Acitretin 25 Mg Capsules
Read all of this leaflet carefully before you
start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet
3 What Acitretin is and what it is used for
3 What you need to know before you take Acitretin
[3 How to take Acitretin
[4 Possible side effects
3 How to store Acitretin
3 Contents of the pack and other information
[1 What Acitretin is and what it is used for
The name of your medicine is “Acitretin 10 mg Capsules” or “Acitretin 25 mg Capsules” but will be referred to as “Acitretin” throughout the leaflet.
Acitretin belongs to a group of medicines known as retinoids. Retinoids are derived from vitamin A.
The medicine is used to treat severe skin problems where the skin has become thick and may be scaly and which does not respond to other conventional treatments satisfactorily.
Acitretin is used to treat
• extensive and serious forms of various skin disorders resulting from disturbances of the outer layer of skin (the epidermis), such as psoriasis, together with a dry, scaling, waxy rash.
• specific skin disorders characterized by dry scales as a result of marked keratinization (ichthyosis, an organic process by which keratin is deposited in cells and the cells become horny like nails and hair) and similar disorders in which a skin rash (pityriasis) or small elevations of skin and mucosa (lichen ruber) occur.
[2 What you need to know before you take Acitretin
Do not take Acitretin
• if you are pregnant.
• if you are a girl or woman of childbearing
age and could therefore become pregnant because this medicine can cause malformations in the unborn baby. If you have discussed the possible risks with the doctor and nevertheless decide to use this medicine, you must STRICTLY follow a number of instructions (see “Only under STRICT conditions can Acitretin be prescribed to women who might become pregnant, because of the risk for congenital malformations (harmful
effects on the unborn baby”)).
• if you are breast-feeding.
• if your liver is not working properly.
• if your kidneys are not working properly.
• if you have very high levels of fat or cholesterol in your blood (also known as “hyperlipidaemia”).
• if you use other retinoid medicines or
medicines, vitamin supplements or foods that contain high levels of vitamin A (more than 5000 IU per day) (See “Other medicines and Acitretin”).
• if you use an antibiotic tetracycline.
• if you use a medicine called methotrexate (a medicine that is used in the treatment of cancer, psoriasis and rheumatic diseases).
• if you use the so-called mini-pill (a contraceptive pill with only a low progesterone content).
• if you are allergic (hypersensitive) to acitretin or any of the other ingredients of this medicine (listed in section 6) or to other “retinoid” medicines. Hypersensitivity usually shows itself in the form of skin reactions, such as a rash, hives and/or itching.
• if you are a child.
If one or more of these warnings are
applicable for you, talk to your doctor before
taking Acitretin.
Warnings and precautions
• if you are a blood donor. You must not give blood while you are taking Acitretin or for
1 year after you stop taking it.
• if you receive donor blood. You must not receive donor blood from patients treated with acitretin if you are a woman of childbearing age.
• if you suffer from high levels of sugar in the blood (diabetes). You will need to check your blood sugar levels more often when you start taking this medicine.
• if you drink alcohol (see “Pregnancy” and “Possible side effects”). Talk to your doctor about your alcohol use.
• if you notice that you have problems with your vision, especially in the dark (see “Driving and using machines”).
• if you wear contact lenses. Acitretin causes dry eyes, therefore you have to wear glasses throughout the period of treatment.
• if Acitretin is to be used in children. Growth and bone development must be checked at regular intervals. In long-term treatment of children, the doctor must carefully weigh the possible severe side effects against the benefit of therapy with this medicine.
• if you are going out into strong sunlight or you are going to use a sun bed, Acitretin can make the effects of UV light on the skin stronger. In this case avoid too much sun and do not use a sun bed. Before going out in the sun, you must make sure you have adequate sun protection.
Talk to your doctor if any of the above warnings
apply to you or have applied to you in the past.
Furthermore it is important to know that:
• Your doctor should have your blood tested to check your liver function before the start of treatment. Your blood must also be tested every week or every other week during the first 1 to 2 months after the start of treatment. After this, it should be tested at least every 3 months. If your liver seems to be working abnormally, this must be monitored every week. If this abnormal liver function results in early discontinuation of treatment, the liver function must be monitored for at least 3 months after stopping Acitretin therapy.
