TRETIVA 10MG CAPSULE 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 TRETIVA 10MG CAPSULE 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 TRETIVA 10MG CAPSULE as it may cause side effects. Do not donate blood while consuming TRETIVA 10MG CAPSULE and after stopping TRETIVA 10MG CAPSULE at least for one month or undergo cosmetic procedures while taking TRETIVA 10MG CAPSULE or at least for 6 months after stopping it.
TRETIVA 10MG CAPSULE is not recommended for use in patients having liver or kidney disease, hyperlipidaemia (high blood lipid levels), high levels of Vitamin A. TRETIVA 10MG CAPSULE 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.
TRETIVA 10MG CAPSULE 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. TRETIVA 10MG CAPSULE should be used with caution in elderly patients (65 years and older).
TRETIVA 10MG CAPSULE 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 TRETIVA 10MG CAPSULE 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 TRETIVA 10MG
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 TRETIVA 10MG WORKS?
TRETIVA 10MG CAPSULE 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. TRETIVA 10MG CAPSULE also inhibits keratinization (development of a horn-like character by the epithelial tissue), which might be a cause of acne.
DIRECTIONS FOR USE
Take TRETIVA 10MG CAPSULE as advised by your physician. Do not crush or chew it. Swallow TRETIVA 10MG CAPSULE 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 TRETIVA 10MG
COMMON EFFECTS OF TRETIVA 10MG
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 EFFECTS OF TRETIVA 10MG
Hair loss
Stop taking TRETIVA 10MG CAPSULE 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
Severe muscle weakness, muscle, joint, back pain, difficulty moving especially after exercise
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take TRETIVA 10MG CAPSULE 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
TRETIVA 10MG CAPSULE is not recommended for use in pregnant women and women planning a pregnancy. Inform your doctor if you become pregnant during treatment with TRETIVA 10MG CAPSULE. It is not recommended to get pregnant for one month after stopping TRETIVA 10MG CAPSULE 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 TRETIVA 10MG CAPSULE, during treatment and for a month afterwards. Discuss with your doctor regarding suitable contraceptive methods.
BREAST FEEDING
TRETIVA 10MG CAPSULE 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 TRETIVA 10MG CAPSULE.
ALCOHOL
Avoid consuming alcohol while taking TRETIVA 10MG CAPSULE as it may increase side effects. Inform your doctor if you are an alcoholic.
KIDNEY
TRETIVA 10MG CAPSULE should be used with caution in patients with kidney problems. Consult your doctor before taking it.
LIVER
TRETIVA 10MG CAPSULE is not recommended for use in patients with liver disease. Consult your doctor before taking it.
ALLERGY
Do not take TRETIVA 10MG CAPSULE if you are allergic to Isotretinoin, soya, peanuts or any of the other ingredients of this medicine.
LUNGS
TRETIVA 10MG CAPSULE should be used with caution in patients having asthma. Consult your doctor before taking it.
OTHERS
TRETIVA 10MG CAPSULE is not recommended for use if you have:
High blood fat levels
High levels of Vitamin A
Before taking TRETIVA 10MG CAPSULE 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:
TRETIVA 10MG CAPSULE is not recommended for use in children below 12 years of age. TRETIVA 10MG CAPSULE 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 TRETIVA 10MG CAPSULE in elderly patients. Consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking TRETIVA 10MG CAPSULE, 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 TRETIVA 10MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of TRETIVA 10MG CAPSULE overdose are severe headache, abdominal pain, nausea, dizziness, redness of face, vomiting, somnolence, irritability, and itching.
MORE INFORMATION
Keep TRETIVA 10MG CAPSULE out of reach of children
Store TRETIVA 10MG CAPSULE between 15-30°C
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