Melphalan 50 mg Powder and Solvent for Solution for Injection/Infusion

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions about your illness or your medicine, ask your doctor or nurse.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1 What Melphalan is and what it is used for
2 Before you have Melphalan
3 How to have Melphalan
4 Possible side effects
5 How to store Melphalan
6 Further information

Do not have Melphalan if:

• You are allergic (hypersensitive) to melphalan or any of the other ingredients of Melphalan injection (See section 6: Further information)

Do not have Melphalan if the above applies to you. If you are not sure, talk to your doctor or nurse before having Melphalan.

Take special care with Melphalan

Before you use Melphalan, tell your doctor or nurse if:

• you have had radiotherapy or chemotherapy, now or recently
• you have a kidney problem.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Melphalan.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular, tell your doctor or nurse if you are taking any of the following:

• other cytotoxic drugs (chemotherapy)
• nalidixic acid (an antibiotic used to treat urinary tract infections)
• ciclosporin (used to prevent rejection of organs or tissues following a transplant or to treat certain skin conditions like psoriasis and eczema or to treat rheumatoid arthritis).

Having vaccines while you are taking Melphalan

If you are going to have a vaccination speak to your doctor or nurse before you have it. This is because some vaccines (like polio, measles, mumps and rubella) may give you an infection if you have them whilst you are being treated with Melphalan.

Pregnancy and breast-feeding

Do not have Melphalan if you are planning to have a baby. This applies to both men and women. Melphalan may harm your sperm or eggs. Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner are having this injection. Ask your doctor for advice.

If you are already pregnant, it is important to talk to your doctor before having Melphalan.

Do not breast-feed while having Melphalan. Ask your doctor or midwife for advice.

If you have more Melphalan than you need

Your doctor will give you Melphalan so it is unlikely that you will receive too much. If you think you have been given too much or have missed a dose, tell your doctor or nurse.

If you get any of the following, talk to your specialist doctor or go to hospital straight away:

• allergic reaction, the signs may include:
  • a rash, lumps or hives on the skin
  • swollen face, eyelids or lips
  • sudden wheeziness and tightness of the chest
  • collapse (due to cardiac arrest)
• any signs of fever or infection (sore throat, sore mouth or urinary problems)
• any unexpected bruising or bleeding or feeling extremely tired, dizzy or breathless, as this could mean that too few blood cells of a particular type are being produced
• if you suddenly feel unwell (even with a normal temperature)
• if your muscles are achy, stiff or weak and your urine is darker than usual or brown or red in colour ‑ when you have Melphalan directly into your arm or leg.

Talk to your doctor if you have any of the following side effects which may also happen with this medicine:

Very common (affects more than 1 in 10 people)

• a drop in the number of blood cells and platelets
• feeling sick (nausea), being sick (vomiting) and diarrhoea
• mouth ulcers - with high doses of Melphalan
• hair loss - with high doses of Melphalan
• a tingling or warm feeling where Melphalan was injected
• problems with your muscles like wasting and aching - when you have Melphalan directly into your arm or leg

Common (affects less than 1 in 10 people)

• hair loss - with usual doses of Melphalan
• high levels of a chemical called urea in your blood - in people with kidney problems who are being treated for myeloma
• a muscle problem which can cause pain, tightness, tingling, burning or numbness - called compartment syndrome. This can happen when you have Melphalan directly into your arm or leg

Rare (affects less than 1 in 1,000 people)

• an illness where you have a low number of red blood cells as they are being destroyed prematurely - this can make you feel very tired, breathless and dizzy and can give you headaches or make your skin or eyes yellow
• lung problems which may make you cough or wheeze and make it difficult to breathe
• liver problems which may show up in your blood tests or cause jaundice (yellowing of the whites of eyes and skin)
• mouth ulcers - with normal doses of Melphalan
• skin rashes or itching skin

The following side effects also happen with Melphalan:

• leukaemia - cancer of the blood
• in women: your periods stopping

What Melphalan contains

The active ingredient is melphalan. Each Melphalan injection contains 50 mg of melphalan.

The other ingredients are povidone K12 and hydrochloric acid. Melphalan is dissolved in a diluent before being injected. The diluent contains water, sodium citrate, propylene glycol and ethanol.

What Melphalan looks like and contents of the pack

Each pack contains one Melphalan Injection vial and one Melphalan Injection Diluent vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Manufacturer: