PAXNEURY 1 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. Paxneury 1 mg prolonged-release tablets, 2 mg prolonged-release tablets, 3 mg prolonged-release tablets, 4 mg prolonged-release tablets, 5 mg prolonged-release tablets, 6 mg prolonged-release tablets, 7 mg prolonged-release tablets
   1. What is Paxneury and what is it used for What is Paxneury
   2. What you need to know before taking Paxneury Do not take Paxneury
   3. How to take Paxneury
   4. Possible side effects
   5. How to store Paxneury
   6. Contents of the pack and other information What Paxneury contains

Paxneury 1 mg prolonged-release tablets, 2 mg prolonged-release tablets, 3 mg prolonged-release tablets, 4 mg prolonged-release tablets, 5 mg prolonged-release tablets, 6 mg prolonged-release tablets, 7 mg prolonged-release tablets

guanfacina

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

the medicine. If the medicine is given to your child, replace “you” with “your
child”.

Contents of this leaflet:

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

1. What is Paxneury and what is it used for What is Paxneury

Paxneury contains the active ingredient guanfacine. This medicine belongs to a group of
medicines that affect brain activity. This medicine can improve attention,
concentration and reduce impulsivity and hyperactivity.

What is Paxneury used for
This medicine is used for the treatment of "attention deficit/hyperactivity disorder"
(ADHD) in children and adolescents aged 6-17 years for whom the stimulant medicine currently
used is not suitable and/or the medicine currently used does not adequately control the symptoms
of ADHD.
The medicine is prescribed as part of a treatment program, which usually includes:

• psychological therapy
• educational therapy
• social therapy

Information about ADHD
People who suffer from ADHD find it difficult to:

• stay still
• concentrate.

ADHD can cause problems in everyday life. Children and adolescents with ADHD
may have difficulty learning and doing their homework. They may find it difficult to behave well at
home, at school or in other places.

2. What you need to know before taking Paxneury Do not take Paxneury

• 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 if you have a family history of heart problems
• you have recently fainted
• you have thoughts or feelings of suicide
• you suffer from other psychiatric illnesses

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

• experience feelings or adopt aggressive behaviours or
• have thoughts or feelings of suicide

If taken for long periods, Paxneury may have an effect on weight and height; your doctor will therefore
monitor growth.
Do not stop taking Paxneury without consulting your doctor. Abrupt discontinuation of
treatment with Paxneury may cause withdrawal symptoms such as an increase in heart rate
and blood pressure (see section 4).
If you fall into any of the above cases (or if in doubt), consult your doctor or pharmacist before
taking this medicine, as it may worsen these problems. Your doctor will
monitor you regularly to assess the effects of the medicine.

Children (under 6 years of age) and adults (18 years and over)
This medicine should not be used in children under 6 years of age and in adults aged
18 years and over, because it is not known whether it is effective or safe.

Checks performed by the doctor during treatment with Paxneury
Before starting to take this medicine, the doctor will perform checks to ensure that this
medicine is safe for you and able to help you. During treatment with this medicine, the
doctor will repeat these checks once a week in the initial period, after dose adjustments, at least every 3 months for the first year, then at least twice a year. These checks may
include:

• blood pressure and heart rate and other heart checks, if appropriate
• response to treatment, especially if the medicine causes drowsiness or makes you feel sleepy
• height and weight

Talk to your doctor if you do not feel better or if you feel worse and very sleepy or experience
drowsiness after taking this medicine for about 6 weeks. Your doctor may want to
review the treatment.

Other medicines and Paxneury
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Paxneury can affect the action of other medicines and
vice versa.
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 drowsiness (sedatives)
• medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics)
• medicines that can affect how Paxneury is eliminated from the liver (see the table below)

If you fall into any of the above cases, or if in doubt, consult your doctor or pharmacist before
taking this medicine,

Paxneury with food, drinks and alcohol

• Do not take this medicine with fatty foods (e.g. a high-fat breakfast), as they may affect the mechanism of action of the medicine.
• Do not drink grapefruit juice with this medicine, as it may affect the mechanism of action of the medicine.
• Do not drink alcohol when taking this medicine, as it may cause drowsiness or make you feel sleepy.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

• Do not take this medicine if you are pregnant or not using contraceptive measures. It is not known whether Paxneury may have effects on the unborn child.
• Do not breastfeed during treatment with Paxneury, unless indicated by your doctor.

