ZINOSAL 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Tianeptine sodium

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Zinosal and what is it used for

Zinosal contains the active substance Tianeptine sodium.

Zinosal belongs to a group of medicines known as antidepressants.

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

2. What you need to know before you take Zinosal

Do not take Zinosal

• If you are allergic to tianeptine sodium or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines for depression, such as monoamine oxidase inhibitors (MAOIs). A minimum interval of 2 weeks between MAOI treatment and tianeptine treatment is required. A 24-hour interval is required only when tianeptine is replaced with an MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Zinosal.

Precautions

Do not stop treatment abruptly; the dose should be reduced over a minimum period of 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 a few weeks, but sometimes longer.

You may be more likely to have these thoughts:

• If you have previously thought about harming yourself or committing suicide.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults under 25 with psychiatric disorders who are being treated with an antidepressant.

If you ever have thoughts of harming yourself or committing suicide, contact your doctor or go to the hospital immediately. It may be helpful to explain to a family member or close friend that you are suffering from depression 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 in your behavior.

If you enter a manic phase (hyperactive behavior or thoughts), you should consult your doctor.

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

If you have impaired renal function. Your doctor may consider it necessary to adjust the dose.

Taking Zinosal with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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

• Monoamine oxidase inhibitors (MAOIs), used, for example, for the treatment of depression (such as moclobemide, tranilcipromine, etc.) or Parkinson's disease (such as selegiline, 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, convulsions, muscle spasms, and alcohol withdrawal).

Taking Zinosal with food, drinks, and alcohol

Zinosal should be taken before meals.

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

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

3. How to take Zinosal

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

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

The tablets should be taken before meals.

The tablets should be swallowed whole with a little water.

Use in patients over 70 years of age

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

Use in children and adolescents (under 18 years)

Zinosal should not be administered normally to children and adolescents.

Patient with renal or hepatic impairment

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

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

Duration of treatment:

• It may take several weeks before you start to feel better. Therefore, you should continue taking Zinosal even if it takes some time to notice an improvement in your condition.
• Do not change the dose of your medicine without talking to your doctor first.
• Continue taking the tablets for the time recommended by your doctor. If you interrupt treatment too early, symptoms may reappear. It is recommended to maintain treatment for at least 6 months after you feel better 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 emergency department of the nearest hospital. Always carry the Zinosal packaging with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. The symptoms of overdose would include: nausea, vomiting, dizziness, and drowsiness.

If you forget to take Zinosal

Do not take a double dose to make up for forgotten doses.

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

If you stop taking Zinosal

Treatment with Zinosal 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 film-coated tablets, even if you feel well, unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

• Anorexia (eating disorder)
• Nightmares
• Insomnia
• Drowsiness
• Dizziness
• Headache
• Fainting
• Tremor
• Visual disturbance
• Hot flushes
• Rapid or abnormal heartbeats, chest pain
• Breathing difficulties
• Dry mouth, constipation, abdominal pain, nausea, vomiting, flatulence, diarrhea, heartburn
• Back pain, muscle pain
• Weakness
• Sensation of a lump in the back of the throat

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

• Itching, urticaria (rash)

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

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

Side effects of unknown frequency:

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

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet.

Reporting of side effects:

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

5. Storage of Zinosal

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 blister and carton after EXP.

The expiry date is the last day of the month stated.

PVC/PVdC/aluminum blister:

Do not store above 25°C.

Aluminum/aluminum blister:

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Zinosal:

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

The other ingredients are:

Core of the tablet:

Mannitol (E421)

Corn starch

Hydroxypropylcellulose (E463)

Magnesium stearate

Coating:

Methylhydroxypropylcellulose (E464)

Microcrystalline cellulose (E460)

Stearic acid (E570)

Methacrylic acid copolymer

Talc (E553b)

Titanium dioxide (E171)

Triethyl citrate (E1505)

Anhydrous colloidal silica

Sodium bicarbonate (E500ii)

Yellow iron oxide (E172)

Sodium lauryl sulfate

Appearance of the product and contents of the pack

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

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

Package sizes:

30 film-coated tablets.

90 film-coated tablets.

Not all pack sizes may be marketed.

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

Date of last revision of this leaflet:July 2019

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