10 mg and 20 mg soft capsules
isotretinoin

1. What Isotretinoin Actavis is and what it is used for

Isotretinoin Actavis contains the active substance isotretinoin belonging to a group of drugs called retinoids, which are related to the A vitamin. It reduces the activity of the sebaceous glands which produce fat in the skin.

Isotretinoin Actavis is a prescription drug used to treat severe forms of acne, such as nodular or conglobatic acne or acne with a risk of permanent scarring that has not shown improvement after other treatments for acne, including antibiotic treatment and topical treatment.

It is recommended that treatment be monitored or supervised by a specialist (eg dermatologist ) with expertise in the use of systemic retinoids for the treatment of severe acne and fully understand the risks of isotretinoin treatment and the requirements for monitoring.

Isotretinoin contained in Isotretinoin Actavis may also be approved for the treatment of other conditions not mentioned in this product information. 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 Actavis

Do not take Isotretinoin Actavis

  • 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 elevated levels of blood fats (eg cholesterol or triglycerides ).
  • if you have very high levels of vitamin A in your body (hypervitaminosis A). 
  • if you are taking antibiotics containing tetracyclines (see “Other medicines and Isotretinoin Actavis”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Isotretinoin Actavis.

ravidity prevention program

Women who are pregnant should not take Isotretinoin Actavis 

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 Actavis is only taken for a short time during pregnancy.

  • You must not take Isotretinoin Actavis if you are pregnant or if you think you may be pregnant.
  • You must not take Isotretinoin Actavis if you are breast-feeding. Isotretinoin Actavis is likely to pass into breast milk and may harm your baby.
  • You must not take Isotretinoin Actavis 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 Actavis under very strict conditions. This is because of the risk of my ket serious damage in 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 Actavis.

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

  • 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 Actavis, 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 Actavis

  • 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 Actavis (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 Actavis, 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 Isotretinoin Actavis are too low to cause harm to the partner’s unborn child. 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 Actavis as unborn babies can be harmed if pregnant women get your blood.

Special precautions to be taken by all patients

  • Talk to your doctor before taking Isotretinoin Actavis if you have anyonce had problems with your mental health, including depression, aggressive tendencies or mood swings. Isotretinoin Actavis can affect your mood.
  • Your skin is likely to become dry. Use a moisturizing ointment or skin cream and lip balm during the treatment. To prevent skin irritation, you should avoid using peels or acne treatments that are not prescribed by your doctor.
  • Avoid too much sun and do not use a sun lamp or solarium. Your skin can become much more sensitive to sunlight. Before going out in the sun, use a sun protection product with a high protection factor, at least a sun protection factor of 15. 
  • Do not undergo any cosmetic facials. Isotretinoin Actavis can make the skin more fragile. Do not do hair removal with wax, skin abrasion or laser treatment (to remove uneven skin or scars) during the treatment, or at least 6 months after the treatment. This can cause scarring, skin irritation, or, in rare cases, discoloration of the skin.
  • Isotretinoin Actavis can cause dry eyes and visual impairment. Dry eyes can be relieved if you use an eye ointment or tear substitute. Hypersensitivity to contact lenses may occur, which may mean that you need to wear glasses during treatment. Impaired night vision can occur all of a sudden, so be careful when driving and using machines at night.
  • Isotretinoin Actavis can cause muscle and joint pain. Reduce intense exercise and physical activity.
  • Isotretinoin Actavis can increase blood fats, such as cholesterol and triglycerides . Your doctor will take samples of these before, during and after treatment with Isotretinoin Actavis. Tell your doctor if you already have high blood fat levels. If your blood lipid levels remain at a high level, your doctor may reduce the dose or discontinue Isotretinoin Actavis.
  • Isotretinoin Actavis has been associated with inflammatory bowel disease. If you get severe (bloody) diarrhea, stop treatment with Isotretinoin Actavis immediately and contact your doctor.
  • Isotretinoin Actavis may increase blood sugar levels. In rare cases, patients may develop diabetes . Your doctor may monitor your blood sugar levels during treatment, especially if you already have diabetes , high blood fat levels, are overweight or if you drink a lot of alcohol.
  • Persistent headaches may occur, along with nausea, vomiting and visual changes including blurred vision. This can be a symptom of increased pressure inside the skull, especially if Isotretinoin Actavis is taken with an antibiotic called tetracycline . Discontinue treatment immediately and contact your doctor.
  • Severe skin reactions (eg erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis ) have been reported with the use of isotretinoin. See section 4, “Possible side effects”.
  • An allergic reaction may occur, such as rash and itching . Severe (anaphylactic) reactions may include: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips and mouth. Even sudden swelling of hands, feet and ankles. If you develop an allergic reaction , stop taking Isotretinoin Actavis and seek medical attention immediately.
  • Isotretinoin Actavis may increase liver enzyme levels. Your doctor will take blood samples before, during and after your treatment with Isotretinoin Actavis to check these levels. If they remain high, your doctor may reduce the dose or discontinue treatment.

