Package leaflet: Information for the patient

Tript-OH 50 mg hard capsules, 100 mg hard capsules, 200 mg hard capsules, 25 mg granules for oral solution

L-5-hydroxytryptophan
Please read all of 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tript-OH is and what it is used for
What you need to know before taking Tript-OH
How to take Tript-OH
Possible side effects
How to store Tript-OH
Contents of the pack and other information

1. What Tript-OH is and what it is used for

Tript-OH contains the active substance L-5-hydroxytryptophan, a compound that mediates chemical reactions in the brain and is a precursor to serotonin, a natural substance present in the body.
Tript-OH is indicated for the treatment of "post-anoxic myoclonus", namely a sudden, involuntary contraction of a muscle or group of muscles occurring after a reduction or absence of oxygen supply to the brain.

2. What you need to know before taking Tript-OH

Do not take Tript-OH

if you are allergic to L-5-hydroxytryptophan or to any of the other ingredients of this medicine (listed in section 6)
if you have severe kidney function impairment
if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Tript-OH.
Your doctor may carry out tests to assess your kidney and heart function before prescribing Tript-OH.
As reported for dietary supplements containing L-tryptophan, Tript-OH may cause a disease leading to thickening of the skin (scleroderma-like syndrome) or an increase in a type of white blood cells (eosinophils) accompanied by muscle pain (eosinophilia-myalgia syndrome).
During treatment, your doctor may periodically perform clinical examinations and blood tests to detect early signs of possible muscle problems or an increase in a type of white blood cells (eosinophils) in the blood.
Inform your doctor before taking Tript-OH:

if you have or have had self-harming behaviors or suicidal thoughts, because your doctor will closely monitor you during treatment with Tript-OH, as Tript-OH may increase the risk of developing suicidal tendencies, especially at the beginning of treatment or when the dose is changed. Your doctor will closely monitor you during treatment with Tript-OH.
if you are taking antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants, because Tript-OH may enhance their effects.

Inform your doctor or inform the person caring for you to contact the doctor if, during treatment with Tript-OH, you notice:

worsening of your condition
changes in behavior
emergence of suicidal behaviors or thoughts

During treatment with Tript-OH, you will not develop tolerance (loss of effectiveness of the medicine over time) or dependence.
Other medicines and Tript-OH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking one or more of the following medicines, as you will be monitored during treatment with Tript-OH:

medicines used to treat depression: selective serotonin reuptake inhibitors (SSRIs such as citalopram and fluoxetine), monoamine oxidase inhibitors (MAOIs), tricyclic and tetracyclic antidepressants
lithium (a medicine used to treat manic and hypomanic episodes and depressive states)
carbidopa (a medicine used to treat Parkinson's disease)
alpha-methyldopa (a medicine used to treat high blood pressure)
methysergide (a medicine used to treat migraine)

Pregnancy, breastfeeding and fertility
Do not take Tript-OH if you are pregnant, suspect you may be pregnant, or are breastfeeding. If you are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Clinical studies on fertility have not been conducted.
Driving and use of machines
After taking Tript-OH, you may experience drowsiness and dizziness, which may affect your ability to drive or operate machinery.
Tript-OH granules for oral solution contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 5 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus. It may be harmful to teeth.

3. How to take Tript-OH

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
If you have renal disorders, your doctor may prescribe tests to assess your kidney
function before prescribing Tript-OH.
The recommended dose is 600–1000 mg per day, divided into 3 separate administrations.
Dissolve the contents of one sachet in half a glass of water.
The duration of treatment may vary from patient to patient and, in some cases, may last for several months. You must not stop treatment abruptly and without first consulting your doctor.
If you take more Tript-OH than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
To date, no cases of overdose with Tript-OH have been reported.
If you forget to take Tript-OH
Do not take a double dose to make up for the missed dose.
If you stop treatment with Tript-OH
You must not stop treatment abruptly and without first consulting your doctor. If you have any
doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

nausea*
stomach discomfort*
vomiting
upper abdominal pain
gastrointestinal disturbances
diarrhoea
reduced appetite
early satiety
drowsiness

Uncommon side effects (may affect up to 1 in 100 people)

aversion to food
insomnia
headache
dizziness
taste disturbances
smell disturbances
tremor
difficulty performing certain voluntary movements (ataxia)
flushing
eructation
abdominal pain
difficulty digesting (dyspepsia)
awareness of heartbeat (palpitations)
chest discomfort
weight gain

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

Suicidal thoughts
Suicidal behaviour

Side effects with unknown frequency (frequency cannot be estimated from the available data)

Changes in blood pressure (returning to normal within 48 hours)

* Your doctor may reduce your dose for a few days or prescribe medicines to reduce stomach acidity or that act on the function of the digestive system.

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 at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tript-OH

Keep in the original packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
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 Tript-OH contains
Tript-OH hard capsules

The active substance is L-5-hydroxytryptophan. Each capsule contains 50 mg or 100 mg or 200 mg of L-5-hydroxytryptophan.
The other ingredients are starch, mannitol, magnesium stearate.
The capsule shell is composed of animal gelatin, indigotine (capsules of 50 mg and 200 mg), titanium dioxide, yellow iron oxide (capsules of 100 mg and 200 mg), erythrosine (capsules of 100 mg and 200 mg).

Tript-OH 25 mg granules for oral solution

The active substance is L-5-hydroxytryptophan. Each sachet contains 25 mg of L-5-hydroxytryptophan.
The other ingredients are apricot flavour, macrogol 4000, sucrose.

Description of the appearance of Tript-OH and package contents
Each package of Tript-OH 50 mg hard capsules contains one blister strip of 30 hard capsules.
Each package of Tript-OH 100 mg hard capsules contains one blister strip of 20 hard capsules.
Each package of Tript-OH 200 mg hard capsules contains one blister strip of 20 hard capsules.
Each package of Tript-OH 25 mg granules for oral solution contains 20 sachets of 5 g granules.

Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)