Revlimid 5 mg hard capsules

What Revlimid is

Revlimid belongs to a group of medicines called immunomodulatory medicines, which can modify or regulate the functioning of the immune system.

What Revlimid is used for

Revlimid in combination with dexamethasone is used to treat adult patients who have been diagnosed with multiple myeloma. Multiple myeloma is a type of blood cancer that affects the white blood cells that produce antibodies.

Follow all of your doctor?s instructions carefully, even if they differ from the general information given in this leaflet.

DO NOT TAKE Revlimid

• if you are pregnant or think you may be pregnant or are planning to become pregnant, as Revlimid is expected to be harmful to an unborn child (see section 2, ?Take special care with Revlimid? and ?Pregnancy?).
• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2 ?Take special care with Revlimid? and ?Pregnancy?). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
• if you are allergic (hypersensitive) to lenalidomide or any of the other ingredients of Revlimid listed in Section 6, ?What Revlimid contains?. If you think you may be allergic, ask your doctor for advice.

If any of these apply to you, tell your doctor before you take Revlimid.

Take special care with Revlimid
Please talk to your doctor in the following situations:

For women taking Revlimid
Before 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

• you will have pregnancy tests under the supervision of your doctor (before treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except in the case of confirmed tubal sterilisation AND
• you must use effective methods of contraception for 4 weeks before starting treatment, during treatment, and until 4 weeks after stopping treatment. Your doctor will advise you on appropriate methods of contraception.

For men taking Revlimid
Revlimid passes into human semen. If your female partner is pregnant or able to become pregnant, and she doesn?t use effective methods of contraception, you must use condoms, during treatment and 1 week after the end of treatment.

All patients
Before starting the treatment you should tell your doctor if you had blood clots in the past. During the treatment with Revlimid you have an increased risk of developing blood clots in the veins and arteries.

Before and during the treatment with Revlimid you will have regular blood tests as Revlimid may cause a fall in the blood cells that help fight infection and help the blood to clot. Your doctor should ask you to have a blood test:

• before treatment
• every week for the first 8 weeks of treatment
• at least every month after that. Your doctor may adjust your dose of Revlimid or stop your treatment based on the results of your blood tests and on your general condition.

Before you start treatment you should tell your doctor if you have kidney disease. Your doctor may adjust your dose of Revlimid based on this information.

You should not donate blood during treatment and for 1 week after the end of treatment.

At the end of the treatment you should return all unused capsules to the pharmacist.

Taking other medicines

Please tell your doctor or pharmacist of all other medicines that you are taking or have recently taken, including medicines obtained without a prescription.

Taking Revlimid with food and drink
The Revlimid capsules can be taken either with or without food (see Section 3, ?How and when to take the Revlimid capsule?).

Pregnancy

You must not take Revlimid if you are pregnant, as it is expected to be harmful for an unborn baby. In addition, you must not become pregnant while taking Revlimid.
Therefore you must use effective methods of contraception if you are a woman of childbearing potential (see Section 2, ?Take special care with Revlimid?).

If you do become pregnant during the treatment with Revlimid, you must stop the treatment and inform your doctor immediately.

For men taking Revlimid, please see section 2 ?Take special care with Revlimid?. If your partner becomes pregnant whilst you are taking Revlimid, you should inform your doctor immediately. It is recommended that your partner seeks medical advice.

Breast-feeding

You should not breastfeed when taking Revlimid, as it is not known if Revlimid passes into human milk.

Driving and using machines:
Do not drive or operate machines if you experience side effects, such as dizziness, tiredness, sleepiness or blurred vision.

Important information about some of the ingredients of Revlimid

Revlimid contains lactose (a type of sugar). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Revlimid.

Revlimid is taken in combination with dexamethasone. Always take Revlimid and dexamethasone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should refer to the package leaflet for dexamethasone for further information on its use and effects.

Revlimid dosage

The usual starting dose is 25 mg once per day. Revlimid is taken in treatment cycles, each cycle lasting 28 days.

Treatment cycle:

• On days 1-21: take 25 mg of Revlimid once per day
• On days 22-28: do NOT take Revlimid After completing each cycle, start a new one.

Your doctor may adjust your dose of Revlimid or stop your treatment based on the results of your blood tests and on your general condition (see Section 2, Take special care with Revlimid?).

Dexamethasone dosage

The usual starting dose is 40 mg once per day. Dexamethasone is also taken in treatment cycles, each cycle lasting 28 days.

First 4 treatment cycles:

• On days 1-4, 9-12 and 17-20: take 40 mg dexamethasone once per day
• On days 21-28: do NOT take dexamethasone

Following treatment cycles:

• On days 1-4: take 40 mg dexamethasone once per day
• On days 5-28: do NOT take dexamethasone After completing each cycle, start a new one.

Your doctor may reduce your dose of dexamethasone based on your general condition (see Section 2, "Take special care with Revlimid?).

How and when to take Revlimid

You should swallow the Revlimid capsules whole, preferably with water, once a day. Do not break, open or chew the capsules. The Revlimid capsules can be taken either with or without food.

You should take Revlimid at about the same time each day.

Duration of the treatment with Revlimid

Revlimid is taken in treatment cycles, each cycle lasting 28 days (see above ?Dosage?). You should continue the cycles of treatment until your doctor tells you to stop.

