Moventig 25 mg film-coated tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Moventig 12.5 mg film-coated tablets

Moventig 25 mg film-coated tablets

naloxegol

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 must not give it to others, even if they have the same symptoms as you. 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.

Leaflet contents

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

1. What Moventig is and what it is used for

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

Opioid-induced constipation may cause symptoms such as:

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

In patients with opioid-induced constipation who have tried at least one laxative and experienced inadequate relief of constipation, Moventig has demonstrated in clinical trials an increase in the number of bowel movements and improvement in opioid-induced constipation symptoms.

2. What you need to know before taking 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 intestinal obstruction (blocked bowel), or if you have been warned that you are at risk of intestinal obstruction.
• if you have bowel cancer or "peritoneal" cancer (the lining of the abdominal cavity), advanced or recurrent ovarian cancer, or are receiving medications to treat cancer such as VEGF inhibitors (e.g., bevacizumab).
• if you are taking certain medicines, such as ketoconazole or itraconazole (used to treat fungal infections), clarithromycin or telithromycin (antibiotics), or ritonavir, indinavir, or saquinavir (used to treat HIV).

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Moventig:

• if you have a stomach ulcer, Crohn’s disease (an inflammatory bowel disease), diverticulitis (another condition involving intestinal inflammation), cancer in the bowel or in the "peritoneum" (the lining of the abdominal cavity), or any condition that may affect the wall of your bowel
• if you currently have unusually severe, persistent, or worsening stomach pain
• if the natural protective barrier between the blood vessels and the brain is compromised, for example due to brain or central nervous system cancer, or if you have a central nervous system disorder such as multiple sclerosis or Alzheimer’s disease – contact your doctor immediately if you stop experiencing pain relief from your opioid medication or if you develop symptoms of opioid withdrawal (see section 4)
• if you are taking methadone (see section “Taking Moventig with other medicines” below)
• if you have had a heart attack within the past 6 months, heart failure with daily shortness of breath, or other serious heart problems causing daily symptoms
• if you have kidney problems – your doctor may advise you to take a different dose (see section “How to take Moventig” below)
• if you have severe liver problems

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

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

• if you develop severe, persistent, or worsening stomach pain. This could be a sign of bowel wall damage, which may be life-threatening. Contact your doctor immediately, as it may be necessary to reduce the dose or stop taking Moventig.
• if you need to stop taking your opioid medicine for more than 24 hours.
• if you experience symptoms of opioid withdrawal (see 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 medicines and Moventig

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Also, inform your doctor about the opioid medicines you are using 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 – used to treat fungal infections
• clarithromycin or telithromycin – antibiotics
• ritonavir, indinavir, or saquinavir – used to treat HIV

Do not take Moventig if any of the above apply to you.

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

• other medicines for constipation (any laxatives)
• 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 have any doubts), speak with your doctor, pharmacist, or nurse before taking Moventig.

Taking Moventig with food and drink

You should not drink large amounts of grapefruit juice while taking Moventig, as large quantities may alter the amount of medicine that reaches your body.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine. Because there is limited information on the use of this medicine in pregnant women, Moventig is not recommended during pregnancy.

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

Driving and using machines

Moventig is not expected to affect your ability to drive or operate machinery.

Moventig contains sodium

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

3. How to take Moventig

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

The recommended dose is one 25 mg tablet daily.

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 otherwise. Moventig may be used with or without laxatives.

Stop Moventig if 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 your 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 may 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 ensure no medicine is left behind, 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 there are less than 12 hours until your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Stop taking the medicine and contact your doctor immediately if you experience symptoms of opioid withdrawal (if you have a combination of three or more of these symptoms: feeling depressed, nausea, vomiting, muscle aches, increased tearing, runny nose, pupil dilation, goosebumps, excessive sweating, diarrhoea, yawning, fever or insomnia), which usually occur during the first few days after starting treatment with naloxegol. Opioid withdrawal symptoms may affect up to 1 in 100 people.

Other possible adverse effects:

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

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

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

• flatulence
• nausea (feeling of sickness)
• vomiting
• nasopharyngitis (nasal congestion or obstruction)
• headache
• excessive sweating

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

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the carton after “EXP”. The expiry date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Moventig

• 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 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 pack

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

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

Moventig 12.5 mg tablets are available in aluminium blisters with 30 or 90 film-coated tablets in non-perforated blisters and as 30 x 1 or 90 x 1 film-coated tablets in single-dose perforated blisters.

Moventig 25 mg tablets are available in aluminium blisters with 10, 30 or 90 film-coated tablets in non-perforated blisters and as 10 x 1, 30 x 1, 90 x 1 or 100 x 1 film-coated tablets in single-dose perforated blisters.

In your country, only certain pack sizes may be marketed.

Marketing Authorisation Holder

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Manufacturer responsible for batch release

Piramal Pharma Solutions (Dutch) B.V.

Bargelaan 200

Leiden

2333CW

The Netherlands

Further information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

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