Thalidomide Celgene 50 mg hard capsules

What Thalidomide Celgene is:

Thalidomide Celgene contains an active substance called thalidomide. This belongs to a group of medicines known as ?immunosuppressive? medicines. These work by acting on the cells involved in your immune system. The immune system is part of the body?s defence which helps to fight illness and infection.

What Thalidomide Celgene is used for:

Thalidomide Celgene is used to treat multiple myeloma, a cancer of the bone marrow. Multiple myeloma is a type of blood cancer that affects a subgroup of white blood cells that produce antibodies. It is used in combination with two other medicines, melphalan and prednisone, for the first line treatment of multiple myeloma in patients ? 65 years or those who cannot receive high dose chemotherapy. In the principal clinical trial, this combination was associated with a prolongation of the survival time by an average of 18 months.

To find out more about these medicines, please ask your doctor or read the Package Leaflet that comes with these medicines.

You will have been given specific instructions by your doctor, particularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).

You will have been given a patient card or any other relevant document by your doctor. Read it carefully and follow the related instructions.

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If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide. See also further information in this section under ?Take special care with Thalidomide Celgene? and ?Pregnancy?.

Do not take Thalidomide Celgene:

• If you are pregnant or think you may be pregnant or are planning to become pregnant, as Thalidomide Celgene causes birth defects and foetal death.
• If you are able to become pregnant but are unable to follow the necessary pregnancy prevention measures (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).
• If you are allergic (hypersensitive) to thalidomide or any of the other ingredients of Thalidomide Celgene (listed in section 6. "What Thalidomide Celgene contains:?).

Do not take Thalidomide Celgene if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Thalidomide Celgene.

Take special care with Thalidomide Celgene:

Talk to your doctor before taking this medicine in the following situations:

For all patients taking Thalidomide Celgene
Check with your doctor before taking this medicine if:

• You are at high risk of a blood clot developing in your veins (deep vein thrombosis) or in your lungs (pulmonary embolism).
• You do not understand the contraception advice given to you by your doctor or if you do not feel able to follow this advice.
• You have nerve damage, such as numbness, tingling or pain in your hands or feet.

For women taking Thalidomide CelgeneBefore starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
If you are able to become pregnant:

• Your doctor will make sure that you have pregnancy tests
• before treatment
• every 4 weeks during treatment
• 4 weeks after stopping treatment
• You must use one effective method of contraception:
• for 4 weeks before starting treatment
• during treatment
• until 4 weeks after stopping treatment 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 and will give you a record of this on your patient card or any other relevant documents.

For men taking Thalidomide CelgeneThalidomide passes into semen. Therefore do not have unprotected intercourse.

• Pregnancy and any exposure during pregnancy must be avoided. Always use a condom:
• during treatment
• for 1 week after stopping treatment
• You must not donate semen:
• during treatment
• for 1 week after stopping treatment

Donating Blood:

You must not donate blood during Thalidomide Celgene treatment and for 1 week after stopping treatment.

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If you are not sure if any of the above apply to you, talk to your doctor before taking Thalidomide Celgene.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines since other medicines could interfere with the effect of thalidomide. This includes medicines obtained without a prescription, including herbal medicines.

Make sure you tell your doctor if you are taking any medicines which cause sleepiness as thalidomide may increase their effects.

Taking Thalidomide Celgene with food and drink:

Thalidomide Celgene can be taken with or without food (see section 3, ?How to take Thalidomide Celgene?).

Do not drink alcohol while you are taking Thalidomide Celgene. This is because alcohol can make you sleepy and Thalidomide Celgene can make you even sleepier.

Pregnancy:

Thalidomide causes severe birth defects or death to an unborn baby.

• As little as one capsule taken by a pregnant woman can cause a baby to have serious birth defects.
• These defects can include shortened arms or legs, malformed hands or feet, eye or ear defects, and problems with internal organs. If you are pregnant, you must not take Thalidomide Celgene. In addition, you must not become pregnant while taking Thalidomide Celgene.

You must use one effective method of contraception if you are a woman who is able to become pregnant (see section 2, ?Take special care with Thalidomide Celgene?).
You must stop treatment and inform your doctor straight away if:

• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
• You have heterosexual intercourse without using an effective method of contraception. If you do become pregnant during the treatment with thalidomide, you must stop the treatment and inform your doctor immediately.

For men taking Thalidomide Celgene who have a female partner who is able to become pregnant, please see section 2 ?Take special care with Thalidomide Celgene?. If your partner becomes pregnant whilst you are taking thalidomide, you should inform your doctor immediately.

Breast-feeding:

Do not breastfeed when taking Thalidomide Celgene as it is not known if thalidomide is passed into human breast milk.

Driving and using machines:

Do not drive or use any tools or machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.

Important information about some of the ingredients of Thalidomide Celgene: Thalidomide Celgene contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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Always take Thalidomide Celgene exactly as your doctor has told you to. You should check with your doctor if you are not sure.

Thalidomide Celgene is not suitable under the age of 18.

How much to take:

The usual dose is 200 mg (4 capsules) a day. 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 Celgene and for how long you will need to take it.

Thalidomide Celgene 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.

Taking this medicine:

• Take this medicine by mouth
• Swallow the capsules whole with a full glass of water
• Do not crush or chew
• Take the capsules as a single dose before going to bed. This will make you less likely to feel sleepy at other times.

