GRANISETRON AUROVITAS SPAIN 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Granisetron Aurovitas Spain 1 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Granisetron Aurovitas Spain and what is it used for
2. What you need to know before you take Granisetron Aurovitas Spain
3. How to take Granisetron Aurovitas Spain
4. Possible side effects
5. Storage of Granisetron Aurovitas Spain

1. Contents of the pack and further information

1. What is Granisetron Aurovitas Spain and what is it used for

Granisetron Aurovitas Spain contains a medicine called granisetron. This belongs to a group of medicines called serotonin receptor antagonists, 5-HT3, or “antiemetics”, which means they prevent or stop nausea and vomiting. These tablets are only for adults.

Granisetron Aurovitas Spain is used to prevent and treat nausea and vomiting (feeling sick) caused by certain treatments such as chemotherapy or radiotherapy in anticancer therapy.

2. What you need to know before you take Granisetron Aurovitas Spain

Do not take Granisetron Aurovitas Spain

• if you are allergic to granisetron (hypersensitive) or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, consult your doctor, nurse or pharmacist before taking these tablets.

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Granisetron Aurovitas Spain, especially:

• if you have problems with constipation due to intestinal obstruction
• if you have heart problems, are receiving anticancer medicines that can harm your heart and/or have any disorder of the levels of salts such as potassium, sodium or calcium (electrolyte disturbances)
• if you are taking another medicine from the group of “5-HT3 receptor antagonists”. This group includes dolasetron and ondansetron, used like Granisetron Aurovitas Spain, for the treatment and prevention of nausea and vomiting.

Serotonin syndrome is a rare but potentially life-threatening reaction that can occur with granisetron (see section 4). It can cause serious changes in how your brain, muscles, and digestive system work. The reaction can occur if you take granisetron alone but is more likely to occur if you take granisetron with other medicines (in particular fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Make sure to tell your doctor, nurse or pharmacist about all the medicines you are taking.

Children

Children should not take these tablets.

Other medicines and Granisetron Aurovitas Spain

Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription. This is because Granisetron Aurovitas Spain may interact with some medicines. Also, some medicines may interact with these tablets.

Tell your doctor or nurse if you are taking or might take any of the following medicines:

• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. For example: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (serotonin-noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. For example: venlafaxine, duloxetine
• medicines used to treat irregular heartbeats, other “5-HT3 receptor antagonists” such as dolasetron or ondansetron (see “Warnings and precautions”)
• phenobarbital, a medicine used to treat epilepsy
• ketoconazole, a medicine used to treat fungal infections
• erythromycin, an antibiotic used to treat bacterial infections.

Taking Granisetron Aurovitas Spain with food and drinks

You can take Granisetron Aurovitas Spain with or without food. Each tablet should be swallowed with a little water.

Pregnancy, breastfeeding and fertility

Do not take these tablets if you are pregnant, trying to become pregnant or are breastfeeding, unless your doctor has told you to.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine.

Driving and using machines

Granisetron Aurovitas Spain has no or negligible influence on the ability to drive and use machines.

Granisetron Aurovitas Spain contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Granisetron Aurovitas Spain contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Granisetron Aurovitas Spain

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Each tablet should be swallowed whole with water.

The recommended dose of Granisetron Aurovitas Spain varies from one patient to another. It depends on age, weight, and whether you are taking other medicines to prevent or treat nausea and vomiting. Your doctor will decide how much you should take.

Prevention of nausea or vomiting (feeling sick)

The first dose of Granisetron Aurovitas Spain should be taken one hour before starting radiotherapy or chemotherapy treatment. The dose will be one 1 mg tablet twice a day or two 1 mg tablets once a day or one 2 mg tablet once a day for up to one week after radiotherapy or chemotherapy.

Treatment of nausea or vomiting (feeling sick)

The dose is usually one 1 mg tablet twice a day or two 1 mg tablets once a day or one 2 mg tablet once a day.

If you take more Granisetron Aurovitas Spain than you should

If you think you have taken more tablets than you should, tell your doctor or nurse. Symptoms of overdose include mild headache. You will be treated according to your symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Granisetron Aurovitas Spain

If you think you have missed a dose, ask your doctor or nurse.

Do not take a double dose to make up for forgotten doses.

If you stop taking Granisetron Aurovitas Spain

Do not stop taking your medicine before your treatment has finished. If you stop taking the treatment, your symptoms may come back.

If you have any other questions about 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 side effects, you should see your doctor immediately:

• allergic reactions (anaphylaxis). The signs can include swelling of the throat, or your face, lips and mouth become swollen, and difficulty breathing or swallowing.

Other side effects that may occur while taking this medicine are:

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),
• blood tests show changes in liver function,
• diarrhea.

Uncommon: may affect up to 1 in 100 people

• Serotonin syndrome. The signs can include diarrhea, nausea, vomiting, fever and high blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucinations, chills, muscle spasms, shaking or stiffness, loss of coordination and restlessness,

• skin rash or an allergic reaction or hives. The signs can include red spots that itch,
• changes in heartbeats (rhythm) and changes in the ECG (electrocardiogram),
• abnormal involuntary movements, such as tremors, muscle stiffness and muscle contractions.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Granisetron Aurovitas Spain

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

Store in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Granisetron Aurovitas Spain

• The active substance is granisetron (as granisetron hydrochloride), 1 mg.
• The other ingredients are:
• • Core of the tablet: lactose, microcrystalline cellulose, sodium starch glycolate (type A) potato, hypromellose, magnesium stearate.
  • Coating of the tablet: Opadry II 85F 18378 white (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).

Appearance of the product and pack size

Appearance:

Triangular, biconvex, film-coated tablet, white and marked with “G1” on one side.

PACK SIZE:

Blister packs of 5, 10 and 100 (10x10) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of last revision of this leaflet: April 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)