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  • Acnetin 16mg 30 capsules — Made in Belgium — Free Delivery

Acnetin 16mg 30 capsules — Made in Belgium — Free Delivery

(Acnetin 16mg )
Acnetin 16mg 30 capsules — Made in Belgium — Free Delivery
Acnetin 16mg 30 capsules — Made in Belgium — Free Delivery
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S.M.B. Technology Brand: S.M.B. Technology
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Description Acnetin 16mg 30 capsules — Made in Belgium — Free Delivery

Indications

Severe forms of acne (in particular nodular and conglobatic acne, acne with a tendency to permanent scarring), not amenable to standard treatment methods (systemic antibiotic therapy, local treatment).

Application

Aknetin is prescribed for adults and children over the age of 12 years, starting with a dose of 0.4 mg / kg / day. capsules should be taken with meals 1-2 times a day. in case of missing the prescribed dose of the preparation, it is not recommended to take a double dose! the therapeutic effect of acnetin, as well as the undesirable effects, are dose-dependent and have varying degrees of severity, which requires an individual dose adjustment during treatment. for most patients, the dose of the preparation  is 0.4–0.8 mg / kg / day.
Often, at the beginning of treatment, there is a short-term exacerbation of the disease. The effectiveness of treatment and side effects differ in different patients, therefore, after 4 weeks of therapy, the dose for adults should be individually selected in the range of 0.1–1 mg / kg / day. The maximum daily dose of 1 mg / kg body weight can only be prescribed for a limited period.
Typically, the course of treatment lasts 16-24 weeks. When evaluating the results of therapy, it must be remembered that the effect of the preparation continues after the termination of treatment. In this regard, a second course should be prescribed no earlier than 8 weeks later.
For most patients, a single course of treatment is enough to get rid of acne. If a relapse is confirmed, a second course of isotretinoin can be offered. The dose for retreatment is prescribed in accordance with the above recommendations.
For patients who do not tolerate the recommended doses, it is possible to continue treatment at a lower dose, which should be accompanied by an increase in the duration of treatment and, accordingly, may lead to an increased risk of relapse. In such patients, it is necessary to continue the course of treatment with the appointment of the maximum acceptable dose.
Children. The preparation is not recommended for children under 12 years of age, since the safety and efficacy of use in this age group have not been studied.

Contraindications

Women of reproductive age if all conditions of the "pregnancy prevention program" are not met (see special instructions); hypersensitivity to isotretinoin or any of the components of the preparation; liver failure; severe hyperlipidemia; hypervitaminosis a; concomitant therapy with tetracyclines. due to the fact that the preparation contains soybean oil, it is contraindicated in patients with allergies to peanuts and soybeans.

Side effects

Some of the side effects of isotretinoin are dose dependent. usually, adverse reactions are reversible after dose adjustment or discontinuation of the preparation, but some may persist after discontinuation of treatment. the symptoms most often reported with isotretinoin are dry skin, mucous membranes, including lips (cheilitis), nasal cavity (nosebleeds), eyes (conjunctivitis).
The following categories are used to describe the frequency of adverse reactions: very often (≥1 / 10), often (≥1 / 100, 1/10), rarely (≥1 / 10,000, 1/1000), very rarely (≤1 / 10 000).
Infections: very rarely - gram-positive bacterial infections of the skin and mucous membranes.
Disorders of the blood and lymphatic system: very often - anemia, accelerated ESR, thrombocytopenia, thrombocytosis; often neutropenia; very rarely - lymphadenopathy.
Immune system disorders: rarely - allergic skin reactions, anaphylactic reactions, hypersensitivity reactions.
Disorders of metabolism, metabolism: very rarely - diabetes mellitus, hyperuricemia.
Mental disorders: rarely - depression, increased depression, a tendency to aggression, anxiety, mood changes; very rarely - behavioral disorders, psychotic disorders, suicide attempts, suicide.
Nervous system disorders: often - headache; very rarely - benign intracranial hypertension, convulsions, drowsiness, dizziness.
Disorders from the organ of vision: very often - blepharitis, conjunctivitis, dry eyes, eye irritation; very rarely - blurred vision, cataracts, impaired color perception, intolerance to contact lenses, corneal opacity, decreased acuity of twilight vision, keratitis, edema of the optic nerve papilla (as a manifestation of benign intracranial hypertension), photophobia, visual impairment.
Hearing and labyrinth disorders: very rarely - hearing impairment.
Vascular disorders: very rarely - vasculitis (eg Wegener's granulomatosis, allergic vasculitis).
Disorders of the respiratory system, chest and mediastinum: often - nosebleeds, dry nose, nasopharyngitis; very rarely - bronchospasm (especially in patients with asthma), dysphonia.
Disorders from the digestive tract: very rarely - colitis, ileitis, dry throat, gastrointestinal bleeding, hemorrhagic diarrhea, inflammatory bowel disease, nausea, pancreatitis (see SPECIAL INSTRUCTIONS).
Hepatobiliary disorders: very often - an increase in the level of transaminases (see. SPECIAL INSTRUCTIONS); very rarely - hepatitis.
Disorders of the skin and subcutaneous tissue: very often - cheilitis, dermatitis, dry skin, localized peeling, itching, erythematous rash, skin trauma (risk of damage from friction); rarely - alopecia; very rarely - fulminant forms of acne, exacerbation of acne (hyperemia of acne), erythema (face), exanthema, hair disorders, hirsutism, onychodystrophy, paronychia, photosensitivity, pyogenic granuloma, skin hyperpigmentation, increased sweating; the frequency is unknown (the frequency cannot be estimated based on the available data) - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Disorders from bones, muscles and connective tissue: very often - arthralgia, myalgia, back pain (especially in children and adolescents); very rarely - arthritis, calcification (calcification of ligaments and tendons), premature closure of growth zones of the pineal glands, exostosis, hyperostosis, decreased bone density, tendinitis.
Disorders of the kidneys and urinary system: very rarely - glomerulonephritis.
General disorders: very rarely - tissue granulation (increased formation), increased fatigue.
Laboratory indicators: very often - hypertriglyceridemia, a decrease in HDL levels; often - hypercholesterolemia, hyperglycemia, hematuria, proteinuria; very rarely - an increase in CPK in the blood.