If you take more Thalidomide Celgene than you should:

If you take more Thalidomide Celgene 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 Celgene:

If you forget to takeThalidomide Celgene at your regular time and

• less than 12 hours have passed: take your capsules immediately.
• more than 12 hours have passed: do not take your capsules. Take your next capsules at the usual time the next day.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Thalidomide Celgene can cause side effects although not everybody gets them. The frequency of side effects is classified into the following categories:

Very common Affects more than 1 user in 10 Common Affects 1 to 10 users in 100 Uncommon Affects 1 to 10 users in 1,000 Rare Affects 1 to 10 users in 10,000 Very rare Affects less than 1 user in 10,000

The following side effects may happen with this medicine:

Stop taking Thalidomide Celgene and see a doctor straight away if you notice the following serious side effects ? you may need urgent medical treatment:

• Severe skin reactions including rashes, which is a common side effect and blistering of the skin and mucosa (Stevens Johnson Syndrome and toxic epidermal necrolysis, which are rare side effects). You may have a high temperature (fever) at the same time.

Tell your doctor straight away if you notice any of the following serious side effects:

• Numbness, tingling, abnormal co-ordination or pain in your hands and feet.

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This may be due to nerve damage (called ?peripheral neuropathy?), which is a very common side effect. It may become very severe, painful and disabling. If you experience such symptoms, speak to your doctor straight away, who may reduce the dose or discontinue the treatment. This side effect usually happens after you have been taking this medicine for several months but can happen sooner than this. It can also happen some time after treatment has stopped. It may not go away, or may go away slowly.

• Sudden pain in your chest or difficulty in breathing. This may be due to blood clots in the arteries leading to your lungs (called ?pulmonary embolism?), which is a common side effect. These can happen during treatment, or after treatment has stopped.
• Pain or swelling in your legs, especially in your lower leg or calves. This may be due to blood clots in the veins of your leg (deep vein thrombosis), which is a common side effect. These can happen during treatment, or after treatment has stopped.

Other side effects include:
Very common

• Constipation.
• Feeling dizzy.
• Sleepiness, feeling tired.
• Shaking (tremor).
• Swelling of hands and feet.
• Numbness and tingling
• Low blood cell counts. This may mean that you are more likely to develop infections. Your doctor may monitor your blood cell counts during treatment with Thalidomide Celgene. Common
• Indigestion, feeling sick (nausea), being sick (vomiting), dry mouth.
• Rash, dryness of the skin.
• Feeling weak, faint or unsteady, lack of energy or strength, low blood pressure.
• Fever, feeling generally unwell.
• A spinning feeling in your head, making it difficult to stand up and move normally.
• Having difficulty in seeing or speaking, which is temporary. This may be due to a clot in an artery in the brain.
• Blurred vision.
• Shortness of breath, difficulty breathing.
• Chest infection (pneumonia), lung disease.
• A slow heart rate, heart failure.
• Depression, confusion, mood changes, anxiety. Uncommon
• Having difficulty seeing or speaking due to bleeding from an artery in the brain.
• Feeling dizzy when you stand up.
• Inflammation and swelling of the tubes in your lungs (bronchitis).
• Inflammation of the cells lining your stomach wall.
• A hole in part of your large bowel (colon) which can cause infection.

Additional side effects have been reported after this medicine was marketed. These include

• very serious skin reaction (toxic epidermal necrolysis)
• underactive thyroid (hypothyroidism)
• bowel obstruction
• sexual dysfunction, for example impotence
• a fall in the number of white blood cells (neutropenia) accompanied by fever and infection
• a fall in the number of red and white blood cells and platelets at the same time (pancytopenia)
• Tumour Lysis Syndrome - metabolic complications that can occur during the treatment of cancer and sometimes even without treatment. These complications are caused by the break-down products of dying cancer cells and may include the following: changes to blood

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chemistry; high potassium, phosphorus, uric acid, and low calcium consequently leading to changes in kidney function, heart beat, seizures, and sometimes death.

• allergic reactions such as a localised or generalised pruritic rash
• hearing decreased or deafness
• kidney disease (renal failure) If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children and any other person not directly involved in the treatment.

Do not use after the expiry date stated on the wallet card and the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

At the end of your treatment you should return all unused capsules to the pharmacist or doctor. These measures will prevent misuse.

What Thalidomide Celgene contains:

• The active substance is thalidomide. Each capsule contains 50mg of thalidomide.
• The other ingredients are anhydrous lactose, microcrystalline cellulose, povidone (K90), stearic acid, colloidal anhydrous silica, and crospovidone (Type A). The capsule shell contains gelatin and titanium dioxide (E171). The printing ink is composed of shellac, black iron oxide (E172) and propylene glycol.

What Thalidomide Celgene looks like and contents of the pack:

Thalidomide Celgene are white hard capsules marked ?Thalidomide 50 mg Celgene?. The capsules are supplied in a wallet card containing 28 capsules (2 blisters of 14 capsules each).

Marketing Authorisation Holder:

Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom.

Manufacturer:

Penn Pharmaceutical Services Limited, Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, United Kingdom.

Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire, SL4 1NA, United Kingdom.

This leaflet was last approved in

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