Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - intuniv

Document Subject

Generated Narrative: MedicinalProductDefinition mpd2fbf2f2639d83ae5727c01cf5210fc3

identifier: http://ema.europa.eu/identifier/EU/1/15/1040/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Intuniv 1 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d2fbf2f2639d83ae5727c01cf5210fc3

identifier: http://ema.europa.eu/identifier/EU/1/15/1040/001-002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - intuniv

Attesters

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

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.

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

experience aggressive feelings or behaviour, or

have suicidal thoughts or feelings 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 it is 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) Medicines Used to treat Aprepitant Nausea and vertigo. Atazanavir, efavirenz, etravirine, fosamprenavir, indinavir, nevirapine, ritonavir, saquinavir HIV infection. Ciprofloxacin, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampicin, telithromycin Bacterial infections. Fluconazole, itraconazole, posaconazole, ketoconazole Fungal infections. Crizotinib, imatinib Cancer. Diltiazem, verapamil Cardiovascular conditions. Boceprevir, telaprevir Viral hepatitis. Suboxone Substance dependence. Bosentan Cardiovascular conditions (e.g. constriction of blood vessels in the lung). Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone Used to control epilepsy. Modafinil Is a medicine that promotes alertness and is used to treat sleep disorders. St. John s Wort Is a herbal preparation that is used to treat depression. 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 .

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.

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

aggression

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.

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.

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 one side and 503 on the other side.

The 4 mg prolonged-release tablets are oval and green, hard tablets, debossed with 4MG on one side and 503 on the other side. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 medinfoEMEA@takeda.com Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta akeda HELLAS S.A. Tel: +30 210 6387medinfoEMEA@takeda.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Takeda Farmac utica Espa a S.A. Tel: +34 917 90 42 medinfoEMEA@takeda.com Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

akeda . . : +30 210 6387medinfoEMEA@takeda.com Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com This leaflet was last revised in . Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: