3.1 mg / 24 hours transdermal
patch granisetron
What SANCUSO is and what it is used for
The active substance in SANCUSO is granisetron, which belongs to a group of medicines called antiemetics and anti-nausea drugs.
SANCUSO is a transdermal patch used to prevent nausea and vomiting in adults who receive medicines used to treat cancer for three to five days. The patch is used for people who have difficulty swallowing tablets (eg due to soreness, dryness, or inflammation of the mouth or throat).
You need to talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.
What you need to know before using SANCUSO
Do not use SANCUSO
- if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to any other anti-nausea medicine whose name ends in “section”, e.g. ondansetron.
Warnings and cautions
Talk to your doctor or nurse before using this treatment if any of the following apply to you:
- if you have been told that you have heart disease
- if you have a stomach ache or your stomach is swollen
- if you have kidney or liver problems.
The medicine may not have as good an effect and/or may affect the skin if it is exposed to direct sunlight or light from sun lamps or tanning beds. It is important to follow these instructions:
- while using the transdermal patch, protect it with clothing if you are out in the sun or near a sun lamp or solarium
- the skin where the medicine has been applied should be covered for a further ten days after the transdermal patch has been removed to protect against direct sunlight.
It is unknown how activities such as swimming, strenuous exercise, sauna baths, or whirlpool baths can affect medicine. Avoid these activities while using the transdermal patch. You can continue to shower and wash as usual while using the transdermal patch.
Heat, from e.g. hot water bottles or heating pads, should be avoided in the area where the transdermal patch is located.
Children and young people
This medicine should not be used by children and adolescents under 18 years of age.
Other medicines and SANCUSO
Tell your doctor or nurse if you have recently taken, or might take any other medicines. SANCUSO may affect the effectiveness of other medicines. In addition, some other medicines may affect the effect of SANCUSO. You should especially tell your doctor or nurse if you are taking the following medicines:
- paracetamol used for pain.
- phenobarbital is used for epilepsy.
- ketoconazole is used to treat fungal infections.
- SSRIs (selective serotonin reuptake inhibitors) are used to treat depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram.
- SNRIs ( serotonin and norepinephrine reuptake inhibitors) are used to treat depression and/or anxiety, including venlafaxine, and duloxetine.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant unless your doctor has explicitly recommended it. If you are breastfeeding, stop breastfeeding while wearing the patch.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
SANCUSO has no or negligible effect on the ability to drive or use machines.
How to use SANCUSO
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or nurse.
The recommended dose is a transdermal patch. The drug in the transdermal patch gradually passes through the skin into the body and therefore the patch should be applied 1 to 2 days (24 to 48 hours) before starting cancer treatment.
The drug is intended for use on the skin. This medicine supplies the active substance slowly and steadily through the skin and into the bloodstream throughout the transdermal patch.
Things to remember when using the transdermal patch
- The transdermal patch must not be stored outside the sealed sachet.
- The transdermal patch must not be cut into smaller pieces.
- Use only one transdermal patch at a time.
- When removing the transdermal patch, check your skin and tell your doctor if you notice any severe skin reaction (if your skin is very red, itchy, or if you have blisters).
- The transdermal patch may be affected by direct sunlight or sunlight. While using the transdermal patch, you must have it covered, e.g. under clothing, if there is a risk of exposure to sunlight or sun lamps. Continue to keep the application site covered for another ten days after removing the transdermal patch.
- Contact with water during a bath or shower does not change the effect of SANCUSO. However, it may cause the transdermal patch to partially come off. Avoid exposing the transdermal patch to water for a long time.
- There is no information on the effect of other activities on the transdermal patch, e.g. strenuous exercise or sauna bath, or whirlpool. Therefore, you should avoid these activities while using the transdermal patch.
- Heat (from eg hot water bottles or heating pads) should be avoided in the area where the transdermal patch is located.
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 receive planned cancer treatment. The transdermal patch can be applied up to 2 days (48 hours) before treatment. Let the transdermal patch sit on at all times during the treatment. The transdermal patch can last for up to seven days depending on how long the chemotherapy lasts. Remove the transdermal patch at the earliest 1 day (24 hours) after the end of cancer treatment.
Where to apply the transdermal patch
Put the transdermal patch on a clean, dry and healthy area of skin on the outside of the upper arm. If it is inappropriate to put the transdermal patch on your arms, your doctor may ask you to put it on your stomach. The area you choose must not have oily skin or be freshly shaved. There must also be no skin problems such as. damage (scratches or abrasions) or irritation ( redness or rash). Do not apply SANCUSO to areas that have been treated with creams, oils, lotions, powders, or other skin products that may prevent the transdermal patch from adhering well to the skin.
How to apply the transdermal patch
- Take a sachet out of the box and tear it up at the notch. Each sachet contains a transdermal patch that sits on a rigid plastic film.
- Remove the transdermal patch from the sachet.
