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INTRODUCTION
ACFREE 10 TABLET contains Isotretinoin which belongs to the group of medicines called Retinoids. It is used in adults and children (older than 12 years of age) to treat severe form of acne (such as nodular acne, conglobate acne, and acne that is at risk of permanent scarring), which has not improved after other anti-acne treatments. Acne is an inflammatory skin condition which is characterized by spots, oily skin, nodular lesions etc. on face, back, and chest, which can be painful.
During treatment with ACFREE 10 TABLET your doctor might conduct certain blood tests and pregnancy tests, and you will be supervised by a skin doctor. You will be advised to reduce intensive exercise and physical activity. Before you go out in the sun, use a sunscreen with a high protection factor (SPF 15 or higher).
Avoid too much sun and using a sun-lamp or sun-bed. Avoid consuming alcohol while taking ACFREE 10 TABLET as it may cause side effects. Do not donate blood while consuming ACFREE 10 TABLET and after stopping ACFREE 10 TABLET at least for one month or undergo cosmetic procedures while taking ACFREE 10 TABLET or at least for 6 months after stopping it.
ACFREE 10 TABLET is not recommended for use in patients having liver or kidney disease, hyperlipidaemia (high blood lipid levels), high levels of Vitamin A. ACFREE 10 TABLET should be used with caution in patients who have or had mental illness or family history of mental illness, asthma, diabetes, heart or bone problems like osteoporosis, or eating disorder.
ACFREE 10 TABLET is not recommended for use in pregnant women, women planning a pregnancy, breast feeding women, and in children (below 12 years of age) so, consult your doctor for advice. ACFREE 10 TABLET should be used with caution in elderly patients (65 years and older).
ACFREE 10 TABLET may cause depression, psychosis, suicidal thoughts, or thoughts of self-harm in some patients. Consult your doctor if you experience any such behaviour or thoughts.
Most common side effects of taking ACFREE 10 TABLET are dry skin of face and lips, joint or muscle pain, headache, easy bruising or bleeding, weakness, etc. Consult your doctor if any of the symptoms deteriorate.
USES OF ACFREE 10 TABLET
- Used in adults and children (older than 12 years of age) to treat severe form of acne which has not improved after other anti-acne treatments
HOW ACFREE 10 TABLET WORKS
ACFREE 10 TABLET helps in treating acne by inhibiting the function of sebaceous glands (oil glands in skin) thus, reducing the secretion of oil (sebum) in the skin. ACFREE 10 TABLET also inhibits keratinization (development of a horn-like character by the epithelial tissue), which might be a cause of acne.
DIRECTIONS FOR USE
Take ACFREE 10 TABLET as advised by your physician. Do not crush or chew it. Swallow ACFREE 10 TABLET as whole with a glass of water or a mouthful of food. Take it on a full stomach. Your doctor will decide the right dose and duration of therapy for you according to your age, body weight and disease condition.
SIDE EFFECTS OF ACFREE 10 TABLET
COMMON
- dry skin, especially of the lips and face, inflamed skin, chapped and inflamed lips, rash, mild itching, slight peeling
- more fragile and red skin than usual, especially of the face
- back, muscle or joint pain (particularly in children and teenagers)
- inflammation of the eye and eyelid area, dry and irritated eyes
- raised liver enzymes
- changed blood fat and cholesterol levels
- easy bruising, bleeding or clotting
- anaemia (weakness, dizziness, pale skin)
- headache
- protein or blood in the urine
- becoming more prone to get infections
- dry and crusted inside of the nose causing mild nosebleeds
- sore or inflamed throat and nose
RARE
- hair loss
Stop taking ACFREE 10 TABLET and consult your doctor immediately in case you experience any of the following:
- persistent pain in your lower back or buttocks (signs of sacroiliitis)
- Severe skin reactions (Ex. erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis) (blistering and peeling of skin, severe rashes, fever, multiple lesions especially in mouth, nose, eyes and genitals, conjunctivitis, flu-like symptoms)
- depression or related disorders (sad or altered mood, anxiety, emotional discomfort), worsening depression, becoming violent or aggressive
- thoughts or feelings about hurting self or ending own lives, suicide attempts or suicide
- unusual behaviour
- psychosis (loss of contact with reality, like hearing voices or seeing things that are not real)
- serious reactions (trouble breathing or swallowing due to sudden swelling of the throat, face, lips and mouth, sudden swelling of the hands, feet and ankles, hives, bruises, eczema, bruising, red patches on hands and legs)
- sudden tight chest, breathlessness and wheezing, particularly if you have asthma
- rhabdomyolysis (muscle weakness along with trouble moving arms or legs, painful, swollen, bruised areas of the body, dark urine, reduced or no urination, confusion or dehydration)
- hepatitis (yellow skin or eyes, tiredness)
- kidney inflammation (difficulty urinating, swollen and puffy eyelids, excessive tiredness)
- increased intracranial pressure (continuous headache, along with nausea, vomiting and eyesight changes including blurred vision)
- serious gut conditions (severe tummy pain, with or without severe bloody diarrhoea, nausea, vomiting)
- vision problems like night vision problems, persistent dryness of eyes, intolerance to contact lenses
- inflamed pancreas
- hearing problems, ringing sound in ears
- severe muscle weakness, muscle, joint, back pain, difficulty moving especially after exercise
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take ACFREE 10 TABLET with, or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If nausea persists, contact your doctor.
Vomiting:
Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like eating – you don't have to eat or avoid any specific foods. Do not take any medicine for vomiting without your doctor's consultation. If vomiting does not get better, contact your doctor.
Diarrhoea:
Drink lots of fluids, like water or fruit juice to maintain hydration. Check with your doctor before taking any medicine for diarrhea. If diarrhea does not get better, contact your doctor.
Headache:
Drink plenty of water and get adequate rest. Try to be relaxed and stress free. Consult with your doctor before taking any medicine for headache. If headache persists, consult your doctor.
Dizziness:
Lie down until dizziness is improved, then get up slowly. Don’t hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs. If dizziness persists, consult your doctor.
Skin rash:
Avoid hot showers because hot water can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if your skin rash gets worse.
Eye irritation or itching:
Wash your eyes with plain cold water. Place an ice pack on your eye to soothe the irritation. Avoid straining your eyes by keeping away from mobile phones, laptops, or television. Wear protective sunglasses while going outdoors.
Blurred vision:
Avoid driving or going outside on your own if you have blurred eyesight. Close your eyes for some time until your eyesight gets clear. Contact your doctor if your vision remains blur for a long period.
WARNING & PRECAUTIONS
PREGNANCY
ACFREE 10 TABLET is not recommended for use in pregnant women and women planning a pregnancy. Inform your doctor if you become pregnant during treatment with ACFREE 10 TABLET. It is not recommended to get pregnant for one month after stopping ACFREE 10 TABLET treatment because some medicine may still be left in your body. Consult your doctor before taking it.
Contraception must be used for a month before taking ACFREE 10 TABLET, during treatment and for a month afterwards. Discuss with your doctor regarding suitable contraceptive methods.
BREASTFEEDING
ACFREE 10 TABLET is not recommended for use in breast feeding women as it may pass through breast milk. Consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate machinery if you experience dizziness, drowsiness or decreased night vision after taking ACFREE 10 TABLET.
ALCOHOL
Avoid consuming alcohol while taking ACFREE 10 TABLET as it may increase side effects. Inform your doctor if you are an alcoholic.
KIDNEY
ACFREE 10 TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking it.
LIVER
ACFREE 10 TABLET is not recommended for use in patients with liver disease. Consult your doctor before taking it.
ALLERGY
Do not take ACFREE 10 TABLET if you are allergic to Isotretinoin, soya, peanuts or any of the other ingredients of this medicine.
LUNGS
ACFREE 10 TABLET should be used with caution in patients having asthma. Consult your doctor before taking it.
OTHERS
ACFREE 10 TABLET is not recommended for use if you have:
- high blood fat levels
- high levels of Vitamin A
Before taking ACFREE 10 TABLET inform your doctor if you:
- have or had mental illness or family history of mental illness such as depression, mood disorders, psychosis, aggressive behaviour, or hurting or killing self
- have diabetes
- are fructose intolerant
- are overweight
Use in paediatrics:
ACFREE 10 TABLET is not recommended for use in children below 12 years of age. ACFREE 10 TABLET can be used in adolescents (more than 12 years of age) only after puberty. Consult your child’s doctor for advice.
