Patient Information Leaflet

Moventig 12.5 mg Film-Coated Tablets

Moventig 25 mg Film-Coated Tablets

naloxegol

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Moventig contains the active ingredient naloxegol. It is a medication used in adults for the treatment of constipation caused specifically by certain pain-relieving medications, called opioids (such as morphine, oxycodone, fentanyl, tramadol, codeine), taken regularly. It is used when laxatives have not provided acceptable relief from constipation.

Constipation associated with opioids can cause symptoms such as:

• abdominal pain
• straining during bowel movements (the need to push very hard to expel stool from the rectum, which can also cause pain in the anus during the pushing motion)
• hard stools (stools that are "as hard as a rock")
• incomplete rectal emptying (after a bowel movement, a sensation that stool remains in the rectum with a need to be expelled)

In patients with constipation who take opioids, who have tried at least one laxative and had incomplete relief from constipation, Moventig has demonstrated in clinical trials to increase the number of bowel movements and improve symptoms of opioid-induced constipation.

Do not take Moventig:

• if you are allergic to naloxegol, similar medications, or any of the other components of this medication (listed in section 6).
• if you have or may have intestinal obstruction (blocked intestine) or if you have been warned that you are at risk of intestinal obstruction.
• if you have intestinal cancer or "peritoneal" (digestive tract lining) cancer, advanced or recurrent ovarian cancer, or if you are receiving cancer medications, such as VEGF inhibitors (e.g. bevacizumab).
• if you are taking certain medications, such as ketoconazole or itraconazole (for fungal infections), clarithromycin or telithromycin (antibiotics), or ritonavir, indinavir, or saquinavir (for HIV).

Do not use Moventig if you are in any of the above situations. If you have doubts, speak with your doctor, pharmacist, or nurse before taking Moventig.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Moventig:

• if you have stomach ulcers, Crohn's disease (an inflammatory bowel disease), diverticulitis (another disease in which the intestine becomes inflamed), intestinal or peritoneal (digestive tract lining) cancer, or any disease that may alter the wall of your intestine.
• if you currently have unusually intense, persistent, or worsening stomach pain.
• if the natural barrier that protects the blood vessels in your head and brain is altered, for example, if you have brain or central nervous system cancer, or if you have a central nervous system disease such as multiple sclerosis or Alzheimer's disease - consult your doctor immediately if you stop noticing the pain relief you get from your opioid medication or if you experience symptoms of opioid withdrawal syndrome (see section 4).
• if you are taking metadone (see the section "Taking Moventig with other medications" below).
• if you have had a heart attack in the last 6 months, heart failure with daily shortness of breath, or other serious heart problems that have caused daily symptoms.
• if you have kidney problems - your doctor may recommend a different dose (see the section "How to take Moventig" below).
• if you have severe liver problems.

If any of the above situations apply to you (or if you have doubts), speak with your doctor, pharmacist, or nurse before taking Moventig.

Consult your doctor, pharmacist, or nurse while taking Moventig:

• if you develop intense, persistent, or worsening stomach pain. This could be a sign of damaged intestinal wall and may be potentially fatal. Consult your doctor immediately, as you may need to reduce the dose or stop taking Moventig.
• if you have to interrupt your opioid medication for more than 24 hours.
• if you experience symptoms of opioid withdrawal syndrome (see the section 4 below). Inform your doctor, as you may need to stop taking Moventig.

Children and adolescents

Moventig is not recommended for use in children and adolescents under 18 years of age, as it has not been studied in these age groups.

Other medications and Moventig

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Also, inform your doctor about the opioid medications you use and the dose.

Do not take Moventig if you are using any of the following medications (see the section "Do not take Moventig"):

• ketoconazole or itraconazole - for fungal infections
• clarithromycin or telithromycin - antibiotics
• ritonavir, indinavir, or saquinavir - for HIV

Do not take Moventig if you are in any of the above situations.

Inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• other medications for constipation (any laxative);
• metadone;

• diltiazem or verapamil (medications for high blood pressure or angina). You may need to take a lower dose of Moventig;
• rifampicin (an antibiotic), carbamazepine (for epilepsy), or St. John's Wort (for depression). You may need to stop taking Moventig;
• medications called "opioid antagonists" (such as naltrexone and naloxone) that are used to counteract the effects of opioids.

If any of the above situations apply to you (or if you have doubts), speak with your doctor, pharmacist, or nurse before taking Moventig.

