Xermelo 250 mg comprimidos recubiertos con pelicula

Prospect: information for the patient

Xermelo 250 mg film-coated tablets

telotristat etylate

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospectus, as you may need to refer to it again.

- If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

1. What Xermelo is and for what it is used

2. What you need to know before starting to take Xermelo

3. How to take Xermelo

4. Possible adverse effects

5. Storage of Xermelo

6. Contents of the pack and additional information

What is Xermelo

This medication contains the active ingredient telotristat etylate.

How is Xermelo used

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

Your doctor will prescribe this medication if your diarrhea is not well controlled with injections of other medications called “somatostatin analogs” (lanreotide or octreotide). You must continue receiving injections of these other medications while taking Xermelo.

How Xermelo works

When the tumor releases too much serotonin into the bloodstream, it can cause diarrhea.

This medication works by reducing the amount of serotonin formed by the tumor and reducing diarrhea.

Do not take Xermelo:

- If you are allergic to telotristat or any of the other components of this medication

(listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Xermelo:

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

• If you have kidney problems. This is because this medication has not been completely studied in patients with kidney problems.

Report side effects

Inform your doctor immediately if you experience any of the following signs and symptoms that indicate your liver may not be functioning correctly:

• Feeling or having unexplained nausea (nausea or vomiting), abnormally dark urine, yellow skin or eyes, pain on the right side of the abdomen.

Your doctor will perform blood tests to check how your liver is functioning and will decide if you should continue taking or not this medication.

Consult your doctor or pharmacist:

• If you are feeling disheartened, depressed or if you have no interest in your usual activities while taking this medication.

• If you experience signs of constipation, because telotristat reduces the number of bowel movements.

Tests

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

Children and adolescents

This medication is not recommended for patients under 18 years old, as it has not been studied in this age group.

Other medications and Xermelo

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. This is because Xermelo may affect the functioning of other medications or other medications may affect the functioning of Xermelo. This could mean that your doctor needs to change the doses you are taking. You must inform your doctor of all medications, including:

• Medications for diarrhea. Both Xermelo and this type of medication reduce the number of bowel movements and, when taken together, may cause severe constipation. Your doctor may need to change the dose of your medications.

• Medications used to treat epilepsy, such as valproic acid.

• Medications used to treat neuroendocrine tumors, such as sunitinib or everolimus.

• Medications used to treat depression, such as bupropion or sertraline.

• Medications used to prevent transplant rejection, such as cyclosporine.

• Medications used to lower cholesterol levels, such as simvastatin.

• Oral contraceptives, such as ethinylestradiol.

• Medications used to treat hypertension, 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 breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

You should not take this medication if you are pregnant or may be pregnant. The effects of telotristat on the baby are unknown.

Women should use effective birth control methods during treatment with this medication.

You should not breastfeed while taking Xermelo, as this medication may pass to the baby.

Driving and operating machinery

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

Xermelo contains lactose

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

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

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 for how long you should take Xermelo.

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

How to take this medication

• Take this medication always with a meal or with some food.

• You should continue receiving injections of somatostatin analogs (lanreotide or octreotide) while taking Xermelo.

If you take more Xermelo than you should

You may feel or have nausea, diarrhea, or stomach pain. Talk to a doctor. Bring the medication packaging with you.

If you forget to take Xermelo

If you forget to take a dose, take the next dose when it's time, skipping the missed dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Xermelo

Do not stop taking Xermelo without consulting your doctor.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Inform your doctor immediately if you notice any of the following adverse effects:

• Feeling or having nausea, abnormally dark urine, yellow skin or eyes, pain in the upper right side of the abdomen. These may be signs that the liver is not functioning correctly. This could be reflected in changes in blood test results, such as an increase in liver enzymes: gamma-glutamyl transferase (very frequent, may affect more than 1 in 10 people), transaminases and alkaline phosphatase in blood (frequent, may affect up to 1 in 10 people).

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Other Adverse Effects

Inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Frequent Adverse Effects:

• Abdominal pain

• Feeling tired or weak (fatigue)

Common Adverse Effects:

• Gas

• Fever

• Headache

• Constipation

• Swollen abdomen

• Loss of appetite

• Swelling (accumulation of fluid in the body)

Inform your doctor, pharmacist, or nurse if you notice any of the adverse effects listed above.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more informationabout the safety of this medication.

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

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

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Xermelo

• The active ingredient is telotristat etylate. Each tablet contains etipratate of telotristat equivalent to 250 mg of telotristat etylate.

• The other components are: anhydrous lactose (see section 2 “Xermelo contains lactose”), hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica, partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), and talc (E553b).

Appearance of the product and contents of the packaging

The tablets are white to off-white, film-coated, and oval-shaped. Each tablet measures approximately 17 mm in length and 7.5 mm in width, with the inscription “T-E” on one face and “250” on the other. The tablets are packaged in an aluminum-PVC/PCTFE/PVC blister. The blisters are packaged in a cardboard box.

Boxes of 90 and 180 tablets. Some package sizes may only be marketed.

Marketing Authorization Holder

SERB SAS

40 Avenue George V

75008 Paris

France

Manufacturer

Beaufour Ipsen Industrie Rue Ethé Virton

28100 Dreux France

Date of the last review of this leaflet:

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan drugs.