Patient Information Leaflet

Intuniv 1 mg prolonged-release tablets

Intuniv 2 mg prolonged-release tablets

Intuniv 3 mg prolonged-release tablets

Intuniv 4 mg prolonged-release tablets

guanfacina

This medicine is subject to additional monitoring, which will help speed up the detection of any new information about its safety. You can contribute by reporting any side effects you may experience. The final part of section 4 includes information on how to report these side effects.

Read 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 are unsure, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• This leaflet has been written as if the reader is the person taking the medicine. If you are administering this medicine to your child, always substitute “you” with “your child”.

What is Intuniv

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

What is Intuniv used for

This medication is used to treat "attention deficit hyperactivity disorder" (ADHD) in children and adolescents from 6 to 17 years old in whom current stimulant medications are not appropriate and/or current medications do not adequately control ADHD symptoms.

The medication is administered as part of a treatment program, which typically includes the following:

• psychological therapy
• educational therapy
• social therapy

About ADHD

People with ADHD have problems with:

• staying seated quietly;
• concentrating.

ADHD can cause problems in daily life. Children and adolescents with ADHD may have difficulties with learning and homework. It may be difficult for them to behave well at home, school, or other places.

Do not take Intuniv:

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

Warnings and precautions

Consult 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 fainted recently;
• if you have suicidal thoughts or ideas;
• if you have another psychiatric disorder.

Consult your doctor or pharmacist if you are taking this medication and:

• you experience aggressive feelings or behaviors, 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 consulting your doctor first. If you suddenly stop taking Intuniv, you may experience withdrawal symptoms such as increased heart rate and high blood pressure (see section 4).

If any of the above points affect you (or if you are unsure), consult your doctor or pharmacist before taking this medication. This is because this medication may worsen these problems. Your doctor will monitor you regularly to see how this medication affects you.

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

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

Checks your doctor will perform while taking Intuniv

Before starting to take this medication, your doctor will ensure that this medication is safe for you and will help you. While taking this medication, your doctor will repeat these checks every week at the beginning of treatment, after dose adjustments, at least every 3 months during the first year, and then at least twice a year. These checks may include:

• blood pressure and heart rate and other heart tests, if necessary;
• response to treatment, specifically if it causes sleep or drowsiness;
• height and weight.

You should consult your doctor if you do not improve or if you worsen and have a lot of sleep or are drowsy after taking this medication for about 6 weeks. Your doctor may want to review your treatment.

Taking Intuniv with other medications

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

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

• blood pressure medications (anti-hypertensives);
• epilepsy medications such as valproic acid;
• sleep-inducing medications (sedatives);
• mental health medications (benzodiazepines, barbiturates, and antipsychotics);
• medications that may affect how the liver eliminates Intuniv (see the table below).

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

Taking Intuniv with food, drinks, and alcohol

• Do not take this medication with fatty foods (e.g., a breakfast rich in fats), as they may affect how this medication works.
• Do not take orange juice with this medication, as it may affect how this medication works.
• Do not drink alcohol while taking this medication, as it may cause sleep or drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• Do not take this medication if you are pregnant or if you do not use contraception.It is unknown if

Intuniv will affect the fetus.

• Do not breastfeed while taking Intuniv unless your doctor tells you to.

Driving and using machines

You may feel dizzy or drowsy when taking this medication, especially at the beginning of treatment, and this may last from 2 to 3 weeks or possibly longer. If you experience it, do not drive, ride a bike, use tools or machines, or participate in activities that may cause injuries until you know how this medication affects you. Dizziness and fainting have also been reported, although they are not common effects.

Intuniv contains lactose:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Intuniv contains sodium

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

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

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, 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 may increase your dose more slowly depending on how you respond to treatment. The recommended maintenance dose is between 0.05 and 0.12 mg per kg of body weight per day.

How to take Intuniv

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

Inform your doctor if you cannot swallow the tablet whole.

Treatment duration

If you need to take Intuniv for more than a year, your doctor will monitor your response to treatment and may interrupt the medication for a brief period; this can be done during school vacations. This break will indicate whether you need to continue taking the medication.

If you take more Intuniv than you should

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

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

If you forgot to take Intuniv

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

• If you have forgotten two or more doses, consult your doctor, as it may be necessary to restart Intuniv administration with a lower dose.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Intuniv

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

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.If you are concerned about something, consult your doctor.

If you do not feel well while taking the medicine, speak with an adult immediately.

Severe side effects

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

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

Other side effects

The following side effects have been reported.

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

• sleep (drowsiness);
• fatigue (tiredness);
• headache;
• abdominal pain (stomach pain).

Common(may affect up to 1 in 10people)

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

Uncommon(may affect up to 1 in 100people)

• allergic reaction (hypersensitivity);
• chest pain;
• indigestion (dyspepsia);
• breathing difficulties (asthma);
• weakness (asthenia);
• pale skin (pallor);
• seizures or convulsions;
• frequency of urination;
• agitation;
• aggression;
• changes in liver function test results (elevated alanine aminotransferase);
• high blood pressure;
• unusual heart rhythm (sinus arrhythmia and first-degree atrioventricular block);
• fast heart rate (tachycardia);
• slow heart rate;
• dizziness when standing (postural dizziness);
• itching (pruritus);
• seeing or hearing things that do not exist (hallucinations).

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

• excessive sleep (hypersomnia);
• high blood pressure (hypertension);
• uncomfortable feeling.

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

• a severe withdrawal side effect, high blood pressure after sudden discontinuation of Intuniv; symptoms may include headaches, feeling of confusion, nervousness, agitation, and tremors (hypertensive encephalopathy).

Frequency not known(cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if you observe damage to the tablets or the blister pack.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Intuniv Composition

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

• Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg of guanfacina
• The other components 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, and glycerol dibehenate.
• The 3 mg and 4 mg tablets also include aluminum lake of indigo carmine (E132) and yellow iron oxide (E172).

Appearance of the product and contents of the package

Intuniv is a prolonged-release tablet, meaning that the active ingredient is released from the tablet over a period of time. The tablets come in package sizes of 7, 28, or 84, but only some package sizes may be marketed.

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Takeda Pharmaceuticals International AG Ireland Branch

Block 2 Miesian Plaza

50-58 Baggot Street Lower

Dublin 2

D02 HW68

Ireland

Responsible manufacturer

Takeda Pharmaceuticals International AG Ireland Branch

Block2 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 more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

More detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu