Hetlioz

Italy
Brand name Hetlioz
Form capsules, hard gelatin
Active substance / Dosage
TASIMELTEON
Prescription type Prescription only
ATC code
N05CH03
Registration number 044394
Manufacturer VANDA PHARMACEUTICALS NETHERLANDS B.V.
Hetlioz capsules, hard gelatin

Table of Contents

Package leaflet: Information for the patient

HETLIOZ 20 mg hard capsules

tasimelteon
Please 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 questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What HETLIOZ is and what it is used for

HETLIOZ contains the active substance tasimelteon. This type of medicine is called a "melatonin agonist", which acts as a regulator of the body's daily rhythms.
It is used for the treatment of non-24-hour sleep-wake disorder (non-24 syndrome) in blind adults.
How HETLIOZ works
In sighted people, changes in light levels between day and night help synchronize the body's internal rhythms, including feeling sleepy at night and being alert during the day.
The body controls these rhythms through various pathways, including the rise and fall in production of the hormone melatonin.
Blind patients affected by non-24 syndrome cannot perceive light, so the body's rhythms become misaligned from the normal 24-hour cycle; this results in periods of daytime sleepiness and inability to sleep at night. The active substance in HETLIOZ, tasimelteon, acts like a clock for the body's rhythms, resetting them each day. It aligns the body's rhythms to the standard 24-hour day-night cycle, thereby improving sleep patterns. Due to individual differences in each person's body rhythms, it may take weeks or even up to 3 months to notice an improvement in symptoms.

2. What you need to know before taking HETLIOZ

Do not take HETLIOZ
if you are allergic to tasimelteon or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
After taking HETLIOZ, you should prepare for sleep and carry out only those activities you would normally do before going to bed.
Children and adolescents
Do not give HETLIOZ to children under 18 years of age. HETLIOZ has not been studied in individuals under 18 years of age, and its effects are unknown.
Other medicines and HETLIOZ
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including:

  • medicines known to reduce the activity of an enzyme called “CYP1A2”. An example is fluvoxamine, used to treat depression and obsessive-compulsive disorder (OCD);
  • medicines known to reduce the activity of an enzyme called “CYP3A4”. An example is ketoconazole, used to treat fungal infections;
  • medicines known to increase the activity of an enzyme called “CYP3A4”. An example is rifampicin, used to treat tuberculosis (TB);
  • medicines known to reduce the activity of an enzyme called “CYP2C19”. An example is omeprazole, used to treat heartburn and gastroesophageal reflux disease (GERD);
  • medicines called “beta-blockers”, used to treat high blood pressure and other heart problems. These include atenolol, metoprolol, and propranolol.

If you fall into any of the categories listed above (or if you are unsure), consult your doctor or pharmacist before
taking HETLIOZ.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. As a precautionary measure, it is preferable to avoid using tasimelteon during pregnancy. If you become pregnant while being treated with HETLIOZ, contact your doctor immediately, as the use of HETLIOZ is not recommended during pregnancy or breastfeeding.
HETLIOZ contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this
medicine.
HETLIOZ contains sunset yellow FCF (E110)
Inform your doctor if you are allergic to sunset yellow FCF (E110). HETLIOZ contains sunset yellow FCF (E110),
which may cause allergic reactions.
HETLIOZ contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘sodium-free’.

3. How to take HETLIOZ

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is one capsule every night, taken one hour before bedtime. Try to take the
medicine at the same time each night. Due to individual differences in each person's body rhythms, it may take weeks or months to notice an improvement in symptoms. Therefore,
your doctor may ask you to take HETLIOZ for up to 3 months before assessing whether it is effective for you.
Taking HETLIOZ

  • Take the medicine by mouth.
  • Swallow the capsule whole.
  • It is best to take HETLIOZ on an empty stomach, as food may reduce the amount of medicine absorbed by the body. If you consume a high-fat meal within one hour of your usual dosing time, wait 2 hours before taking HETLIOZ.
  • To open the bottle, press down on the cap and turn it counterclockwise.

If you take more HETLIOZ than you should
If you accidentally take more HETLIOZ than prescribed by your doctor, contact your doctor or the nearest hospital immediately. Take the bottle with you to clearly identify the medicine taken.
If you forget to take HETLIOZ

  • Skip the missed dose. Take the next dose at your usual time the following day. Do not take a double dose.

If you stop taking HETLIOZ
Do not stop treatment with HETLIOZ without consulting your doctor.

  • If HETLIOZ is not taken every night, the body's rhythms will once again become misaligned with the normal 24-hour day-night cycle. This means symptoms will return.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine.

Very common: may affect more than 1 in 10 people

  • headache

Common: may affect up to 1 in 10 people

  • change in sleep pattern
  • difficulty sleeping
  • dizziness
  • dry mouth
  • fatigue
  • indigestion
  • nausea
  • blood tests showing changes in liver function (alanine aminotransferase)
  • unusual dreams
  • drowsiness

Uncommon: may affect up to 1 in 100 people

  • altered or abnormal taste
  • blood tests showing changes in liver function (aspartate aminotransferase and gamma-glutamyl transferase)
  • increased daytime urination
  • nightmares
  • ringing in the ears
  • feeling of mental fogginess

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

5. How to store HETLIOZ

  • 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 bottle and the carton after “EXP”. The expiry date refers to the last day of that month.
  • This medicine does not require any special storage temperature conditions.
  • Store in the original container and keep the bottle tightly closed to protect the medicine 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 HETLIOZ contains

  • The active substance is tasimelteon. Each hard capsule contains 20 mg of tasimelteon.
  • The other ingredients are anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate.
  • The capsule shell is composed of gelatin, titanium dioxide, brilliant blue FCF, erythrosine, and orange yellow S (E110).
  • The white printing ink contains shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide.

Description of the appearance of HETLIOZ and contents of the pack
HETLIOZ hard capsules are dark blue, opaque, with “VANDA 20 mg” printed in white. Each bottle has a child-resistant cap and contains 30 hard capsules.
Marketing Authorization Holder
Vanda Pharmaceuticals Netherlands B.V.
Basisweg 10
1043 AP Amsterdam
The Netherlands
Manufacturer
AcertiPharma B.V.
Boschstraat 51
4811 GC Breda
The Netherlands
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Lithuania
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Bulgaria Luxembourg/Luxembourg
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Czech Republic Hungary
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Denmark Malta
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Germany Netherlands
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Estonia Norway
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Greece Austria
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Spain Poland
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
France Portugal
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Croatia Romania
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Ireland Slovenia
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Iceland Slovakia
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Italy Finland/Sweden
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel/Puh: +49 (0)30 800 98845
Cyprus Sweden
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
Tel: +49 (0)30 800 98845 Tel: +49 (0)30 800 98845
Latvia United Kingdom (Northern Ireland)
Vanda Pharmaceuticals Netherlands B.V. Vanda Pharmaceuticals Netherlands B.V.
+49 (0)30 800 98845 Tel: +49 (0)30 800 98845

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