Atamax 40 mg hard capsules EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Atamax 40 mg hard capsules EFG
atomoxetine
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Atamax is and what it is used for
- What you need to know before taking Atamax
- How to take Atamax
- Possible adverse effects
- How to store Atamax
- Contents of the pack and other information
1. What Atamax is and what it is used for
What it is used for
Atamax contains atomoxetine and is used in the treatment of attention deficit hyperactivity disorder (ADHD). It is used:
- in children from the age of 6 years
- in adolescents
- in adults
It is used only as part of a comprehensive treatment programme for the condition, which must also include non-pharmacological treatments such as counselling or behavioural therapy.
It is not used for the treatment of ADHD in children under 6 years of age, because it is not known whether the medicine is effective or safe in this population.
In adults, this medicine is used for the treatment of ADHD when symptoms are highly problematic and affect work or social life, and when symptoms of the disorder were present during childhood.
How it works
This medicine increases the amount of noradrenaline in the brain. Noradrenaline is a naturally occurring chemical that enhances attention and reduces impulsivity and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and therefore does not cause dependence.
It may take several weeks after starting treatment with this medicine before symptoms improve fully.
About ADHD
Children and adolescents with ADHD find it difficult:
- to sit still
- to concentrate
It is not their fault that they cannot do these things. Many children and adolescents find these things difficult. However, in patients with ADHD, these difficulties can cause problems in daily life. Children and adolescents with ADHD may have difficulty learning and completing homework. They may struggle to behave appropriately at home, at school, or in other settings. ADHD does not affect a child's or adolescent's intelligence.
Adults with ADHD also find it difficult to manage the same challenges faced by children, but this may result in problems with:
- work
- relationships
- low self-esteem
- education
2. What you need to know before starting to take Atamax
Do not take Atamax:
- if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
- if you have taken a type of medicine called monoamine oxidase inhibitors (MAOIs) in the last two weeks, for example phenelzine. MAOIs are sometimes used for depression and other mental disorders; taking Atamax together with an MAOI could cause serious or life-threatening side effects. You must also wait at least 14 days after stopping this medicine before taking an MAOI.
- if you have a type of eye condition called narrow-angle glaucoma (increased pressure in your eye).
- if you have serious heart problems that could worsen due to an increase in heart rate and/or blood pressure, as this may be an effect of Atamax.
- if you have serious problems with the blood vessels in your brain, such as stroke, inflammation and weakening of part of a blood vessel (aneurysm), or narrowed or blocked blood vessels.
- if you have a tumor in your adrenal gland (pheochromocytoma).
Do not take Atamax if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine. The reason is that this medicine may worsen these conditions.
Warnings and precautions
Both adults and children should consider the following warnings and precautions. Consult your doctor or pharmacist before starting Atamax if you have:
- Serotonin syndrome
Serotonin syndrome is a potentially life-threatening condition that may occur when Atamax is taken in combination with other medicines (see section 2 “Other medicines and Atamax”). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, lack of coordination and stiffness, hallucinations, coma, rapid heartbeat, increased body temperature, rapid changes in blood pressure, sweating, flushing, tremors, overactive reflexes, nausea, vomiting, and diarrhea. Contact a doctor or go immediately to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.
- Treatment with Atamax may make you feel aggressive, hostile, or violent; or worsen these symptoms if they were present before treatment. It may also cause unusual changes in your behavior or mood (including physical aggression, threatening behavior, and thoughts of harming others). If you or your family and/or friends notice any of these reactions, speak with your doctor or pharmacist immediately.
- suicidal thoughts or suicide attempts.
- heart problems (including heart defects) or increased heart rate. Atamax may increase your heart rate (pulse). Cases of sudden death have been reported in patients with heart defects.
- high blood pressure. Atamax may increase your blood pressure.
- low blood pressure. Atamax may cause dizziness or fainting in people who have low blood pressure.
- problems with sudden changes in your blood pressure or heart rate.
- cardiovascular disease or history of stroke (cerebrovascular accident).
- liver problems. You may need a lower dose.
- psychotic symptoms including hallucinations (hearing voices or seeing unreal things), believing things that are not true, or being suspicious.
- mania (feeling elated or overexcited, leading to unusual behavior) and agitation.
- aggression.
- feelings of dislike and anger (hostility).
- history of epilepsy or if you have had seizures for any other reason. Atamax may increase the frequency of seizures.
- mood changes different from usual (mood swings) or feelings of unhappiness.
- repeated, difficult-to-control muscle spasms in any part of the body or repetition of sounds and words.
Consult your doctor or pharmacist if you have any of the symptoms listed above before starting treatment. The reason is that Atamax may worsen these conditions. Your doctor will want to monitor how the medicine affects you.
Tests your doctor will perform before you start taking Atamax
These tests are to determine whether Atamax is the right medicine for you.
