Package Insert: Information for the User

Gliolan 30 mg/ml powder for oral solution

5-aminolevulinic acid hydrochloride

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.

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

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 convert 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 at the same time to respect the healthy tissue.

Do not take Gliolan

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

• in case of acute or chronic porphyria, suspected or confirmed (hereditary or acquired disorders of certain enzymes in the heme synthesis pathway);

• in case of pregnancy, suspected or confirmed.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliolan.

• For 24 hours after administration of this medication, protect your eyes and skin from intense light(for example, surgical lighting, direct sunlight, or concentrated interior bright light).

• If you have or have had aheart disease, you must inform your doctor. In this case, this medication should be used with caution as it may cause a drop in blood pressure.

Renal or hepatic insufficiency

No studies have been conducted in patients with hepatic or renal insufficiency. Therefore, this medication should be used with caution in such patients.

Older patients

No special instructions are available for the use of this medication in older patients with normal organ function.

Children and adolescents (<18

No experience with Gliolan in children and adolescents. Therefore, this medication is not recommended in this age group.

Other medications and Gliolan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, especially those that may cause skin problems when the skin is exposed to intense light (for example, certain types of antibiotics), but also those obtained without a prescription (for example, St. John's Wort extracts or Hypericum perforatum).

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

Avoid using any other medication that may cause liver damage during the 24 hours following Gliolan administration.

Administration of Gliolan with food and beverages

This medication is usually used once, specifically 2-4 hours before anesthesia for surgery of certain brain tumors called gliomas. Do not eat or drink for at least 6 hours before the start of anesthesia.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

The influence of this medication itself on the ability to drive and use machines is nil.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effects include mild alterations 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). Side effects observed withgreater frequency are a feeling of discomfort (vomiting), a desire to vomit (nauseas) and a mild increase in some enzymes (transaminases, γ-GT, amylase) or bilirubin (a bile pigment produced in the liver by the destruction of the red pigment) in theblood.

Inform 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

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

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

Side effects that are infrequent (may affect up to 1 in 100 people):A feeling of discomfort (nauseas), decrease in blood pressure (hypotension), skin reactions (for example, exanthema, similar in appearance to a sunburn).

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

Side effects that are very frequent (may affect more than 1 in 10 people):Mild alterations in blood cell counts (red and white blood cells, platelets) and a 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 pigment of the blood) in the blood. These findings reach theirmaximum levels at 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.

Side effects that are frequent (may affect up to 1 in 10 people):

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

Side effects that are infrequent (may affect up to 1 in 100 people):

Decrease in blood pressure (hypotension), swelling of the brain (cerebral edema).

Side effects that are very rare (may affect up to 1 in 10,000 people) or unknown frequency (cannot be estimated from available data):

Decrease in sense of touch (hypoesthesia), and loose or watery stools

(diarrhea).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

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 through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Gliolan

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

One milliliter of the reconstituted solution contains 23.4 mg of 5-ALA, which corresponds to 30 mg of 5-ALA HCl.

Appearance of the product and contents of the container

This medication is an oral powder for solution. The powder is a compact mass of white to off-white color. The reconstituted solution is a clear, colorless to slightly yellowish liquid.

Gliolan is supplied in a glass vial and is presented in containers of 1, 2, and 10 vials. Only some container sizes may be commercially available.

Marketing Authorization Holder

photonamic GmbH & Co. KG

Eggerstedter Weg 12

25421 Pinneberg

Germany

Responsible Manufacturer

Lyocontract GmbH

Pulverwiese 1

38871 Ilsenburg

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Phone: +34 93 205 86 86

Last review date of this leaflet:

The detailed information about this medication 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.