Musculoskeletal System

Naxotec^®

About Naxotec® 500g

Naxotec® is a drug belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), widely used in the treatment of painful and inflammatory conditions. Its active substance is Naproxen, a compound with analgesic, antipyretic and anti-inflammatory properties. Naxotec® is indicated to treat a variety of conditions, including pain associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, musculoskeletal conditions, postoperative pain, toothache, and menstrual cramps.

How does Naxotec® work?

Naxotec® is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic action. Its mechanism of action involves the inhibition of the production of prostaglandins, substances responsible for the inflammatory process, pain and fever. In this way, the drug reduces inflammation, relieves pain, and controls fever in various conditions, such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, musculoskeletal pain, menstrual cramps, and postoperative pain.

Chemical Union

As a multinational company with 100% national capital, and with more than eight decades of operations, União Química has built a history of achievements, with a prominent position among the ten largest and most solid companies in the national pharmaceutical industry.

Active Ingredient

Naproxen

Presentation

10 and 24 tablets of 500mg.

Naxotec® Leaflet Topics

Indications and contraindications

Naxotec® is a drug indicated as:

• Analgesic and anti-inflammatory – Acts to relieve pain and inflammation resulting from the underlying condition.

Indications and contraindications:

• Acute inflammatory pain, such as sore throat and associated inflammatory processes;

• Fever and aches in adults, except for breastfeeding women, including toothache, abdominal pain, and cold- and flu-related symptoms;

• Muscle and joint pain, such as torticollis, bursitis, tendonitis, low back pain, pain in the tennis leg and elbow;

• Rheumatological diseases, in periods of crisis, such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and gout;

• Menstrual cramps, providing relief from pain associated with the menstrual cycle.

•Postoperative, including orthopaedic surgeries and tooth extractions;

• Post-traumatic pain, such as sprains, strains, bruises and pain resulting from sports activities.

Contraindications

The use of Naxotec® is contraindicated for:

• Patients with a history of allergy to naproxen or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• Subjects with gastric ulcers, active gastritis, inflammatory bowel disease, or a history of digestive bleeding;
• People with severe kidney, liver or heart failure;
• Patients with a tendency to bleeding or coagulation disorders;
• Women in the third trimester of pregnancy;
• Children under 12 years of age, unless specifically recommended by a doctor.

The use of the drug should be done under medical guidance, respecting the appropriate dosage for each condition.

Dosage and how to use Naxotec®

NAXOTEC should be administered in the fasted state or with meals. The tablet should be ingested with a little liquid, without chewing. Absorption may be delayed with food.

Treatment with this drug should not last for more than 7 days unless recommended by the doctor, as it can cause problems with the kidneys, stomach, intestines, heart, and blood vessels.

Important precautions during use

The use of Naxotec® should be done as directed by a doctor, respecting the minimum effective dose for the shortest time necessary. The drug should not be used together with other nonsteroidal anti-inflammatory drugs (NSAIDs), as it may increase the risk of adverse effects.

Patients who are elderly, have a history of gastric ulcers, digestive bleeding, or inflammatory bowel diseases (such as Crohn's disease and ulcerative colitis) should report any unusual symptoms to their doctor, as there is a risk of serious gastrointestinal complications, including bleeding and perforation. Treatment should be discontinued in case of signs of gastrointestinal bleeding.

Individuals with kidney, heart or hepatic impairment should use Naxotec® with caution as the drug may affect the function of these organs. There is also a small increase in the risk of cardiovascular events, such as myocardial infarction and stroke, especially in patients with risk factors for cardiovascular disease, such as hypertension, diabetes, and smoking.

In addition, prolonged use can interfere with female fertility. Women who have difficulty getting pregnant should consider stopping the drug under medical advice.

Naxotec® Side Effects

Like other NSAIDs, Naxotec® can cause adverse effects, the intensity and frequency of which vary according to the body's response to treatment. Among the main side effects reported are:

• Gastrointestinal: abdominal pain, nausea, vomiting, heartburn, diarrhea, constipation, ulcers, digestive bleeding and gastric perforation;
• Renal and urinary disorders: kidney failure, fluid retention and changes in kidney function tests;
• Cardiovascular: increased blood pressure, fluid retention, swelling and a higher risk of cardiovascular events, such as myocardial infarction and stroke;
• Neurological: dizziness, drowsiness, insomnia, headache and, in rare cases, seizures;
• Hematological: anemia, reduction in platelet count and increased risk of bleeding;
• Dermatological: allergic skin reactions, including skin rashes, itching, and, in rare cases, severe reactions such as Stevens-Johnson Syndrome;
• Respiratory: shortness of breath, asthmatic crises and respiratory allergic reactions.

Should any adverse effects manifest, the use of the drug should be discontinued and a doctor should be consulted immediately.