Neotigason 10 mg. 30 capsules
Neotigason contains the active substance acitretin. It belongs to a group of medicines known as retinoids.
Neotigason is used to treat serious skin problems that are characterized by thickening and scaling of the skin, such as psoriasis, ichthyosis, pityriasis rubra pilaris, and keratosis follicularis (Darius disease). It exerts its effect by helping your skin to recover more normal.
Neotigason prescribed and administered under the supervision of a physician dermatologist (a specialist in skin diseases).
2. What you should know before using for Neotigason
Do not take Neotigason if:
you are pregnant, you think you might be pregnant or likely to become pregnant while being treated with Neotigason or for two years after termination. It is necessary to take measures to avoid pregnancy, see section "Pregnancy and lactation"
you are allergic (hypersensitive) to acitretin or any of the other ingredients of this medicine listed in Section 6 "Contents of the pack and other information" or if you are taking other medicines from the group of retinoids such as isotretinoin and tazarotene;
have severe liver problems;
have severe kidney problems;
you have very high levels of fats (lipids) in the blood;
being treated with drugs called tetracyclines (to treat infections) or methotrexate (used to treat skin problems, arthritis or cancer) - see section "Other medicines and Neotigason"
taking vitamin A, see section "Other medicines and Neotigason."
Talk to your doctor before taking Neotigason if you believe that any of the above applies to you.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Neotigason:
If you have diabetes. When you have more frequent blood sugar control at the beginning of treatment Neotigason;
If you have high levels of fat in the blood or if you are overweight. You may need your doctor to conduct blood tests during treatment with Neotigason to check the amount of fat in the blood;
If you suffer from cardiovascular disease. You may need your doctor to see you more often, for example. monitor blood pressure;
If you consume large amounts of alcohol;
If you have liver problems.
Other things to keep in mind while taking Neotigason:
Neotigason can reduce night vision (see "Driving and using machines" at this point and also point 4);
Neotigason may increase intracranial blood pressure should be checked as soon as possible by your doctor. For symptoms, see section 4;
Neotigason can enhance the effects of ultraviolet radiation on the skin. Before you expose yourself to sunlight, use protective cream (with at least SPF 15) to protect the skin. Exposure to artificial UV radiation and excessive exposure to sunlight should be avoided;
The function of your liver and values of fats (lipids) in your blood should be checked before treatment and periodically thereafter during the treatment itself. Your doctor also periodically check your bones as Neotigason can cause bone changes, especially in children and elderly patients undergoing long-term treatment;
Treatment with Neotigason in high doses can cause mood changes (including irritability, aggression and depression);
A serious condition that leads to the high permeability of small blood vessels (capillaries) called "syndrome of systemic leakage of capillaries / retinoic acid syndrome" has been reported very rarely during treatment with Neotigazon. This can lead to severe hypotension (low blood pressure), edema (accumulation of fluid, which leads to swelling) and shock (collapse). See further in section 4;
Serious skin reactions with symptoms such as rash, blistering or peeling of the skin (exfoliative dermatitis) reported very rarely. See further in Section 4.
Women of childbearing potential: Neotigason causes damage to the unborn child. It is necessary to take precautions against pregnancy and to conduct pregnancy tests during treatment with Neotigason and for two years after its termination (see also section "Pregnancy and lactation"). Women of childbearing age should not consume alcohol during treatment and for 2 months after its termination.
Blood donation: You should not donate blood while taking Neotigason and for two years after his arrest. This is because of the high risk of birth defects to the unborn child who Neotigason can cause. Therefore, women of childbearing age should not receive blood from patients who were treated with Neotigazon or were such within the previous two years.
If any of the above warnings applies to you or if you are not sure about something, ask your doctor or pharmacist for advice before taking Neotigason.
Other medicines and Neotigason
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines, including medicines obtained without a prescription.