Driving and operating machinery
You may experience dizziness and drowsiness when taking this medicine, especially at the beginning of
treatment, and these symptoms may last for 2-3 weeks or more. If this happens, do not drive vehicles
or bicycles, do not use tools or machinery and do not perform activities that could cause accidents
until you have ascertained what the effects of this medicine are on you. Fainting has also been reported, but this is not a common effect.

Paxneury contains lactose
Lactose is a type of sugar. If your doctor has diagnosed you with intolerance to some sugars,
contact him before taking this medicine.

Paxneury contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Paxneury

Treatment will begin under the supervision of a qualified specialist in behavioral disorders of childhood and/or adolescence.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
As part of the treatment, the doctor will carefully monitor the effects of Paxneury on you during the initial period and/or dose changes.

Dosage to be taken

• The doctor will prescribe an initial dose of 1 mg per day. The doctor may increase the dose based on body weight and the effectiveness of Paxneury, but not more than 1 mg per week. Depending on the response to treatment, the doctor may increase the dose more slowly. The recommended maintenance dose is between 0.05 and up to 0.12 mg per kg of body weight per day.
• You may not notice an immediate effect at the beginning of treatment; some patients may notice an improvement after the first week, but this may take longer.
• The daily dose will be between 1 and 7 mg, depending on age and response to treatment with Paxneury, but not exceeding 7 mg.

How to take Paxneury

• This medicine should be taken once a day, in the morning or evening.
• It can be taken with or without food, but it should not be taken with fatty foods (e.g. a high-fat breakfast).
• Swallow the tablet whole with a glass of water or other liquid (but not with grapefruit juice).
• Do not break, crush or chew the tablet; this affects the mechanism of action of the medicine. Tell your doctor if you cannot swallow the tablet whole.

Duration of treatment
If you need to take Paxneury for more than a year, your doctor will check the response to treatment and may have you stop taking the medicine for a short period, for example during school holidays.
This will be to check if the medicine is still necessary for you.

If you take more Paxneury than you should
If you take more Paxneury than you should, consult your doctor or go to hospital immediately.
Bring the package of the medicine with you and tell the doctor the amount taken.
The following effects may occur: low or high blood pressure, slowed heart rate, slowed breathing, feeling tired or weak.

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

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

If you stop taking Paxneury
Do not stop treatment with this medicine without consulting your doctor first.

• If you stop treatment with this medicine, blood pressure and heart rate may increase (see section 4 below).
• To stop treatment, your doctor will slowly reduce the dose of Paxneury to minimize unwanted 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 have any doubts, consult your doctor.

If you experience any discomfort during treatment with this medicine, immediately inform an adult.
Serious side effects
The following serious side effects have been reported: feeling sleepy (sedation), feeling dizzy (hypotension), slowed heartbeat (bradycardia), feeling faint or losing consciousness (syncope), a serious withdrawal effect manifesting as increased blood pressure following abrupt discontinuation of Paxneury treatment; symptoms may include headache, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).
Some of these side effects are more likely to occur at the beginning of treatment and may disappear with continued therapy; if any of these effects occur, contact your doctor immediately.

Other side effects
The following side effects have been reported.

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

• feeling sleepy (feeling drowsy)
• feeling tired (fatigue)
• headache
• stomach or abdominal pain (abdominal pain).

Common(may affect up to 1 in 10 people)

• low heart rate
• decreased blood pressure
• feeling restless or irritable
• difficulty sleeping (insomnia), interrupted sleep (intermediate insomnia) or nightmares
• feeling depressed, worried (anxiety) or mood swings (emotional lability)
• lack of energy (lethargy)
• weight gain
• loss of appetite
• dry mouth
• bedwetting (enuresis)
• nausea or vomiting
• diarrhea, 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)
• difficulty breathing (asthma)
• feeling weak (asthenia)
• pale skin (pallor)
• seizures or convulsions
• frequent need to urinate (pollakiuria)
• feeling agitated
• aggression
• changes in liver function test results (increased alanine aminotransferase)
• increased blood pressure
• irregular heartbeat (sinus arrhythmia and first-degree atrioventricular block)
• fast heartbeat (tachycardia)
• decreased heart rate
• feeling dizzy when standing up (postural dizziness)
• itching
• 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)
• feeling unwell (malaise).

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

• a serious withdrawal effect manifesting as increased blood pressure following abrupt discontinuation of Paxneury treatment; symptoms may include headache, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).

Not known(frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paxneury

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 package and on the blister after
“Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not use this
medicine if the tablets or the blister appear damaged.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information What Paxneury 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
• Each 5 mg tablet contains guanfacine hydrochloride, equivalent to 5 mg of guanfacine
• Each 6 mg tablet contains guanfacine hydrochloride, equivalent to 6 mg of guanfacine
• Each 7 mg tablet contains guanfacine hydrochloride, equivalent to 7 mg of guanfacine

The other components are hypromellose 2208, methacrylic acid-ethyl acrylate copolymer (type A),
lactose monohydrate, povidone K-30, crospovidone (type A), microcrystalline cellulose, colloidal anhydrous silica,
sodium lauryl sulfate, polysorbate 80, fumaric acid, glycerol dibehenate

Description of the appearance of Paxneury and contents of the pack
Paxneury is an extended-release tablet: this means that its active ingredient is released
from the tablet over a certain period. The tablets are supplied in packs of 28.

• The 1 mg guanfacine extended-release tablets are white, round, with a diameter of 8 mm, biconvex and with the inscription “I” embossed on one side.
• The 2 mg guanfacine extended-release tablets are white, elongated in shape 14 x 6 mm, biconvex and with the inscription “II” embossed on one side
• The 3 mg guanfacine extended-release tablets are white, round, with a diameter of 6 mm, biconvex and with the inscription “3” embossed on one side.
• The 4 mg guanfacine extended-release tablets are white, round, with a diameter of 7 mm, biconvex and with the inscription “IV” embossed on one side.
• The 5 mg guanfacine extended-release tablets are white, round, with a diameter of 8 mm, biconvex and with the inscription “V” embossed on one side.
• The 6 mg guanfacine extended-release tablets are white, round, with a diameter of 9 mm, biconvex and with the inscription “VI” embossed on one side.
• The 7 mg guanfacine extended-release tablets are white, elongated in shape 12.5 x 6.5 mm, biconvex and with the inscription “7” embossed on one side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neuraxpharm Pharmaceuticals, S.L
Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona, Spain

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí
Barcelona, Spain
or
Neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Strasse 23, Richrath
Langenfeld (Rheinland)
40764, Germany
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Neuraxpharm Belgium
Tél/Tel: +32 (0)2 732 56 95

Lietuva
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 475 96 00

България
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 475 96 00

Luxembourg/Luxemburg
Neuraxpharm Belgium
Tél/Tel: +32 (0)2 732 56 95

Česká republika
Neuraxpharm Bohemia s.r.o.
Tel: +420 739 232 258

Magyarország
Neuraxpharm Hungary Kft.
Tel.: +3630 464 6834

Danmark
Neuraxpharm Sweden AB
Tlf: +46 (0)8 30 91 41
(Sverige)

Malta
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 475 96 00

Deutschland
neuraxpharm Arzneimittel GmbH
Tel: +49 2173 1060 0

Nederland
Neuraxpharm Netherlands B.V.
Tel.: +31 70 208 5211

Eesti
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 475 96 00

Norge
Neuraxpharm Sweden AB
Tlf:+46 (0)8 30 91 41
(Sverige)

Ελλάδα
Brain Therapeutics PC
Τηλ: +302109931458

Österreich
Neuraxpharm Austria GmbH
Tel.: + 43 (0) 2236 320038

España
Neuraxpharm Spain, S.L.U.
Tel: +34 93 475 96 00

Polska
Neuraxpharm Polska Sp. z.o.o.
Tel.: +48 783 423 453

FrancePortugal
Neuraxpharm France
Tél: +33 1.53.62.42.90
Neuraxpharm Portugal, Unipessoal Lda
Tel: +351 910 259 536

Hrvatska
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 602 24 21

România
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 602 24 21

Ireland
Neuraxpharm Ireland Ltd
Tel: +353 (0)1 428 7777

Slovenija
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 602 24 21

Ísland
Neuraxpharm Sweden AB
Sími: +46 (0)8 30 91 41
(Svíþjóð)

Slovenská republika
Neuraxpharm Slovakia a.s.
Tel: +421 255 425 562

Italia
Neuraxpharm Italy S.p.A.
Tel: +39 0736 980619

Suomi/Finland
Neuraxpharm Sweden AB
Puh/Tel: +46 (0)8 30 91 41
(Ruotsi/Sverige)

Κύπρος
Brain Therapeutics PC
Τηλ: +302109931458

Sverige
Neuraxpharm Sweden AB
Tel: +46 (0)8 30 91 41

Latvija
Neuraxpharm Pharmaceuticals, S.L.
Tel.: +34 93 475 96 00

United Kingdom (Northern Ireland)
Neuraxpharm Ireland Ltd
Tel: +353 (0)1 428 7777

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu: http://www.ema.europa.eu.