Efridol

Efridol

• Active ingredient: Nimesulide.

Efridol is available in the form of granules for preparation of suspension for ingestion.

This form is especially convenient for those who have difficulty swallowing tablets. Before taking the contents of the sachet are dissolved in water, obtaining a liquid with a pleasant taste.

• One dose (1 sachet) contains 2 g of granules, which corresponds to 100 mg of nimesulide.

• Packaging: 30 sachets in a cardboard box.

The yellow granules are flavored with orange flavoring, which makes it easier to take.

Efridol is used for short-term relief of pain of various origins. It does not treat the cause of pain but helps to quickly reduce its intensity. The drug is prescribed for the following conditions:

• headache and toothache;

• muscle and joint pain;

• back pain;

• menstrual pain (dysmenorrhea);

• osteoarthritis (arthrosis);

• gout attack;

• pain syndrome in bruises, sprains, dislocations.

Efridol is used as a symptomatic remedy — that is, to relieve pain against the background of the underlying disease. Its use should be limited in time.

Efridol is taken orally, after meals. This reduces the load on the stomach and decreases the risk of side effects. Adults:

• The usual dose is 100 mg of nimesulide (1 sachet) twice a day.

• The contents of one sachet are dissolved in a glass of water immediately before taking.

• Maximum course duration — no more than 15 days.

Elderly patients:

• Dose adjustment is generally not required, but it is important to monitor liver and kidney function.

Children and adolescents:

• Under 12 years — contraindicated.

• From 12 to 18 years — used in the usual dosage, without correction.

Patients with impaired liver or kidney function:

• The drug is contraindicated in severe hepatic or renal insufficiency.

For treatment to be safe and effective, it is important to follow the doctor's recommendations, not exceed the course duration, and not use the drug unnecessarily.

Before starting Efridol, it is important to ensure that the patient does not have conditions for which the drug is contraindicated. This will help avoid serious complications. Efridol should not be taken in the following cases:

• allergy to nimesulide or any excipients of the drug;

• peptic ulcer of the stomach and intestines (active phase or exacerbations in the history);

• gastrointestinal, cerebral, or other bleeding;

• severe hepatic insufficiency or elevated liver enzymes;

• severe renal insufficiency (if the patient is not on dialysis);

• severe heart failure;

• pregnancy and breastfeeding;

• age under 12 years.

If one or more contraindications are present, the doctor should consider alternative therapy options.

Although nimesulide is effective in relieving pain and inflammation, it should be taken with caution in a number of cases. The following conditions require increased monitoring or discontinuation.

• Liver function: in case of nausea, vomiting, abdominal pain, darkening of urine or yellowing of the skin, the drug should be immediately discontinued and consult a doctor. These symptoms may indicate liver damage.

• Cardiovascular diseases: nimesulide may increase the risk of thrombosis, especially in patients with hypertension, angina pectoris or heart attack. Caution should be exercised not to exceed the recommended dosage and duration of treatment.

• Gastrointestinal risks: in case of abdominal pain, vomiting with blood or black stools you should immediately stop taking the drug and seek medical attention - these are signs of bleeding from the GI tract.

• Fever and flu-like symptoms: if these occur, you should also discontinue the drug as they may be a marker of a serious adverse reaction.

• Elderly age (65+): elderly patients require regular monitoring of liver, kidney and cardiovascular function.

Efridol is not intended for long-term administration. If treatment for longer than 15 days is necessary, the doctor should choose another remedy.

Efridol (nimesulide) may interact with other medications, which can either increase the risk of side effects or reduce the effectiveness of treatment. This is especially important if you're taking multiple drugs as part of a complex treatment plan.

Medications that increase bleeding risk:

• Anticoagulants: warfarin, heparin, rivaroxaban, apixaban

• Antiplatelet drugs: acetylsalicylic acid (aspirin), clopidogrel

• Other NSAIDs

Taking these together with Efridol can raise the risk of gastrointestinal ulcers and internal bleeding, especially in older adults.

