MANOLLIA 20 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Manollia 20 mg Hard Capsules EFG

lisdexamfetamine dimesylate

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

1. What is Manollia and what is it used for

What is Manollia

Manollia contains the active substance lisdexamfetamine dimesylate, which acts on brain activity. It helps to improve attention, concentration, and reduce impulsivity.

It is a long-acting medicine that works gradually over 13 hours.

What is it used for

Manollia is part of a comprehensive treatment program for "Attention Deficit Hyperactivity Disorder" (ADHD).

• for children and adolescents between 6 and 18 years old in whom previous treatment with methylphenidate has been inadequate for ADHD.
• for adults who have had ADHD since childhood. If you have not received treatment for ADHD before, your doctor will check if you had ADHD as a child before prescribing this medicine.

You should inform your doctor if you do not feel better or if you feel worse after one month of treatment. This medicine is not recommended for all patients with ADHD, and the decision to use this medicine is based on a comprehensive medical evaluation.

This medicine is not indicated for the treatment of ADHD in children under 6 years of age, as it is unknown whether it is safe or beneficial for such young individuals.

How it works

Manollia improves the activity of certain parts of the brain that are underactive. The medicine may help improve attention, concentration, and reduce impulsive behavior.

The medicine is administered as part of a treatment program that usually includes:

• psychological therapy;
• educational therapy;
• social therapy.
• behavioral therapy
• occupational therapy

It can only be prescribed by doctors who have experience in treating people with behavioral problems.

About ADHD

People with ADHD have difficulties:

• sitting still;
• concentrating.

These individuals are not to blame for being unable to do these things. However, ADHD can cause problems in daily life.

Children and adolescents with ADHD may have difficulties learning and doing homework. They may have trouble behaving well at home, at school, and in other places.

ADHD does not affect a person's intelligence.

2. What you need to know before you take Manollia

Do not take Manollia:

• if you are allergic to lisdexamfetamine or any of the other ingredients of this medicine (listed in section 6);
• if you are taking a medicine called a "monoamine oxidase inhibitor" (MAOI) that is used for depression or if you have taken an MAOI in the last 14 days;
• if you have thyroid problems;
• if you feel exceptionally excited, more active, or more uninhibited than usual;
• if you have or have had any heart problems, such as a heart attack, irregular heartbeats, chest pain, heart failure, heart disease, or congenital heart problems;
• if you have high or very high blood pressure or narrowing of the blood vessels;
• if you have high eye pressure (glaucoma).

Do not take this medicine if you have any of the above circumstances. If you are unsure, consult your doctor or pharmacist before taking this medicine, as it may worsen these problems.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with lisdexamfetamine if:

• you have ever abused prescription medicines or street drugs;
• you have had kidney problems;
• you have had seizures (fits, convulsions, epilepsy) or changes in your electroencephalogram (EEG);
• you have had uncontrollable tremors in any part of your body or if you repeat sounds and words;
• you have high blood pressure;
• you have a family history of irregular heartbeat (visible on an electrocardiogram) or if you have a condition or are undergoing treatment that makes you prone to arrhythmias or changes in sodium levels;
• you have a heart problem not listed in the previous section "Do not take lisdexamfetamine";
• you have a mental health problem, including:

• sudden mood changes (from manic to depressive states, also known as "bipolar disorder");
• starting to behave aggressively or hostilely or worsening of these behaviors;
• seeing, hearing, or feeling things that are not real (hallucinations);
• believing things that are not real (delusions);
• feeling more suspicious than usual (paranoia);
• feeling agitated, anxious, or tense;
• feeling depressed or guilty.

Or if you are a woman who may become pregnant, plan to become pregnant, or are breastfeeding (see the section "Pregnancy and breastfeeding").

Inform your doctor or pharmacist if you have any of the above circumstances before starting treatment. This is because lisdexamfetamine may worsen these problems. Your doctor will want to monitor how the medicine affects you.

If this medicine is not used correctly, it can cause abnormal behavior, and the user may start to depend on the medicine. Inform your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Do not give this medicine to anyone else, even if the symptoms seem similar.

This medicine may cause heart rhythm disorders in some patients. If you experience palpitations or irregular heartbeats during treatment, you should inform your doctor immediately. The risk of heart problems may increase with increasing dose. Therefore, you should follow the recommended dose.

Checks that your doctor will make before you start taking Manollia

These checks are done to decide if lisdexamfetamine is the right medicine for you. Your doctor will ask you about:

• other medicines you are taking;
• if there is a family history of sudden unexplained death;
• any other medical problem (such as heart problems) that you or your family have had;
• how you feel, if you feel happy or sad, if you have strange thoughts or if you have had these feelings in the past;
• if you have a family history of "tics" (uncontrollable tremors in any part of the body or repetition of sounds and words);
• any mental health or behavioral problem that you or your family have had. Your doctor will review your mental health history and check if anyone in your family has a history of suicide, bipolar disorder (mood changes from manic to depressive states), or depression.

