Alitretinoin Douglas

Alitretinoin Douglas

Manufacturer:

Douglas

Distributor:

Apex Pharma Marketing
Full Prescribing Info
Contents
Alitretinoin.
Description
The active substance is Alitretinoin.
Each capsule, soft contains 10 mg or 30 mg of alitretinoin.
The active substance in Alitretinoin capsules is alitretinoin. It belongs to a group of medicines known as retinoids, which are related to Vitamin A. Alitretinoin capsules come in two strengths, containing 10 mg or 30 mg of alitretinoin.
Excipients/Inactive Ingredients: Capsule content: Soya-bean oil (refined), partially hydrogenated soya-bean oil, hydrogenated vegetable oil, glycerol monostearate, triglycerides (medium chain), all-rac-α-tocopherol.
Capsule shell: Gelatin, glycerol, sorbitol liquid (non-crystallising) (E420), titanium dioxide (E171), water purified, and iron oxide yellow (E172).
10-mg Capsule: Iron oxide red (E172), and iron oxide black (E172).
Indications/Uses
Alitretinoin is used to treat adults with severe chronic hand eczema that has not got better after any other topical treatments, including steroids. Treatment with Alitretinoin must be supervised by a specialist skin doctor (a dermatologist).
Dosage/Direction for Use
Always take this medicine exactly as the doctor or pharmacist had told. Check with a doctor or pharmacist if not sure.
When to take the capsules: The capsule should be taken with a main meal, preferably at the same time each day. The capsules should be swallowed whole and not chewed.
How much to take: The dose is either 10 or 30 mg once daily. If the body can't tolerate the recommended 30 mg dose, the patient may be prescribed the lower 10 mg dose.
How long should the patient takes the capsules: A course of treatment usually lasts for 12 to 24 weeks depending how patient's disease gets better. If the patient's first treatment was successful, the doctor may prescribe another course of treatment if symptoms return.
If the patient takes more Alitretinoin than the patient should: If the patient takes too many capsules or someone else accidentally takes the medicine, contact a doctor, pharmacist or nearest hospital immediately.
If the patient forgets to take Alitretinoin: If the patient misses a dose take it as soon as the patient can. However, if it is nearly time for the next dose, skip the missed dose and carry on as before. Do not take a double dose to make up for a forgotten capsule.
If the patient has any further questions on the use of this medicine, ask a doctor or pharmacist.
Contraindications
Do not take Alitretinoin: If the patient is pregnant or breast-feeding.
If there is any chance that the patient could become pregnant, the patient must follow the precautions under "Pregnancy and prevention programme", see Precautions.
If the patient has liver disease.
If the patient has severe kidney disease.
If the patient has high blood fats (such as high cholesterol or raised triglycerides).
If the patient has thyroid disease, which is not sufficiently treated.
If the patient has very high levels of vitamin A in the body (hypervitaminosis A).
If the patient is allergic to alitretinoin, to other retinoids (such as isotretinoin), to peanut or soya or any of the other ingredients of this medicine (listed in Description).
If the patient is taking tetracycline (a type of antibiotic).
If any of these apply to the patient, go back to the doctor. The patient must not take Alitretinoin.
Warnings
Can seriously harm an unborn baby.
Women must use effective contraception.
Do not use if the patient is pregnant or the patient thinks she may be pregnant.
Special Precautions
Pregnancy and prevention programme: Women who are pregnant must not take Alitretinoin: This medicine can seriously harm an unborn baby (the medicine is said to be 'teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Alitretinoin is taken only for a short time during pregnancy.
The patient must not take Alitretinoin if she is pregnant or if the patient thinks she might be pregnant.
The patient must not take Alitretinoin if she is breastfeeding. The medicine is likely to pass into the milk and may harm the baby.
The patient must not take Alitretinoin if she could get pregnant during treatment.
The patient must not get pregnant for one month after stopping this treatment because some medicine may still be left in the body.
Women who could get pregnant are prescribed Alitretinoin under strict rules. This is because of the risk of serious harm to the unborn baby: These are the rules: The doctor must explain the risk of harm to the unborn baby - the patient must understand why she must not get pregnant and what she needs to do to prevent getting pregnant.
The patient must have talked about contraception (birth control) with a doctor. The doctor will give information on how not to get pregnant. The doctor may send a specialist for contraception advice.
Before starting the treatment, the doctor will ask the patient to take a pregnancy test. The test must show that the patient is not pregnant when starting treatment with Alitretinoin.
