Makes Vyvanse's fear worse

Elvanse 50 mg hard capsules

Shire Pharmaceutical Ireland Ltd

Standard drug Human
Date of approval12.04.2016
Submission statusDelivery through a (public) pharmacy
Prescription StatusSingle-dose medicinal products based on a doctor's prescription
Pharmacological groupPsychostimulants, agents for the treatment of adhs and nootropics

All information

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Shire Pharmaceutical Ireland Ltd

What is it and what is it used for?

What is Elvanse?

Elvanse contains the active substance lisdexamfetamine dimesylate, which helps improve the activity of your brain. It can help improve your alertness and concentration, and reduce your impulsiveness.

Elvanse is a long-acting medicine that works steadily for 13 hours.

What is it used for?

Elvanse is intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is used:

In children and adolescents between 6 and 18 years of age who have previously been treated with methylphenidate, but this treatment has not proven to be sufficiently effective for ADHD You may be able to continue taking Elvanse as an adult if your doctor thinks you have clearly benefited from treatment.

If after a month you don't feel better, or even worse, contact your doctor.

Elvanse is not used to treat ADHD in children under 6 years of age because it is not known whether it is safe in such young children or whether they will benefit from the treatment.

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What do you need to consider before use?

Do NOT take Elvanse

  • 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) for depression or if you have taken an MAOI in the past 14 days,
  • if you have a thyroid problem
  • if you feel unusually aroused, overactive, or disinhibited
  • if you have ever had heart problems - for example a heart attack, irregular heartbeat, chest pain and discomfort, heart failure, a heart disease or a congenital heart defect,
  • if you have high or very high blood pressure or narrowing of the blood vessels
  • if you suffer from increased pressure in the eye (glaucoma).

Do not take Elvanse if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Elvanse. This is important because Elvanse can make these problems worse.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Elvanse if you:

  • have ever had problems with drug or substance abuse
  • Have kidney problems
  • have ever had fits (seizures, convulsions, epilepsy) or abnormal brain wave recordings (EEGs),
  • already have your period - only applies to girls (see section "Pregnancy, breastfeeding and fertility"),
  • have difficult-to-control repeated twitching of body parts or repeated uttering of certain sounds or words,
  • have high blood pressure
  • have a family or medical history of an irregular heartbeat (shown on the electrocardiogram) or if you have medical conditions and / or are taking medicines that make you prone to heart rhythm or electrolyte disturbances,
  • have a heart problem that is not listed under "Do not take Elvanse" above,
  • have a mental-emotional problem such as:
    • Mood swings (between manic and depressive - so-called "bipolar disorder"),
    • new aggressive or hostile behavior or a worsening of existing aggressiveness,
    • Seeing, hearing or feeling things that are not there (hallucinations)
    • Believing things that are not real (delusions)
  • unusually suspicious behavior (paranoia),
  • Restlessness, anxiety or tension,
  • Feeling depressed or guilty.

Before starting treatment, tell your doctor or pharmacist if any of the above applies to you. This is important because Elvanse can make these problems worse. Your doctor will then need to monitor how the medicine is affecting you.

Elvanse can cause irregular heartbeat in some patients. If you experience palpitations or an irregular heartbeat during treatment, inform your doctor immediately. The risk of heart problems may increase as the dose increases. The recommended dosage should therefore be adhered to.

Checks by your doctor before starting Elvanse treatment

These reviews will help decide if Elvanse is the right medicine for you. Your doctor will ask you about the following:

  • whether and which other medicines you may be taking,
  • whether there have been any sudden unexplained deaths in the family,
  • possible other illnesses (such as heart disease) that you or family members may have,
  • how you feel, for example if you feel happy or sad, have strange thoughts, or if you have had these feelings in the past
  • whether anyone in your family has or has had “tics” (difficult-to-control, repeated twitching of body parts or repeated uttering of certain sounds or words),
  • Mental or emotional problems or behavioral problems that you or other family members are suffering from or have previously suffered from. Your doctor will review your history of mental and emotional illness to determine if anyone in your family has known suicide, bipolar disorder (mood swings between manic and depressed), or depression.

It is important that you provide as much information as possible. This will help your doctor decide whether Elvanse is the right medicine for you. Your doctor may decide that you need further medical evaluation before you start taking the medicine.

