Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Granisetron may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
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. 2.
e 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-sickness medicines whose name ends in "setron" e.g. ondansetron. Warnings and precautions Tell your doctor or nurse before using this treatment if any of the following applies to you: –
if you have been told you have a heart disorder or disease if you have pain in your stomach or your stomach is swollen if you have problems with your kidneys or liver.
1
This medicine may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds. It is important to do the following: while you wear the transdermal patch, keep it covered with clothing if you will be in sunlight or near a sunlamp, including tanning beds keep the skin where this medicine was applied covered for another 10 days after the transdermal patch is taken off to protect from exposure to direct sunlight. It is not known how activities such as swimming, strenuous exercise or using a sauna or whirlpool, may affect this medicine. Avoid these activities while wearing this transdermal patch. You can continue to shower and wash normally while wearing the transdermal patch. External heat, for example from hot water bottles or heat pads, should be avoided on the area of the transdermal patch. Children and adolescents This medicine should not be used by children or adolescents under 18 years. Other medicines and SANCUSO Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. SANCUSO can affect the way some medicines work. Also, some other medicines can affect the way SANCUSO works. In particular, tell your doctor or nurse if you are taking the following medicines: Paracetamol, used to treat pain. Phenobarbital, used to treat epilepsy. Ketoconazole, used to treat fungal infections. SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram. SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine. Buprenorphine, Opioids or other serotonergic medicines. Pregnancy and breast-feeding Do not use this medicine if you are pregnant unless your doctor has specifically recommended it. Stop breast-feeding while wearing the patch. If you are pregnant or breast-feeding, 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 your ability to drive or use any machines. 3.
SANCUSO
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.
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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. 4.
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. 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. 3
5. 6. 7. 8.
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. Wash your hands after applying the transdermal patch. Keep the transdermal patch in place for the whole time you are having chemotherapy. 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 use more SANCUSO than you should If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your doctor. If you forget to use SANCUSO It is important to use this medicinal product as instructed by your doctor to prevent you feeling sick or being sick following your chemotherapy. If you have forgotten to apply your transdermal patch at the right time, apply it as soon as you remember, and tell your doctor as soon as possible before your chemotherapy treatment. If you stop using SANCUSO It is important to use this medicine during the whole length of your chemotherapy (up to 7 days) to prevent you feeling sick or being sick following your chemotherapy. Talk to your doctor if you want to remove the patch before the end of your chemotherapy treatment course (up to 7 days). If you have any further questions on the use of this medicine, ask your doctor or nurse. 4.
Possible side effects
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:
•
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.
Other possible side effects: Uncommon side effects are: headache, a feeling of "spinning" even when you are standing still (vertigo) decreased appetite, weight loss flushing (or redness) feeling sick (nausea), retching, dry mouth pain in your joints swelling due to water retention (oedema) changes in liver function tests (if you are having blood tests, tell the doctor or nurse that you have been given SANCUSO). Rare side effects (may affect up to 1 in 1,000 people) are: abnormal muscle movements (such as shaking, muscle rigidity and muscle contractions).
with a frequency not known (cannot be estimated from available data): allergic skin reactions. The signs may include red, raised itchy bumps Other possible side effects associated with granisetron products (frequency not known): Allergic reactions including urticaria (itchy, red, raised skin rash) and anaphalaxis (a serious allergic reaction which may include sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching) Difficulty sleeping/disturbed sleep Excessive sleepiness Prolonged QT interval in the ECG (changes to the heart rate trace (ECG) indicating a heart rhythm disorder) Constipation Diarrhoea Lack of energy/weakness /Loss of strength Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme – Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
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 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.
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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. 6.
What SANCUSO contains The active substance is granisetron. Each 52 cm2 transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron in 24 hours. The other ingredients are: Transdermal patch adhesive: acrylate-vinylacetate copolymer Backing layer: polyester Rigid plastic film: siliconised polyester What SANCUSO looks like and contents of the pack SANCUSO is a thin, clear, rectangular-shaped transdermal patch with rounded corners, stuck onto a rigid plastic film. The transdermal patch is contained in a sachet. Each carton contains one transdermal patch. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Grünenthal Limited TOR Building, Saint Cloud Way, Maidenhead, Berkshire, SL6 8BN United Kingdom Manufacturer Pharbil Waltrop GmbH (a subsidiary of NextPharma) Im Wirrigen 25 45731 Waltrop Germany This leaflet was last revised in 01/2025
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SANCUSO 3.1 mg/24 hours transdermal patch comes as patch containing 3.1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in SANCUSO 3.1 mg/24 hours transdermal patch is granisetron.
This leaflet reproduces the patient information leaflet approved for SANCUSO 3.1 mg/24 hours transdermal patch, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
SANCUSO transdermal patch is indicated in adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti‑emetic administration is complicated by factors making swallowing difficult (see section 5.1).
Posology
Adults
Apply a single transdermal patch 24 to 48 hours before chemotherapy, as appropriate.
Due to a gradual increase in plasma levels of granisetron following application of the transdermal patch, a slower onset of efficacy compared to 2 mg oral granisetron may be observed at the start of chemotherapy; the patch should be applied 24‑48 hours before chemotherapy.
The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy. The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.
Following routine haematological monitoring, the transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed in order to reduce the possibility of unnecessary exposure to granisetron.
Use of concomitant corticosteroids
The Multinational Association of Supportive Care in Cancer (MASCC) guidelines recommend the administration of dexamethasone with 5HT3 antagonist prior to chemotherapy. In the pivotal SANCUSO study, the concomitant use of corticosteroids, e.g. dexamethasone, was permitted provided it was part of the chemotherapy regimen. Any increase in corticosteroid use during the study was reported as rescue treatment.
Special populations
Elderly
Dosing as for adults (see sections 4.4 and 5.2).
Renal or hepatic impairment
No dose adjustment is necessary. Dosing as for adults (see sections 4.4 and 5.2). Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Paediatric population
The safety and efficacy of SANCUSO in children aged 0 to 18 years have not yet been established. No data are available.
Method of administration
The transdermal patch should be applied to clean, dry, intact healthy skin on the outer part of the upper arm. If it is not possible to apply the transdermal patch to the arm, it can be applied to the abdomen.
The transdermal patch should not be placed on skin that is red, irritated or damaged.
Each transdermal patch is packed in a sachet and should be applied directly after the sachet has been opened. The release liner is removed prior to application.
The transdermal patch should not be cut into pieces.
In the event of a transdermal patch becoming completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary). If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch. If this is not possible, a new transdermal patch should be applied on the opposite arm. The newly applied transdermal patch should be removed in line with the timing recommended above.
Hypersensitivity to the active substance, to other 5‑HT3 receptor antagonists or to any of the excipients listed in section 6.1.
Application site reactions
In clinical trials with SANCUSO, application site reactions were reported which were generally mild in intensity and did not lead to discontinuation of use. If severe reactions, or a generalised skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
Gastrointestinal disorders
Granisetron may mask a progressive ileus and/or gastric distension caused by an underlying condition. Patients with signs of sub‑acute intestinal obstruction should be monitored following its administration, as granisetron may reduce lower bowel motility.
Cardiac disorders
5‑HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. This may potentially have clinical significance in patients with pre‑existing arrhythmias or cardiac conduction disorders and/or treated with antiarrhythmics or beta blockers. No clinically relevant effects have been observed in clinical studies with SANCUSO.
Exposure to sunlight
Granisetron may be affected by direct natural or artificial sunlight, see section 5.3 for further information. Patients must cover the transdermal patch application site, e.g. with clothing, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal.
Showering or washing
Showering or washing normally can be continued while wearing SANCUSO. Activities such as swimming, strenuous exercise or using a sauna should be avoided.
External heat
External heat (for example hot water bottles or heat pads) should be avoided on the area of the transdermal patch.
Special populations
No dose adjustments are necessary for the elderly or patients with renal or hepatic impairment. Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Serotonin syndrome
There have been reports of serotonin syndrome with the use of 5‑HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs). There have also been reports of possible drug-drug interactions between buprenorphine/Opioids and serotonergic medicinal products leading to serotonin syndrome. Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Skin Reactions
In clinical studies with granisetron transdermal patch, application site reactions generally mild in intensity were reported and did not lead to discontinuation of use. If severe reactions, or a generalised skin reaction occur (e.g. allergic rash, including erythematous, macular, papular rash or pruritus), the transdermal patch must be removed.
Potential for drug abuse and dependence
Granisetron has no known potential for abuse and dependence.
