Label: information for the user

Visudyne 15mg powder for solution for infusion

verteporfina

Read this label carefully beforeyou are given thismedication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to otherswho have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,evenifthey do not appearin this label. See section4.

Contents ofthe label

1.What Visudyne is and for what it is used

2.What you need to know before Visudyne is administered to you

3.How to use Visudyne

4.Possible adverse effects

5.Storage of Visudyne

6.Contents of the package and additional information

What is Visudyne

Visudyne contains the active ingredient verteporfina, which is activated by the light of a laser in a treatment called photodynamic therapy. When Visudyne is administered through an infusion, it is distributed throughout the body through the blood vessels, including those in the back of the eye. When the laser light falls on the eye, Visudyne is activated.

How is Visudyne used

Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia.

These diseases cause vision loss. Vision loss is caused by new blood vessels (choroidal neovascularization) that damage the retina (the light-sensitive membrane that covers the back of the eye). There are two types of choroidal neovascularization: classic and occult.

Visudyne is used to treat predominantly classic choroidal neovascularization in adults with age-related macular degeneration, and also to treat all types of choroidal neovascularization in adults with pathological myopia.

Do not administer Visudyne

• if you areallergicto verteporfina or any of the other components of this medication (listed in section6).
• if you haveporphyria(a rare disease that may increase sensitivity to light).
• if you havesevere liver problems.

If you are in any of these situations,inform your doctor. Do not administer Visudyne.

Warnings and precautions

Consultyour doctor, pharmacist, or nursebefore Visudyne is administered

-If you experience any problems related to perfusion or symptoms during or after treatmentsuch as chest pain, sweating, dizziness, rash, difficulty breathing, hot flashes, irregular heart rhythm, or seizures, inform your doctor or nurse immediately, as it may be necessary to interrupt the perfusion and treat you urgently. Problems related to perfusion may also include sudden loss of consciousness.

-If you have any liver problems or a bile duct obstruction,inform your doctor before starting treatment with Visudyne.

-If during perfusion, Visudyne leaks out,and especially if the affected area is exposed to light, it may cause pain, swelling, blistering, and changes in the skin color of the filtration area. If this occurs, stop the perfusion, treat the skin with cold compresses, and protect it completelyfrom light until the skin color returns to normal. You may need to take pain medication.

-You will experience sensitivity to bright light for 48hours after perfusion.During this time, avoid direct exposure to sunlight, bright interior lights such as tanning salons, bright halogen lights, high-intensity lamp lights used in surgery or by dentists, or light from medical devices that emit light, such as pulse oximeters (used to measure blood oxygen levels). If you need to go outside during the day in the first 48hours after treatment, protect your skin and eyes with protective clothing and dark sunglasses. Sunscreens do not provide protection. Normal indoor light is safe.

-Do not stay in the darkas exposure to normal indoor light will help your body eliminate Visudyne more quickly.

-If you notice any eye problems after treatment, such as vision loss, inform your doctor.

Other medications and Visudyne

Inform your doctor, nurse, or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor or pharmacist if you are taking any of the following medications, as they may increase your sensitivity to light:

• tetracyclines or sulfonamides (used to treat bacterial infections),
• phenothiazines (used to treat psychiatric disorders, nausea, and vomiting),
• sulfonilurea (used to treat diabetes),
• medications used to lower blood sugar,
• thiazide diuretics (used to reduce high blood pressure),
• griseofulvin (used to treat fungal infections),
• calcium channel blockers (used to treat high blood pressure, angina, and abnormal heart rhythms),
• antioxidants such as beta-carotene or medications that can eliminate or inactivate free radicals (such as dimethyl sulfoxide (DMSO), formic acid, mannitol, and alcohol),
• vasodilators (used to dilate blood vessels by relaxing smooth muscle),
• or, if you are undergoing radiation therapy,

Pregnancy and breastfeeding

-There is very little experience with the use of Visudyne in pregnant women. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant. Visudyne will only be administered if your doctor considers it absolutely necessary.

-Verteporfina passes into breast milk in small amounts. Inform your doctor if you are breastfeeding. They will decide if you should receive Visudyne. It is recommended that, if you receive Visudyne, you do not breastfeed for 48hours after administration.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

After treatment with Visudyne, you may experience some vision problems, such as abnormal or decreased vision, which may be temporary. If this occurs, do not drive or operate tools or machines until your vision improves.

Visudyne contains small amounts of hydroxytoluene butylate (E321)

This component is irritating to the eyes, skin, and mucous membranes.

Therefore, in case ofdirect contact with Visudyne, wash the area thoroughly with water.

Visudyne treatment is a two-stage process

• First, your doctor or pharmacist will prepare the Visudyne perfusion solution. This will be administered by your doctor or nurse through a vein using a perfusion pump (intravenous perfusion).

• The second stage is the activation of Visudyne in the eye 15minutes after the start of perfusion. Your doctor will place a special contact lens in your eye and treat you using a special laser. It will take 83seconds for the laser to release the necessary dose to activate Visudyne. During this time, you must follow your doctor's instructions and keep your eyes still.

Visudyne therapy may be repeated as needed, every 3months, up to 4times per year.

Use in children

Visudyne is a treatment only for adults and is not indicated for use in children.

