Label: information for the user

Relistor 12 mg/0.6 ml injectable solution

Methyl naltrexone bromide

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. Storage of Relistor

1. Contents of the package and additional information

Relistor contains an active ingredient called methyl naltrexone bromide that acts by blocking the adverse effects of opioid pain medications on the intestine.

It is indicated for the treatment of constipation caused by moderate to strong pain medications called opioids (for example, morphine or codeine). It is used for patients when other constipation medications (laxatives) have not been effective. Your doctor has prescribed you opioids. Your doctor will inform you if you should continue with your usual laxative therapy or discontinue it when you start taking this medication.

This medication should only be used in adults (18 years of age and older).

Do not use Relistor

• If you are allergic to methyl naltrexone bromide or any of the other ingredients in this medication (listed in section 6).
• If you or your doctor suspect that you have or have had intestinal obstruction or if your abdomen requires immediate surgical intervention (this condition must be diagnosed by your doctor)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Relistor

• If you have severe stomach symptoms that persist or worsen, contact your doctor immediately as it could be a perforation of the intestinal wall (intestinal perforation). See section 4.

• If you have Crohn's disease or a gastrointestinal ulcer.
• If you feel unwell, vomit, shake, sweat, have abdominal pain and/or feel your heart rate is rapid just after taking Relistor, speak with your doctor.

• If you have a severe liver or kidney disease.
• If you start to have severe or persistent diarrhea (repeated watery stools), discontinue treatment and consult your doctor immediately.
• It is essential to have a bathroom available and, if needed, have assistance, as you may have a bowel movement within 30 minutes after the medication injection.
• Inform your doctor if you experience persistent stomach pain, nausea, or vomiting, whether they appear for the first time or worsen the ones you already have.
• Inform your doctor if you have had a colostomy, have a peritoneal catheter, or suffer from diverticulitis or fecal impaction, as this medication should be used with caution in these cases.

• If you receive palliative treatment for your advanced disease, this medication should only be used for a limited time, which is usually less than 4 months.
• This medication should not be used to treat patients with constipation not related to opioid use. Inform your doctor if you already had constipation before taking opioid medications (for pain).

Children and adolescents

Do not administer this medication to children and adolescents under 18 years old, as the potential risks and benefits are unknown

Use of Relistor with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may allow you to take other medications, even those you were using before for constipation.

Pregnancy and breastfeeding

The effects of methyl naltrexone bromide on pregnant women are unknown.

Your doctor will decide if you can use Relistor if you are pregnant.

Women using this medication should not be breastfeeding, as it is unknown if methyl naltrexone bromide passes into breast milk.

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

Driving and operating machines

Dizziness is a frequent adverse effect of this medication. This could affect your ability to drive or operate machines.

Important information about some of the components of Relistor

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended dose for patients with chronic pain (except patients receiving palliative treatment for advanced disease) is 12 mg of methyl naltrexone bromide (0.6 ml of solution) administered via subcutaneous injection (under the skin), as needed, at least 4 times a week and no more than once a day (7 times a week).

The recommended dose for patients receiving palliative treatment for advanced disease is 8 mg of methyl naltrexone bromide (0.4 ml of solution) for patients weighing between 38-61 kg or a dose of 12 mg (0.6 ml of solution) for patients weighing between 62-114 kg. The dose is administered every 48 hours (every 2 days) via subcutaneous injection (under the skin).

Your doctor will determine the dose.

This medication is administered via subcutaneous injection under the skin in: (1) the upper part of the legs (thighs), (2) the abdomen (lower part of the abdomen, below the navel) and (3) the upper part of the arms (if not self-administered). (See INSTRUCTIONS FOR PREPARING AND ADMINISTERING A RELISTOR INJECTION).

After receiving the injection, you may experience a bowel movement within a time frame that varies from a few minutes to several hours. Therefore, it is recommended that you have access to a bathroom or a commode nearby.

If you use more Relistor than you should

If you have used more medication than you should have (either because you have injected too much at one time, or because you have used more than one injection in 24 hours), you may experience dizziness when standing up, so inform your doctor or pharmacist immediately. Always carry the medication packaging with you, even if it is empty.

If you forget to use Relistor

If you forget to administer a dose, inform your doctor or pharmacist as soon as possible. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Relistor

Consult with your doctor or pharmacist if you wish to discontinue treatment with this medication.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Cases of intestinal wall perforation (gastroduodenal perforation) have been observed in patients using Relistor. The frequency of this event is unknown based on available data. If you experience severe or persistent stomach pain, stop taking this medication and immediately contact your doctor.

