RIZMOIC 200 MICROGRAMS FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Rizmoic 200 micrograms film-coated tablets

naldemedine

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 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.

Contents of the pack

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

1. What is Rizmoic and what is it used for

Rizmoic contains the active substance naldemedine.

It is a medicine used in adults to treat constipation caused by analgesics, called opioids (e.g. morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).

Your opioid analgesic may cause you to have the following symptoms:

• decreased frequency of bowel movements
• hard stools;
• stomach pain;
• rectal pain when passing hard stools;
• feeling that the bowel is not empty after passing stools.

Rizmoic can be used in patients who use an opioid for cancer pain or long-term non-cancer pain after they have previously been treated with a laxative.

2. What you need to know before you take Rizmoic

Do not take Rizmoic:

• if you are allergic to naldemedine or any of the other ingredients of this medicine (listed in section 6);
• if you have a blockage or perforation of the intestine, or if there is a high risk of intestinal blockage, as the blockage can cause a hole in the wall of the intestine.

Do nottake this medicine if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Rizmoic.

Warnings and precautions

Consult your doctor or pharmacist before taking Rizmoic:

• if you have a disease that can affect the intestinal wall, such as:
• a stomach ulcer;
• enlarged colon due to a disease called Ogilvie's syndrome;
• diverticulitis (a disease in which there is inflammation of the intestine);
• intestinal or peritoneal cancer. The peritoneum is the lining of the intestine;
• a disease that causes severe inflammation of the digestive tract, such as Crohn's disease.

• if you have brain or central nervous system cancer, multiple sclerosis, or Alzheimer's disease. If you have these diseases and experience symptoms of opioid withdrawal (see section 4) or if the opioid stops providing you with pain control, contact your doctor immediately;

• if you have had a heart attack, stroke, or transient ischemic attack in the last 3 months. Your doctor should monitor you if you take Rizmoic;

• if you have severe liver disease, such as alcoholic liver disease, viral liver infection, or liver failure. Rizmoic should not be used in these patients;

• 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 applies to you, or if in doubt, consult your doctor or pharmacist before taking Rizmoic.

Consult your doctor or pharmacist immediately while taking Rizmoic:

• if you experience severe, persistent, or worsening stomach pain, as it may be a symptom of developing a hole in the wall of the intestine and can be life-threatening.

Consult your doctor or pharmacist immediately and stop taking Rizmoic;

• if you experience symptoms of opioid withdrawal(see section 4 Posible side effects) that may appear between a few minutes and several days after taking a medicine like Rizmoic. Stop taking Rizmoic and contact your doctor if you experience symptoms of opioid withdrawal;
• if you experience severe diarrhea or severe stomach pain, inform your doctor, so that they can monitor you and treat you with rehydration and appropriate medications if necessary.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as the effects of the medicine in children and adolescents are unknown.

Other medicines and Rizmoic

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

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

• rifampicin, clarithromycin, or telithromycin (antibiotics);
• itraconazole or ketoconazole (medicines used to treat fungal infections);
• ritonavir, indinavir, or saquinavir (medicines for HIV infection);
• phenytoin, carbamazepine, phenobarbital (medicines used to treat epilepsy);
• St. John's Wort (Hypericum perforatum), a herbal medicine used for depression;
• cyclosporin, a medicine used in transplant patients or to treat rheumatoid arthritis.

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

Rizmoic with drinks

Do not drink large amounts of grapefruit juice while taking Rizmoic. If you do, you may have too much naldemedine in your blood and may experience more side effects (possible side effects are listed in section 4).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 unknown. Using Rizmoic during pregnancy may cause opioid withdrawal syndrome in the baby (see section 4). Your doctor will advise you whether you can take Rizmoic if you are pregnant.

Do not breastfeed while taking Rizmoic, as it is unknown whether naldemedine passes into breast milk. Consult your doctor if you are already breastfeeding.

Driving and using machines

Rizmoic has no influence on the ability to drive and use machines.

Rizmoic contains sodium

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

3. How to take Rizmoic

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose is one 200 microgram tablet once a day.

• You can take Rizmoic with or without laxatives.

• You can take Rizmoic at any time of day, with or without food. However, once you start taking the medicine, take it at approximately the same time every day.

• No dose adjustment of your opioid is needed before starting Rizmoic.

If you stop taking your opioid

Your doctor will advise you to stop taking Rizmoic when you stop taking your opioid analgesic. Consult your doctor or pharmacist before stopping treatment with Rizmoic to avoid worsening symptoms.

If you take more Rizmoic than you should

If you have taken more Rizmoic than you should, talk to a doctor or go to a hospital. They will monitor you for symptoms of opioid withdrawal (see section 2, under "Warnings and precautions", and section 4).

If you forget to take Rizmoic

If you forget to take a Rizmoic tablet, 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 the next tablet.

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

If you stop taking Rizmoic

Stopping Rizmoic while continuing to take your opioid may cause you to have constipation again. Inform your doctor if you stop taking Rizmoic.

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

4. Possible side effects

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

The most serious side effects seen in patients taking Rizmoic have been symptoms of opioid withdrawal. This side effect is uncommon (may affect up to 1 in 100 people).

Stop taking Rizmoic and contact your doctor if you experiencea combination of 3 or more of the following symptoms of opioid withdrawalon the same day:

• Depression
• nausea (feeling sick) or vomiting
• muscle pain
• tearful eyes or runny nose
• dilated pupils
• gooseflesh
• sweating
• diarrhea
• yawning
• fever
• inability to sleep

The following side effects may occur with this medicine:

If you are being treated with an opioid for chronic non-cancer pain.

Rare (may affect up to 1 in 1,000 people):

• If you experience a severe allergic reaction, stop taking Rizmoic and go to a doctor or hospital immediately. Severe allergic reactions include: swelling of the hands, feet, ankles, face, lips, or throat which may cause difficulty in swallowing or breathing, itching of the skin, and hives.

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

• Diarrhea
• stomach pain
• nausea (feeling sick)
• vomiting

If you are being treated with an opioid for cancer.

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

• diarrhea

Common:

• stomach pain

If you are being treated with an opioid for cancer or chronic non-cancer pain.

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

• gastrointestinal perforation (a hole that develops in the wall of the intestine)

Reporting of side effects

If you experience 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 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 Rizmoic

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 and on the blister after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect the tablets from light and moisture.

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

6. Contents of the pack and other information

What Rizmoic contains

• Each tablet contains 200 micrograms of naldemedine (as tosilate).
• The other ingredients are:

Core of the tablet: mannitol, sodium croscarmellose (see section 2 under "Rizmoic contains sodium") and magnesium stearate.

Film coating: hypromellose, talc, and yellow iron oxide (E172).

Appearance and packaging

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

This medicine is available in aluminum blisters containing 7, 10, or 14 tablets.

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

This medicine is also available in single-dose aluminum blisters containing 10 tablets.

Package sizes of 30 x 1 tablet in single-dose blisters.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

Manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

You can get more information on this medicine by contacting the local representative of the marketing authorisation 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/.