How is it used?

How much should I take?

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Elvanse is intended exclusively for you. Do not pass this medicine on to other people, even if they seem to have similar symptoms.

How to take Elvanse

  • Take Elvanse in the morning before breakfast. It can be taken with or without food.
  • You can take Elvanse in two different ways:

O The hard capsule can be swallowed whole with enough water.

  • Open the hard capsule and empty the contents:
    • either on a soft food such as B. yogurt
    • or in a glass of water or orange juice.

Use a spoon to break pieces that stick together and stir the Elvanse and yoghurt or water or orange juice well until everything is completely mixed. Eat all of the yogurt or drink all of the water or orange juice immediately after mixing with Elvanse. Do not save any of these for later. If a film remains in the container or glass, this is not a concern - it is not the active ingredient.

dose

  • Your doctor will tell you what strength to take each day.
  • The recommended starting dose is 30 mg. Your doctor may later increase this to 50 mg or 70 mg. The maximum daily dose is 70 mg.
  • Your doctor may reduce the dose if you have kidney problems.
  • Do not split the dose of a hard capsule but take all of the contents of the capsule. Do not take less than one hard capsule a day.

If you do not feel better after a month of treatment

If you are not feeling better, tell your doctor. You may need different treatment.

Improper use of Elvanse

If Elvanse is not used as intended, it can lead to abnormal behavior. You may then also develop the feeling that you “need” the medicine for reasons other than treating your ADHD. Let your doctor know if you have ever had a problem with alcohol, medicines, or drugs.

If you take more Elvanse than you should

If you have taken too much of the medicine, contact a doctor immediately or call the emergency services. Say how much you took.

Signs of overdose may include: restlessness, tremors, increased uncontrolled movements, muscle twitching, faster breathing, confusion, a tendency to assault, seeing, Feeling or hearing things that are not really there (hallucinations), panic, high fever or muscle breakdown. Afterwards, tiredness and dejection can set in. Changes in heartbeat (slow, fast or irregular), high or low blood pressure, circulatory collapse, convulsions and coma may occur, as well as nausea, vomiting, diarrhea and abdominal cramps.

If you forget to take Elvanse

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, wait until the next day. Avoid taking it in the afternoon because of the possibility of difficulty sleeping (insomnia).

If you stop taking Elvanse

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

Do not stop taking the medicine without talking to your doctor first. You should not suddenly stop taking this medicine on your own.

Medical interventions as part of your treatment with Elvanse Your doctor will perform some tests, including:

  • Before starting treatment - to make sure Elvanse is safe for you and that you will benefit from treatment.
  • After you start treatment - Your doctor will do certain tests at least every 6 months, and possibly more often. These tests will also be carried out if the dose is changed. The examinations include:
    • Checking your appetite,
    • Measurement of height and weight,
    • Measurement of blood pressure and heart rate,
    • Checking if you have any problems with your mood, mood, or any other unusual feelings, or if these have worsened while taking Elvanse.

Long term treatment

Elvanse should not and does not have to be taken indefinitely. If you have been taking Elvanse for more than a year, your doctor should stop treatment for a short time, for example during holidays. This will help determine if you still need the medicine.

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

How do I have to take my medication (capsules)?

  • You have to swallow the capsule with water. But you can also open the capsule and dissolve the entire contents in a glass of water or orange juice or with a soft food, such as Mix the yogurt together.
  • After mixing, you should eat the whole portion of yoghurt or drink the whole glass of water or orange juice immediately.
  • You should take one capsule every morning. You can take the capsule with or without food.
  • You must not stop treatment with the medication without first asking your doctor.
  • If you forget to take your medication, contact an adult. You must NOT take 2 capsules at once to make up for the missed dose.

What are the possible side effects?

Other medicines and Elvanse

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

DO NOT take Elvanse if you

are taking a so-called monoamine oxidase inhibitor (MAOI) for depression or have taken an MAOI in the past 14 days. Taking an MAOI with Elvanse can cause a sudden rise in blood pressure. Your doctor or pharmacist can tell you if any of the medicines you are currently taking is an MAOI.

