Macugen 0.3 mg solution for injection

Macugen is an ophthalmic medicine which means it is for eye treatment only.

Macugen is used for the treatment of the wet form of age-related macular degeneration (AMD). This disease leads to vision loss resulting from damage to the central part of the retina (called the macula), at the back of the eye. The macula enables the eye to provide the fine central vision that is needed for activities such as driving a car, reading fine print and other similar tasks.

In the wet form of AMD, abnormal blood vessels grow under the retina and macula. These new blood vessels may bleed and leak fluid, causing the macula to bulge or lift up, thus distorting or destroying central vision. Under these circumstances vision loss may be rapid and severe. Macugen works by inhibiting the growth of these abnormal blood vessels and by stemming the bleeding and leakage. Macugen is used for the treatment of all types of abnormal blood vessels growth in adult AMD patients.

Macugen must not be used
If you are hypersensitive (allergic) to pegaptanib or any of the other ingredients of Macugen. If you have an infection in or around the eye.

Take special care with Macugen

Macugen is given as an injection into the eye. Occasionally, an infection or bleeding in the eye can occur after Macugen treatment (in the next two weeks). It is important to identify and treat these types of conditions as soon as possible. Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision. If your doctorcannot be reached for any reason, an alternate should be contacted immediately.

In some patients the pressure inside the treated eye may increase for a short period directly after the injection. Your doctor may monitor this after each injection.

Children

Macugen should not be used in children and adolescents under 18 years old.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines obtained without a prescription.

Pregnancy

There is no experience of using Macugen in pregnant women; therefore the potential risks are unknown. If you are pregnant or planning to become pregnant, please discuss this with your doctor before Macugen treatment.

Breast-feeding
It is not known whether Macugen is excreted in human milk. Macugen is not recommended during breast-feeding. Ask your doctor or pharmacist for advice before Macugen treatment.

Driving and using machines
You may experience temporary visual blurring after receiving Macugen. If you are affected, do not drive or use machines until this resolves.

Important information about some of the ingredients of Macugen

This medicine contains less than 1 mmol sodium (23 mg) per 90 microlitre dose, i.e. essentially ?sodium-free?.

All injections of Macugen will be administered by your doctor.

Macugen is administered as a single injection (0.3 mg) into your eye at intervals of 6 weeks (i.e. 9 times per year). The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye. Your doctor will monitor your condition and recommend how long you should be treated with Macugen.

Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully. Please tell your doctor if you are known to be allergic to any substance. Please follow these instructions carefully.

Before the injection, your doctor will give you some local anaesthetic (numbing medicine). This will reduce or prevent any pain you might have with the injection, which is a simple and rapid procedure.

After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.

If you forget to attend an appointment
Contact the hospital or clinic as soon as possible to re-schedule your appointment.

If you have any further questions on the use of this medicine, ask your doctor of pharmacist.

Like all medicines, Macugen can cause side effects although not everybody gets them. In some rare cases, serious allergic reaction has been reported soon after the injection. Please seek immediate medical help if you experience any of the following soon after the injection: sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting or diarrhoea.

Uncommonly, an infection in the internal portion of the eye can occur after Macugen treatment in the next two weeks. The symptoms you might experience are described in section 2 of this leaflet ("Take special care with Macugen"). Please read section 2. It tells you what to do if you have any of these symptoms.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

Very common side effects are most probably caused by the injection procedure rather than the medicine, and include: eye inflammation, eye pain, increased pressure inside the eye, small marks on the eye surface (punctate keratitis), small particles or spots in your vision (vitreous floaters or opacities).

Other common eye side effects reported to be possibly caused by the medicine or by the injection procedure include: blurred vision, visual disturbance, eye discomfort, decreased vision, increased sensitivity to light, appearance of flashing lights, bleeding that occurs around the eye (periorbital bleeding), bloodshot eye (conjunctival haemorrhage), disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear (vitreous detachment), clouding of the lens (cataract), disorder of the surface of the eye (cornea), , swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva), eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil,

Other common non-visual side effects reported to be possibly caused by the medicine or by the injection procedure includes: headache or nasal discharge.