Mental health problems

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

Children and young people

Isotretinoin Actavis is not recommended for use in children below 12 years of age, as the efficacy and safety of this age group are not known. It should only be used in adolescents over 12 years of age after puberty.

Other medicines and Isotretinoin Actavis

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

  • Do not take vitamin A supplements at the same time as Isotretinoin Actavis. If both are taken together, the risk of side effects may increase.
  • Do not take Isotretinoin Actavis and tetracyclines (a type of antibiotic ) at the same time. Taking both together can cause increased pressure in the head with symptoms such as headache, nausea, vomiting, visual disturbances and swelling of the optic nerve papilla.
  • Do not use any skin treatments for acne at the same time as Isotretinoin Actavis. It is good to use skin creams and emollients (skin creams or preparations that prevent water loss and have a softening effect on the skin).

Pregnancy and breastfeeding

You must not take Isotretinoin Actavis if you are pregnant.
If you become pregnant during treatment with Isotretinoin Actavis or the month after, there is a high risk of very serious harm to the unborn baby.

Therefore, if you are a woman of childbearing potential, you must use effective contraception during and up to one month after treatment with Isotretinoin Actavis (see section 2 “Warnings and precautions”).

If you become pregnant while taking Isotretinoin Actavis or during the month after stopping treatment, stop taking the medicine (if treatment is still ongoing) and tell your doctor immediately.

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

You must not take Isotretinoin Actavis if you are breastfeeding. The medicine is likely to pass into your breast milk and may harm your baby.

Driving and using machines

Your night vision may deteriorate during treatment. This can happen suddenly. In rare cases, this has continued after treatment has stopped. Drowsiness and dizziness have been reported in very rare cases. Caution should be exercised when driving or using machines.

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 Actavis contains sodium, sorbitol, soybean oil and the dye nycockin

Sodium

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

Sorbitol

This medicine contains 5.31 mg sorbitol per 10 mg capsule and 16.99 mg sorbitol per 20 mg capsule. 

Soybean oil

If you are allergic to peanuts or soy, do not use this medicine.

Nykockin

The dye Nykockin (E124) may cause allergic reactions.

How to take Isotretinoin Actavis

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

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

The capsules are swallowed whole with a drink.

The recommended dose is:

Adults, adolescents, and the elderly

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

After a few weeks, your doctor may need to adjust your dose. This depends on how your medicine is doing. For most patients, the dose is between 0.5 and 1.0 mg/kg body weight daily.

If you have the impression that the effect of Isotretinoin is too strong or too weak, talk to your doctor or pharmacist.

Children

Isotretinoin Actavis should not be used in children under 12 years of age.

Impaired renal function

If you have severe kidney problems, your treatment should normally start at a lower dose (eg 10 mg daily) which can be increased up to the highest tolerated dose.

A treatment regimen normally lasts 16 to 24 weeks. Most patients only need one cure. Your acne may continue to improve for up to 8 weeks after treatment. Normally, you will not start a new treatment until then. Some people may experience that the acne worsens during the first weeks of treatment. This usually improves as treatment continues.

If you take more Isotretinoin Actavis than you should

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.

Contact your doctor, pharmacist, or nearest hospital if you have taken more Isotretinoin Actavis capsules than indicated in this information or more than your doctor has prescribed. Symptoms of overdose include headache, nausea, vomiting, drowsiness, irritability, and itching

If you forget to take Isotretinoin Actavis

If you forget to take 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 can be serious and require immediate medical attention. If you notice any of the following side effects, contact your doctor immediately:

Rare (may affect up to 1 in 100 people):

  • Severe allergic / anaphylactic reactions with sudden swelling of the face, lips, mouth and throat with difficulty breathing or swallowing, swelling of the hands and feet If you have a severe allergic reaction , seek medical attention immediately.

Very rare (may affect up to 1 in 10,000 people):

  • Prolonged headache with nausea, vomiting and blurred vision. These may be signs of “benign intracranial hypertension”, especially when Isotretinoin Actavis is taken with antibiotics containing tetracycline .
  • Severe abdominal pain with or without bloody diarrhea, nausea and vomiting. This can be a sign of serious problems in the gastrointestinal tract.
  • Yellow skin or eyes and feeling tired. These may be signs of jaundice (hepatitis).
  • Muscle weakness that can be potentially life-threatening and can be linked to difficulty moving the arms and legs, with painful, swollen areas of the body with bruising, as well as dark-colored urine, decreased amount of urine or no urine production, confusion or dehydration. This is a sign of rhabdomyolysis , a breakdown of muscle tissue that can lead to kidney failure .
  • Difficulty urinating, swollen eyelids, feeling of extreme fatigue. These are signs of kidney inflammation. Discontinue Isotretinoin Actavis immediately and contact your doctor.

