ISOTRETINOINA 10 mg Софт Капсулы

Содержание инструкции

1. Isotretinoina Difa Cooper 10 mg soft capsules, 20 mg soft capsules
   1. What is Isotretinoina Difa Cooper and what is it used for
   2. What you need to know before using Isotretinoina Difa Cooper
   3. How to use Isotretinoina Difa Cooper
   4. Possible side effects
   5. How to store Isotretinoina Difa Cooper
   6. Contents of the pack and other information

Isotretinoina Difa Cooper 10 mg soft capsules, 20 mg soft capsules

Isotretinoin

Generic medicine

WARNING
MAY CAUSE SERIOUS HARM TO THE FETUS
Women must use effective contraceptive methods
Do not use if you are or think you might be pregnant

Medicinal product subject to additional monitoring. This will allow the rapid
identification of new safety information. You can contribute by reporting
any adverse effects experienced during the use of this medicine.
See the end of section 4 for information on how to report adverse effects.

Contents of this leaflet:

• 1. What Isotretinoina Difa Cooper is and what it is used for
• 2. What you need to know before you use Isotretinoina Difa Cooper
• 3. How to use Isotretinoina Difa Cooper
• 4. Possible side effects
• 5. How to store Isotretinoina Difa Cooper
• 6. Contents of the pack and other information

1. What is Isotretinoina Difa Cooper and what is it used for

Isotretinoina Difa Cooper contains the active ingredient isotretinoin which is similar to
Vitamin A. Isotretinoin acts against acne by reducing the activity of the sebaceous
glands, preventing the formation of blackheads and inhibiting skin inflammatory
processes.
Isotretinoina Difa Cooper is used for the treatment of severe forms of acne (such as
nodular acne or conglobate acne or acne with a risk of permanent scarring)
resistant to appropriate standard therapies with oral antibiotics and topical
therapy.

Read this leaflet carefully before taking this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to others,even if they have the same symptoms as you ,because it could be dangerous, even if their disease symptoms are the same as yours.
• If any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

2. What you need to know before using Isotretinoina Difa Cooper

Treatment with Isotretinoina Difa Cooper must be prescribed and monitored by a doctor (preferably a doctor specializing in the treatment of skin problems). The doctor makes available to all patients an informative guide and, in addition, for female patients, the guide on contraceptive methods. If the doctor has not delivered these guides or has not explained the following precautionary measures or they have not been fully understood, before starting treatment, talk to your doctor.

Do not use Isotretinoina Difa Cooper

• If you are pregnant or breastfeeding.
• If there is any possibility that you may become pregnant, you must take the precautions reported in the “Pregnancy Prevention Program” in the “Warnings and Precautions” section.
• If you are potentially fertile and do not meet all the conditions regarding contraception (birth control) (see “Warnings and precautions”).
• If you have liver disease (hepatic insufficiency).
• If you have excessively high levels of lipids in the blood.
• If you have excessively high levels of vitamin A in the body (hypervitaminosis A).
• If you are allergic to isotretinoin, soy, peanuts, Ponceau 4R dye (E124) or any of the excipients of this medicine (listed in section 6).
• If you are taking tetracyclines (antibiotics).

Warnings and precautions
Pregnancy Prevention Program

Pregnant women must not use Isotretinoina Difa Cooper
This medicine can seriously harm the fetus (it is said to be “teratogenic”) – it can cause abnormalities in the unborn child at the level of the brain, face, ear, eye, heart and some glands (thymus and parathyroid glands). It can also likely induce abortion. This can happen even if Isotretinoina Difa Cooper is used for a short time during pregnancy.

• You must not use Isotretinoina Difa Cooper if you are pregnant or if you think you might be.
• You must not use Isotretinoina Difa Cooper if you are breastfeeding. The medicine can pass into the milk and harm the newborn.
• You must not use Isotretinoina Difa Cooper if you could become pregnant during treatment.
• You must not become pregnant for one month after finishing this treatment as some medicines may remain in your body.

