1 mg, 2 mg, 3 mg or 4 mg prolonged-release tablets are
guanfacine
1. What Intuniv is and what it is used for
What Intuniv is
It contains the active substance guanfacine. This drug belongs to a group of drugs that affect the activity of the brain. This medicine can help improve your attention and concentration and make you less impulsive and hyperactive.
What Intuniv is used for
It is used to treat ADHD ( Attention Deficit Hyperactivity Disorder ) in children and adolescents aged 6 to 17 years for whom current stimulant drugs are not appropriate and/or current drugs do not provide adequate control of ADHD symptoms.
The drug is given as part of a treatment program that usually consists of:
- psychological treatment (psychotherapy)
- training
- social therapy .
About ADHD
People with ADHD have difficulty:
- sit still
- concentrate.
ADHD can cause problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They have difficulty behaving well at home, at school, or elsewhere.
2. What you need to know before taking 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 cautions
Talk to your doctor or pharmacist before taking Intuniv if:
- you have low or high blood pressure , heart problems or have heart problems in the family
- you have recently fainted
- you have suicidal thoughts or suicidal feelings
- you have other psychiatric conditions.
Intuniv can affect your weight and height if you take it for a long time and therefore your doctor will check how you grow.
Do not stop taking Intuniv without talking to a doctor. If you suddenly stop taking Intuniv, you may experience withdrawal symptoms in the form 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. The reason for this is that this drug can aggravate these problems. Your doctor will routinely check how this medicine is affecting you.
Children (under 6 years) and adults (18 years and older)
This medicine should not be used in children under 6 years of age and adults who are 18 years and older, as it is not known if it works or is safe.
Checks that your doctor will do when you take Intuniv
Before you start taking this medicine, your doctor will check if this medicine is safe for you and that it will help you. When you take this medicine, your doctor will repeat these checks every week during the initial treatment, after dose adjustments, at least every three months during the first year, and thereafter at least twice a year. These checks include:
- your blood pressure and heart rate and if necessary other controls of your heart
- your response to treatment, especially if it makes you sleepy or drowsy
- your height and weight.
You must talk to a doctor if you do not feel better or if you feel worse and feel very sleepy or drowsy after taking this medicine for about 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. The reason for this is that Intuniv and certain 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 blood pressure (blood pressure lowering agents)
- antiepileptic drugs such as valproic acid
- medicines that make you sleepy (sedatives)
- medicines for mental health problems ( benzodiazepines , barbiturates and antipsychotics)
- medicines that may affect how Intuniv is broken down by the liver (see table below).
| Drug | Used to treat |
| Aprepitant | nausea and dizziness |
| Atazanavir, efavirenz, etravirine, fosamprenavir, indinavir, nevirapine, ritonavir, saquvinavir | HIV – infection |
| Ciprofloxacin, chloramphenicol, clarithromycin, erythromycin, rifabutin, rifampicin, telithromycin | bacterial infections |
| Fluconazole , itraconazole, posaconazole, ketoconazole | fungal infections |
| Crizotinib, imatinib | cancer |
| Diltiazem, verapamil | cardiovascular disease |
| Boceprevir, telaprevir | virus hepatitis |
| Suboxon | drug addiction |
| Bosentan | cardiovascular disease (eg narrowing of blood vessels in the lungs) |
| Carbamazepine, oxcarbazepine, phenobarbital, phenytoin , primidone | epilepsy |
| Modafinil | is a drug that promotes wakefulness and is used to treat sleep disorders |
| St. John’s wort | is an herbal preparation used to treat mild depression and mild anxiety |
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, drink and alcohol
- Do not take this medicine with high-fat foods (eg high-fat breakfast) as it may affect the way this medicine works.
- Do not drink grapefruit juice with this medicine, as it may affect the way this medicine works.
- Do not drink alcohol while taking this medicine, as it may make you drowsy or drowsy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 not using contraception. It is not known if Intuniv will affect your unborn baby.
- Do not breast-feed while taking Intuniv unless your doctor tells you to.
Driving and using machines
You may feel dizzy and drowsy while taking this medicine, especially at the beginning of treatment, and this may last for two to three weeks or longer. If this happens, do not drive, cycle, use any tools or machines or engage in any activity that may 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 a small amount of sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
How to take Intuniv
Treatment will be initiated under the supervision of an appropriate specialist in behavioral disorders in children and/or adolescents.
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
As part of your treatment, your doctor will closely monitor how Intuniv affects you during the initial 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 not by more than 1 mg per week. Depending on how you respond to treatment, your doctor may increase the dose more slowly. The recommended maintenance dose is from 0.05 up to 0.12 mg per kg body weight per day.
- You may not notice any immediate effect when you start treatment. Some patients may notice an improvement after the first week, but it may 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 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 high-fat foods (eg high-fat breakfast).
- Swallow the tablet whole with a glass of water or other liquid (but not grapefruit juice).
- The tablet must not be broken, crushed or chewed, as this will affect the way the tablet works. Tell your doctor if you are unable to swallow the tablet whole.
