MANOLLIA 10 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Manollia 10 mg/ml Oral Solution

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 symptoms 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 Package Leaflet

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 impulsiveness.

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

What is it used for

Manollia is used to treat "Attention Deficit Hyperactivity Disorder" (ADHD). It is used:

• in children and adolescents aged 6 to 18 years in whom previous treatment with methylphenidate has been inadequate for ADHD. You may continue to take this medicine into adulthood if your doctor considers that the treatment is being beneficial.

You should tell your doctor if you do not feel better or if you feel worse after one month of treatment.

This medicine is not indicated for the treatment of ADHD in children under 6 years of age, as it is not known if it is safe or effective in such young patients.

How it works

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

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

• psychological therapy;
• educational therapy;
• social therapy.

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

About ADHD

People with ADHD have difficulties with:

• sitting still;
• concentrating.

These people are not to blame for not being able 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 the intelligence of the child or adolescent.

2. What you need to know before you take Manollia

Do not take this medicine if:

• you are allergic to lisdexamfetamine or any of the other ingredients of this medicine (listed in section 6);
• 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 (see below the section "Other medicines and Manollia");
• you have thyroid problems;
• you feel exceptionally excited, more active, or more uninhibited than usual;
• you have or have had heart problems, such as a heart attack, irregular heartbeats, chest pain and discomfort, heart failure, heart disease, or congenital heart problems;
• you have high or very high blood pressure or narrowing of the blood vessels;
• you have high eye pressure (glaucoma).

Do not take this medicine if you have any of the above conditions. If you are not sure, 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, drugs, or alcohol;
• you have had kidney problems;
• you have had seizures (fits, convulsions, epilepsy) or changes in the electroencephalogram (EEG);
• you have started your period (only for girls) (see the section "Pregnancy, breastfeeding, and fertility");
• you have had tremors that are difficult to control in any part of the 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 included in the previous section "Do not take lisdexamfetamine";
• you have a mental health problem, including:

• sudden mood changes (from manic to depressive states, known as "bipolar disorder");
• you start to behave aggressively or hostilely or if these behaviors worsen;
• you see, hear, or feel things that are not real (hallucinations);
• you believe things that are not real (delusions);
• you feel more suspicious than usual (paranoia);
• you feel agitated, anxious, or tense;
• you feel depressed or guilty.

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

Heart rhythm problems

This medicine may cause heart rhythm problems 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 higher doses. Therefore, you should follow the recommended dose.

Checks that your doctor will make before you start taking this medicine

These checks are made 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" (a difficult-to-control and repeated tremor of any part of the body or the 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), or depression.

It is important 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.

Children under 6 years

This medicine should not be used in children under 6 years, as safety and efficacy have not been established in this age group.

Other medicines and lisdexamfetamine

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

Do not take this medicine 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.The use of an MAOI with lisdexamfetamine may 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 important to consult your pharmacist when purchasing 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 not sure if the medicines you are taking are on the list above, consult your doctor or pharmacist before taking this medicine.

Doping control

This medicine may produce a positive result in doping control.

Pregnancy and breastfeeding

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 pass into breast milk. Available data on the use of lisdexamfetamine dimesylate 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, muscle hypertonia).

Do not use this medicine during pregnancy unless your doctor explicitly tells you to.

Amphetamines pass into breast milk and may reach the baby. 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 methyl parahydroxybenzoate, propyl parahydroxybenzoate, and propylene glycol.

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

This medicine contains 100 mg of propylene glycol in each milliliter of oral solution.

This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

3. How to take Manollia

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

Dose

• Your doctor will tell you what dose to take each day.
• The recommended starting dose is 30 mg (3 ml), but your doctor may decide to start with 20 mg (2 ml). Later, your doctor may increase the dose. The maximum daily dose is 70 mg (7 ml).
• If you have kidney problems, your doctor may reduce the dose.

How to take Manollia

• Take this medicine in the morning before breakfast. It can be taken with or without food.
• This medicine is for oral use only.

Instructions for opening the bottle and using the syringe

1. Open the bottle:press the cap down and turn it counterclockwise.
2. Only for the first use:a pressure insert adapter (PIBA) and an oral syringe are provided. The adapter is inserted into the neck of the bottle to facilitate the extraction of the solution with the oral syringe. If the adapter is not already in place, remove it along with the oral syringe from the plastic wrapper. With the bottle on a flat surface, insert it firmly into the neck of the bottle while keeping the flat surface of the adapter facing up and press down on it (see Fig. 1).

Figure 1

1. Push the syringe plunger down to the lowest position of the syringe (towards its tip) to eliminate excess air. Insert the syringe into the adapter with a slight twisting motion and make sure it is secure. Hold the syringe in place; turn the bottle upside down and gently pull the plunger down to obtain the dose (see Fig. 2).

Figure 2

1. Fill the syringe by pulling the plunger down until just beyond the graduation mark corresponding to the prescribed amount in milliliters (ml). Eliminate air bubbles from the syringe by pushing the plunger up to the graduation mark.
2. Turn the bottle right side up. Remove the oral syringe from the bottle by holding and gently twisting it (see Fig. 3).

