10 mg and 30 mg soft capsules
alitretinoin
1. What Alitretinoin Orifarm is and what it is used for
The active substance in Alitretinoin Orifarm is alitretinoin. It belongs to a class of medicines known as retinoids, which are related to the A vitamin.
Alitretinoin Orifarm is used to treat adult patients with severe chronic hand eczema who have not improved after other topical treatments, e.g. steroid is. Treatment with Alitretinoin Orifarm must be supervised by a dermatologist (a dermatologist ).
Alitretinoin contained in Alitretinoin Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Alitretinoin Orifarm
Do not take Alitretinoin Orifarm
- if you are allergic to alitretinoin, other retinoids (eg isotretinoin), peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breastfeeding.
- if there is a chance that you may become pregnant, you must follow the precautions listed under “Pregnancy Prevention Program”, see the section “Warnings and Precautions”.
- if you have liver disease.
- if you have severe kidney disease.
- if you have high blood fats (eg high cholesterol or elevated triglyceride levels).
- if you have untreated thyroid disease.
- if you have a very high vitamin A content in your body ( hypervitaminosis A).
- if you are taking tetracycline (a type of antibiotic ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Alitretinoin Orifarm.
Pregnancy prevention programs
Women who are pregnant should not take Alitretinoin Orifarm
This medicine can seriously harm an unborn baby (it is said to be “teratogenic”). The drug 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 Alitretinoin Orifarm is only taken for a short time during pregnancy.
- You must not take Alitretinoin Orifarm if you are pregnant or think you may be pregnant.
- You must not take Alitretinoin Orifarm if you are breast-feeding. The drug is likely to pass into breast milk and may harm your baby.
- You must not take Alitretinoin Orifarm if you may become pregnant during treatment.
- You must not become pregnant for one month after stopping treatment as a certain amount of medicine may still be present in the body.
Women who may become pregnant are prescribed Alitretinoin Orifarm according to strict rules. The reason for this is the risk of serious injury to the unborn child
The rules are as follows:
- The doctor must explain the risk of harm to the unborn child, you must understand why you must not become pregnant and what you need to do to prevent becoming pregnant.
- You must have talked about birth control (contraception) with your doctor. Your doctor will give you information on how to avoid getting pregnant. Your doctor may refer you to a contraceptive specialist.
- Before starting treatment, you will be asked by your doctor to perform a pregnancy test. The test must show that you are not pregnant when starting treatment with Alitretinoin Orifarm.
Women must use effective contraception before, during, and after treatment with Alitretinoin Orifarm
- You must agree to use at least one very reliable method of contraception (eg IUDsor contraceptives ) or two effective methods that work in different ways (eg birth control pills and condoms). Consult your doctor about which methods are suitable for you.
- You must use contraception for one month before taking Alitretinoin Orifarm, during treatment, and for one month after treatment.
- You must use contraception even if you are not menstruating or sexually active (unless your doctor decides it is not necessary).
Women must agree to take pregnancy tests before, during, and after treatment with Alitretinoin Orifarm
- You must agree to make regular follow-up visits, preferably every month.
- You must agree to take regular pregnancy tests, preferably every month during treatment and, as a certain amount of medicine may still be present in your body, one month after stopping treatment with Alitretinoin Orifarm (unless your doctor decides it is not necessary in your case).
- You must agree to have extra pregnancy tests if your doctor tells you to.
- You must not become pregnant during treatment or for one month after stopping it as a certain amount of medicine may still be present in the body.
- Using a checklist, your doctor should discuss all of these points with you and ask you (or a parent/guardian) to sign it. It is a form that confirms that you have become aware of the risks and will follow the above rules.
If you become pregnant while taking Alitretinoin Orifarm, stop taking the medicine immediately, and consult a doctor. Your doctor may refer you to a specialist for advice.
If you become pregnant within one month of stopping Alitretinoin Orifarm, contact your doctor. Your doctor may refer you to a specialist for advice.
Advice for men
The levels of alitretinoin in the semen of men taking Alitretinoin Orifarm are too low to harm their partner’s unborn children. However, you must never give medicine to anyone else.
Additional precautions
You must never give this medicine to another person. Return any unused capsules to pharmacy staff after treatment.
You must not donate blood during treatment with this medicine or for one month after stopping treatment with Alitretinoin Orifarm as the unborn baby may be harmed if a pregnant patient receives your blood.
Talk to your doctor before taking Alitretinoin Orifarm:
- If you have ever had any kind of mental illness, e.g. depression, aggressive tendencies, or mood swings. Thoughts of harming yourself or committing suicide are also included. The reason for this is that your mood may be affected while you are taking Alitretinoin Orifarm.
- If you have kidney disease. Alitretinoin Orifarm is not recommended for people with moderate kidney disease. If you have kidney disease, ask your doctor if Alitretinoin Orifarm is a suitable medicine for you.
