SANCUSO 3.1 mg/24 hours transdermal patch

granisetron

The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and antinauseants.

SANCUSO is a transdermal (skin) patch used to prevent nausea (feeling sick) and vomiting (being sick) in adults receiving chemotherapy treatments (medicines to treat cancer) lasting 3 to 5 days and who have difficulty swallowing tablets (for example due to soreness, dryness or inflammation of the mouth or throat).

You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.

Always use this medicine exactly as your doctor has told you. Check with your doctor or nurse if you are not sure.

The recommended dose is one single transdermal patch. The medicine in the transdermal patch passes gradually through your skin into your body and, therefore, the patch is applied 1 to 2 days (24 to 48 hours) before the start of chemotherapy treatment.

This medicine is for transdermal use. This medicine delivers the active substance slowly and constantly through your skin and into your blood stream for the duration that you are wearing the transdermal patch.

Things to remember when using the transdermal patch

• Do not keep or store the transdermal patch outside the sealed sachet.
• Do not cut the transdermal patch into smaller pieces.
• Use only one transdermal patch at a time.
• When you remove the transdermal patch, check your skin and tell your doctor if you notice a serious skin reaction (if your skin is very red, itchy or you notice any blisters).
• The transdermal patch may be affected by direct sunlight or exposure to sunlamps. While you are wearing the transdermal patch you must keep it covered, e.g. under clothing, if there is a risk of exposure to sunlight or sunlamps. Continue to keep the application site covered for a further 10 days after removing the transdermal patch.
• Contact with water during bathing or showering will not change the way SANCUSO works.
• However, the transdermal patch may become partially unstuck. Try to avoid wearing the transdermal patch in water for long periods of time.
• There is no information on the effect on the transdermal patch of activities such as strenuous exercise or the use of sauna or whirlpools; therefore, you should avoid these activities while wearing this transdermal patch.
• You should avoid external heat (for example hot water bottles or heat pads) on the area of the transdermal patch.

When to apply and remove the transdermal patch

Do not remove the transdermal patch from the sachet until you are ready to use it. Apply a transdermal patch at least 1 day (24 hours) before you are scheduled to have chemotherapy treatment. The transdermal patch may be applied up to a maximum of 2 days (48 hours) before chemotherapy. Wear the transdermal patch all the time during your chemotherapy. The transdermal patch can be worn for up to 7 days depending on the duration of your chemotherapy treatment. Remove the transdermal patch at least 1 day (24 hours) after completing your chemotherapy.

Where to apply the transdermal patch

Put the transdermal patch on a clean, dry, healthy area of skin on the outside part of your upper arm. If your arms are not suitable areas to apply the transdermal patch your doctor may ask you to put it on your abdomen. The area you choose should not be oily, recently shaved or have any skin problems such as being injured (cut or scraped) or irritated (redness or a rash). Do not put SANCUSO on areas that have been treated with creams, oils, lotions, powders or other skin products that could keep the transdermal patch from sticking well to your skin.

How to apply the transdermal patch

1. Remove a sachet from the box and tear it open using the slit provided. Each sachet contains one transdermal patch stuck onto a rigid plastic film.
2. Take the transdermal patch out of the sachet.

3. The sticky side of the transdermal patch is covered by a two-piece rigid plastic film. Bend the transdermal patch in the middle and remove one half of the rigid plastic film. Be careful not to stick the transdermal patch to itself and avoid touching the sticky side of the transdermal patch.
4. While holding the remaining half of the rigid plastic film, apply the transdermal patch to the skin on the outside part of your upper arm.
5. Remove the second half of the rigid plastic film and press the whole transdermal patch firmly in place with your fingers and smooth down. Press firmly making sure there is good contact with the skin, especially around the edges.
6. Wash your hands after applying the transdermal patch.
7. Keep the transdermal patch in place for the whole time you are having chemotherapy.
8. Do not re-use the transdermal patch after removal, see below for instructions on transdermal patch removal and disposal (see section 5).

After removing the transdermal patch

1. The used transdermal patch will still contain some granisetron and should be disposed of immediately as described in section 5.
2. After removing the transdermal patch you may find some sticky material is left on your skin. Gently wash the area with soap and water to remove it. Alcohol or other dissolving liquids such as nail polish remover may cause skin irritation and should not be used.
3. Wash your hands.
4. You may see mild redness on the skin where the transdermal patch is removed. This redness should go away over time. If it does not, tell your doctor.

If the transdermal patch becomes unstuck

If the transdermal patch starts to become unstuck, the same transdermal patch may be secured to the same area of skin. If required, use surgical bandages or medical adhesive tape to keep the transdermal patch in place. If the transdermal patch is lost or becomes damaged go back to your doctor.

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

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

If you are being treated with chemotherapy that is moderately or highly capable of making you feel sick, you may still be sick despite treatment with anti-sickness medicine, including this medicine.

Tell your doctor immediately if you develop constipation or if your stomach becomes painful or swollen. Constipation is a common side effect and may affect up to 1 in 10 people.

Remove the transdermal patch and tell your doctor if you notice:

• signs and symptoms of a condition called Serotonin Syndrome, which can be serious and in some cases life threatening. These may include changes in blood pressure (which could make you feel dizzy or have a headache), fast heartbeat, blurred vision (which may be due to dilation of the pupil of the eye), sweating, increased bowel movements/noises, shivering, tremor, muscle twitching or jerking, and overactive reflexes. You may also have a high or very high temperature (fever), feel agitated or confused, have stiff muscles, and notice that you are talking faster. How many people will get Serotonin Syndrome is not known (cannot be estimated from available data)
• a serious skin reaction (if your skin is very red, itchy or you notice any blisters). Skin reactions at the site of application, such as irritation, itching or redness are uncommon and may affect up to 1 in 100 people.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after ‘EXP’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Used transdermal patches still contain active ingredients, which may be harmful to others. Fold the used transdermal patch in half with the sticky side inwards and dispose of it safely, out of the reach of children. Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.