Intuniv 3 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Intuniv 1 mg prolonged-release tablets

Intuniv 2 mg prolonged-release tablets

Intuniv 3 mg prolonged-release tablets

Intuniv 4 mg prolonged-release tablets

guanfacine

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 at the end of this leaflet includes information on how to report adverse reactions.

Read all of this leaflet carefully before you start taking this medicine, because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• This leaflet has been written as if the reader were the person taking the medicine. If you are administering this medicine to your child, always replace "you" with "your child".

Contents of this leaflet

1. What Intuniv is and what it is used for
2. What you need to know before taking Intuniv
3. How to take Intuniv
4. Possible adverse reactions
5. How to store Intuniv
6. Contents of the pack and other information

1. What Intuniv is and what it is used for

Intuniv contains the active substance guanfacine. It belongs to a group of medicines called antihypertensives, specifically central α₂-adrenergic agonists. Although Intuniv is related to antihypertensive medicines, it is used to treat Attention Deficit Hyperactivity Disorder (ADHD).

ADHD is a disorder that affects behavior. People with ADHD may be overactive, impulsive, and easily distracted, and may have difficulty concentrating.

Intuniv is used in the treatment of ADHD in children and adolescents aged 6–17 years, when stimulants are not suitable. It can be used alone or in combination with a stimulant medicine. Intuniv helps improve ADHD symptoms such as inattention, hyperactivity, and impulsivity.

What Intuniv is

Intuniv contains the active substance guanfacine. This medicine belongs to a group of medicines that affect brain activity. This medicine may help improve your attention and concentration and make you less impulsive and hyperactive.

What Intuniv is used for

This medicine is used to treat "attention deficit hyperactivity disorder" (ADHD) in children and adolescents aged 6 to 17 years when current stimulant medicines are not suitable and/or current medicines do not adequately control ADHD symptoms.

The medicine is given as part of a treatment programme, which usually includes the following:

• psychological therapy
• educational therapy
• social therapy

About ADHD

People with ADHD have difficulties with:

• sitting still;
• concentrating.

ADHD can cause problems in daily life. Children and adolescents with ADHD may have learning difficulties and problems with schoolwork. They may find it hard to behave appropriately at home, at school, or in other settings.

2. What you need to know before starting to take Intuniv

Do not take Intuniv:

• if you are allergic to guanfacine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Intuniv:

• if you have low or high blood pressure, heart problems, or a family history of heart problems;
• if you have recently fainted;
• if you have suicidal thoughts or ideas;
• if you suffer from another psychiatric disorder.

Talk to your doctor or pharmacist if you are taking this medicine and:

• experience aggressive feelings or behaviors, or
• have suicidal thoughts or feelings.

Intuniv may affect your weight and height if taken for prolonged periods. Therefore, your doctor will monitor your growth.

Do not stop taking Intuniv without first consulting your doctor. If you stop taking Intuniv suddenly, you may experience withdrawal symptoms such as increased heart rate and high blood pressure (see section 4).

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine. This is because this medicine may worsen these conditions. Your doctor will monitor you periodically to assess how the medicine affects you.

Children (under 6 years) and adults (18 years or older)

This medicine should not be used in children under 6 years of age or in adults 18 years of age or older, because it is not known whether it is effective or safe.

Checks your doctor will carry out when you are taking Intuniv

Before you start taking this medicine, your doctor will make sure that this medicine is safe for you and will help you. While you are taking this medicine, your doctor will repeat these checks weekly at the beginning of treatment, after dose adjustments, at least every 3 months during the first year, and thereafter at least twice a year. These checks may include:

• blood pressure and heart rate, and other heart tests if appropriate;
• response to treatment, particularly whether it causes sleepiness or drowsiness;
• height and weight.

You should consult your doctor if you do not improve or if your condition worsens, or if you are very sleepy or drowsy after taking this medicine for about 6 weeks. Your doctor may wish to review your treatment.

Taking Intuniv with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Intuniv and certain medicines may interact.

Specifically, inform your doctor or pharmacist if you are taking any of the following types of medicines:

• medicines that lower blood pressure (antihypertensives);
• medicines for epilepsy such as valproic acid;
• medicines that cause sleepiness (sedatives);
• medicines for mental health conditions (benzodiazepines, barbiturates, and antipsychotics);
• medicines that may affect how the liver eliminates Intuniv (see the following table).

If any of the points above apply to you or if you are unsure, consult your doctor or pharmacist before taking this medicine.

Taking Intuniv with food, drinks, and alcohol

• Do not take this medicine with fatty foods (e.g., a high-fat meal), as they may affect how this medicine works.
• Do not drink grapefruit juice with this medicine, as it may affect how this medicine works.
• Do not drink alcohol while taking this medicine, as it may cause drowsiness or sleepiness.

Pregnancy and breastfeeding

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

• Do not take this medicine if you are pregnant or if you are not using contraception. It is unknown whether Intuniv will affect the unborn baby.
• Do not breast-feed while taking Intuniv unless your doctor has instructed you otherwise.

Driving and using machines

You may feel dizzy or drowsy when taking this medicine, especially at the beginning of treatment, and this may last for 2 to 3 weeks or possibly longer. If this occurs, do not drive, ride a bicycle, operate tools or machinery, or engage in activities that could result in injury until you know how this medicine affects you. Fainting has also been reported, although this is not a common side effect.

Intuniv contains lactose:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Intuniv contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Intuniv

Your treatment will begin under the supervision of a specialist in childhood and/or adolescent behavioral disorders.

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

As part of your treatment, your doctor will closely monitor how Intuniv affects you at the beginning of treatment and/or during dose adjustments.

How much to take

• Your doctor will start your treatment with 1 mg daily. Your doctor may increase your dose depending on your body weight and how Intuniv works for you, but not by more than 1 mg per week.