Methotrexate (used to treat skin problems, arthritis or cancer), tetracyclines (antibiotics to treat infections) or vitamin A and other retinoids (such as isotretinoin and tazarotene) should not be used concomitantly with Neotigazon see also section "Do not take Neotigason ".
Tell your doctor if you are taking phenytoin (for epilepsy) or birth control pills containing only low-dose progesterone before you start treatment with Neotigazon.
Neotigason food, beverages and alcohol
Women of childbearing age should not consume alcohol (in drinks, food or medicines) during treatment with Neotigazon and for 2 months after its termination. Concomitant administration of acitretin alcohol can result in the formation of the substance etretinate, which may cause harm to the unborn child.
Pregnancy, lactation and fertility
Neotigason can cause harm to the fetus during pregnancy. The following instructions must be strictly observed, even if you have problems getting pregnant:
Neotigazon not take if you are pregnant, you think you might be pregnant or might become pregnant during treatment with this medicine and for 2 years after its termination.
Do not take Neotigason if you are breastfeeding.
Control of pregnancy: If you are a woman aged in which you can get pregnant, you should use effective means of birth control (contraception) without interruption for at least four weeks before treatment with Neotigason during the treatment itself and for two years after termination. The main method of contraception is the use of combined hormonal contraceptive product or intrauterine device, it is advisable to also used a condom (condom) or diaphragm. Low dose progesterone-only products are not recommended.
Pregnancy tests: Within 3 days before starting treatment, your doctor will do a pregnancy test to be negative. Start taking Neotigason after a negative pregnancy test on the second or third day of the next menstrual cycle.
During treatment with Neotigason You will need to conduct periodic pregnancy tests at intervals of 28 days.
Before each new prescription Neotigason Your doctor will require a negative pregnancy test. This test should not be held for more than three days.
After discontinuation of Neotigason must be conducted periodic pregnancy tests at intervals of 1-3 months for 2 years after the last dose.
While taking Neotigason and for two years thereafter, immediately contact your doctor if you become pregnant or think you may be pregnant.
If you have any questions about these instructions, talk to your doctor or pharmacist before taking Neotigason.
Driving and using machines
Your vision may be impaired, especially at night while taking Neotigazon. Be careful if you have to drive or operate machinery.
Neotigason contains glucose
If your doctor told you that you have an intolerance to some sugars, contact him before taking this medicine.
3. How to take Neotigason
Always take this medicine exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.
It is recommended that the capsule be taken once daily with food or milk.
The usual adult dose at the beginning of the treatment is 25 mg (eg. 1 capsule containing 25 mg acitretin) or 30 mg (e. 3 capsules each containing 10 mg acitretin). Your doctor may change the dose depending on your illness and other factors such as your overall condition. The maximum recommended daily dose is 75 mg (e. 3 capsules each containing 25 mg acitretin).
Women of childbearing potential:
Start taking Neotigason the second or third day of the next menstrual cycle. Your doctor will require testing for pregnancy up to 3 days before treatment with Neotigason, at the time of treatment and periodically for two years after termination. The results of these tests must be negative. It is also necessary to use effective methods of birth control (contraception) without interruption for at least four weeks before treatment with Neotigazon during the treatment and for two years after its termination - see also section "Pregnancy , breastfeeding and fertility. "
Use in children
Neotigason should not be used in children only when all other alternative treatments have proved ineffective. The doctor will determine the dose depends on the condition and body weight of the child.
If you take more than the amount Neotigason
If you take a higher dose than prescribed or if someone else has taken your medicine, immediately contact a doctor or go to hospital! Symptoms of overdose are headache, dizziness, nausea or vomiting, drowsiness, irritability and itching of the skin.
If you forget to take Neotigason
Take Neotigazon soon guess. If it's soon time for your next dose skip the missed dose. Do not take a double dose to make up the missed dose.
If you stop taking Neotigason
Do not stop taking Neotigason without consulting your doctor.
If you have further questions about using 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.