special instructions

"Pregnancy prevention program". this preparation is teratogenic. isotretinoin is contraindicated in women of reproductive age, unless the woman's condition meets all of the following criteria:
  • she has been diagnosed with a severe form of acne (nodular and conglobatic acne, acne with a tendency to permanent scarring), which does not respond to standard methods of treatment (systemic antibiotic therapy, local treatment);
  • she understands the teratogenic risk of the preparation;
  • she understands the need to visit a doctor every month;
  • she is able to adhere to reliable and continuous contraceptives for 1 month before, during and within a month after the end of treatment with Aknetin; it is desirable to use simultaneously 2 different methods of contraception, including barrier;
  • even with amenorrhea, she must adhere to reliable contraception;
  • she must confirm that she understands the nature of the preventive measures;
  • she is informed about the danger of pregnancy during treatment with Acnetin and understands the need to immediately consult if pregnancy is suspected;
  • she understands the need and agrees to carry out a pregnancy test before, during and 5 weeks after treatment;
  • she confirms that she is aware of the dangers of using isotretinoin and the need for preventive measures.
The use of contraceptives according to the above recommendations during treatment with isotretinoin should be recommended even for sexually inactive women, unless the doctor believes that there is every reason that there is no risk of becoming pregnant.
The doctor must be sure that the patient:
  • is able to understand and fulfill all of the above requirements for the prevention of pregnancy;
  • understands the specified conditions;
  • adheres to at least one, and preferably two, effective contraceptives, including the barrier method, for 1 month before, during and within a month after the end of treatment with Acnetin;
  • received a negative result of a reliable pregnancy test before, during and 5 weeks after the end of therapy. The dates and results of the pregnancy test should be documented.
Pregnancy prevention. Patients should be familiar with contraceptive methods. If they are not using effective contraceptive methods, the doctor should provide appropriate advice.
The minimum requirement is the use of at least 1 effective method of contraception in women who are at risk of becoming pregnant. It is best to use two complementary methods of contraception, including the barrier method. Contraceptive methods should be continued for at least another 1 month after stopping treatment with Acnetin, even in patients with amenorrhea.
Pregnancy test. According to current practice, a pregnancy test with a minimum sensitivity of 25 mIU / ml should be performed in the first 3 days of the menstrual cycle.
Before starting treatment. To exclude a possible pregnancy, the doctor must register the result and the date of the first pregnancy test before starting contraceptive use. In patients with irregular menstrual cycles, the timing of a pregnancy test depends on sexual activity. The test should be performed 3 weeks after unprotected intercourse. The doctor should inform the patient about contraceptive methods. A pregnancy test should be performed on the day of the appointment of Aknetin or 3 days before the patient's visit to the doctor. Test results should be recorded by the specialist. The preparation can only be intended for patients who receive effective contraception for at least 1 month before starting treatment with Acnetin. The test should ensure that the patient is not pregnant at the time of initiation of isotretinoin treatment.
During treatment. The patient must see a doctor every 28 days. The need for monthly pregnancy testing is determined by local practice and taking into account sexual activity and a history of recent menstrual periods (abnormal menstruation, lack of periodicity, or amenorrhea). If indicated, a pregnancy test should be performed on the day of the visit or 3 days before the doctor's visit.
Completion of treatment. 5 weeks after the end of treatment, a final test is performed to exclude pregnancy. The pharmacist must make sure that a prescription for Acnetin is given to a woman of reproductive age only for 30 days of treatment, continuation of treatment requires a new prescription of the preparation by the doctor.
Ideally, pregnancy testing, prescription and preparation administration are recommended within one day. The dispensing of Aknetin at the pharmacy should be carried out only within 7 days from the date of the prescription.
Male patients. Existing data indicate that in women, the exposure of the preparation, which came from the semen and seminal fluid of men taking Acnetin, is insufficient for the manifestation of the teratogenic effects of the preparation. Men should exclude the possibility of using the preparation by others, especially women.
Additional caveats. Patients should be informed to never give this medicine to others and to return unused capsules to the doctor after treatment ends. Patients should not donate blood during treatment and for 1 month after its termination, since there is a potential risk of transfusion transmission to the fetus from the pregnant woman.