Depending on your response to treatment, your doctor may increase your dose more slowly. The recommended maintenance dose is between 0.05 and 0.12 mg per kg of body weight per day.

• You may not notice an immediate effect at the beginning of treatment; some patients notice improvement after the first week, although it may take longer.
• The daily dose will range between 1 and 7 mg, depending on your age and how you respond to Intuniv, although it will not exceed 7 mg.

How to take Intuniv

• This medicine should be taken once daily, either in the morning or at night.
• It can be taken with or without food, but should not be taken with fatty foods (e.g., a high-fat breakfast).
• Swallow the tablet whole with water or another liquid (not grapefruit juice).
• Do not break, crush, or chew the tablet, as this will affect how it works.

Inform your doctor if you are unable to swallow the tablet whole.

Duration of treatment

If you need to take Intuniv for longer than one year, your doctor will monitor your response to treatment and may interrupt the medicine for a brief period; this may be done during school holidays. This break will help determine whether you still need to continue taking the medicine.

If you take more Intuniv than you should

If you take more Intuniv than you should, consult a doctor or go to a hospital immediately. Take the medicine package with you and tell them how much you have taken.

The following effects may occur: high or low blood pressure, slow heart rate, slow breathing, tiredness, or exhaustion.

If you forget to take Intuniv

If you forget a dose, wait until the next day and take your usual dose.

• If you forget two or more doses, consult your doctor, as you may need to restart Intuniv at a lower dose.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Intuniv

Do not stop taking this medicine without first consulting your doctor.

• If you stop taking this medicine, you may experience an increase in blood pressure and heart rate (see section 4 below).
• To stop taking the medicine, your doctor will gradually reduce your dose of Intuniv to minimize any adverse effects.

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 everyone gets them. If you are concerned about anything, consult your doctor.

If you do not feel well while taking this medicine, speak to an adult immediately.

Serious adverse effects

The following adverse effects have been reported: drowsiness (sedation), dizziness (hypotension), and slow heart rate (bradycardia), fainting or loss of consciousness (syncope), a serious withdrawal reaction involving high blood pressure after sudden discontinuation of Intuniv; symptoms may include headache, confusion, nervousness, agitation, and tremors (hypertensive encephalopathy).

Some of these adverse effects are more likely to occur at the beginning of treatment and may disappear as treatment continues. If you experience any of these adverse effects, consult your doctor immediately.

Other adverse effects

The following adverse effects have been reported.

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

• sleepiness (somnolence);
• tiredness (fatigue);
• headache;
• stomach pain (abdominal pain).

Common (may affect up to 1 in 10 people)

• slow heart rate;
• decrease in blood pressure;
• restlessness or irritability;
• trouble sleeping (insomnia) or interrupted sleep (sleep maintenance insomnia) or nightmares;
• depression, worry (anxiety), or mood changes (affective lability);
• lack of energy (lethargy);
• weight gain;
• loss of appetite;
• dry mouth;
• involuntary loss of urine (enuresis);
• nausea or vomiting;
• diarrhoea, abdominal discomfort, or constipation;
• low blood pressure when standing up (orthostatic hypotension);
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• allergic reaction (hypersensitivity);
• chest pain;
• indigestion (dyspepsia);
• breathing problems (asthma);
• weakness (asthenia);
• pale skin colour (pallor);
• seizures or convulsions;
• need to urinate frequently (polyuria);
• agitation;
• aggression;
• changes in liver blood test results (increased alanine aminotransferase);
• increase in blood pressure;
• unusual heart rhythm (sinus arrhythmia and first-degree atrioventricular block);
• fast heartbeat (tachycardia);
• reduction in heart rate;
• dizziness when standing up (postural dizziness);
• itching of the skin (pruritus);
• seeing or hearing things that are not there (hallucinations).

Rare (may affect up to 1 in 1,000 people)

• sleeping more than usual (hypersomnia);
• high blood pressure (hypertension);
• malaise.

Very rare (may affect up to 1 in 10,000 people)

• a serious withdrawal reaction involving high blood pressure after sudden discontinuation of Intuniv; symptoms may include headache, confusion, nervousness, agitation, and tremors (hypertensive encephalopathy).

Frequency not known (cannot be estimated from the available data)

• difficulty in achieving or maintaining an erection (erectile dysfunction).

Reporting of adverse effects

If you experience any adverse effect, talk to 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 national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Intuniv

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any damage to the tablets or to the blister pack.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Intuniv

Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg of guanfacine.

• Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg of guanfacine.

• Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg of guanfacine.

• Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacine.

• The other components are hypromellose 2208, methacrylic acid-ethyl acrylate copolymer, lactose monohydrate, povidone, crospovidone (type A), microcrystalline cellulose, colloidal anhydrous silica, sodium lauryl sulfate, polysorbate 80, fumaric acid, glycerol dibehenate.

• The 3 mg and 4 mg tablets also contain indigo carmine aluminum lake (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Intuniv is a prolonged-release tablet, which means that the active substance is released from the tablet over a period of time. The tablets come in pack sizes of 7, 28 or 84, although only certain pack sizes may be marketed.

• The 1 mg prolonged-release tablets are hard, white, round tablets, engraved with "1MG" on one side and "503" on the other.
• The 2 mg prolonged-release tablets are hard, white, oval tablets, engraved with "2MG" on one side and "503" on the other.
• The 3 mg prolonged-release tablets are hard, green, round tablets, engraved with "3MG" on one side and "503" on the other.
• The 4 mg prolonged-release tablets are hard, green, oval tablets, engraved with "4MG" on one side and "503" on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland

Manufacturer

Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
D02 HW68
Ireland

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50–58 Baggot Street Lower
Dublin 2
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.euopa.eu