Stop taking Neotngason and contact your doctor immediately if you experience the following side effects:
Severe headache, nausea, vomiting and visual disturbances. These may be symptoms of increased intracranial blood pressure (very rare - may affect up to 1 in 10,000 patients);
Allergic reaction of immediate type with symptoms such as skin rash, swelling or itching of the skin red and swollen eyelids, severe nasal congestion, asthma or wheezing. This reaction may be slight to life-threatening (side effect not known);
Yellowing of the skin and whites of the eyes, which can be a sign of jaundice (very rare - may affect up to 1 in 10 000 patients) or inflammation of the liver (uncommon - may affect up to 1 in 100 patients). Other symptoms that may occur: loss of appetite, fever, malaise, nausea, dark urine, and discomfort in the abdomen;
A serious condition that leads to the high permeability of small blood vessels (capillaries), called "syndrome systemic leakage of capillaries / retinoic acid syndrome", which may lead to severe hypotension (low blood pressure), edema (accumulation of fluid, leading to swelling) and shock (collapse). Symptoms include swelling or puffiness, difficulty breathing, stomach cramps, muscle aches, extreme thirst and a general feeling of tiredness and weakness (side effect not known);
Serious skin reactions with symptoms such as rash, blistering or peeling of the skin (exfoliative dermatitis) (adverse reaction not known).
Other side effects that can be observed:
Very common (may affect more than 1 in 10 patients):
Dryness, irritation or inflammation of the eye, which can be a cause of intolerance to contact lenses;
Dryness and irritation, runny nose or nose bleeds;
Dry mouth, thirst;
Dryness or inflammation of the lips, which can be remedied by applying greasy cream;
Hair loss, itchy, scaly skin on the palms and soles, and even the whole body;
Changes in liver function (shown by blood tests);
Increased levels of fats in the blood (shown by blood tests).
Common side effects (may affect up to 1 in 10 patients):
Inflammation of the lining of the mouth, abdominal pain, diarrhea, nausea, vomiting;
Thinning of the skin, moist, clammy skin or rash, skin irritation, changes in the structure of hair, brittle nails, skin infection around the nail, skin redness;
Joint and muscle pain;
Swelling of the hands, ankles and feet.
Uncommon side effects (may affect up to 1 in 100 patients):
Splitting, cracking or fine linear skin lesions around the mouth (cracks), blisters and inflammation of the skin (bullous dermatitis), increased skin sensitivity to sunlight (photosensitivity reactions).
Rare side effects (may affect up to 1 in 1000 patients):
Damage to the peripheral nervous system, which may include symptoms such as muscle weakness, numbness and tingling in arms and legs or burning, stabbing or shooting pains.
Very rare side effects (may affect up to 1 in 10,000 patients):
Weakened night vision, inflammation of the eye cornea (ulcerative keratitis);
Bone pain, changes in bone growth.
Side effects with unknown frequency:
Vaginal infection caused by fungi (known as candidiasis or thrush);
Hearing impairment, tinnitus;
Flushing of the skin;
Breach of taste sensations, rectal bleeding;
Small, red skin blemishes that can easily be bloody (pyogenic granuloma), dropping the eyelashes or eyebrows (madarosis), swelling, skin rash, causing itching or redness, thinning of the skin;
Deterioration or improvement in blood sugar control in diabetics.
Sometimes there is an initial worsening of the symptoms of psoriasis after initiation of treatment.
5. How to store Neotigason
Keep out of reach of children!
Store in the original container.
Do not store above 25 ° C.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
Due to the risk of harmful effects on the fetus, the drug should not be given to other people. Unused or expired product should be returned to the pharmacy for disposal.
6. Contents of the pack and other information
The active substance is acitretin. Each capsule contains 10 mg or 25 mg acitretin.
Other ingredients are: glucose; sodium ascorbate; gelatin; cellulose, microcrystalline; black iron oxide (E172); iron oxide yellow (E172); iron oxide red (E172); titanium dioxide (E171).