clots;
• medicines used to treat diabetes (sulfonylureas);
• medicines used to treat epilepsy (hydantoin derivatives);
• medicines used to treat high blood pressure;
• medicines that increase urine production (furosemide);
• medicines used to treat heart conditions (digitalis glycosides, e.g., digoxin);
• quinolone antibiotics used to treat infections (ciprofloxacin, moxifloxacin);
• mifepristone;
• medicines used to treat mental disorders (lithium, SSRIs, e.g., fluoxetine, citalopram);
• medicines that increase uric acid excretion from the body and prevent gout attacks (probenecid);
• medicines used to treat obesity, in combination with diet and exercise (sibutramine);
• medicines that suppress the immune system (cyclosporine, tacrolimus);
• medicines used to treat cancer (methotrexate);
• medicines used to treat muscle pain, spasms, and stiffness (baclofen);
• medicines used to treat AIDS (zidovudine);
• medicines used to treat joint pain and inflammation (corticosteroids).

Taking Nalgesin PRO with food and drink

Swallow the tablets with a sufficient amount of liquid, preferably during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nalgesin PRO should not be used if you are in 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 also increase the risk of bleeding in you and your child and cause prolongation or delay of labor. During the first six months of pregnancy, do not take the medicine unless it is absolutely necessary and prescribed by your doctor. If treatment is necessary during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. If treatment is necessary for more than a few days, your doctor may recommend additional monitoring.
Nalgesin PRO should not be taken during the last trimester of pregnancy.
Naproxen passes into breast milk. Breastfeeding is not recommended while taking Nalgesin PRO.
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after treatment is stopped.

Driving and using machines

Dizziness, drowsiness, fatigue, and vision disturbances are possible side effects after taking Nalgesin PRO. If you experience these symptoms, do not drive or operate machinery.

Nalgesin PRO contains sodium

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

3. How to take Nalgesin PRO

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets with water, preferably during meals. The tablet can be divided into two equal doses.
Adults
Acute musculoskeletal disorders and other pains of various origins from mild to moderate
severity
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
of the spine
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.
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 necessary.

• 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.
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 headache
For migraine treatment, the recommended dose is 825 mg of naproxen sodium at the first signs of an impending attack, followed by an additional dose of 275-550 mg after 30 minutes if necessary.
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
Use the lowest effective dose of Nalgesin PRO.
Patients with renal impairment
Nalgesin PRO should be used with caution in patients with renal impairment. A reduced dose should be given to such patients. Do not take Nalgesin PRO if you have severe renal failure (see "When not to take Nalgesin PRO").
Patients with hepatic impairment
Nalgesin PRO should be used with caution in patients with hepatic impairment. A reduced dose should be given to such patients. Do not take Nalgesin PRO if you have severe hepatic failure (see "When not to take Nalgesin PRO").
If you feel that the effect of Nalgesin PRO is too strong or too weak, talk to your doctor or pharmacist.

Overdose of Nalgesin PRO

Overdose may cause stomach pain, nausea, vomiting, dizziness, tinnitus, irritability, and in severe cases, bleeding vomiting, black stools, changes in consciousness, respiratory disorders, seizures, and kidney failure.
In case of overdose, the doctor will take appropriate action.

Missed dose of Nalgesin PRO

Do not take a double dose to make up for a missed tablet.
Take the medicine at the same time every day. If you miss a dose, take it as soon as you remember.

Stopping Nalgesin PRO treatment

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

4. Possible side effects

Like all medicines, Nalgesin PRO can cause side effects, although not everybody gets them.
Stop taking Nalgesin PRO and consult your doctor 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 coffee grounds-like material;
• black stools or blood in urine;
• skin reactions, such as itching rash;
• breathing difficulties and (or) swelling of the face or throat;
• fatigue with loss of appetite;
• sore throat with mouth ulcers, fatigue, and fever;
• nosebleeds, skin bruising;
• unusual fatigue and decreased urine output;
• swelling of the face, feet, or ankles;
• chest pain;
• changes in 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.
• characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same location (locations) after re-exposure to the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching;

Side effects are most often associated with high doses.
Common (may affect up to 1 in 10 people):

• constipation, stomach pain, nausea, indigestion, diarrhea, mouth ulcers, bloating;
• headache, dizziness, balance disorders, drowsiness, paresthesia;
• 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), hives, excessive sweating;
• tinnitus, hearing disorders;
• vision disturbances;
• edema, rapid heartbeat or palpitations;
• thirst, sweating, fatigue, peripheral edema;
• breathing difficulties (dyspnea), bronchial asthma.

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

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

Rare (may affect up to 1 in 1000 people):

• agranulocytosis;
• mouth ulcers (ulcerative stomatitis), recurrence or worsening of ulcerative colitis or Crohn's disease (see section 4.4), esophagitis, gastritis, and pancreatitis;
• cognitive function disorders;
• angioedema;
• malaise, weakness.

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

• seizures;
• corneal clouding, optic disc swelling, optic neuritis, optic perineuritis;
• hypertension;
• women's fertility disorders, menstrual disorders;
• increased creatinine levels, abnormal liver function test results, prolonged bleeding time, hyperkalemia;
• photosensitivity, allergic reactions (anaphylactic and anaphylactoid reactions, including fatal anaphylaxis).

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

• blood morphology changes (aplastic anemia, hemolytic anemia);
• meningitis (aseptic meningitis);
• skin hypersensitivity reactions (toxic epidermal necrolysis, erythema multiforme, photosensitivity reactions resembling late porphyria cutanea and blistering skin separation, Stevens-Johnson syndrome, erythema nodosum, lichen planus, pustular reactions, lupus erythematosus);
• vasculitis;
• high blood sugar (hyperglycemia), low blood sugar (hypoglycemia).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help to gather more information on the safety of this 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 which is stated on the packaging after "EXP". The expiry date refers to the last day of that month.
The batch number is stated on the packaging after "Lot".
Store in the original package to protect from light.
Medicines should 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 PRO contains

• The active substance of Nalgesin PRO is naproxen sodium. Each coated tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• The other ingredients are: povidone K30, microcrystalline cellulose, talc, magnesium stearate; the composition of the Opadry 02F205004 bluecoating: hypromellose, titanium dioxide (E 171), macrogol 8000, and indigo carmine (E 132). See section 2 "Nalgesin PRO contains sodium".

What Nalgesin PRO looks like and contents of the pack

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

Marketing authorization 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 more information about this medicine, contact the local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00

Date of last revision of the leaflet: