Gliolan

Package leaflet: Information for the user

Gliolan 30 mg/ml powder for oral solution

5-aminolevulinic acid hydrochloride
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Gliolan is and what it is used for

Gliolan is used to visualise certain types of brain tumours called malignant gliomas during surgical removal of the tumour.
Gliolan contains a substance called aminolevulinic acid (5-ALA). 5-ALA accumulates preferentially in tumour cells, where it is converted into another similar substance. If the tumour is subsequently exposed to blue light, this new substance emits a red-violet fluorescence that helps to better distinguish between normal and tumour tissue. This assists the surgeon in removing the tumour while preserving healthy tissue.

2. What you should know before taking Gliolan

Do not take Gliolan

• if you are allergic to 5-ALA or porphyrins.
• if you have confirmed or suspected acute or chronic porphyria (inherited or acquired disorders of certain enzymes in the haem biosynthesis pathway).
• if you are pregnant or suspect you might be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliolan.

• For 24 hours after administration of the medicine, protect your eyes and skin from intense light (for example, direct sunlight or indoor lighting with focused light).
• If you have or have had heart disease, inform your doctor. In such cases, the medicine should be used with caution due to the possible reduction in blood pressure.

Renal or hepatic impairment
No studies have been conducted in patients with impaired liver or kidney function; therefore, the medicine should be used with caution in these patients.
Elderly
There are no special instructions for use in elderly patients with normal organ function.
Children and adolescents (< 18 years)
There is no experience with Gliolan in children and adolescents; therefore, the medicine is not recommended in this age group.
Other medicines and Gliolan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those that may cause skin problems when the skin is exposed to intense light (for example, certain types of antibiotics), as well as over-the-counter medicines (for example, hypericin or St. John’s wort extracts).
One case of severe prolonged sunburn lasting for 5 days has been reported in a patient who took this medicine together with a hypericin extract. Such products must not be taken for 2 weeks after taking Gliolan.
Avoid other medicines that may be potentially harmful to the liver during the 24 hours following Gliolan administration.
Gliolan with food and drink
This medicine is usually administered only once, specifically 2 to 4 hours before anaesthesia for surgical procedures on certain types of brain tumour called gliomas. For at least 6 hours before anaesthesia, you must not eat or drink anything.
Pregnancy and breastfeeding
Pregnancy
It is not known whether Gliolan is harmful to the foetus. Do not take this medicine if you are pregnant.
Breastfeeding
It is not known whether this medicine is excreted in breast milk. Women must not breastfeed for 24 hours after treatment with the medicine.
Driving and using machines
This medicine itself does not impair the ability to drive or operate machinery.

3. How to take Gliolan

This medicine is a powder which must be mixed with drinking water before use.
This must be done by the pharmacist or nurse and not by you personally. The usual dose is 20 mg
of 5-ALA HCl per kilogram of body weight. The pharmacist or nurse will calculate the exact dose you require and the quantity of solution (in ml) that you must drink. You must drink the prepared solution
between 2 and 4 hours before anaesthesia.
If the surgical procedure is postponed by more than 12 hours, it must be rescheduled for the next day or later. Another dose of this medicine may be administered 2–4 hours before anaesthesia.
If you take more Gliolan than you should
If you have taken more Gliolan than you should, your doctor will take the necessary measures to prevent any problems, including providing adequate protection from intense light (e.g. direct sunlight).
If you forget to take Gliolan
This medicine is administered only once on the day of the surgical procedure, between 2 and 4 hours
before the start of anaesthesia. If you have forgotten to take the medicine within this time frame, do not take it immediately before the start of anaesthesia. In this case, if possible, both anaesthesia and surgery should be delayed by at least 2 hours.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most serious adverse reactions include mild changes in blood cell counts (red blood cells, white blood cells, platelets), disorders affecting the nervous system (neurological disorders) such as partial paralysis on one side of the body (hemiparesis), and blood clots that may block blood vessels (thromboembolism). Other frequently observed adverse reactions are vomiting, nausea, and mild increases in certain enzymes (transaminases, γ-GT, amylase) or in bilirubin (a bile pigment produced in the liver from the breakdown of the red pigment of blood) in the blood.
If you experience any adverse reaction, consult your doctor immediately.
Adverse reactions are divided into the following two categories:

• Adverse reactions occurring immediately after taking Gliolan and before the start of anaesthesia
• Adverse reactions associated with Gliolan, anaesthesia, and tumour resection

After taking Gliolan and before the start of anaesthesia, the following adverse reactions may occur:
Uncommon adverse reactions (may affect up to 1 in 100 people):
nausea, reduction in blood pressure (hypotension), skin reactions (e.g. rash, similar to sunburn).

In association with anaesthesia and tumour resection, the following additional adverse reactions may occur:
Very common adverse reactions (may affect more than 1 in 10 people):
mild changes in blood cell counts (red blood cells, white blood cells, platelets), and mild increase in certain enzymes (transaminases, γ-GT, amylase) or in bilirubin (a bile pigment produced in the liver from the breakdown of the red pigment of blood) in the blood.
These changes usually peak between 7 and 14 days after surgery. They will completely resolve within a few weeks. Usually, no symptoms are experienced when these changes occur.
Common adverse reactions (may affect up to 1 in 10 people):
nausea, vomiting, disorders affecting the nervous system (neurological disorders) such as partial paralysis on one side of the body (hemiparesis), total or partial loss of ability to use or understand language (aphasia), epileptic syndromes (seizures), and blindness in half of the visual field in one or both eyes (hemianopsia), and blood clots that may block blood vessels (thromboembolism).
Uncommon adverse reactions (may affect up to 1 in 100 people):
reduction in blood pressure (hypotension), brain swelling (cerebral oedema).
Very rare adverse reactions (may affect up to 1 in 10,000 people) or frequency not known (frequency cannot be estimated from the available data):
decreased sense of touch (hypoesthesia) and loose or watery stools (diarrhoea).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system detailed in Annex V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Gliolan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Keep the vial in the outer packaging to protect the medicine from light.
The reconstituted solution is physically and chemically stable for 24 hours at 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Gliolan and contents of the pack
This medicinal product is a powder for oral solution. The powder is a white or almost white paste. The
reconstituted solution is a clear, colourless or slightly yellowish liquid.
Gliolan is supplied in a glass vial and is available in packs containing 1, 2 and 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder
photonamic GmbH & Co. KG
Eggerstedter Weg 12
25421 Pinneberg
Germany

Manufacturer
photonamic GmbH & Co. KG
Eggerstedter Weg 12
25421 Pinneberg
Germany
Lyocontract GmbH
Pulverwiese 1
38871 Ilsenburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, Nederland Italia
Pharmanovia Benelux B.V. medac pharma s.r.l. a socio unico
Burgemeester Guljélaan 2 Via Viggiano 90
NL-4837 CZ Breda I-00178 Roma
Netherlands/Belgium/Netherlands Tel: + 39 06 51 59 121
Tel/Tél: + 31 (0)76 5600030 [email protected]
[email protected]

България, Deutschland, Eesti, Ελλάδα, Norge
Hrvatska, Ísland, Κύπρος, Latvija, Lietuva, medac Gesellschaft für klinische
Luxembourg/Luxemburg, Magyarország, Spezialpräparate G.m.b.H, Tyskland, filial
Malta, Österreich, România, Slovenija/ Postboks 84
United Kingdom (Northern Ireland) N-1312 Slependen
medac GmbH Tlf: +47 90 63 81 04
Theaterstraße 6
D-22880 Wedel Polska
Germany medac GmbH Sp. z o.o.
Tel./Tel/Sími/Τηλ/Tél: + 49 (0)4103 8006-0 Oddział w Polsce
[email protected] ul Postępu 21 B
PL-02-676 Warszawa
Tel.: + 48 22 430 00 30
[email protected]

Česká republika Portugal
medac GmbH organizační složka medac GmbH
Želetavská 1525/1 sucursal em Portugal
CZ 140 00 Praha 4 Alameda António Sérgio nº22 6ºC
Tel: +420 774 486 166 P-1495-132 Algés
[email protected] Tel: + 351 21 410 75 83/4
[email protected]

Danmark Slovenská republika
medac Gesellschaft für klinische medac GmbH
Spezialpräparate G.m.b.H, Tyskland, filial organizačná zložka Slovensko
Bagerstræde 28, 1. Staromestská 3
DK-4640 Faxe SK-811 03 Bratislava
Tlf.: +46 (0)44 7850 666 Tel: +420 774 486 166
[email protected]

España Suomi/Finland
Laboratorios Gebro Pharma, S.A. medac Gesellschaft für klinische
Tel: + 34 93 205 86 86 Spezialpräparate G.m.b.H, Tyskland, filial
Spektri Business Park
Metsänneidonkuja 4
FIN-02130 Espoo
Puh/Tel: + 358 (0)10 420 4000

France Sverige
medac SAS medac Gesellschaft für klinische
1 rue Croix Barret Spezialpräparate G.m.b.H, Tyskland, filial
F-69007 Lyon Hyllie Boulevard 34
Tél: + 33 (0)4 37 66 14 70 S-215 32 Malmö
[email protected] Tel: +46 (0)44 7850 666

Ireland
Fannin Ltd
Fannin House
South County Business Park
Leopardstown
IRL - Dublin 18
Tel: + 353 (0)1 290 7000
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.