Medications that affect kidney function:

• Diuretics (e.g. furosemide, hydrochlorothiazide) — their effectiveness may be reduced

• ACE inhibitors and ARBs (e.g. enalapril, losartan) — may increase the risk of kidney damage

Drugs that can increase the toxicity of nimesulide:

• Methotrexate — raises the risk of harmful effects on the liver and bone marrow

• Cyclosporine and tacrolimus — can increase the risk of kidney toxicity

Medications that alter how nimesulide is processed by the body:

• Liver enzyme inducers (rifampicin, carbamazepine, phenobarbital) — may speed up metabolism, reducing the drug’s effectiveness

• CYP2C9 inhibitors (fluconazole, voriconazole) — slow down drug elimination, increasing the chance of side effects

Other potential interactions:

• Lithium — blood levels may rise, increasing the risk of toxicity

• Antacids — may reduce how well nimesulide is absorbed

• Oral diabetes medications — may cause fluctuations in blood sugar levels
  
  

Recommendations: Before starting Efridol, inform your doctor about all medications you're currently taking — including prescription drugs, over-the-counter treatments, and supplements. Avoid using Efridol alongside other NSAIDs. If you’re taking blood thinners or blood pressure medications, your doctor may recommend regular blood and kidney function tests to ensure safe use.

Efridol should not be used at any stage of pregnancy. It may interfere with fetal development and increase the risk of complications, particularly during the third trimester.

Nimesulide can pass into breast milk, so it’s not recommended during breastfeeding. If treatment is absolutely necessary, women should temporarily stop nursing while taking the medication.

There is also some evidence that nimesulide may affect a woman’s ability to conceive, especially with prolonged use. If you're trying to get pregnant, it's best to avoid this medication and consult your doctor for safer alternatives.

• During the period of use, caution should be exercised when driving, working with machinery, and in situations requiring increased concentration. If symptoms from the nervous system appear, it is better to refrain from potentially dangerous activities until the effects completely disappear.

Like all drugs from the NSAID group, Efridol can cause side effects, especially with prolonged use, exceeding the dose, or in patients with comorbidities. Most common adverse reactions:

• headache;

• dizziness;

• nausea;

• diarrhea.

Rare but possible reactions:

• elevated liver enzymes in the blood;

• increased blood pressure;

• gastritis;

• bloating;

• skin rash and itching.

Very rare but potentially dangerous side effects:

• anaphylactic reactions (including angioedema);

• severe skin reactions, including Stevens-Johnson syndrome;

• gastrointestinal bleeding;

• jaundice, liver failure;

• myocardial infarction;

• stroke.

If during treatment any unusual symptoms appear, especially related to the liver (yellowing of the skin, darkening of urine), GI tract (bloody vomiting, black stools), or skin reactions — the drug should be immediately discontinued and a doctor consulted.

Exceeding the recommended dose of nimesulide can lead to dangerous consequences. Overdose most often occurs with accidental intake of several doses in a row or exceeding the frequency of administration. Main symptoms of overdose:

• nausea and vomiting;

• drowsiness;

• abdominal pain;

• signs of gastrointestinal bleeding.

First aid and treatment:

• gastric lavage (effective in the first hours after intake);

• activated charcoal to reduce drug absorption;

• symptomatic therapy under medical supervision;

• monitoring of liver and kidney function.

There is no specific antidote. In case of serious symptoms, seek medical help immediately.

Nimesulide is a representative of the non-steroidal anti-inflammatory drugs (NSAIDs) group, more precisely, sulfonanilides. It has:

• anti-inflammatory,

• analgesic,

• antipyretic effects.

Its mechanism of action is based on selective inhibition of the cyclooxygenase-2 (COX-2) enzyme. COX-2 is involved in the synthesis of prostaglandins — substances responsible for inflammation, pain, and temperature elevation. Thanks to this mechanism, nimesulide:

• reduces inflammation and swelling in the affected area;

• decreases pain sensations;

• helps reduce temperature during inflammatory processes.

