Granisetron Mylan Generics
ItalyTable of Contents
Patient Information Leaflet
Granisetron Mylan Generics 1 mg film-coated tablets, 2 mg film-coated tablets
granisetron
Generic medicine
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Granisetron Mylan Generics is and what it is used for
- What you need to know before taking Granisetron Mylan Generics
- How to take Granisetron Mylan Generics
- Possible side effects
- How to store Granisetron Mylan Generics
- Contents of the pack and other information
The name of your medicine is Granisetron Mylan Generics 1 mg film-coated tablets or
Granisetron Mylan Generics 2 mg film-coated tablets (referred to as Granisetron Mylan
Generics in the remainder of this leaflet).
1. What Granisetron Mylan Generics is and what it is used for
Granisetron Mylan Generics contains a medicine called granisetron. This medicine belongs to a group of medicines known as “5-HT receptor antagonists” or “antiemetics”. These tablets are for use in adults only.
Granisetron Mylan Generics is used to prevent or treat nausea and vomiting (feeling sick and the urge to vomit) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer.
2. What you need to know before taking Granisetron Mylan Generics
Do not take Granisetron Mylan Generics
If you are allergic to granisetron or to any of the other ingredients of this medicine (listed in
section 6).
If you are unsure, consult your doctor, nurse, or pharmacist before taking this
medicine.
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before taking Granisetron Mylan Generics if:
- you have intestinal motility disorders due to a blockage in your bowel
- you have heart problems, have been treated for cancer with a medicine known to damage the heart, or have problems with levels of salts such as potassium, sodium, and calcium in your body (electrolyte imbalances)
- you are allergic to other "5-HT receptor antagonist" medicines. These include dolasetron and ondansetron, which are used like this medicine in the treatment and prevention of nausea and vomiting.
Serotonin syndrome is an uncommon but potentially life-threatening reaction that
may occur with granisetron. It may cause serious changes in the way the brain, muscles, and
digestive system function (see section 4, “Possible side effects”). This reaction may
occur when taking granisetron alone, but is more likely if you are also taking certain other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine,
citalopram, escitalopram, venlafaxine, duloxetine). Make sure you inform your doctor, nurse, or pharmacist about all medicines you are taking.
Children and adolescents
Children and adolescents must not take this medicine.
Other medicines and Granisetron Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those obtained without a prescription.
This is because Granisetron Mylan Generics may affect how some medicines work. Likewise, some other medicines may affect how this medicine works.
In particular, inform your doctor, nurse, or pharmacist if you are taking the following medicines:
- medicines used to treat irregular heartbeat
- medicines that may cause irregular heartbeat as a possible side effect, such as dolasetron, ondansetron
- phenobarbital, a medicine used to treat epilepsy
- a medicine called ketoconazole, used to treat fungal infections
- the antibiotic erythromycin, used to treat bacterial infections
- medicines known as selective serotonin reuptake inhibitors (SSRIs), used to treat depression and/or anxiety, such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
- medicines known as serotonin-noradrenaline reuptake inhibitors (SNRIs), used to treat depression and/or anxiety, such as venlafaxine, duloxetine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding,
ask your doctor, nurse, or pharmacist for advice before taking this medicine.
You should normally not take this medicine during pregnancy. It is not known whether this
medicine passes into breast milk.
Driving and using machines
Granisetron Mylan Generics normally has no or a negligible effect on the ability to drive or
use tools or machines.
Granisetron Mylan Generics contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
3. How to take Granisetron Mylan Generics
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.
The tablets should be swallowed whole with water.
The dose of Granisetron Mylan Generics varies from patient to patient. It depends on your age, weight, and whether the medicine is being given to prevent or treat nausea and vomiting. Your doctor will decide the correct dose for you.
Prevention of nausea or vomiting
The first dose of Granisetron Mylan Generics is usually given one hour before radiotherapy or chemotherapy. The recommended dose is one 1 mg tablet twice daily or one 2 mg tablet once daily, for up to one week after radiotherapy or chemotherapy.
Treatment of nausea or vomiting
The recommended dose is one 1 mg tablet twice daily or one 2 mg tablet once daily.
If you take more Granisetron Mylan Generics than you should
If you have taken too many Granisetron Mylan Generics tablets, contact your doctor or nurse. Symptoms of overdose may include mild headache. You will be treated according to your symptoms.
If you forget to take a dose of Granisetron Mylan Generics
If you think you have missed a dose of your medicine, speak to your doctor or nurse.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Granisetron Mylan Generics
Do not stop taking the medicine before the treatment is complete. If you stop treatment prematurely, symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, nurse, or pharmacist.
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 side effects, you must contact your doctor immediately or go
straight to the nearest hospital:
Uncommon (may affect up to 1 in 100 people)
- allergic reactions (anaphylaxis). Signs may include swelling of the throat, face, lips, mouth or other parts of the body, difficulty breathing or swallowing, skin rash, itching or hives
- changes in heart rate (rhythm) and abnormalities observed on ECG (electrical recording of heart activity)
- serotonin syndrome: signs may include diarrhea, nausea, vomiting, high body temperature and elevated blood pressure, excessive sweating, rapid heartbeat, agitation, confusion, hallucinations, shivering, tremors, muscle jerks or stiffness, loss of coordination and restlessness.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
- headache
- constipation. Your doctor will monitor your condition
Common (may affect up to 1 in 10 people)
- difficulty sleeping (insomnia)
- changes in liver function seen in blood tests
- diarrhea
Uncommon (may affect up to 1 in 100 people)
- skin rashes
- involuntary abnormal movements, including tremors, muscle stiffness, and muscle contractions
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Granisetron Mylan Generics
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Granisetron Mylan Generics contains
The active substance is granisetron hydrochloride. Each tablet contains 1 mg or 2 mg of granisetron in
the form of granisetron hydrochloride.
The other ingredients (excipients) are monohydrate lactose (see section 2 “Granisetron Mylan
Generics contains lactose and sodium”), microcrystalline cellulose, magnesium stearate, titanium dioxide
(E171), sodium starch glycolate, macrogol, hypromellose and polysorbate.
Description of the appearance of Granisetron Mylan Generics tablets and package contents
The tablets are round, white to almost white in colour. The 1 mg tablet is marked with “GS” on one
side and is smooth on the other side, while the 2 mg tablet is marked with “GS2” on one
side and is smooth on the other side.
Granisetron Mylan Generics is available in blisters containing 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100,
150, 200, 250 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Manufacturers responsible for batch release:
Generics UK Ltd
Station Close, Potters Bar
Hertfordshire EN6 1TL
United Kingdom
McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
This medicinal product is authorised in the European Economic Area Member States under the
following names
Italy: Granisetron Mylan Generics tablets 1 mg film-coated tablets
Granisetron Mylan Generics tablets 2 mg film-coated tablets
Slovakia: Granisetron Mylan 1 mg
Czech Republic: GRANISETRON MYLAN 1 mg, potahované tablety
Hungary: Granigen 1 mg filmtabletta
Netherlands: Granisetron Mylan 1 mg, filmomhulde tabletten
Granisetron Mylan 2 mg, filmomhulde tabletten