Granisetron Aurovitas Spain 1 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Granisetron Aurovitas Spain 1 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.4.

Contents of the leaflet

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

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

3. How to take Granisetron Aurovitas Spain

4. Possible side effects

5. How to store Granisetron Aurovitas Spain

6. Contents of the pack and other information

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

Granisetrón Aurovitas Spain contains a medicine called granisetron. It belongs to a group of medicines known as serotonin 5-HT3 receptor antagonists, or "antiemetics", which means they prevent or reduce nausea and vomiting. These tablets are indicated only in adults.

Granisetrón Aurovitas Spain is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiotherapy in anticancer therapy.

2. What you need to know before taking Granisetrón Aurovitas Spain

Do not take Granisetrón Aurovitas Spain

• if you are allergic to granisetron (hypersensitive) 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 these tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Granisetrón Aurovitas Spain, especially:

• If you have constipation due to intestinal obstruction
• If you have heart problems, are receiving anticancer medicines that may harm your heart and/or suffer from electrolyte imbalances such as low levels of 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, which, like Granisetrón Aurovitas Spain, are used to treat and prevent nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction that may occur with granisetron (see section 4). It may cause serious changes in how your brain, muscles and digestive system function. The reaction may occur when taking granisetron alone, but is more likely if you are taking granisetron together with other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Make sure to inform your doctor, nurse or pharmacist about all medicines you are taking.

Children

Children must not take these tablets.

Other medicines and Granisetrón Aurovitas Spain

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might need to take any other medicines, including those obtained without a prescription. This is because Granisetrón Aurovitas Spain may interact with certain medicines. Also, some medicines may interact with these tablets.

Inform your doctor or nurse if you are taking or may have taken 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-norepinephrine reuptake inhibitors) used to treat depression and/or anxiety. For example: venlafaxine, duloxetine
• medicines used to treat irregular heartbeats, other "5-HT3 receptor antagonist" medicines 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 Granisetrón Aurovitas Spain with food and drinks

You may take Granisetrón 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 breastfeeding, unless your doctor has told you to do so.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, nurse or pharmacist before using this medicine.

Driving and using machines

The effect of Granisetrón Aurovitas Spain on the ability to drive and use machines is none or negligible.

Granisetrón Aurovitas Spain contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Granisetrón Aurovitas Spain contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take Granisetron Aurovitas Spain

Follow exactly the instructions for the use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Each tablet should be swallowed whole with water.

The recommended dose of Granisetron Aurovitas Spain varies from patient to patient. 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 of discomfort)

The first dose of Granisetron Aurovitas Spain should be administered one hour before starting radiotherapy or chemotherapy treatment. The dose will be one 1 mg tablet twice daily, or two 1 mg tablets once daily, or one 2 mg tablet once daily, with treatment lasting up to one week after radiotherapy or chemotherapy.

Treatment of nausea or vomiting (feeling of discomfort)

The usual dose is one 1 mg tablet twice daily, or two 1 mg tablets once daily, or one 2 mg tablet once daily.

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 may include mild headache (cephalalgia). You will be treated according to your symptoms.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Granisetron Aurovitas Spain

If you think you have missed a dose of your medicine, 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 the end of the treatment. If you interrupt the treatment, your symptoms may return.

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you notice any of the following adverse effects, you must immediately consult your doctor:

• allergic reactions (anaphylaxis). Signs may include throat swelling, or swelling of the face, lips, and mouth, and difficulty breathing or swallowing.

Other adverse 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. Signs may include diarrhea, nausea, vomiting, high fever and high blood pressure, excessive sweating and rapid heart rate, agitation, confusion, hallucinations, chills, muscle spasms, twitching or stiffness, loss of coordination, and restlessness,

• skin rashes or an allergic reaction or urticaria. Signs may include itchy red spots,

• changes in heart rhythm (rhythm) and changes in the ECG (electrocardiogram),

• abnormal involuntary movements, such as tremors, muscle rigidity, and muscle contractions.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 packaging to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Granisetron Aurovitas Spain

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

Appearance of the product and contents of the pack

Appearance:

White, triangular, biconvex, film-coated tablet, marked with "G1" on one side.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel: 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 the most recent review of this leaflet: April 2022

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