- If you have high blood fats, you may need to have blood tests more often. Alitretinoin Orifarm often raises blood fat levels, such as cholesterol or triglycerides. If your blood fats remain high, your doctor may reduce the dose or discontinue treatment with Alitretinoin Orifarm.
- If you have high blood sugar ( diabetes ), your blood sugar level may need to be checked more often and your doctor may start your treatment with Alitretinoin Orifarm at a lower dose.
- If you have had thyroid disease. Alitretinoin Orifarm can lower your thyroid hormone levels. If your thyroid hormone levels are low, your doctor may prescribe supplements.
You must be careful during the treatment:
- If you experience vision problems, contact your doctor immediately. Treatment with Alitretinoin Orifarm may need to be stopped and your vision may need to be monitored.
- If you experience severe headaches, nausea, vomiting, and visual disturbances. It may be a sign of increased pressure in the head. You should contact a doctor.
- If you have bloody diarrhea, stop treatment immediately, and contact a doctor as soon as possible.
- If you are going to be in bright sunlight or sunbathe solarium. Your skin may become more sensitive to sunlight. If necessary, use a sunscreen with a sun protection factor of at least 15.
- If you get dry skin and dry lips during the treatment, use a moisturizing ointment or cream and a lip balm.
- Cut back on intense physical exercise: alitretinoin can cause muscle pain and joint pain.
- If you get dry eyes, moisturizing eye ointment, or tear replacement drops can help. If you wear contact lenses, you may need to wear glasses during treatment with alitretinoin. Dry eyes and vision problems disappear when treatment is stopped.
- Alitretinoin Orifarm may increase liver enzyme levels. Your doctor will take blood samples during treatment to check these levels. If levels remain elevated, the doctor may reduce the dose of one or discontinue alitretinoin Orifarm.
- If you get an allergic reaction (reddening of the skin, itching ) on your arms or legs. Tell your doctor, it may be necessary to stop treatment with Alitretinoin Orifarm.
Mental disorders
You may not notice any changes in your mood or behavior, so it is very important that you tell friends and family that you are taking this medicine. They can notice these changes and help you quickly identify problems that you need to talk to a doctor about.
If you get mental problems, e.g. depression, aggressive tendencies, mood swings, or thoughts of harming yourself or committing suicide, you must immediately stop taking Alitretinoin Orifarm and contact a doctor as soon as possible.
Children and young people
Alitretinoin Orifarm is not recommended for use in children below 18 years. It is not known how well the drug works in this age group.
Other medicines and Alitretinoin Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take other retinoid medicines (eg isotretinoin), vitamin A supplements, or tetracycline (a type of antibiotic ) while you are taking Alitretinoin Orifarm. This increases the risk of side effects.
Tell your doctor or pharmacist
- you are taking amiodarone (a medicine that regulates your heart rate). Amiodarone is not recommended to be taken with Alitretinoin Orifarm.
- you are taking ketoconazole, fluconazole, or miconazole (medicines used to treat infections ). Your doctor may decide to lower your dose of Alitretinoin Orifarm.
- you are taking simvastatin (a medicine used to lower cholesterol ). Alitretinoin Orifarm may reduce the amount of this medicine in the body.
- you are taking gemfibrozil (another drug used to lower cholesterol ) or oxandrolone (an anabolic steroid ). Your doctor may decide to lower your dose of Alitretinoin Orifarm.
- you are taking paclitaxel (used to treat cancer), rosiglitazone, or repaglinide (used to treat diabetes ). Alitretinoin Orifarm may increase the amount of these medicines in the body.
Pregnancy and breastfeeding
Pregnancy
Do not take Alitretinoin Orifarm if you are pregnant. Alitretinoin Orifarm is likely to cause severe birth defects (it is a ‘teratogenic’ medicine). It also increases the risk of miscarriage. You must not become pregnant during treatment with Alitretinoin Orifarm or during the month following treatment.
For more information on pregnancy and birth control, see section 2, Pregnancy Prevention Program.
Breast-feeding
Do not take Alitretinoin Orifarm if you are breast-feeding. The drug is likely to pass into breast milk and may harm your baby.
Driving and using machines
Night vision may be impaired during treatment. Be careful if you drive or use tools or machines when it is dark outside or when you are in a tunnel.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Alitretinoin Orifarm contains soybean oil and sorbitol
This medicine contains 13 mg sorbitol in each 10 mg capsule and 26 mg sorbitol in each 30 mg capsule.
This medicine contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
How to take Alitretinoin Orifarm
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Alitretinoin Orifarm should be taken with the main meal, preferably at the same time each day. The capsules should be swallowed whole and not chewed.
The recommended dose is 10 mg or 30 mg once a day. If your body does not tolerate the recommended dose of 30 mg, you may be prescribed the lower dose of 10 mg.
A course of treatment usually lasts for 12 to 24 weeks, depending on how the disease improves. If the first treatment is successful, the doctor may prescribe another round of treatment if the symptoms return.
