LANTANON 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lantanon 10 mg film-coated tablets

Mianserin, hydrochloride

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 experience 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 Lantanon is and what it is used for
2. What you need to know before you take Lantanon
3. How to take Lantanon
4. Possible side effects
5. Storing Lantanon
6. Contents of the pack and other information

1. What Lantanon is and what it is used for

Lantanon belongs to a group of medicines called antidepressants. Lantanon relieves the depressed mood that causes 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 2-4 weeks after treatment.

2. What you need to know before you take Lantanon

Do not takeLantanon

• if you are allergic to the active substance (mianserin) or to any of the other ingredients of this medicine (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 recently taken (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Use in children and adolescents under 18 years

Lantanon should not normally be used 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 greater risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, your doctor may prescribe Lantanon to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed Lantanon to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed below progress or 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 suicidal thoughts. This could worsen when you start taking antidepressants for the first time, as these medicines usually take two weeks or sometimes more to take effect.

You may be more prone to thinking this way if:

• you have previously had suicidal thoughts or thoughts of harming yourself,
• you are a young adult. Clinical trial information 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 suicidal thoughts at any time, consult your doctor or go to a hospital immediately.

It may be useful to tella relative or close friend that 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 is getting worse, 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 or have had:

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

Always consult your doctor, even if you have had these diseases or disorders in the past.

Taking Lantanon with other medicines

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

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 for the next two weeks.

Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants), selegiline (for Parkinson's disease), and linezolid (an antibiotic).

Be careful ifyou take Lantanon with:

• medicines for epilepsysuch as carbamazepine and phenytoin;
• medicines to prevent blood clottingsuch as warfarin.

Lantanon may increase the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. In case of taking them together, it is recommended that your doctor perform blood tests;

• medicines that can affect heart rate, 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 advisable to drink alcohol during treatment with Lantanon.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

3. How to take Lantanon

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

In general, you will start with a low dose (3 tablets a day, i.e., 30 mg of mianserin hydrochloride), which may be gradually increased if necessary, as indicated by your doctor, until the most effective daily dose is reached. For the treatment to be successful, it is very important that you take your tablet(s) every day. Take the recommended doses strictly.

Take the tablet(s) at the same time every day, preferably once, at night before bedtime. If your doctor recommends it, Lantanon can be taken in divided doses, half during the day (one in the morning and one at night before bedtime). The tablets should 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 early or too abruptly, your illness may worsen. Inform your doctor how the treatment is going. Your doctor will indicate how to gradually reduce the dose in case you can finish your treatment.

If you take more Lantanon than you should

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

You can also contact the Toxicology Information Service. Phone 91 562 04 20.

Vomiting should be induced as soon as possible. Prolonged sedation or drowsiness may occur. The symptoms of a possible overdose may be changes in your heart rate (fast, irregular heartbeat) and/or fainting, which can be symptoms of a potentially life-threatening disease known as Torsades de pointes.

If you forget to take Lantanon

If you have to take one dose a daybefore bedtime 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 tablets twice a day(one in the morning after breakfast and one at night, before bedtime) and you have forgotten to take one or both doses, do the following:

• if you have forgotten the morning dose, simply take it with the night dose,
• if you have forgotten the night dose or both doses, do not try to recover them; the next day, continue with the recommended dose both in the morning and at night.

If you interrupt treatment with Lantanon

Although Lantanon does not cause addiction, sudden cessation of treatment may cause dizziness, agitation, anxiety, headache, and nausea. Therefore, the dose should be gradually decreased.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Temporarily, Lantanon may cause the following side effects:

• drowsiness,
• weight gain,
• thoughts of harming yourself or suicidal thoughts.

Consult your doctor or go to a hospital immediately.

In rare cases, Lantanon may cause a decrease in white blood cells in the blood, with decreased resistance to infections. If you have a fever, sore throat, mouth ulcers, or other signs of infection while taking Lantanon, you should contact your doctor immediately and have a blood test. These symptoms usually appear 4-6 weeks after treatment and are generally reversible after stopping treatment with Lantanon.

Other possible side effects are:

• low blood pressure, characterized by dizziness, dizziness, or fainting, especially when standing up quickly,
• epileptic seizures (seizures),
• hypomania (abnormal mood, similar to mania, but less intense),
• swelling of the ankles or feet due to fluid accumulation (edema),
• yellowing of the eyes or skin; may suggest liver function changes,
• hepatitis (liver inflammation),
• slow heart rate after the initial dose,
• malignant neuroleptic syndrome (the most important symptoms are rigidity throughout the body, involuntary movements, and elevated body temperature),
• joint pain,
• restless legs syndrome,
• rash,
• changes in your heart rate (fast, irregular heartbeat) and/or fainting, which can be symptoms of a potentially life-threatening disease known as Torsades de pointes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lantanon

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

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lantanon

• The active substance is mianserin hydrochloride. Each tablet contains 10 mg of mianserin hydrochloride.
• The other ingredients are:

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

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

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Date of last revision of this leaflet: March 2015

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/