30 mg / ml powder for oral solution
5-aminolevulinic acid hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
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 packaging and other information

1. What Gliolan is and what it is used for

Gliolan is used to visualize certain brain tumors (called malignant gliomas ) during a brain operation.

Gliolan contains a substance called aminolevulinic acid (5 ‑ ALA). 5 ‑ ALA accumulates mainly in tumor cells where it is converted to another similar substance. If the tumor is then illuminated with blue light, this new substance emits a red-violet light, which makes it easier to see what is normal tissue and what is tumor tissue. This makes it easier for the surgeon to remove the tumor while sparing normal, healthy tissue.

2. What you need to know before you take Gliolan

Do not take Gliolan

  • if you are allergic to 5 ‑ ALA or porphyrins
  • if you have known or suspected acute or chronic types of porphyria (ie hereditary or acquired disorders of certain enzymes in the synthesis of red blood pigments).
  • in case of known or suspected pregnancy.

Warnings and cautions

Talk to your doctor or pharmacist before taking Gliolan.

  • For 24 hours after receiving this medicine , protect your eyes and skin from strong light (for example, direct sunlight or strong, focused indoor light).
  • If you have a heart condition or have had a heart condition in the past, tell your doctor. In this case, this medicine should be used with caution, as your blood pressure may drop.

Impaired kidney or liver function

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

On older

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

Children and adolescents (under 18 years)

There is no experience with Gliolan in children and adolescents. Therefore, this medicine is not recommended for 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 medicines that can cause skin problems if the skin is exposed to strong light (for example certain types of medicines called antibiotics ), but also over-the-counter medicines (for such as hypericin or St. John’s wort extract ).

A case of severe sunburn lasting 5 days has been reported in a patient after taking this medicine and a hypericin extract. You should not take any such products for up to 2 weeks after taking Gliolan.

Within 24 hours of taking Gliolan, avoid any other medicines that may harm your liver.

Gliola with food and drink

This drug is usually used at one time, namely 2‑4 hours before anesthesia for surgery of certain brain tumors called gliomas. You should not drink or eat for at least 6 hours before the anesthesia begins.

Pregnancy and breastfeeding

Pregnancy

It is not known if Gliolan harms unborn babies. Do not use this medicine if you are pregnant.

Breast-feeding

It is not known if this medicine passes into breast milk. Breast-feeding mothers should not breastfeed for 24 hours after treatment with this medicine.

Driving and using machines

This drug in itself has no effect on the ability to drive and use machines.

3. How to take Gliolan

This medicine is a powder, which must first be mixed with drinking water before use. This is always done by a pharmacy staff or a nurse and not by yourself. The usual dose is 20 mg 5 ‑ ALA HCl per kilogram body weight. The pharmacy staff or nurse will calculate the exact dose you need and the amount of solution (in milliliters) you need to drink. You must drink the reconstituted solution 2-4 hours before anesthesia.

If the operation is postponed by more than 12 hours, the operation must be rebooked until the next day or later. An additional dose of this medicine can be taken 2-4 hours before anesthesia.

If you take more Gliolan than you should

If you take more Gliolan than you should, your doctor will decide on the necessary measures to avoid any problems, including adequate protection against strong light (for example, direct sunlight).

If you forget to take Gliolan

This medicine is given only once on the day of surgery, 2 – 4 hours before the start of anesthesia. If you forget to take this medicine during this time, you should not take it just before anesthesia starts. In that case, anesthesia and surgery must, if possible, be postponed for at least 2 hours.

If you have any further questions on the use of this product, 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 slight changes in the number of blood cells (red and white blood cells, platelets ), disorders that affect the nervous system (neurological disorders), such as partial paralysis of one side of the body (hemiparesis) and blood clots that can block blood vessels ( thromboembolism ). Other side effects that have been frequently observed are vomiting, nausea, and a slight increase in the blood of certain enzymes ( transaminases, γ ‑ GT, amylase) or bilirubin (a bile pigment formed in the liver by the breakdown of red blood pigments).

Tell your doctor immediately if you have any problems.

The side effects are divided into the following two categories:

  • side effects that occur immediately after you take Gliolan and before anesthesia
  • side effects are a combination of Gliolan, anesthesia and tumor removal .

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

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

Nausea decreased blood pressure ( hypotension ), skin reactions (for example, a rash that looks like a tan).

In combination with anesthesia and tumor removal, additional side effects may occur:

Very common side effect ar ( ka n affect more than 1 of 10 users ):

Mild changes in the number of blood cells (red and white blood cells, platelets) and a slight increase in certain enzymes ( transaminases, γ ‑ GT, amylase) or bilirubin (a bile pigment formed in the liver by the breakdown of red blood pigments) in the blood. These changes reach a maximum between 7 and 14 days after surgery. The changes will disappear completely within a few weeks. You usually do not get any symptoms when these changes occur.

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

Nausea, vomiting, disorders affecting the nervous system (neurological disorders), such as partial paralysis of one side of the body (hemiparesis), total or partial loss of ability to use or understand the language ( aphasia ), seizures (seizures), and blindness in half the field of vision in one or both eyes (hemianopsis) and blood clots that can clog blood vessels ( thromboembolism ).

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

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

Very rare  side effects are can ekomma affect up to 1 in 10 000 users ) or his reported (affecting an unknown number of users) :

Impaired sensation ( hypesthesia ) and loose or watery stools (diarrhea).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Store the bottle in the outer carton. Sensitive to light.

The reconstituted solution is physicochemically 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. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is 5-aminolevulinic acid hydrochloride

(5 ‑ ALA HCl). One bottle contains 1.17 g

5 ‑ aminolevulinic acid (5 ‑ ALA), corresponding to 1.5 g of 5 ‑ ALA HCl.

One ml reconstituted solution contains 23.4 mg 5 ‑ ALA, equivalent to 30 mg 5 ‑ ALA HCl).

What the medicine 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 colorless to slightly yellowish liquid.

Gliolan is marketed in glass bottles in packages of 1, 2 and 10 bottles. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

medac

Society for clinical

Special preparations mbH

Theaterstr. 6

22880 Wedel

Germany

Tel. +49 4103 8006‑0

Fax: +49 4103 8006‑100

Muhammad Nadeem

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