The following adverse effects are very frequent and may affect more than 1 in 10 patients. If you experience any of these adverse effects intensely or persistently, consult your doctor:

• Abdominal pain (stomach pain)
• Nausea
• Diarrhea (frequent liquid stools)
• Flatulence (gas, belching)

Other frequent adverse effects that may affect up to 1 in 10 patients are:

• Dizziness (dizziness)
• Symptoms similar to opioid withdrawal syndrome (such as feeling cold, chills, runny nose, sweating, goosebumps, hot flashes, rapid heartbeat)

• Reactions at the injection site (e.g., itching, burning, pain, redness, inflammation at the site where the medication was injected)
• Vomiting

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and vial after EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Keep the vial and packaging to protect it from light.

Only use this medication if the solution is transparent, colorless to light yellow, and does not contain particles or sediment.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of unused packaging and medication. This will help protect the environment.

Composition of Relistor

Aspect of the product and content of the package

Relistor is an injectable solution. It is transparent, colorless to light yellow and does not contain particles or sediment.

Each vial contains 0.6 ml of solution.

Packages containing more than one vial present cardboard interior packages with: one vial, a 1 ml syringe with a retractable needle and two alcohol-impregnated cotton balls.

The following presentations are available:

1 vial

Package with 2 vials, 2 injection syringes with retractable needles and 4 alcohol-impregnated cotton balls (contains 2 cardboard interior packages)

Package with 7 vials, 7 injection syringes with retractable needles and 14 alcohol-impregnated cotton balls (contains 7 cardboard interior packages).

Only some package sizes may be commercially available.

Marketing Authorization Holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Responsible for manufacturing

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Irlanda

Bausch Health Poland Sp. z o. o.,

ul.Przemyslowa2,

35-959Rzeszów,

Polonia

Przedsiebiorstwo Farmaceutyczne Jelfa SA

ul. Wincentego Pola 21

58-500 Jelenia Góra,

Polonia

Last review date of this leaflet: 11/2023

The detailed information of this medicine is available on the website of the European Medicines Agency (EMA)http://www.ema.europa.eu/.

QUESTIONS FOR THE PATIENT

This section contains important questions that you will have to answer before using and during treatment with Relistor.

If you answer "No" to any of the following questions during the course of your treatment with the medicine, please contact your doctor, nurse or pharmacist.

1. Are you receiving opioid therapy (such as morphine or codeine) for your disease?
2. Have 48 hours or more passed since your last bowel movement?
3. Are you familiar with the technique of self-injection or has your doctor (or nurse or pharmacist) explained it to you?

1. Do you have enough mobility to reach the bathroom, or do you have someone to care for you and help you?
2. Do you have the contact number of your healthcare center?

INSTRUCTIONS FOR PREPARING AND ADMINISTERING A RELISTOR INJECTION

This section is divided into the following sub-sections:

Introduction

Stage 1: Pre-injection instructions

Stage 2: Syringe preparation

Stage 3: Choosing and preparing the injection site

Stage 4a: Injecting Relistor using the package that contains a syringe and retractable needle

Stage 4b: Injecting Relistor using a normal syringe and needle

Stage 5: Waste disposal

Introduction

The following instructions explain how to inject Relistor. Please read them carefully and follow them step by step. Your doctor, nurse or pharmacist will instruct you on the self-administration techniques. Do not attempt to administer an injection until you are sure you know how to do it. This injection should not be mixed with any other medication in the same syringe.

You may have a package that contains a cardboard interior package with everything you need to inject yourself, or you may only have the medicine vial. If you receive only the vial, you will need several cotton balls with alcohol and an injection syringe.

Stage 1: Pre-injection instructions

1. Choose a flat, clean and well-lit surface where you can place the contents of your Relistor package. Make sure you have enough time to complete the injection.

1. Wash your hands thoroughly with soap and water.

1. Prepare the necessary materials for the injection, the Relistor vial, a 1 ml syringe for subcutaneous injection (with or without a retractable needle), 2 alcohol-impregnated cotton balls and a gauze or cotton ball.

1. Make sure the solution inside the vial is transparent, colorless to light yellow and does not contain visible particles. If not, do not use the solution. Contact your pharmacist, nurse or doctor for advice.

Stage 2: Syringe preparation

1. Remove the plastic protective cap from the vial.

1. Clean the rubber stopper of the vial with an alcohol-impregnated cotton ball and place it on the flat surface. Make sure not to touch the rubber stopper again.

1. Take the syringe from its surface. Hold the syringe barrel with one hand and pull the needle cap straight out. Leave the needle cap on the surface. DO NOT touch the needle or let it touch any other surface.

Carefully pull the plunger of the syringe all the way down to the 0.4 ml mark for 8 mg of Relistor or to the 0.6 ml mark for 12 mg of Relistor. Your doctor, nurse or pharmacist will have informed you of the dose prescribed and how often you should inject it. For patients receiving palliative treatment for advanced disease, common doses are included in the following table. Generally, the dose is given every 48 hours (every two days) by subcutaneous injection (under the skin).

