Moventig 25 mg film-coated tablets

• 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.

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

• if you are allergic to naloxegol or similar medicines or any of the other ingredients of this medicine (listed in section 6).
• if your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels are at risk of becoming blocked.
• if you have cancer in your gut or ‘peritoneum’ (the lining of your stomach area), advanced or recurrent ovarian cancer or if you are taking medicines used to treat cancer such as “VEGF inhibitors” (e.g. bevacizumab).
• if you are taking certain other 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 any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.

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

• if you have stomach ulcers, Crohn’s Disease (an illness where your gut is inflamed), diverticulitis (another illness where your gut is inflamed), cancer in your gut or ‘peritoneum’ (the lining of your stomach area), or any conditon that might damage 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 in the head and in the brain is damaged, for example if you have cancer in the brain or the central nervous system, or if you have a disease of the central nervous system like multiple sclerosis or Alzheimer’s disease – contact your doctor immediately if you experience lack of pain relief from your opioid medicine or symptoms of opioid withdrawal syndrome (see section 4).
• if you are taking methadone (see section below “Other medicines and Moventig”)
• if you have had a heart attack within the last 6 months, have heart failure with daily shortness of breath or other severe problems with your heart which cause daily symptoms
• if you have kidney problems – your doctor may tell you to take a different dose (see section below “How to take Moventig”)
• if you have severe liver illness

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.

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

• if you develop severe, persistent or worsening stomach pain. This could be a symptom of damage to the wall of the gut and can be life-threatening. Tell your doctor immediately, you may need a lower dose or to stop taking Moventig.
• if your opioid medicine is to be stopped for more than 24 hours
• if you experience symptoms of opioid withdrawal syndrome (see section 4 below). Tell your doctor, you may need to stop taking Moventig.

Moventig is not recommended for use in children and adolescents below 18 years of age because it has not been studied in these age-groups.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor what opioid pain medicines you are taking and the dose of them.

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

• ketoconazole or itraconazole - to treat fungal infections
• clarithromycin or telithromycin - antibiotics
• ritonavir, indinavir or saquinavir – to treat HIV

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

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

• other medicines for constipation (any laxatives)
• methadone
• diltiazem or verapamil (for high blood pressure or angina). You may need to take a lower dose of Moventig
• rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John’s wort (for depression). You may need to stop taking Moventig
• medicines called ‘opioid antagonists’ (such as naltrexone and naloxone) which are used to counteract the effects of opioids

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.

You should not drink large amounts of grapefruit juice whilst taking Moventig. This is because large amounts can affect how much of the naloxegol medicine gets into the body.

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. As there are additional data from the use of this medicine in pregnant women, the use of Moventig during pregnancy is not recommended.

As it is not known whether this medicine is excreted in human milk, do not use Moventig during breast-feeding.

Moventig is not expected to affect you being able to drive a car or use any tools or machines.

This medicine contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free’.

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

• Crush the tablet to a powder
• Pour the powder into half a glass of water (120 ml)
• Stir and drink immediately
• To make sure there is no medicine left, rinse the empty glass with another half a glass of water (120 ml), and drink it

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

• If you miss a dose of Moventig, take it as soon as you remember. However, if it is 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.

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

• stomach pain
• diarrhoea (passing of frequent, watery stools)

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

• passing wind
• nausea (feeling sick to the stomach)
• vomiting
• nasopharyngitis (runny or stuffy nose)
• headache
• excessive sweating

Not known (frequency cannot be estimated from the available data):

• allergic reaction
• gastrointestinal perforation (a hole developing in the bowel wall)

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:

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is naloxegol.
  • Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as naloxegol oxalate.
  • Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate.
• The other ingredients are:
  • tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) – see section 2 under ‘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).

Moventig 12.5 mg: a mauve coloured, oval, dimensions 10.5 x 5.5 mm film-coated tablet, marked “nGL” on one side and “12.5” on the other side.

Moventig 25 mg: a mauve coloured, oval, dimensions 13 x 7 mm, film-coated tablet, marked “nGL” on one side and “25” on the other side.

Moventig 12.5 mg tablets are available in aluminium blisters in pack sizes of 30 or 90 film-coated tablets in non-perforated blisters and 30x 1 or 90x1 film-coated tablets in perforated unit dose blisters.

Moventig 25 mg tablets are available in aluminium blisters in pack sizes of 10, 30 or 90 film--coated tablets in non-perforated blisters and 10x1, 30x1, 90x1 or 100x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed in your country.