Processing time
If you need to take Intuniv for more than a year, your doctor will check how you respond to the treatment, and your doctor may stop the treatment for a short time. This can be done 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 a hospital doctor immediately. Take the medicine pack with you and tell them how much you have taken.
The following effects may occur low or high blood pressure, slow heart rate, slow breathing, fatigue, or fatigue.
If you forget to take Intuniv
If you miss a dose, wait until the next day and take your usual dose.
- If you have missed two or more doses , talk to your doctor. You may need to resume treatment with Intuniv at 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, your blood pressure and heart rate may increase (see section 4 below).
- To stop the medicine, the doctor will gradually reduce your Intuniv- dose to minimize potential side effects are.
If you have any further questions on the use of this product, 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, talk to your doctor.
If you feel unwell in any way while taking this medicine, tell an adult immediately.
Serious side effects are
The following serious side effects have been reported: drowsiness ( sedation ), dizziness (low blood pressure ), slow heartbeat ( bradycardia ), fainting or loss of consciousness ( syncope ), a severe withdrawal effect due to high blood pressure if you stop taking Intuniv suddenly. Symptoms may include headache, confusion, nervousness, restlessness, and tremors (blood pressure-induced encephalopathy ).
Some of these side effects are more likely to occur at the beginning of treatment and may disappear when you continue your treatment. If you get any of these side effects, talk to your doctor immediately.
Other side effects are
The following side effects have been reported.
Very common (may affect more than 1 in 10 people)
- drowsiness ( somnolence )
- fatigue
- headache
- abdominal pain (abdominal pain).
Common (may affect up to 1 in 10 people)
- low heart rate
- lowered blood pressure
- restlessness or irritation
- insomnia (insomnia) or interrupted sleep (insomnia in the middle of the night) or nightmares
- depression, anxiety (mood swings) or mood swings (affect lability)
- lack of energy ( lethargy )
- weight gain
- loss of appetite
- dry mouth
- wetting themselves ( enuresis )
- nausea or vomiting
- diarrhea, stomach discomfort or constipation
- low blood pressure when getting up ( orthostatic hypotension )
- rash.
Uncommon (may affect up to 1 in 100 people)
- allergic reaction (hypersensitivity)
- chest pain
- stomach upset ( dyspepsia )
- breathing difficulties ( asthma )
- feeling of weakness ( asthenia )
- pallor
- seizures or convulsions
- need to urinate frequently (pollakisuri)
- indignation
- changes in blood test results on liver function (increased alanine aminotransferase )
- high blood pressure
- abnormal heart rhythm (first-degree sinus arrhythmia and atrioventricular block)
- rapid heartbeat ( tachycardia )
- decreased heart rate
- dizziness when getting up (postural dizziness)
- itchy skin ( itching )
- see or hear things that do not exist (hallucinations).
Rare (may affect up to 1 in 1,000 people)
- sleep more than normal ( hypersomnia )
- high blood pressure ( hypertension )
- feeling sick.
Very rare (may affect up to 1 in 10,000 people)
- a serious withdrawal effect in the form of high blood pressure if you suddenly stop taking Intuniv. Symptoms may include headache, confusion, nervousness, restlessness and tremors (blood pressure- induced encephalopathy ).
No known frequency (can not be calculated 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if the tablets or blister packs look damaged.
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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- Each 1 mg tablet contains guanfacine hydrochloride equivalent to 1 mg guanfacine.
- Each 2 mg tablet contains guanfacine hydrochloride equivalent to 2 mg guanfacine.
- Each 3 mg tablet contains guanfacine hydrochloride equivalent to 3 mg guanfacine.
- Each 4 mg tablet contains guanfacine hydrochloride equivalent to 4 mg guanfacine.
- The other ingredients are hypromellose 2208, copolymer of methacrylic acid and ethyl acrylate, lactose monohydrate , povidone, crospovidone type A, microcrystalline cellulose, colloidal anhydrous silica, sodium lauryl sulfate, polysorbate 80, fumaric acid, glycerol dibhenate.
- 3 mg and 4 mg tablets also contain indigo carmine aluminum lacquer (E 132) and yellow iron oxide E 172.
What the medicine looks like and contents of the pack
Intuniv is a prolonged-release tablet, which means that the active substance is released from the tablet for a period of time. The tablets are available in pack sizes of 7, 28, or 84, but not all pack sizes may be available.
- 1 mg prolonged-release tablets are round, white, hard tablets, marked with 1MG on one side and 503 on the other side.
- 2 mg prolonged-release tablets are oval, white, hard tablets, marked with 2MG on one side and 503 on the other side.
- 3 mg prolonged-release tablets are round, green, hard tablets, marked with 3MG on one side and 503 on the other side.
- 4 mg prolonged-release tablets are oval, green, hard tablets, marked with 4MG on one side and 503 on the other.
Marketing Authorization Holder and Manufacturer
Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Ireland
tel: +800 66838470
Email: medinfoEMEA@shire.com