Intuniv - patient leaflet, side effects, dosage

Patient leaflet - Intuniv

B. PACKAGE LEAFLET

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. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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 as though the person taking the medicine is reading it. If you are

giving this medicine to your child, please replace “you” with “your child” throughout.

What is in this leaflet:

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

1. What Intuniv is and what it is used for

What Intuniv is

Intuniv contains the active substance guanfacine. This medicine belongs to a group of medicines which affects brain activity. This medicine can help improve your attention, 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 6–17 years old for whom current stimulant medication is not appropriate and/or current medication does 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 find it hard to:

sit still
concentrate.

ADHD can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They can 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 taking this medicine if:

you have low or high blood pressure, heart problems or have a family history of heart problems
you have fainted recently
you have thoughts or feelings of suicide
you suffer from any other psychiatric conditions

Intuniv may affect your weight and height if taking for long periods, your doctor will therefore monitor your growth.

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

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

Children (under 6 years old) and adults (18 years and over)

This medicine should not be used in children under 6 years of age and adults 18 years and over because itis not known if it works or is safe.

Checks your doctor will do when you take Intuniv

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

your blood pressure and heart rate and other checks on your heart if appropriate
your response to treatment, in particular if it makes you sleepy or drowsy
your height and weight

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

Other medicines and Intuniv

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

In particular, tell your doctor or pharmacist if you are taking any of the following types of medicines:

medicines that lower your blood pressure (antihypertensives)
medicines for epilepsy such as valproic acid
medicines that make you sleepy (sedatives)
medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics)
medicines that can affect the way Intuniv is eliminated by the liver (please see table below)

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking this medicine.

Intuniv with food, drinks and alcohol

Do not take this medicine with fatty foods (e.g., high fat breakfast), as it may affect the way this

medicine works.

Do not take grapefruit juice with this medicine as it can have an effect on the way this medicine

works.

Do not drink alcohol when taking this medicine as it may make you sleepy or drowsy.

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 you are not using contraception. It is not known

if Intuniv will affect your unborn baby.

Do not breast-feed while taking Intuniv unless told to do so by your doctor.

Driving and using machines

You may feel dizzy and drowsy when taking this medicine, especially at the start of treatment and this may last for 2 to 3 weeks possibly longer. If this happens, do not drive, cycle, use any tools or machines or participate in activities that could cause injury until you know how this medicine affects you. Fainting has also been reported but is not a common effect.

Intuniv contains lactose

Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Intuniv contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Intuniv

Your treatment will start under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.

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

As part of your treatment your doctor will closely monitor how Intuniv is affecting you during initial dosing and/or dose adjustments.

How much to take

Your doctor will start you on 1 mg per day. Your doctor may increase your dose based on your body weight and how Intuniv is working for you but not by 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 up to 0.12 mg per kg of bodyweight per day.
You may not notice an immediate effect upon starting treatment, some patients may notice an improvement after the first week but it could take longer.
Your daily dose will be between 1 and 7 mg depending on your age and how you respond to Intuniv, but not more that 7 mg.

How to take Intuniv

This medicine should be taken once a day either in the morning or evening.
It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast).
Swallow the tablet whole with a drink of water or other liquid (but not grapefruit juice).
Do not break, crush or chew the tablet; this will affect how the tablet 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 monitor your response to treatment and your doctor may stop the medicine for a short time; this may happen during a school holiday. This 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: low or high blood pressure, slow heart rate, slow breathing rate, feeling tired or exhausted.

If you forget to take Intuniv

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

If you have missed 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 first talking to your doctor.

If you stop taking this medicine your blood pressure and heart rate may increase (see section 4

below).

To stop the medicine, your doctor will slowly reduce your Intuniv dose to minimise any side

effects.

If you have any further questions on 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, speak to your doctor.

If you feel unwell in any way while you are taking your medicine please tell an adult straight away.

Serious side effects

The following serious side effects have been reported: feeling drowsy (sedation), feeling dizzy (hypotension), slow heart beat (bradycardia), feeling faint or loss of conciousness (syncope), a serious withdrawal side effect of high blood pressure after suddenly stopping Intuniv; symptoms may include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).

Some of these side effects are more likely to occur at the start of treatment and may disappear as you continue with your treatment, if you experience any of these side effects contact your doctor straight away.

Other side effects

The following side effects have been reported.

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

feeling sleepy (somnolence)
feeling tired (fatigue)
headache
tummy pain (abdominal pain).

Common (may affect up to 1 in 10 people)

low heart rate
blood pressure decreased
feeling restless or irritable
trouble sleeping (insomnia) or broken sleep (middle insomnia) or nightmares
feeling depressed, worried (anxiety) or having mood swings (affect lability)
lack of energy (lethargy)
weight gain
loss of appetite
have a dry mouth
wetting yourself (enuresis)
feeling (nausea) or being sick (vomiting)
diarrhoea, abdominal discomfort or constipation
low blood pressure when standing up (orthostatic hypotension)
rash.

Uncommon (may affect up to 1 in 100 people)

allergic reaction (hypersensitivity)
chest pain
indigestion (dyspepsia)
trouble breathing (asthma)
feeling weak (asthenia)
pale skin colour (pallor)
fits or convulsions
need to urinate frequently (pollakiuria)
feeling agitated
changes in liver blood test results (increased alanine aminotransferase)
increase in blood pressure
unusual heart rhythm (sinus arrhythmia and first-degree arterioventricular block)
fast heart beat (tachycardia)
reduced heart rate
feeling dizzy when standing up (postural dizziness)
itchy skin (pruritus)
seeing or hearing things that are not there (hallucination).

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

sleeping more than normal (hypersomnia)
high blood pressure (hypertension)
feeling unwell (malaise).

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

a serious withdrawal side effect of high blood pressure after suddenly stopping Intuniv;

symptoms may include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).

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

difficulty to get or keep 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. How to store 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 pack after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if the tablets or blister pack look damaged.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Intuniv contains

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, silica colloidal anhydrous, sodium laurilsulfate, polysorbate 80, fumaric acid, glycerol dibehenate.

The 3 mg and 4 mg tablets also contain indigo carmine aluminium lake (E 132) and yellow iron

oxide (E 172)

What Intuniv looks like 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 but not all pack sizes may be available.

The 1 mg prolonged-release tablets are round and white, hard tablets, debossed with 1MG on

one side and 503 on the other side.

The 2 mg prolonged-release tablets are oval and white, hard tablets, debossed with 2MG on one

side and 503 on the other side.

The 3 mg prolonged-release tablets are round and green, hard tablets, debossed with 3MG on