12 mg / 0.6 ml solution for injection
Methylnaltrexone bromide
What Relistor is and what it is used for
Relistor contains an active substance called methylnaltrexone bromide, which works by blocking the side effects of opioid painkillers that affect the intestines.
Relistor treats constipation caused by medicines for moderate to severe pain called opioids (eg morphine, codeine ). It is used in patients when the effect of other medicines for constipation, called laxatives, has been insufficient. Opioids are prescribed by doctors. Your doctor will tell you if you should stop taking or continue to take your regular laxatives when you start using this medicine.
This medicine should only be used by adults (18 years and older).
What you need to know before using Relistor
Do not use Relistor
- If you are allergic to methylnaltrexone bromide or any of the other ingredients of this medicine (listed in section 6).
- If you or your doctor know that you have a bowel obstruction (intestinal obstruction) or if you need immediate abdominal surgery (which has been diagnosed by your doctor).
Warnings and cautions
Talk to your doctor or pharmacist before using Relistor
- If you have severe stomach symptoms that are persistent or worsening, contact your doctor immediately as these may be symptoms that a hole is forming in the intestinal wall (intestinal perforation). See section 4.
- If you have Crohn’s disease or ulcers in the gastrointestinal tract
- If you feel nauseous, vomit, shiver, sweat, have abdominal pain, and/or feel your heart beat faster shortly after taking Relistor, talk to your doctor.
- If you have severe liver or kidney disease.
- If you have severe or persistent diarrhea (repeated watery stools), you should stop treatment and contact a doctor immediately.
- It is important to be close to a toilet with help if needed, as bowel movements can occur within 30 minutes after injection of the drug.
- Tell your doctor if you experience abdominal pain that continues, (feels) nausea or vomiting (vomiting) that is new or gets worse.
- Also tell your doctor if you have a colostomy, peritoneal catheter (a tube that goes into your abdomen), or suffer from the diverticular disease (intestinal pockets) or fecal matter, as this medicine should be used with caution in such cases.
- If you are receiving treatment to relieve pain and suffering ( palliative care) for your severe illness, this medicine will only be used for a limited time, usually less than 4 months.
- This medicine should not be used to treat patients with constipation that is not related to opioid use. Tell your doctor if you have previously suffered from constipation after using opioids (for pain).
Children and young people
Do not give this medicine to children and adolescents under 18 years of age, as the potential risk and benefits are not known.
Other drugs and Relistor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may allow you to take other medicines, including those used for constipation.
Pregnancy and breastfeeding
The effects of methylnaltrexone bromide in pregnant women are not known. Your doctor will decide if you can use Relistor if you are pregnant.
Women who use this medicine should not breastfeed because it is not known if methylnaltrexone bromide passes into human breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Dizziness is a common side effect of this medicine. This can affect your ability to drive and use machines.
Relistor contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How to use Relistor
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for patients with long-term pain (except for patients receiving palliative care for severe illness) is 12 mg methylnaltrexone bromide (0.6 ml solution) given as an injection under the skin if necessary, but at least 4 times a week and up to once a day (7 times a week).
The recommended dose for patients receiving palliative care in severe disease is 8 mg methylnaltrexone bromide (0.4 ml solution) for patients weighing 38-61 kg or 12 mg (0.6 ml solution) for patients weighing 62-114 kg. Dose one is given every 48 hours (every other day) as an injection under the skin.
Your doctor will decide what dose you should take.
This medicine is given as an injection under the skin (as a subcutaneous injection ) in either (1) the thighs, (2) the abdomen (stomach), or (3) the upper arm (not by self-injection). (See INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION WITH RELISTOR at the end of this leaflet.)
You can get a bowel movement within minutes to a couple of hours after injection one. You should therefore have access to a toilet or basin nearby.
If you use more Relistor than you should
If you have used more of this medicine than you should (either by injecting too much at one time or by using more than one injection in 24 hours) you may feel dizzy when you get up, contact your doctor or pharmacist immediately. Always take the outer carton of medicine with you, even if it is empty.
If you forget to use Relistor
If you miss a dose, contact your doctor or pharmacist as soon as possible. Do not take a double dose to make up for a forgotten dose.
If you stop using Relistor
You should contact your doctor or pharmacist if you want to stop using this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Cases of perforation of the intestinal wall ( gastrointestinal perforation ) have been reported in patients using Relistor. How often this happens is not known from the data available. If you get a lot of stomach pain, or if the pain does not go away, stop taking this medicine and contact a doctor immediately.
The following side effects are very common and may affect more than 1 in 10 people. If you get any of these side effects, which are either severe or do not go away, talk to your doctor:
- Abdominal pain (stomach pain)
- Nausea (feeling of nausea)
- Diarrhea (frequent watery stools)
- Flatulence (weather stresses)
Other common side effects that can affect up to one in 10 people are:
- Dizziness
- Symptoms similar to those of opioid withdrawal (any of the following: you are freezing, have chills (shivering), runny nose, sweating, hair on the skin, redness, rapid heartbeat)
- Injection site reactions (eg burning, burning sensation, pain, redness, edema )
- Vomiting
How to store Relistor
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 carton and bottle after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Keep the vial in the outer carton. Sensitive to light.
Use this medicine only if the solution is clear, colorless to pale yellow, and does not contain flakes or particles.
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.
Contents of the pack and other information
Content declaration
- The active substance is methylnaltrexone bromide. Each 0.6 ml vial contains 12 mg of methylnaltrexone bromide. One ml of solution for injection contains 20 mg of methylnaltrexone bromide.
- The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride, water for injections, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).
What the medicine looks like and the contents of the pack
Relistor is a solution for injection. It is clear, colorless to pale yellow, and does not contain flakes or particles.
Each vial contains 0.6 ml of solution for injection.
Packages containing more than one vial contain inner packs consisting of a vial, a 1 ml syringe with a retractable needle, and two alcohol swabs.
The following pack sizes are available:
A vial
A pack containing 2 vials, 2 syringes with retractable needles, and 4 alcohol swabs (ie 2 inner packs).
A pack containing 7 vials, 7 syringes with retractable needles, and 14 alcohol swabs (ie 7 inner packs).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra,
Poland