Uncommon eye side effects reported to be possibly caused by the drug or by the injection procedure include: inflammation of your eye or of the outer surface of the eye, bleeding in the eye or the internal portion of the eye (vitreous), eye strain, inflammation of the central part of the surface of the eye (keratitis), small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye, itching of the eyelids, disturbance in your eye?s reaction to the light (pupillary reflex impaired), small erosion on the central part of the surface of the eye (cornea), drooping eyelid, scar inside the eye (retinal scar), small lump on your eyelid due to inflammation (chalazion), decreased pressure inside the eye, injection site reaction, injection site vesicles, displacement or tear of a layer in the back of the eye (retina), disorder of the pupil, of the coloured part of the eye (iris), retinal artery occlusion, eversion of the eyelid, eye movement disorder, eyelid irritation, blood in your eye, discoloured eye, deposit eye, inflammation of the eye (iritis), optic nerve cupping, deformation of the pupil, occlusion of the vein at the back of the eye, discharge of inner jelly of the eye.

Uncommon non-visual side effects reported to be possibly caused by the drug or by the injection procedure include: nightmare, depression, deafness, vertigo, palpitations, high blood pressure, dilatation of the aorta (the main blood vessel), inflammation of the higher respiratory tract, vomiting, indigestion, irritation and inflammation of the skin, hair colour changes, rash, itching, night sweats, back pain, tiredness, shivering, tenderness, chest pain, sudden fever, generalised aches and pains, elevation of the liver enzymes, abrasion.

If you notice other side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use after the expiry datestated which is on the label and carton after EXP. The expiry date refers to the last day of that month.

oC -8oC. Store in a refrigerator 2Do not freeze.

Macugen should be discarded if kept at room temperature for more than two weeks.

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.

What MACUGEN contains

• The active substance is pegaptanib. Each single dose pre-filled syringe delivers a dose of 0.3 mg pegaptanib.
• The other ingredients are sodium chloride, monobasic sodium phosphate monohydrate,dibasic sodium phosphate heptahydrate, sodium hydroxide, hydrochloric acid and water for injections.

What MACUGEN looks like and contents of the pack

Macugen solution for injection is supplied in a single dose pack.

Each pack contains a pouch in a carton, containing a 1 ml pre-filled syringe, Type I glass, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip. The syringe has a pre-attached polycarbonate plastic .luer lock adaptor and the tip is sealed with an elastomeric tip cap. The pack is supplied without a needle. The pre-filled syringe will be used once and then thrown away.

Marketing Authorisation Holder

Pfizer Limited
Ramsgate Road
Sandwich
CT13 9NJ
United Kingdom

Manufacturer

Pfizer Ireland Pharmaceuticals
Pottery Road
Dun Laoghaire
Co Dublin
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Pfizer S.A. N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. TélTel 32 02 554 62 11

, . 359 2 970 4333 Magyarország Pfizer Kft. Tel. 36 1 488 37 00

eská republika Pfizer s.r.o. Tel 420 283 004 111 Malta V.J. Salomone Pharma Ltd. Tel 356 21 22 01 74

Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer bv Tel 31 010 406 43 01

Deutschland Pfizer Pharma GmbH Tel 49 0 30 550055 51000 Norge Pfizer AS Tlf 47 67 52 61 00

Eesti Pfizer Luxembourg SARL, Eesti filiaal Tel 372 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. 30 210 678 5800 Polska Pfizer Polska Sp. z o.o. Tel. 48 22 335 61 00

España Pfizer S.A. Tel 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 5500

France Pfizer Tél 33 01 58 07 34 40 România Pfizer Romania S.R.L. Tel 40 021 207 2800

Ireland Pfizer Healthcare Ireland Tel 1800 633 363 toll free 44 01304 616161 Slovenija Pfizer Luxembourg SARL, Pfizer podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel 386 01 52 11 400

Ísland Vistor hf Sími 354 535 7000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 421-2-3355 5500

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy Puh.Tel 358 09 43 00 40

GEO. PAVLIDES ARAOUZOS LTD 35722818087 Sverige Pfizer AB Tel 46 08 550 520 00

Latvija Pfizer Luxembourg SARL, filile Latvij Tel 371 670 35 775 United Kingdom Pfizer Limited Tel 44 01304 616161

Lietuva
Pfizer Luxembourg SARL, filialas Lietuvoje
Tel. +3705 2514000

This leaflet was last approved in

Annex IV

Grounds for one additional renewal

Grounds for one additional renewal

Based upon the data that have become available since the granting of the Marketing Authorisation, the CHMP considers that the benefit-risk balance of Macugen remains positive, but considers that its safety profile is to be closely monitored. The reason for this is that the issue of hypersensitivity reactions needs to be further investigated. In addition, the CHMP considers that there is a need for continued monitoring of potentially serious adverse ocular events and recommended that the MAH should continue to submit yearly PSURs.

Therefore, based on the safety profile of Macugen, which requires the submission of yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.