Rubexet Liposomal 20 mg/10 ml/50 mg/25 ml

RUBEXET LIPOSOMAL contains the active substance doxorubicin hydrochloride. It is used to treat different types of cancers, including breast, ovarian, skin cancer and cancer of the bone marrow.

RUBEXET LIPOSOMAL should not be administered :

• if you are hypersensitive (allergic) to doxorubicin, or any of the other ingredients of RUBEXET LIPOSOMAL (listed in section 6)
• if you are pregnant or breastfeeding
• if you have AIDS - related skin cancer for which other therapies are available.
• If you are younger than 18 years old.

Warnings and precautions

Special care should be taken with RUBEXET LIPOSOMAL :

• if you have heart problems
• if you are already experiencing bone marrow suppression due to other cancer treatments or your HIV status
• if you have had your spleen removed.

RUBEXET LIPOSOMAL can cause redness, swelling and blistering on the palms of the hands and soles of the feet. This is called hand - foot syndrome. Your doctor may prescribe Vitamin B6 and corticosteroids to prevent and treat this condition. Other techniques you can use to prevent and treat hand - foot syndrome are:

• Keeping the hands and feet cool by exposing them to cool water (soaks, bath or swimming)
• Avoiding very hot water
• Avoid wearing gloves, socks or shoes that are too tight.

Other medicines and RUBEXET LIPOSOMAL

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Tell your doctor if you are taking any other medicines to treat the cancer.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine.

RUBEXET LIPOSOMAL should not be used if you are pregnant or breastfeeding.

If you are a woman of childbearing potential, use effective contraception during your treatment (or your partner’s treatment) and for 6 months after.

Driving and using machines

RUBEXET LIPOSOMAL may make you feel dizzy or sleepy. If this happens do not drive or use machinery.

It is not always possible to predict to what extent RUBEXET LIPOSOMAL may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which RUBEXET LIPOSOMAL affects you.

RUBEXET LIPOSOMAL contains hydrogenated soy phosphatidylcholine. This is made from soyabean. If you are allergic to peanuts or soya you should not be given RUBEXET LIPOSOMAL.

RUBEXET LIPOSOMAL contains sucrose. If you are a diabetic patient, you may have to adjust your diabetic medication because of the sugar content in this medicine.

• You will not be expected to give yourself RUBEXET LIPOSOMAL. It will be given to you by a person qualified to do so.
• Your doctor will tell you how long your treatment with RUBEXET LIPOSOMAL will last. If you have the impression that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.
• RUBEXET LIPOSOMAL will be administered to you as an infusion into your vein. It may take from 30 to 90 minutes to administer.
• Your doctor will determine the appropriate dose of RUBEXET LIPOSOMAL to administer to you.

If you receive more RUBEXET LIPOSOMAL than you should

Since a healthcare professional will administer RUBEXET LIPOSOMAL, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you miss a dose of RUBEXET LIPOSOMAL

Since a healthcare provider will administer RUBEXET LIPOSOMAL, it is unlikely that a dose will be missed.

RUBEXET LIPOSOMAL can have side effects.

Not all side effects reported for RUBEXET LIPOSOMAL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving RUBEXET LIPOSOMAL, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, RUBEXET LIPOSOMAL should be stopped, tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing
• itching of the skin and rash
• sweating, fever, shivering, chills
• convulsions

These are all very serious side effects. If you have them, you may have had a serious reaction to RUBEXET LIPOSOMAL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Redness and swelling on hands and feet, which are tender and painful, blistering
• Redness, swelling, stinging or tenderness at the injection site.
• Unexplained bruising or abnormal bleeding which may indicate a blood abnormality
• Fever, chills, cough, shivering which may indicate an infection
• Change in heart rate, chest pain, shortness of breath, which may indicate a heart problem

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects

White patches on the inner cheeks, tongue, roof of the mouth, and throat

Painful blisters on your torso

Fever, mouth sores, fatigue, swollen lymph glands (may indicate changes in your blood cells)

Decreased appetite

Feeling confused, anxious, depressed and experiencing difficulty sleeping.

Tingling sensation in hands and feet, headache, change in taste

Feeling lethargic, dizzy, stiffness of arms and legs

Eye infections

Rapid heart rate

Low or high blood pressure, flushing

Cough, nose bleeds

Nausea, vomiting, diarrhoea, constipation, stomach pain or discomfort, dry mouth

Dry skin, itchy skin

Darkened patches on skin, excessive sweating

Muscle pain or spasms, joint or bone pain

Pain on urination

Fever, fatigue, weakness

Decreased weight

Less frequent side effects or frequency unknown

Cold sores

Feeling faint, sleepy

Blurred vision, increased tear production

Feeling faint when standing up suddenly

Asthma, tightness in throat

Flatulence, gum disease, ulcers on lips, inflammation of the tongue

Acne, skin rash, changes to your nails, like spots, discoloration, nail separation

Breast pain, itchy or burning vagina or scrotum

Radiation recall, where the skin may look like a severe sunburn and may blister, peel, and become red, swollen, and painful.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of RUBEXET LIPOSOMAL.

• Store all medicines out of reach of children.
• Store in a refrigerator (2 °C – 8 °C). Do not freeze.
• Store in the original package.