• If you suffer from high levels of sugar in your blood (diabetes), if you have high levels of fats in your blood, if you are overweight or if you drink a lot of alcohol and are in long-term treatment, your blood must be checked for the amount of fats.
• Before treatment with Acitretin and during long-term therapy, your doctor will take x-rays of certain bones at regular intervals (e.g. once a year) because this medicine may cause changes in your bones. If this applies to you, the doctor will discuss with you the advantages and disadvantages of continuation of therapy.
Please inform your doctor if you notice the following possible signs of bone changes:
pain in bones, joints or muscles, restricted mobility.
• A serious condition which causes the small blood vessels (capillaries) to leak has been reported very rarely (Capillary Leak Syndrome/Retinoic Acid Syndrome). This can lead to severe hypotension (low blood pressure), oedema (build up of fluid leading to swelling) and shock (collapse).
• A serious skin reaction with symptoms such as rash, blistering or peeling of the skin (Exfoliative dermatitis) has been reported very rarely.
Other medicines and Acitretin
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription.
The effect of phenytoin (a medicine for epilepsy) may be increased by Acitretin. The dosage of phenytoin may need to be adjusted.
Do not take Acitretin together with:
• the antibiotic tetracycline, because increased pressure in the brain may occur.
• methotrexate (a medicine that is used in the treatment of cancer, psoriasis and rheumatic diseases), because this combination can cause inflammation of the liver.
• the so-called mini-pill (a contraceptive pill with only a low progesterone content). Acitretin may reduce the contraceptive effect, therefore you must not use these pills as a contraceptive together with Acitretin.
• medicines or vitamin A supplements that contain high levels of vitamin A (more than 5000 IU per day).
• other retinoid medicines such as isotretinoin.
Acitretin with food and alcohol
You should not drink alcohol during treatment with Acitretin as the risk for side effects would be increased.
Girls and women of childbearing age must not
drink alcohol at all during treatment with Acitretin and 2 months after stopping it (see “Only under STRICT conditions can Acitretin be prescribed to women who might become pregnant, because of the risk for congenital malformations (harmful effects on the unborn baby”)).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must NOT take Acitretin if you are pregnant. If you do get pregnant during treatment with this medicine in spite of the described precautions (see “Only under STRICT conditions can Acitretin be prescribed to women who might become pregnant, because of the risk for congenital malformations (harmful effects on the unborn baby”)) or in the 2 years following treatment, there is a high risk of severe malformations of the unborn baby. Therefore you should NEVER use Acitretin during pregnancy and you should not get pregnant within 2 years following treatment.
Only under STRICT conditions can Acitretin be prescribed to women who might become pregnant, because of the risk for congenital malformations (harmful effects on the unborn baby).
These are the conditions:
- you must suffer from a severe disorder that does not show any improvement with other treatments.
- you must be able to understand the instructions provided by your doctor and adequately follow them.
- your doctor has explained the risks of becoming pregnant during treatment and for 2 years after stopping it. Also your doctor must have explained the precautionary measures and what the consequences of pregnancy might be.
- you must be able to adequately take
precautions to prevent a pregnancy.
- you must be able to understand what may happen if you do not use an effective method of birth control.
- you must use an effective method of birth control for at least 1 month before you start taking the medicine and for 2 years after you stop taking it. You will be advised to use a combination of 2 methods (a birth control pill or intra-uterine device combined with a condom or diaphragm).
- you must undergo a reliable pregnancy test within 3 days before starting treatment and this test must indicate that you are not pregnant.
- you must start treatment on the second or third day after your next normal period.
- you are strongly advised to undergo a pregnancy test every month of treatment.
- you must undergo a pregnancy test within 3 days of your next prescription.
- you must undergo pregnancy tests every 1 -3 months for a period of 2 years after stopping Acitretin.
- you must not drink any alcohol while you are taking Acitretin and for 2 months after stopping it, because alcohol can increase the risk of malformations.
- your doctor will check if you understand everything, and if so to confirm that you do and that you are prepared to follow all measures.
