KEPLAT 20 mg Transdermal Patch

Do not expose the treated areas to sunlight or UV lamps in solariums for the entire duration of treatment and
for two weeks after its interruption

Warnings and precautions
Talk to your doctor or pharmacist before using KEPLAT:

• If you suffer from allergic reactions or have a previous allergy, especially after the administration of other analgesics, antipyretic medicines and other NSAIDs
• If you have Crohn's disease or ulcerative colitis, chronic dyspepsia, previous bronchial asthma
• If you suffer from liver, kidney or heart diseases
• If you suffer from fluid retention
• Use caution if you are elderly as you are generally more prone to adverse effects.

Exposure to sunlight (even when the sky is cloudy) or to UVA lamps of areas treated with
KEPLAT can induce skin reactions that may be severe (photosensitization). Therefore it is necessary to:

• protect the treated parts from the sun with clothing for the entire duration of treatment and for two weeks after its interruption in order to avoid any risk of photosensitization
• wash your hands thoroughly after each application of KEPLAT.

Treatment should be discontinued immediately if any skin reaction occurs
following the application of KEPLAT
Prolonged or repeated use of the product may cause sensitization phenomena (hypersensitivity).

Paediatric population
In some paediatric patients treated with ketoprofen, gastric bleeding, occasionally
severe, and gastric ulcers have been found; therefore the medicine should be administered under strict medical supervision who will have to
assess from time to time the dosage scheme necessary.
The safety and efficacy of ketoprofen cutaneous formulations in children have not been established.

Other medicines and KEPLAT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
It is important to inform your doctor if you are taking methotrexate, anticoagulants, some medicines for blood
pressure or for the heart, antidiabetics or lithium.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not use KEPLAT in the last 3 months of pregnancy. You should not use KEPLAT in the first 6 months of
pregnancy, unless strictly necessary and under the advice of your doctor. If treatment is necessary during this
period, the minimum dose should be used for the shortest possible time.
Oral formulations (e.g. tablets) of ketoprofen can cause adverse effects on the fetus. It is not known whether
KEPLAT involves the same risk when used on the skin.

Breastfeeding
KEPLAT is not recommended during breastfeeding.

Driving and using machines
KEPLAT may affect your ability to drive vehicles or use machines due to the possible onset of
dizziness or drowsiness.

3. How to use KEPLAT

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose is:

Adults:Apply one patch per day, unless otherwise prescribed by your doctor.

Use in children and adolescents:Between 12 and 18 years, as prescribed by your doctor. Do not use in children
under 12 years of age.
The patch should be applied to the painful area and replaced daily.
Before applying the patch, cleanse and dry the affected area. Remove the protective film and apply the
adhesive part directly to the skin.
If the patch needs to be applied to joints with high mobility such as the elbow or knee, a bandage can be
applied to the flexed joint, in order to keep the patch in place.
Instructions for application

• 1. Fold the patch in half along the perforated division of the plastic coating
• 2. Position the patch on the part of the body that hurts the most, clean and dry
• 3. Remove one half of the plastic coating from the perforated edge and flatten the adhesive surface onto the area to be treated
• 4. Remove the other half of the plastic coating in the same way and flatten the entire patch onto the area to be treated

DO NOT chew or swallow the patch.

Duration of treatment
As prescribed by your doctor, but not exceeding 14 days.

If you use more KEPLAT than you should
If you have used more KEPLAT than you should have, inform your doctor or pharmacist immediately.
No cases of overdose have been reported.

If you forget to use KEPLAT
Just apply KEPLAT as soon as you remember and then continue with the normal dose.
DO NOT take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, KEPLAT can cause side effects, although not everybody gets them.

Stop using KEPLATand seek immediate medical attention if:

• Skin rash, hives, blisters, redness, burning, itching, skin peeling or bruising at the application site.
• Swelling of the face, runny nose, tightness in the chest, wheezing (severe allergic reactions).

Mild skin reactions have been reported at the application sites of KEPLAT:
Uncommon (may affect up to 1 in 100 people): redness, burning sensation, itching, allergic skin reactions, skin reactions during exposure to sunlight.
The following side effects have also been reported:
Dermatological reactions

• Rare (may affect up to 1 in 1,000 people): photosensitivity and urticaria. Rarely, more serious reactions such as bullous or blistering eczema have occurred, which may spread beyond the application site or become widespread.
• Not known (frequency cannot be estimated from the available data): skin peeling and bruising at the application site.

Renal and urinary disorders

• Very rare (may affect up to 1 in 10,000 people): cases of worsening of pre-existing renal insufficiency.

Gastrointestinal disorders

• Not known (frequency cannot be estimated from the available data): stomach ulcer. If a stomach ulcer is active or suspected, treatment should be stopped immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. . By reporting side effects you can
help provide more information on the safety of this medicine.

• 5. How to store KEPLATKeep this medicine out of the sight and reach of children. Store KEPLAT in the original packaging to protect it from light. The validity of the product after opening is 3 months (record the date of first opening in the appropriate space). Each time you take a patch from the packaging, carefully close the open side of the sachet to protect the remaining patches from light.

Do not use KEPLAT after the expiry date stated on the carton or more than 3 months after first opening.
The expiry date refers to the product in intact packaging, correctly stored .
Do not dispose of any medicine in the water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment .

6. Contents of the pack and other information

Contents of KEPLAT
The active ingredient is ketoprofen. Each patch contains 20 mg of ketoprofen.
The other ingredients are: styrene-isoprene-styrene copolymer, poly-isobutylene 1200000, poly-isobutylene, glycerol rosin hydrogenated ester,
zinc stearate, liquid paraffin, polyester backing layer, plastic film.

Description of the appearance of KEPLAT and contents of the pack
KEPLAT is a flesh-colored medicated patch of 70 cm, with a flexible support matrix. The adhesive side is coated
with a plastic film.
One pack contains one sachet with 7 patches or 2 patches.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hisamitsu Italia S.r.l.
Via Paolo da Cannobio 9, 20122 Milano, Italy
Manufacturer
Hisamitsu Pharmaceutical Co., Inc, 408 Tashirodaikan- machi, Tosu, Saga, 841-0017, Japan
Release Batch Responsible
Millmount Healthcare Ltd
Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60, Ireland
Sales Concessionaire
Abiogen Pharma S.p.A.
Via Meucci, 36 - Ospedaletto - Pisa

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Czech Republic, Hungary, Italy, Portugal: KEPLAT