For serotonergic medicinal products (e.g. SSRIs and SNRIs, buprenorphine, opiods or other serotonergic medicinal products), there have been reports of serotonin syndrome following concomitant use of 5‑HT3 antagonists and other serotonergic medicinal products (including SSRIs and SNRIs).
Co-administration of intravenous 5‑HT3 receptor antagonists with oral paracetamol in human subjects has been reported to result in a block in the analgesic effect via a pharmacodynamic mechanism.
As granisetron is metabolised by hepatic cytochrome P450 active substance-metabolising enzymes (CYP1A1 and CYP3A4), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron.
In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma clearance (approximately 25%) following intravenous administration of granisetron.
In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family. The clinical significance of this is unknown.
In vitro studies using human microsomes indicate that granisetron neither stimulates nor inhibits the cytochrome P450 enzyme system.
In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).
No clinically relevant interactions between SANCUSO and emetogenic cancer chemotherapies have been seen. Furthermore, no interaction has been observed between granisetron and emetogenic cancer therapies. In agreement with these data, no clinically relevant interactions have been reported in clinical studies with SANCUSO. In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of granisetron.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
There are limited amount of data (less than 300 pregnancy outcomes) from the use of granisetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of SANCUSO during pregnancy.
Breast-feeding
It is unknown whether granisetron or its metabolites are excreted in human milk. Breast‑feeding should be discontinued during treatment with SANCUSO.
Fertility
There are no data on the effect of granisetron on human fertility.
The effect of SANCUSO on the ability to drive or operate machinery has not been studied.
Summary of the safety profile
The safety profile of SANCUSO is derived from controlled clinical trials and from post‑marketing experience. The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 8.7% of patients. The majority of adverse reactions were mild or moderate in severity.
Tabulated list of adverse reactions
Adverse reactions from clinical studies and spontaneous reports with SANCUSO are listed in the table below.
Within the system organ class, the adverse reactions are listed by frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Adverse reactions are presented in order of decreasing seriousness within each frequency grouping.
Table 1: Adverse reactions reported for SANCUSO
System Organ Class
Adverse reaction
Frequency
Immune system disorder
Hypersensitivity reactions
Not known
Metabolism and nutrition disorders
Decreased appetite
Uncommon
Nervous system disorders
Headache
Uncommon
Dystonia
Rare
Dyskinesia
Rare
Serotonin syndrome
Unknown
Ear and labyrinth disorders
Vertigo
Uncommon
Vascular disorders
Flushing
Uncommon
Gastrointestinal disorders
Constipation
Common
Dry mouth, nausea, retching
Uncommon
Hepatobiliary disorders
Alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased
Uncommon
Musculoskeletal and connective tissue disorders
Arthralgia
Uncommon
General disorders and administration site conditions
Generalised oedema
Uncommon
Application site irritation*
Uncommon
Application site reactions**
Unknown
* Application site irritation includes: Application site pruritus and Skin irritation (Spontaneous reports)
**Application site reactions includes: Application site erythema, Application site rash, Application site pain, Application site hypersensitivity, Application site vesicles, Application site burn, Application site urticaria and Application site discolouration.
Description of selected adverse reactions
Patients who are being treated with moderately or highly emetogenic chemotherapy may still experience vomiting despite treatment with antiemetic therapy, including SANCUSO.
Serotonin Syndrome
There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone, but mostly in combination with other serotonergic medicinal products (including Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Noradrenaline (norepinephrine) Reuptake Inhibitors (SNRIs)). There have also been reports of possible drug-drug interactions between buprenorphine/Opioids and serotonergic medicinal products leading to serotonin syndrome (see section 4.5). Appropriate observation of patients for serotonin syndrome-like symptoms is advised.
Class effects
Class effects for granisetron seen with other formulations (oral and intravenous) include the following:
- Hypersensitivity reactions, e.g. anaphylaxis, urticaria
- Insomnia
- Headache
- Extrapyramidal reactions
- Somnolence
- Dizziness
- QT prolongation
- Constipation
- Diarrhoea
- Elevated hepatic transaminases
- Rash
- Asthenia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme - Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There is no specific antidote for granisetron. In the event of overdose, the transdermal patch should be removed. Symptomatic treatment should be given.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about SANCUSO 3.1 mg/24 hours transdermal patch. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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