Instructions for Aertal (Aceclofenac)
Release Form:
1.5% external note: 60 g tuba
Description:
Cream for outdoor use of white color.
1 g
aceclophenac (100% micro-lit) 15 mg
Auxiliary substances: wax emulsion, paraffin liquid, methylparahydroxybenzoate, propylparahydroxybenzoate, water.
60 g - aluminum (1) tubes - cardboard packs.ATX codes
M02AA25 Aceclofenac
Pharmacological groups / Group membership:
NWF for outdoor use
Active substance:
aceclofenac
Pharmacy Group:
Drugs for local use in joint and muscle pain; NPAs for local use: aceclophenok
Retention Terms
The drug should be stored in a place not accessible to children at a temperature not exceeding 25°C.
Shelf life
Shelf life - 2 years.
Pharmaceuticals:
Aceclofenac is an NPAV that also has a hot-reducing and analgesic effect. The drug suppresses the development of edema and erythema, regardless of the etiology of inflammation. Aceclofenac inhibits the formation of prostaglandins and leukotrienes by reversible OH inhibition.
Clinical efficiency and security
The established clinical effectiveness of the drug is supplemented by good tolerance.
Aertal cream is suitable for patients with traumatic injuries or inflammatory diseases of the musculoskeletal system.
It has been proven that Aertal cream has anti-inflammatory and pain-relieving effects in local application to treat injuries to the musculoskeletal system.
Indications:
treatment of local pain due to traumatic injuries and inflammatory diseases of the musculoskeletal system, including sporting injuries;
To reduce inflammation of tendons, ligaments, muscles and joints in cases of stretching, overstretching and bruising;
lumbago;
the curve;
periarthritis.
Method of application, course and dosage:
Crem Aertal is designed for outdoor use only. Do not apply cream under the occlusionic bandages.
After applying the cream, the hands should be washed, except when the hands are a zone of application of the cream. The drug should not be caught in the eyes or mouth cavity.
Aertal can only be applied to intact skin.
Aertal should be applied with light massing movements on the affected area 3 times/day. The dose applied depends on the size of the affected area: 1.5-2 g of Aertal cream (approximate corresponds to a 5-7 cm-long strip of cream).
It is necessary to pay the patient's attention to the fact that when using the drug without being assigned by the doctor for treatment of damage to muscles and joints (stretching, overvoltage, bruises) or tendinite, the duration of use should not exceed 2 weeks.
The duration of use of the drug without the appointment of the doctor to treat arthritis should not exceed 3 weeks.
If the symptoms deteriorate or do not decrease after 7 days of use, the patient should consult a doctor for further examination.
The experience of using Aertal cream in children is not present, so Aertal cream is shown against the use in children.
Correction of dosage in elderly patients is not required.
Overdose:
Cases of overdose of aceklofenac are unknown.
Symptoms: The exact symptoms of the overdose of aceklofenac are unknown. In case of improper use or accidental intake of the drug, arterial hypotension, kidney failure, convulsions, irritation of the mucous membrane of the LCT, as well as oppression of breath can develop.
Treatment: Conducting symptomatic and supporting therapy. The intake of the drug should be prevented as soon as possible by washing the stomach and assigning the activated carbon. Forced diuresis, hemodialysis or hemomperfusion is ineffective due to high degree of linking aceclophenac with plasma proteins of blood and its intense metabolism.
Drug Interaction:
Although there is no evidence of possible interaction of aceclophenac with other drugs, care must be taken when assigning it to patients taking other drugs, especially those containing lithium, digoxine, or co-therapy with oral anticoagulants, di urethics or painkillers.
Use in pregnancy and breastfeeding
Pregnancy
Crem Aertal is contraindicated for use in pregnancy. There is no information on the use of Aertal cream during pregnancy.
Breastfeeding period
It is not known whether aceclophenac enters breast milk. Aertal cream should not be used during breastfeeding.
Side Action
The Aertal creamen's tolerability is demonstrated.
In some cases, a slight or moderate local irritation is described, accompanied by skin hyperemia and itching, which disappears when the treatment is terminated.
In rare cases the Varicella zoster virus, combined with the treatment of NPAs, can cause serious complications in the form of skin infection and soft tissues.
In addition, there are separate reports of photosensitivity reactions (≥1/1000 to <1/100) of areas of skin exposed to cream, exposed to intense sunlight without adequate protection against UV radiation.