Educational materials. To help doctors, pharmacists and patients avoid the risk of the effects of Acnetin on the fetus, the manufacturer provides educational materials aimed at preventing the teratogenic effects of the preparation, recommendations on the use of contraception before starting therapy, and recommendations on the need for pregnancy testing.
Full information on teratogenic risk and strict adherence to measures to prevent pregnancy is contained in the "Pregnancy Prevention Program", which must be provided to all patients - both men and women.
Mental disorders. In patients who received Acnetin, depression, depression with aggravation, anxiety, tendency to aggressiveness, mood changes, psychotic symptoms, and very rarely - suicidal thoughts, suicidal attempts and suicide were revealed (see SIDE EFFECTS). Care should be taken with patients with a history of depression, and patients should be monitored for depression during treatment, and referred to appropriate specialists if necessary. However, the abolition of Aknetin may not lead to the disappearance of symptoms and require further monitoring by specialists.
Skin and subcutaneous tissue disorders. In rare cases, at the beginning of therapy, an exacerbation of acne is noted, which usually disappears after 7-10 days without adjusting the dose of the preparation. Intense exposure to sunlight or UV rays should be avoided. If it is necessary to protect from the sun, highly protective factors with a light filter of at least 15. Do not carry out deep chemical dermabrasion and laser treatment during treatment with Acnetin and within 5-6 months after treatment, since there is a high risk of hypertrophic scars in atypical areas and less often - the appearance of hyper- and hypopigmentation in the treatment areas. During treatment with Acnetin and within 6 months after treatment, epilation cannot be carried out using wax applications due to the risk of epidermis exfoliation. The simultaneous use of Aknetin with local keratolytic or exfoliative agents for the treatment of acne should be avoided due to the possibility of increasing the severity of local irritation (see INTERACTIONS).
Patients receiving Acnetin are advised to use moisturizing ointments or body creams, lip balm to reduce dry skin and lips at the beginning of treatment.
In the post-registration period of using the preparation, cases of severe skin reactions (exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. Since these cases are difficult to differentiate from other skin reactions that may occur (see ADVERSE EFFECTS), patients should be warned of the signs and symptoms of these conditions and should be closely monitored for severe skin reactions. If skin reactions are suspected, treatment with isotretinoin should be discontinued.
Allergic reactions. Anaphylactic reactions have rarely been reported, in some cases after previous topical use of retinoids. Allergic skin reactions have been reported infrequently. Serious cases of allergic vasculitis, often with purple (blue and red spots), extremities and non-cutaneous manifestations have been reported. Serious allergic reactions require interruption of therapy and close monitoring.
Disorders of the organ of vision. Dry eyes, corneal opacities, deterioration in night vision and keratitis usually resolve after discontinuation of the preparation. If the mucous membrane of the eye is dry, applications of a moisturizing eye ointment or an artificial tear preparation can be used. If you are intolerant of contact lenses, glasses should be used during treatment.
In some patients, a decrease in night vision acuity is possible, which sometimes occurs suddenly (see. Ability to influence the reaction rate when driving vehicles or other mechanisms). If there are complaints of vision, such patients should be referred to an ophthalmologist and consider discontinuing the preparation.
Disorders of the musculoskeletal system and connective tissue. Against the background of the use of Acnetin, pain in the muscles and joints, an increase in CPK in the blood plasma are possible, especially with intense physical exertion (see SIDE EFFECTS).
Several years after the use of Aknetin for the treatment of dyskeratosis in very high doses, bone changes developed, including premature closure of the epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons. The dose level, duration of treatment, and total cumulative dose in these patients generally exceeded those recommended for acne treatment.
Benign intracranial hypertension. Cases of benign intracranial hypertension have been described, some of them were caused by simultaneous use with tetracyclines (see CONTRAINDICATIONS, INTERACTIONS). Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, blurred vision, and swelling of the optic papilla. Patients who develop benign intracranial hypertension should immediately discontinue the preparation.
