Label: information for the patient

HEXVIX 85 mg powder and solvent for intravesical solution

Hexaminolevulinate

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1.What is Hexvix and how it is used

2.What you need to know before Hexvix is administered

3.How to use Hexvix

4.Possible adverse effects

5.Storage of Hexvix

6.Contents of the package and additional information.

This medication is for diagnostic use only.

This medication is used to help detect bladder cancer. It is administered before your doctor uses a special device called a "cystoscope" that allows them to visualize the inside of your bladder. A cystoscope helps visualize possible tumors and therefore, to eliminate abnormal cells that illuminate in blue light after the administration of Hexvix.

You should not use Hexvix:

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Hexvix, including the liquid used to dissolve it (see Section 6 Additional information).
• If you have porphyria (a rare and hereditary blood disease)

Warnings and precautions:

Consult your doctor or nurse before starting to use Hexvix.

• If you have a urinary tract infection or if you feel burning or stinging when urinating.
• If you have recently undergone BCG therapy in the bladder.
• If you have recently had a bladder operation.

These circumstances may cause local reactions in your bladder, which may make it difficult for your doctor to interpret what they observe during the examination.

Other medicines and Hexvix:

Inform your doctor if you are taking or have recently taken other medicines, including those obtained without a prescription.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine.

Driving and operating machines

Consult your doctor about driving and operating machines after receiving Hexvix.

Hexvix must be prepared and administered by qualified personnel. Hexvix is usually administered in a hospital or clinic.

Your doctor will administer it as follows:

1. A small tube called a catheter will be inserted into your bladder.
2. Your bladder will be emptied through this tube.
3. Hexvix will be introduced into your bladder through this tube.
4. Hexvix will be left inside your bladder for 60 minutes.
5. Once this time has passed, your bladder will be emptied with the catheter.
6. Your doctor will use a device called a cystoscope to examine your bladder.

If You Use More Hexvix Than You Should

No adverse effects are expected in the event of an increase in the time Hexvix remains in the bladder beyond 60 minutes or an increase in the amount of Hexvix used. If you are concerned about this, consult your doctor or nurse.

Like all medicines, Hexvix may cause side effects, although not everyone will experience them. There is a risk of possible side effects related to the technique (cystoscopy) used to explore your bladder. Generally, the use of Hexvix as an additional method to standard cystoscopy for a more precise diagnosis of bladder cancer is well tolerated. If side effects occur, they will be typical of the examination technique, and are usually not severe or prolonged. The following side effects may appear after the exploration process using this medication:

Frequent(may affect up to 1 in 10 people):

• Nausea, vomiting.
• Diarrhea.
• Constipation.
• Muscle cramp or pain in and around the stomach (abdomen).
• Pain or difficulty urinating.
• Inability to empty the bladder (urinary retention).
• Blood in the urine.
• Pain after the procedure.
• Fever (elevated temperature)

Rare(may affect up to 1 in 100 people):

• Headache
• Burning sensation while urinating (caused by infection or inflammation in your bladder).
• Frequent need to urinate.
• Sepsis (blood poisoning).
• Inability to sleep or difficulty falling asleep.
• Pain in the urethra, through which urine passes.
• Continuous urge to urinate (with urgency).
• Increased white blood cell count, increased bilirubin concentrations (a yellow pigment of bile) or liver enzyme concentrations, which should be observed in blood test results.
• Decreased red blood cell count (anemia).
• Inflammation of the glans penis (balanitis).
• Back pain.
• Gout.
• Rash (exanthema, skin eruption).
• Itching (pruritus).

Unknown frequency(cannot be estimated from available data):

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use.www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication once the expiration date printed on the outer packaging has passed. The expiration date refers to the last day of the month.

Powder and solvent: the product does not require special conditions for conservation.

Solution (after preparation): store between 2 °C and 8 °C (in refrigerator) for a maximum period of 2 hours.

The hospital staff must ensure that the product is stored and disposed of properly and that it is not used after the expiration date printed on the outer packaging.

Composition of Hexvix

?The active ingredient is hexaminolevulinate in the form of a hydrochloride.

?The remaining ingredients are sodium phosphate, dihydrogen potassium phosphate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package

• Each package contains a vial of powder, white to light beige or pale yellow in color, containing 85 mg of the active ingredient hexaminolevulinate (as hydrochloride), and a preloaded syringe, containing 50 ml of a transparent and colorless liquid to dissolve the powder.
• The Hexvix powder is dissolved in 50 ml of the solution provided in the package. Once the powder is mixed with the solvent, a solution containing 1.7 mg/ml of hexaminolevulinate is obtained, corresponding to 8 mmol/l of hexaminolevulinate solution.

Holder of the marketing authorization and responsible for manufacturing:

Photocure ASA

Hoffsveien, 4

NO-0275 Oslo,

Norway

For more information about this medication, please contact the holder of the marketing authorization.

This medication has been authorized under the commercial name Hexvix in the following member states of the European Economic Area and in the United Kingdom (Northern Ireland):Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, and United Kingdom (Northern Ireland).

Last review date of this leaflet:January 2022

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

This information is intended only for medical professionals or healthcare professionals:

Instructions for handling

Hexaminolevulinate may cause sensitization through contact with the skin.

All steps must be performed with sterile material and in aseptic conditions.

Reconstitution procedure: Hexvix powder and solvent for Hexvix in preloaded syringe

Hexvix is nowreconstituted and ready for use.The appearance of the reconstituted solution is a clear or slightly opalescent solution, and colorless to pale yellow.

Add two hours to the current time and write the expiration date resulting from this and the date on the syringe label

This product is for single use only. Any remaining product should be discarded. No special requirements for disposal.

It has been demonstrated that the solution maintains its chemical and physical stability for a period of 2 hours at 2 ºC – 8 ºC. From a microbiological point of view, the product should be used immediately. If not, the times and conditions for conservation before use are the responsibility of the user and should not normally exceed 2 hours at 2 ºC - 8 ºC.