If you take more Revlimid than you should

If you take more Revlimid than was prescribed, tell your doctor immediately.

If you forget to take Revlimid
If you forget to take Revlimid at your regular time and

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

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

Like all medicines, Revlimid 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 Not known Cannot be estimated from the available data

It is important to note that Revlimid may reduce the number of white blood cells that fight infection and also the blood cells which help the blood to clot (platelets). Revlimid may also cause blood clots in the veins (thrombosis).
Therefore you must tell your doctor immediately if you experience:

• any fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection
• any bleeding or bruising in the absence of injury
• any chest or leg pain
• any shortness of breath

Very common side effects are given below. You should consult your doctor if you experience any of these:

• A fall in the number of white blood cells (the cells that fight infection), platelets (the cells that help the blood to clot, which may lead to bleeding disorders) and red blood cells (anaemia leading to tiredness and weakness)
• Constipation, diarrhoea, nausea, rashes, vomiting, muscle cramps, muscle aches, bone pain, tiredness, generalised swelling including swelling of the limbs
• Fever and flu like symptoms including fever, muscle ache, headache, and chills
• Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor, taste disturbance
• Decreased appetite, low levels of potassium in the blood
• Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs)
• Infection of the lung and the upper respiratory tract, shortness of breath, nosebleed
• Blurred vision
• Headache

Common side effects are given below. You should consult your doctor if you experience any of these:

• Chest pain
• Difficulty breathing
• Infections of all types
• Infection of the sinuses that surround the nose
• Bleeding from the gums, stomach, or bowels, bruising
• Increased blood pressure or a fall in blood pressure, slow, fast or irregular heart beat
• Increased pigmentation of skin
• Skin eruptions, skin cracking, flaking
• Hives, itching, dry skin, increased sweating, dehydration
• Sore inflamed mouth, dry mouth, difficulty swallowing
• Abdominal pain
• Production of much more or much less urine than usual (which may be a symptom of kidney failure), passing blood in the urine
• Shortness of breath especially when lying down (which may be a symptoms of heart failure)
• Difficulty in obtaining an erection
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless, feeling sick or vomiting (which may be symptoms of a heart attack/myocardial infarction)
• Stroke, fainting
• Muscle weakness
• Joint swelling
• Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood
• Depression
• Cataract
• Reduced vision
• Deafness
• Abnormal liver test results
• Impaired balance, movement difficulty
• Ringing in the ears (tinnitus)

Uncommon side effects are given below. You should consult your doctor if you experience any of these:

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• Bleeding within the skull
• Circulatory problems
• Loss of vision
• Loss of libido (sex drive)
• Passing large amount of urine with bone pain and weakness, which may be symptoms of Fanconi syndrome (a kidney disorder)
• Colitis and caecitis (inflammation of the large intestine), both of which may be manifested as abdominal pain, bloating, or diarrhoea
• Renal tubular necrosis (a type of kidney impairment) which may be evident by production of much more or much less urine than usual
• Skin discoloration, sensitivity to sunlight
• Certain types of tumour of skin
• Hypersensitivity/Angioedema (types of allergic reaction that may be manifested as hives, rashes, swelling of eyes, mouth or face, difficulty of breathing, or itching)

Rare side effects are given below. You should consult your doctor if you experience any of these:

• Serious allergic reaction that may begin as rash in one area but spread with extensive loss of skin over the whole body
• Tumour lysis syndrome - metabolic complications that can occur during 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 chemistry; high

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

Side effects where the frequency is not known are given below. You should consult your doctor if you experience any of these:

• Sudden, or mild but worsening pain in the upper abdomen and/or back, which remains for a few days, possibly accompanied by nausea, vomiting, fever and a rapid pulse ? these symptoms may be due to inflammation of the pancreas.
• Wheezing, shortness of breath or a dry cough, which may be symptoms caused by inflammation of the tissue in the lungs.

If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use Revlimid after the expiry date, which is stated on 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.
• Do not use any pack that is damaged or shows signs of tampering.

All unused Revlimid capsules should be returned to the pharmacist.

What Revlimid contains

Revlimid 5 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
• capsule contents: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
• capsule shell: gelatine and titanium dioxide (E171)
• printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 10 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
• capsule contents: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
• capsule shell: gelatine, titanium dioxide (E171), indigo carmine (E132) and yellow iron oxide (E172)
• printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 15 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
• capsule contents: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
• capsule shell: gelatine, titanium dioxide (E171) and indigo carmine (E132)
• printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

Revlimid 25 mg hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
• capsule contents: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium and magnesium stearate
• capsule shell: gelatine and titanium dioxide (E171)
• printing ink: shellac, propylene glycol, potassium hydroxide and black iron oxide (E172).

What Revlimid looks like and contents of the pack

Revlimid 5 mg hard capsules are white, with ?REV 5 mg? written on them.

Revlimid 10 mg hard capsules are blue-green/pale yellow, with ?REV 10 mg? written on them.

Revlimid 15 mg hard capsules are pale blue/white, with ?REV 15 mg? written on them.

Revlimid 25 mg hard capsules are white, with ?REV 25 mg? written on them.

The capsules are provided in packs. Each pack contains three blisters, each with seven capsules. This gives a total of 21 capsules per pack.

Marketing Authorisation Holder

Celgene Europe Limited
Riverside House
Riverside Walk
Windsor
Berkshire
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

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last approved in XX/YYYY