ISODIFA 5 mg Kapsułka Miękka

Treść ulotki

1. Isodifa 5 mg soft capsules, 10 mg soft capsules, 20 mg soft capsules, 30 mg soft capsules
   1. What is Isodifa and what is it used for
   2. What you need to know before taking Isodifa
2. Isodifa should not be taken during pregnancy. If there is a possibility of becoming pregnant,
   1. How to use Isodifa
   2. Possible side effects
   3. How to store Isodifa
   4. Package Contents and Other Information

Isodifa 5 mg soft capsules, 10 mg soft capsules, 20 mg soft capsules, 30 mg soft capsules

Isotretinoin
Generic medicine
Isotretinoin
Generic medicine

WARNING
CAN CAUSE SERIOUS HARM TO THE FETUS
Women must use effective contraceptive methods
Do not use if you are or think you may 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.

Read this leaflet carefully before taking this medicine as 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Isodifa and what is it used for

Isodifa contains the active ingredient isotretinoin. This is a substance similar to
Vitamin A belonging to a class of medicines called retinoids (for the
treatment of acne).
Isodifa 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 other anti-acne therapies
such as oral antibiotics and topical therapy.
Treatment with Isodifa must be supervised by a dermatologist (doctor
specialized in the treatment of skin problems).

2. What you need to know before taking Isodifa

Do not use Isodifa

• If you are pregnant or breastfeeding.
• If there is any possibility that you may become pregnant, you must take the precautions described in the “Pregnancy Prevention Program” in the “Warnings and Precautions” section.
• if you are allergic to isotretinoin, Ponceau 4R (E124), soy, peanuts or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you have high levels of lipids (cholesterol, triglycerides) in your blood
• if you have high levels of vitamin A in your body (hypervitaminosis A)
• if you are taking tetracyclines (a type of antibiotic)

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

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

For women who may become pregnant, Isodifa is prescribed with very
restrictive 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 talked 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 Isodifa

Women must use effective contraceptive treatment before, during and after
using Isodifa

• 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 Isodifa, 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 Isodifa

• You must agree to undergo regular check-ups, preferably every month
• You must agree to undergo regular pregnancy tests, preferably every month during treatment and, as some medicines can remain in your body, 1 month after stopping Isodifa (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 can 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 Isodifa, stop takingthis medicine immediately, and see your doctor. The doctor may send you to a specialist for a consultation. Also, if you become pregnant within one month of stopping Isodifa, 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 usingIsodifa 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 the treatment return
the unused capsules to the pharmacist.
You should not donate blood during treatment with this medicine and for 1 month
after stopping using Isodifa as if a pregnant patient were to receive your
blood it could harm the fetus.
Other precautions

• Isodifa can increase levels of fats such as triglycerides or cholesterol in your 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 Isodifa. Tell your doctor if you already suffer from high levels of these substances in your blood and if you suffer from diabetes, are overweight, or suffer from alcoholism, as in these cases it may be necessary to perform blood tests more frequently.
• Isodifa can 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 Isodifa, to check liver values. If the levels of liver enzymes remain high, the doctor may reduce the dose or stop therapy with Isodifa.
• Isodifa can increase blood sugar levels and in rare cases diabetes mellitus has beendiagnosed.The doctor will monitor blood sugar levels during treatment, especially if you suffer from diabetes, are overweight or suffer from alcoholism.
• Use an emollient ointment or cream and lip balm during thetreatmentas dryness of the skin or lips may occur during treatment with Isodifa.

Talk to your doctor before taking Isodifa

• If you have had mental health problems. This includes 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 taking Isodifa. Mental health problems You may notice some changes in your mood and behavior and 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.
• If you suffer from kidney failure. In this case, therapy should start with a lower dose.
• Isodifa affects night vision. Dry eyes or vision problems may occur during treatment with Isodifa which usually resolve after the end of treatment. Be careful when driving vehicles or using machinery at night as these symptoms can occur suddenly. If you wear contact lenses and experience dry eyes, you may need to wear glasses during the duration of treatment with Isodifa. If you experience any vision problems, tell your doctor immediately, as it may be necessary to stop treatment with Isodifa and monitor vision.
• If you suffer from severe skin reactions(e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)), reported with the use of isotretinoin. The rash may progress with widespread blisters or peeling of the skin. You also need to check for ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

stop treatment and consult your doctor promptly if you experience:

• Allergic reaction(redness or rash) or a severe anaphylactic reaction
• Persistent headache, nausea, vomiting and visual disturbances. Isodifa has been very rarely associated with a condition called benign intracranial hypertension.
• Bloody diarrhea(e.g. blood in the stool). Isodifa has been very rarely associated with inflammatory bowel disease.