Women must use effective contraception before, during and after taking Alitretinoin: The patient must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with a doctor which methods would be suitable for the patient.
The patient must use contraception for a month before taking Alitretinoin, during treatment and for a month afterwards.
The patient must use contraception even if she does not have periods or she is not sexually active (unless the doctor decides this is not necessary).
Women must agree to pregnancy testing before, during and after taking Alitretinoin: The patient must agree to regular follow-up visits, ideally every month.
The patient must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in the body, 1 month after stopping Alitretinoin (unless the doctor decides it is not necessary in this case).
The patient must agree to extra pregnancy tests if the doctor asks her.
The patient must not get pregnant during treatment or for a month afterwards because some medicine may still be left in the body.
The doctor will discuss all these points with the patient, using a checklist and will ask the patient (or a parent/guardian) to sign it. This form confirms that the patient had been told about the risks and that the patient will follow the rules previously mentioned.
If the patient gets pregnant while taking Alitretinoin, stop taking the medicine straight away, and contact a doctor. The doctor may send the patient to a specialist for advice.
Also, if the patient becomes pregnant within one month after she stopped taking Alitretinoin, the patient should contact a doctor. The doctor may send the patient to a specialist for advice.
Advice for men: The levels of oral retinoid in the semen of men taking Alitretinoin are too low to harm their partners' unborn baby. However, the patient must never share the medication with anyone.
Additional precautions: The patient should never give this medicinal product to another person. Please take any unused capsules to a pharmacist at the end of treatment.
The patient should not donate blood during treatment with this medicine and for 1 month after stopping Alitretinoin because an unborn baby could be harmed if a pregnant patient receives the blood.
Talk to a doctor or pharmacist before taking Alitretinoin: If the patient ever had any kind of mental health problems. This includes depression, aggressive tendencies or mood changes. It also includes thoughts about hurting self or ending life. This is because, mood may be affected while taking Alitretinoin.
If the patient has kidney disease. Alitretinoin is not recommended for people with moderate kidney disease. If the patient has kidney disease - check with a doctor if Alitretinoin is suitable for the patient.
If the patient has high blood fats, the patient may need blood tests more often. Alitretinoin commonly increases blood fats, such as cholesterol or triglycerides. If the patient's blood fats stay high, the doctor may lower the dose, or take off the Alitretinoin.
If the patient has high blood sugar (diabetes), the patient's blood sugar levels may need to be checked more often and the doctor may start on a lower dose of Alitretinoin.
If the patient has been suffering from thyroid disease. Alitretinoin may lower the patient's thyroid hormone levels. If the patient's thyroid hormone level is low, the doctor may prescribe supplements.
The patient needs to take care during treatment: If the patient experiences any problems with sight, tell a doctor immediately. Alitretinoin may need to be stopped and patient's sight monitored.
If the patient gets a persistent headache, nausea or vomiting (feeling or being sick) and blurred vision, these may be signs of a condition called benign intracranial hypertension.
Stop the capsules immediately and contact a doctor as soon as possible.
If the patient has bloody diarrhoea stop the capsules immediately and contact a doctor as soon as possible.
Minimise patient's exposure to sunlight and avoid sun lamps. Patient's skin may become more sensitive to sunlight. Before the patient goes out in the sun, use a sun protection product with a high protection factor (SPF 15 or higher). If the patient gets dry skin and lips during treatment, use a moisturising ointment or cream and a lip balm.
Cut down on intensive physical exercise: alitretinoin can cause muscle and joint pain.
If the patient develops dry eyes, lubricating eye ointment or tear replacement drops can help. If the patient wears contact lenses, the patient may need to wear glasses during alitretinoin treatment. Dry eyes and sight problems normally return to normal once treatment is stopped.
Alitretinoin may increase liver enzyme levels. The doctor will do blood tests during treatment to check these levels. If they stay high, the doctor may lower the dose or take off the Alitretinoin.
Mental health problems: The patient may not notice some changes in mood and behaviour and so it is very important to tell friends and family that the patient is taking this medicine. They may notice these changes and help the patient quickly identify any problems that the patient needs to talk to the doctor about.
If the patient develops any mental health problems including depression, aggressive tendencies, mood changes, thoughts about hurting self or ending life, the patient must stop taking Alitretinoin immediately and contact a doctor as soon as possible.