For patients with chronic pain (except patients receiving palliative treatment for advanced disease), load the syringe to the 0.6 ml mark for 12 mg of Relistor.

1. Insert the needle straight down into the center of the rubber stopper of the vial. Do not insert the needle at an angle, as it may bend or break. To prevent it from slipping, hold the vial with the other hand on the flat surface. You will feel a slight resistance when the needle penetrates the stopper. Check that the needle tip is inside the vial.

1. Expel the air from the syringe by pushing the plunger gently down to inject air into the Relistor vial.

1. If you are using the syringe with a retractable needle provided, DO NOT PULL THE PLUNGER ALL THE WAY DOWN. Stop pulling the plunger when you feel resistance. If you pull the plunger all the way down, you will hear a "click", which means the safety mechanism has been activated, and the needle will retract into the syringe. If this happens, discard the product and start again with another vial and syringe.

With the needle still in the vial, turn the vial completely around (see figure). Keep the syringe at eye level so you can see the dosing marks and make sure the needle tip is always inside the liquid. Pull the plunger slowly down to the 0.4 ml or 0.6 ml mark on the syringe or as advised by your doctor, nurse or pharmacist, depending on the dose prescribed. You may observe that there is a little liquid or bubbles left in the vial once the syringe has been filled properly, which is normal.

1. With the needle still inserted in the Relistor vial given a turn (inverted), check if there are air bubbles in the syringe. If there are bubbles, gently tap the syringe with your finger to make them rise to the top; keep holding the Relistor vial and the syringe. Push the plunger gently up until all the air bubbles are expelled. If you spill some of the solution in the vial, pull the plunger slowly back to extract the correct amount of solution from the syringe again. Due to the safety design of the syringe, a small air bubble may resist extraction. Do not worry about this, as it will not affect the accuracy of the dose or pose any risk to your health.

1. Make sure you always have the correct dose in the syringe. If you are unsure, contact your doctor, nurse or pharmacist.

1. Remove the syringe and needle from the vial. Keep the needle attached to the syringe. Do not touch the needle or let it touch any surface. Once the medicine has been extracted from the syringe, it must be used within 24 hours, as Relistor is affected by light and may not work properly if left in the syringe for more than 24 hours.

Stage 3: Choosing and preparing the injection site

1. The three body areas recommended for Relistor injection are: (1) upper legs (thighs), (2) abdomen (stomach) and (3) upper arms (only if someone else is giving you the injection).

1. It is recommended to change the injection site each time an injection is administered. Avoid injecting in the same place repeatedly. Do not inject in areas where the skin is sensitive, has bruises, is red or is hard. Avoid areas with scars or stretch marks.

1. To prepare the skin area where Relistor will be injected, clean the injection site with an alcohol-impregnated cotton ball. DO NOT TOUCH THIS AREA AGAIN BEFORE ADMINISTERING THE INJECTION. Let the injection site dry to the air before the injection.

Stage 4a: Injecting Relistor using the package that contains a syringe and retractable needle

1. Hold the syringe filled with the needle pointing upwards, and check the syringe again to see if it contains air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Push the plunger slowly up to expel the air bubbles out of the syringe.

1. Hold the syringe with one hand as if it were a pencil. With the other hand, take a firm grip on a clean area of skin.

1. Insert the needle straight down into the skin at a slight angle (45 degrees) with a quick and short movement.

1. Once the needle is inserted, release the skin grip and push the plunger all the way down to inject Relistor.

1. When you hear a "click", that means all the contents have been injected, and the needle will automatically retract into the syringe. You may experience a small bleeding at the injection site. Press a gauze or cotton ball over the injection site. Do not rub the injection site. If necessary, cover the injection site with a bandage.

Stage 4b: Injecting Relistor using a normal syringe and needle

1. Hold the syringe filled with the needle pointing upwards, and check the syringe again to see if it contains air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Push the plunger slowly up to expel the air bubbles out of the syringe.

1. Hold the syringe with one hand as if it were a pencil. With the other hand, take a firm grip on a clean area of skin.

1. Insert the needle straight down into the skin at a slight angle (45 degrees) with a quick and short movement.

1. Once the needle is inserted, release the skin grip and push the plunger all the way down to inject Relistor.

1. Once the syringe is empty, quickly remove the needle from the skin at the same angle it was inserted. You may experience a small bleeding at the injection site. Press a gauze or cotton ball over the injection site. Do not rub the injection site. If necessary, cover the injection site with a bandage.

Stage 5: Waste disposal

The syringe with the retracted needle or the syringe and needle should never be reused. Never put the needle cap back on the needle. Dispose of the syringe with the retracted needle or the syringe and needle in a puncture-resistant container as instructed by your doctor, nurse or pharmacist.