What to avoid when taking Isodifa:

• Avoid prolonged exposure to sunlight and do not use UV radiation lamps or tanning beds. The skin may become more sensitive to light during treatment with Isodifa. Before exposure to the sun, apply a protective sunscreen with a high sun protection factor of at least SPF 15.
• Avoid cosmetic procedures such as dermabrasion or laser treatments(removal of moles or scars) and waxing during treatment and for at least 6 months after the end of treatment. Isodifa can make your skin more fragile and this can cause scarring or irritation.
• Reduce intense physical activity during treatment with Isodifaas muscle and joint pain has been observed during treatment with Isodifa.
• Do not donate bloodboth during and for one month after the end of treatment with Isodifa. If a pregnant woman were to receive this blood, the child could be born with serious malformations.

Children and adolescents
Isodifa is not indicated for the treatment of acne in prepubertal age and use is not
recommended in children under the age of 12 years.

Other medicines and Isodifa
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
Do not take vitamin preparations containing vitamin A or tetracyclines (a type of
antibiotic) during therapy with Isodifa, due to the increased risk of side
effects.
Do not use any other skin treatment for acne during treatment with
Isodifa to avoid increased local irritation.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy

Isodifa should not be taken during pregnancy. If there is a possibility of becoming pregnant,

use effective contraception during and for one month after treatment with
Isodifa.

If pregnancy occurs or is suspected during treatment or within one month after treatment with Isodifa, stop
treatment immediately and contact your doctor promptly.
If used during pregnancy, Isodifa risks damaging the fetus(in medical
terms, it is teratogenic). It also increases the risk of miscarriage.
Isodifa can cause serious abnormalities of the brain, face, ear, eye, heart and some glands (called the thymus gland and the parathyroid gland)
of the fetus.
BreastfeedingIsodifa should not be taken during breastfeeding

because it probably passes into
breast milk and can harm the baby.
For further information on pregnancy and contraception, see section 2 of the
“Pregnancy Prevention Program”

Driving and operating machinery
Isodifa has a low or moderate influence on the ability to drive or operate
machinery.
Night vision may be affected during treatment and this can occur
without warning. In rare cases, this problem can persist after the end of
treatment. Be careful when driving vehicles or using
machinery.
Drowsiness, dizziness and visual disturbances have been reported very rarely. If
you experience these side effects, you should not drive, operate machinery or participate in activities where these symptoms may put you or others at risk.

Isodifa contains

• Soybean oil. If you are allergic to peanuts or soy, do not use this medicine. This medicine contains 3.5 mg of sorbitolin each 5 mg capsule (15.23 mg of sorbitol in each 30 mg capsule) (5.31 mg of sorbitol in each 10 mg capsule) (15.98 mg of sorbitol in each 20 mg capsule). This medicine contains less than 1 mmol of sodium(23 mg) per capsule, i.e. essentially “sodium-free”.
• (10 mg and 20 mg:) Isodifa contains the colouring agent Ponceau 4R (E124), which may cause allergic reactions.

3. How to use Isodifa

Always use Isodifa exactly as your doctor has instructed. If you have any doubts,
consult your doctor or pharmacist.

• The capsules must be taken with food one or two times a day
• Swallow the capsules whole, do not chew or suck them.

Occasionally acne may worsen during the first few weeks of treatment, and
should improve with continued treatment.

Dosage
The doctor will prescribe an individual dose depending on body weight and other
clinical parameters such as renal insufficiency, etc.
Specific individual doses may be improved by combining the different dosages
available (10 mg, 20 mg or 30 mg capsules).
Adults including adolescents and the elderly
The usual starting dose is 0.5 mg per kg of body weight per day (0.5 mg/kg/day).
After a few weeks, the doctor may adjust the dose. This depends on the response
to treatment. For most patients the dose is between 0.5 and 1.0 mg/kg per
day.
If you feel that the effect of Isodifa is too strong or too weak, tell your
doctor or pharmacist.
Patients with severe renal impairment
If you suffer from severe renal impairment, treatment with Isodifa should be started with
a reduced dose, for example 10 mg/day and then increased to the maximum
tolerated dose.
Children under 12 years of age
Isodifa is not indicated in children under 12 years of age.
Patients with intolerance
if you do not tolerate the recommended dose, your doctor may
decide to continue treatment at a reduced dose. In such cases the treatment will have a
longer duration and a higher risk of relapse.