3. The sticky side of the transdermal patch is covered by a two-part, 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 together and avoid touching the sticky side of the transdermal patch.
4. Hold the remaining half of the rigid plastic film and place the transdermal patch on the skin on the outside of the upper arm.
5. Remove the remaining half of the rigid plastic film and press the entire transdermal patch firmly with your fingers and smooth it out. Press firmly so that it is guaranteed to have good contact with the skin, especially around the edges.
6. Wash your hands after applying the transdermal patch.
7. Leave the transdermal patch on for the duration of your cancer treatment.
8. Do not reuse the transdermal patch after removing it. See the instructions below on how to remove and dispose of the transdermal patch (see section 5).
After removing the transdermal patch
- The transdermal patch used still contains some granisetron and should be discarded immediately as described in section 5.
- After removing the transdermal patch, sticky material may remain on the skin. Wash the area gently with soap and water to remove it. Alcohol or other solvents such as nail polish remover can irritate the skin and should not be used.
- Wash your hands.
- You can see a slight redness on the skin when the transdermal patch has been removed. This redness should disappear over time. Talk to your doctor if it does not.
If the transdermal patch comes off
If the transdermal patch starts to come off, you can apply the same transdermal patch to the same area of skin. If necessary, you can use surgical dressings or surgical tape to hold the transdermal patch in place. If you lose the transdermal patch or if it is damaged, contact your doctor.
If you use more SANCUSO than you should
If you use more SANCUSO than you should, just remove the extra patch (s) and consult a doctor.
If you forget to use SANCUSO
You must use the medicine according to your doctor’s instructions to prevent nausea or vomiting after the cancer treatment. If you forget to put on the transdermal patch at the right time, put it on as soon as you remember, and tell your doctor as soon as possible before the cancer treatment.
If you stop using SANCUSO
You must use the medicine throughout your cancer treatment (up to seven days) to prevent nausea or vomiting after the cancer treatment. Talk to your doctor if you want to remove the patch before the cancer treatment is over (up to seven days).
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you are receiving cancer treatment that may make you feel unwell or to a high degree, you may still feel unwell despite treatment with anti-nausea medicines, including this medicine.
Tell your doctor immediately if you get constipation or if your stomach hurts or swells. Constipation is a common side effect and occurs in less than 1 in 10 users.
Remove the transdermal patch and tell your doctor if you notice any serious skin reaction (if your skin is very red, itchy, or if you have blisters). Skin reactions at the application site, e.g. irritation, itching, or redness, are less common and occur in less than 1 in 100 users.
Other possible side effects:
Uncommon side effects are:
- headache and a feeling that it spins even when you stand still ( vertigo )
- decreased appetite and weight loss
- herding (or redness )
- nausea, nausea, and dry mouth
- joint pain
- swelling due to water accumulating in the body ( edema )
- changes in liver function tests (if you are going to have blood tests, tell your doctor or nurse that you have received SANCUSO).
Rare side effects (may affect less than 1 in 1,000 people) are:
- abnormal muscle movements (eg tremors, muscle stiffness, and muscle cramps).
Side effects with no known frequency (can not be calculated from the available data):
- allergic skin reactions. These signs may be red, raised, or itchy bumps.
Other possible side effects are associated with granisetron drugs (no known frequency):
- allergic reactions including urticaria (itchy, red, raised skin rash) and anaphylaxis (a severe allergic reaction that may include sudden wheezing, difficulty breathing, swollen eyelids, swollen face, and swollen lips, rash, and itching )
- difficult to sleep / disturbed sleep
- excessive sleepiness
- prolonged ECT interval in ECG (changes in heart rate recording ( ECG ) showing a heart rhythm disorder)
- constipation
- diarrhea
- no energy / weakness / lost strength
How to store SANCUSO
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 carton and sachet after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Used transdermal patches still contain active ingredients that may be harmful to others. Fold the transdermal patch in the middle with the sticky side inwards and throw it away safely, out of the reach of children. 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.
Contents of the packaging and other information
Content declaration
- The active substance is granisetron. Each 52 cm 2 transdermal patch contains 34.3 mg of granisetron which releases 3.1 mg of granisetron in one day.
- Other ingredients are:
- The adhesive of the transdermal patch: copolymer of acrylate and vinyl acetate
- Backing: polyester
- Rigid plastic film: siliconized polyester.
What the medicine looks like and the contents of the pack
SANCUSO is a thin, transparent, rectangular transdermal patch with rounded corners, attached to a rigid plastic film. The transdermal patch is in a sachet. Each carton contains a transdermal patch.
Marketing Authorisation Holder
Kyowa Kirin Holdings BV
Bloemlaan 2
2132NP Hoofddorp
Netherlands
Tel. +31 (0) 237200822
Manufacturer
Parboil Waltrop GmbH (a subsidiary of NextPharma)
I’m Wirrigen 25
45731 Waltrop
Germany