Rizmoic 200 micrograms film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to naldemedine or any of the other ingredients of this medicine (listed in section 6).
• if your bowel is blocked or perforated, or if there is a high risk of your bowel becoming blocked, as a blockage may cause a hole to develop in the bowel wall.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Rizmoic.

Talk to your doctor or pharmacist before taking Rizmoic:

• if you suffer from a disease which may affect your bowel wall such as:
  • a stomach ulcer;
  • an enlarged colon due to a condition known as Ogilvie's syndrome;
  • diverticulitis (an illness where your gut is inflamed);
  • cancer of the bowel or peritoneum. The peritoneum is the lining of your gut area.
  • a disease causing severe inflammation of the digestive tract such as Crohn's disease .
• if you have cancer of the brain or central nervous system, multiple sclerosis, or Alzheimer's disease. If you have these conditions and develop opioid withdrawal symptoms (see section 4) or if the opioid medicine no longer controls your pain, contact your doctor immediately.
• if you have had a heart attack within the last 3 months or if you have other severe problems with your heart which cause daily symptoms
• if you have severe liver disease such as alcoholic liver disease, viral liver infection or impaired liver function.
• if you are taking certain medicines such as itraconazole to treat fungal infections, or an antibiotic called rifampicin to treat tuberculosis and other infections. See 'Other medicines and Rizmoic'.

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

Talk to your doctor or pharmacist immediately whilst taking Rizmoic:

• if you develop severe, lasting or worsening stomach pain as this could be a symptom of developing a hole in your bowel wall and can be life-threatening. Speak to your doctor immediately and stop taking Rizmoic.
• if you suffer from symptoms of opioid withdrawal syndrome (see section 4 Possible side effects) which can develop within minutes to several days after taking a medicine such as Rizmoic. Stop taking Rizmoic and contact your doctor if you develop opioid withdrawal symptoms.
• if you have severe diarrhoea or stomach ache, tell your doctor, so that the doctor can monitor you and treat you with rehydration and appropriate medicines if needed.

This medicine is not for children or adolescents under the age of 18 years because the effects of the medicine in children and adolescents are not known.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Talk to your doctor or pharmacist if you are taking any of the following medicines:

• Rifampicin, clarithromycin or telithromycin (antibiotic medicines)
• Itraconazole or ketoconazole (medicines to treat fungal infections)
• Ritonavir, indinavir or saquinavir (medicines for HIV infection)
• Phenytoin, carbamazepine, phenobarbital (medicines to treat epilepsy)
• St John’s wort (Hypericum perforatum), a herbal medicine used for depression

Using these medicines with Rizmoic may affect the way naldemedine works or increase its side effects.

You should not drink large amounts of grapefruit juice whilst taking Rizmoic.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The effects of the medicine in pregnant women are not known. Your doctor will advise you about whether you can use Rizmoic if you are pregnant.

Do not breast-feed during treatment with Rizmoic as it is not known if naldemedine passes into breast milk. Talk to your doctor if you are already breast-feeding.

Rizmoic has no influence on your ability to drive or to use machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

You should stop taking Rizmoic when you stop taking your opioid pain medicine.

If you have taken more Rizmoic than you should, talk to your doctor or go to the hospital. You will be monitored for opioid withdrawal symptoms (see section 2, under ‘Warnings and Precautions’, and section 4).

If you miss a tablet of Rizmoic, take it as soon as you remember.

However if it is less than 12 hours until your next dose, skip the missed dose, and wait until it is time to take your next tablet.

Do not take a double dose to make up for a forgotten tablet.

Stopping Rizmoic while continuing to take your opioid medicine may cause the constipation to return.

Talk to your doctor if you stop taking Rizmoic.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

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.

• Each tablet contains 200 micrograms of naldemedine (as tosylate).
• The other ingredients are:
  Tablet core: Mannitol, croscarmellose sodium (see section 2 under ‘Rizmoic contains sodium’) and magnesium stearate.
  Film coating: hypromellose , talc and yellow iron oxide (E172).

Rizmoic is a round, approximately 6.5 mm diameter, yellow film-coated tablet debossed with '222' and the Shionogi logo on one side and '0.2' on the other side.

The medicine is available in aluminium blisters, containing 7,10 or 14 tablets.

Pack sizes of 7, 10, 28, 30, 84 or 100 tablets.

Not all pack sizes may be marketed in your country.