PACKAGE LEAFLET: INFORMATION FOR USERS OF NEOTIGASON (ACITRETIN)Neotigason 10 mg hard capsules
Neotigason 25 mg hard capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
| • |
Keep this leaflet. You may need it again later. |
| • |
If you have any further questions, please contact your doctor or pharmacist. |
| • |
Do not share this medicine with others. It has been prescribed for you only. It may harm them, even if they have the same symptoms as you. |
| • |
If you experience any of the side effects listed in section 4, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist. |
What is Neotigason and what is it used for?
2. When should you not use Neotigason or be extra careful with it?
3. How to take Neotigason?
4. Possible side effects
5. How to store Neotigason?
6. Contents of the pack and other information 1.
WHAT IS NEOTIGASON AND WHAT IS IT USED FOR? Neotigason contains a medicine called acitretin. This belongs to a group of medicines called 'retinoids'. Neotigason is used to treat serious skin problems where the skin has become thick and scaly. These skin problems include psoriasis, ichthyosis, pityriasis rubra pilaris and keratosis follicularis (Darier's disease). The medicine works by helping the skin to grow more normally. Neotigason is normally used under the supervision of a specialist dermatologist (skin doctor).
2. WHEN SHOULD YOU NOT USE THIS MEDICINE OR SHOULD YOU BE EXTRA CAUTIONARY? When should you not use this medicine?
| • |
You are pregnant, think you may be pregnant, or could become pregnant while taking Neotigason or within 3 years of stopping. Pregnancy prevention measures are necessary; see the section on "Pregnancy and breastfeeding"; |
| • |
you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6), or if you are taking other 'retinoids', including isotretinoin and tazarotene; |
| • |
you are breastfeeding; |
| • |
you have severe liver problems; |
| • |
you have severe kidney problems; |
| • |
you have high levels of fats (lipids) in your blood; |
| • |
you are taking medicines called tetracyclines (against infection) or methotrexate (for skin problems, arthritis or cancer), see the section 'Other medicines and tetracyclines'; |
| • |
You are taking vitamin A, see the section 'Taking other medicines?'. |
Talk to your doctor before taking Neotigason if you think any of the above applies to you.
When should you be extra careful with this medicine? Talk to your doctor or pharmacist before taking this medicine:
| • |
If you have diabetes, your blood sugar levels will need to be checked more often when you start taking Neotigason. |
| • |
If you have high blood fat levels or are obese. Your doctor may need to perform blood tests while you are taking Neotigason to monitor the amount of fat in your blood. |
| • |
If you have heart or blood vessel problems. Your doctor may need to check your blood pressure more often. |
| • |
if you drink a lot of alcohol; |
| • |
if you have liver problems; |
| • |
if you notice reduced night vision; |
| • |
If you experience severe headache, nausea, vomiting, and/or visual disturbances. These may be symptoms of increased intracranial blood pressure, which should be checked by your doctor as soon as possible. |
| • |
If you are going outside in bright sunlight or if you plan to use a tanning bed. Neotigason can increase the effects of UV light on the skin. Before going outside in bright sunlight, apply a sunscreen (with an SPF of at least 15) to exposed skin. Unsupervised use of a tanning bed should be avoided. |
Your liver function and blood fat levels must be checked before starting treatment and regularly during treatment. Your doctor will also check your bones regularly, as Neotigason can cause bone changes, especially in children and elderly people receiving long-term treatment.
Women of childbearing potential:
Neotigason causes malformations in the unborn child. Contraceptive measures and pregnancy tests are required during treatment and for 3 years after stopping treatment with Neotigason; see also the section "Pregnancy and breast-feeding." Women of childbearing potential should not consume alcohol (in drinks, food, or medicines) during and for 2 months after stopping treatment; see the section "Neotigason with food, drink, and alcohol."
Blood donation:
You must not donate blood while taking Neotigason and for 3 years after stopping treatment. This is due to the high risk of Neotigason causing abnormalities in the unborn child. Women of childbearing potential should therefore not receive blood samples from patients who are being treated with Neotigason or have been treated with it within the last three years. If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before taking Neotigason.