If you have received more Visudyne than you should

In case of Visudyne overdose, the period during which you present light sensitivity may be prolonged, and you may need to follow the light protection instructions indicated in section2 for more than48hours. Your doctor will advise you accordingly.

Visudyne and light overdose in the treated eye may cause severe vision loss.

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

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

Some side effects can be serious:

Common(can affect up to 1 in 10patients)

• Eye disorders: severe vision loss (loss of 4or more lines in the 7days following treatment), visual disturbances such as blurred or confused vision, flashes of light, decreased vision, and changes in the field of vision in the treated eye such as dark or gray shadows, blind spots, or black spots.
• General disorders: hypersensitivity (allergic reactions), syncope (fainting), headache, dizziness, difficulty breathing.

Uncommon(can affect up to 1 in 100patients)

• Eye disorders: retinal or vitreous hemorrhage (a substance like transparent gel that fills the eyeball behind the lens), swelling or fluid retention in the retina, and retinal displacement in the treated eye.
• Injection site reactions: like with other types of injections, some patients experienced bleeding at the injection site, skin discoloration, and hypersensitivity. If this occurs, you will have increased sensitivity to light in that area of the skin until the green discoloration fades.
• General disorders: rash, urticaria, itching

Rare(can affect up to 1 in 1,000patients)

• Eye disorders: lack of blood supply to the retina or choroid (the vascular layer of the eye) in the treated eye.
• General disorders: feeling unwell.

Frequency not known(the frequency cannot be estimated from the available data)

• Eye disorders: retinal tear, swelling or fluid retention in the macula.
• General disorders: vasovagal reactions (fainting), sweating, flushing, or changes in blood pressure. In rare cases, hypersensitivity and vasovagal reactions can be severe and potentially include seizures.
• There have been reports ofmyocardial infarction, especially in patients with a history of heart disease, in some cases within 48hours following treatment with Visudyne. In the event of suspected myocardial infarction, seek immediate medical attention.
• Localized skin tissue death (necrosis).

If you experience any of these side effects,inform your doctor immediately.

Other side effects:

Common(can affect up to 1 in 10patients)

• Injection site reactions: like with other types of injections, some patients experienced pain, swelling, inflammation, and exudation at the injection site.

• General disorders:feeling of dizziness(nausea), sunburn-like reactions, fatigue, reaction associated with perfusion, which primarily presents as chest pain or back pain and increased cholesterol levels.

Uncommon(can affect up to 1 in 100patients)

• General disorders: pain, increased blood pressure, increased sensitivity, and fever.

Frequency not known(the frequency cannot be estimated from the available data)

• Injection site reactions: like with other types of injections, some patients experienced blister formation.
• General disorders: changes in heart rate. Reaction associated with perfusion that can radiate to other areas, including but not limited to the pelvis, shoulders, or chest.

Reporting of side effects

If you experience any type of side effect,consultyour doctor, nurse, or pharmacist,even if it is a possible side effect that does not appear in this leaflet.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 on 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” and on the vial after “EXP.”The expiration date is the last day of the month indicated.

Do not store at a temperature above 25?°C.Store the vial in the outer packaging to protect it from light.

Chemical and physical stability during use has been demonstrated for 4hours at 25?°C.From a microbiological standpoint, the medication should be used immediately.If not, the storage conditions and time during previous use prior to its use will be the responsibility of the user and will not last more than 4hours at less than 25?°C, protected from light.

Composition of Visudyne

-The active ingredient is verteporfin. Each vial contains 15mg of verteporfin. After reconstitution, 1ml contains 2mg of verteporfin. 7.5ml of reconstituted solution contains 15mg of verteporfin.

-The other components are dimiristoil-phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, hydroxytoluene butylated (E321) and lactose monohydrate.

Appearance of the product and contents of the package

Visudyne is supplied in the form of dark green to black powder in a transparent glass vial. Prior to use, the powder is reconstituted in water to form an opaque greenish dark solution.

Visudyne is available in packages containing1vial of powder.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

Delpharm Huningue S.A.S.

26 rue de la Chapelle

68330 Huningue

France

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Last review date of this leaflet:

Other sources of information

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

This information is intended solely for healthcare professionals:

Reconstitute Visudyne in 7.0ml of water for injectable preparations to obtain 7.5ml of a solution with a concentration of 2.0mg/ml. Reconstituted Visudyne is an opaque greenish dark solution. It is recommended that reconstituted Visudyne be visually checked before administration for the presence of particles anddecoloration. Toachieve a dose of 6mg/m2of body surface area (the recommended dose for treatment) dilute the required amount of Visudyne solution in a dextrose50mg/ml (5%) solution for infusionto a final volume of 30ml. Do not use sodium chloride solution. It is recommended to use a standard infusion filter with hydrophilic membranes (such as polyethersulfone) with a pore size of not less than 1.2micrometers.

For storage conditions, please see section5 of this leaflet.

The vial and any unused reconstituted solution must be discarded after use (single use).

If solution is spilled, it must be recovered with a damp cloth. It should be avoided to come into contact with the eyes andskin. It isrecommended to use rubber gloves and eye protection.The disposal of unused medication and all materials that have come into contact with it, will be carried out in accordance with local regulations.