10 mg, 20 mg capsules, soft
Isotretinoin

What Isotretinoin Orifarm is and what it is used for

Isotretinoin Orifarm contains the active substance isotretinoin. It is related to vitamin A and belongs to a group of drugs called retinoids. Retinoids are commonly used to treat skin problems.

Isotretinoin Orifarm is used for treating severe forms of acne (such as nodular or conglobatic acne or acne with a risk of permanent scarring) that have not shown improvement after other treatments for acne, including antibiotic treatment and topical treatment. 

Isotretinoin contained in Isotretinoin Orifarm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Isotretinoin Orifarm

Isotretinoin should only be prescribed by or under the supervision of a physician who has specialist knowledge in the use of systemic retinoids for the treatment of severe acne and fully understands the risks of isotretinoin treatment and the requirements for monitoring.
You can get written information about the use of isotretinoin from your doctor. If you have not received this material, contact your doctor

Do not take Isotretinoin Orifarm:

  • If you are pregnant or breastfeeding. 
  • If there is a possibility that you could become pregnant, you must follow the precautions under “Pregnancy prevention program”, see the section in “Warnings and precautions”.
  • If you are allergic to isotretinoin, soy, peanuts or any of the other ingredients of this medicine (listed in section 6). 
  • If you have impaired liver function. 
  • If you have very high levels of blood fats.
  • If you have very high levels of vitamin A in your body. 
  • If you are taking tetracycline (a type of antibiotic ). 

Warnings and cautions

Pregnancy prevention programs


Pregnant women should not take Isotretinoin Orifarm
This medicine can seriously harm an unborn baby (the drug is so-called “teratogenic”) – it can cause severe malformations of the unborn baby’s brain, face, ears, eyes, heart, and certain glands ( thymus and parathyroid gland). It also increases the risk of miscarriage. This can happen even if Isotretinoin Orifarm is only taken for a short time during pregnancy.

  • You must not take Isotretinoin Orifarm if you are pregnant or think you may be pregnant.
  • You must not take Isotretinoin Orifarm if you are breast-feeding. Isotretinoin Orifarm is likely to pass into breast milk and may harm your baby.
  • You must not take Isotretinoin Orifarm if you may become pregnant at any time during treatment.
  • You must not become pregnant for one month after stopping this treatment as a certain amount of medicine may still be present in your body.

Women who may become pregnant are prescribed Isotretinoin Orifarm under very strict conditions. This is due to the risk of very serious injuries to the unborn baby.
These are the conditions:

  • Your doctor must have explained the risk of birth defects: you must understand why you must not become pregnant and how to prevent pregnancy.
  • You must have discussed the use of effective contraception with your doctor, the doctor should give you information on how to prevent pregnancy. Your doctor may refer you to a contraceptive specialist.
  • Before starting treatment, your doctor will ask you to perform a pregnancy test, this must be negative (ie show that you are not pregnant) in order for you to start treatment with Isotretinoin Orifarm.

Women must use effective contraception before, during, and after treatment with Isotretinoin Orifarm

  • You must agree to use at least one effective contraceptive (eg IUDs or contraceptive implants) or two effective means that work differently (eg a hormonal contraceptive pill and a condom). Discuss with your doctor which methods are best for you.
  • You must use contraception for 1 month before taking Isotretinoin Orifarm, during treatment and for 1 month after treatment.
  • You must use contraception even if you are not menstruating or not sexually active (unless your doctor deems it necessary).

Women must agree to take pregnancy tests before, during, and after treatment with Isotretinoin Orifarm

  • You must agree to go on a follow-up visit, preferably every month.
  • You must agree to take regular pregnancy tests, preferably every month during treatment and, as a certain amount of medicine may still remain in your body, 1 month after stopping treatment with Isotretinoin Orifarm (unless your doctor decides it is not necessary in your case).
  • You must agree to extra pregnancy tests if your doctor asks you to.
  • You must not become pregnant during the treatment period or within a month after the end of treatment as a certain amount of medicine may still remain in your body.
  • The doctor will discuss these points with you using a checklist and will ask you (or your parent / guardian) to sign it. You hereby confirm that you have been informed of the risks and that you will comply with the above conditions.

If you become pregnant during treatment with Isotretinoin Orifarm, stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.

If you become pregnant within one month of stopping treatment, consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men The
levels of retinoids in the semen of men who use Isotretionoin Orifarm are too low to cause harm to their partner’s unborn children. However, you must remember to never give your medicine to anyone else.

Additional precautions

You should never give this medicine to anyone else. Return any unused capsules to the pharmacy when the treatment is completed.


You should not donate blood during treatment with this medicine or within 1 month after stopping treatment with Isotretinoin Orifarm as unborn babies can be harmed if pregnant women get your blood.


Talk to your doctor before taking Isotretinoin Orifarm:

  • If you have previously had very high blood fat levels ( cholesterol , triglycerides ). Talk about this, and your doctor will take some blood samples to monitor these levels before, during and at the end of treatment.
  • If you have elevated levels of liver enzymes. Your doctor will take some blood samples before and regularly during treatment with Isotretinoin Orifarm to monitor your liver values. 
  • If you suffer from diabetes . You need to be aware that Isotretinoin Orifarm can raise your blood sugar levels
  • If you are overweight, suffer from any lipid metabolic disease or if you drink a lot of alcohol. Your blood fat and blood sugar levels may be elevated and your doctor may decide to monitor your blood levels more often than in patients who do not have these problems.
  • If you have ever had problems with your mental health, including depression, aggressive tendencies or mood swings. This also applies to thoughts of harming yourself or committing suicide. Your mood can be affected while you are taking Isotretinoin Orifarm.
  • If you experience that your skin and / or lips become dry during treatment with Isotretinoin Orifarm. Use a moisturizing ointment or skin cream and lip balm during the treatment.
  • If you use creams and / or local acne treatments that have not been prescribed by your doctor. Avoid using these treatments during your treatment with Isotretinoin Orifarm.
  • If you experience an allergic reaction (skin redness, itching ) or an anaphylactic reaction . Tell your doctor as it may be necessary to stop Isotretinoin Orifarm treatment.
  • If you experience persistent headaches, nausea, vomiting and blurred vision. Discontinue treatment immediately and contact your doctor. 
  • If you experience severe bloody diarrhea. Discontinue treatment immediately and contact your doctor. 
  • If you develop dry eyes, corneal opacity, impaired night vision or corneal inflammation during treatment . These symptoms usually go away when treatment is stopped. If you experience any of the above symptoms, consult your doctor so that your vision can be examined. Always be careful when driving or using machines at night as impaired night vision can occur quite suddenly. If you wear contact lenses and get dry eyes, you may need to wear glasses during treatment with Isotretinoin Orifarm. Dry eyes can be prevented if you use a mild eye ointment or eye drops (tear substitute).
  • If you are exposed to sunlight. You may become more sensitive to sunlight during treatment with Isotretinoin Orifarm. Avoid sunbathing too much and do not sunbathe in a solarium or under a sun lamp. Before going out in the sun, use a sun protection product with a high protection factor, at least SPF 15.
  • If you are undergoing cosmetic treatments, such as skin abrasions or laser treatments (to remove uneven skin or scars) and hair removal with wax, as treatment with Isotretinoin Orifarm may make your skin more delicate. Skin abrasions and laser treatments should be avoided during and at least 5-6 months after the treatment, while waxing hair removal should be avoided during and at least 6 months after the treatment. Failure to follow these instructions may result in scarring and skin irritation.
  • If you are very physically active, as muscle and joint pain may occur during treatment with Isotretinoin Orifarm, especially in patients who are very physically active.
  • If you are a blood donor. Do not donate blood during and one month after treatment with Isotretinoin Orifarm.

Mental health problems

You yourself may not notice any changes in your mood and behavior, so it is very important that you tell your friends and family that you are taking this medicine. They can notice these changes and help you quickly identify any problems that you need to talk to your doctor about.

Other medicines and Isotretinoin Orifarm

If different medicines are used at the same time, they can affect each other’s effects. Contact your doctor if you are taking any of the following medicines while taking Isotretinoin Orifarm, as does one may need to be changed: 

  • Vitamin A supplement.
  • Tetracycline is (a kind of antibiotic ). 
  • Methotrexate (immunosuppressive agent)


Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Isotretinoin Orifarm with food and drink

Isotretinoin Orifarm must be taken with a meal.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy:
Warning! Do not take Isotretinoin Orifarm if you are pregnant. Isotretinoin Orifarm is very harmful to the fetus. Contact your doctor immediately if you become pregnant during treatment. 