- you must follow these precautions again during any repeat treatment with Acitretin.
- You must also follow these precautions if you never use birth control because you are infertile. Only if your uterus has been removed, would these precautions not apply to you.
please turn over ►
GENUS PHARMACEUTICALS *Trademark 24980503
G E N/ACT/PI L/342_01 04/08/2015
Continued: Before you take Acitretin
Breast-feeding
You must not take Acitretin if you are breastfeeding, because acitretin passes into the milk and may harm the baby.
Driving and using machines
Your night vision may get worse during treatment. This can happen suddenly. In rare cases, this has continued after the treatment has stopped. Be careful if you are driving or using any tools or machines at night or in a tunnel (see "Warnings and precautions").
[3 How to take Acitretin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Take Acitretin at a meal time, preferably with a drink of milk.
• Swallow each capsule whole.
The dose varies from one patient to another. Your doctor will work out the right dose for you.
Adults and elderly people
• The usual starting dose for adults and elderly people is 25 mg or 30 mg once a day.
• After 2 to 4 weeks, your doctor may increase or decrease your dose. This will depend on how well it works and how it affects you.
• The maximum dose is 75 mg a day.
• Most people take Acitretin for up to 3 months. However, your doctor may decide that you need to take it for longer.
Use in children and adolescents
Acitretin is not normally given to children. If it is given to a child, the doctor will decide the correct dose. This is based on the child’s weight.
You can use additional local treatments of the skin, including skin care products, after consultation with your doctor.
If you take more Acitretin than you should
If you take more Acitretin than you should, you may suffer from headache, nausea and/or vomiting, drowsiness, irritability and itching. Stop taking the medicine and consult your doctor immediately.
If you forget to take Acitretin
Do not take a double dose of Acitretin to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember and continue according to the dosing schedule. However, if it is nearly time for the next dose, skip the missed dose.
If you stop taking Acitretin
Your doctor can judge best if and how you must stop taking Acitretin. Always contact your doctor before you want to stop taking the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
• The side effects of Acitretin are dose related. The higher the daily dose, the greater the risk of side effects.
• Most side effects occur at the start of treatment when the dose still has to be adjusted. Most side effects are reversible after altering the dose or discontinuation of treatment.
• Occasionally the symptoms of your skin may get worse in the beginning of treatment.
• As Acitretin is a vitamin A derivative, most of its side effects are similar to the symptoms that occur if someone has used too much vitamin A.
Very common side effects
(affecting more than 1 of 10 patients treated)
• over 80% of patients experienced:
- dry skin and mucous membranes, dry lips and possibly inflamed lips.
• 40 - 80% of patients experienced:
- dry mucous membranes of the skin and nose
- peeling of the skin, especially the palms of the hands and soles of the feet
- inflammation of the nasal mucosa.
• 10 - 40% of patients experienced:
- nose bleed
- scaling and thinning of healthy skin with increased sensitivity
- reddening of the skin
- itching
- sensation of “burning skin”
- sensation of “sticky skin”
- inflammatory skin changes
- hair loss
- swelling and pain in the area around your nails
- fragile nails
- inflammation of the eye (conjunctivitis)
- feeling more thirsty than usual
- feeling cold.
Using moisturisers or “emollients” from the start of treatment can help you to deal with dry skin problems.
Side effects of the skin and mucous membranes occur rather soon (a few days) after start of treatment, hair loss cannot be expected until several weeks into the treatment.
These side effects are reversible after altering the dose or discontinuation of treatment. However, new growth of hair will take some months, due to the hair growth cycle.
Common side effects
(affecting 1 to 10 of 100 patients treated)
• chapping
• inflammation of oral mucosa and gums
• blisters on skin
• changes in skin and hair colour
• change in the growth rate and texture of hair
• visual disturbances such as dry eye, blurred vision, impaired night vision. Wearing of contact lenses might become impossible. For this reason you should wear glasses before treatment with Acitretin (see “Warnings and precautions”).