Hepatobiliary disorders. It is recommended to monitor the level of liver enzymes before treatment, 1 month after its start, and then every 3 months, if there is no clinical indication for more frequent monitoring. There was a temporary and reversible increase in hepatic transaminases, in most cases within normal limits, which returned to normal during treatment. If the level of transaminases exceeds the norm, it is necessary to reduce the dose of the preparation  or cancel it.
Renal failure Renal impairment or renal failure does not affect the pharmacokinetics of isotretinoin. Therefore, isotretinoin can be taken by patients with renal insufficiency. However, it is recommended to start with a low dose and titrate to the maximum tolerated dose (see APPLICATION).
Lipid metabolism. It is necessary to determine the level of lipids in blood plasma on an empty stomach (before, 1 month after the start of treatment, then every 3 months, if there is no clinical indication for more frequent monitoring). Usually, an elevated plasma lipid level normalizes after dose reduction or preparation withdrawal, as well as if the diet is followed. The use of isotretinoin is associated with an increase in TG levels. Stop taking isotretinoin in case of uncontrolled hyperlipidemia or symptoms of pancreatitis. An increase in TG levels of 800 mg / dL or 9 mmol / L may be accompanied by the development of acute pancreatitis, possibly fatal.
Gastrointestinal Disorders. With isotretinoin treatment, inflammatory bowel disease (including regional ileitis) may develop in patients without a history of bowel disease. Patients with severe (hemorrhagic) diarrhea should immediately discontinue the preparation.
High-risk groups. Patients with diabetes mellitus, obesity, alcoholism or disorders of fat metabolism during treatment with isotretinoin may require more frequent monitoring of glucose and / or lipid levels in blood plasma. An increase in fasting blood glucose and the diagnosis of new cases of diabetes have been reported during treatment with isotretinoin.
Application during pregnancy or lactation. Pregnancy is an absolute contraindication to the use of isotretinoin (see CONTRAINDICATIONS). If pregnancy occurs during the period when a woman is taking isotretinoin, despite precautions, or within a month after the end of therapy, there is a very high risk of giving birth to a child with severe and serious malformations.
Isotretinoin-related fetal malformations include CNS abnormalities (hydrocephalus, cerebellar malformations / abnormalities, microcephaly), facial malformations, cleft palate, outer ear abnormalities (absence of the outer ear, small or absent external auditory canal), malformations development of eyes (microphthalmia), anomalies of the heart and blood vessels (conotruncal heart defects such as tetrad of Fallot, transposition of great vessels, defect of the septa), anomalies of the thymus and parathyroid glands. In addition, the risk of spontaneous miscarriages increases.
If pregnancy occurs in a woman who is being treated with isotretinoin, therapy should be discontinued and a doctor who specializes and has experience in teratology should be consulted for assessment and consultation.
Lactation. Due to the high lipophilicity of isotretinoin, there is a high probability that it passes into breast milk. Due to possible side effects in a child associated with the action of the preparation through breast milk, the use of isotretinoin is contraindicated during breastfeeding.
The ability to influence the reaction rate when driving vehicles or other mechanisms. During treatment and, in rare cases, after it, some patients experienced a decrease in the acuity of twilight vision (see SIDE EFFECTS, SPECIAL INSTRUCTIONS). Since in some individuals the manifestation of these phenomena was sudden, patients should be informed about the possibility of this problem and warned about the need to use caution when driving or other mechanisms. Very rarely, cases of drowsiness, dizziness, visual impairment have been reported. Patients should be warned that if these symptoms occur, they should not drive vehicles, operate machinery, or engage in any other activity that may endanger them or those around them.

Interactions

Due to the possible increase in the severity of symptoms of hypervitaminosis a, the simultaneous administration of isotretinoin and vitamin a should be avoided.
Cases of a benign increase in intracranial pressure (pseudotumor of the brain) have been reported with the simultaneous use of isotretinoin with tetracyclines. Therefore, simultaneous use with tetracyclines should be avoided (see CONTRAINDICATIONS, SPECIAL INSTRUCTIONS).
Combined use with topical keratolytic or exfoliative preparations for the treatment of acne is contraindicated due to the possible increase in local irritation (see SPECIAL INSTRUCTIONS).

Overdose

Isotretinoin is a vitamin A derivative. Although the acute toxicity of isotretinoin is low, in the event of an unintentional overdose, signs of vitamin A hypervitaminosis may appear. manifestations of acute vitamin A toxicity include severe headache, nausea or vomiting, drowsiness, irritability, itching. the symptoms of accidental and deliberate overdose are probably the same. these symptoms are reversible and disappear without the need for treatment.

Storage conditions

In original packaging at a temperature not exceeding 25 ° c.

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