Package Insert: Information for the Patient

Rizmoic 200 micrograms Film-Coated Tablets

naldemedina

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Rizmoic contains the active ingredient naldemedine.

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

Its opioid analgesic may cause the following symptoms:

• decreased frequency of bowel movements
• hard stools;
• stomach pain;
• pain in the rectum when evacuating hard stools;
• sensation that the intestine is still not empty after evacuating.

Rizmoic can be used in patients who use an opioid for oncological pain or non-oncological pain for a long time after having previously received treatment with a laxative.

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 intestinal blockage or perforation, or if there is a high risk of intestinal blockage, as blockage may cause a hole in the intestinal wall.

Do not take this medicine if any of the above circumstances apply to you. If in doubt, consult your doctor or pharmacist before starting to take Rizmoic.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizmoic:

• if you have a disease that may affect the intestinal wall, such as:

• stomach ulcer;
• enlarged colon due to a disease called Ogilvie 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 cancer in the brain or central nervous system, multiple sclerosis or Alzheimer's disease. If you have these diseases and present symptoms of opioid withdrawal (see section 4) or if the opioid no longer provides 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 hepatitis or liver insufficiency. Rizmoic should not be used in these patients;

• if you are taking certain medications 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 circumstances apply to you, or if in doubt, consult your doctor or pharmacist before starting to take Rizmoic.

Consult your doctor or pharmacist immediately while taking Rizmoic:

• if you presentsevere, persistent or worsening stomach pain,as it may be a symptom of developing a hole in the intestinal wall and can be potentially fatal.

Consult your doctor or pharmacist immediately and stop taking Rizmoic;

• if you presentsymptoms of opioid withdrawal(see section 4 Possible 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 present symptoms of opioid withdrawal;
• if you presentsevere diarrhea or intense stomach pain, inform your doctor, so that he can monitor you and treat you with rehydration and the necessary medications if necessary.

Children and adolescents

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

Other medicines and Rizmoic

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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 to treat depression;
• ciclosporin, a medicine used in transplant patients or to treat rheumatoid arthritis.

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

Rizmoic with beverages

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. The effects of the medicine on pregnant women are unknown. The use of Rizmoic during pregnancy may cause opioid withdrawal syndrome in the baby (see section 4). Your doctor will advise you on whether you can take Rizmoic if you are pregnant.

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

Driving and operating machinery

The influence of Rizmoic on the ability to drive and operate machinery is negligible.

Rizmoic contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

• Rizmoic can be taken with or without laxatives.

• Rizmoic can be taken at any time of day, with food or between meals. However, once you start taking the medication, take it approximately at the same time every day.

If you stop taking your opioid

Your doctor will recommend that you discontinue use of Rizmoic when you stop taking your opioid analgesic. Consult your doctor or pharmacist before interrupting treatment with Rizmoic to avoid worsening symptoms.

If you take more Rizmoic than you should

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

If you forget to take Rizmoic

If you forget to take one Rizmoic tablet, take it as soon as you remember.

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

Do not take a double dose to compensate for missed doses.

If you stop taking Rizmoic

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effects observed in patients using Rizmoic have been opioid withdrawal symptoms. This side effect is rare (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 opioid withdrawal symptoms on the same day:

The following side effects may occur with this medicine:

If you receive treatment with an opioid for chronic non-cancer pain.

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

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

• diarrhea
• stomach pain
• nausea (feeling of vomiting)
• vomiting

If you receive treatment with an opioid for cancer.

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

Common:

If you receive treatment with an opioid for cancer or chronic non-cancer pain.

Unknown frequency (cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blisters after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Rizmoic

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

Tablet core: mannitol, sodium croscarmellose (see section 2 under "Rizmoic contains sodium") and magnesium stearate.

Coating with film: hypromellose, talc and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

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

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

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

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

Responsible for manufacturing

Shionogi B.V.

Herengracht 464

1017CAAmsterdam

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorisation holder:

Last date of revision of this leaflet: November 2023

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