1 mg and 2 mg film-coated tablets
granisetron
What Granisetron STADA is and what it is used for
Granisetron Stada contains the active substance granisetron. It belongs to a group of medicines called ‘5 ‑ HT 3 receptor antagonists’ or ‘antiemetics’ (medicines that prevent nausea and vomiting). These tablets are used for adults only.
Granisetron Stada is used to prevent and treat nausea and vomiting caused by other medical treatments, such as chemotherapy and radiation therapy for cancer.
Granisetron contained in Granisetron Stada may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Granisetron STADA
Do not take Granisetron STADA
- if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor, pharmacist, or nurse before taking these tablets.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking these tablets, especially if you:
- have problems with your bowel movements due to blockages in the intestines.
- have heart problems, are treated for cancer with a drug that is known to be harmful to the heart or have problems with salt levels in the body, such as potassium , sodium or calcium (electrolyte changes).
- take another medicine that is “5-HT 3 receptor antagonists”. This includes dolasetron, ondansetron which is used in the same way as Granisetron Stada to treat and prevent nausea and vomiting.
Serotonin syndrome is a less common but possibly life-threatening reaction that may occur with the use of granisetron (see section 4). It can cause serious changes in the functioning of your brain, muscles, and digestive system. The reaction may occur if you take granisetron alone but are more likely if you take granisetron with certain other medicines (especially fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlaflaxine, duloxetine). Tell your doctor, pharmacist, or nurse about any medicines you are taking.
Children
Children should not take these tablets.
Other medicines and Granisetron STADA
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Granisetron Stada may affect the way some medicines work. Some other medicines may also affect the way these tablets work.
In particular, tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:
- drugs used to treat irregular heartbeats
- other medicines that are “5 ‑ HT 3 receptor antagonists” such as dolasetron or ondansetron (see “Warnings and Precautions” above)
- phenobarbital, a drug used to treat epilepsy
- a drug called ketoconazole used to treat fungal infections
- the antibiotic erythromycin used to treat bacterial infections
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and / or anxiety. For example fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram
- SNRIs ( serotonin noradrenaline uptake inhibitors) used to treat depression and / or anxiety. For example venlafaxine , duloxetine.
Pregnancy and breastfeeding
You should not take these tablets if you are pregnant, planning to become pregnant, or breastfeeding unless your doctor tells you to.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Driving and using machines
Granisetron Stada has no or negligible influence on your ability to drive or use tools and machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Granisetron STADA contains lactose and sodium
Lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, is essential ‘sodium-free. is next to “sodium-free”.
How to use Granisetron STADA
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
The recommended dose varies from one patient to another. It depends on your age, weight, and whether you are receiving the medicine to prevent or treat nausea and vomiting. Your doctor will calculate the dose you should receive.
To prevent nausea or vomiting
The first dose of Granisetron Stada is usually given one hour before radiation therapy or chemotherapy. Dose one will either be:
- a 1 mg tablet twice daily or
- two 1 mg tablets once daily or
- one 2 mg tablet once daily
for up to one week after the radiotherapy or chemotherapy.
Treatment for nausea or vomiting
Dose one will usually be either:
- a 1 mg tablet twice daily or
- two 1 mg tablets once daily or
- one 2 mg tablet once daily.
If you take more Granisetron STADA than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center on tel. 112 for assessment of the risk and advice.
Symptoms of overdose include mild headache. You will be treated depending on your symptoms.
If you forget to take Granisetron STADA
If you forget to take your medicine, talk to your doctor, pharmacist or nurse.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Granisetron STADA
Do not stop taking your medicine until the treatment is finished. If you stop taking the medicine, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following problems, see a doctor immediately:
- allergic reactions ( anaphylaxis ). Signs of this may be swelling of the throat, face, lips and mouth, difficulty breathing and swallowing.
Other side effects that may occur when you take this medicine are:
Very common (may affect more than 1 user in 10):
- headache
- constipation. Your doctor will examine you.
Common (may affect up to 1 in 10 people):
- sleep problems (insomnia)
- Changes in the way your liver works are shown by blood tests
- diarrhea.
Uncommon (may affect up to 1 in 100 people):
- skin rash or an allergic skin reaction or hives ( urticaria ). Signs of this may be red, raised itchy rashes
- altered heartbeat (rhythm) and changes seen on ECG (electrical recording of the heart)
- abnormal involuntary movements, such as tremors, muscle stiffness and muscle contractions
- serotonin syndrome. Symptoms may include diarrhea, nausea, vomiting, fever, high blood pressure , excessive sweating and rapid heartbeat , agitation, confusion, hallucinations, chills, muscle tremors, twitching or stiffness, loss of coordination and restlessness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Granisetron STADA
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 blister and the carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is granisetron.
Each 1 mg film-coated tablet contains 1 mg granisetron (as hydrochloride).
Each 2 mg film-coated tablet contains 2 mg granisetron (as hydrochloride).
Other ingredients are:
Lactose monohydrate, microcrystalline cellulose (E460), hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433).
What the medicine looks like and contents of the pack
Granisetron Stada 1 mg tablets are round, white or whitish film-coated tablets, marked with “GS” on one side and without labeling on the other side.
Granisetron Stada 2 mg tablets are round, white or whitish film-coated tablets, marked with “GS2” on one side and without labeling on the other side.
Pack sizes
- Granisetron Stada 1 mg tablets: blisters of 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100, 150, 200, 250, 500 white tablets.
- Granisetron Stada 2 mg tablets: blisters of 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100, 150, 200, 250, 500 white tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands.
Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany
STADAPHARM GmbH, Feodor-Lynen-Strasse 35, 30625 Hanover, Germany.
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark