Patient leaflet - ISOTRETINOIN 5 MG CAPSULES
3. how to take isotretinoin 5 mg
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults including adolescents and the elderly
The usual starting dose is 0.5 mg per kilogram body weight per day (0.5 mg/kg/day). So if you weigh 60 kg, your dose will usually start at 30 mg a day.
Take the capsules once or twice daily.
Take on a full stomach. Swallow them whole, with a drink or a mouthful of food.
After a few weeks your doctor may adjust your dose. This will depend on how you are getting on with your medicine. For most patients the dose will be between 0.5 and 1.0 mg/kg/day. If you think that Isotretinoin 5 mg is too strong or too weak, talk to your doctor or pharmacist.
Patients with severe renal insufficiency
If you have severe kidney problems, you will usually start on a lower dose (such as 10 mg/day) which will be increased up to the highest dose your body can tolerate. If your body can't tolerate the recommended dose, you may be prescribed a lower dose: that can mean you are treated for longer and your acne might be more likely to come back.
Use in children
Isotretinoin is not recommended for use in children less than 12 years of age due to insufficient data on efficacy and safety. Use in children over 12 years only after puberty.
A course of treatment usually lasts for 16 to 24 weeks. Your acne may continue to improve for up to 8 weeks after the treatment finishes. You won't usually start another course until then.
Some people find their acne gets worse during the first weeks of treatment. It usually improves as treatment goes on.
If you take more Isotretinoin 5 mg than you should
The following symptoms are possible: severe headache, nausea or vomiting, somnolence, irritability and itching. If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.
If you forget to take Isotretinoin 5 mg
If you miss a dose take it as soon as you can. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The effects often wear off, or stop when treatment is stopped. Others can be serious and you must immediately contact your doctor.
Side effects requiring immediate medical attention:
Skin problems
Unknown frequency (frequency cannot be estimates from available data)'.
- Serious skin rashes (erythema multiforme, Stevens-Johnsons syndrome and toxic epidermal necrolysis), which are potentially life-threatening and require immediate medical attention. These appear initially as circular patches often with central blisters usually on arms and hands or legs and feet, more severe rashes may include blistering of the chest and back. Additional symptoms such as infection of the eye (conjunctivitis) or ulcers of the mouth, throat or nose may occur. Severe forms of rash may progress to widespread peeling of the skin which can be life threatening. These serious skin rashes are often preceded by headache, fever, body aches (flulike symptoms).
If you develop a serious rash or these skin symptoms, stop taking Isotretinoin 5 mg and contact your doctor immediately.
Mental problems
Rare (may affect up to 1 in 1,000 people):
- Depression or related disorders. Signs of this include sad or altered mood, anxiety, feelings of emotional discomfort.
- Existing depression getting worse.
- Becoming violent or aggressive.
Very rare (may affect up to 1 in 10,000 people):
- Some people have had thoughts or feelings about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide). These people may not appear to be depressed.
- Unusual behaviour.
- Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.
Contact your doctor straight away if you get signs of any of these mental problems. Your doctor may tell you to stop taking Isotretinoin 5 mg. That may not be enough to stop the effects: you may need more help, and your doctor can arrange this.
Allergic reactions
Rare (may affect up to 1 in 1,000 people)'.
- Serious (anaphylactic) reactions: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth. Also sudden swelling of the hands, feet and ankles.
Very rare (may affect up to 1 in 10,000 people)'.
- Sudden tight chest, shortness of breath and wheezing, particularly if you have asthma.
If you have a serious reaction, get emergency medical help immediately.
If you have any allergic reaction, stop taking Isotretinoin 5 mg and contact your doctor.
Bones and muscles
Unknown frequency (frequency cannot be estimated from available data)'.
- Muscle weakness which can be potentially life-threatening, may be associated with trouble moving arms or legs, painful, swollen, bruised areas of the body, dark-coloured urine, reduced or no urine output, confusion or dehydration. These are signs of rhabdomyolysis, a breakdown of muscle tissue which can lead to kidney failure. This may occur if you are doing intensive physical activity while you're on Isotretinoin 5 mg.
Liver and kidney problems
Very rare (may affect up to 1 in 10,000 people)'.
- Yellow skin or eyes, and feeling tired. These can be signs of hepatitis.
Stop taking Isotretinoin 5 mg straight away and contact your doctor.
- Difficulty urinating (passing water), swollen and puffy eyelids, feeling excessively tired. These may be signs of kidney inflammation.
Stop taking Isotretinoin 5 mg straight away and contact your doctor.
Nervous system problems
Very rare (may affect up to 1 in 10,000 people)'.
- Lasting headache, along with feeling sick (nausea), being sick (vomiting) and change in your eyesight including blurred vision. These may be signs of benign intracranial hypertension, especially if Isotretinoin 5 mg is taken with antibiotics called tetracycline.
Stop taking Isotretinoin straight away and contact your doctor.
Gut and stomach problems
Very rare (may affect up to 1 in 10,000 people)'.
- Severe abdominal (tummy) pain, with or without severe bloody diarrhoea, feeling sick (nausea) and being sick (vomiting). These can be signs of serious gut conditions.
Stop taking Isotretinoin 5 mg straight away and contact your doctor.
Eye disorders
Very rare (may affect up to 1 in 10,000 people)'.
- Blurred vision.
If you get blurred vision, stop taking Isotretinoin 5 mg straight away and contact you doctor. If your sight is affected in any other way tell a doctor as soon as you can
Other side effects:
Very common (may affect more than 1 in 10 people)
- Dryness of the skin, especially of the lips and face; inflamed skin, chapped and inflamed lips, rash, mild itching and slight peeling. Use a moisturising cream from the start of treatment.
- Skin becomes more fragile and redder than usual, especially the face.
- Back pain; muscle pain; joint pain particularly in children and teenagers.
- To avoid making any bone or muscle problems worse, cut down on intensive physical activity while you're on Isotretinoin 5 mg.
- Inflammation of the eye (conjunctivitis) and eyelid area; eyes feel dry and irritated. Ask a pharmacist for suitable eye drops. If you get dry eyes and wear contact lenses, you may need to wear glasses instead.
- Raised liver enzymes seen in blood tests.
- Changed levels of fats in the blood (including HDLor triglycerides).
- Bruising, bleeding or clotting more easily if clotting cells are affected.
- Anaemia weakness, dizziness, pale skin if red blood cells are affected.
Common (may affect up to 1 in 10 people):
- Headache.
- Higher levels of cholesterol in the blood.
- Protein or blood in the urine.
- More liable to get infections if the white blood cells are affected.
- Inside of the nose becomes dry and crusted, causing mild nosebleeds.
- Sore or inflamed throat and nose.
- Allergic reactions such as rash, itchiness. If you have any allergic reaction, stop taking Isotretinoin 5 mg and contact your doctor.
Rare (may affect up to 1 in 1,000 people)'.
- Hair loss (alopecia). This is usually only temporary. Your hair should return to normal after the treatment ends.
Very rare (may affect up to 1 in 10,000 people)'.
- You may see less well at night; colour blindness and colour vision gets worse.
- Sensitivity to light may increase; you may find that you need to wear sunglasses to protect your eyes from too bright sunlight.
- Other sight problems including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).
- Excessive thirst; frequent need to urinate; blood tests show an increase in your blood sugar. These can all be signs of diabetes.
- Acne can get worse in the first few weeks, but symptoms should improve with time.
- Skin inflamed, swollen, and darker than usual, especially on the face.
- Excess sweating or itching.
- Arthritis; bone disorders (delayed growth, extra growth and changes to bone density); growing bones may stop growing.
- Calcium deposits in soft tissue, sore tendons, high levels of muscle breakdown products in your blood if you exercise vigorously.
- Increased sensitivity to light.
- Bacterial infections at the base of the nail, changes to nails.
- Swellings, discharging, pus.
- Thickened scarring after surgery.
- Increased body hair.
- Convulsions, drowsiness, dizziness.
- Lymph glands may become swollen.
- Dry throat, hoarseness.
- Hearing difficulties.
- Generally feeling unwell.
- High levels of uric acid in the blood.
- Bacterial infections.
- Inflammation of the blood vessels (sometimes with bruising, red patches).
Unknown frequency (frequency cannot be estimated from available data)'.
- Dark or cola-coloured urine
- Problems getting or maintaining an erection
- Lower libido
- Breast swelling with or without tenderness in males
- Vaginal dryness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website:
Osterreich
Bundesamt fur Sicherheit im Gesundheitswesen
Traisengasse 5 1200 WIEN
OSTERREICH
Fax: + 43 (0) 50 555 36207
Website:
5. how to store
ISOTRETINOIN 5 MG
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package.
Important! Please return any unused capsules to your pharmacist at the end of treatment. Only keep it if your doctor tells you to.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Isotretinoin 5 mg contains The active substance is Isotretinoin.
Each capsule contains 5 mg of isotretinoin.
The other ingredients are:
Capsule filling:
Soya-bean oil, refined all-rac-a-Tocopherol Disodium edetate Butylhydroxyanisole (E 320) Soya-bean oil, partially hydrogenated Hydrogenated vegetable oil Beeswax, yellow
Capsule shell:
Gelatin Glycerol
Sorbitol, liquid (non-crystallising) (E 420)
Purified water
Titanium dioxide (E 171)
What Isotretinoin 5 mg looks like and contents of the pack
The soft-gelatin capsules are faint pinkish/cream to cream coloured oval, containing a yellow/orange, opaque, viscous liquid.
The capsules come in blister packs of 10, 15, 20, 30, 50, 56 or 60 capsules [Not all pack sizes may be marketed.]
Marketing Authorisation Holder and Manufacturer
Ennogen Healthcare Limited Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, UK
This leaflet was last revised in March 2020.
Other sources of information
Detailed information on this medicine is available on the Medicines and Healthcare Products Regulatory Agency website:
ENV03
^jinogen Healthcare
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- ■(Ajesseoeu jou si siqj sepioep jojoop jnoA sse|un) eAijoe A||enxes jou eje noA jo spoued eAeq jou op noA ji ueAe uoijdeoejjuoo esn jsnw noA spjBMjejjB qjuow b joj pus juewjBejj Buunp ‘Bw g uiouijejjosi 6ui>|bj ejojeq qjuow
- b joj uoijdeoBJjuoo esn jsnw noA noA joj eiqejins
eq p|noM spoqjew qoiqM jojoop jnoA qjiM ssnosiQ '(wopuoo b puB ||id eAijdeoBJjuoo |Buowjoq b e|dwBxe joj) sAbm juejejjip ui 410M jBqj spoqjew eAijoejje omj ‘jo (juB|dwi eAijdeoBJjuoo jo eoiAep euuejn bjjui ub e|dwBxe joj) uoijdeoBJjuoo
- jo poqjew e|qBi|ej Ajba euo jseei jb esn oj eejfie jsnw noA
Bw g uiouijejjosi Bui^ej jejje pue Buunp ‘ejojeq uoijdeoejjuoo eAijoejje esn jsnw uewo/vt
- ■fiw g uiouijejjosi qjiM juewjeejj fiuijjejs ueqM jueuBejd jou eje noA jeqj Moqs jsnw jsej eqj_ qsej AoueuBejd e e>|ej oj noA >|se him jojoop jnoA ‘juewjeejj jjbjs noA ejojeg eoiApB uoijdeoBJjuoo joj jsi|Bioeds b oj noA pues Abw jojoop eqj_ quBufiejd jeB oj jou Moq uo uoijbwjojui noA eAifi ||im jojoop eqj_ jojoop jnoA qjiM (iojjuoo qjjjq) uoijdeoBJjuoo jnoqB pe>||Bj eABq jsnw noA juBufiejd
- BuijjeB jueAejd oj op oj peeu noA jaqM pue juBufiejd jeB jou jsnw noA AqM puBjsjepun jsnw noA – Aqsq woqun eqj oj wjeq jo >|su eqj uiB|dxe jsnw jojoop jnoA :se|nj eqj bjb eseqj.
