Read the whole leaflet carefully before you start taking this medicine.
-    Keep the 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.    What Triptosan is and what it is used for
2.    What should you know before taking Triptosan
3.    How to use Triptosan
4.    Possible side effects
5.    How to store Triptosan
6.    Further information

1.    WHAT TRIPTOSAN IS AND WHAT IT IS USED FOR

It is believed that depression occurs when the concentration of certain substance (named serotonin) in the brain decreases. Triptosan enhances concentration of serotonin in the brain.

Triptosan is prescribed for treatment of mild depression.

2.    WHAT SHOULD YOU KNOW BEFORE TAKING TRIPTOSAN

Do not take Triptosan in the following cases:
•    if you are allergic (have increased sensitivity) to oxytryptan or any other ingredient of Triptosan.
•    if you suffer from severe liver insufficiency or other severe liver diseases;
•    if you suffer from severe kidney insufficiency or other severe kidney diseases;
•    if you have cancer;
•    if you take other medicines for depression treatment;
•    if so-called eosinophilic myalgia syndrome (EMS) has occurred after the intake of L-tryptophan.

Take special care with Triptosan

Triptosan is not recommended for children and teenagers up to 18 years old.

As it is usual with other medicines for depression, condition may not improve for a few weeks or longer, therefore doctor’s recommendations should be strictly followed and the dosing of the medicine shouldn’t be changed or the usage stopped.
Suicidal ideas and worsening of depression or anxiety disorders
If you are depressed or feel anxious, some thoughts about hurting yourself or suicide may arise. Such thoughts arise more often in patients who start antidepressants for the first time, as some time (usually two weeks, but sometimes more) should pass before the treatment effect becomes apparent.

Probability of such ideas is higher in cases when:
•    the patient was thinking about self-hurting or suicide before;
•    the patient is a young adult.
Data from clinical studies revealed that when young adults (patients younger than 25 years old) develop a psychic disorder and are treated with antidepressants, the risk for suicidal behaviour is higher.

If you are considering self-hurting or suicide, seek for your doctor immediately or turn to emergency room of the nearest hospital.
It may be useful to tell your relatives or friends that you have depression or feel anxious. Ask them to read this package leaflet. You may ask them for a prompt if they notice that your depression or anxiety has become worse or if they start to worry about changes in your behaviour.
When taking medicines containing L-tryptophan, eosinophilic myalgia syndrome (EMS) may occur. Causes of this disorder are not clear. You should seek for your doctor immediately if under the treatment with Triptosan following symptoms have developed: pain in your joints or muscles; fever, breathlessness, inflammation of peripheral nerves (neuropathy), swelling or lesion of skin (sclerosis, rash, hives). Doctor would determine whether this is EMS and whether further treatment with Triptosan is possible.
So-called serotonin syndrome may occur while taking oxytryptan alone or especially together with other antidepressants. It is characterized by excitement, anxiety, tachycardia, elevated arterial blood pressure and body temperature, flush in a face and neck, enhanced reflexes, dizziness, tremor, sweating, increased peristaltic, disorientation, dilatation of pupils and muscle twitch.

Taking other medicines

Please inform your doctor or pharmacist, if you take or have been recently taking other medicines, including the ones obtained without prescription.

Tell your doctor if you take the following medicines together with Triptosan:
•    drugs for psychosis from the group of phenothiazine (e.g. levomepromazine, fluphenazine, thioridazine), as sexual function may deteriorate in some cases;
•    sleep inducing and anxiety reducing drugs, so-called benzodiazepines (e.g. alprazolam, bromazepam, brotizolam, chlordiazepoxide, diazepam, estazolam and others), as sexual function may deteriorate in some cases.

Taking Triptosan with food and drinks
Food does not influence the use of Triptosan. The medicine can be taken during or without meals.

Pregnancy and breast-feeding
Consult your doctor before you take any medicine. It is not recommended to take Triptosan during pregnancy or breast-feeding period.

