Expiration date: 08/2025

Composition: 

100 g gel meloxicam - 1 g. excipients: metilpirrolidone - 15 g, ethanol 95% - 25 g, carbomer - 0.9 g, trometamol, from 2 g to 3 g (up to pH 7.5-8.9), oil of orange flowers - 0.015 g, lavender oil - 0.01 g purified water to 100 g.

Clinico-pharmacological group: NSAIDs for external use

Pharmaco-therapeutic group: NSAIDs for external use

Indications

• symptomatic therapy of osteoarthritis, accompanied by pain syndrome.
  

Used for symptomatic therapy, reducing pain and inflammation; disease progression is not affected.

Dosage regimen

Outwardly. Not to use inside.

A strip of gel with a length of about 4 cm (2 g) applied 2 times/day with a thin layer to clean, dry skin over the lesion and gently RUB for 2-3 min.

The duration of therapy is determined individually, may vary depending on the site of the damage and note the therapeutic effect and is not more than 4 weeks.

Side effect

To drugs from the group of NSAIDs for external use described following side effects.

With the skin: redness, papular-vesicular lesions, desquamation, photosensitivity.

Allergic reactions: itching and burning of the skin, erythema multiforme, urticaria, systemic anaphylactic reactions.

If you experience adverse reactions, including not listed above, the patient should stop using the gel and tell your doctor.

Contraindications

• full or partial combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including history);
  
• violation of the integrity of the skin in areas proposed application;
  
• child and adolescence to 18 years (effectiveness and safety have not been established);
  
• pregnancy;
  
• hypersensitivity to meloxicam and other ingredients (including other NSAIDs).
  

With caution the drug should be used when ulcers stomach and duodenal ulcers (in the acute phase); active gastrointestinal bleeding; progressive kidney disease; liver failure, severe or active liver disease; confirmed hyperkalemia; inflammatory bowel diseases; violation of coagulation; chronic heart failure; elderly patients.

Application of pregnancy and breastfeeding

The drug is contraindicated during pregnancy and breastfeeding.

Application for violations of liver function

With caution should use the drug with hepatic failure, severe or active liver disease.

Application for violations of renal function

With caution the drug should be used in progressive kidney disease.

Use in children

The drug is contraindicated in childhood and adolescence to 18 years (efficacy and safety not established).

Use in elderly patients

With caution should use the drug in elderly patients.

Special instruction

The necessary control of the physician in the appointment of the gel Amelotex® in elderly patients with impaired renal function and liver, chronic heart failure, patients with gastroduodenal bleeding and ulcers in the acute stage or severe bleeding disorders.

Amelotex® gel is recommended to be applied only to intact skin, avoiding open wounds. Avoid contact of gel with eyes and mucous membranes.

To decrease the risk of adverse reactions need to use the minimum effective dose with minimal duration of treatment. If the patient's condition is not improving, he should see a doctor.

You should not use the drug in patients with hypersensitivity to NSAIDs in history. In case of development of hypersensitivity reactions treatment should be discontinued.

During the period of treatment may develop photosensitivity reactions. To reduce the risk of photosensitivity, patients should avoid UV exposure and tanning.

Effects on ability to drive vehicles and management mechanisms

Amelotex® gel has no influence on the management of transport and occupation of other potentially hazardous activities, require high concentration and psychomotor speed reactions.

Overdose

Due to low systemic absorption with the application of gel Amelotex® overdose when applied topically is unlikely.

Drug interaction

Amelotex® gel should not be used together with other drugs for external use.

It is not recommended to apply the gel simultaneously with other NSAIDs.

With simultaneous use with other drugs meloxicam forms (tablets, injection), the daily dose should not exceed 15 mg.

Conditions of supply of pharmacies

The drug is approved for use as non-prescription medicines.