Aqeq ujoqun eqj oj wjeq snoues jo ^su eqj jo esneoeq si siqj. se|nj joujs jepun Bw g uiouijejjosi pequosejd eje jueuBejd jeB pinoo oqM uewo/vt
- Apoq jnoA ui jje| eq ||ijs Abw euioipew ewos esneoeq juewjeejj siqj Buiddojs jejje qjuow euo joj jueuBejd jeB jou jsnw noA juewjeejj Buunp jueuBejd jeB pinoo noA ji Bw
- g uiouijejjosi e>|ej jou jsnw noA Aqeq
jnoA wjeq Aew pue >niw jnoA ojui ssed oj A|e>m si euioipew eqj. 'Buipeej-jseejq eje noA ji Bw
- g uiouijejjosi e>|ej jou jsnw noA jueuBejd eq jqBiw noA ^juiqj
- noA ji jo jueuBejd eje noA ji Bw g uiouijejjosi e>|ej jou jsnw noA
AoueuBejd Buunp ewij poqs e joj A|uo ue>|ej si Bw g uiouijejjosi ji ueAe ueddeq Aew siqj_ A|e>|!| ejow efieujeosiw e se>|ew os|e j| (pue|6 piojAqjejed pue pue|6 snwAqj) spue|6 uiejjeo pue jjeeq ‘eAe ‘jee ‘eoej ‘uiejq s.Aqeq woqun eqj jo seijjiewjouqe snoues esneo ueo ji – (.oiuefiojejej, eq oj pies si euioipew eqj) Aqeq woqun ue wjeq A|snoues ueo euioipew siqj_
Bw g uiouijejjosi e^ej jou jsnw jueuBejd eje oqM uewo/vt
ewwejBojg uoijueAejg AoueuBejg
■fiw g uiouijejjosi
- Bupiej e|iqM pejoejje eq Aew poow jnoA esneoeq si siqj_ eji| jnoA Buipue jo j|esjnoA Buijjnq jnoqe sjqfinoqj sepn|oui os|e j| sefiueqo poow jo seiouepuej eAissejfiBe ‘uoissejdep sepn|oui siqj_ sweiqojd qj|eeq |ejuew jo pui>| Aue peq jeAe eAeq noA j| :6w g uiouijejjosi Bupiej ejojeq jsioewjeqd jo jojoop jnoA oj >||ej_ suoijneoejd pue sBuiujbm
■fiw g uiouijejjosi
Aub 6ui>|bj ejojeq jojoop jnoA oj >|OBq oB noA oj A|dde eseqj jo Aue j| (.,6w g uiouijejjosi pue seuioipew Jeqjo,, ees) ewij ewes eqj jb (oijoiqijuB jo edAj b) seuipAoejjej qjiM
- juewjeejj BuiAieoej eje noA ji
(y sisouiwejiAjedAq)
Apoq jnoA ui y uiwbjia
- jo s|eAe| qfiiq Ajoa eAeq noA ji (sepueoA|6uj jo
- |ojejse|oqo qfiiq fi e) sjbj pooiq jo s|eAe| qfiiq Ajoa eAeq noA ji
- eseesip joaii eAeq noA ji
(9 uoijoes ui pejsi|) euioipew siqj jo sjueipejBui jeqjo Aue jo eAos jo jnueed ‘u/ou/jeojos/
- oj oiBjene eje noA ji
"Suoijneoejd pue s6uiwb/\/\„ uo uoijoes ees ‘„ewwBjfiojd
- uoijueAejd pue AoueuBejd,, jepun suoijneoejd eqj mo||oj jsnw noA ‘jueuBejd ewooeq pinoo noA eoueqo Aue si ejeqj j|