Taking other medicines?
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. Methotrexate (for skin problems, arthritis or cancer), tetracyclines (for infections) or vitamin A and other retinoids (such as isotretinoin and tazarotene) should not be used in combination with Neotigason; see also the section 'When should you not take Neotigason?'. Tell your doctor if you are taking phenytoin (for epilepsy) or the 'minipill' (a contraceptive pill with low progesterone levels) before starting treatment with Neotigason.
What to take Neotigason with food, drink, and alcohol
Women of childbearing potential should not consume alcohol (in drinks, food, or medicines) during treatment with Neotigason and for 2 months after treatment has stopped. Taking acitretin and alcohol at the same time can lead to the formation of etretinate, which can be harmful to the unborn child. Once formed, it takes a relatively long time for it to be completely eliminated from the body.
Pregnancy and breastfeeding
Neotigason causes malformations in the unborn child. The following guidelines must be strictly followed, even if you have fertility problems:
Do not take Neotigason if you are pregnant, think you may be pregnant, or could become pregnant while taking this medicine or within 3 years of stopping treatment.
Do not take Neotigason if you are breastfeeding.
Contraception:
If you are a woman of childbearing age, you must use an effective method of contraception without interruption for at least 4 weeks before starting Neotigason, during treatment, and for 3 years after stopping treatment. The primary method of contraception is a combined hormonal contraceptive or an intrauterine device (IUD), and it is recommended that you also use a condom or a diaphragm (cap). The 'minipill' (a contraceptive pill with a low progesterone content) is not recommended.
Pregnancy tests:
Your doctor will want to perform a pregnancy test up to 3 days before starting treatment. This must be negative. Start taking Neotigason after you have a negative pregnancy test, on the second or third day of your next menstrual period. You will also be asked to have regular pregnancy tests every 28 days while taking Neotigason. To renew your Neotigason prescription, your doctor will require a negative pregnancy test. The test should not be older than 3 days.
After stopping treatment with Neotigason, pregnancy tests should be performed every 1 to 3 months for a period of 3 years after the last dose. If you become pregnant or think you may be pregnant during treatment with Neotigason, or for 3 years after treatment has finished, contact your doctor immediately. If you have any questions about these instructions, talk to your doctor or pharmacist before starting Neotigason.
Driving and using machines:
Your vision, especially at night, may be affected while taking Neotigason. Be careful when driving or using tools or machines.
Neotigason contains glucose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE THIS MEDICINE: Always take this medicine exactly as your doctor has told you. If you are unsure about the correct use, contact your doctor. The capsules should preferably be taken once a day with a meal or some milk. The usual starting dose for adults is 25 mg (i.e., one capsule of 25 mg acitretin) or 30 mg (i.e., three capsules of 10 mg acitretin each). Your doctor may adjust the dose depending on your condition and other factors, such as your general health. The maximum recommended daily dose is 75 mg (i.e., three capsules of 25 mg acitretin each).
Women of childbearing potential:
Start taking Neotigason on the second or third day of your next menstrual period. Your doctor will want to perform a pregnancy test up to three days before starting treatment, regularly during treatment, and for three years after treatment. The result of the pregnancy test must be negative. You must also use an effective method of contraception (contraception) without interruption for at least 4 weeks before starting Neotigason, during treatment, and for 3 years after stopping treatment; see also the section "Pregnancy and breastfeeding."
Use in children:
Neotigason should only be given to children if all other treatments prove inadequate. The doctor will decide on the dose, which depends on factors such as the child's illness and body weight. If
you take more Neotigason than you should:
If you have used or taken too much Neotigason, contact your doctor or pharmacist immediately. Symptoms of overdose include headache, dizziness, feeling sick or nauseous, feeling drowsy or irritable, or itchy skin.
If you forget to take Neotigason:
Take Neotigason as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
Do not stop taking Neotigason without talking to your doctor.