Selective action on COX-2 allows reducing the risk of stomach mucosa damage compared to traditional NSAIDs, however, side effects cannot be completely eliminated.

The pharmacokinetic properties of Efridol ensure its rapid and effective action: Absorption: nimesulide is well and quickly absorbed from the GI tract. Maximum plasma concentration is reached 2-3 hours after intake. Plasma protein binding: about 97.5%, which provides long-lasting action and accumulation at the inflammation site. Metabolism: occurs in the liver, where nimesulide is converted into an active metabolite — hydroxynimesulide. Excretion: 50% of the drug is excreted by the kidneys, about 29% — through the intestine. Half-life: 3-5 hours.

In patients with impaired liver or kidney function, pharmacokinetics may change, so the drug is contraindicated for them.

• Non-steroidal anti-inflammatory drugs (NSAIDs), sulfonanilide derivatives.

In addition to the active ingredient nimesulide, Efridol granules contain auxiliary components. They provide stability, taste, and solubility of the drug. Main excipients:

• Cetomacrogol 1000 — stabilizer, helps evenly distribute components in solution;

• Sucrose — adds a sweet taste, facilitating intake;

• Citric acid — regulates acidity, improves taste;

• Maltodextrin — filler, gives structure to granules;

• Orange flavoring — improves the organoleptic properties of the drug, especially important for those sensitive to medication tastes.

Before taking the drug, it is important to familiarize yourself with the full composition. If the patient is allergic to sucrose or flavorings, consult a doctor.

• The shelf life of Efridol is 3 years from the date of manufacture. After this period, the drug should not be used — its effectiveness may decrease, and safety is not guaranteed. Keep the package out of reach of children and always check the expiration date on the package before use.

To maintain the quality and effectiveness of Efridol, it is necessary to observe storage conditions:

• temperature — not above 25°C;

• avoid exposure to moisture and direct sunlight;

• store in the original packaging;

• keep away from children.

Failure to comply with storage conditions may lead to the destruction of active components and reduced effectiveness of the drug.

• Efridol is available as granules for suspension preparation, packaged in individual sachets. Each sachet contains 2 g of granules, which corresponds to 100 mg of nimesulide. One package contains 30 sachets. Packaging — cardboard box with instructions for use. Sachets are easy to open and convenient to carry. Before use, the granules are dissolved in water — resulting in a suspension with orange flavor.

The drug should not be disposed of in sewage or with household waste. Expired medication residues must be disposed of according to sanitary requirements:

• check with a pharmacy or medical institution where you can safely turn in the drug;

• do not give the remains to other people — even if they have similar symptoms;

• do not use damaged sachets or drug with altered color, smell, or consistency after dissolution.

Proper disposal helps not only preserve health but also reduce the risk of environmental pollution.

Efridol is registered and available in:

• Italy

• Romania

• Moldova

Before using in another country, it is recommended to check the official registration of the drug and its trade name in the local registry of medicinal products.

• Aesculapius Farmaceutici S.r.l. (Italy)

• Efridol is dispensed by prescription. Self-medication can be dangerous, especially with comorbidities or when taking other medications.

For safe use of Efridol, it is important to follow several rules:

• Do not use for more than 15 days. The drug is intended for short-term symptomatic treatment.

• Do not exceed the recommended dose. This will not accelerate the effect but will increase the risk of adverse reactions.

• If symptoms of liver damage appear (yellowing of the skin, darkening of urine, pain in the right hypochondrium), immediately stop taking and consult a doctor.

• Do not combine with other NSAIDs — this increases the risk of bleeding and ulcers.

• Patients with chronic liver, kidney, or heart diseases should use only as prescribed by a doctor and under laboratory test control.

• Do not use for fever or viral infections — risk of severe skin reactions.

Following these recommendations helps minimize side effects and get maximum benefit from treatment.

• M01AX17 – NSAIDs (nimesulide).

• R52.1 – Acute pain.
•  N94.6 – Dysmenorrhea.