REGRANEX 0.01% gel

The name of your medicine is REGRANEX. It contains a substance called becaplermin. Becaplermin is a human recombinant Platelet Derived Growth Factor (rhPDGF).
REGRANEX is used to help the growth of normal tissue in order to heal skin ulcers. It is used with other good wound care measures to help with the healing of the ulcers.

Good wound care measures include:

• Your doctor or healthcare professional removing dead skin/debris from the wound whenever necessary
• Keeping weight off your feet, perhaps by wearing special orthopaedic shoes or by other methods
• Your doctor or healthcare professional treating any infection of the wound - treatment with REGRANEX should be stopped if the wound becomes infected
• Continuing to visit your doctor or healthcare professional and following your treatment plan

REGRANEX is used for skin ulcers that:

• Are not more than 5 square centimetres (see diagram opposite) and have a good blood supply
• Are due to complications of diabetes.

Insert diagram of size (circle measuring 2.524 cm in diameter)

By using REGRANEX, it is more likely that your skin ulcers will heal quickly and completely.

Do not use REGRANEX:

• If you are allergic (hypersensitive) to becaplermin or to any of the other ingredients of REGRANEX (listed in section 6 below)
• If you have or have had cancer
• If your ulcer is infected
• If your ulcer is larger than 5 square centimetres (see diagram above)
• If you are under 18 years of age.

Do not use this medicine if any of the above apply to you. If you are unsure, talk to your doctor or pharmacist before using REGRANEX.

Take special care with REGRANEX

Check with your doctor or pharmacist before using this medicine if:

• You have any severe or persistently worsening types of cancer
• You have infections of the bone which may be seen as fever, severe pain around the bone that is affected, swelling and redness of the joints
• You have diseases of the arteries.

Taking other medicines

Do not apply any medicines to your ulcer while using REGRANEX, except for salt solution (saline) or water to clean the ulcer.

Please tell your doctor or pharmacist if you are using or have recently used any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

Pregnancy and breast-feeding

• Do not use this medicine if you are pregnant, think you might be pregnant or planning to become pregnant
• Do not use this medicine if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast- feeding.

Important information about possible allergies to some of the ingredients

REGRANEX contains E218 (methyl parahydroxybenzoate) and E216 (propyl parahydroxybenzoate). These may cause allergic reactions (possibly delayed).

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

The usual dose is one application once a day for a maximum of 20 weeks.

Before using REGRANEX

• Wash your hands thoroughly. Do this before you apply REGRANEX
• Your ulcer should be cleaned with salt solution or water. This is important to ensure the ulcer heals as quickly and completely as possible, and to remove any REGRANEX gel from the previous application.

Applying REGRANEX

• Apply REGRANEX gel once a day using a clean cotton swab or wooden spatula. Apply a thin layer of REGRANEX gel to the entire wound area. You can obtain wooden spatulas from your pharmacist
• Cover the ulcer with a moist saline (salt) gauze dressing. The dressing should be changed at least once a day to keep the wound moist.

Further information

• Only apply REGRANEX to the wound area. Avoid contact with any other area of the body
• Do not touch the wound with the tip of the tube
• Do not use air- or water-tight (occlusive) dressings on the wound. If you are unsure, check with your doctor or pharmacist
• Do notapply pressure or walk on the ulcer during treatment. Follow your doctor?s advice to relieve pressure from your ulcer.

Your doctor will monitor the progress of your treatment.

Contact your doctor immediately if you notice signs of infection of the ulcer (redness, swelling, fever, pain, or odour). You should stop using it until the infection has cleared.

When to stop using REGRANEX

REGRANEX should not be used continuously for more than 20 weeks.

If there is no sign of healing after the first ten weeks of treatment, contact your doctor. Your doctor will decide whether you should continue to use REGRANEX.

If your ulcer heals and then returns, do not use REGRANEX again without first checking with your doctor.

If you use too much REGRANEX

If you apply too much REGRANEX, it is unlikely to do you any harm. Always try to follow the instructions for use exactly.

If you forget to use REGRANEX

• Apply the next dose as soon as possible. If it is almost time for the next application, forget about the missed dose and continue as normal
• Do not apply a double amount to make up for a missed dose.

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

Like all medicines, REGRANEX can have side effects, although not everybody gets them.

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

Stop using REGRANEX and tell your doctor straight away if you notice or suspect the following:

• Excessive growth of new tissue at the wound (rare)
• Infected skin ulcer (very common)

Other side effects

Common

• Infections of the bone which may be seen as fever, severe pain, swelling and redness around the bone that is affected
• Redness and pain of skin

Uncommon

• Burning sensation at the application site

Rare

• Blisters and swelling under the skin

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use REGRANEX after the expiry date, which is stated on the tube and the outer carton after EXP. The expiry date refers to the last date of that month.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Close the tube tightly after each use.

Use within 6 weeks after opening the seal of the tube. Please record the date of opening on the tube label.

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 REGRANEX contains

The active substance in REGRANEX is becaplermin. Each gram of Regranex contains 100 micrograms of becaplermin.

The other ingredients are: carmellose sodium (E466), sodium chloride, sodium acetate, glacial acetic acid (E260), methyl parahydroxybenzoate (methylparaben) (E218), propyl parahydroxybenzoate (propylparaben) (E216), metacresol, lysine hydrochloride and water for injections.

What REGRANEX looks like and contents of the pack

Regranex is presented as a gel and is filled in multi-dose tubes containing 15 grams.

Regranex is a clear colourless to straw-coloured gel.

Marketing Authorisation Holder

JANSSEN-CILAG INTERNATIONAL NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium

Manufacturer

JANSSEN PHARMACEUTICA NV
Turnhoutseweg, 30
B-2340 Beerse
Belgium

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien JANSSEN-CILAG N.V.S.A. Tel 32 3 280 54 11 LuxembourgLuxemburg JANSSEN-CILAG N.V.S.A. BelgiqueBelgien Tel 32 3 280 54 11

Johnson Johnson, d.o.o. . 359 2 489 94 00 Magyarország JANSSEN-CILAG Kft. Tel 36 23 513-800

eská republika JANSSEN-CILAG s.r.o. Tel 420 227 012 222 Malta A.M.Mangion Ltd Tel 356 2397 6000

Danmark JANSSEN-CILAG AS Tlf 45 45 94 82 82 Nederland JANSSEN-CILAG B.V. Tel 31 13 583 73 73

Deutschland JANSSEN-CILAG GmbH Tel 49 2137-955-0 Norge JANSSEN-CILAG AS Tlf 47 24 12 65 00

Eesti Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Tel 372 617 7410 Österreich JANSSEN-CILAG Pharma GmbH. Tel 43 1 610 300

JANSSEN-CILAG .... 30 210 809 0000 Polska JANSSENCILAG Polska Sp. z o.o. Tel 48 22 237 60 00

España Laboratorios Dr. Esteve, S.A. Tel 34 93 446 60 00 Portugal JANSSEN-CILAG FARMACÊUTICA, LDA Tel 351 21-436 88 35

France ETHICON Tel 33 1 55 00 22 00 Info. Méd. Tel 33 1 55 00 22 33 Romania Johnson Johnson d.o.o. Janssen-Cilag Romania Tel 40 21 207 1800

Slovenija Johnson Johnson d.o.o. Tel 386 1 401 18 30 Ireland JANSSEN-CILAG Ltd. United Kingdom Tel 44 1 494 567567

Ísland JANSSEN-CILAG AB, co Vistor hf Tel 354 535 7000 Slovenská republika Johnson Johnson s.r.o. Tel 421 233 552 600

Italia JANSSEN-CILAG SpA Tel 39 022510.1 SuomiFinland JANSSEN-CILAG OY PuhTel 358 207 531 300

T 357 22 755 214 Sverige JANSSEN-CILAG AB Tel 46 8 626 50 00

Latvija Janssen-Cilag Polska Sp. z o.o. filile Latvij Tel 371 678 93561 United Kingdom JANSSEN-CILAG Ltd. Tel 44 1 494 567567

Lietuva
UAB ?Johnson & Johnson?
Tel: +370 5 278 68 88

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