Taking Moventig with beverages

Do not take large amounts of grapefruit juice while using Moventig, as large amounts may alter the amount of medication that reaches your body.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medication. Since there are additional data on the use of this medication in pregnant women, Moventig is not recommended during pregnancy.

Since it is unknown whether this medication is excreted in breast milk, do not take Moventig during breastfeeding.

Driving and operating machinery

It is not expected that Moventig will affect your ability to drive vehicles or use tools or machines.

Moventig contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 12.5 mg / 25 mg tablet; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 25 mg tablet per day.

Take Moventig in the morning to avoid bowel movements at night. Moventig should be taken on an empty stomach at least 30 minutes before the first meal of the day or 2 hours after the first meal.

When starting treatment with Moventig, it is not necessary to stop using laxatives unless your doctor tells you to. Moventig can be used with or without laxatives.

Stop taking Moventig if treatment with opioid analgesics is also stopped.

Your doctor may recommend a lower dose of 12.5 mg

• if you have kidney problems
• if you take diltiazem or verapamil (for high blood pressure or angina)

Your doctor may indicate an increase in dose to 25 mg depending on how you respond to the medication.

If you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can crush it and mix it with water as follows:

• Crush the tablet until it becomes a powder
• Pour the powder into half a glass of water (120 ml)
• Stir and drink immediately
• To make sure there are no remaining medication residues, rinse the empty glass with another half glass of water (120 ml) and drink it

If you take more Moventig than you should

If you take more Moventig than you should, consult a doctor or go to the hospital.

If you forget to take Moventig

• If you forget to take a dose of Moventig, take it as soon as you remember. However, if less than 12 hours are left until the next dose, omit the missed dose.
• Do not take a double dose to make up for the missed doses.

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

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

Stop taking the medication and inform your doctor immediatelyif you experience symptoms of opioid withdrawal (if you have three or more of the following symptoms: feeling depressed, nausea, vomiting, muscle pain, increased tearing, runny nose, dilated pupils, goosebumps, excessive sweating, diarrhea, yawning, fever, or insomnia) that usually appear in the first few days after starting treatment with naloxegol. Opioid withdrawal symptoms can affect up to 1 in 100 people.

Other possible adverse effects:

Very common (may affect more than 1 in 10 people):

• Abdominal pain
• Diarrhea (frequent elimination of watery stools)

Common (may affect up to 1 in 10 people):

• Flatulence
• Nausea (stomach discomfort)
• Vomiting
• Nasopharyngitis (nasal congestion or obstruction)
• Headache
• Excessive sweating

Unknown frequency (cannot be estimated from available data):

• Allergic reaction
• Gastrointestinal perforation (a hole that appears in the intestinal wall)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. 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 box after “CAD”. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Moventig

• The active ingredient is naloxegol.

• Each film-coated tablet (tablet) of Moventig 12.5 mg contains 12.5 mg of naloxegol as naloxegol oxalate.
• Each film-coated tablet (tablet) of Moventig 25 mg contains 25 mg of naloxegol as naloxegol oxalate.

• The other components are:

• tablet core: mannitol (E421), microcrystalline cellulose (E460), sodium croscarmellose (E468) –see section 2 “Moventig contains sodium”–, magnesium stearate (E470b), propyl gallate (E310)
• film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172) and iron oxide black (E172).

Appearance of the product and contents of the container

Moventig 12.5 mg: oval-shaped tablet of purple color, coated with film, 10.5 x 5.5 mm in size, with the inscription “nGL” on one side and “12.5” on the other.

Moventig 25 mg: oval-shaped tablet of purple color, coated with film, 13 x 7 mm in size, with the inscription “nGL” on one side and “25” on the other.

Moventig 12.5 mg tablets are presented in aluminum blisters with 30 or 90 film-coated tablets in unperforated blisters and as 30 x 1 or 90 x 1 film-coated tablets in perforated unit-dose blisters.

Moventig 25 mg tablets are presented in aluminum blisters with 10, 30 or 90 film-coated tablets in unperforated blisters and as 10 x 1, 30 x 1, 90 x 1 or 100 x 1 film-coated tablets in perforated unit-dose blisters.

It is possible that only some sizes of packaging are marketed in your country.

Marketing authorization holder

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Responsible for manufacturing

Piramal Pharma Solutions (Dutch) B.V.

Bargelaan 200

Leiden

2333CW

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

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