Other medicines and Alitretinoin: Do not take other retinoid medicines (e.g. isotretinoin), vitamin A supplements or tetracyclines (a type of antibiotic) while taking Alitretinoin. This increases the risk of side effects.
Tell a doctor or pharmacist if: The patient is taking amiodarone (a medicine that helps to regulate heart rate). Amiodarone is not recommended to be taken together with Alitretinoin.
The patient is taking ketoconazole, fluconazole, miconazole (medicines used to treat infections). The doctor may decide to reduce the dose of Alitretinoin.
The patient is taking simvastatin (a medicine used to lower cholesterol). Alitretinoin may decrease the amount of this medicine in the body.
The patient is taking gemfibrozil (another medicine used to lower cholesterol) or oxandrolone (an anabolic steroid). The doctor may decide to reduce the dose of Alitretinoin.
The patient is taking paclitaxel (used to treat cancer), rosiglitazone or repaglinide (used to treat diabetes). Alitretinoin may increase the amount of these medicines in the body.
Tell a doctor or a pharmacist if the patient is taking, or have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines.
Alitretinoin capsules contains soya oil: If the patient is allergic to peanut or soya, do not use this medicinal product.
Alitretinoin capsules contains sorbitol: This medicine contains 13.28 mg sorbitol in each capsule.
Driving and using machines: The patient may not see as well at night during the treatment. If this happens, the patient should not drive or operate machinery.
Use in Children and Adolescents: Alitretinoin is not recommended for people aged under 18 years old. It is not known how well it works in this age group.
Use In Pregnancy & Lactation
Pregnancy, breast-feeding and fertility: Pregnancy and prevention programme: Women who are pregnant must not take Alitretinoin: This medicine can seriously harm an unborn baby (the medicine is said to be 'teratogenic') - it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also makes a miscarriage more likely. This may happen even if Alitretinoin is taken only for a short time during pregnancy.
The patient must not take Alitretinoin if she is pregnant or if the patient thinks she might be pregnant.
The patient must not take Alitretinoin if she is breastfeeding. The medicine is likely to pass into the milk and may harm the baby.
The patient must not take Alitretinoin if she could get pregnant during treatment.
The patient must not get pregnant for one month after stopping this treatment because some medicine may still be left in the body.
Women who could get pregnant are prescribed Alitretinoin under strict rules. This is because of the risk of serious harm to the unborn baby: These are the rules: The doctor must explain the risk of harm to the unborn baby - the patient must understand why she must not get pregnant and what she needs to do to prevent getting pregnant.
The patient must have talked about contraception (birth control) with a doctor. The doctor will give information on how not to get pregnant. The doctor may send a specialist for contraception advice.
Before starting the treatment, the doctor will ask the patient to take a pregnancy test. The test must show that the patient is not pregnant when starting treatment with Alitretinoin.
Women must use effective contraception before, during and after taking Alitretinoin: The patient must agree to use at least one very reliable method of contraception (for example an intra uterine device or contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with a doctor which methods would be suitable for the patient.
The patient must use contraception for a month before taking Alitretinoin, during treatment and for a month afterwards.
The patient must use contraception even if she does not have periods or she is not sexually active (unless the doctor decides this is not necessary).
Women must agree to pregnancy testing before, during and after taking Alitretinoin: The patient must agree to regular follow-up visits, ideally every month.
The patient must agree to have regular pregnancy tests, ideally every month during treatment and, because some medicine may still be left in the body, 1 month after stopping Alitretinoin (unless the doctor decides it is not necessary in this case).
The patient must agree to extra pregnancy tests if the doctor asks her.
The patient must not get pregnant during treatment or for a month afterwards because some medicine may still be left in the body.
The doctor will discuss all these points with the patient, using a checklist and will ask the patient (or a parent/guardian) to sign it. This form confirms that the patient had been told about the risks and that the patient will follow the rules previously mentioned.
If the patient gets pregnant while taking Alitretinoin, stop taking the medicine straight away, and contact a doctor. The doctor may send the patient to a specialist for advice.
Also, if the patient becomes pregnant within one month after she stopped taking Alitretinoin, the patient should contact a doctor. The doctor may send the patient to a specialist for advice.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common effects (may affect more than 1 in 10 people): Headache.
Raised blood fats: higher levels of fats (triglycerides) and cholesterol in the blood.
Common effects (may affect up to 1 in 10 people): Blood cell disorders: increase in the number of blood platelets (cells that help blood to clot), decrease in the number of red and white blood cells seen in blood tests.