If you have any further questions on the use of 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 Neotigason and talk to your doctor straight away if you experience any of the following side effects at the same time:
| • |
severe headache; |
| • |
to feel nauseous or ill; |
| • |
facial problems. |
Very common (affecting more than 1 in 10 people):
| • |
dry, irritated or swollen eyes, which means you can no longer tolerate contact lenses; |
| • |
dehydration and inflammation of the mucous membranes (nosebleeds and runny nose); |
| • |
dry mouth, thirst; |
| • |
Dry or inflamed lips, which can be relieved by applying a greasy ointment. Itching, hair loss, peeling skin on the palms of the hands or soles of the feet, or even on the rest of the body; |
| • |
altered liver function (as shown by blood tests); |
| • |
increased levels of fat in your blood (shown by blood tests). |
Common (affects 1 to 10 patients out of 100):
| • |
headache; |
| • |
inflammation of the mucous membranes of the mouth, abdominal pain, diarrhea, nausea, being sick; |
| • |
sensitive skin, sticky feeling of the skin or rash, skin inflammation, changes in hair texture, brittle nails, skin infection around the nail, redness of the skin; |
| • |
joint pain, muscle pain; |
| • |
swelling of the hands, feet and ankles. |
Sometimes (affects 1 to 10 patients in 1000):
| • |
dizziness; |
| • |
blurred vision; |
| • |
inflammation of the gums; |
| • |
inflammation of the liver; |
| • |
fissures, cracks or fine linear scars in the skin, e.g. around the mouth (ragades), blisters and inflammation of the skin (bullous dermatitis), skin that is much more sensitive to the sun (photosensitivity reaction). |
Rarely (affects 1 to 10 patients in 10,000):
| • |
damage to the peripheral nervous system, which can lead to symptoms such as muscle weakness, numbness and tingling in the feet and hands, burning, stabbing or shooting pains. |
Very rare (affecting less than 1 in 10,000 people):
| • |
increased blood pressure in the skull; |
| • |
night blindness, inflammation of the cornea of the eye (ulcerative keratitis); |
| • |
yellowing of the skin or whites of the eyes (jaundice); |
| • |
bone pain, changes in bone growth. |
Side effects with unknown frequency:
| • |
vaginal infection (also known as candida or thrush); |
| • |
hypersensitivity; |
| • |
decreased hearing, ringing in the ears (tinnitus); |
| • |
hot flashes; |
| • |
taste changes; blood in the rectum; |
| • |
small, reddish bumps on the skin that may bleed easily (pyogenic granulomas); |
| • |
improvement or worsening of glucose tolerance in patients with diabetes mellitus; |
| • |
changes in voice sound (dysphonia). |
Psoriasis symptoms may sometimes worsen at the start of treatment. Reporting side effects If you experience any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this leaflet.
5. HOW TO STORE THIS MEDICINE? Keep out of the sight and reach of children. Store in the original package in order to protect from moisture. Store at room temperature (15-25°C). Do not use this medicine after the expiry date which is stated on the packaging. It states a month and a year. The expiry date refers to the last day of that month. Due to the risk of fetal malformations, this medicine must not be passed on to others. Unused or expired medicines should be returned to a pharmacy for disposal.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What this medicine contains?
The active substance in this medicine is acitretin. Each capsule contains 10 or 25 mg of acitretin. The other ingredients are glucose, sodium ascorbate, microcrystalline cellulose, gelatin, iron oxide black, yellow, red (E172), titanium dioxide (E171), shellac, propylene glycol, ammonium hydroxide. See section 2 'Neotigason contains glucose'.
What Neotigason looks like and contents of the pack?
Neotigason 10 mg is available as brown-white capsules with the imprint “10”.
Neotigason 25 mg is available as yellow-brown capsules with the imprint “25”.
Pack sizes: 30 hard capsules in a PVC/PVDC blister.
Method of supply: Medicinal product subject to medical prescription. |