Use in geriatrics:
There is no proper information about the use of ACFREE 10 TABLET in elderly patients. Consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ACFREE 10 TABLET, inform your doctor if you are taking any of the following medicines:
- Vitamin A supplements
- medicines used to treat bacterial infections (Ex. minocycline, doxycycline)
- phenytoin (used to treat fits)
- medicines used to treat various inflammatory conditions (Ex. betamethasone, prednisolone, dexamethasone)
- medicines used to prevent pregnancy (Ex. Norethindrone, ethinyl Oestradiol)
- St. John’s wort (herbal medicine used to treat mental disorders)
- other medicines used to treat acne like keratolytic or exfoliative agents (Ex. salicylic acid, benzoyl peroxide)
Overdosage:
In case you or anybody else accidently take too much of ACFREE 10 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of ACFREE 10 TABLET overdose are severe headache, abdominal pain, nausea, dizziness, redness of face, vomiting, somnolence, irritability, and itching.
SYNOPSIS
| Drug | : | Isotretinoin |
| Pharmacological Category | : | Retinoids |
| Therapeutic Indication | : | Severe Acne |
| Dosage Forms | : | Tablet, Soft gel Capsule, Capsule |
MORE INFORMATION
- Keep ACFREE 10 TABLET out of reach of children
- Store ACFREE 10 TABLET between 15-30°C
FAQs ABOUT ACFREE 10 TABLET
Can ACFREE 10 TABLET cause irregular periods?
According to some studies, menstrual irregularity was observed during treatment follow-ups. Consult your doctor if you experience irregularity in your periods during treatment with ACFREE 10 TABLET.
Is ACFREE 10 TABLET safe to take in pregnancy?
No. ACFREE 10 TABLET is not recommended for use in pregnant women and women planning a pregnancy. Inform your doctor if you become pregnant during treatment with ACFREE 10 TABLET. It is not recommended to get pregnant for one month after stopping ACFREE 10 TABLET treatment because some medicine may still be left in your body. Consult your doctor before taking it. Contraception must be used for a month before taking ACFREE 10 TABLET, during treatment and for a month afterwards. Discuss with your doctor regarding suitable contraceptive methods.
Can I play sports during ACFREE 10 TABLET treatment?
Cut down on extreme exercise and physical activity as ACFREE 10 TABLET can cause muscle and joint pain especially in children and teenagers taking up vigorous physical activity. Consult your doctor if you can play sports during this treatment.
Can I go out in the sun during ACFREE 10 TABLET treatment?
Sensitivity to light may increase during treatment with ACFREE 10 TABLET so, avoid going too much into the sun and don’t use a sun-lamp or sun-bed. Before you go out in the sun, wear sunglasses and use sunscreen with a high protection factor (SPF 15 or higher).
Can undergo cosmetic procedures while taking ACFREE 10 TABLET?
No. Do not undergo cosmetic procedures such as skin waxing, dermabrasion, laser, or artificial UV light detanning while taking ACFREE 10 TABLET or at least for 6 months after stopping it as they could cause scarring, skin irritation, or changes in your skin colour. Consult your doctor before undergoing any cosmetic procedure while taking ACFREE 10 TABLET.
REFERENCES
1. KD Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of Medical Pharmacology, 7th edition 2013. Page- 894.
2. Layton A. The use of isotretinoin in acne. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. May-June 2009. [Accessed on 8th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2835909/
3. Jellerichs, Bradley. Clinical Use of Isotretinoin. Journal of the Dermatology Nurses’ Association. 2018. [Accessed on 8th October 2022] https://journals.lww.com/jdnaonline/Abstract/2018/01001/Clinical_Use_of_Isotretinoin.4.aspx
4. Ennogen Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in March 2022]. [Accessed on 8th October 2022] https://www.medicines.org.uk/emc/files/pil.10519.pdf
5. Sun Pharmaceutical Industries. Isotretinoin. [Revised in April 2022]. [Accessed on 8th October 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ef0cff8-19c1-4441-b780-fca6c7ee1615
USEFUL DIAGNOSTIC TESTS
- Blood Glucose tests
- Liver function test
- Pregnancy tests
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