Duration of treatment
A treatment cycle generally lasts from 16 to 24 weeks.
Acne may continue to improve for up to 8 weeks after the end of treatment.
Therefore, a new treatment cycle should not be started before at least this period has elapsed.
Most patients only need a single cycle
of treatment.

Remember that this medicine has been prescribed for you!
Only a doctor can prescribe it. Do not give this medicine to others. This
medicine could be dangerous for other individuals, even if their symptoms are
the same as yours.

If you use more Isodifa than you should
The following symptoms may occur: severe headache, nausea or vomiting,
drowsiness, irritability and redness.
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 Isodifa
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 as normal. Do not use
a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone gets them.

Side effects that require immediate medical attention:
Stop taking the capsules and contact your doctor IMMEDIATELY if you experience one
of the following side effects

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

• Severe (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 feeling of tightness in the chest, shortness of breath and wheezing, especially if you have asthma.
• Yellowing of the skin or eyes and fatigue. These can be signs of hepatitis.
• Difficulty urinating, swollen eyelids, excessive fatigue. These can be signs of kidney inflammation.
• Persistent headache, with feeling unwell (nausea), feeling unwell (vomiting) and changes in vision, including blurred vision. These can be signs of benign intracranial hypertension, especially if Isodifa is taken with antibiotics called tetracyclines.
• severe abdominal (stomach) pain, with or without severe bloody diarrhea, feeling unwell (nausea) and feeling unwell (vomiting). These can be signs of serious intestinal conditions.
• Muscle weakness that can be potentially life-threatening can be associated with problems with the movement of arms or legs, pain, swelling, bruised parts of the body, dark urine, reduced or absent urination, confusion or dehydration. These are signs of rhabdomyolysis, a breakdown of muscle tissue that can lead to kidney failure. This can occur if you are doing intense physical activity during treatment with Isodifa.

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

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), potentially life-threatening and requiring immediate medical attention. These initially appear as circular areas often with central blisters normally on arms and hands or legs and feet, more severe rashes may include blisters on the chest and back. Additional symptoms such as eye infection (conjunctivitis) or ulcers of the mouth, throat or nose may occur. Severe rash forms can progress to widespread peeling of the

skin which can be life-threatening. These severe skin lesions are often
preceded by headache, fever, body aches (flu-like symptoms).

Mental problems

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

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

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

• Some people have had thoughts or intentions of harming themselves or ending their lives (suicidal ideas), have tried 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 do not exist.

Contact your doctor immediately if you experience symptoms of any of these mental
problems.Your doctor may tell you to stop taking Isodifa. This may not
be enough to end the effects: you may need further
help and your doctor can arrange this.
Some of the side effects associated with the use of isotretinoin are dose-related. The
side effects are generally reversible after dose reduction or
discontinuation of treatment, however some may persist after discontinuation of
treatment.

Other side effects:

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

• dry skin, especially of the lips and face; Inflamed skin, chapped and inflamed lips, rash, mild itching and slight flaking of the skin. Use a moisturizer from the start of treatment.
• The skin becomes more fragile and redder than usual, especially on the face.
• Back pain; muscle pain; Joint pain, especially in children and adolescents. To avoid worsening bone or muscle problems, reduce intense physical activity during treatment with Isodifa.
• Inflammation of the eye (conjunctivitis) and the area around the eyelids; Eyes feel dry and irritated. Ask your pharmacist for suitable eye drops. If you experience dry eyes and wear contact lenses, you may need to wear glasses.
• Increased liver enzymes in the blood.
• Changes in blood fat levels (including HDL or triglycerides).
• Increased bruising, bleeding or clotting - if blood clotting cells are affected.
• Anemia - weakness, dizziness, pale skin - if red blood cells are affected.

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

• Headache.
• Higher cholesterol levels in the blood.
• Blood tests show increased blood sugar.
• Protein or blood in the urine.
• Increased susceptibility to infections if white blood cells are affected.
• Dryness and crusting inside the nose, causing mild pain.
• Inflamed throat and nose.

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

• Hair loss (alopecia). This is usually temporary. Hair should grow back after stopping treatment.
• Allergic reactions such as rash and itching. If you have allergic reactions, stop taking Isodifa and contact your doctor.

