Intuniv 3mg prolonged-release tablets

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 medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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, pharmacist, or nurse.
• 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.
• This leaflet has been written in a way that assumes the reader is the person taking the medicine. If you are giving this medicine to your child, please replace “you” with “your child”.

Contents of the pack

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

1. What is Intuniv and what is it used for

What is Intuniv

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 from 6 to 17 years old in whom current stimulants are not appropriate and/or current medications do not adequately control the symptoms of ADHD.

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

• psychological therapy
• educational therapy
• social therapy

About ADHD

People with ADHD have problems with:

• sitting still;
• concentrating.

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

2. What you need to know before you take Intuniv

Do not take Intuniv:

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking 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 have any other psychiatric disorder.

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

• you have aggressive feelings or behaviour, or
• you have suicidal thoughts or feelings.

Intuniv may affect your weight and height if you take it for a long time. Therefore, your doctor will monitor your growth.

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

If any of the above applies to you (or if you are not sure), talk to your doctor or pharmacist before taking this medicine. This is because this medicine may make these problems worse. Your doctor will monitor you regularly to see how this medicine affects you.

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

This medicine must not be used in children under 6 years or in adults 18 years or older because it is not known if it works or if it is safe.

Checks that your doctor will make when you take Intuniv

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

• blood pressure and heart rate and other heart tests, if necessary;
• response to treatment, in particular if you are feeling sleepy or drowsy;
• height and weight.

You should talk to your doctor if you do not improve or if you get worse and are very sleepy or drowsy after taking this medicine for about 6 weeks. Your doctor may want to review your treatment.

Taking Intuniv with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Intuniv and some medicines may interact with each other.

In particular, tell 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 problems (benzodiazepines, barbiturates, and antipsychotics);
• medicines that may affect how the liver removes Intuniv (see the table below).

If any of the above applies to you or if you are not sure, talk to 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 fatty breakfast), as they may affect how this medicine works.
• Do not take 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 sleepiness or drowsiness.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Do not take this medicine if you are pregnant or if you are not using contraception. It is not known if Intuniv affects the unborn baby.

Do not breast-feed while taking Intuniv unless your doctor tells you to.

Driving and using machines

You may feel dizzy or sleepy when taking this medicine, especially at the start of treatment, and this may last for 2 to 3 weeks or possibly longer. If this happens, do not drive, ride a bike, use tools or machines, or take part in activities that may put you or others at risk 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 told you that you have an intolerance to some sugars, contact them 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 start under the supervision of a specialist in child and/or adolescent behavioural disorders.

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

How much to take

• Your doctor will start your treatment with 1 mg per day. Your doctor may increase your dose based on your body weight and how Intuniv works for you, but no more than 1 mg per week.

Depending on how you respond 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 see an immediate effect when you start treatment; some patients notice an improvement after the first week, although it may take longer.
• The daily dose will be between 1 and 7 mg, depending on your age and how you respond to Intuniv, but will not be more than 7 mg.

How to take Intuniv

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

Tell your doctor if you cannot swallow the tablet whole.

Duration of treatment

If you need to take Intuniv for more than a year, your doctor will check your response to treatment and may stop the medicine for a short period; this can be done during school holidays. This break will show if you still need to take the medicine.

If you take more Intuniv than you should

If you take more Intuniv than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you and tell them how much you have taken.

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

If you forget to take Intuniv

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

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

If you stop taking Intuniv

Do not stop taking this medicine without talking to your doctor first.

• If you stop taking this medicine, you may have increased blood pressure and heart rate (see section 4).
• To stop taking the medicine, your doctor will slowly reduce your dose of Intuniv to minimize any side effects.

If you have any other 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. If you are worried about anything, talk to your doctor.

If you do not feel well while taking the medicine, talk to an adult straight away.

Serious side effects

The following side effects have been reported: drowsiness (sedation), dizziness (hypotension), and slow heart rate (bradycardia), fainting or loss of consciousness (syncope), a serious withdrawal side effect, with high blood pressure after suddenly stopping Intuniv; symptoms can include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).

Some of these side effects are more likely to happen at the start of treatment and may disappear as treatment continues. If you get any of these side effects, talk to your doctor straight away.

Other side effects

The following side 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
• low blood pressure
• restlessness or irritability
• sleep problems (insomnia) or interrupted sleep (maintenance insomnia) or nightmares;
• depression, worry (anxiety) or mood changes (mood swings);
• 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 (pallor);
• seizures or convulsions;
• need to urinate frequently (pollakiuria);
• agitation;
• aggression;
• changes in liver blood test results (increased alanine aminotransferase);
• high blood pressure;
• unusual heart rhythm (sinus arrhythmia and first-degree atrioventricular block);
• fast heart rate (tachycardia);
• reduced 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 side effect, with high blood pressure after suddenly stopping Intuniv; symptoms can include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).

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

• difficulty getting or maintaining an erection (erectile dysfunction).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Intuniv

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other 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 ingredients are hypromellose 2208, methacrylic acid-ethyl acrylate copolymer, lactose monohydrate, povidone, crospovidone (type A), microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, polysorbate 80, fumaric acid, glycerol dibehenate.
• The 3 mg and 4 mg tablets also contain aluminum lake of indigo carmine (E132) and yellow iron oxide (E172).

Appearance and packaging of the product

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, but not all pack sizes may be marketed.

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

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

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

Date of the last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu