MEDITOP

Read all of this leaflet carefully before you are given MEDITOP.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor, pharmacist or other health care provider.

SCHEDULING STATUS:

S4

MEDITOP 4 mg (Lyophilized powder for injection) Contains sugar:

Mannitol 48 mg per vial

Meditop

WHAT MEDITOP IS AND WHAT IT IS USED FOR:

MEDITOP belongs to a group of medicines called cytostatic agents (anti-cancer medicines).

MEDITOP may be used to treat ovarian cancer after failure or relapse of initial treatment with other anti-cancer medicines.

MEDITOP is used to treat small cell lung cancer that has come back after initial chemotherapy.

MEDITOP may be used in advanced cervical cancer if surgery and/or radiotherapy are not possible. When treating cervical cancer, MEDITOP is combined with another medicine called cisplatin.

WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MEDITOP You should not receive MEDITOP:

  1. If you know that you are allergic to any of the ingredients of the injection, if you have had any unusual or allergic reaction to topotecan or any of the ingredients of the injection. (See section 6)
  2. If you are pregnant or breast feeding or if you think you might be pregnant.
  3. If your blood cell counts are too low. Your doctor will tell you based on the results of the last blood test.

Warnings and precautions:

Before you are given this medicine your doctor needs to know:

If you are pregnant or plan to become pregnant – MEDITOP may harm a baby conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor or pharmacist for advice.

If you plan to father a child. (See section ‘PREGNANCY & BREAST-FEEDING)

If you have any kidney or liver problems. Your dose of MEDITOP may need to be adjusted.

Other Medicines and MEDITOP:

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription.
Remember to tell your doctor if you start to take any other medicines while you are on MEDITOP.

MEDITOP with food and drink:

There is no known interaction between MEDITOP and alcohol. However, you should check with your doctor whether drinking alcohol is advisable for you.

Pregnancy and breast feeding:

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.
MEDITOP should not be used in pregnant women. It may harm the baby if conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor or pharmacist for advice. Do not try and become pregnant/father a child until a doctor advises you that it is safe to do so.
Male patients who may wish to father a child, should ask their doctor for family planning advice or treatment. If pregnancy occurs during treatment, tell your doctor immediately.

Do not breast feed if you are being treated with MEDITOP. Do not restart breast-feeding until the doctor tells you it is safe to do so.

Driving and using machinery:

MEDITOP can make people feel tired.

If you feel weak or tired, do not drive and do not use machines.

It is not always possible to predict to what extent MEDITOP 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 MEDITOP affects you.

How MEDITOP is given:

A doctor or nurse will give you a suitable dose of MEDITOP as an infusion (a drip) into your vein. It will take approximately 30 minutes to administer.

  • For ovarian and small cell lung cancer, you will have treatment once a day for 5 days.
  • For cervical cancer, you will have treatment once a day for 3 days.

This pattern of treatments will normally be repeated every 3 weeks, for all cancers. The treatment may vary depending on the results of your regular blood tests.

Stopping treatment

Your doctor will decide when to stop the treatment.

POSSIBLE SIDE-EFFECTS

MEDITOP can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice immediately.

If you notice any of the following, MEDITOP should be stopped, tell your doctor immediately or go to the casualty department at your nearest hospital:

Allergic or hypersensitivity reactions (including rash and red welts), swelling under the skin.

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

If the following happens tell your doctor immediately or go to the casualty department at your nearest hospital.

  • Fever
  • Serious worsening of your general condition
  • Local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).

These may be signs of infection. MEDITOP may cause a decrease in the number of your white blood cells, which play an important role in fighting infections, this is called neutropenia. Your doctor will arrange for you to have regular blood tests to monitor these white blood cells.

If you experience any of the following conditions, please report it to a doctor or nurse immediately:

  • Occasionally severe stomach pain, fever, and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).
  • Feeling generally weak and tired (temporary anaemia). In some cases, you may need a blood transfusion.
  • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
  • Weight loss and loss of appetite (anorexia); tiredness; weakness; feeling unwell.
  • Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
  • Inflammation and ulcers of the mouth tongue and gums.
  • High fever

These are all very serious side effects. If you have them, you need to seek medical help immediately

Tell your doctor if you notice any of the following:

  • Frequent side effects:
  • Yellow skin
  •  Itching sensation
  • Hair loss
  • High body temperature
  • Weakness, fatigue and lack of energy

Less frequent side effects:

  • Scarring of the lung tissue which causes a dry cough and shortness of breath.
  • Damage or a hole in the stomach or intestine which results in sudden severe pain, swelling and bloating of the abdomen, fever, nausea and vomiting.

If you are being treated for cervical cancer you may get side effects from the other medicine (cisplatin) that you will be given along with MEDITOP. Those effects are described in the cisplatin patient information.

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

HOW TO STORE MEDITOP

Keep this medicine out of sight and reach of children.

Store MEDITOP (injection) at or below 25 °C. Do not use MEDITOP after the expiry date which is stated on the vial and on the box.

  • Keep the medicine in a tightly closed container.
  • Keep the vial in the outer carton to protect it from light.
  • Once the concentrate has been diluted for infusion the solution can be kept for 24 hours in a refrigerator (2 °C – 8 °C).
    Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains or sewerage systems (e.g. toilet)

CONTENTS OF THE PACK AND OTHER INFORMATION:

MEDITOP contains topotecan hydrochloride equivalent to 4 mg topotecan base.

The other ingredients include: tartaric acid, mannitol, hydrochloric acid and sodium hydroxide

CONTENTS OF THE PACK AND OTHER INFORMATION:

MEDITOP contains topotecan hydrochloride equivalent to 4 mg topotecan base.

The other ingredients include: tartaric acid, mannitol, hydrochloric acid and sodium hydroxide

HOLDER OF CERTIFICATE OF REGISTRATION:

Medivision (Pty) Ltd

100 Northern Parkway Rd Crownwood Office Ormonde

THIS LEAFLET WAS LAST REVISED IN:

27/07/2021

REGISTRATION NUMBER / APPLICATION NUMBER:

49/26/0800.

ACCESS TO THE CORRESPONDING PROFESSIONAL INFORMATION:

The access to the professional information is included in the carton of the medication. Alternatively, the above Holder of Certificate may be contacted for this information.

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