Leaflet: information for the user

Lantanon 10 mg film-coated tablets

Mianserine hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Lantanon and what is it used for

2.What you need to know before you start taking Lantanon

3.How to take Lantanon

4.Possible side effects

5.Storage of Lantanon

6.Contents of the pack and additional information

Lantanon belongs to a group of medications called antidepressants. Lantanon alleviates the depressed mood caused by depression. Depression is an emotional disorder. During depression, changes occur in the brain: brain nerve cells communicate with each other through chemical substances and in depression, the normal amount of these substances is lower. Antidepressants can correct these deficiencies and restore normal brain function. In general, improvement is experienced within 2-4 weeks of treatment.

Do not takeLantanon

• if you are allergic to the active ingredient (mianserina) or any of the other components of this medication (listed in section 6).
• if you have mania (a state of euphoria and hyperactivity).
• if you have liver disease.
• if you are taking or have taken in the last two weeks monoamine oxidase inhibitors (MAOIs).

Use in children and adolescents under 18 years

Lantanon should not be used normally in the treatment of children and adolescents under 18 years. At the same time, you should know that in patients under 18 years there is a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Despite this, the doctor who prescribes it may prescribe Lantanon to patients under 18 years when they decide it is the best option for the patient. If the doctor who prescribes it has prescribed Lantanon to a patient under 18 years and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed below progress or if you experience complications when patients under 18 years are taking Lantanon. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of Lantanon in this age group have not yet been demonstrated.

Suicidal thoughts and worsening of depression

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to take effect.

You may be more prone to thinking this way if:

• you have previously had suicidal thoughts or self-harm thoughts,
• you are a young adult. The information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders and who are being treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful to tell a close relative or friendthat you are depressed or feel anxious, and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety are worsening, or if they are concerned about changes in your behavior.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lantanon:

• if you have had or have at the moment:

• epilepsy (seizures)
• diabetes
• liver disorders, such as jaundice
• kidney diseases
• difficulty urinating due to an enlarged prostate
• heart diseases, including certain types of heart disease that change your heart rhythm, a recent heart attack, heart failure, or taking certain medications that are known to change your heart rhythm
• problems with blood pressure
• glaucoma (increased intraocular pressure)
• psychiatric disorders such as schizophrenia and bipolar depression (which alternate periods of euphoria/hyperactivity and periods of depression)

Consult your doctor even if you have had these diseases or disorders in the past.

Taking Lantanon with other medications

The effect of Lantanon may be affected by other medications or Lantanon may affect other medications.Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Lantanonwith:

• monoamine oxidase inhibitors(MAOIs). Also, do not take Lantanon during the two weeks after stopping MAOIs. If you stop taking Lantanon, do not take MAOIs during the following two weeks.

Examples of MAOIs are moclobemida, tranilcipromina (both are antidepressants), selegilina (for Parkinson's disease), and linezolida

(an antibiotic).

Be careful ifyou take Lantanon with:

• medications for epilepsysuch as carbamazepina and phenitoína;
• blood thinnerssuch as warfarina.

Lantanon may increase the effects of warfarina in the blood. Inform your doctor if you are taking this medication. If you take them together, it is recommended that your doctor perform blood tests;

• medications that can affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Lantanon with food, drinks, and alcohol

Lantanon may increase the effect of alcohol. Therefore, it is not recommended to drink alcohol during treatment with Lantanon.

Pregnancy and breastfeeding

Although animal experiments and limited human data indicate that mianserina does not cause damage to the fetus or damage to the newborn and passes into breast milk in very small amounts, the benefits of using Lantanon during pregnancy or breastfeeding should be weighed against the possible risks to the fetus or newborn.

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

Driving and operating machinery

• Lantanon may cause drowsiness,
• Do not drive because Lantanon may affect the safety of your driving,
• Do not use tools or machines.

