Neotigason - Acitretin uses, dose and side effects

Neotigason is used for severe forms of psoriasis and other skin conditions that are characterized by disorders in the formation of new skin. Neotigason has a normalizing effect on the processes that take place during the formation of the outer layer of the skin, but exactly how Neotigason works is not known. Only after a few weeks of treatment can you see an effect of Neotigason.

What you need to know before you take Neotigason

Do not take Neotigason

if you are allergic to acitretin or any of the other ingredients of this medicine (listed in section 6) or to other vitamin A-related substances.
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 have impaired liver or kidney function.
if you are taking vitamin A supplements or other vitamin A-related substances
if you have elevated blood fat levels.
if you are taking an antibiotic called tetracycline (for infection ) or a medicine containing the active substance methotrexate.

Warnings and cautions

Talk to your doctor or pharmacist before taking Neotigason

if you have diabetes . You need to check your blood sugar levels more often when you start using Neotigason.
if it turns out when checking your liver values that the liver function is not normal. If liver function does not return to normal, or worsens, treatment must be stopped. If this happens, liver function should be monitored for at least 3 months. Liver function should be checked before treatment, every two weeks during the first 2 months of treatment, and every 3 months thereafter.
if you experience severe headache, nausea, vomiting and visual disturbances during treatment. If these signs of illness occur at the same time, treatment should be stopped and a doctor should be consulted.
if you have cardiovascular problems. Your blood fat and cholesterol levels must be checked before and during treatment.
if bone changes occur in the body. Your doctor may then weigh the risk against the benefit of the treatment.
Avoid strong sunlight and tanning beds as Neotigason enhances the effect of UV light.
if you are a blood donor, you must not donate blood during and 3 years after the end of treatment.
Women of childbearing potential should not consume alcohol (in beverages, food or medicine) during treatment with Neotigason and 2 months after stopping treatment as the residual product etretinate may then be formed. Etretinate is very harmful to the fetus and has a long half-life (120 days), which means that it stays in the body for a long time and can mean that the risk of birth defects remains for 3 years after stopping treatment with Neotigason.
if you experience a serious but very rare condition (capillary leakage syndrome / retinoic acid syndrome) that causes leakage from small blood vessels (the capillaries ). This can lead to a severe drop in blood pressure ( hypotension ), edema (swelling due to fluid in the tissues ) and shock (collapse).
if you experience a severe but very rare skin reaction with symptoms such as rash, blistering or flaky skin (exfolative dermatitis ).
if you have ever had problems with your mental health, including depression, aggressive tendencies or mood swings. Neotigason can affect your mood.

Acitretin usually increases blood fats, such as cholesterol or triglycerides, which have been associated with pancreatitis.

Tell your doctor if you experience severe pain in the abdomen and back (these may be signs of inflammation of the pancreas).

Mental health problems

You may not notice any changes in your mood and behavior, so you must 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.

Pregnancy prevention programs

Women who are pregnant should not take Neotigason

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 Neotigason is only taken for a short time during pregnancy.

You must not take Neotigason if you are pregnant or think you may be pregnant.
You must not take Neotigason if you are breast-feeding. Neotigason is likely to pass into breast milk and may harm your baby.
You must not take Neotigason if you may become pregnant at any time during treatment.
You must not become pregnant for 3 years after stopping this treatment as a certain amount of medicine may still remain in your body.

Women who can become pregnant are prescribed Neotigason 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 do a pregnancy test, this must be negative (ie show that you are not pregnant) in order for you to start treatment with Neotigason.

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

You must agree to use at least one effective contraceptive (eg IUD or contraceptive implant) 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 Neotigason, during treatment and for 3 years 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 Neotigason

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 medicines may still remain in your body, every three months for 3 years after stopping treatment with Neotigason
You must agree to extra pregnancy tests if your doctor asks you to.
You must not become pregnant during the treatment period or within 3 years after the end of treatment because 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 Neotigason, stop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.

If you become pregnant within 3 years 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 Neotigason 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 3 years after stopping treatment with Neotigason as unborn babies can be harmed if pregnant women get your blood.

Other medicines and Neotigason

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Vitamin A , tetracyclines ( antibiotics) and the drug methotrexate should not be used during treatment with Neotigason.
So-called mini- pills should not be used as acitretin affects the effect. Other contraceptives should be used instead.
Neotigason may affect the effect of phenytoin (against epilepsy ) if both medicines are used at the same time.

Neotigason and alcohol

When Neotigason and alcohol are taken concomitantly, the residual product etretinate may be formed. Etretinate is very harmful to the fetus. Therefore, women of childbearing potential should not consume alcohol (in beverages, foods, or medicines) during treatment with Neotigason and 2 months after stopping treatment.

Pregnancy, breastfeeding and fertility

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

Do not use Neotigason if you are pregnant, think you may be pregnant or become pregnant while taking this medicine or for another three years after stopping treatment. Do not use Neotigason if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Neotigason is harmful to the fetus. It is, therefore, necessary for women of childbearing potential treated with Neotigason to use effective contraception (preferably two complementary methods) without interruption starting 1 month before the start of treatment, during the treatment period, and for a further three years after the end of treatment.