Women who can become pregnant are prescribed Isotretinoina Difa Cooper
with very strict rules. This is due to the risk of harm that can be caused to the fetus.
These are the rules:

• The doctor must explain the risk of harm to the fetus - you must understand that you must not become pregnant and what you need to do to prevent pregnancy.
• The doctor must have spoken to you about contraception (birth control). The doctor will give you information on how not to become pregnant. The doctor may send you to a specialist for contraceptive counseling.
• Before starting treatment, the doctor will tell you to take a pregnancy test. The test must show that you are not pregnant when you start treatment with Isotretinoina Difa Cooper

Women must use effective contraceptive treatment before, during and after using Isotretinoina Difa Cooper

• You must agree to use at least one very reliable contraceptive method (for example an intrauterine device or a contraceptive implant) or, two effective methods that work in different ways (for example hormonal contraceptive pill and a condom). Talk to your doctor about which method may be suitable for you.
• You must use contraceptives for one month before using Isotretinoina Difa Cooper, during treatment and for one month after the end of treatment
• You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor tells you that it is not necessary).

Women must agree to undergo pregnancy tests before, during and after using Isotretinoina Difa Cooper

• You must agree to undergo regular check-up visits, preferably every month
• You must agree to undergo regular pregnancy tests, preferably every month during treatment and, as some medicines may remain in your body, 1 month after stopping Isotretinoina Difa Cooper (unless your doctor decides that this is not necessary in your case).
• You must agree to perform additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or in the following month as some medicines may remain in your body.
• The doctor will discuss all these points with you, using a checklist and will ask you (or a relative/guardian) to sign it. This document will serve to confirm that you have been informed of the risks and that you will have to follow the above rules.

If you become pregnant while taking Isotretinoina Difa Cooper, stop taking this
medicine immediately, and consult your doctor. The doctor may send you to a
specialist for a consultation.
Also, if you become pregnant within one month of stopping Isotretinoina Difa
Cooper, you should contact your doctor. The doctor may send you to a
specialist for a consultation.

Advice for men
Levels of oral retinoids in the semen of men usingIsotretinoina Difa Cooper
are too low to harm the fetus of their partner. However, you should never share
your medicines with anyone.

Further precautions
You should never give this medicine to anyone else. At the end of treatment
return the unused capsules to the pharmacist.
You should not donate blood during treatment with this medicine and for 1
month after stopping Isotretinoina Difa Cooper as if a pregnant patient were to
receive your blood, it could harm her fetus.
Talk to your doctor before taking Isotretinoina Difa Cooper

• If you have had mental health problems including depression, aggressive tendencies or mood changes. This also includes thinking about harming yourself or ending your life. This is because your mood may change while you are taking Isotretinoina Difa Cooper.

Mental health problems
You may not notice some changes in your mood and behavior and therefore it is very
important that you tell your friends and family that you are taking this medicine.
They may notice these changes and help you identify problems that need to be
discussed with your doctor.

• SkinA sudden worsening of acne sometimes occurs in the early period of therapy. However, this usually resolves with continued treatment, within 7-10 days, and usually does not require a dose adjustment.
• Avoid prolonged exposure to sunlight or UV radiation. If necessary, use adequate protective measures (long clothes, hats, a sunscreen with a high protection factor, at least 15). Avoid using solariums and going to tanning beds.
• Avoid aggressive dermabrasion (chemical or laser therapy) during treatment and for a period of 5-6 months after the end of treatment due to the risk of deep scarring, skin irritation and changes in pigment inflammation (increased or decreased pigmentation).
• Avoid using waxing for at least 6 months

after the end of treatment for the risk of skin tears.

• Avoid the concomitant administration of Isotretinoina Difa Cooper and any other anti-acne medicine with keratolytic or exfoliating action as this may increase skin irritation. (see “Other medicines and Isotretinoina Difa Cooper”).It is recommended to use a skin or cream moisturizer and a lip balm from the beginning of treatment as treatment with Isotretinoina Difa Cooper may cause dryness of the skin and lips. EyesVision may be affected at night (night blindness) and this may occur without warning. Be careful when driving vehicles or using machinery. (see “Driving and operating machinery”). An eye examination is recommended for patients who experience any visual disturbances. Treatment with Isotretinoina Difa Cooper may need to be discontinued. In addition, dry eyes, blurred vision and corneal inflammation may occur, which usually resolve after the end of treatment. Dry eyes can be treated by applying an eye ointment to moisturize or artificial tears. Intolerance to contact lenses may occur, so patients using contact lenses may be forced to wear glasses during the duration of treatment. Musculoskeletal systemMuscle and joint pain and increased levels of creatine phosphokinase in the blood may occur, especially in those who engage in intense physical activity (see section 4 “Possible side effects”). Caution should be exercised and intense physical activity should be reduced during therapy with Isotretinoina Difa Cooper. Liver and biliary tractIsotretinoina Difa Cooper may increase levels of liver enzymes; the doctor will subject patients to blood tests before the start of therapy, during and at the end of treatment with Isotretinoina Difa Cooper, to check liver values. If the levels of liver enzymes remain high, the doctor may reduce the dose or stop therapy with Isotretinoina Difa Cooper. Fat levels in the bloodTell your doctor if you suffer from high levels of fats in the blood as Isotretinoina Difa Cooper may increase levels of fats (such as triglycerides or cholesterol) in the blood; the doctor will subject patients to blood tests to monitor these values before the start of therapy, during and at the end of treatment with Isotretinoina Difa Cooper. Usually increased levels of fats in the blood return to normal values by reducing the dose or stopping treatment and may also resolve with a modification of the diet. Isotretinoina Difa Cooper should be discontinued if these levels are too high or if signs of pancreatitis occur. KidneysTell your doctor if your kidney function is impaired, as a dose adjustment may be necessary (see section 3 “How to use Isotretinoina Difa Cooper”).