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

Generally, you will start with a low dose (3 tablets a day, that is 30 mg of hydrochloride mianserin), which in case of need can be gradually increased by your doctor's indication to reach the most effective daily dose. For the treatment to be successful, it is very important that you take your tablets every day. Take strictly the recommended doses.

Take the tablets at the same time every day, preferably all at once, at night before going to bed. If your doctor recommends it, Lantanon can be taken in divided doses in equal parts during the day (one in the morning and one at night before going to bed). The tablets must be swallowed, without chewing, with a little water or other liquid.

Do not stop taking Lantanon just because your symptoms seem to have disappeared. If you stop treatment too soon or too abruptly, your illness may worsen. Inform your doctor about how you are doing with the treatment. Your doctor will indicate how to gradually lower the dose in case you can finish your treatment.

If you take moreLantanonthan you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately.

You can also consult the Toxicological Information Service. Phone 91 562 04 20.

You must induce vomiting as soon as possible. Prolonged sedation or drowsiness may appear. The symptoms of a possible overdose may be changes in your heart rhythm (rapid or irregular heartbeat) and/or dizziness, which may be symptoms of a potentially fatal disease known as Torsades de pointes.

If you forgot to takeLantanon

If you have to takea daily dosebefore going to bed and you forget, do not take the missed dose the next morning because you may have drowsiness during the day. Continue treatment at night with your recommended dose.

If you have to take the tabletstwice a day(one in the morning after breakfast and one at night before going to bed) and you forget to take one or both doses, do the following:

-if you forgot themorning dose, simply take it with the night dose,

-if you forgot thenight doseorboth doses,do nottry to recover them; the next day continue with the recommended dose both in the morning and at night.

If you interrupt the treatment withLantanon

Although Lantanon does not create addiction, abrupt treatment interruption may cause dizziness, agitation, anxiety, headache, and nausea. Therefore, the dose must be gradually reduced.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.Temporarily, Lantanon may cause the following adverse effects:

• drowsiness,
• weight gain,
• thoughts of self-harm or suicide.

Consult your doctor or go to the hospital immediately.

In rare cases, Lantanon may produce a decrease in white blood cells, resulting in a weakened immune system and increased susceptibility to infections. If you have a fever, sore throat, mouth sores, or other signs of infection while taking Lantanon, you must contact your doctor immediately and have a blood test. These symptoms occur mainly within 4-6 weeks of treatment and are generally reversible upon completion of treatment with Lantanon.

Other possible adverse effects are:

• low blood pressure, characterized by dizziness, lightheadedness, or fainting, especially when standing up quickly,
• seizures (convulsions),
• hypomania (abnormal mood, similar to mania, but of lesser intensity),
• swelling of ankles or feet due to fluid accumulation (edema),
• yellow discoloration of the eyes or skin, which may indicate liver function abnormalities,
• hepatitis (inflammation of the liver),
• slow heart rate after the initial dose,
• malignant neuroleptic syndrome (the most important symptoms are rigidity, involuntary movements, and elevated body temperature),
• joint pain,
• restless legs syndrome,
• hives,
• changes in heart rhythm (rapid or irregular heartbeat) and/or dizziness, which may be symptoms of a potentially life-threatening condition known as Torsades de pointes.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

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

Composition of Lantanon

• The active ingredient is hydrochloride ofmianserine. Each tablet contains 10 mg of hydrochloride of mianserine.
• The other components are:

Core:potato starch, anhydrous colloidal silica, magnesium stearate, methylcellulose, dihydrate calcium hydrogen phosphate.

Coating: hydroxypropylmethylcellulose (hypromellose), polyethylene glycol 8000, titanium dioxide (E-171).

Appearance of the product and content of the container

Lantanon 10 mg tablets are round, convex on both sides and marked with the code “ORGANON*” on one face and the code CT/4 on the other. The tablets are presented in child-resistant blisters, in boxes of 60tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible for manufacturing

Organon Heist bv

Industriepark30

2220Heist‑op‑den‑Berg

Belgium

Last review date of this leaflet: March 2015

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/