Driving and using machines
Dizziness may occur while taking Triptosan. If you feel dizzy do not drive, nor operate machines.

3.    HOW TO USE TRIPTOSAN

Take Triptosan exactly as your doctor has told you. In case of doubt, please consult your doctor or pharmacist.

Triptosan capsules should be taken with a glass of water.

Adults
Dose should be determined by your doctor. Usual Triptosan dosing for an adult is 150 mg (1 capsule) twice daily.

Doctor will evaluate your condition once per every 3-4 weeks and will make a decision on further treatment.

Elderly patients
For the elderly Triptosan treatment should be initiated with a half dose of adult.

If you took more Triptosan than you should
If you have taken too much Triptosan accidentally, please seek for your doctor or turn to emergency room of the nearest hospital.

If you forgot to take Triptosan    
Do not take a double dose of medicine to compensate for the forgotten one.

If you stop taking Triptosan
The use of Triptosan should be stopped gradually, diminishing the dose. Abrupt stopping may cause undesirable effects.

If you have any further questions about the use of this medicine consult your physician or pharmacist.
 
4.    POSSIBLE SIDE EFFECTS

Triptosan, as any other medicine, can cause side effects, although not everybody experiences them.

Usual side effects of Triptosan are bellyaches, nausea, diarrhoea and loss of appetite. However these side effects were of low intensity, decreased and disappeared in 2-3 days if usual dose was applied.

Very common side effects (affects more than 1 in every 10 users) are: nausea and vomiting. Side effects of digestive origin depend on the dose and occur more frequent when Triptosan is taken alone.

Common side effects (affects more than 1 in every 100 users) are: euphoria (elevated mood), headache, drowsiness, pain in the upper part of belly and diarrhoea.

Uncommon side effects (affects more than 1 in every 1000 users) are: eosinophilia (an increase in count of certain, eosinophilic, blood cells), insomnia and flush.

Rare side effects (affects more than 1 in every 10 000 users) are: decrease of appetite and worsening of depression.

Side effects of unknown frequency are: loss of appetite, dizziness, palpitation, increased or decreased blood pressure, changes in electrocardiogram. With higher doses elevated mood (mania or hypomania) temporarily may be present.

According to data of drug post-marketing surveillance, syndrome of eosinophilic myalgia (EMS) may occur. It is related to increase in count of eosinophilic blood cells, pain in joints and muscles, fever, breathlessness, neuropathy, swelling and lesion of skin (in a form of rash and hives).

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please, inform your doctor or pharmacist.

5.    HOW TO STORE TRIPTOSAN

Keep out of reach of children.

Triptosan should be stored in an original package in order to protect from humidity.
Do not use the medicine after the expiry date indicated on the blister and the outer package. For the expiry date the last day of month applies.
Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist  how to dispose of medicines no longer required. These measures will help to  protect the environment.

6.    FURTHER INFORMATION

What Triptosan contains

-The active substance is oxytryptan. Each hard capsule contains 150 mg of oxytryptan.
-The excipients are microcrystalline cellulose, talc, magnesium stearate, colloidal anhydrous silica, in the body of the capsule – gelatine, titanium dioxide E 171.

What Triptosan looks like and contents of the pack

Triptosan hard capsules are white cylindrical capsules filled with white or off-white powder.

Triptosan is packed in blisters, each containing 20 capsules. Cartons contain 2 or 3 blisters (40 or 60 capsules).
Not all sizes of cartons may be available for supply.

Marketing authorization holder and manufacturer
UAB “Aconitum”
Taikos ave.102,
LT-51195 Kaunas,
Lithuania
Tel. +370 37 328008
Fax: +370 37 338487
E-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Consult marketing authorization holder, if you want more information about this medicine.

The latest date of approval of this package information leaflet is 2011-01-17

The latest review of the package information leaflet is available online at the website of State Medicines Control Agency (SMCA) under the Ministry of Health of the Republic of Lithuania http://www.vvkt.lt/