Figure 3

1. Empty the oral syringe into a glass of water, cola, or fruit juice, or directly into the patient's mouth by sliding the upper ring down and drinking it immediately; do not mix the solution with tea to dilute itas this may alter the characteristics and efficacy of the product. Any mixture outside of the recommendations is the responsibility of the healthcare professional or user.
2. After use, the bottle cap should be replaced, leaving the adapter in place.
3. Wash the oral syringe with cold or warm water after each use and dry it completely before the next use.

The oral syringe has a maximum volume of 8 ml.

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 this medicine

If lisdexamfetamine is not used correctly, it may cause abnormal behavior. You may also start to feel that you need the medicine for reasons that have nothing to do with ADHD.

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

If you take more Manollia than you should

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

Signs of overdose may include: restlessness, tremors, increased uncontrolled movements, muscle tremors, rapid breathing, confusion, tendency to fight or argue, seeing, feeling, or hearing things that are not real (hallucinations), panic state, high fever, or muscle collapse. You may then feel tired and depressed. You may also experience nausea, vomiting, diarrhea, and stomach cramps.

There may also be changes in heart rhythm (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 first consulting your doctor. Do 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 make sure this medicine 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 Manollia for more than a year, your doctor should interrupt treatment for a short period, such as during vacations. This allows your doctor to see if you still need the medicine.

If you have any other 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 occur, consult your doctor immediately:

Frequent (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• seeing, feeling, or hearing things that are not real (hallucinations);
• feeling more excited, active, or uninhibited than usual (mania);
• allergic reaction (hypersensitivity);
• shortness of breath or swelling of the legs (signs of heart muscle disease).

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).

If you experience any of the above adverse effects, consult your doctor immediately.

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

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

• decreased appetite;
• weight loss;
• inability to sleep;
• dry mouth;
• stomach pain;
• headache.

Frequent (may affect up to 1 in 10 people)

• feeling agitated, nervous, anxious, depressed, aggressive, irritable, or having sudden mood swings;
• feeling more drowsy, tired, or restless than usual;
• inability to achieve or maintain an erection or changes in sexual desire;
• feeling dizzy;
• uncontrolled tremors, shakes, or being more active than usual;
• rapid or irregular heartbeat (tachycardia);
• breathing difficulties;
• nausea, vomiting, or diarrhea;
• constipation;
• high fever or excessive sweating;
• skin rash;
• teeth grinding.

Uncommon (may affect up to 1 in 100 people)

• talking non-stop;
• feeling depressed, worried, sad, or uneasy (dysphoria);
• feeling too happy or excited (euphoria);
• excessive skin picking;
• uncontrolled tremors or shakes;
• itching, skin rash, or red, raised skin areas that itch (urticaria);
• blurred vision;
• excessive pupil dilation;
• poor blood circulation that causes fingers and toes to become numb and pale (Raynaud's phenomenon);
• high blood pressure;
• metal taste or changes in taste (dysgeusia);
• fainting;
• nosebleeds.

Effects on Weight

Manollia may cause weight loss in some children and adolescents.

• You may not gain weight.
• Your doctor will carefully monitor your height and weight, as well as your eating habits.
• If you are not growing as expected, your doctor may interrupt treatment with this medicine for a short period.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Manollia

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

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

Do not store above 30°C.

After first opening: do not store for more than 30 days.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. 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 milliliter of oral solution contains 10 mg of lisdexamfetamine dimesylate, equivalent to 2.95 mg of dexamfetamine.

• The other ingredients are: sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, propylene glycol (E1520), sodium saccharin, and purified water.

Appearance and Package Contents

Oral solution.

The solution is clear and colorless to slightly yellow.

Ambber glass bottle or brown amber PET bottle closed with a child-resistant and tamper-evident plastic cap, containing 100 ml of oral solution.

A dosing syringe and a plastic cap that can be inserted into the bottle to allow the dosing syringe to be inserted (bottle adapter) are also provided. The dosing syringe has a volume of 8 ml and the graduations are in 0.1 ml increments up to the maximum daily dose of 7 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

Manufacturer

Adalvo Limited,

Malta Life Sciences Park

Sir. Temi Zammit Buildings

Building 1, Level 4

San Gwann, SGN 3000

Malta

or

Labomed Pharmaceutical Company S.A

84, Ioannou Metaxa str.

Koropi, Attika, 19441,

Greece

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:

Malta Lisdexamfetamine Aristo 10mg/ml oral solution

Germany Lisdex-Aristo 10 mg/ml Lösung zum Einnehmen

Spain Manollia 10 mg/ml oral solution

Netherlands Lisdexamfetamine Aristo 10 mg/ml drank

Date of last revision of this leaflet: February 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 this 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 how 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 your doctor several times for check-ups. 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.
• Teenage 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?

• Your doctor, mother, father, or caregiver will tell you how much oral solution to take each day.
• An adult will also help you or teach you how to open the bottle and use the dosing syringe.
• The recommended starting dose is 3 ml, but your doctor may decide to start with 2 ml. Later, your doctor may increase the dose. The maximum daily dose is 7 ml.
• Take one dose 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 doses 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 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 usual 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.

This medicine contains sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, and propylene glycol, ingredients that can cause allergic reactions (possibly delayed).

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

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