MedPath
HSA Approval

HARUFEN PLASTER 30MG

SIN16447P

HARUFEN PLASTER 30MG

HARUFEN PLASTER 30MG

March 21, 2022

SEA PHARMA CONSULTANCY PTE LTD

SEA PHARMA CONSULTANCY PTE LTD

Regulatory Information

SEA PHARMA CONSULTANCY PTE LTD

SEA PHARMA CONSULTANCY PTE LTD

Therapeutic

General Sale List

Formulation Information

PLASTER

**3\. How to use HARUFEN** Adults: Apply on plaster to the affected area after removal of release paper twice daily. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you still have a lot of pain after use of HARUFEN, tell your doctor. Your doctor will check how well HARUFEN is working at regular intervals. **Before you stick HARUFEN on the affected area** If you have had a recent bath or shower, you should wait until your skin cools before using the plaster. **Sticking the plaster on** **Step 1: Open the pouch and take plasters out** Tear open or cut the pouch along the cutting line. When using scissors, be careful no to damage the Plasters. Take out one plaster. **Step 2: Remove the middle zigzag release paper from the plaster.** A protective liner covers the sticky (adhesive) side of the plaster. Peel off middle zigzag release paper from the plaster. Do not touch the sticky part of the plaster with your fingers. **Step 3: Apply the plaster and press it firmly onto the skin** Apply the sticky side of the plaster onto your chosen skin side. **Step 4: Remove the remaining sides of the release paper** Peel off the remaining sides of the release paper and stretch the plaster as needed for a smooth and even plaster application. Press down the plaster firmly to make sure that the edges stick well. **Removing the HARUFEN plaster** Gently pull on 1 edge of the HARUFEN plaster to remove it off your skin. Fold the HARUFEN plaster in half and throw the used HARUFEN plaster in the trash out of the reach of children and pets. Wash your hands with soap and water right away. **Bathing, showering and swimming** If at all possible contact with water should be avoided whilst using HARUFEN. Bathing, showering or swimming can be done in the time period when you are not wearing the plaster. If you took a recent bath or shower, you should wait until your skin cools before using the plaster. **How to remove HARUFEN** When changing the plaster, remove the old plaster slowly. If it does not come off easily, you can soak it in warm water for a few minutes before removing the plaster. **If you use more plasters than you should** If you use more plasters than necessary or wear them for too long, this may increase the risk of getting side effects. If you have any further questions on the use of this product, ask your doctor or pharmacist.

TOPICAL

Medical Information

**1\. What HARUFEN is and what it is used for** HARUFEN contains ketoprofen, a non-steroidal anti-inflammatory drug which works by reducing the pain in your skin. HARUFEN is used for relief of pain and inflammation of the following diseases or symptoms: - Arthritis deformans. - Periarthritis of shoulder. - Tendonitis. - Peritendinitis. - Humeral epicondylitis (tennis elbow etc.). - Muscle pain. - Swelling and posttraumatic swelling and pain.

**2\. What you need to know before you use HARUFEN** Do not us HARUFEN plaster if you: - Are allergic to ketoprofen or any of the other ingredients in HARUFEN plaster (listed in section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Have patients who have and have had aspirin-induced asthma or asthma attack caused by other non-steroidal anti-inflammatory drugs (NSAIDs).

M02AA10

ketoprofen

Manufacturer Information

SEA PHARMA CONSULTANCY PTE. LTD.

SINIL Pharmaceutical Co., Ltd.

Active Ingredients

Ketoprofen

30 mg

Ketoprofen

Documents

Patient Information Leaflets

Harufen Plaster PIL.pdf

Approved: March 21, 2022

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