Rizmoic

Package leaflet: Information for the patient

Rizmoic 200 micrograms film-coated tablets

naldemedina
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rizmoic is and what it is used for

Rizmoic contains the active substance naldemedine.
It is a medicine used in adults for the treatment of constipation caused by painkillers
called opioids (e.g. morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone,
methadone).
Opioid painkillers may cause the following symptoms:

• reduced frequency of bowel movements
• hard stools
• stomach ache
• rectal pain during passage of hard stools
• sensation of incomplete bowel emptying after defecation.

Rizmoic may be used in patients who are taking an opioid medicine for cancer pain
or for chronic non-cancer pain, after having previously been treated with a laxative.

2. What you need to know before taking Rizmoic

Do not take Rizmoic

• if you are allergic to naldemedine or to any of the other ingredients of this medicine (listed in section 6)
• if your intestine is blocked or perforated, or if you are at high risk of intestinal blockage, as such blockage may lead to the development of a hole in the intestinal wall. Do not take this medicine if you fall into any of the above-mentioned conditions. If you have any doubts, consult your doctor or pharmacist before taking Rizmoic.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rizmoic:

• if you have a disease that may affect the intestinal wall, for example:
• stomach ulcer;
• enlarged colon due to a condition known as Ogilvie’s syndrome;
• diverticulitis (a condition in which the intestine is inflamed);
• intestinal or peritoneal cancer. The peritoneum is the lining of the abdominal cavity;
• a disease causing severe inflammation of the gastrointestinal tract, such as Crohn’s disease.
• if you have brain or central nervous system cancer, multiple sclerosis, or Alzheimer’s disease. If you have any of these conditions and develop symptoms of opioid withdrawal (see section 4), or if your opioid medicine no longer controls your pain, contact your doctor immediately.
• if you have had a heart attack, stroke, or transient ischemic attack within the last 3 months. Your doctor must monitor you if you are taking Rizmoic.
• if you have severe liver disease, such as alcoholic liver disease, viral liver infection, or impaired liver function. Rizmoic must not be used in these patients.
• if you are taking certain medicines such as itraconazole for fungal infections, or an antibiotic called rifampicin for the treatment of tuberculosis and other infections. See “Other medicines and Rizmoic”.

If you fall into any of the above-mentioned conditions or if you have any doubts, consult your doctor or pharmacist before taking Rizmoic.
Contact your doctor or pharmacist immediately during treatment with Rizmoic:

• if you develop severe, persistent, or worsening stomach pain, because it may be a sign of developing a hole in the intestinal wall, which can be fatal. Contact your doctor immediately and stop taking Rizmoic.
• if you experience symptoms of opioid withdrawal syndrome (see section 4 Possible side effects), which may occur within minutes up to several days after taking a medicine like Rizmoic. Stop taking Rizmoic and contact your doctor if you develop symptoms of opioid withdrawal.
• if you have severe diarrhoea or stomach pain, inform your doctor so that you can be monitored and treated with rehydration and appropriate medicines, if necessary.

Children and adolescents
This medicine is not intended for children or 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 (antibiotic medicines)
• Itraconazole or ketoconazole (medicines for treating fungal infections)
• Ritonavir, indinavir, or saquinavir (medicines for HIV infection)
• Phenytoin, carbamazepine, phenobarbital (medicines for the treatment of epilepsy)
• St John’s wort (Hypericum perforatum), a herbal medicine used for depression
• Cyclosporine, a medicine used in patients who have undergone organ transplantation or used for the treatment of rheumatoid arthritis.

Taking these medicines together with Rizmoic may affect the action of naldemedine or increase its side effects.

Rizmoic and beverages
You should not drink large amounts of grapefruit juice during treatment with Rizmoic, because this may cause excessive increases in the amount of naldemedine in the blood and may lead to more side effects (possible side effects are listed in section 4).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The effects of the medicine in pregnant women are unknown. Taking Rizmoic during pregnancy may cause opioid withdrawal in the baby (see section 4). Your doctor will inform you whether you can use Rizmoic during pregnancy.
Do not breastfeed during treatment with Rizmoic, as it is not known 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 or use machines.