The following patients have a higher risk of developing side effects
In patients with diabetes, overweight, high alcohol consumption or fat metabolism disorders, the doctor must be informed as the health status of the patients must be carefully monitored and frequent monitoring of blood fat levels and/or blood sugar concentration may be necessary.
During treatment with isotretinoin, fasting blood sugar levels may be increased and new cases of diabetes have also been reported.

Children
Isotretinoina Difa Cooper is not indicated for the therapy of prepubertal acne and should not be taken by children under the age of 12 years.

You must immediately stop treatment and consult your doctor
promptly if you experience any of the following symptoms:

• Nausea, vomiting, disturbances in the upper abdomen, as these may be signs of pancreatitis
• Headache, nausea and vomiting, visual disturbances, as these may be signs of increased pressure in the brain
• Severe diarrhea with blood, severe abdominal pain and/or cramps, as these may be signs of severe intestinal inflammation
• Severe hypersensitivity reactions, such as skin rash, often accompanied by blue and red spots, itching, swelling of the face and limbs, difficulty breathing, circulatory symptoms, which sometimes include collapse. Other medicines and Isotretinoina Difa CooperTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

The following drugs must not be used during therapy with Isotretinoina Difa Cooper:

• vitamin preparations containing vitamin A for the risk of overdose (see “Do not use Isotretinoina Difa Cooper”).
• tetracyclines (an antibiotic) for the risk of increased pressure in the brain (see “Do not use Isotretinoina Difa Cooper”).
• Other anti-acne medicines with keratolytic or exfoliating action on the superficial layer of the skin as this may increase skin irritation (see “Warnings and precautions”)

Isotretinoina Difa Cooper with food and drink
The capsules must be taken with food.

Pregnancy, breastfeeding and fertility

• Isotretinoina Difa Cooper must not be taken during pregnancy
• Isotretinoina Difa Cooper must not be taken during breastfeedingbecause isotretinoin probably passes into breast milk and can harmthe baby.

For more information on pregnancy and contraception, see section 2 of the “Pregnancy Prevention Program”

Driving and operating machinery
Night vision may be affected (night blindness) and this can occur
without warning. In rare cases this problem may persist after the end of
treatment. Exercise caution when driving vehicles or using
machinery. Very rarely, drowsiness, dizziness and visual disturbances have been reported. If these disorders occur, you should not drive, operate machinery or
engage in other activities where these symptoms may put yourself or others at risk (see “Warnings and precautions” and paragraph 4 “Possible side
effects”).

Isotretinoina Difa Cooper contains sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before
taking this medicine.

Isotretinoina Difa Cooper contains Ponceau 4R (E 124)
This medicine contains the dye Ponceau 4R (E 124), which may cause
allergic reactions

3. How to use Isotretinoina Difa Cooper

Always use this medicine exactly as your doctor has instructed, who will determine how many capsules must be taken daily. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Dosage in adults, adolescents and elderly patients
The usual starting dose is 0.5 mg/kg per day. After a few weeks, your doctor may adjust the dose. This depends on the response to treatment and the appearance of undesirable effects. For most patients, the dose is between 0.5 and 1.0 mg/kg per day.

Patients who do not tolerate Isotretinoina Difa Cooper at the usual dosage
In patients who do not tolerate the recommended dose, it is possible that the doctor will continue the treatment at a reduced dose. In such cases, the treatment will have a longer duration and a higher risk of relapse.

