PAXNEURY 1 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Paxneury 1 mg prolonged-release tablets

Paxneury 2 mg prolonged-release tablets

Paxneury 3 mg prolonged-release tablets

Paxneury 4 mg prolonged-release tablets

Paxneury 5 mg prolonged-release tablets

Paxneury 6 mg prolonged-release tablets

Paxneury 7 mg prolonged-release tablets

guanfacine

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• This package leaflet has been written in a way that assumes the reader is the person taking the medicine. If you are giving this medicine to your child, you should always replace “you” with “your child”.

Contents of the package 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. Storing Paxneury
6. Package contents and further information

1. What Paxneury is and what it is used for

What Paxneury is

Paxneury contains the active substance guanfacine. This medicine belongs to a group of medicines that affect brain activity. This medicine may help improve your attention and concentration and make you less impulsive and hyperactive.

What Paxneury is used for

This medicine is used to treat “attention deficit hyperactivity disorder” (ADHD) in children and adolescents from 6 to 17 years old in whom current stimulant medicines are not suitable and/or current medicines do not adequately control the symptoms of ADHD.

The medicine is given as part of a treatment program, which usually includes the following:

• psychological therapy
• educational therapy
• social therapy

About ADHD

People with ADHD have problems with:

• sitting still;
• concentrating.

ADHD can cause problems in everyday life. Children and adolescents with ADHD may have difficulties with learning and with schoolwork. They may find it hard to behave well at home, at school, or in other places.

2. What you need to know before you take 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 you start taking Paxneury:

• if you have low or high blood pressure, heart problems, or a family history of heart problems;
• if you have recently fainted;
• if you have suicidal thoughts or ideas;
• if you have any other psychiatric disorder.

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

• you have aggressive feelings or behavior, or
• you have suicidal thoughts or feelings.

Paxneury 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 Paxneury without talking to your doctor first. If you stop taking Paxneury suddenly, you may have withdrawal symptoms such as increased heart rate and high blood pressure (see section 4).

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

Children (under 6 years of age) and adults (from 18 years of age)

This medicine must not be used in children under 6 years of age or in adults from 18 years of age because it is not known if it works or if it is safe.

Checks that your doctor will carry out when you take Paxneury

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

• blood pressure and heart rate and other heart tests, if necessary;
• response to treatment, in particular if it makes you sleepy or drowsy;
• height and weight.

You should talk to your doctor if you do not improve or if you get 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 Paxneury

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

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 sleepiness (sedatives);
• medicines for mental health problems (benzodiazepines, barbiturates, and antipsychotics);
• medicines that may affect how the liver removes Paxneury (see the table below).

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

Taking Paxneury with food, drinks, and alcohol

• Do not take this medicine with fatty foods (e.g., a fatty breakfast), as they may affect how this medicine works.
• Do not take grapefruit juice with this medicine, as it may affect how this medicine works.
• Do not drink alcohol while taking this medicine, as it may cause sleepiness or drowsiness.
• 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 if you are not using contraception. It is not known if Paxneury will affect the unborn baby.
• Do not breastfeed while taking Paxneury unless your doctor tells you to.

Driving and using machines

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

Paxneury contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Paxneury contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially sodium-free.

3. How to take Paxneury

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

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

As part of your treatment, your doctor will closely monitor how Paxneury affects you at the start of 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 Paxneury works for you, but no 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 and 0.12 mg per kg of body weight per day.
• You may not see an immediate effect when you start treatment; some patients notice an improvement after the first week, although it may take longer.
• The daily dose will be between 1 and 7 mg, depending on your age and how you respond to Paxneury, but it will not be more than 7 mg.

How to take Paxneury

• Take this medicine once a day, either in the morning or at night.
• You can take it with or without food, but do not take it with fatty foods (e.g., a fatty breakfast).
• Swallow the tablet whole with water or another liquid (that is not grapefruit juice).
• Do not break, crush, or chew the tablet, as this will affect how it works. 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 monitor your response to treatment and may interrupt the medicine for a short period; this can be done during school holidays. This break will show if you need to continue taking the medicine.

If you take more Paxneury than you should

If you take more Paxneury than you should, talk to a doctor or go to a hospital straight away. Take the medicine package with you and tell them how much you have taken.

The following effects may happen: high or low blood pressure, slow heart rate, slow breathing rate, tiredness or exhaustion.

If you forget to take Paxneury

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

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

If you stop taking Paxneury

Do not stop taking this medicine without talking to your doctor first.

• If you stop taking this medicine, you may have increased blood pressure and heart rate (see section 4).
• To stop taking the medicine, your doctor will slowly reduce your dose of Paxneury to minimize any side effects.

If you have any other questions about 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 concerned about any of these, talk to your doctor.

If you do not feel well while taking the medicine, talk to an adult straight away. Serious side effects

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

Some of these side effects are more likely to happen at the start of treatment and may disappear as treatment continues. If you get any of these side effects, talk to your doctor straight away.

Other side effects

The following side effects have been reported.

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

• sleepiness (somnolence);
• tiredness (fatigue);
• headache;
• stomach pain (abdominal pain).

Common(may affect up to 1 in 10 people)

• slow heart rate;
• low blood pressure;
• restlessness or irritability;
• sleep problems (insomnia) or interrupted sleep (maintenance insomnia) or nightmares;
• depression, worry (anxiety) or mood changes (affective 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 up (orthostatic hypotension);
• skin rash.

Uncommon(may affect up to 1 in 100 people)

• allergic reaction (hypersensitivity);
• chest pain;
• indigestion (dyspepsia);
• breathing problems (asthma);
• weakness (asthenia);
• pale skin (pallor);
• seizures or convulsions;
• need to urinate frequently (pollakiuria);
• agitation;
• aggression;
• changes in liver blood test results (increased alanine aminotransferase);
• high blood pressure;
• unusual heart rhythm (sinus arrhythmia and first-degree atrioventricular block);
• fast heart rate (tachycardia);
• reduced heart rate;
• dizziness when standing up (postural dizziness);
• itching (pruritus);
• 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);
• malaise.

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

• a serious withdrawal side effect, with high blood pressure after suddenly stopping Paxneury; symptoms may include headaches, feeling confused, nervousness, agitation, and tremors (hypertensive encephalopathy).

Frequency not known(cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through 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. Storing 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 carton and blister after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any damage to the tablets or the blister.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information Composition of Paxneury

• 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, crospovidone (type A), microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, polysorbate 80, fumaric acid, glycerol dibehenate.

Appearance of the Product and Package Contents

Paxneury is a prolonged-release tablet, which means that the active ingredient is released from the tablet over a period of time. The tablets come in packages of:

• The 1 mg guanfacine tablets are white, round, 8 mm in diameter, biconvex with the inscription “I” on one face.
• The 2 mg guanfacine tablets are white, biconvex and oblong, 14 x 6 mm, with the inscription “II” on one face.
• The 3 mg guanfacine tablets are white, round, 6 mm and biconvex with the inscription “3” on one face.
• The 4 mg guanfacine tablets are white, round, 7 mm and biconvex, with the inscription “IV” on one face.
• The 5 mg guanfacine tablets are white, round, 8 mm and biconvex, with the inscription “V” on one face.
• The 6 mg guanfacine tablets are white, round, 9 mm and biconvex, with the inscription “VI” on one face.
• The 7 mg guanfacine tablets are white, biconvex and oblong, 12.5 x 6.5 mm, with the inscription “7” on one face.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Prospectus:

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.