XERMELO 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Xermelo 250 mg film-coated tablets

telotristat ethyl

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Xermelo and what is it used for

What is Xermelo

This medicine contains the active substance telotristat ethyl.

What Xermelo is used for

This medicine is used in adults with a condition called “carcinoid syndrome”, which occurs when a tumour, called a “neuroendocrine tumour”, releases a substance called serotonin into the bloodstream.

Your doctor will prescribe this medicine to you if your diarrhoea is not well controlled with injections of other medicines called “somatostatin analogues” (lanreotide or octreotide). You should continue to receive injections of these other medicines while you are taking Xermelo.

How Xermelo works

When the tumour releases too much serotonin into the bloodstream, you may get diarrhoea.

This medicine works by reducing the amount of serotonin produced by the tumour and reducing diarrhoea.

2. What you need to know before you take Xermelo

Do not take Xermelo:

• If you are allergic to telotristat or any of the other ingredients of this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Xermelo:

• If you have liver problems. This is because this medicine has not been studied in patients with severe liver problems. Your doctor will decide if you need to reduce your daily dose of Xermelo. Your doctor will also monitor your liver.
• If you have kidney problems. This is because this medicine has not been fully studied

in patients with kidney problems.

Looking for side effects

Tell your doctor immediately if you get any of the following signs and symptoms that your liver may not be working properly:

• Feeling or being sick (nausea or unexplained vomiting), unusually dark urine, yellow skin or eyes, pain in the right upper side of your stomach.

Your doctor will do blood tests to check how your liver is working and will decide if you should keep taking this medicine.

Talk to your doctor or pharmacist:

• If you feel unenthusiastic, depressed or if you have no interest or pleasure in doing your usual activities, while taking this medicine.
• If you get signs of constipation, because telotristat reduces the number of bowel movements.

Tests

• Your doctor may do blood tests before you start taking this medicine and while you are taking it. This is to check that your liver is working normally.

Children and adolescents

This medicine is not recommended for patients under 18 years of age, because it has not been studied in this age group.

Other medicines and Xermelo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Xermelo may affect the way other medicines work or other medicines may affect the way Xermelo works. This might mean that your doctor needs to change the doses of your medicines. You should tell your doctor about all medicines, including:

• Medicines for diarrhoea. Both Xermelo and these types of medicines reduce the number of bowel movements and, when taken together, may cause severe constipation. Your doctor may need to change the dose of your medicines.
• Medicines used to treat epilepsy, such as valproic acid.
• Medicines used to treat neuroendocrine tumours, such as sunitinib or everolimus.
• Medicines used to treat depression, such as bupropion or sertraline.
• Medicines used to prevent transplant rejection, such as cyclosporin.
• Medicines used to lower cholesterol levels, such as simvastatin.
• Oral contraceptives, such as ethinylestradiol.
• Medicines used to treat high blood pressure, such as amlodipine.
• Octreotide. If you need treatment with subcutaneous injections of octreotide, you should receive the injection at least 30 minutes after taking Xermelo.

Pregnancy and breast-feeding

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.

Do not take this medicine if you are pregnant or think you might be pregnant. It is not known how telotristat may affect the baby.

Women must use effective contraceptive methods during treatment with this medicine.

Do not breast-feed while taking Xermelo, because this medicine may pass into the breast milk.

Driving and using machines

Telotristat may have a small effect on your ability to drive or use machines or tools. If you feel tired, wait until you feel better before driving or using machines or tools.

Xermelo contains lactose

Xermelo contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

3. How to take Xermelo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much to take

The recommended dose is one tablet (250 mg) three times a day. The maximum dose of Xermelo is 750 mg in 24 hours.

Your doctor will decide how long you should take Xermelo.

If you have liver problems, your doctor will decide if you need to reduce your daily dose of Xermelo.

How to take this medicine

• Always take this medicine with a meal or with some food.
• You should continue to receive injections of somatostatin analogues (lanreotide or octreotide) while you are taking Xermelo.

If you take more Xermelo than you should

You may feel or be sick, get diarrhoea or stomach pain. Talk to a doctor. Take the medicine pack with you.

If you forget to take Xermelo

If you forget to take a dose, take the next dose when it is due, skipping the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Xermelo

Do not stop taking Xermelo without talking to your doctor.

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.

Tell your doctor immediately if you get any of the following side effects:

• Feeling or being sick, unusually dark urine, yellow skin or eyes, pain in the upper right side of your stomach. These may be signs that your liver is not working properly. This may be shown by changes in your blood test results, such as increased liver enzymes: gamma-glutamyl transferase (very common, may affect more than 1 in 10 people), transaminases and alkaline phosphatase in the blood (common, may affect up to 1 in 10 people).

Other side effects

Tell your doctor, pharmacist or nurse if you get any of the following side effects:

Very common side effects:

• Stomach pain (abdominal pain)
• Feeling tired or weak (fatigue)

Common side effects:

• Wind
• Fever
• Headache
• Constipation
• Bloated stomach
• Loss of appetite
• Swelling (fluid build-up in the body)

Tell your doctor, pharmacist or nurse if you get any of the side effects listed above.

Reporting of side effects

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 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 Xermelo

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 blister after EXP. The expiry date refers to the last day of that month.

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 to protect the environment.

6. Contents of the pack and other information

What Xermelo contains

• The active substance is telotristat ethyl. Each tablet contains telotristat ethyl equivalent to 250 mg of telotristat ethyl.
• The other ingredients are: anhydrous lactose (see section 2 “Xermelo contains lactose”), hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, silica, colloidal anhydrous, polyvinyl alcohol (partially hydrolysed) (E1203), titanium dioxide (E171), macrogol 3350 (E1521) and talc (E553b).

Appearance and packaging

The tablets are white to off-white, film-coated and oval. Each tablet is approximately 17 mm long and 7.5 mm wide and has “T-E” engraved on one side and “250” on the other. The tablets are packaged in aluminium-PVC/PCTFE/PVC blisters. The blisters are packaged in a cardboard box.

Packs of 90 and 180 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

SERB SAS

40 Avenue George V

75008 Paris

France

Manufacturer

Beaufour Ipsen Industrie Rue Ethé Virton

28100 Dreux France

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other web sites about rare diseases and orphan medicines.