Thyroid problems: decreased levels of thyroid hormones.
Eye problems: inflammation of the eye (conjunctivitis) and eyelid area; eyes feel dry and irritated.
Ask a pharmacist for suitable eye drops. If the patient wears contact lenses and get dry eyes, the patient may need to wear glasses instead.
Ear problems: persistent noise in the ears (tinnitus).
Dizziness.
Blood and circulation: flushing, high blood pressure (hypertension).
Gut and stomach problems: feeling sick (nausea), being sick (vomiting), dry mouth.
Muscle and joint pain: muscle pain, joint pain, lack of energy (fatigue). High levels of muscle breakdown products in the blood if the patient exercises vigorously.
Skin and hair problems: dryness of the skin, especially of the face, dry and inflamed lips, redness of the skin, itchy skin rash, inflamed skin, hair loss.
Liver problems: raised liver enzymes seen in blood tests.
Uncommon effects (may affect up to 1 in 100 people): Sight problems including blurred vision, distorted vision, cloudy surface on the eye (corneal opacity, cataracts).
If the patient's sight is affected, stop taking Alitretinoin immediately and contact a doctor.
Skin problems: itchy skin, skin peeling, rash, dry skin eczema.
Ear, nose and throat problems: nose bleeding.
Gut and stomach problems: indigestion (dyspepsia).
Bone disorders: extra growth of bone, including the spine disorder ankylosing spondylitis.
Rare effects (may affect up to 1 in 1,000 people): Lasting headache, along with feeling sick (nausea), being sick (vomiting) and changes in the patient's eyesight including blurred vision. These may be signs of benign intracranial hypertension.
If the patient experiences these symptoms, stop taking Alitretinoin immediately and contact a doctor.
Blood and circulation: inflammation of blood vessels.
Skin and hair problems: nail disorders, increased sensitivity of the skin to sunlight, hair texture changes.
Mental problems: Rare effects (may affect up to 1 in 1,000 people): Depression or related disorders: Signs of this include sad or altered mood, anxiety, feelings of emotional discomfort.
Existing depression getting worse.
Becoming violent or aggressive.
Very rare effects (may affect up to 1 in 10,000 people): Some people have had thoughts or feelings about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide). These people may not appear to be depressed.
Unusual behaviour.
Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there.
Contact a doctor straight away if the patient gets signs of any of these mental problems. The doctor may tell the patient to stop taking Alitretinoin. That may not be enough to stop the effects. The patient may need more help, and the doctor can arrange this.
Other side effects: Other side effects have occurred in a very small number of people but their exact frequency is unknown: Severe allergic reactions: Signs include: raised and itchy rash (hives); swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing; collapse.
Contact a doctor immediately if the patient gets these symptoms. Stop taking Alitretinoin.
Gut and stomach disorders: Severe stomach (abdominal) pain, with or without bloody diarrhoea, feeling sick (nausea) and being sick (vomiting).
Stop taking Alitretinoin immediately and contact a doctor. These can be signs of serious gut conditions.
Problems seeing at night: Sight problems normally return to normal once treatment is stopped.
Blood and circulation: Swelling of the hands, lower legs and feet (peripheral oedema).
Side effects of other medicines in the same family as Alitretinoin: These effects haven't been seen in Alitretinoin so far, but they can't be ruled out.
They are very rare and may affect less than 1 user in 10,000.
Diabetes: Excessive thirst; frequent need to urinate; blood tests show an increase in the blood sugar.
These can all be signs of diabetes.
Bone disorders: Arthritis; bone disorders (delayed growth, changes to bone density); growing bones may stop growing.
Eye and visual disorders: Colour blindness and colour vision gets worse; intolerance to contact lenses.
In rare cases soya oil can lead to severe allergic reactions.
Reporting of side effects: If the patient gets any side effects, talk to a doctor or pharmacist. This includes any possible side effects not listed in this leaflet. The patient can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects the patient can help provide more information on the safety of this medicine.
Storage
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask a pharmacist how to throw away medicines the patient no longer use. These measures will help protect the environment.
ATC Classification
D11AH04 - alitretinoin ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
Presentation/Packing
Cap 10 mg (light brown, oval soft gelatin, 10 mm x 6 mm, and contain a yellow to orange, opaque, viscous suspension) x 30's. 30 mg (yellow, oval soft gelatin, 13 mm x 8 mm, containing a yellow to orange, opaque, viscous suspension) x 30's.
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