Acnutan BSK®

Each liquid capsule contains 10 or 20 mg of Isotretinoin as the active ingredient.

Each box contains 30 liquid Capsules and patient leaflet.

Always take isotretinoin exactly as your doctor told you.

Take on full stomach

Swallow the capsules whole with a glass of water  

To relieve dry mouth suck one sugarless hard candies or chew sugarless gum.

Your acne may get worse during the beginning of treatment but this is normal

Treatment of cystic or nodular acne which is at risk of causing permanent scarring in adults and adolescents from 12 years of age only after puberty.

Isotretinoin reduce skin oil and inflammation.

AcnutanBSK ^® contains Isotretinoin – a substance related to vitamin A, and one of a group of medicines called retinoid for treatment of cystic or nodular acne which is at risk of causing permanent scarring in adults and adolescents from 12 years of age only after puberty. You will use Isotretinoin when your acne has not got better with anti-acne treatments, including antibiotics (tetracycline or minocycline) and skin treatments. Isotretinoin reduce skin oil and inflammation.

AcnutanBSK ^® 10&20 mg capsules treatment must be supervised by a dermatologist (a doctor specialized in the treatment of skin problems).

Tell your doctor or pharmacist if you are taking or have recently taken or might take any of the following medicine:

Any other medicines including herbal and non-prescription products

Do not take vitamin A supplements or tetracycline (a type of antibiotic), or use any skin treatment for acne while you are on Isotretinoin.

Skin irritation may be increased if Isotretinoin is given with topical anti-acne treatment

Avoid taking Isotretinoin with hormonal contraceptives, phenytoin and corticosteroids.

Do not take Isotretinoin:

If you are pregnant or think may be

If you are breastfeeding

If you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention Programm

If you are allergic to Isotretinoin or other vitamin A derivatives, peanut or soya or any other ingredients of this medicine

If you have liver disease

If you have very high levels of blood fats (e.g. high cholesterol or triglycerides)

 If you have very high levels of vitamin A in your body (hypervitaminosis A)

  If you have diabetes

  If you have bone disorder such as osteoporosis, osteomalacia or decreased bone density.

In case of alcohol abuse.

If you are receiving treatment with tetracyclines (a type of antibiotic) at the same time (see “Other medicines and Isotretinoin”)

If any of these apply to you, go back to your doctor before taking any Isotretinoin.

 Isotretinoin is likely to damage an unborn baby (in medical language it is teratogenic).

With oral use Measure hepatic function and serum lipids before treatment, 1 month after starting and then every 3 months (reduce dose or discontinue if transaminase or serum lipids persistently raised).

Patient should avoid exposure to UV light (including sunlight) and use sunscreen and emollient (including lip balm) preparations from the start of treatment.

With oral use Warn patient to avoid wax epilation (risk of epidermal stripping), dermabrasion, and laser skin treatments (risk of scarring) during treatment and for at least 6 months after stopping.

You must remember not to share your medication with anyone else.

The use of Isotretinoin in children under the age of 12 is not recommended.  This is because it is not known if Isotretinoin is safe or effective in this age group.

Do not donate blood while you are taking Isotretinoin or for one month afterwards.

Talk to your doctor or pharmacist before taking isotretinoin capsules if you have:

• A history of diabetes,
• Dry eye syndrome (associated with risk of keratitis)
• A history of depression (monitor for depression)
• Any kidney problems  

If you forgot one dose, take it as soon as you remember but if it is almost time for the next dose, skip it and take the drug as directed by the doctor.

Like all medicines, isotretinoin can cause side effects although not everybody gets them. If you are worried, speak to your doctor.

Common side effect:

Anemia , arthralgia , dryness of eyes (with blepharitis and conjunctivitis) . dryness of lips (sometimes cheilitis) . dryness of nasal mucosa (with epistaxis) . dryness of pharyngeal mucosa (with hoarseness) . dryness of skin (with dermatitis, scaling, thinning, erythema,  pruritus) . epidermal fragility (trauma may cause blistering) . hematuria . headache . myalgia . neutropenia proteinuria . raised blood-glucose concentration . raised plasma-triglyceride and cholesterol concentration (with reduced high-density lipoprotein concentration) . raised serum-transaminase concentration . thrombocytopenia . thrombocytosis

Less common or rare:

Aggressive behaviour .alopecia .anxiety .depression .mood changes .skin reactions

Acne fulminant . allergic vasculitis . arthritis . benign intracranial hypertension . blurred vision . bone changes following long-term administration . calcification of tendons and ligaments following long-term administration . cataracts . colour blindness . convulsions . corneal opacities . decreased night vision . decreased tolerance to contact lenses . diabetes mellitus . dizziness . drowsiness . early epiphyseal closure following long-term administration . exacerbation of acne . gastrointestinal hemorrhage . glomerulonephritis . Gram-positive infections of skin and mucous membranes. granulomatous lesions . hemorrhagic diarrhea . hepatitis . hirsutism . hyperuricemia . Impaired hearing . increased sweating . inflammatory bowel disease . keratitis . lymphadenopathy malaise . nail dystrophy . nausea . papilledema . paronychia . photophobia . photosensitivity . psychosis .

raised serum-creatine kinase concentration . reduced bone density following long-term administration . skeletal hyperostosis following long-term administration . skin hyperpigmentation suicidal ideation . tendinitis . visual disturbances.

In rare case, fetal pancreatitis has been reported with Isotretinoin

Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) have rarely been observed when treating with Isotretinoin.

Isotretinoin is contradicted during pregnancy and breastfeeding

Keep this medicine below 25 °C and protect it from light and moisture.

Store in the original package.

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blisters. The expiry date refers to the last day of that month