Patient Leaflet Updated 03-Jul-2024 | Zentiva
Thalidomide 50mg capsules, hard
Thalidomide 50 mg capsules, hard
Thalidomide causes birth defects and foetal death.
Do not take thalidomide if you are pregnant or could become pregnant. You must follow the contraception advice given to you by your doctor.
1. What Thalidomide capsules are and what they are used for
2. What you need to know before you take Thalidomide capsules
3. How to take Thalidomide capsules
4. Possible side effects
5. How to store Thalidomide capsules
6. Contents of the pack and other information
The name of your medicine is Thalidomide 50 mg capsules, hard (called Thalidomide capsules throughout this leaflet). Thalidomide capsules contains an active substance called thalidomide. This belongs to a group of medicines which affect how your immune system works.
Thalidomide capsules are used with two other medicines called ‘melphalan’ and ‘prednisone’ to treat adults with a type of cancer called multiple myeloma. It is used in people who have recently been diagnosed and who have not been prescribed another medicine for their multiple myeloma before who are aged 65 years and over, or aged less than 65 years who cannot be treated with high dose chemotherapy, which can be very difficult for the body to handle.
Multiple myeloma is a type of cancer which affects a certain type of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide out of control. This can damage the bone and kidneys. Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a ‘remission’.
Thalidomide capsules work by helping the body’s immune system and directly attacking the cancer. It works in a number of different ways by:
You will have been given specific instructions by your doctor, particularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Pregnancy Prevention Programme).
You will have been given an educational brochure for patient by your doctor. Read it carefully and follow the related instructions.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take Thalidomide capsules. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not take Thalidomide capsules if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Thalidomide capsules.
Talk to your doctor, pharmacist or nurse before taking Thalidomide capsules.
For women taking Thalidomide capsules
Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely. Even if you do not have a menstrual bleeding following cancer therapy, you may become pregnant.
If you are able to become pregnant:
Your doctor will tell you what method of contraception to use.
If you are able to become pregnant, your doctor will record with each prescription that the necessary measures, as outlined above, have been taken.
For men taking Thalidomide capsules
Thalidomide passes into semen. Therefore, do not have unprotected intercourse, even if you had a vasectomy.
For all patients
Talk to your doctor before taking Thalidomide capsules if:
Your thyroid function may be checked before you take thalidomide and monitored during treatment.
At any time during or after your treatment, tell your doctor or nurse immediately if you experience: blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms prior to treatment with Thalidomide capsules, tell your doctor about any change in these symptoms.
Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the body which can lead to kidneys failure (this condition is called Tumour Lysis Syndrome) (see also section 4 “Possible side effects”).
Your doctor should evaluate if you develop additional types of haematological malignancies (called acute myeloid leukaemia and myelodysplastic syndromes) during your treatment with Thalidomide capsules (see also section 4 “Possible side effects”).
You must not donate blood during Thalidomide capsules treatment and for at least 7 days after stopping treatment.
If you are not sure if any of the above apply to you, talk to your doctor before taking Thalidomide capsules.
Thalidomide capsules is not recommended for use in children and young people under 18 years.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
Make sure you tell your doctor if you are taking any medicines which:
Do not drink alcohol while you are taking Thalidomide capsules. This is because alcohol can make you sleepy and Thalidomide capsules can make you even sleepier.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Thalidomide causes severe birth defects or death to an unborn baby.
If you are pregnant, you must not take Thalidomide capsules. In addition, you must not become pregnant while taking Thalidomide capsules.
You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, “What you need to know before you take Thalidomide capsules”).
You must stop treatment and inform your doctor straight away if:
If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately.
For men taking Thalidomide capsules who have a female partner who is able to become pregnant, please see section 2 “What you need to know before you take Thalidomide capsules”. If your partner becomes pregnant whilst you are taking Thalidomide capsules, you should inform your doctor immediately.
Breast-feeding
Do not breastfeed when taking Thalidomide capsules as it is not known if thalidomide is passed into human breast milk.
Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Thalidomide capsules exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 200 mg (4 x 50 mg capsules) a day for adults aged 75 years and under or 100 mg (2 x 50 mg capsules) a day for adults aged over 75 years. However your doctor will choose the dose for you, monitor your progress and may adjust your dose. Your doctor will tell you how to take Thalidomide capsules and for how long you will need to take it (see section 2, “What you need to know before you take Thalidomide capsules”).
Thalidomide capsules is taken daily in treatment cycles, each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6 week cycle.
To remove the capsule from the blister, press only one end of the capsule out to push it through the foil. Do not apply pressure on the centre of the capsule as this can cause it to break.
If you take more Thalidomide capsules than you should, talk to a doctor or go to a hospital straightaway. If possible, take the medicine pack and this leaflet with you.
If you forget to take Thalidomide capsules at your regular time and
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
It is important to note that a small number of patients with multiple myeloma may develop additional types of cancer, especially haematological malignancies, and it is possible that this risk may be increased with Thalidomide capsules treatment; therefore your doctor should carefully evaluate the benefit and risk when you are prescribed Thalidomide capsules.
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)
Not known (frequency cannot be estimated from the available data):
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.
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.
Do not use if you notice any damage or signs of tampering.
At the end of your treatment you should return all unused capsules to the pharmacist or doctor. These measures will prevent misuse.
Hard gelatin capsule (Size ‘4’) with white opaque cap and white opaque body imprinted with SML on cap and 28 on body with black ink containing white to off white granular powder.
The capsules are supplied in PVC/ PCTFE (Aclar)- aluminium blisters.
Pack size: 28 capsules.
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Manufacturer
This leaflet was last revised in June 2024
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