GLIOLAN 30 mg/ml POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Gliolan 30 mg/ml Powder for Oral Solution

5-aminolevulinic acid hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Gliolan and what is it used for

Gliolan is used for the visualization of certain brain tumors (called malignant gliomas) during tumor surgery.

Gliolan contains a substance called 5-aminolevulinic acid (5-ALA). The uptake of 5-ALA is greater in tumor cells, which transform it into another similar substance. If the tumor is then exposed to blue light, this new substance emits a red-violet light that helps to better distinguish between normal tissue and tumor tissue. This helps the surgeon to remove the tumor and spare healthy tissue at the same time.

2. What you need to know before you take Gliolan

Do not take Gliolan

• if you are allergic to 5-ALA or porphyrins;

• in case of acute or chronic porphyria, suspected or confirmed (inherited or acquired disorders of certain enzymes of the red blood cell pigment synthesis pathway);

• in case of pregnancy, suspected or confirmed.

Warnings and precautions

Consult your doctor or pharmacist before taking Gliolan.

• For 24 hours after administration of this medicine, protect your eyes and skin from intense light(e.g. surgical lighting, direct sunlight, or bright indoor lighting).

• If you have or have had a heart conditionin the past, you should inform your doctor. In this case, this medicine should be used with caution because it may cause a drop in blood pressure.

Renal or hepatic impairment

No trials have been conducted in patients with hepatic or renal impairment. Consequently, this medicine should be used with caution in such patients.

Elderly patients

There are no special instructions for the use of this medicine in elderly patients with normal organic function.

Children and adolescents (<18 years)

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

Other medicines and Gliolan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those that can cause skin problems when exposed to intense light (e.g. certain types of antibiotics), but also those available without a prescription (e.g. St. John's Wort extracts or Hypericum perforatum).

A case of severe sunburn lasting 5 days has been reported in a patient after using this medicine and a St. John's Wort extract. You should not take any of these products during the 2 weeks following the use of Gliolan.

During the 24 hours following the intake of Gliolan, avoid the use of any other medicine that may cause liver damage.

Taking Gliolan with food and drinks

Generally, this medicine is used once, specifically 2-4 hours before anesthesia for the surgery of certain brain tumors called gliomas. You should not eat or drink for at least 6 hours before the start of anesthesia.

Pregnancy and breastfeeding

Pregnancy

It is not known whether Gliolan can cause harm to the embryo or fetus. Do not use this medicine if you are pregnant.

Breastfeeding

It is not known whether this medicine passes into breast milk. Mothers who are breastfeeding a baby should not do so during the 24 hours following treatment with this medicine.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

3. How to take Gliolan

This medicine is a powder that must be mixed first, before use, with drinking water. This procedure will always be performed by a pharmacist or a nursing professional and never by you. The usual dose is 20 mg of 5-ALA HCl per kilogram of body weight. The pharmacist or nursing professional will calculate the exact dose you need and the amount of solution (in ml) you need to drink. You will have to drink the prepared solution 2-4 hours before anesthesia.

If the surgery is postponed for more than 12 hours, it should be rescheduled for the next day or later. You can take another dose of this medicine 2-4 hours before anesthesia.

If you take more Gliolan than you should

If you have taken more Gliolan than you should, your doctor will decide what measures are necessary to avoid any problems, including sufficient protection from intense light (e.g. direct sunlight).

If you forget to take Gliolan

This medicine is administered once, on the day of surgery, 2-4 hours before the start of anesthesia. If you have forgotten to take this medicine during this time period, it is not recommended to take it just before the start of anesthesia. In this case, both anesthesia and surgery should be postponed for at least 2 hours, if possible.

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

4. Possible side effects

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

The most serious side effects include mild changes in blood cell counts (red and white blood cells, platelets), disorders affecting the nervous system (neurological disorders) such as partial paralysis affecting one side of the body (hemiparesis) and blood clots that can block blood vessels (thromboembolism). More frequently observed side effects are feeling unwell (vomiting), feeling sick (nausea), and a slight increase in some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by the destruction of the red blood cell pigment) in the blood.

Tell your doctor immediately if you experience any discomfort.

Side effects are divided into the following two categories:

• side effects immediately after taking Gliolan and before anesthesia

• combined side effects of Gliolan, anesthesia, and tumor resection.

After taking Gliolan and before the start of anesthesia, the following side effects may occur:

Uncommon side effects (may affect up to 1 in 100 people):Feeling unwell (nausea), low blood pressure (hypotension), skin reactions (e.g. rash, similar to sunburn).

In combination with anesthesia and tumor resection, other side effects may occur:

Very common side effects (may affect more than 1 in 10 people):Mild changes in blood cell counts (red and white blood cells, platelets) and slight increase in some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver as a result of the destruction of the red blood cell pigment) in the blood. These findings reach their maximum levels 7-14 days after surgery. The changes will resolve completely within a few weeks. You will usually not experience any symptoms when these changes occur.

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

Feeling unwell (nausea), being sick (vomiting), disorders affecting the nervous system (neurological disorders), such as partial paralysis of one side of the body (hemiparesia), loss of total or partial ability to use or understand language (aphasia), epileptic seizures (convulsions), and blindness of half of the visual field in one or both eyes (hemianopsia), and blood clots that can block blood vessels (thromboembolism).

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

Low blood pressure (hypotension), brain swelling (cerebral edema).

Rare side effects (may affect up to 1 in 10,000 people) or unknown frequency (cannot be estimated from the available data):

Decreased sense of touch (hypoesthesia), and loose or watery stools (diarrhea).

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 them directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliolan

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 after EXP. The expiry date is the last day of the month stated.

Store the vial in the outer packaging to protect it from light.

The reconstituted solution is physically and chemically stable for 24 hours at 25°C.

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. Contents of the pack and further information

Composition of Gliolan

The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl). One vial contains 1.17 g of 5-aminolevulinic acid (5-ALA), which corresponds to 1.5 g of 5-ALA HCl.

One ml of reconstituted solution contains 23.4 mg of 5-aminolevulinic acid (5-ALA), which corresponds to 30 mg of 5-ALA HCl.

Appearance of the product and pack contents

This medicine is a powder for oral solution. The powder is a compact white to off-white mass. The reconstituted solution is a clear liquid with a colorless to slightly yellowish appearance.

Gliolan is supplied in a glass vial and is available in packs of 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

Lyocontract GmbH

Pulverwiese 1

38871 Ilsenburg

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Laboratorios Gebro Pharma, S.A.

Tel: + 34 93 205 86 86

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.