Elvanse and certain other medicines can affect each other. If you are currently taking any of the following medicines, please talk to your doctor or pharmacist before taking Elvanse:

  • Medicines for severe mental and emotional problems,
  • Medicines to lower or increase blood pressure,
  • Medicines used during surgery, such as pain relievers,
  • Cough and cold medicine. Some of these medicines contain substances that can affect blood pressure. It is therefore important to consult your pharmacist when purchasing such medicines.

Medicines that may affect the acidity of your urine, such as vitamin C (ascorbic acid) or sodium hydrogen carbonate (found in medicines for indigestion, for example).

If you are not sure whether the medicines you are currently taking are on the list above, ask your doctor or pharmacist before taking Elvanse.

Drug tests

Elvanse may give a positive result on drug use tests. This also includes doping controls in sport.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.

Your body breaks down Elvanse into other substances, which can overcome the placenta and pass into breast milk. The available data on the use of Elvanse during the first three months of pregnancy do not indicate an increased risk of congenital malformations in the child, but possibly an increased risk of preeclampsia (a disease that usually occurs after 20 weeks of pregnancy and is caused by high blood pressure and protein in the child Urine) and premature birth. Newborn babies exposed to amfetamine during pregnancy may develop withdrawal symptoms (tremors, irritability, excessive tension in muscles).

You should only use this medicine during pregnancy as directed by your doctor. Do not breast-feed while taking Elvanse. The effects of Elvanse on fertility are unknown.

Ability to drive and Ability to use machines

Warning: This medicine may affect your ability to react and drive

You may feel dizzy, have trouble focusing your eyes, or have blurred vision when taking Elvanse. In this case, certain activities such as driving a car, using machines, cycling, horse riding or climbing trees are dangerous.

Elvanse contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. it is almost "sodium free".

What side effects are possible?

Like all medicines, this medicine can have side effects, although not everybody gets them. Your doctor will talk to you about these side effects.

Certain side effects can be serious. If you experience any of the side effects listed below, see a doctor straight away:

Common (may affect up to 1 in 10 people)

  • irregular heartbeat (palpitations),
  • Chest pain (may indicate heart problems).

Uncommon (may affect up to 1 in 100 people)

  • Seeing, feeling or hearing things that are not really there (hallucinations)
  • Feeling unusually aroused, overactive, or disinhibited (mania)
  • allergic reaction (hypersensitivity),
  • Breathlessness or swelling of the legs (signs of heart muscle disease).

Not known (frequency cannot be estimated from the available data)

  • severe allergic reaction characterized by a sharp drop in blood pressure, difficulty breathing and hives / itching (anaphylactic reaction),
  • Seeing or feeling or hearing things that are not really there, paranoia, delusions (psychotic episodes),
  • Fits (seizures)
  • abnormal heart rhythm, life threatening irregular heart rhythm (seen on electrocardiogram). See Section 2, Warnings and Precautions,
  • allergic liver damage, which may be expressed by yellowing of the whites of the eyes and / or the skin (eosinophilic hepatitis),
  • Skin swelling (angioedema) or a severe rash which shows up as severe blistering of the skin and mucous membranes (Stevens-Johnson syndrome).

If you experience any of the above side effects, please see a doctor immediately.

The following are among the other side effects. If these are severe, please inform your doctor or pharmacist:

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

Common (may affect up to 1 in 10 people)

  • Feeling agitated, confused or "hippy", anxiety, depression, aggressiveness, irritability or mood swings,
  • unusual sleepiness, tiredness or restlessness,
  • Inability to get or maintain an erection or changes in sex drive,
  • Dizziness,
  • uncontrolled jerking or jerky movements, tremors or unusually vigorous activity
  • fast or irregular heartbeat (tachycardia)
  • Difficulty breathing
  • Nausea, vomiting, or diarrhea,
  • Constipation,
  • high temperature (fever) or excessive sweating
  • Skin rash,
  • Grinding teeth.

Uncommon (may affect up to 1 in 100 people)

  • hardly interruptible and often extremely fast speaking,
  • Feeling depressed, anxious, feeling sad or depressed (dysphoria)
  • excessively elated or excited mood (euphoria),
  • compulsive overworking of the skin,
  • uncontrolled twitching or erratic movements of the body,
  • Itching, rash, or red, itchy hives (hives, urticaria)
  • blurred vision,
  • excessive dilatation of the pupils,
  • poor blood circulation resulting in numbness and whitening of the toes and fingers (Raynaud's syndrome),
  • high blood pressure,
  • metallic taste in the mouth or altered taste sensation (dysgeusia)
  • brief loss of consciousness (syncope).

Effects on Weight

Elvanse can lead to reduced weight in some children and adolescents.

  • There may be no weight gain.
  • Your doctor will carefully monitor your height and weight, as well as how well you are eating.
  • If the expected growth does not occur, your doctor may interrupt treatment with Elvanse for a short time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system.

Federal Office for Safety in Health Care Traisengasse 5

1200 VIENNA AUSTRIA

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

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

What side effects are possible?

Side effects are undesirable effects that can occur when you take medication. If you notice any of the following effects, contact an adult immediately. He can then speak to your doctor. The main side effects that you may experience are:

  • You feel that your heart is beating faster than normal or that it is beating irregularly.
  • You see, feel or hear things that are not really there.
  • You feel unusually aroused or you are overactive.
  • You are having a severe allergic reaction. This can make you dizzy, have trouble breathing, or itchy skin.
  • You get seizures.
  • You notice that your eyes and / or skin have turned yellow.
  • You have swelling or a severe rash with blisters on the skin or elsewhere.

If you feel uncomfortable while taking your medication, contact an adult immediately.

You should also consider these things:

  • Make sure you keep your medication in a safe place so that no one else can take it.
  • This medication is only for you - you must NOT give it to anyone else. The drug can help you, but it could harm other people.
  • If you forget to take your medication, you must not take 2 capsules at once the next time. Next time you should only take 1 capsule at the usual time.
  • It is important not to take too much of the drug or you can get sick.
  • If you have taken too much of the medication, tell your parent or guardian immediately.
  • You must not stop taking the medication until your doctor tells you it is okay to stop taking the medication.

How should it be stored?

Do not store above 25 ° C.

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 bottle and the carton after "EXP". The expiry date refers to the last day of the month indicated.

Do not use this medicine if the hard capsules appear damaged in any way.

Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

additional Information

What Elvanse contains

The active substance is lisdexamfetamine dimesylate.

Each 30 mg capsule contains 30 mg lisdexamfetamine dimesylate, equivalent to 8.9 mg dexamfetamine.

Each 50 mg capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to 14.8 mg dexamfetamine.

Each 70 mg capsule contains 70 mg lisdexamfetamine dimesylate, equivalent to 20.8 mg dexamfetamine.

The other ingredients are:

  • Capsule contents: microcrystalline cellulose, croscarmellose sodium, magnesium stearate
  • Capsule shell: gelatin, black printing ink (shellac and iron (II, III) oxide E172)
  • Colorants in the capsule shells: titanium dioxide (E171)
    • The 30 mg capsule also contains erythrosine (E127).
    • The 50 mg capsule also contains brilliant blue FCF (E133).
    • The 70 mg capsule also contains brilliant blue FCF (E133) and erythrosine (E127).

What Elvanse looks like and contents of the pack

Hard capsules.

The 30 mg capsules consist of a white, opaque body and a pink, opaque upper part with the imprint "S489" and "30 mg" with black printing ink.

The 50 mg capsules consist of a white, opaque body and a blue, opaque upper part with the imprint "S489" and "50 mg" with black printing ink.

The 70 mg capsules consist of a blue, opaque body and a pink, opaque upper part with the imprint "S489" and "70 mg" with black printing ink.

Pack sizes: 28 or 30 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza

50 - 58 Baggot Street Lower Dublin 2

Ireland

Tel: +44 (0) 1256 894 959

Email: [email protected]

This medicinal product is approved in the member states of the European Economic Area (EEA) under the following names:

Belgium Elvanse
Denmark Elvanse
Germany Elvanse
Finland Elvanse
Ireland Tyvense
Luxembourg Elvanse
Netherlands Elvanse
Norway Elvanse
Austria Elvanse
Poland Elvanse
Portugal Elvanse
Sweden Elvanse
Spain Elvanse

Czech Republic Elvanse

Approval number:

Elvanse 30 mg hard capsules: Z.Nr. 136851

Elvanse 50 mg hard capsules: Z.Nr. 136852

Elvanse 70 mg hard capsules: Z.Nr. 136853

This leaflet was last revised in January 2021.

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