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

  • Severe skin rash (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis ). 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 skin detachment, which can be life-threatening. Such severe skin rashes are often preceded by headaches, fever and body aches ( flu-like symptoms ). If you get a rash or these skin problems, stop taking Isotretinoin Actavis and contact your doctor immediately. 

Mental health problems

Rare (may affect up to 1 in 100 people):

  • 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

Very rare (may affect up to 1 in 10,000 people):

  • 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 Actavis. It may not be enough to stop the side effects, you may need more help and your doctor can fix it.

Other side effects:

Very common (may affect more than 1 user in 10):

  • Anemia ( anemia ) with symptoms such as weakness, dizziness and pale skin (if red blood cells are affected).
  • Easier to get bruises, bleeding and that the blood clots more easily (if platelets are affected).
  • Dry skin, reddening of the skin, sensitive skin, local peeling of the skin, itching , dry eyes, eye irritation, inflammation of the skin, lips, eyes and / or eyelid edge.
  • Elevated levels of liver enzymes.
  • Pain in joints, muscles and back, especially in teenagers.
  • Elevated levels of blood fats and lower levels of High Density Lipoprotein ( HDL ).

Common (may affect up to 1 in 10 people): 

  • Headache.
  • Dry nose, nosebleeds, pain or inflammation of the throat and nose.
  • Increased tendency to get an infection due to reduced white blood cell count
  • Increased cholesterol and blood sugar levels.
  • Blood or protein in the urine.

Rare (may affect up to 1 in 1,000 people): 

  • Allergic skin reactions with rash and itching . If you get an allergic reaction , stop taking Isotretinoin Actavis and consult a doctor.
  • Hair loss.

Very rare (may affect up to 1 in 10,000 people): 

  • Bacterial infection in the skin and mucous membranes.
  • Lymph nodes can become swollen.
  • Diabetes with symptoms such as excessive thirst and need to urinate frequently.
  • High levels of uric acid in the blood.
  • Swelling of the optic nerve papilla.
  • Cramps, drowsiness, dizziness.
  • Nausea, general malaise.
  • Blurred vision, color blindness, color vision disorders, cloudiness of the lens of the eye (cataracts), cloudiness or scarring of the surface of the eye (corneal cloudiness), hypersensitivity to contact lenses, impaired night vision, photosensitivity may increase; You may find that you need to wear sunglasses to protect your eyes from strong sunlight, inflammation of the cornea, visual disturbances.
  • Impaired hearing.
  • Inflammation of the blood vessels (sometimes with red spots, which may resemble bruises).
  • Sudden pressure on the chest, shortness of breath and wheezing, especially if you have asthma .
  • Hoarseness, dry throat.
  • Severe acne (acne fulminans), aggravated acne , redness of the skin (especially on the face), rash, hair diseases, increased body hair, infection at the base of the nail, nail changes, photosensitivity, color changes on the skin, red increases on the skin that bleeds easily (pyogenic granuloma), increased sweating .
  • Arthritis (joint inflammation). 
  • Skeletal diseases, (delayed growth, extra growth and altered bone density), calcification of soft tissue , tendon pain. 
  • Increased connective tissue formation (which can cause thickened scarring).
  • Increased levels of creatinine phosphokinase in the blood (signs of high levels of breakdown products from muscles in the blood)

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

  • Problems getting and maintaining an erection
  • Decreased sex drive
  • Breast augmentation with or without tenderness in men
  • Vaginal dryness

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 Actavis

Keep this medicine out of the sight and reach of children.

Store the blister card in the outer carton. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Content declaration

  • The active substance is isotretinoin: Each capsule contains 10 mg of isotretinoin or 20 mg of isotretinoin.
  • Other ingredients are:Capsule contents: Refined soybean oil, all-rac-alpha-Tocopherol, disodium edetate, butylhydroxyanisole, hydrogenated vegetable oil, partially hydrogenated soybean oil, yellow beeswax.Capsule shell:0 mg capsules : The gelatin, glycerol 98% – 101% liquid sorbitol, purified water, cochineal red (E124), black iron oxide (E172), titanium dioxide (E 171).20 mg capsules: Gelatin, glycerol 98% – 101%, liquid sorbitol, purified water, nycockin (E124), indigo carmine (E 132), titanium dioxide (E 171).

What the medicine looks like and contents of the pack

Isotretinoin Actavis 10 mg capsules: Light purple, oval, soft gelatin capsules containing a yellow/orange opaque viscous liquid, 10 mm x 7 mm.

Isotretinoin Actavis 20 mg capsules: Red-brown, oval, soft gelatin capsules containing a yellow/orange opaque viscous liquid, 13 mm x 8 mm.

Pack sizes:

Isotretinoin Actavis 10 mg: 10, 20, 30, 60, 90 and 100 capsules.

Isotretinoin Actavis 20 mg: 10, 20, 30, 60, 90 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjörður

Iceland

Muhammad Nadeem

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