PAXNEURY 3 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 starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• This package leaflet has been written as if the reader is the person taking the medication. If you are giving this medication to your child, 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 taking Paxneury
3. How to take Paxneury
4. Possible side effects
5. Storage of Paxneury
6. Contents of the pack and further information

1. What is Paxneury and what is it used for

What is Paxneury

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

What Paxneury is used for

This medication is used to treat "attention deficit hyperactivity disorder" (ADHD) in children and adolescents aged 6 to 17 years in whom current stimulant medications are not suitable and/or current medications do not adequately control ADHD symptoms.

The medication is administered as part of a treatment program, which normally 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 daily 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 taking Paxneury

Do not take Paxneury:

• if you are allergic to guanfacine or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 another psychiatric disorder.

Consult your doctor or pharmacist if you are taking this medication and:

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

Paxneury may affect your weight and height if you take it for extended periods. Therefore, your doctor will monitor your growth.

Do not stop taking Paxneury without consulting your doctor first. If you stop taking Paxneury suddenly, you may experience withdrawal symptoms such as increased heart rate and high blood pressure (see section 4).

If any of the above points apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medication. This is because this medication may worsen these problems. Your doctor will monitor you regularly to see how this medication affects you.

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

This medication should 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 perform when you take Paxneury

Before starting to take this medication, your doctor will ensure that this medication is safe for you and that it will help you. While taking this medication, your doctor will repeat these checks every week at the beginning of treatment, after dose adjustments, at least every 3 months during the first year, and then at least twice a year. These checks may include:

• blood pressure and heart rate and other heart tests, if necessary;
• response to treatment, specifically if it causes sleepiness or drowsiness;
• height and weight.

You should consult your doctor if you do not improve or if you worsen and experience excessive sleepiness or drowsiness after taking this medication for about 6 weeks. Your doctor may want to review your treatment.

Other medications and Paxneury

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

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

• medications that lower blood pressure (antihypertensives);
• medications for epilepsy such as valproic acid;
• medications that cause sleepiness (sedatives);
• medications for mental health problems (benzodiazepines, barbiturates, and antipsychotics);
• medications that may affect how the liver eliminates Paxneury (see the table below).

If any of the above points apply to you or if you are unsure, consult your doctor or pharmacist before taking this medication.

Taking Paxneury with food, drinks, and alcohol

• Do not take this medication with fatty foods (e.g., a fatty breakfast), as they may affect how this medication works.
• Do not take grapefruit juice with this medication, as it may affect how this medication works.
• Do not drink alcohol while taking this medication, as it may cause sleepiness or drowsiness.
• Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• Do not take this medication if you are pregnant or if you do not use contraceptives. It is not known if Paxneury affects the fetus.
• 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 medication, 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 engage in activities that may cause injury until you know how this medication affects you. Fainting has also been reported, although it is not a frequent effect.

Paxneury contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Paxneury contains sodium

This medication 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 child and/or adolescent behavioral disorders.

Follow the instructions for taking this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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 not 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 starting treatment; some patients notice 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 exceed 7 mg.

How to take Paxneury

• This medication should be taken once a day, either in the morning or at night.
• It can be taken with or without food, but it should not be taken with fatty foods (e.g., a fatty breakfast).
• Swallow the tablet whole with water or another liquid (not grapefruit juice).
• Do not break, crush, or chew the tablet, as this will affect how it works. Inform 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 medication for a short period; this can be done during school holidays. This break will indicate if you need to continue taking the medication.

If you take more Paxneury than you should

If you take more Paxneury than you should, consult a doctor or go to a hospital immediately. Take the medication package with you and tell them how much you have taken.

The following effects may occur: 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 the usual dose.

• If you have forgotten two or more doses, consult 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 medication without consulting your doctor first.

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

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. If you are concerned about anything, consult your doctor.

If you do not feel well while taking the medication, talk to an adult immediately. Serious side effects

The following side effects have been reported: sleepiness (sedation), dizziness (hypotension), and slow heart rate (bradycardia), fainting or loss of consciousness (syncope), a serious withdrawal effect with high blood pressure after sudden interruption of Paxneury; symptoms may include headaches, confusion, 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 treatment continues. If you experience any of these side effects, consult your doctor immediately.

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;
• decreased 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);
• increased blood pressure;
• abnormal 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 do not exist (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 effect with high blood pressure after sudden interruption of Paxneury; symptoms may include headaches, confusion, nervousness, agitation, and tremors (hypertensive encephalopathy).

Frequency not known(cannot be estimated from available data)

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Paxneury

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. 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.

Product Appearance 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 Leaflet:

Other Sources of Information

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