It is essential that you provide as much information as possible. This will help your doctor decide if lisdexamfetamine is the right medicine for you. Your doctor may decide that other tests need to be done before you start taking this medicine.

Effects on weight

• Manollia may cause weight loss in some patients
• There may also be a lack of weight gain in children and adolescents
• If you are a child or adolescent, your doctor will closely monitor your height and weight, as well as your diet.
• If you are not growing as expected or if you are losing weight, your doctor may stop treatment with Manollia.
• In the case of adults, the doctor will monitor your weight and diet.

Other medicines and Manollia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Manollia if:

• you are taking a medicine called a "monoamine oxidase inhibitor" (MAOI) that is used for depression or have taken an MAOI in the last 14 days. Taking an MAOI with lisdexamfetamine can cause a sudden increase in blood pressure. Your doctor or pharmacist may tell you if you are taking a medicine that is an MAOI.

Manollia may interact with other medicines. If you take any of the following medicines, consult your doctor or pharmacist before taking this medicine:

• medicines for severe mental health problems;
• medicines used to increase or decrease blood pressure;
• medicines used during surgery, such as painkillers;
• cough and cold remedies. Some of these medicines may affect blood pressure, so it is essential that you consult your pharmacist when purchasing any of these medicines;
• medicines that may affect urine acidity, such as vitamin C (ascorbic acid) or sodium bicarbonate (e.g., in medicines for indigestion).

If you are unsure if the medicines you are taking are on the list above, consult your doctor or pharmacist before taking this medicine.

Doping control and use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Pregnancy and breastfeeding

Pregnancy

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

Your body breaks down this medicine into other substances that can cross the placenta and enter breast milk. Available data on the use of this medicine during the first three months of pregnancy do not indicate an increased risk of congenital malformations in the child, but may increase the risk of preeclampsia (a condition that usually occurs after 20 weeks of pregnancy and is characterized by high blood pressure and protein in the urine) and premature birth.

Newborns exposed to amphetamine during pregnancy may exhibit withdrawal symptoms (tremors, irritability, hypertonia). You should not use this medicine during pregnancy unless your doctor explicitly tells you to.

Breastfeeding

This medicine should not be used during breastfeeding

Driving and using machines

You may feel dizzy, have problems fixing your gaze, or see blurry when taking lisdexamfetamine. If this happens, it is dangerous to perform activities such as driving, using machines, riding a bicycle or horse, or climbing trees.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is, essentially "sodium-free".

3. How to take Manollia

How much to take

Follow the instructions for taking this medicine exactly as described in this leaflet or as your doctor has told you. If you are unsure, consult your doctor or pharmacist again.

Manollia is only for you. Do not give this medicine to anyone else, even if they have similar symptoms.

How to take Manollia

• Take the medicine in the morning before breakfast. It can be taken with or without food.
• There are two ways to take Manollia:

• Swallow the capsule whole with a glass of water.
• Open the capsule and empty the contents into:

• a soft food like yogurt,
• a glass of water or orange juice.

Use a spoon to dissolve any lumps and mix the medicine and yogurt, water, or orange juice well. Take all the yogurt or drink all the water or orange juice immediately after mixing with Manollia. Do not store it. Do not worry if a film remains in the glass or container; it is not the active ingredient.

Dose

• Your doctor will tell you the daily dose you should take.
• The recommended starting dose is 30 mg, but your doctor may decide to start with 20 mg. Later, your doctor may increase the dose. The maximum daily dose is 70 mg.
• If you have kidney problems, your doctor may reduce the dose.
• If you are an elderly patient, your doctor will assess your blood pressure and cardiovascular status before starting treatment and during treatment (see section 2 "Do not take Manollia" and "Warnings and precautions"). Your doctor may reduce the dose.
• Do not divide the dose of a capsule; take the entire contents of the capsule. Do not take less than one capsule per day.

If you do not feel better after 1 month of treatment

If you do not feel better, inform your doctor. You may need a different treatment.

Incorrect use of Manollia

If lisdexamfetamine is not used correctly, it can cause abnormal behavior. You may also start to feel that you need the medicine for reasons that are not related to ADHD.

Inform your doctor if you have ever had problems with alcohol, prescription medicines, or street drugs.

If you take more Manollia than you should

If you take too much medicine, contact a doctor or call an ambulance immediately. Tell them how much you have taken.

In case of overdose or accidental ingestion, consult a doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medicine and the amount ingested.

