Prospect: information for the user

ZINOSAL 12.5 mg film-coated tablets E.F.G

Tianeptine sodium

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section4.

1.What isZinosal and for what it is used

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

3.How to take Zinosal

4.Possible adverse effects

5.Storage of Zinosal

6.Contents of the package and additional information

Zinosal contains Tianeptine sodium as its active ingredient.

Zinosal belongs to a group of medications known as antidepressants.

Zinosal is indicated for the treatment of major depression in adults.

Do not take Zinosal

• If you are allergic to tianeptine sodium or any of the other components of this medication(listed in section 6).
• If you are taking other medications for depression, such as monoamine oxidase inhibitors (MAOIs).A two-week interval is required between MAOI treatment and tianeptine treatment. A 24-hour interval is required only when tianeptine is substituted with an MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zinosal.

Precautions

Do not stop treatment abruptly; the dose should be reduced over a period of at least 7 to 14 days.You should be aware that, after stopping treatment with tianeptine, some side effects may occur, such as anxiety, muscle pain, abdominal pain, insomnia, and joint pain.

Children and adolescents (under 18 years)

Zinosal should not be used in the treatment of children and adolescents under 18 years.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes think about harming yourself or ending your life. These thoughts may be more frequent when starting treatment with antidepressants, as these medications take time to start working, usually two weeks, but sometimes longer.

You may be more prone to having these thoughts:

• If you have thought about harming yourself or suicidal thoughts in the past.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who received treatment with an antidepressant.

If you ever have thoughts of harming yourself or suicidal thoughts, contact your doctor or go to the hospital immediately. It may help to explain to a close family member or friend that you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse or if they are concerned about changes they see in your behavior.

If you enter a manic phase (hyperactive behavior or thoughts), you shouldconsultyour doctor.

If you are to undergo surgery that requires general anesthesia. Zinosal treatment should be suspended 24 to 48 hours before the use of anesthesia. However, if an emergency intervention is necessary, it can be performed without prior suspension, but under proper surgical supervision.

If you have renal function impairment.Your doctor may consider a dose adjustment.

Taking Zinosal with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication,includingthoseacquiredwithoutprescription.

Inform your doctor if you are taking any of the following medications:

• MAOIs, which are used, for example, to treat depression(such asmoclobemide, tranylcypromine, etc)or Parkinson's disease (such asselegiline, etc).
• Mianserin (antidepressant).
• Other central nervous system depressants such as:
• Opioid analgesics (such as codeine, buprenorphine, fentanyl, etc).
• Antihistamines (used to treat allergic reactions).
• Benzodiazepines (used to treat anxiety, insomnia, agitation, seizures, muscle spasms, alcohol withdrawal).

Taking Zinosal with food, drinks, and alcohol

Zinosalshouldbe takenbeforemeals.

It is not recommended to consume alcohol during treatment with Zinosal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Unless your doctor tells you otherwise, Zinosal should not be used during pregnancy or breastfeeding.

Driving and operating machinery

During treatment with Zinosal, you may feel drowsy or dizzy. Do not driveor operate tools or machines until you know how Zinosal affects you.

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

Adults

The usual dose is 3 coated tablets per day (12.5 mg of tianeptine sodium), one in the morning, one at noon, and one at night.

The tablets should be taken before meals.

The tablets should be swallowed whole with a little water.

Use in patients over 70 years old

The dose in patients over 70 years old should be reduced to 2 tablets per day.

Use in children and adolescents (under 18 years old)

Zinosal should not be administered normally to children and adolescents.

Patients with renal or hepatic insufficiency

The dose in patients with renal insufficiency should be reduced to 2 tablets per day.

No dose modification is necessary in patients with alcohol dependence with or without cirrhosis.

Treatment duration:

• It may take several weeks before you start feeling better.Therefore, you should continue taking Zinosal even if it takes some time to notice an improvement in your condition.
• Do not modify the dose of your medication without talking to your doctor first.
• Continue taking the coated tablets for the time recommended by your doctor.If you interrupt treatment too soon, symptoms may reappear.It is recommended to maintain treatment for a minimum of 6 months after feeling well again.

IN ANY CASE, FOLLOW YOUR DOCTOR'S INSTRUCTIONS TO THE LETTER.

If you take more Zinosal than you should

In case of overdose or accidental ingestion, contact your doctor or go to the nearest hospital emergency department. Always carry the Zinosal packaging with you.You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.Symptoms of overdose may include: nausea, vomiting, dizziness, and drowsiness.

If you forgot to take Zinosal

Do not take a double dose to compensate for the missed doses.

If you forget to take your tablet, take it as soon as you remember.If it is almost time for the next dose, take it at the usual time.

If you interrupt treatment with Zinosal

Zinosal treatment should not be stopped abruptly; it is necessary to gradually reduce the dose over a period of 7-14 days.

Do not stop taking your coated tablets, even if you feel well, unless your doctor tells you to.

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

Like all medicines, Zinosal may cause side effects, although not everyone will experience them.

The following side effects have been reported with the use of Zinosal:

Frequent side effects (may affect up to 1 in 10 people) include:

•Anorexia (eating disorder)

•Nightmares

•Insomnia

•Drowsiness

•Dizziness

•Headache

•Collapsing

•Tremor

•Visual disturbance

•Hot flashes

•Abnormal or rapid heartbeats, chest pain

•Difficulty breathing

•Dry mouth, constipation, abdominal pain, nausea, vomiting, flatulence, diarrhea, stomach burning

•Back pain, muscle pain

•Weakness

•Sensation of a lump in the back of the throat

Less frequent side effects (may affect up to 1 in 100 people) include:

•Itching, urticaria (rash)

Rare side effects (may affect up to 1 in 1000 people) include:

•Substance abuse and dependence, especially in patients under 50 years old with a history of drug or alcohol abuse

Side effects of unknown frequency:

•Suicide and suicidal behavior. See warnings and precautions section.

If you experienceside effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out ofsightand reach of children.

Do not usethismedicationafter the expiration date that appears on the blister pack and the cardboard box after CAD.

The expiration date is the last day of the month indicated.

Blister pack of PVC/PVdC/aluminum:

Do not store at a temperature above 25°C.

Blister pack of aluminum/aluminum:

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Zinosal:

The active ingredient is tianeptine sodium.Each film-coated tablet contains 12.5mg of tianeptine in the form of sodium salt.

The other components are:

Tablet core:

Manitol (E421)

Maize starch

Hydroxypropylcellulose (E463)

Magnesium stearate

Film coating:

Methylhydroxypropylcellulose(E464)

Microcrystalline cellulose (E460)

Stearic acid (E570)

Methacrylic acid copolymer

Talc (E553b)

Titanium dioxide (E171)

Triethyl citrate (E1505)

Anhydrous colloidal silica

Bisodium citrate (E500ii)

Yellow iron oxide (E172)

Sodium lauryl sulfate

Appearance of the product and contents of the package:

Zinosal is presented in film-coated tablets, yellowish in color, biconvex, with a diameter of 7mm.

Zinosal is available in PVC/PVdC/aluminum blisters and in aluminum/aluminum blisters.

Package sizes:

30film-coated tablets..

90 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Exeltis Healthcare S.L

Avda. de Miralcampo 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Manufacturer:

Laboratorios Liconsa S.A.

Avda. Miralcampo 7

Polígono Industrial Miralcampo

Azuqueca de Henares

19200 Guadalajara

Spain

Last review date of this leaflet:July 2019

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”