MOVENTIG 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Moventig 12.5 mg film-coated tablets

Moventig 25 mg film-coated tablets

naloxegol

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 Moventig and what is it used for
2. What you need to know before you take Moventig
3. How to take Moventig
4. Possible side effects
5. Storage of Moventig
6. Contents of the pack and other information

1. What is Moventig and what is it used for

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

Opioid-induced constipation can cause symptoms such as:

• stomach pain
• rectal straining (need to push very hard to pass stools from the rectum, which can also cause pain in the anus during straining)
• hard stools (stools “hard as a stone”)
• incomplete emptying of the rectum (after a bowel movement, feeling that stools remain in the rectum and need to be passed)

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

2. What you need to know before you take Moventig

Do not take Moventig:

• if you are allergic to naloxegol, to similar medicines, or to any of the other ingredients of this medicine (listed in section 6).
• if you have or may have a bowel obstruction (blocked intestine) or if you have been warned that you are at risk of bowel obstruction.
• if you have intestinal cancer or “peritoneal” cancer (the lining of the digestive region), advanced or recurrent ovarian cancer, or are receiving certain medicines to treat cancer, such as VEGF inhibitors (like bevacizumab).
• if you are taking certain medicines, such as ketoconazole or itraconazole (to treat fungal infections), clarithromycin or telithromycin (antibiotics), or ritonavir, indinavir, or saquinavir (to treat HIV).

Do not use Moventig if you are in any of the above situations. If you are unsure, talk to your doctor, pharmacist, or nurse before taking Moventig.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Moventig:

• if you have stomach ulcers, Crohn's disease (an inflammatory disease of the intestine), diverticulitis (another disease in which the intestine becomes inflamed), cancer in the intestine or in the “peritoneum” (the lining of the digestive region), or any disease that may alter the wall of your intestine
• if you currently have unusually severe, persistent, or worsening stomach pain
• if the natural protective barrier between the blood vessels in your head and brain is disrupted, for example, when 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 pain relief from your opioid medicine or if you experience symptoms of opioid withdrawal (see section 4)
• if you are taking methadone (see also the section “Taking Moventig with other medicines”)
• 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 tell you to take a lower dose (see also the section “How to take Moventig”)
• if you have severe liver problems

If any of the above situations apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before taking Moventig.

Talk to your doctor, pharmacist, or nurse while taking Moventig:

• if you develop severe, persistent, or worsening stomach pain. This could be a symptom of a damaged intestine wall and can be potentially life-threatening. Consult your doctor immediately because you may need to reduce the dose or stop taking Moventig.
• if you need to interrupt your opioid medicine for more than 24 hours.
• if you experience symptoms of opioid withdrawal (see section 4). Tell your doctor, 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 medicines and Moventig

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Also, tell your doctor about the opioid medicines you use and the dose.

Do not take Moventig if you are using any of the following medicines (see section “Do not take Moventig”):

• ketoconazole or itraconazole - for the treatment of fungal infections
• clarithromycin or telithromycin - antibiotics
• ritonavir, indinavir, or saquinavir - to treat HIV

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

Tell your doctor, pharmacist, or nurse if you are taking any of these medicines:

• other medicines for constipation (any laxative);
• methadone;

• diltiazem or verapamil (medicines 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;
• medicines called “opioid antagonists” (such as naltrexone and naloxone) used to counteract the effects of opioids.

If any of the above situations apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before taking Moventig.

Taking Moventig with drinks

Do not drink large amounts of grapefruit juice while using Moventig because large amounts can alter the amount of medicine that gets into your body.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine. Since there are limited data on the use of this medicine in pregnant women, Moventig is not recommended during pregnancy.

As it is not known if this medicine is excreted in breast milk, do not take Moventig while breast-feeding.

Driving and using machines

Moventig is unlikely to affect your ability to drive or use tools or machines.

Moventig contains sodium

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

3. How to take Moventig

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist.

The recommended dose is one 25 mg tablet per day.

Take Moventig in the morning to avoid bowel movements during the 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, you do not need to stop using laxatives unless your doctor tells you to. Moventig can be used with or without laxatives.

Stop taking Moventig if your treatment with opioid painkillers is also stopped.

Your doctor may recommend a lower dose of 12.5 mg

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

Your doctor may increase the dose to 25 mg depending on how you respond to the medicine.

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 into a powder
• Pour the powder into half a glass of water (120 ml)
• Stir and drink immediately
• To make sure you get all the medicine, 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, talk to a doctor or go to a 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 it is less than 12 hours until the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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.

Stop taking the medicine and tell your doctor immediatelyif you get symptoms of opioid withdrawal (if you have a combination of three or more of these symptoms: feeling depressed, nausea, vomiting, muscle pain, increased tear production, runny nose, dilated pupils, gooseflesh, excessive sweating, diarrhea, yawning, fever, or insomnia) that usually occur in the first few days after starting treatment with naloxegol. Opioid withdrawal symptoms can affect up to 1 in 100 people.

Other possible side effects:

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

• stomach pain
• diarrhea (frequent passage of watery stools)

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

• bloating
• nausea (stomach upset)
• vomiting
• nasopharyngitis (congestion or blockage of the nasal passages)
• headache
• excessive sweating

Frequency not known (cannot be estimated from the available data):

• allergic reaction
• gastrointestinal perforation (a hole that appears in the wall of the intestine)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Moventig

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 after “EXP”. The expiry date refers to the last day of that month.

Store below 25°C.

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 protect the environment.

6. Contents of the pack and other information

What Moventig contains

• The active substance 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 ingredients 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), red iron oxide (E172), and black iron oxide (E172).

Appearance and packaging

Moventig 12.5 mg: oval, film-coated, purple tablet, 10.5 x 5.5 mm, with “nGL” engraved on one side and “12.5” on the other.

Moventig 25 mg: oval, film-coated, purple tablet, 13 x 7 mm, with “nGL” engraved on one side and “25” on the other.

Moventig 12.5 mg tablets are available in aluminum blisters of 30 or 90 film-coated tablets and as 30 x 1 or 90 x 1 film-coated tablets in unit-dose blisters.

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

Not all pack sizes may be marketed in your country.

Marketing authorization holder

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Manufacturer

Piramal Pharma Solutions (Dutch) B.V.

Bargelaan 200

Leiden

2333CW

Netherlands

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

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.