Uncommon side effects
(affecting 1 to 10 of 1,000 patients treated)
• muscle, joint and bone pain
After long-term treatment with Acitretin, bone changes may occur (extra growth on the surface of your bones, thinning of bones, reduced bone density [osteoporosis], premature stop of bone growth) and calcifications in soft tissues (ligaments and tendons) (see “Warnings and precautions”).
• increased retention of water in the body (oedema)
• sensation of heat
• changed sense of taste
• headache.
Rare side effects
(affecting 1 to 10 of 10,000 patients treated)
• increased sensitivity of the skin to sunlight, as a result of which sunburn can occur after only a brief exposure to the sun
• inflammations or ulcers of the cornea
• gastro-intestinal troubles (e.g. nausea, vomiting, abdominal pain, diarrhoea, digestive disorders)
• inflammation of the liver (hepatitis) and jaundice
• increased pressure in the brain (pseudotumor cerebri).
Symptoms can include severe headache, nausea, vomiting and blurred vision. If you experience these symptoms immediately stop taking the medicine and contact your doctor.
Not known
(frequency cannot be estimated from the
available data)
• A serious condition which causes the small
blood vessels (capillaries) to leak (Capillary Leak Syndrome/Retinoic Acid Syndrome). This can lead to severe hypotension (low blood pressure), oedema (build up of fluid leading to swelling) and shock (collapse).
• A serious skin reaction with symptoms such as rash, blistering or peeling of the skin (Exfoliative dermatitis).
• Loss of eyelashes or eyebrows (madarosis).
• Immediate allergic reaction with symptoms such as skin rash, swelling or itching of the skin, red and swollen eyes, severe nasal congestion, asthma or wheezing. The reaction can be minor to life-threatening.
Other side effects observed during treatment with Acitretin
• increased occurrence of vaginal infection (also known as Candida or thrush)
• increased levels of liver enzymes
• increased levels of fats and cholesterol in the blood.
These changes are particularly seen in patients with a disposition to increased fatty acid levels, (diabetes, obesity, alcohol misuse or disturbance of fat metabolism), but they are not of a lasting nature and may be treated by dietary means. However, potential arterial stenosis (when the carotid arteries become narrow or blocked) due to the increased fatty acid and cholesterol levels cannot be excluded.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
[3 How to store Acitretin
Keep out of the sight and reach of children.
Do not use the medicine after the expiry date
which is stated on the carton and blister label after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package, in order to protect from moisture.
Medicines 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.
[6 Contents of the pack and other information
What Acitretin contains
The active substance is acitretin.
Acitretin 10 mg capsule: Each hard capsule, contains 10 mg acitretin.
Acitretin 25 mg capsule: Each hard capsule, contains 25 mg acitretin.
The other ingredients are:
Capsule filling:
- Maltodextrin
- Sodium ascorbate
- Microcrystalline cellulose Capsule shell:
- Gelatin
- Propylene glycol
- Sodium laurilsulfate
- Titanium dioxide (E171)
- Iron oxide yellow (E172)
- Iron oxide black (E172)
- Iron oxide red (E172)
- Purified water
- Shellac
What Acitretin looks like and contents of the pack
Acitretin 10 mg capsules consist of a white to off-white body and a brown cap printed in black with “A10” on the capsule body and filled with a yellow powder.
Acitretin 25 mg capsules consist of a yellow to light yellow body and a brown cap printed in black with “A25” on the capsule body and filled with a yellow powder.
The capsules are packaged in PVC/PVDC aluminium blister packs.
Pack sizes: 30 and 60 hard capsules.
Not all pack sizes may be marketed.
POM
PL 06831/0251 Acitretin 10 mg Capsules PL 06831/0252 Acitretin 25 mg Capsules
Marketing Authorisation Holder and Manufacturer
Genus Pharmaceuticals
Linthwaite, Huddersfield, HD7 5QH, UK.
This medicinal product is authorised in the Member States of the EEA under the following names:
|
NL |
Acitretine CF 10 and 25 mg capsules |
|
UK |
Acitretin 10 and 25 mg capsules |
This leaflet was last revised in August 2015
24980503 307082
trademark GENUS PHARMACEUTICALS
GEN/ACT/PIL/342_01
04/08/2015