FOSCARNET TILLOMED 24 mg/ml SOLUTION FOR INFUSION

2. What you need to know before you use Foscarnet Tillomed

Do not useFoscarnet Tillomed:

• If you are allergic 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.

Warnings and precautions

Talk to your doctor or nurse before you start using Foscarnet Tillomed if:

• You have kidney problems.
• You have heart problems.

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

Children and adolescents

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

Other medicines and Foscarnet Tillomed

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.

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

• Pentamidine (for infections).
• Amphotericin B (for fungal infections).
• Acyclovir (for viral infections).
• Antibiotics called aminoglycosides, such as gentamicin or streptomycin (for infections).
• Cyclosporin A, methotrexate, or tacrolimus (used to suppress the immune system).
• Protease inhibitors, such as ritonavir and saquinavir.
• Laxatives.
• Quinidine, amiodarone, sotalol, or other medicines that can affect your heart rate and rhythm.
• Tranquilizers (neuroleptics).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

This medicine is not recommended during pregnancy.

You should not try to become pregnant during treatment with this medicine and for up to 6 months after treatment. You should use effective contraception during or up to 6 months after treatment.

Men who are being treated with this medicine should not father a child during or up to 6 months after treatment.

Do not use this medicine if you are breastfeeding.

Driving and using machines

Foscarnet may affect your ability to drive or use machines. Talk to your doctor before doing so.

Tests before and during your treatment with Foscarnet Tillomed

Your doctor may do blood and urine tests before and during your treatment with Foscarnet Tillomed. This is to check how well your kidneys are working and the level of minerals in your blood.

Foscarnet Tillomed contains sodium

This medicine contains 1.375 mg of sodium (the main component of cooking/table salt) in each 250 ml vial. This is equivalent to 69% of the maximum recommended daily intake of sodium for an adult.

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

3. How to use Foscarnet Tillomed

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again.

• This medicine will be given to you by a doctor or nurse. It will be given as an intravenous infusion. It may be given through a central line in your chest if you already have one in place.
• Each infusion will last at least 1 hour. Do not interfere with the infusion during administration.
• The amount of foscarnet you are given will depend on how well your kidneys are working and your weight.
• It is important to receive enough fluid with the infusion. This will help prevent kidney problems. If you need fluid, your doctor or nurse will provide it to you at the same time as foscarnet.

Use of Foscarnet Tillomed for CMV infection

If you are being treated with this medicine for CMV retinitis, treatment will be done in two stages. The first stage is called induction treatment and the second stage is called maintenance treatment.

Induction treatment

• During induction, you will be given infusions every 8 hours, usually for 2 or 3 weeks.
• The usual dose for induction treatment is 60 mg of Foscarnet per kilogram of body weight (60 mg/kg) three times a day (every 8 hours) or 90 mg/kg of body weight, twice a day (every 12 hours).
• Your doctor will tell you when it is time to switch to maintenance treatment.

Maintenance treatment

• During maintenance treatment, you will be given one infusion per day.
• The usual dose for maintenance treatment is 60 to 120 mg of Foscarnet per kilogram of body weight (60-120 mg/kg).

Your doctor will tell you if you need to take more or less of this medicine and how often you should take it. This is to make sure you get the right dose for you.

Your doctor may also prescribe a medicine called ganciclovir to make sure you get the right treatment.

Use of Foscarnet Tillomed for Herpes Simplex Virus

• If you are being treated with this medicine for a Herpes Simplex Virus infection, treatment will be done in one stage.
• You will be given one infusion every 8 hours.
• Your sores (lesions) may start to heal after about 1 week. However, you may need to continue treatment with this medicine for 2 or 3 weeks, or until your sores have healed.
• The usual dose is 40 mg of Foscarnet per kilogram of body weight (40 mg/kg).

Personal hygiene

Wash your genitals carefully after urinating. This will help prevent the development of sores.

If Foscarnet Tillomed solution comes into contact with skin or eyes

If the solution accidentally comes into contact with skin or eyes, wash the affected area immediately with water.

Use in children and adolescents:

The safety and efficacy of this medicine in children and adolescents under 18 years have not been established.

If you use more Foscarnet Tillomed than you should

If you think you have been given too much Foscarnet, tell your doctor immediately.

If you miss a dose of Foscarnet Tillomed

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

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

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

If you experience any of the above side effects, tell your doctor immediately or go to the nearest emergency department.

Other side effects include:

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

• Loss of appetite.
• Diarrhea.
• Feeling sick.
• Feeling weak or tired.
• High temperature or chills.
• Feeling dizzy.
• Headache.
• Numbness
• Skin rash.
• Changes in how well your kidneys are working (shown by blood tests).
• Low levels of white blood cells. Signs include infections and high temperature (fever).
• Changes in the level of red blood cells (shown by blood tests). This can make you feel tired or look pale.
• An imbalance in the levels of salts and minerals in your blood, including weakness, cramps, thirst, numbness or tingling of the skin, and muscle spasms.

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

• Stomach pain (abdomen), constipation, indigestion, or gastrointestinal bleeding.
• Pancreatitis (inflammation of the pancreas) or changes in how well the pancreas is working. Signs include severe stomach pain and changes shown by blood tests.
• Feeling anxious, nervous, depressed, agitated, aggressive, or confused.
• Coordination problems.
• Seizures (fits).
• Loss of feeling in the skin.
• Itching of the skin.
• General feeling of being unwell.
• Swelling of feet and legs.
• Strong heartbeat (palpitations) or change in rhythm, e.g. torsade de pointes or tachycardia.
• High blood pressure.
• Low blood pressure. This can make you feel dizzy.
• Changes in tests that show how well your heart is working (ECG).
• Muscle problems, including changes shown by blood tests and painful, weak, or trembling muscles.
• Shakiness (tremors).
• Nerve damage that can cause changes in sensation or muscle weakness (neuropathy).
• Swelling, pain, and redness along a vein or where the injection needle is inserted.
• Genital ulcers.
• Changes in how well your liver is working (shown by blood tests).
• Low levels of platelets in the blood, which can cause bruising more easily.
• Blood infection.
• Kidney problems, including pain in the kidneys (you may feel pain in the lower back) and kidney failure. Changes may be shown by blood or urine tests.
• Need to urinate more often than usual. Rarely, you may also feel very thirsty or dehydrated.
• Chest pain.

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

• Itchy rash (urticaria).
• Too much acid in the blood. This can make you breathe more quickly.
• Reduced levels of all blood cells (pancytopenia)

Frequency not known: cannot be estimated from the available data

• Unusual heartbeats.
• An ulcer in the esophagus (the tube that food travels through from the throat to the stomach), which can be painful.
• Severe muscle problems with muscle tissue breakdown (rhabdomyolysis). Symptoms include unusual urine color and severe muscle weakness, tenderness, or stiffness.
• Blood in the urine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Foscarnet Tillomed

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date is the last day of the month stated.
• Do not refrigerate or freeze.
• This medicine must not be stored below 8°C, as precipitation may occur at lower temperatures. The precipitation remains even if the infusion solution is frozen and thawed again.
• This medicine may be used again if it has been stored accidentally in the refrigerator or if the infusion solution has been exposed to temperatures below freezing. The vial should be shaken vigorously several times and kept at room temperature for 4 hours until all the precipitate has completely dissolved.

After opening:

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

After dilution:

Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8°C and 20-25°C, when the solution is diluted from 24 mg/ml to 12 mg/ml of foscarnet sodium hexahydrate in PVC bags. From a microbiological point of view, the product should be used immediately. If not used immediately, storage conditions and times before use are the responsibility of the user and should not exceed 24 hours when stored between 2 and 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

• Do not use this medicine if you notice any damage to the vial, discoloration, or other signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Composition ofFoscarnet Tillomed

• The active ingredient is foscarnet sodium hexahydrate.
• 1 ml of infusion solution contains 24 mg of foscarnet sodium hexahydrate. Each 250 ml vial contains 6,000 mg of foscarnet sodium hexahydrate.
• The other components are: hydrochloric acid, diluted to adjust the pH and water for injectable preparations.

Appearance of the product and container contents

Foscarnet Tillomed is a clear and colorless infusion solution in glass vials. Each pack contains 1 vial or 10 vials of 250 ml.

Only some pack sizes may be marketed.

Marketing authorization holder

Laboratorios Tillomed Spain, S.L.U.

C/ Cardenal Marcelo Spínola 8

28016 Madrid, Spain

Manufacturer[1]

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road Portmarnock,

Co. Dublin

Ireland

Siegfried Hameln GmbH

Langes Feld 13

31789 Hameln

Germany

SGS Pharma Magyarorszag Kft.

Derkovits Gyula Utca 53,

Budapest XIX,1193,

Hungary

Tillomed Malta Limited

Malta Life Science Park

LS2.01.06 Industrial Estate

San Gwann, SGN 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria : Foscarnet Tillomed 24 mg / ml Infusionslösung

Czech Republic : Foscarnet Tillomed

Denmark : Foscarnet “Tillomed”

Estonia : Foscarnet sodium Tillomed

Finland : Foscarnet Tillomed 24 mg/ml infuusioneste, liuos

France : Foscarnet Tillomed 24 mg/ml solution pour perfusion

Germany : Foscarnet Tillomed 24 mg / ml Infusionslösung

Greece : Foscarnet Tillomed 24 mg / ml δι?λυμα για ?γχυση

Ireland : Foscarnet sodium hexahydrate Tillomed 24 mg/ml solution for infusion

Italy : Foscarnet Tillomed

Latvia : Foscarnet sodium Tillomed

Lithuania : “Foscarnet Tillomed” 24 mg / ml infuzinis tirpalas

Netherlands : Foscarnet Tillomed 24 mg / ml oplossing voor infusie

Norway : Foskarnetnatriumheksahydrat Tillomed

Poland : Foscarnet sodium hexahydrate Tillomed

Portugal : Foscarnet Tillomed 24 mg / ml solução para perfusão

Slovakia : Foscarnet Tillomed 24 mg / ml infúzny roztok

Spain : Foscarnet Tillomed 24 mg/ml solución para perfusión EFG

Sweden : Foscarnet Tillomed 24 mg/ml infusionsvätska, lösning

Date of last revision of this leaflet 05/2022

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This information is intended only for healthcare professionals:

Instructions for use and handling

When perfused in peripheral veins, the solution must be diluted from 24 mg/ml to 12 mg/ml of foscarnet sodium hexahydrate before use. Individual doses of this medicinal product must be transferred aseptically to plastic infusion bags (PVC bags) and diluted with equal parts of sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution.

Storage and validity period of the medicinal product and the diluted solution: see section 5.

Each vial of this medicinal product should only be used to treat a single patient with a single infusion.

Accidental contact with the skin or eyes of the foscarnet sodium hexahydrate solution may cause local irritation and a burning sensation. In case of accidental contact, the affected area should be washed with water.

[1]

1Only the actual manufacturer is indicated in the printed leaflet