The signs of overdose may include: restlessness, tremors, increased uncontrolled movements, muscle tremors, rapid breathing, confusion, tendency to fight or argue, seeing, hearing, or feeling things that are not real (hallucinations), panic state, high fever, or muscle collapse. Afterwards, you may feel tired and depressed. You may also experience nausea, vomiting, diarrhea, and stomach cramps. There may also be changes in heart rate (slow, fast, or irregular), high or low blood pressure, circulatory collapse, seizures, and coma.

If you forget to take Manollia

Do not take a double dose to make up for forgotten doses. If you forget a dose, wait until the next day. Avoid taking the dose in the afternoon due to the possibility of sleep disorders (insomnia).

If you stop taking Manollia

If you stop taking this medicine, your ADHD symptoms may return.

Do not stop taking the medicine without consulting your doctor first. You should not stop taking the medicine suddenly or on your own.

What your doctor will do while you are taking Manollia

Your doctor will perform some tests

• Before starting: to ensure that Manollia is safe and beneficial for you.
• After starting: your doctor will perform tests at least every 6 months, and even more often. Tests will also be performed when you change dose. These tests will include:

• appetite control,
• height and weight measurement,
• blood pressure and pulse measurement,
• checking if you have had mood, mood, or any other unusual feelings or if these issues have worsened while taking this medicine.

Long-term treatment

This medicine does not need to be taken forever. If you take lisdexamfetamine for more than a year, your doctor should interrupt treatment for a short period, such as during holidays. This allows your doctor to see if you still need the medicine.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Your doctor will inform you about these adverse effects.

Some adverse effects can be serious. If any of the following adverse effects appear, go to the doctor immediately:

Frequent (may affect up to 1 in 10 people)

• irregular heartbeats (palpitations);
• chest pain (could be a sign of heart problems).

Infrequent (may affect up to 1 in 100 people)

• feeling more excited, active, or uninhibited than usual (mania);
• allergic reaction (hypersensitivity);

Frequency not known (cannot be estimated from available data)

• severe allergic reaction characterized by a sharp drop in blood pressure, difficulty breathing, and hives/itching (anaphylactic reaction);
• seeing, feeling, or hearing things that are not real, paranoia, delusions (psychotic episodes);
• seizures (convulsive crises);
• abnormal heartbeat, potentially life-threatening irregular heartbeat (observed on an electrocardiogram). See section 2, Warnings and precautions;
• allergic liver injury that can be detected by the yellow color of the eyes and/or skin (eosinophilic hepatitis);
• skin swelling (angioedema) or severe skin rash with significant blisters on the skin and mucous membranes (Stevens-Johnson syndrome).
• shortness of breath or swelling of the legs (signs of heart muscle disease)

*The following serious adverse effects are more frequent in children and/or adolescents than in adults.

• seeing, feeling, or hearing things that are not real is infrequent in children and adolescents
• shortness of breath or swelling of the legs (signs of heart muscle disease) are infrequent in adolescents

If you experience any of the above adverse effects, go to the doctor immediately.

Other adverse effects include the following. If they worsen, inform your doctor or pharmacist:

Very frequent (may affect more than 1 in 10 people)

• decreased appetite;
• inability to sleep;
• dry mouth;
• headache.

Frequent (may affect up to 1 in 10 people)

• feeling agitated, nervous, anxious, depressed, aggressive, irritable, or having mood changes;
• feeling tired* or restless;
• inability to achieve or maintain an erection or changes in sexual desire;
• feeling dizzy;
• uncontrolled spasms, tremors, or unusual activity;
• repeated and uncontrollable spasms of any part of the body or repetition of sounds and words (tics)
• rapid or irregular heartbeat (tachycardia);
• high blood pressure*;
• breathing difficulties;
• nausea, vomiting, or diarrhea;
• constipation;
• weight loss*;
• excessive sweating;
• stomach pain;
• grinding teeth.

Infrequent (may affect up to 1 in 100 people)

• fever*;
• talking non-stop;
• feeling depressed, worried, sad, or uneasy (dysphoria);
• feeling too happy or excited (euphoria);
• excessive skin picking;
• uncontrolled tremors or shaking;
• itching, rash*, or red elevated rashes that itch (urticaria);
• blurred vision;
• metallic taste or changes in taste (dysgeusia)
• fainting;
• nosebleeds.

Frequency not known (cannot be estimated from available data)

• excessive pupil dilation*;
• aggression;
• poor blood circulation that causes fingers and toes to become numb and pale (Raynaud's phenomenon)*;

*The following side effects are more frequent in children and/or adolescents than in adults.

• weight loss is very common in children and adolescents;
• stomach pain is very frequent in children;
• fever is frequent in children and adolescents;
• feeling unusually sleepy is frequent in children and adolescents;
• rash is common in children;
• high blood pressure is infrequent in children and adolescents;
• poor blood circulation that causes fingers and toes to become numb and pale (Raynaud's phenomenon) is infrequent in children;
• excessive pupil dilation is infrequent in children and adolescents;

Reporting adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website http://www.aemps.gob.es/.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Manollia

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the bottle and carton after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if the capsules show any signs of damage.