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

• Decreased vision at night; changes in color vision.
• Increased sensitivity to light; you may need to wear sunglasses to protect your eyes from too much sunlight.
• Other vision problems, including blurred vision, distorted vision, cloudy appearance of the eye (corneal opacity, cataracts).
• Excessive thirst; Frequent need to urinate. These can be signs of diabetes.
• Acne may worsen in the first few weeks, but symptoms should improve over time.
• Inflamed skin, swollen and darker than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; Bone disorders (delayed growth, additional growth and changes in bone density); Growing bones may stop growing.
• Calcium deposits in soft tissues, painful tendons, high levels of muscle metabolism products in the blood in case of excessive physical exertion.
• Increased sensitivity to light.
• Bacterial infections at the base of the nails, changes in the nails.
• Swelling, rashes, pus.
• Thick scars after surgery.
• Increased body hair.
• Seizures, drowsiness, dizziness.
• Lymph nodes may become swollen.
• Dry throat, hoarseness.
• Difficulty hearing.
• General feeling of unwellness.
• High levels of uric acid in the blood.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising, red spots).

Frequency unknown: (frequency cannot be estimated from available data)

• Dark urine
• Problems getting or maintaining an erection
• Decreased libido
• Enlargement of the breasts with or without tenderness in men
• Vaginal dryness

Soybean oil can rarely cause allergic reactions.
(10 mg and 20 mg:) Ponceau 4R (124) can cause allergic reactions.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Isodifa

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
outer packaging and on the blister after EXP. The expiry date refers to the last day
of the month.
Do not store at a temperature above 30°C. Store in the original packaging
to protect the medicine from light.
Return unused Isodifa to the pharmacist at the end of treatment. Do not dispose of any
medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Isodifa Contains

• The active ingredient is isotretinoin. Each capsule contains 5 mg of isotretinoin. Each capsule contains 10 mg of isotretinoin Each capsule contains 20 mg of isotretinoin Each capsule contains 30 mg of isotretinoin
• Other ingredients are: 5 mg capsules:Capsule content: yellow beeswax, refined soybean oil, partially hydrogenated soybean oil, hydrogenated vegetable oil, DL-alpha-tocopherol, disodium edetate, butylhydroxytoluene Capsule shell: gelatin, glycerol, non-crystallized liquid sorbitol (E420), titanium dioxide (E171) 10 mg Capsules:Capsule content: yellow beeswax, refined soybean oil, partially hydrogenated soybean oil, hydrogenated vegetable oil, DL-alpha-tocopherol, disodium edetate, butylated hydroxyanisole

Capsule shell: gelatin, glycerol, non-crystallized liquid sorbitol (E 420),
titanium dioxide (E 171), ponceau 4R (E 124) and black iron oxide (E 172)

20 mg Capsules:
Capsule content: yellow beeswax, refined soybean oil, partially hydrogenated soybean oil,
hydrogenated vegetable oil, DL-alpha-tocopherol, disodium
edetate, butylated hydroxyanisole
Capsule shell: gelatin, glycerol, non-crystallized liquid sorbitol (E 420),
titanium dioxide (E 171), indigo carmine (E 132) and ponceau 4R (E 124)

30 mg Capsules:
Capsule content: yellow beeswax, refined soybean oil, partially hydrogenated soybean oil,
hydrogenated soybean oil, DL-alpha-tocopherol, disodium
edetate, butylated hydroxyanisole
Capsule shell: gelatin, glycerol, non-crystallized liquid sorbitol (E 420),
titanium dioxide (E 171) and red iron oxide (E172)

Description of the appearance of Isodifa and contents of the pack
Isodifa 5 mg capsules are soft gelatin capsules, oval in shape, light pink/cream colored 8
mm x 5 mm, containing an opaque viscous liquid of yellow/orange color
Isodifa 10 mg capsules are soft gelatin capsules, oval in shape, pale violet colored 10 mm x
7 mm, containing an opaque viscous liquid of yellow/orange color
Isodifa 20 mg capsules are soft gelatin capsules, oval in shape, brown colored 13 mm x 8
mm, containing an opaque viscous liquid of yellow/orange color
Isodifa 30 mg capsules are soft gelatin capsules, oval in shape, pink colored 11 mm x 7 mm,
containing an opaque viscous liquid of yellow/orange color
Packs of 20, 30, 50, 60 or 100 soft capsules.
Not all pack sizes may be marketed.

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

• 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 following member states of the EEA with the
following names:
Denmark: Isotretinoin Difa
Italy: Isodifa
Detailed and up-to-date information on this medicinal product is available at the following
URL address: https://www.aifa.gov.it/hu/trova-farmaco