Your doctor will measure your:
- blood pressure and heart rate (pulse) before and during treatment with Atamax
- weight and height if you are a child or adolescent during treatment with Atamax
Your doctor will ask you about:
- other medicines you are taking
- family history of sudden death
- any other medical problems (such as heart problems) that you or your family may have
It is important to provide all the information you can. This will help your doctor decide whether Atamax is the right medicine for you. Your doctor may decide that additional medical tests are needed before starting treatment with this medicine.
Important information about the capsule contents
Do not open Atamax capsules because the capsule contents may irritate the eye. If the capsule contents come into contact with the eye, immediately rinse the affected eye with water and consult a doctor. Hands and any other parts of the body that may have come into contact with the capsule contents should also be washed as soon as possible.
Other medicines and Atamax
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. Your doctor will decide whether you can take Atamax with your other medicines, and in some cases may need to adjust your dose or increase your dose more slowly.
Do not take Atamax with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 “Do not take Atamax”.
If you are taking other medicines, Atamax may affect how they work or cause side effects.
If you are taking any of the following medicines, check with your doctor or pharmacist before taking Atamax.
Atamax may affect or be affected by other medicines. These include:
- some antidepressants, opioids such as tramadol, and medicines used to treat migraine called triptans. These medicines may interact with Atamax and cause serotonin syndrome, a potentially life-threatening condition. (See section 2, Warnings and precautions, Serotonin syndrome).
- medicines that increase blood pressure or are used to control blood pressure
- medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine
- some cough and cold remedies containing medicines that may affect blood pressure. It is important to check with your pharmacist when buying these products.
- some medicines used to treat mental disorders
- medicines known to increase the risk of seizures
- some medicines that cause Atamax to remain in the body longer than normal
(such as quinidine and terbinafine)
- salbutamol (a medicine for the treatment of asthma) when taken orally or by injection may cause a sensation of your heart racing, but this will not worsen your asthma.
The medicines listed below may increase the risk of abnormal heart rhythm when taken with Atamax:
- medicines used to control heart rhythm
- medicines that alter blood salt levels
- medicines for the prevention and treatment of malaria
- some antibiotic medicines (such as erythromycin and moxifloxacin).
If you are unsure whether the medicines you are taking are included in the list above, consult your doctor or pharmacist before taking Atamax.
Pregnancy and breastfeeding
There are no data available on whether this medicine may affect the fetus or pass into breast milk.
- This medicine should not be taken during pregnancy unless your doctor recommends it.
- You should avoid taking this medicine if you are breastfeeding or stop 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 medicine.
Driving and using machines
Atamax may cause tiredness, drowsiness, or dizziness. Be cautious if driving or using machinery until you know how Atamax affects you. If you feel tired, drowsy, or dizzy, you should not drive or use machinery.
Atamax contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.
3. How to take Atamax
- Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. The recommended dose is once or twice daily (in the morning and late afternoon or early evening).
- Children must not take this medicine without adult assistance.
- If you are taking Atamax once daily and experience drowsiness or feel unwell, your doctor may change your treatment schedule to twice daily.
- For oral administration.
- The capsules must be swallowed whole, with or without food.
- The capsules must not be opened, and the contents must not be removed or taken in any other way.
- Taking the medicine at the same time each day may help you remember to take it.
How much to take
If you are a child (from 6 years of age) or adolescent:
Your doctor will determine the dose of Atamax you should take, based on your body weight. Usually, your doctor will start with a lower dose before increasing the amount of Atamax according to your body weight.
- Body weight up to 70 kg: starting with a total daily dose of 0.5 mg per kg of body weight for at least 7 days. Your doctor will then decide whether to increase to the usual maintenance dose of 1.2 mg per kg of body weight per day.
- Body weight over 70 kg: starting with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide whether to increase to the usual maintenance dose of 80 mg per day. The maximum daily dose your doctor will prescribe is 100 mg.
Adults
- Treatment with Atamax should be initiated with a total daily dose of 40 mg for at least 7 days. Your doctor will then decide whether to increase to the usual maintenance dose of 80 mg–100 mg per day. The maximum daily dose your doctor will prescribe is 100 mg.
If you have liver problems, your doctor may prescribe a lower dose.
What your doctor will do during your treatment
Your doctor will perform certain tests
- before you start treatment – to ensure that Atamax is safe and will benefit you.
- after you have started treatment – tests will be performed at least every 6 months, although they may be more frequent.
Tests will also be carried out when the dose is changed. These tests will include:
- measurement of height and weight in children and adolescents.
- measurement of blood pressure and heart rate.
- checking for any problems or whether adverse effects have worsened while taking Atamax.
Long-term treatment
Atamax does not need to be taken indefinitely. If you take Atamax for more than one year, your doctor must review your treatment to determine whether the medicine is still necessary.