If you become pregnant despite the precautions described during treatment with isotretinoin or during the following month, the risk of severe and severe malformations in the fetus is very high. There is also an increased risk of miscarriage.

For more information on pregnancy and contraception, see section 2 “Pregnancy prevention programs”.


Breast-feeding:
Do not take Isotretinoin Orifarm if you are breastfeeding. Isotretinoin Orifarm passes into breast milk and may harm your baby.

Driving and using machines

In some cases, Isotretinoin Orifarm causes side effects that may affect your ability to drive and use machines (see also “Warnings and precautions” and “Possible side effects”).

Your night vision may be impaired during treatment with isotretinoin. This can happen suddenly. In rare cases, this has continued after treatment has stopped. You should therefore be careful when driving or using machines.

In very rare cases, drowsiness, dizziness, and visual disturbances have been reported. If you experience any of these effects, do not drive, use machines or engage in any other activity that could cause these symptoms to put you or others at risk.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Isotretinoin Orifarm contains soybean oil

Isotretinoin Orifarm contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

How to take Isotretinoin Orifarm

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The capsules should be taken with plenty of water (1 1/2 dl). 

The capsules should be taken with a meal once or twice daily. 

Swallow the capsules whole, do not chew them, and do not suck on them. 


Your acne may worsen during the first few weeks of treatment. It should get better with continued treatment


The recommended dose is:

Adults (including adolescents and the elderly) and children aged 12 years and older: 

The usual starting dose is 0.5 mg/kg body weight daily. 

For most patients, the maintenance dose is between 0.5 and 1.0 mg/kg body weight daily. 

Use for children:

Isotretinoin Orifarm is not recommended for use in children below 12 years of age due to insufficient efficacy and safety data. 

Renal impairment: 

If you have severe kidney problems, treatment should start at a lower dose, e.g. 10 mg daily. Later, dose one can be increased up to 1 mg/kg daily or to the highest tolerated dose one. 


Hepatic impairment:
 

Isotretinoin Orifarm should not be used in patients with hepatic impairment. 

The treatment should only be changed or terminated in consultation with a doctor.

If you take more Isotretinoin Orifarm than you should

If you have taken more Isotretinoin Orifarm than you should or more than your doctor has prescribed, contact your doctor, pharmacist, or nearest hospital. 

Isotretinoin is a vitamin A derivative (similar to vitamin A ). The symptoms of isotretinoin poisoning are therefore similar to the symptoms of vitamin A poisoning.

Symptoms: 

  • Headache
  • Nausea or vomiting. 
  • Drowsiness and irritability.
  • Itching .

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Isotretinoin Orifarm

If you miss a dose , take it as soon as possible when you discover it. However, if it is almost time for your next dose , skip the missed dose and continue 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.
Some side effects are dose dependent. The side effects generally decrease when the dose is changed or the treatment is stopped. However, some side effects may persist after stopping treatment

Very common side effect are (can occur in more than 1 in 10): 

  • Anemia ( anemia ) and other changes in the blood picture. 
  • Inflammation of the eyes ( conjunctivitis ) and eyelid edges ( blepharitis ). 
  • Dry and irritated eyes. 
  • Inflammation of the skin and lips. 
  • Dry skin, scaling, itching , red rashes and sensitive skin with a tendency to crack. 
  • Back pain and joint and muscle pain
  • Altered blood fat levels ( triglycerides and HDL (High Density Lipoprotein)). 
  • Elevated levels of liver enzymes ( transaminases ). 


Common side effects are (may affect up to 1 in 10): 

  • Increased level of platelets . 
  • Headache. 
  • Nasal bleeding and runny nose. 
  • Dry nose. 
  • Increased cholesterol and blood sugar levels. 
  • Blood and protein in the urine. 


Rare side effects are
 (may affect up to 1 in 1000 people): 

  • Allergic skin reactions, anaphylactic reactions and extreme sensitivity to various allergic effects. 
  • Hair loss


Very rare side effects are (may affect up to 1 in 10 000 users): 

  • Infection of the mucous membranes and skin. 
  • Increased level of white blood cells . 
  • Swollen lymph nodes . 
  • Diabetes . 
  • Increased amount of uric acid in the blood. 
  • High blood pressure in the head, cramps and dizziness. 
  • Impaired night vision, blurred vision, light shading and disturbances in color vision. 
  • Edema of the eye.
  • Hypersensitivity to contact lenses. 
  • Cataracts (cataracts), corneal clouding and corneal inflammation . 
  • Impaired hearing
  • Inflammation of the blood vessels. 
  • Spasmodic contractions of the lung muscles. 
  • Hoarseness and dryness in the throat. 
  • Inflammation of the colon and inflammation of the lower part of the small intestine. 
  • Gastrointestinal bleeding, bloody diarrhea and inflammatory bowel disease. 
  • Nausea. 
  • Inflammation of the pancreas. 
  • Inflammation of the liver. 
  • Rapid and violent development of acne , worsening acne , redness of the face and rash. 
  • Hair diseases. 
  • Increased body hair in women. 
  • Nail changes and infection in the tissue around the nail base. 
  • Sensitivity to light. 
  • Increased sweating.
  • Cauliflower-like, benign tumors in the skin, usually around the nails. 
  • Increased skin pigmentation. 
  • Arthritis (joint inflammation). 
  • Skeletal diseases, including delayed growth, exostosis and altered bone density. 
  • Calcification of ligaments and tendons and inflammation of tendons. 
  • Muscle breakdown ( rhabdomyolysis ). 
  • Inflammation of the kidneys. 
  • Formation of red granulated tissue . 
  • Feeling sick. 
  • Increased level of creatinine phosphokinase in the blood. 


Has been reported
 (occurs in an unknown number of users): 

  • Severe rash (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis ), which is potentially life-threatening and requires immediate medical attention. These initially appear as round spots, often with blisters in the middle, usually on the arms and hands or legs and feet. More severe forms of rash may include blisters on the chest and back. Additional symptoms such as eye infection ( conjunctivitis ) or sores in the mouth, throat or nose may occur. Severe forms of rash can develop into widespread flaking of the skin, which can be life-threatening. Such severe skin rashes are often preceded by headaches, fever and body aches ( flu-like symptoms ).
  • Problems getting and maintaining an erection .
  • Decreased sex drive.
  • Breast augmentation with or without tenderness in men.
  • Vaginal dryness.

Stop taking Isotretinoin Orifarm and contact your doctor immediately if you develop a rash or this type of skin symptom. 

Mental health problems


Rare side effects are
 (may affect up to 1 in 1000):

  • Depression or similar illnesses. Signs of these may be that you may feel sad or experience a changed mood, worry / anxiety or emotional discomfort.
  • Exacerbation of a depression
  • That you become violent or aggressive.

ycket rare side effect are (may affect up to 1 in 10 000):

  • Some people have had thoughts of harming themselves or taking their own lives (suicidal thoughts), tried to take their own lives (suicide attempts), or have taken their own lives (suicide). These people may not seem depressed.
  • Deviant behavior.
  • Signs of psychosis: lack of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you show signs of any of these mental problems.  Your doctor may tell you to stop taking Isotretinoin Orifarm. It may not be enough to stop the side effects , you may need more help and your doctor can fix it.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Isotretinoin Orifarm

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 / blister after EXP. The expiration date is the last day of the specified month.


Do not store above 30 ° C. 


Return any remaining capsules to the pharmacy when the treatment is over.

6. Contents of the pack and other information

Content declaration

  • The active substance is isotretinoin:
    10 mg capsules, soft: One tablet contains 10 mg isotretinoin.20 mg capsules, soft: One tablet contains 20 mg of isotretinoin.
  • The other ingredients are yellow beeswax, hydrogenated soybean oil, partially hydrogenated soybean oil, refined soybean oil, gelatin, glycerol and the dyes titanium dioxide (E 171), yellow iron oxide (E 172) and red iron oxide (E 172).

What the medicine looks like and contents of the pack

The 10 mg capsules are oval, reddish-orange, soft gelatin capsules (approximately 11 x 7 mm).

The 20 mg capsules are oval, reddish-orange, soft gelatin capsules (approximately 13 x 8 mm).


Pack sizes: 30, 50, 60, 98, 100 and 120 capsules, soft.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S
Energivej 15
5260 Odense S

Denmark

Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm

info@orifarm.com

This medicine is authorized in the European Economic Area under the names:

Denmark: Isotretinoin Orifarm

Finland: Isotretinoin Orifarm

Germany: IsoGalen 10/20 mg soft capsules

Norway: Isotretinoin Orifarm

Sweden: Isotretinoin Orifarm

Muhammad Nadeem

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