Foscarnet sodium Tillomed 24 mg/ml solution for infusion

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

The full name of this medicine is “Foscarnet sodium Tillomed 24 mg/ml solution for infusion” but will be referred to as 'Foscarnet' throughout this leaflet.

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

• If you are allergic (hypersensitive) to foscarnet sodium hexahydrate or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or nurse before you are given foscarnet.

Talk to your doctor or nurse before using Foscarnet if.

• You have problems with your kidneys.
• You have problems with your heart.

If you are not sure if this applies to you, talk to your doctor or nurse before you are given foscarnet.

The safety and efficacy of foscarnet sodium hexahydrate in children have not been established.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines that you buy without a prescription and herbal medicines.

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

• Pentamidine (for infections)
• Amphotericin B (for fungal infections)
• Acyclovir (for viral infections)
• Antibiotics called aminoglycosides, such as gentamicin and streptomycin (for infections)
• Cyclosporine A, methotrexate, or tacrolimus (used to suppress the immune system)
• Medicines called protease inhibitors such as ritonavir and saquinavir
• Laxatives
• Quinidine, amiodarone, sotalol or any other medicines which may affect your heart rate or rhythm
• Tranquilisers (neuroleptics)

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.

Foscarnet is not recommended during pregnancy.

Trying to become pregnant during Foscarnet therapy is not recommended so you should use effective contraception methods during and up to 6 months after therapy.

Men treated with Foscarnet should not father a child during or up to 6 months after therapy.

Do not use Foscarnet if you are breastfeeding.

Foscarnet may affect you being able to drive or use tools and machines. Talk to your doctor before you do any of these activities.

Your doctor may do blood and urine tests before and during your treatment with Foscarnet.

This is to check how well your kidneys are working and the level of minerals in your blood.

This medicine contains 1375 mg sodium (main component of cooking/table salt) in each 250 ml bottle. This is equivalent to 69% of the recommended maximum daily dietary intake of sodium for an adult.

Talk to your doctor or pharmacist if you need 71 ml or more daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

If you are having Foscarnet for CMV retinitis, there will be two stages to your treatment. The first stage is called induction therapy and the second stage is called maintenance therapy.

Induction therapy

• During induction therapy, you will be given an infusion every 8 hours. This will usually happen for 2 or 3 weeks.
• The usual dose for induction therapy is 60 mg of Foscarnet for every kilogram that you weigh (60 mg/kg).
• Your doctor will tell you when you are ready to change to maintenance therapy.

Maintenance therapy

• During maintenance therapy, you will be given an infusion once a day.
• The usual dose for maintenance therapy is 60 to 120 mg of Foscarnet for every kilogram that you weigh (60 to 120 mg/kg).

Your doctor will tell you if you need to have more or less Foscarnet and how often you should have it. This is so that you have the dose that is right for you.

Sometimes your doctor may ask you to have a medicine called ganciclovir as well. This is to make sure that you have the treatment that is right for you.

• If you are being given Foscarnet to treat Herpes Simplex Virus, there is only one stage.
• You will be given an infusion every 8 hours.
• Your wounds (lesions) may start to heal after about 1 week. However, you may need to keep taking Foscarnet for 2 to 3 weeks or until your wounds have healed.
• The usual dose is 40 mg of Foscarnet for every kilogram that you weigh (40 mg/kg).

Wash your genitals carefully after passing water (urine). This will help to prevent any sores from developing.

If you get Foscarnet on your skin or in your eyes by mistake, rinse your skin or your eyes straight away with water.

Use in children and adolescents:

The safety and efficacy of Foscarnet has not been established in children and adolescents below 18 years of age have not been established.

If you think you have been given too much Foscarnet, talk to your doctor straight away.

If you think you have missed a dose, talk to your doctor straight away.

• Severe allergic reactions including a fall in blood pressure, shock and swelling of the skin (angioedema). They are known as hypersensitivity, anaphylactic or anaphylactoid reactions.
• Severe skin rashes. These types of rashes can be associated with redness, swelling, and blisters of the skin, mouth, throat, eyes and other places inside the body and can sometimes result in death. They are called erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

If you get any of the above, tell your doctor straight away or go to the nearest emergency unit.

Very common: (may affect more than 1 in 10 people)

• Loss of appetite
• Diarrhoea
• Feeling or being sick
• Feeling weak or tired
• High temperature or chills
• Feeling dizzy
• Headache
• Pins and needles
• Skin rash
• Changes in how well your kidneys are working (shown in blood tests)
• Low levels of white blood cells. The signs include infections and high temperature (fever)
• Changes to red blood cells (shown in blood tests). This may make you feel tired or look pale
• An imbalance of salts and minerals in your blood. The signs include weakness, cramps, thirst, tingling or itching of the skin and twitching of muscles.

Common: (may affect up to 1 in 10 people)

• Pain in the tummy (abdomen), constipation, indigestion or gastrointestinal bleeding
• Inflamed pancreas (pancreatitis) or changes in how well your pancreas is working. The signs include severe stomach pain and there may be changes that are shown in blood tests
• Feeling anxious, nervous, depressed, agitated, aggressive or confused
• Problems with your co-ordination
• Fits (convulsions)
• Reduced feeling in the skin
• Itchy skin
• Generally feeling unwell
• Swelling of the feet and legs
• Pounding heartbeat (palpitations) or change in rhythm e.g torsade de pointes or fast heartbeat (tachycardia)
• High blood pressure
• Low blood pressure. This may make you feel dizzy
• Changes in tests that show how well your heart is working (ECG)
• Muscle problems. These include changes that are shown in blood tests and painful, sore, weak or twitching muscles
• Shaking (tremors)
• Nerve damage that may cause changes in sensation or muscle weakness (neuropathy)
• Swelling, pain, and redness along a vein or where the injection needle is inserted
• Genital sores
• Changes in how well your liver is working (shown in blood tests).
• Low levels of platelets in your blood. This may make you bruise more easily
• Infection of the blood
• Kidney problems. This includes pain in your kidneys (you may feel this in your lower back) and kidney failure. There may be changes that are shown in blood or water (urine) tests
• Pain when you pass water (urine)
• Passing water (urine) more often than normal. Rarely you may also feel very thirsty or dehydrated
• Pain in your chest

Uncommon: (may affect up to 1 in 100 people)

• An itchy rash (urticaria)
• Too much acid in the blood. This may make you breathe more quickly
• Reduction of all blood cells (pancytopenia)

Not known: frequency cannot be estimated from the available data

• Unusual heartbeat
• An ulcer in your oesophagus (the passage where food travels from the throat to the stomach). This may be painful.
• Severe muscle problems with a breakdown of your muscle tissue (rhabdomyolysis). The signs include abnormal urine colour and severe muscle weakness, tenderness or stiffness.
• Blood in your water (urine)

If you get any side effects, talk to your doctor 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 foscarnet sodium hexahydrate.
• One ml of solution contains 24 mg foscarnet sodium hexahydrate. One 250 ml bottle contains 6000 mg foscarnet sodium hexahydrate.
• The other ingredients are hydrochloric acid, dilute for pH adjustment and water for injections.

Foscarnet is a clear, colourless solution for infusion in glass bottles. Each pack contains 1 bottle or 10 bottles of 250 ml.

Not all pack sizes may be marketed.