Patients with severe kidney problems
In patients with severe kidney problems, treatment with Isotretinoina Difa Cooper should be started with a reduced dose, for example 10 mg/day. The dose should then be increased to the maximum dose tolerated by the patient.
Method of administration
The capsules must be taken one or two times a day, with food.
Swallow the capsules whole, do not chew or suck them.
Duration of treatment
The duration of treatment depends on the daily dose and is generally 16-24 weeks.
Acne may continue to improve for up to 8 weeks after the end of treatment.
Therefore, a new cycle of treatment should not be started before at least this period has elapsed. Most patients only need a single cycle of treatment.

If you use more Isotretinoina Difa Cooper than you should
If you use too many capsules or someone else accidentally takes this medicine, contact your doctor or pharmacist immediately or go to the nearest hospital.

If you forget to use Isotretinoina Difa Cooper
If you forget a dose, take it as soon as possible. If it is close to the time of the next dose, skip the missed dose and continue treatment normally. Do not use a double dose to make up for a missed dose.

If you stop using Isotretinoina Difa Cooper
You should not stop treatment without consulting your doctor, otherwise the acne may recur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Some of the side effects associated with the use of isotretinoin are related to the
dose. Side effects are usually reversible after dose adjustment or
discontinuation of treatment, however, some may persist after
discontinuation of therapy.
The following symptoms are the most
commonly reported side effects of isotretinoin:
dryness of the skin, dryness of the mucous membranes for example of the lips (cheilitis),
of the nasal mucosa (nosebleeds) and of the eyes (conjunctivitis).
The side effects are listed below according to the frequency of
occurrence:

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

• Anemia, increased erythrocyte sedimentation rate, increase or decrease in platelet count
• eye inflammation (conjunctivitis) and eyelid area (blepharitis), dry eyes, eye irritation
• increased liver enzyme values (transaminases) (see section 2 “Warnings and precautions”)
• inflammation of the lips and skin, dry skin, exfoliation of skin and mucous membranes, itching, redness of the skin, susceptibility of the skin to injury (risk of friction trauma)
• muscle or joint pain, back pain (particularly in children and adolescents) (see section 2 “Warnings and precautions”)
• increased levels of fats in the blood, decreased HDL cholesterol

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

• decreased number of white blood cells (Neutropenia)
• headache
• nosebleeds, nasal dryness, inflammation of the nose and throat
• increased cholesterol in the blood, increased blood sugar levels, excretion of blood or protein in the urine

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

• allergic skin reactions, hypersensitivity reactions, including sometimes shock (anaphylactic reactions)
• increased hair loss

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

• skin and mucous membrane infections caused by some bacteria (Gram positive)
• swollen lymph nodes (Lymphadenopathy)
• diabetes mellitus, increased uric acid in the blood
• increased pressure in the brain (benign intracranial hypertension) (see section 2 “Warnings and precautions”), seizures, drowsiness, dizziness
• blurred vision, cataracts, color blindness, difficulty seeing colors (color vision deficiency), intolerance to contact lenses, corneal opacity, night blindness, inflammation of the cornea, swelling of the optic nerve (papilledema, may be associated with visual disturbances as a sign of increased brain pressure), sensitivity to light, visual disturbances
• hearing impairment
• inflammation of blood vessels (for example Wegener's granulomatosis, allergic vasculitis)
• sudden chest tightness with shortness of breath and dyspnea (bronchospasm, especially in asthmatic patients) (see section 2 “Warnings and precautions”), hoarseness
• inflammatory bowel diseases (large intestine, ileum), dryness of the throat, gastrointestinal bleeding, diarrhea containing blood, nausea, inflammation of the pancreas (see section 2 “Warnings and precautions”)
• liver inflammation (hepatitis)
• severe acne (fulminant acne), worsening of acne, inflammatory skin changes (skin redness (facial), rash), changes in hair, increased body hair, changes in nails, inflammation of the tissue surrounding the nails, photosensitivity, growth of skin nodules (pyogenic granuloma), skin hyperpigmentation, increased sweating
• inflammation of the joints, calcium deposition in ligaments and tendons, premature epiphyseal closure, bone formations (exostoses), reduced bone density, tendon inflammation, muscle weakness
• kidney diseases (glomerulonephritis)
• increased formation of connective tissue (granulation tissue), feeling unwell
• increased creatine phosphokinase in the blood

Not known (frequency cannot be estimated from the available data):

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) which are potentially life-threatening and require immediate medical attention. These symptoms initially appear as circular patches, often with central blisters, usually on the arms and hands or legs and feet, more severe rashes may include blisters on the chest and back. Further symptoms such as eye infections (conjunctivitis) or ulcers in the mouth, throat or nose may appear. Severe forms of rash can progress to widespread skin exfoliation, which can be fatal. These are often preceded by headache, fever, muscle aches (flu-like symptoms). If a rash or these skin symptoms appear, stop treatment with Isotretinoina Difa Cooper and contact your doctor immediately.
• Problems achieving or maintaining an erection
• Decreased libido
• Breast enlargement with or without tenderness in men

Mental health problems
Rare effects (may affect up to 1 in 1,000):

• Depression or related disorders. Symptoms of this include sadness or altered mood, anxiety, feelings of emotional distress
• Worsening of existing depression
• Becoming violent or aggressive

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

• Some people have had thoughts or intentions of harming themselves or ending their lives (suicidal ideas), have attempted to end their lives (suicide attempt), or have ended their lives (suicide). These people may not appear depressed.
• Unusual behavior.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience symptoms of any of these
mental health problems.Your doctor may tell you to stop taking Isotretinoina Difa
Cooper. This may not be enough to end the effects: you
may need further help, and your doctor can provide it.

Reporting of side effects
If you get any side effects, even those not listed in
this leaflet, tell your doctor or pharmacist. Side effects can,
also, be reported directly through the national reporting system
at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa.
Reporting of side effects helps to provide more information
on the safety of this medicine.

5. How to store Isotretinoina Difa Cooper

Do not store at a temperature above 30°C. Store in the original packaging to protect the medicine from moisture and light.
Keep this medicine out of sight and reach of children.
Return any unused capsules to the pharmacist.
Do not use this medicine after the expiry date which is stated on the
outer packaging and on the blister. The expiry date refers to the last day of that
month.

6. Contents of the pack and other information

What Isotretinoina Difa Cooper contains
The active ingredient is isotretinoin.

10 mg dosage
Each soft capsule contains 10 mg of isotretinoin

20 mg dosage
Each soft capsule contains 20 mg of isotretinoin

The excipients are:

Capsule content:Refined soybean oil, DL-alpha-tocopherol, disodium
edetate, butylated hydroxyanisole, hydrogenated vegetable oil, soybean oil
partially hydrogenated, yellow beeswax.

Capsule shell

10 mg dosage:gelatin, glycerol 98-101%, sorbitol 70%, purified
water, Ponceau 4R (E 124), black iron oxide (E 172) and titanium dioxide (E
171).

20 mg dosage:gelatin, glycerol 98-101%, sorbitol 70%, purified
water, Ponceau 4R (E 124), indigo carmine (E 132) and titanium dioxide (E
171).

Description of the appearance of Isotretinoina Difa Cooper and contents of the
pack:
10 mg dosage: oblong, soft capsules, pale violet in colour, containing a
opaque, viscous liquid of opaque yellow/orange colour. The soft capsule is 10
mm long.

20 mg dosage: oblong, soft capsules, brown in colour, containing a
opaque, viscous liquid of yellow/orange colour. The soft capsule is 12 mm long.
Packs of 20, 30, 50, 60 or 100 soft capsules.

Marketing Authorisation Holder
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (Varese)

Manufacturer

• Merckle GmbH, Graf-Arco Strasse 3, D-89079 Ulm, Germany
• Merckle GmbH, Ludwing Merckle Strasse 3, D-89143 Blaubeuren, Germany
• TOLL MANUFACTURING SERVICES, S.L., Aragoneses 2, 28108, Alcobendas, Madrid, España.
• Industrial Farmacéutica Cantabria, S.A. C/ Pirita, 9 28850 Torrejón de Ardoz (Madrid) Spain This medicinal product is authorised in the Member States of the European Economic

Area with the following denominations:
10 mg dosage
Denmark Isotretinoin Teva
Germany Isotretinoin-ratiopharm 10 mg soft capsules
Italy Isotretinoina Difa Cooper 10 mg soft capsules

20 mg dosage
Denmark Isotretinoin Teva
Germany Isotretinoin-ratiopharm 20 mg soft capsules
Italy Isotretinoina Difa Cooper 20 mg soft capsules