If you forget to take Alitretinoin Orifarm
Take a missed dose as soon as you can. However, if it is almost time for your next dose, skip the missed dose, and continue as before. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Alitretinoin Orifarm and contact your doctor if you experience any of the following:
Uncommon side effects (may affect up to 1 in 100 people):
- Vision problems, including blurred vision, distorted vision, a cloudy surface of the eye (corneal clouding, cataracts).
Rare side effects (may affect up to 1 in 1,000 people):
- Increased pressure in the brain (headache, nausea, vomiting, pain behind the eyes, visual disturbances).
Has been reported (occurs in an unknown number of users):
- Elevated and itchy skin rash ( hives ), swelling around the eyes, mouth, or lips ( angioedema ) that causes difficulty breathing or fainting due to hypersensitivity ( anaphylactic reaction ).
- Severe abdominal pain with or without bloody diarrhea, nausea, and vomiting.
Other side effects are
Very common side effects (may affect more than 1 user in 10):
- Headache.
- Elevated blood fats ( triglycerides, cholesterol ) in the blood, which leads to an increased risk of atherosclerosis (atherosclerosis).
Common side effects (may affect up to 1 in 10 people):
- Increase in the number of platelets, a decrease in the number of red and white blood cells seen in blood samples.
- Decreased levels of thyroid hormones.
- Dizziness.
- Inflammation of the eye (conjunctivitis) and eyelid area, dry and irritated eyes.
- Persistent noise in the ears ( tinnitus ).
- Redness.
- High blood pressure.
- Nausea, vomiting, dry mouth.
- Transient change in liver function values (blood tests).
- Dry skin, especially on the face, dry and inflamed lips, reddening of the skin, itchy rash, inflamed skin, hair loss.
- Joint pain, muscle pain, fatigue.
- High levels of muscle breakdown products in the blood if you exercise intensively.
Uncommon side effects (may affect up to 1 in 100 people):
- Extra bone growth, e.g. spinal disease ankylosing spondylitis.
- Indigestion ( dyspepsia ).
- Itching, flaky skin, rash, dry eczema.
- Nosebleed.
Rare side effects (may affect up to 1 in 1,000 people):
- Inflammation of the blood vessels.
- Nail diseases.
- Increased skin sensitivity to sunlight.
- Changed hair quality.
Has been reported (occurs in an unknown number of users):
- Impaired night vision.
- Swollen hands, feet, and ankles.
Mental disorders
Rare side effects (may affect up to 1 in 1,000 people):
- Depression or related disorders. Signs of this can be depression, mood swings, anxiety, and a feeling of emotional discomfort.
- Exacerbation of pre-existing depression.
- Violence or aggression.
Very rare (may affect up to 1 in 10,000 people):
- Some people have had thoughts of harming themselves or ending their lives (suicidal thoughts), have tried to end their lives (suicide attempts), or have ended their lives (suicide). Such people may not seem depressed.
- Unusual behavior.
- Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that do not exist.
Contact a doctor immediately if you experience signs of any of these mental disorders. Your doctor may advise you to stop taking Alitretinoin Orifarm. It may not be enough to stop the side effects: you may need more help, and your doctor may arrange this.
Side effects are other medicines in the same group as Alitretinoin Orifarm
These side effects have not been seen with Alitretinoin Orifarm to date, but they can not be ruled out. They are very rare and may occur in less than 1 in 10,000 users.
- Diabetes, signs of which include: Excessive thirst, frequent urination, high blood sugar according to blood tests.
- Color blindness and color vision deteriorate, intolerance to contact lenses.
- Arthritis, bone diseases (delayed growth, changes in bone density), growing bones can stop growing.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Alitretinoin Orifarm
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
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 packaging and other information
Content declaration
- The active substance is alitretinoin. One capsule contains 10 mg or 30 mg of alitretinoin.
- Other ingredients are:
Capsule filling:
Soybean oil, refined; soybean oil, partially hydrated; vegetable oil, hydrated; glycerol monostearate; triglyceride er, medium-chain; all-rac-alpha-tocopherol.
Capsule shell:10 mg capsule: Gelatin; glycerol; sorbitol; titanium dioxide (E 171); red iron oxide (E 172); yellow iron oxide (E 172); black iron oxide (E 172); water.
30 mg capsule: Gelatin; glycerol; sorbitol; titanium dioxide (E 171); yellow iron oxide (E 172); water.
What the medicine looks like and the contents of the pack
10 mg: light brown, oval, soft capsules filled with a yellow to the orange, opaque, viscous solution. The capsules are approximately 10 mm long and 6 mm wide.
30 mg: yellow, oval, soft capsules filled with a yellow to the orange, opaque, viscous solution. The capsules are approximately 13 mm long and 8 mm wide.
Blister:
30, 40, 60, 90, and 100 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Norway, and Finland: Alitretionin Orifarm