If you take more Atamax than you should
Contact your doctor or the nearest hospital emergency department immediately and inform them how many capsules you have taken. The most commonly reported symptoms following an overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor, and abnormal behaviour. Very rarely, serotonin syndrome, a potentially life-threatening condition, has also been reported. (See section 2, Warnings and precautions, Serotonin syndrome).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Atamax
If you miss a dose, take it as soon as possible, but do not exceed the total daily dose within a 24-hour period. Do not take a double dose to make up for a missed dose.
If you stop taking Atamax
If you stop taking Atamax, adverse effects usually do not occur, but symptoms of ADHD may reappear. You should speak with your doctor before stopping treatment.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Although some people do experience adverse effects, most find that Atamax helps them. Your doctor will discuss these adverse effects with you.
Some adverse effects could be serious. If you experience any of the effects described below, contact your doctor immediately.
Uncommon (may affect up to 1 in 100 people)
- feeling or having a very fast heartbeat, abnormal heart rhythm
- suicidal thoughts or feelings
- feeling aggressive
- feelings of dislike and anger (hostility)
- mood changes or mood swings
- severe allergic reaction with symptoms such as:
- swelling of the face and throat
- difficulty breathing
- hives (wheals/small raised red itchy rash)
- seizures
- psychotic symptoms including hallucinations (hearing voices or seeing things that are not real), believing things that are not true, or becoming suspicious.
Children and adolescents under 18 years of age have a higher risk of experiencing adverse effects such as:
- suicidal thoughts or feelings (may affect up to 1 in 100 people)
- mood changes or mood swings (may affect up to 1 in 10 people)
Adults have a lower risk (may affect up to 1 in 1,000 people) of experiencing adverse effects such as:
- seizures
- psychotic symptoms including hallucinations (such as hearing voices or seeing things that are not real), believing things that are not true, or becoming suspicious
Rare (may affect up to 1 in 1,000 people)
- liver problems
Stop treatment with Atamax and contact your doctor immediately if you experience any of the following adverse effects:
- dark urine
- yellowing of the skin or eyes
- abdominal pain when pressed (tenderness) in the upper right side of the abdomen, just below your ribs
- unexplained nausea
- tiredness
- itching
- feeling as if you have caught a cold
Other reported adverse effects have included the following. If any of these worsen, consult your doctor or pharmacist.
Very common adverse effects (may affect more than 1 in 10 people) | |
CHILDREN over 6 years and ADOLESCENTS | ADULTS |
These effects may disappear over time in most patients. |
|
Adverse reactions common (may affect up to 1 in 10 people) | |
CHILDREN over 6 years and ADOLESCENTS | ADULTS |
|
|
Uncommon adverse effects (may affect up to 1 in 100 people) | |
CHILDREN over 6 years and ADOLESCENTS | ADULTS |
(prolongation of QT interval)
|
|
Adverse reactions rare (may affect up to 1 in 1,000 people) | |
CHILDREN over 6 years and ADOLESCENTS | ADULTS |
|
|
Adverse reactions of unknown frequency |
CHILDREN over 6 years and ADOLESCENTS |
|
Effects on growth
Some children experience reduced growth (weight and height) when they start taking Atamax. However, with long-term treatment, children regain appropriate weight and height for their age group. Your doctor will monitor your child's height and weight over time. If your child does not grow or gain weight as expected, your doctor may adjust the dose of Atamax or decide to temporarily discontinue treatment with Atamax.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Atamax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after the abbreviation “EXP”. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Atamax
- The active substance is atomoxetine.
Each hard capsule contains 40 mg of atomoxetine, equivalent to 45.71 mg of atomoxetine hydrochloride.
- Other components are
Capsule contents: Pregelatinized corn starch, colloidal anhydrous silica, and dimethicone.
Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), indigotine (E132), and purified water.
- Printing ink (black): Shellac Glaze-45% (20% esterified) in ethanol, black iron oxide (E172), and propylene glycol.
Appearance of the product and contents of the container
Hard gelatin capsule containing white powder, size No. 3 (length 15.7±0.4 mm), with an opaque blue cap printed with '40' in black ink and an opaque blue body printed with 'mg' in black ink.
Atamax is presented in blister packs contained in a cardboard box.
Available pack sizes: 7, 14, 28 and 56 hard capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LABORATORIOS RUBIÓ, S.A.
Industria, 29
Pol. Ind. Comte de Sert
08755 Castellbisbal
Barcelona – Spain
Manufacturer:
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No.5
69300 Rodopi
Greece
or
Pharmathen S.A.
6, Dervenakion Str
15351 Pallini Attikis
Greece
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria Atomoxetin Pharmathen 40 mg Hard Capsules
Greece ATAMA καψ?κιο σκληρ? 40 mg
Germany ATAMA 40 mg Hard Capsules
Spain Atamax 40 mg hard capsules EFG
Date of the most recent revision of this leaflet: November 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)