Active ingredient
- acitretin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20117/0265 .
Acitretin 10mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Acitretin 10mg and 25mg Capsules
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY
Women must use effective contraception
Do not use if you are pregnant or think you may be pregnant
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Acitretin is and what it is used for
2. What you need to know before you take Acitretin
3. Important information for women
4. How to take Acitretin
5. Possible side effects
6. How to store Acitretin
7. Contents of the pack and other information
1. What Acitretin is and what it is used for
The name of your medicine is Acitretin 10mg Capsules or Acitretin 25mg Capsules but will be referred to as Acitretin throughout this leaflet.
Acitretin Capsules contains a medicine called acitretin. This belongs to a group of medicines called ‘retinoids’. Acitretin is used to treat severe skin problems where the skin has become thick and maybe scaly. These skin problems include psoriasis, ichthyosis and keratosis follicularis (Darier’s disease). It works by making your skin grow more normally.
Acitretin is normally used while under the care of a specialist dermatologist (skin doctor).
2. What you need to know before you take Acitretin
Do not take Acitretin:
Do not take Acitretin Capsules if you are allergic (hypersensitive) to:
Do not take Acitretin if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Acitretin.
PREGNANCY AND PREVENTION PROGRAMME:
Women who are pregnant must not take Acitretin:
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 Acitretin is taken only for a short time during pregnancy.
Women who could get pregnant are prescribed Acitretin under strict rules. This is because of the risk of serious harm to the unborn baby
These are the rules:
Women must use effective contraception before, during and after taking Acitretin:
Women must agree to pregnancy testing before, during and after taking Acitretin:
If you get pregnant while taking Acitretin, stop taking the medicine straight away, and contact your doctor. Your doctor may send you to a specialist for advice.
Also, if you become pregnant within 3 years after you stop taking Acitretin, you should contact your doctor. Your doctor may send you to a specialist for advice.
Advice for men
The levels of oral retinoid in the semen of men taking Acitretin are too low to harm their partners’ unborn baby. However, you must never share your medication with anyone.
Additional precautions
You should never give this medicinal product to another person. Please take any unused Acitretin capsules to your pharmacist at the end of treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acitretin if:
Advice for all patients
Acitretin commonly increase blood fats, such as cholesterol or triglycerides which have been associated with pancreatitis.
Tell your doctor if you experience severe pain in the abdomen and back (these can be signs of inflammation of the pancreas).
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.
Acitretin may affect your liver function. Your doctor may need to do blood tests whilst you are taking this medicine to check your liver function.
Acitretin may cause increased pressure in the head. You should tell your doctor if you experience severe headaches, feeling or being sick or changes in sight. Your doctor may carry out further checks.
Acitretin may cause changes in bone growth. You should tell your doctor if you feel pain in your muscles or bones. Your doctor may carry out further checks.
Mental health problems
You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour. They may notice these changes and help you identify any problems that you need to talk to your doctor about.
Hair loss is a very common side effect of Acitretin.
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Acitretin.
Children
Acitretin should not be given to children. Acitretin may cause changes in bone growth in children.
Other medicines and Acitretin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Acitretin can affect the way some other medicines work. Also some other medicines can affect the way Acitretin works.
Do not take Acitretin, and tell your doctor or pharmacist, if you are taking any of the following medicines:
Tell your doctor or pharmacist if you are taking the following medicine:
Acitretin with food, drink and alcohol
Women of childbearing potential should not consume alcohol (in drinks, food or medicines) during treatment with Acitretin and for 2 months after cessation of therapy. Concurrent ingestion of Acitretin and alcohol may result in formation of a compound (etretinate), which may be harmful to an unborn child, and if formed takes some time for it to be totally removed from the body.
Driving and using machines
Your vision may be affected, particularly at night time, while you are taking Acitretin. Be careful if you are driving or using any tools or machines.
Important information for blood donors
You should not donate blood during treatment with this medicine and for 3 years after stopping Acitretin because an unborn baby could be harmed if a pregnant patient receives your blood.
Important information about Acitretin Capsules
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. Important information for women
Acitretin will damage an unborn baby. The following instructions must be strictly followed, even if you have fertility problems:
Pregnancy, breast-feeding and fertility
For more information on pregnancy and contraception, see section 2 “Pregnancy and prevention programme”.
Birth control (contraception) and pregnancy tests
If you are a female patient at an age where you could get pregnant:
If you have any questions about these instructions, talk to your doctor or pharmacist before taking Acitretin.
4. 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.
The dose varies from one patient to another. Your doctor will work out the right dose for you.
Adults and elderly people
Use in children
Acitretin should not be 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.
If you take more Acitretin than you should
If you take more Acitretin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: a bad headache, dizziness, feeling or being sick, being sleepy or irritable or having itchy skin.
If you forget to take Acitretin
If you stop taking Acitretin
Your doctor can judge best when and how you must stop taking Acitretin. Always contact your doctor before you want to stop taking the medicine.
If someone else takes your Acitretin Capsules by mistake, they should talk to a doctor or go to a hospital straight away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
5. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You will probably have some side effects during treatment with Acitretin, even before you see your skin starting to get better. These effects often wear off as your treatment continues. Your doctor can help you to deal with them.
Stop taking Acitretin and see a doctor straight away if you experience the following side effects:
Your doctor may want to check you regularly to find out if this is happening. These checks are particularly important if a child is taking Acitretin.
Other possible side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Side effects with unknown frequency:
An initial worsening of psoriasis symptoms is sometimes seen at the beginning of the treatment period.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
6. How to store Acitretin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
7. Contents of the pack and other information
What Acitretin Capsules contain
The active substance is acitretin.
Acitretin 10mg Capsule: Each capsule contains 10mg acitretin.
Acitretin 25mg Capsule: Each capsule contains 25mg acitretin.
The other ingredients are:
What Acitretin Capsules look like and contents of the pack
Acitretin 10mg Capsules are brown opaque/white opaque size ‘4’ hard gelatin capsules imprinted with ‘U68’ in white ink on cap containing yellow granular powder.
Acitretin 25mg Capsules are brown opaque/yellow opaque size ‘1’ hard gelatin capsules imprinted with ‘U69’ in white ink on cap containing yellow granular powder.
The capsules are packaged in aluminium blister packs.
Pack sizes: 10, 20, 28, 30, 56, 60, 100 and 120 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in October 2019
Detailed and updated information on this product is available by scanning the QR code included in the PL with a smartphone. The same information is also available on the following URL: www.morningsidehealthcare.com/acitretin and www.mhra.gov.uk.
M0265LAMUKNA-S-002
Morningside House, Unit C Harcourt Way, Meridian Business Park, Leicester, LE19 1WP
+44 (0)116 204 5950
+44 (0)116 204 5950
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+44 (0)116 204 5950