■fiuipeej
- -jseejq jo jueuBejd eje noA j| :Bw g uiouijejjosi e)|ej jou og
9IAI
9 NIONIiaaiOSI 3XV1 nox aaodaa monx
01 aasN noAivHM z
(sweiqojd ui>|s jo juewjeejj eqj ui pesi|eioeds jojoop e) jsiBo|ojewjep e Aq pesiAjedns eq jsnw juewjeejj Bw g uiouijejjosi
sjuewjeejj up>|s pue soijoiqijue |bjo fiuipnpui ‘sjuewjeejj euoe-ijue jeqjo jejje jejjeq jofi jou seq euoe jnoA ueqM fiw g uiouijejjosi esn him nox Ajjeqnd jejje A|uo efie jo sjeeA 3} wojj sjueoseppe pue sj|npe ui (Buujbos jueuewjed jo >|su je euoe jo ‘euoe ejeqo|6uoo jo JB|npou se qons) euoB jo swjoj ejeAes jbsjj oj pesn si fiw g uiouijejjosi seuioipew jo ssep pjouijej eqj oj 6uifiuo|eq ‘eAijBAuep y uiwbjia b siqj_ uiouijejjosi jueipejfiui saijob eqj uibjuoo seinsdeo fiw g uiouijejjosi
uod assn
SI 111VHM a NV SI 9IAI
9 NIONIiaaiOSI 1VHM 'I
UOIJBWJOJUI
jeqjo pue >|OBd eqj jo sjuejuog 9 fiw g uiouijejjosi ejojs oj moh g sjoejje epis eiqissoj 'y fiw g uiouijejjosi e>|Bj oj moh £ fiw g uiouijejjosi e>|Bj noA ejojeq mou>| oj peeu noA jBq/y\ 3 joj pesn ji si jeqM pue si fiw g uiouijejjosi jBq/y\ ■ j
:je|jee| siqj ui si jeqM
-y uoijoes ees
■je|jBe| siqj ui pejsi| jou sjoejje epis eiqissod Aub sepnioui siqj_ jsiOBWJBqd jo jojoop jnoA oj
- >||bj ‘sjoejje epis Aub jefi noA j| sjnoA
- sb ewBS eqj bjb sseum jo sufiis jieqj ji ueAe ‘weqj wjeq Abw ji sjeqjo oj uo ji sssd jou oq A|uo noA joj pequosejd ueeq seq euioipew siqj_ jsiOBWJBqd
- jo jojoop jnoA >|sb ‘suoijsenb jeqjjnj Aub eABq noA j| uibBb ji pBej oj
- peeu Abw nox js|jee| siqj deeyj noA joj uoijbwjojui juejjodwi suiejuoo ji esneoeq euioipew
siqj fiui^ej jjbjs noA ejojeq A||njejBO je|jee| siqj jo ||B peey
sjoejje epis podej oj Moq joj y uoijoes jo pue eqj ees Abw noA sjoejje epis Aub fiuijjodej Aq d|eq ubo nox uoijbwjojui AjejBS Meu jo uoijBOjjijuepi >)oinb M0||B ||IM siqj_ 'fiUUOJIUOW IBUOlJippB oj joefqns si euioipew siqj.^
jueuBejd eq Abw noA ^juiqj jo juBufiejd bjb noA ji esn jou oq
uoijdeoBJjuoo eAijoejje esn jsnw uewo/y\
xava NHoaNn NV IAIHVH A3SAOIH3S NVO
DNINdVM
uiouijejjosi
seinsdeo Sui g uiouijejjosi
H3SA 3H1HO3 NOI1VIAIHO3NI :133dV33 SDVMDVd