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

6. Package contents and additional information

Composition of Manollia

• The active ingredient is lisdexamfetamine dimesylate.

Each hard capsule contains 20 mg of lisdexamfetamine dimesylate, which corresponds to 5.9 mg of dexamfetamine.

• The other ingredients are:

• Capsule content: microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b).
• Capsule shell: gelatin (E441), printing ink (shellac, propylene glycol, and iron oxide black (E172)), titanium dioxide (E171).

Appearance of the product and package contents

Hard capsules with a white body and white cap, printed with "ALV" on the white cap and printed on the white body with "563" in gray ink, containing a white to pale yellow powder.

The capsules are packaged in white high-density polyethylene (HDPE) bottles with a child-resistant white polypropylene (PP) cap and a silica gel desiccant. Do not ingest the desiccant.

Each bottle contains 30 or 100 capsules.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000 Malta

Or

Adalvo Ltd

Malta Life Sciences Park, Building 1,

Level 4, Sir Temi Zammit Buildings,

San Gwann, SGN 3000 Malta

Or

Entafarma UAB

Kloneny Vs 1, Sirvinty R Sav Jauniunu Sen,

LT-19156, Lithuania

Or

Aristo Pharma GmbH

Wallenroder Straße 8 - 10

13435 Berlin,

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovenia Lisdeksamfetamin Aristo 20 mg Trde kapsule

Germany Lisdex-Aristo Hartkapseln

Spain Manollia 20 mg hard capsules EFG

Date of the last revision of this leaflet:May 2024

Other sources of information

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

Information for children and adolescents

This information will help you understand the main aspects of your Manollia medicine.

If you don't like reading, someone like your mother, father, or caregiver (sometimes called "your tutor") can read it to you and answer your questions.

It may be helpful to read small fragments at a time.

Why has my doctor prescribed this medicine for me?

This medicine can help you with ADHD.

ADHD can make you

• run too much;
• be unable to pay attention;
• act quickly without thinking about what will happen next (impulsive behavior).

It affects learning, making friends, and the way you think about yourself. It's not your fault.

While taking this medicine

• In addition to giving you this medicine, your doctor will help you learn ways to cope with your ADHD, such as talking to people who can give you advice or teaching you different ways to do things.
• The medicine should help you with your ADHD.
• You will need to visit the doctor several times so that they can check on you. This is to make sure the medicine is working and that you are growing and developing well.
• If you take the medicine for more than a year, your doctor may stop it to see if you still need it. This will probably happen during school vacations.
• Adolescent girls should ask their doctor for advice before taking this medicine if they think they may be pregnant or are planning to have a baby.

Some people cannot take this medicine

You cannot take this medicine if

• you have heart problems;
• you feel unusually excited or hyperactive.

Some people need to talk to their doctor before starting to take this medicine.

You need to talk to your doctor if:

• you have seizures;
• you are pregnant or breastfeeding;
• you are taking other medicines - your doctor needs to know about all the medicines you are taking;
• you have kidney problems.

How should I take my medicine (capsules)?

• Swallow the capsule with water. Or open the capsule and dissolve the entire contents in a glass of water or orange juice. Or mix the contents with soft foods like yogurt.
• Eat all the yogurt or drink all the water or orange juice immediately after mixing.
• Take one capsule each morning. You can take it with or without food.
• Do not stop taking this medicine without consulting your doctor first.
• If you forget to take your medicine, talk to an adult. DO NOT take 2 capsules to make up for the missed dose.

Possible adverse effects

Adverse effects are unwanted things that can happen when you take a medicine. If you experience any of the following, tell an adult immediately. They can talk to your doctor. The main adverse effects are:

• you feel like your heart is beating faster than usual or that your heartbeats are irregular;
• you see, feel, or hear things that are not real;
• you feel unusually excited or hyperactive;
• you have a severe allergic reaction. This can manifest as dizziness, difficulty breathing, and itching;
• you have seizures;
• you notice yellow eyes and/or skin;
• you have skin swelling or severe skin rashes with significant blisters on the skin or other areas.

If you feel unwell while taking the medicine, tell an adult immediately.

Other things to remember

• Make sure to store the medicine in a safe place, so that no one else can take it.
• The medicine is only for you, DO NOT let anyone else take it. It can help you, but it could harm someone else.
• If you forget to take the medicine, do not take two capsules the next time. Simply take 1 capsule at the next regular time.
• It is important that you do not take too much medicine or you will get sick.
• If you take too much, tell your mother, father, or caregiver immediately.
• Do not stop taking the medicine until your doctor tells you to.

Who should I ask if there's something I don't understand?

Your mother, father, caregiver, doctor, nurse, or pharmacist can help you.