How does it work?
Neotigason capsules contain the active ingredient acitretin, which is a type of medicine known as a retinoid. Retinoids have a structure similar to vitamin A and are involved in the normal growth of skin cells.
Acitretin works by inhibiting the excessive cell growth and keratinisation (process by which skin cells become thickened due to the deposition of a protein within them) seen in psoriasis. It therefore reduces the thickening of the skin, plaque formation and scaling.
The use of this medicine will be supervised by a skin specialist (dermatologist). It is reserved for treating severe skin conditions, such as psoriasis, when other treatments have not been effective.
A course of treatment is normally given for two to four weeks. Depending on how your skin responds, the dose of the medicine may then be changed. After a further six to eight weeks you should see the full benefit of this treatment.
Neotigason capsules should be taken once daily with food or a glass of milk.
What is it used for?
- Severe widespread psoriasis that is resistant to other treatments.
- Palmo-plantar pustular psoriasis (pustular psoriasis affecting the palms of the hands and soles of the feet).
- Severe congenital ichthyosis.
- Severe Darier's disease.
- This medicine MUST NOT be taken by women who are pregnant because it can cause the baby to be born with birth defects. For this reason your doctor will not prescribe the treatment to women who could get pregnant, unless the following criteria are met: At least one, but preferably two (for example the pill and condoms), effective methods of contraception must be used at all times to prevent pregnancy. (The mini-pill should not be used because it is not effective enough.). Contraception must start at least one month before starting treatment, be used at all times during treatment and for at least three years after stopping treatment, even if you don't have a period. Even women with a history of infertility are advised to use an effective method of contraception. Your doctor cannot prescribe acitretin until you have been using effective contraception for at least a month. You will need to have a pregnancy test within two weeks before starting the treatment, which must be negative. After the negative pregnancy test, therapy with acitretin should then be started on the second or third day of your next period. If you think there is a chance you could be pregnant, either during treatment, or in the three years after stopping treatment, you must stop taking this medicine and consult your doctor immediately.
- People taking this medicine should not donate blood during treatment and for at least one year after stopping treatment with this medicine. This is because if a pregnant woman was given the blood the medicine could cause birth defects in her developing baby.
- Avoid exposure to sunlight or sunlamps while using this medicine, as it increases the sensitivity of your skin. If exposure to sunlight cannot be avoided, use protective measures such as sun-creams or protective clothing.
- Acitretin commonly makes skin and lips very dry. It is recommended that you use a moisturiser and lip balm if affected.
- Acitretin can also make your eyes dry. This can be relieved with artificial tear drops or lubricating eye ointment. Ask your doctor or pharmacist for advice. If you wear contact lenses you may find that they become uncomfortable during treatment and you have to wear glasses instead.
- Blurred vision and decreased night vision may occur during treatment with this medicine. For this reason you are advised to be cautious when driving or operating any vehicle at night. If you experience any visual difficulties, tell your doctor so that your vision can be checked.
- This medicine can sometimes cause extra growth of bone on the surfaces of your bones, particularly if you take the medicine for a long time. For this reason, if you notice any aches and pains in your muscles, bones or joints while taking this medicine, you should let your doctor know straight away.
- While taking this medicine you will need to have regular blood tests to monitor your liver function and the levels of fats in your blood.
- The manufacturer recommends that this medicine is not used continuously for longer than six months. However, specialists may sometimes prescribe it for longer than this for people who are benefiting. In this case it is important that you have regular appointments to review your treatment and check for possible side effects.
Use with caution in
- People with diabetes (your blood glucose levels should be checked more frequently than usual when you first start taking this medicine).
- Lipid metabolism disorders.
Not to be used in
- Pregnancy. Pregnancy must also be prevented for three years after stopping treatment.
- Women who could get pregnant, unless all the requirements described in the warning section above are met.
- Decreased kidney function.
- Decreased liver function.
- Uncontrolled high levels of cholesterol in the blood (hypercholesterolaemia).
- Uncontrolled high levels of fats called triglycerides in the blood (hypertriglyceridaemia).
- A condition resulting from the excessive consumption of vitamin A (hypervitaminosis A).
- People taking tetracycline-type antibiotics, methotrexate, or high doses of vitamin A.
- Allergy to other retinoids, eg isotretinoin, tretinoin, tazarotene.
- People with the rare hereditary problem of glucose-galactose malabsorption (this medicine contains glucose).
- This medicine is not normally recommended for children because it may affect the development of their bones. If your doctor feels this medicine is essential for your child, their muscles, bones, joints and growth must be regularly checked.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine MUST NOT be used during pregnancy, as it can cause serious malformations of the developing foetus and result in the baby being born with major birth defects. Women who could get pregnant will only be prescribed this medicine if all the criteria listed in the warning section above are met. At least one and preferably two effective methods of contraception must be used to prevent pregnancy for at least one month before starting treatment, during treatment and for at least three years after finishing treatment. If you think you could be pregnant at any point during treatment or in the three years after stopping treatment you must consult your doctor immediately.
- Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers. Discuss this with your doctor.
- Follow the printed instructions you have been given with this medication.
- Take this medication with or after food.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, does not mean that all people using this medicine will experience that or any side effect.
- Dry skin, causing peeling, thinning, redness, itching and increased skin fragility (see warning section above).
- Peeling of the skin on the palms of the hands and soles of the feet (palmar and plantar exfoliation).
- Other skin reactions, such as stickiness, rash, flushing and sweating.
- Inflammation of the nail bed (paronychia) and weak nails.
- Hair thinning and hair loss (alopecia). If this occurs it will usually happen four to eight weeks after starting treatment, and is reversible after the medicine is stopped.
- Dry eyes, causing eye irritation or inflammation (conjunctivitis) - see warning section above.
- Visual disturbances (eg blurred vision, decreased night vision).
- Dry or cracked lips.
- Inflammation of the mouth and gums.
- Changes in taste.
- Dryness of the lining of the nose (this may cause nosebleeds) and mouth.
- Runny nose.
- Disturbances of the gut, such nausea, vomiting, diarrhoea and abdominal pain.
- Increased liver enzymes.
- Raised levels of triglycerides in the blood (hypertriglyceridaemia).
- Extra growth of bone (see warning section above).
- Pain in the muscles or joints.
- Raised pressure inside the skull (benign intracranial hypertension). If you experience a lasting headache, along with feeling or being sick (nausea and vomiting) and changes in your vision, such as blurred vision, you should stop taking this medicine and consult your doctor immediately.
- Abnormal reaction of the skin to light, usually a rash (photosensitivity).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Treatment with medicines that are applied to the skin, particularly medicines which loosen the dead skin on the skin surface (keratolytics), should usually be stopped while you are taking acitretin. However, moisturisers and topical corticosteroids can be continued if necessary.
You should not take vitamin supplements that contain high doses of vitamin A (more than 4000 to 5000 IU per day) while you are taking this medicine, because this may result in a condition similar to vitamin A overdose. (Bear in mind that vitamin A may be found in multivitamin supplements.) Other retinoid medicines should not be used in combination with this medicine for the same reason.
Tetracycline-type antibiotics, eg minocycline, doxycycline, tetracycline, must not be used in combination with this medicine, because the combination may increase the risk of a condition where there is raised pressure inside the skull (benign intracranial hypertension).
There may be an increased risk of side effects on the liver if this medicine is used in combination with methotrexate. The manufacturers therefore recommend that acitretin is not used in combination with methotrexate.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain acitretin as the active ingredient.