Rizmoic contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take Rizmoic

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The recommended dose is one 200 microgram tablet once daily.
• You may take Rizmoic with or without laxatives.
• You may take Rizmoic at any time of day, with meals or on an empty stomach. However, once you have started treatment with this medicine, take it every day at approximately the same time.
• There is no need to adjust the dose of the opioid medicine before starting Rizmoic.

If you stop taking the opioid medicine
Your doctor will instruct you to stop taking Rizmoic when you discontinue the opioid painkiller. Consult your doctor or pharmacist before stopping treatment with Rizmoic to avoid worsening of symptoms.

If you take more Rizmoic than you should
If you have taken more Rizmoic than you should, consult your doctor or go to hospital immediately. You will be monitored for symptoms of opioid withdrawal (see section 2, “Warnings and precautions”, and section 4).

If you forget to take Rizmoic
If you forget to take a dose of Rizmoic, take it as soon as you remember.
However, if less than 12 hours remain before your next scheduled dose, skip the missed dose and take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Rizmoic
If you stop treatment with Rizmoic while continuing to take the opioid medicine, constipation may return.
Consult your doctor if you stop taking Rizmoic.

If you have any questions about how to use 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 observed in patients treated with 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 a combination of 3 or more of the following symptoms of opioid withdrawal occur on the same day:

• feeling depressed
• nausea (feeling unwell) or vomiting
• muscle pain
• watery eyes or runny nose
• dilated pupils
• goosebumps
• sweating
• diarrhoea
• yawning
• fever
• inability to sleep

The following side effects may occur with this medicine:
If you are being treated with an opioid medicine 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 consult your doctor or go to hospital immediately. Severe allergic reactions include: swelling of the hands, feet, ankles, face, lips or throat, which may cause difficulty swallowing or breathing, itching and hives.

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

• diarrhoea
• stomach pain
• nausea (feeling unwell)
• vomiting

If you are being treated with an opioid medicine for cancer.
Very common (may affect more than 1 in 10 people):

• diarrhoea
  Common:
• stomach pain

If you are being treated with an opioid medicine for cancer or for chronic non-cancer pain.
Not known (frequency cannot be estimated from the available data):

• gastrointestinal perforation (development of a hole in the intestinal wall)

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rizmoic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the tablets from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rizmoic contains

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

Description of the appearance of Rizmoic and package contents
Rizmoic is a yellow, film-coated, round tablet with a diameter of approximately 6.5 mm, imprinted with
“222” and the Shionogi logo on one side and “0.2” on the other.
The medicine is available in aluminum 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.

Marketing Authorisation Holder
Shionogi B.V.
Herengracht 464, 1017CA
Amsterdam
The Netherlands

Manufacturer
Shionogi B.V.
Herengracht 464, 1017CA
Amsterdam
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

AT, BG, CY, CZ, EE, IE, EL, HR, HU, IE, IS, LT, LV, MT, DE, PT, RO, SI, SK
Hexal AG
Shionogi B.V.
Tel: +49 (0)80249080
Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ: +31204917439
[email protected]
[email protected]

ES, IT
Casen Recordati, S.L.
Shionogi Srl
Tel: +34 91 659 15 50
Tel: +39 06 94 805 118
[email protected]
[email protected]

UK (NI)
Sandoz Limited
Tel: +44 (0)1276 698020
[email protected]

FR
Viatris Santé
Tél: +33 (0)1 40 80 15 55
[email protected]

PL
Molteni Farmaceutici Polska Sp. z o.o
Tel.: +48 (12) 653 15 71
e-mail: [email protected]

SE
Viatris AB
Tel: +46 (0)8 630 19 00
[email protected]

DK
Viatris ApS
Tlf: +45 28 11 69 32
[email protected]

FI
Viatris Oy
Puh/Tel: +358 20 720 9555
[email protected]

NO
Viatris AS
Tlf: +47 66 75 33 00
[email protected]

BE & LU
Viatris
Tel/Tél: +32 (0)2 658 61 00
[email protected]

NL
Mylan Healthcare B.V.
Tel: +31 (0)20 426 33 00
[email protected]

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