TIALERA 12.5 mg. 30 tablets
Tialera belongs to a group of medications called antidepressants.
Tialera used for depression of mild, moderate or severe depression.
2. Before you take Tialera
Do not take Tialera:
if you are allergic (hypersensitive) to tianeptine sodium or any of the other ingredients of Tialera (Please see section 6);
if you are taking other medicines for depression such as monoamine oxidase inhibitors (MAOIs).
Take special care with Tialera
If you are depressed and / or have associated with anxiety disorders, sometimes maybe they will take hold thoughts of harming or killing yourself. They can be amplified when you first start taking antidepressants, since these medicines all take some time before they begin to act - usually about two weeks, but maybe longer.
There are more likely to think so:
If you have previously had thoughts about killing or harming yourself;
If you are a young person; Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions who were treated with an antidepressant.
If at any time you are seized thoughts of harming or killing yourself, contact your doctor or go immediately to a hospital. You may be helpful to tell a relative or close friend that you are depressed or have an anxiety-related disorders and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse or if you are worried about changes in your behavior.
If entering a manic phase (overactive behavior or thoughts) should stop using Tialera. Ask your doctor for advice.
If you are to undergo an operation where necessary under general anesthesia, treatment with Tialera must stop 24 to 48 hours prior to administration of anesthesia. However, if you need emergency surgery, it can be done without first stop treatment, but with correct monitoring during surgery.
If you have impaired kidney or liver may be necessary for your doctor to adjust your dosage.
Taking other medicines
The effects of Tialera and other concomitant medicinal products may show interplay.
Tialera should not be administered together with a monoamine oxidase (MAO), which are used for example for the treatment of depression in Parkinson's disease (such as moclobemide or selegiline). It may take at least 2 weeks between the administration of monoamine oxidase inhibitors of the disease and the treatment with Tialera.
It is reported that coadministration with mianserin (class of antidepressant agents) results in reduced efficacy.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Tialera with food and drink
Tialera can be taken with food.
When using Tialera should avoid drinking alcohol.
Pregnancy and lactation
Tell your doctor if you are pregnant or planning to become pregnant. Unless your doctor has given you other instructions Tialera should not be used during pregnancy and lactation.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
It is possible that in some patients this medicine adversely affect the activities which require caution, motor coordination and quick decision-making (such as driving, operating machinery, high performance etc.). Such activities must be carried out only after approval by the doctor.
3. How to take Tialera
Always take Tialera just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist. Your doctor will tell you how to take Tialera and for how long.
The usual dose is 3 tablets a day (12,5 mg sodium Tianeptine): one morning, one at lunch and one evening.
The tablets should be swallowed whole with water.
You can take this product during meals.
Elderly patients and patients with impaired function of the liver and kidneys
The dose for elderly patients over 70 years and in patients with renal impairment should be reduced to two tablets a day.
Use in children and adolescents (under 18 years)
Tialera generally not be used in children and adolescents.
Duration of treatment
It may take several weeks before you start to feel better. Therefore, you should continue to use Tialera even need to take some time before you feel any improvement in his condition.
Do not change the dose of your medication without first discussing this with your doctor.
Continue to use the tablets for as long as you recommend your doctor. If you stop treatment too soon, your symptoms may reappear. It is recommended to continue treatment for at least 6 months after you feel better.
In all cases, strictly complying with your doctor.
If you take more dose Tialera
In case of overdose or accident swallowed by children, consult your doctor. Treatment in such cases must be stopped immediately; will perform gastric lavage and track vital functions. Contact your doctor immediately or go to the emergency department of the nearest hospital. Show them the pack of Tialera.
If you forget to take Tialera
Do not take a double dose to make up the missed dose.
If you forgot to take your tablet, take it as soon as you remember. If almost became time for your next dose, take it at the usual time.
If you stop taking Tialera
Tialera treatment should not be stopped abruptly; the dose should be reduced gradually over a 7 to 14 days.
Do not stop taking the film-coated tablets, even if you feel better, unless your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Tialera can cause side effects, although not everybody gets them.
Adverse drug reactions are classified as follows:
very common: affects more than 1 person in 10 consumer;
Common: affects 1 to 10 persons per 100 users;
Uncommon: affects 1 to 10 persons per 1000 users;
rare: affects 1 to 10 people per 10 000 users;
very rare: affects less than 1 person in 10,000 consumer;
Not known: from the available data can not be estimated.
In Tialera reported the following adverse reactions:
Anorexia (eating disorders);
Fast or abnormal heartbeat, chest pain;
Dry mouth, constipation, abdominal pain, nausea, vomiting, flatulence (bloating), diarrhea, heartburn;
Back pain, muscle pain;
Feeling stuck in the throat lump.
Itching, hives (rash).
Drug dependence and addiction, especially in patients under 50 years of age who have a history of addiction to drugs / alcohol or drugs.
Suicide and suicidal behavior.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Tialera
Keep out of reach of children.
Do not use Tialera after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of that month.
Blister of PVC / PVdC / aluminum:
Do not store above 25 ° C.
For blisters of aluminum / aluminum, this product does not require any special storage conditions.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
The active substance is tianeptine sodium. Each tablet contains 12,5 mg tianeptine sodium salt (tianeptine sodium salt).
Other ingredients are:
hydroxypropyl cellulose (E463);
cellulose, microcrystalline (E460);
stearic acid (E570);
methacrylic acid copolymer;
titanium dioxide (E171);
Triethyl citrate (E1505);
silica colloidal anhydrous;
sodium hydrogen carbonate (E500ii);
yellow iron oxide (E 172);
sodium lauryl sulphate.
Tialera looks like and contents of the pack
Tialera are light yellow, round, biconvex tablets with a diameter of 7 mm. Tialera is available in blister packs of PVC / PVdC / aluminum blister packs of aluminum / aluminum.
15 film-coated tablets;
20 film-coated tablets;
28 film-coated tablets;
30 film-coated tablets.
Not all pack sizes may be marketed.