The following are undesirable reactions reported in clinical trials and post-marketing surveillance; Undesirable reactions are represented by system-organ classes according to the MedDRA classification and the frequency of occurrence: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rarely (≥1/1000 to <1/1000), very rarely (<1/10000).
General disorders and disturbances at the place of injection: not often - photosensitivity reactions, erythema, skin itching; seldom skin irritation; very seldom - bull-like reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Very rare reports of severe skin reactions, sometimes leading to death, are known, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis associated with the use of NPA.
Contraindications to use:
increased sensitivity to drug components: to aceclophenac or any of the auxiliary substances;
Anamnesis indication of increased sensitivity to other NPAs (although possible cross-hypersensitivity with diclofenac has not been confirmed, the drug is not recommended to patients with hypersensitivity to diclofenac in anamnesis);
aceclophenac, like other NPAVs, is contraindicated to patients with acetylsalicinic acid or other NPAVs causing asthma attacks, nettle or acute rhinitis;
Varicella zoster infection
pregnancy;
Children up to 18 years of age;
Infringement of the integrity of the cutaneous cover at the place of intended application.
With caution
liver porphyria (acute), erosive-ulcer lesions of the LCD (in the aggravation phase), severe disorders of liver and kidney function, chronic heart failure; bronchial asthma, nettle or acute rhinitis caused by the use of acetylsalic acid (ACA) or other NPAA; Blood folding disturbances (including hemophilia, longevity of bleeding, propensity for bleeding), old age, lactation period.
Special Instructions:
When developing irritation in the application of the Aertal cream, it is necessary to stop its application and to carry out appropriate treatment.
Crem Aertal may not be used to treat open wounds, mucous membranes, or skin irritations (eczematosis) or when there is another pathological process on the skin at the place of application of the cream. The cream should only be applied to the intact skin.
To prevent photosensitivity reactions, the area covered by the cream should be protected from sunlight.
Hypersensitivity and skin reactions: Just like other NPAs, Aertal cream may cause allergic reactions at the beginning of application, including anaphylactic/anaphylactic reactions. There are reports of serious skin reactions in rare cases, including fatal ones, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of NPAV. Patients are at the highest risk of such reactions at the beginning of the treatment, skin reactions in most cases occur during the first month of treatment. When skin rash, mucous lesions or other hypersensitivity symptoms occur, Aertal cream treatment ® should be stopped.
In rare cases the Varicella zoster virus can cause serious complications in the form of skin infection and soft tissue. At present, the negative impact of NPAs on the course of these infections cannot be completely excluded. Therefore, it is not recommended to use aceclophenac in an infection caused by Varicella zoster virus.
Aertal, a cream for external use, contains methylparahydroxybenzoate and propylparahydroxybenzoate, which can cause allergic reactions (including delayed reactions). Crem Aertal also contains cethylstearyl alcohol (an emulsion wax ingredient), which can cause local skin reactions (e.g. contact dermatitis).
Use in pediatrics
Data on the safety and effectiveness of the use of aceclophenacs in children and adolescents under 18 years of age are not available, so the drug is contraindicated for use in this category of patients.
Impact on the ability to drive vehicles and mechanisms
Crem Aertal has no influence on the ability to drive and operate vehicles.
Application for kidney disorders
Carefully prescribe a drug for severe kidney disorders.
Application for liver disorders
Carefully, you should prescribe a drug for liver porphyria (acute), severe liver function disorders.
Terms of implementation
The drug is released without prescription.
Application of elderly patients
Care should be taken to prescribe the drug to older patients.
Application of children
The experience of using Aertal cream in children is not available, so Aertal cream is not recommended in children.
- Nozology (ICD codes)
- Joint pain
- Krivosheya
- Radiculopathy
- Ishias
- Lumbago with Ishias
- Sinovites and Tenosinovites
- Soft tissue diseases associated with stress, overload and pressure
- Other boursopathy
- Adhesive shoulder capsule
- Milgia
- Neuralgia and Neuritius Unspecified
- Surface injury to an unspecified area of the body (including the abdomen, the hemorrhage, the bruise, the hematoma, the bite of a nonpoisonous insect)
- Intake, stretching and overstretching of the capsules and ligament apparatus of the joint of an unspecified area of the body
