LITAK 2mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What LITAK is and what it is used for
2. What you need to know before you use LITAK
3. How to use LITAK
4. Possible side effects
5. How to store LITAK
6. Contents of the pack and other information

• if you are allergic to cladribine or any of the other ingredients of LITAK (listed in section 6)
• if you are pregnant or breast-feeding
• if you are less than 18 years of age
• if you have moderate to severe kidney or liver impairment
• if you are using other medicines which affect the production of blood cells in the bone marrow (myelosuppression).

Talk to your doctor or pharmacist before using LITAK.

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 cladribine, tell your doctor about any change in these symptoms.

Tell your doctor if you have or have had:

• liver or kidney problems
• infections
  • if you suffer from an infection, this will be treated before you start using LITAK.
  • if you notice any signs of infections (such as flu-like symptoms or fever) during or after treatment with LITAK, inform your doctor immediately.
• fever

Before and during treatment with LITAK, you will have regular blood tests to check whether it is safe for you to continue with your treatment. Your doctor may decide that you should receive blood transfusions to improve your level of blood cells. In addition, the proper function of your liver and your kidneys will be checked.

If you want to father a child, please tell your doctor before treatment with LITAK is started. You should not father a child during treatment and up to 6 months after treatment with LITAK. Your doctor may advise you about the possibility to store deep-frozen sperm (cryoconservation).

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are using any medicines containing:

• corticosteroids, commonly used to treat inflammation
• antiviral agents, used to treat viral infections

You must not use LITAK with other medicines that affect the production of blood cells in the bone marrow (myelosuppression).

You must not use LITAK if you are pregnant. You must take adequate contraceptive precautions during therapy and for at least six months after your last LITAK dose. If pregnancy occurs during your treatment, you must immediately inform your doctor.

You must not breast-feed while you are treated with LITAK and for at least six months after your last LITAK dose.

LITAK has a major effect on the ability to drive and use machines. If you feel drowsy, which may occur due to a low number of red blood cells caused by LITAK treatment, or dizzy, you should not drive or use machines.

In case you inject an incorrect dose, tell your doctor immediately.

Do not inject a double dose to make up for a forgotten dose. In case you miss an injection of a dose, tell your doctor immediately.

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 Website: 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.

• The active substance is cladribine. Each ml solution contains 2 mg cladribine. Each vial contains 10 mg cladribine in 5 ml solution.
• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

LITAK is available in glass vials containing 5 ml of clear, colourless solution for injection.

Pack size of 1 or 5 vials. Not all pack sizes may be marketed.

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

To give yourself a subcutaneous injection, you will need:

• one vial of LITAK (or two vials if you need to inject more than 5 ml).
  Do not use vials which are damaged, or if the solution is not clear or if it contains any particles.
• one sterile syringe (e.g. 10 ml LUER syringe),
• one sterile injection needle (e.g. 0.5 x 19 mm, 25 G x ¾’’),
• alcohol wipes,
• a puncture-proof container for safe disposal of the used syringe.

1. Before injection, allow LITAK to warm up to room temperature.
2. Wash your hands thoroughly.
3. Find a comfortable, well-lit place and put everything you need where you can reach it.

Before you inject LITAK, you must do the following:

1. Remove the red protective cap from the LITAK vial. Do not remove the rubber stopper of the vial. Clean the rubber top of the vial with an alcohol wipe. Remove the syringe from the wrapping without touching the tip of the syringe. Remove the injection needle from the wrapping and place it firmly on the tip of the syringe. Remove the needle guard without touching the needle.
2. Push the needle through the rubber stopper of the vial and turn the vial and the syringe upside down. Be sure that the tip of the needle is in the solution.
3. Draw the correct volume of LITAK into the syringe by pulling back the plunger (your doctor will inform you how many ml of LITAK you need to inject).
4. Pull the needle out of the vial.
5. Make sure there is no air left in the syringe: point the needle upwards and push the air out.
6. Check you have the right volume.
7. Inject straight away.

The most suitable places to inject yourself are the top of your thighs and the abdomen, except for the area around the navel. If someone else is injecting you, they can also use the outer surface of the upper arms or the buttocks.

1. Disinfect your skin by using an alcohol wipe, wait for the area to dry and pinch the skin between your thumb and forefinger, without squeezing it.
2. Put the needle fully into the skin at an angle of about 45°.
3. Pull slightly on the plunger to check that no blood vessel has been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
4. Inject the liquid slowly and evenly for approximately one minute, always keeping the skin pinched.
5. After injecting the liquid, remove the needle.
6. Put the used syringe in the puncture-proof container. Use a new syringe and injection needle for each injection. The vials are for single use only. Return any portion of the contents remaining after use to your doctor or pharmacist for proper disposal.

Put used syringes into a puncture-proof container and keep it out of the reach and sight of children.

Dispose the puncture-proof container as instructed by your doctor, nurse or pharmacist.

Do not put used syringes into the normal household garbage bin.