Gliolan 30 mg/ml powder for oral solution

Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.

Gliolan contains a substance called aminolevulinic acid hydrochloride (5-ALA). 5-ALA is taken up more by tumour cells where it is transformed into another similar substance. If then the tumour is put under blue light exposure this new substance emits a red-violet light which helps to see better what normal tissue is and what tumour tissue is. This helps the surgeon to remove the tumour more completely while sparing healthy tissue.

Do not take Gliolan

• If you are allergic (hypersensitive) to 5-aminolevulinic acid hydrochloride or porphyrins.
• In case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment).
• In case of known or suspected pregnancy.

Take special care with Gliolan

After administration of this medicine, avoid that your eyes and skin are under strong light (for example operating illumination, direct sunlight or brightly focused indoor light) for 24 hours.

If you have a heart disease or had heart disease in the past, you should tell your doctor. In this case, this medicine should be used with caution because the blood pressure may be decreased.

Patients with renal or hepatic impairment

No studies have been performed in patients with poor liver or kidney function. Therefore, this medicine should be used with caution in such patients.

Children and adolescents (< 18 years)

There is no experience with Gliolan in children. Therefore this medicine is not recommended in this age group.

Elderly patients
There are no special instructions for use in elderly patients with normal organ function.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John?s wort extracts). One case of severe sunburn lasting for 5 days has been reported in a patient after having taken this medicine and a hypericin extract. You should not take any such products up to 2 weeks after you have taken Gliolan.
Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.

Taking Gliolan with food and drink

This medicine is generally used once only, namely 2-4 hours before anaesthesia for surgery for certain brain tumours called glioma. You should not drink or eat for at least 6 hours before starting anaesthesia.

Pregnancy and breast-feeding

Use in pregnancy

It is not known whether Gliolan will harm an unborn baby. Do not use this medicine if you are pregnant.

Use in lactation
It is not known whether this medicine enters breast milk. Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.

Driving and using machines
This medicine itself has no influence on the ability to drive and use machines.

This medicine is a powder that must be first mixed with drinking water before use. This is always done by a pharmacist or a nurse and not by yourself. The usual dose is 20 mg per kilogram body weight. The pharmacist or nurse will calculate the exact dose you need. You have to drink the prepared solution 2-4 hours before start of anesthesia.

If the anesthesia/surgery is delayed by some hours, additional doses of this medicine must not be given. If the surgery is delayed by one or more days, another dose of this medicine can be taken 2-4 hours before start of anesthesia.

If you take more Gliolan than you should

If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).

If you forget to take Gliolan
This medicine is given once only at the day of surgery, 2-4 hours before start of anesthesia. If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anesthesia. In this case, anesthesia and surgery must be postponed for at least 2 hours, if possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

After having taken Gliolan and before start of anaesthesia, the following side effects may occur:

Uncommon side effects (likely to occur in more than 1 of 1,000 patients but less than 1 of 100 patients):

Nausea (unsettled stomach), decrease of blood pressure, skin reactions (for example rash, looking like sunburn).

In combination with anaesthesia and tumour resection further side effects may occur:

Very common side effects (likely to occur in more than 1 of 10 patients):

Mild alterations of blood cell counts (red and white cells, platelets), slight increase of some enzymes (transaminases, ?-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood. These changes peak between 7 and 14 days after surgery. The changes will completely resolve within a few weeks. Usually you will not experience any symptoms when these changes occur.

Common side effects (likely to occur in more than 1 of 100 patients but less than 1 of 10 patients):

Nausea (unsettled stomach), vomiting (sickness), neurological disorders (disorders that affect the nervous system like hemiparesis (partial paralysis of one side of the body), aphasia (total or partial loss of ability to use or understand language), convulsions (seizures) and hemianopsia ( blindness for half the field of vision in one or both eyes), thromboembolism (blood clots that may obstruct blood vessels).

Uncommon side effects (likely to occur in more than 1 of 1,000 patients but less than 1 of 100 patients):

Decrease of blood pressure.

Very rare side effects (likely to occur in less than 1 of 10,000 patients), including isolated reports:

Hypesthesia (i.e. decrease of your sense of touch); diarrhoea (loose or watery stools).

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Keep the vial in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Gliolan contains

The active substance is 5-aminolevulinic acid hydrochloride. One vial contains 1.17 g of 5-aminolevulinic acid, corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid, corresponding to 30 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).

What Gliolan looks like and contents of the pack

This medicine is a powder for oral solution. The powder is a white to off-white cake. The reconstituted solution is a clear and colourless to slightly yellowish fluid.
Gliolan is presented in packs of 1, 2 and 10 vials. Not all pack size may be marketed.

Marketing Authorisation Holder

m e d a c
Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstraße 3
D-20354 Hamburg, Germany
Tel. + 49 4103 8006 0
Fax: + 49 4103 8006 100

Manufacturer

m e d a c
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstraße 6
D-22880 Wedel, Germany
Tel. + 49 4103 8006 0
Fax: + 49 4103 8006 100

This leaflet was last approved in.