The first choice of contraceptive can be a combined contraceptive pill or an IUD, it is recommended that condoms or diapers are also used. The patient must have performed a pregnancy test that is negative before starting treatment, the test must be at most 3 days old. Pregnancy tests should be repeated every month during treatment. Treatment should be started 2 or 3 days before normal menstruation. Contact a doctor immediately if you suspect you are pregnant.

Women of childbearing potential should not consume alcohol (in beverages, foods, or medicines) during treatment with Neotigason and for two months after stopping treatment with Neotigason.

You should not breastfeed your baby during treatment with Neotigason.

Driving and using machines

Night vision can be impaired and difficulties in driving in the dark can therefore occur. Contact a doctor if visual disturbances occur.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Neotigason contains glucose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Neotigason

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

Dosage:

Dose one is determined by the doctor, who adjusts it individually for the patient.

The usual dose for adults is initially 10 mg once a day, after which the dose is increased by 5-10 mg every two weeks.

Children are only treated in special cases.

Psoriasis treatment with ointments can be continued during Neotigason treatment, but this should first be discussed with your treating physician.

Preferably take the capsules with a meal or with a little milk.

If you take more Neotigason than you should

In case of acute overdose, Neotigason must be discontinued immediately.

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

Possible side effects

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

Most patients treated with Neotigason experience skin side effects. Most side effects that occur during treatment with Neotigason decrease or disappear if the dose is reduced or the treatment is stopped.

Stop taking Neotigason and see a doctor immediately if you get the following side effects:

swelling of the face, tongue or throat
difficulty swallowing
hives and difficulty breathing ( angioedema , occurs in unknown number of users )

Or the following side effect is at the same time:

Severe headache
Nausea and vomiting
Visual disturbances.

Patients with the above side effects should discontinue treatment and seek medical attention immediately for neurological examination and care. The symptoms may be a sign of a very rare side effect called benign intracranial hypertension (affects less than 1 user in 10,000).

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

dry, irritated or swollen eyes, which can cause contact lens problems
dry, irritated or runny nose, nosebleeds
dry mouth , thirst
dry or inflamed lips, which can be relieved with oily ointment. Itching , hair loss, peeling of the skin on the palms or soles of the feet
liver changes (shown during blood tests)
increased content of blood fats (shown during blood tests).

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

headache
inflammation of the oral mucosa, abdominal pain, diarrhea, nausea and vomiting
sensitive skin that can feel sticky, stinging sensation in the skin or rash, skin inflammation, hair changes, brittle nails, skin infection around nails, skin redness
joint pain, muscle pain
swollen hands, ankles and feet.

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

dizziness
dimsyn
gingivitis
hepatitis
cracks in the mouth pores, blisters and skin inflammation (bullous eczema ), the skin becomes more sensitive to sunlight.

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

muscle weakness, numbness and tingling in the feet and hands or burning, stabbing or flashing pain.

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

elevated pressure in the skull
night blindness , corneal inflammation
yellowing skin and whites of the eyes (jaundice)
skeletal pain, changes in skeletal growth.

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

vaginal infection ( so -called fungus or cod)
hearing loss, ringing in the ear ( tinnitus )
reddening of the skin
leakage from blood vessels, this can lead to severe drop in blood pressure, edema (swelling due to fluid in the tissues ) and shock (collapse)
taste changes, bleeding rectum
small, reddish lumps on the skin that bleed easily (wart-forming tumor)
immediate allergic reaction with symptoms such as rash, swelling or itchy skin, red swollen eyes, stuffy nose, asthma or difficulty breathing. The reaction can be small to life-threatening.
lost eyelashes (madaros)
hives
thinned skin
a severe skin reaction with symptoms such as rash, blistering or flaky skin (exfoliative dermatitis )
changes in how the voice sounds ( dysphonia )

At the beginning of the treatment period, you can sometimes see a worsening of psoriasis.

Diabetics may experience altered glucose tolerance.

How to store Neotigason

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

Do not store above 25 ° C.

Store in the original package. Moisture sensitive.

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

Due to the risk of birth defects, this medicine should not be passed on to others.

The medicine 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.

Contents of the package and other information

Content declaration

The active substance is acitretin. A hard capsule contains 10 mg resp. 25 mg acitretin.
The other ingredients are microcrystalline cellulose, liquid spray-dried glucose , gelatin and sodium ascorbate. The capsule shell consists of gelatin, titanium dioxide (E 171), black, yellow and red iron oxide (E 172). The labeling ink consists of shellac, propylene glycol, ammonium hydroxide and black iron oxide (E 172).

What the medicine looks like and contents of the pack

Neotigason 10 mg, hard capsules are white/brown.

Neotigason 25 mg, hard capsules are yellow/brown.

Pressure packaging with 100 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Manufacturer

Cenexi

52, Rue Marcel and Jacques Gaucher

94120 Fontenay-Sous-Bois

France