Atofab 10 mg. 30 capsules

GEROT LANNACH
Atofab 10 mg. 30 capsules
€ 59.00
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What Atofab is and what it is used for

What is it used for
Atofab contains atomoxetine and is used to treat attention deficit hyperactivity disorder (ADHD). Used in:

children over the age of six;
adolescents;
adults.
The medicinal product is used as part of a comprehensive disease treatment regimen that also requires treatment that does not include medication such as counseling and behavioral therapy.
It is not used for the treatment of ADHD in children below the age of 6 years, as it has not been established that the drug is active in this age group and is safe for use in them.

In adult patients, this product is used to treat ADHD when your symptoms are very troublesome and affect your work or social life and when you have symptoms of the disease as children.

How it works
This medicinal product increases the amount of norepinephrine in the brain. It is a chemical that naturally forms in the brain, increases attention, and decreases impulsivity and hyperactivity in ADHD patients. This medicine is prescribed to help control the symptoms of ADHD. It is not a stimulant and therefore does not lead to addiction.
It may take several weeks from the start of treatment to completely improve your symptoms.

Attention Deficit Hyperactivity Disorder (ADHD) Information
Children and adolescents with ADHD experience:

difficulty sitting quietly and concentrating.
It is not their fault that they cannot do these things. Many children and adolescents make efforts to do these things. However, with ADHD it can lead to problems in daily life, Children and adolescents with ADHD may have learning and homework difficulties. It is difficult for them to keep well at home, at school or elsewhere. ADHD does not affect the intelligence of the child or the young person.

Adults with ADHD have difficulty doing all these things that make it difficult for children; they may also have problems with:

the work;
connections;
low self-esteem;
training.
2. What you need to know before taking Atofab

Do not take Atofab:

if you are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
if you have been taking a medicine known as a monoamine oxidase inhibitor (MAO inhibitor) for the past two weeks, such as phenelzine. MAO inhibitors are sometimes used to treat depression and other mental health problems; taking Atofab with MAO inhibitors can cause serious side effects or be life-threatening. You also need to wait at least 14 days after stopping this medicine before taking MAO inhibitors.
if you have an eye disease called angle-closure glaucoma (increased intraocular pressure).
if you have serious heart problems that may worsen with increasing heart rate and / or blood pressure, as this may be one of the effects of Atofab.
if you have serious problems with the blood vessels in the brain - such as a stroke, swelling and thinning of a part of a blood vessel (aneurysm), or narrowing, obstruction of blood vessels.
if you have an adrenal tumor (pheochromocytoma).
Do not take Atofab if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. This is necessary as this medicine can aggravate these problems.

Warnings and precautions
Both adults and children should be aware of the following warnings and precautions. Discuss with your doctor or pharmacist before taking Atofab if you have:

thoughts or attempts at suicide.
heart problems (including heart defects) or rapid heart rate. Atofab may increase your heart rate (heart rate). Sudden death in patients with heart defects has been reported.
high blood pressure. Atofab may increase blood pressure.
low blood pressure. Atofab can cause dizziness or seizures in people with low blood pressure.
problems with sudden changes in blood pressure or heart rate.
cardiovascular disease or stroke data in the past.
liver problems. You may need a lower dose.
mental symptoms, including hallucinations (hearing voices or seeing things that do not exist), believe in things that are not true, or become suspicious.
mania (a feeling of excitement or excitement that leads to unusual behavior) and excitement,
aggressive moods.
unfriendly and angry (hostile) feelings.
history of epilepsy or seizures for some other reason. Atofab can lead to an increase in seizure frequency.
other than normal moods (mood swings) or you feel very unhappy.
you have difficulty controlling recurrent convulsions of certain parts of the body
Checkups that your doctor will perform before you start taking Atofab
These examinations are necessary to decide if Atofab is the right medicine for you.

Your doctor will measure:

your blood pressure and heart rate (pulse) before and during your treatment with Atofab;
your height and weight, if you are a child or teenager, while taking Atofab.
Your doctor will talk to you about:

other medicines you are taking;
whether there is evidence in the family of a sudden and unexplained death;
for any other medical problems (such as heart problems) that you or your family may have.
It is important that you provide as complete information as possible. This will help your doctor decide if Atofab is the right medicine for you. Before you start taking this medicine, your doctor may decide that other medical devices are needed.

Important information about the contents of the capsules
Do not open Atofab capsules as their contents may irritate the eyes. If the contents of the capsules come in contact with the eyes, the affected eye should immediately be flushed with water and seek medical advice. Hands and any other part of the body that may come in contact with the contents of the capsule should also be washed as soon as possible.

Other medicines and Atofab
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to over-the-counter medicines.
Your doctor will decide if you can take Atofab with other medicines, in some cases it may need to adjust your dose or reduce it as slowly as possible.

Do not take Atofab with medicines called MAO inhibitors (monoamine oxidase inhibitors) that are used to treat depression. See section 2 "Do not take Atofab".

If you take other medicines, Atofab may affect their effects or cause side effects.

If you are taking any of the following medicines, consult your doctor or pharmacist before taking Atofab:

medicines that raise blood pressure or are used to control blood pressure.
medicines such as antidepressants, such as imipramine, venlafaxine, mirtazapine, fluoxetine and paroxetine.
some cough and cold medicines that contain medicines that can affect blood pressure. It is important to consult your pharmacist when purchasing some of these products.
some medicines used to treat mental illness.
medicines that are known to increase the risk of seizures.
some medicines that cause Atofab to stay in the body for longer than usual (such as quinidine and terbinafine).
salbutamol (an asthma medicine) when taken orally or injected may make you feel as if your heart is in a canter, but it won't worsen your asthma.
The following medicines may increase your risk of irregular heart rhythm when taken with Atofab:

drugs used to control heart rate;
medicines that alter the concentration of salts in the blood;
medicines for the prevention and treatment of malaria;
some antibiotic drugs (such as erythromycin and moxifloxacin).
If you are not sure if all the medicines you are taking are included in the list above, ask your doctor or pharmacist before taking Atofab.

Pregnancy and breastfeeding
It is not known whether this medicine can affect the unborn baby or pass into breast milk.
This medicine should not be used during pregnancy unless your doctor has advised you to do so.
If you are breast-feeding you should avoid taking this medicine or stop breast-feeding.

If you are pregnant or breast-feeding, if you think you may be pregnant or planning to become pregnant or breast-feed your baby, talk to your doctor or pharmacist before using this medicine.

Driving and operating are machines
You may feel tired, sleepy or dizzy after taking Atofab. You should be more careful when driving or operating machinery until you understand how Atofab affects you. If you feel tired, sleepy or dizzy, you should not drive or use machines.

3. How to take Atofab

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure about something, ask your doctor or pharmacist. The drug is usually taken once or twice a day (morning and late afternoon or early evening).
Children should not take this medicine without the help of an adult.
If you take Atofab once a day and feel drowsy or feeling unwell, your doctor may change your regimen twice a day.
Oral use.
The capsules should be swallowed whole, with or without food.
Capsules should not be opened, their contents should not
Dosage
If you are a child or teenager (6 years of age or older):
Your doctor will tell you what dose of Atofab you should take and will calculate it according to your weight. Your doctor will usually start with a lower dose before increasing the amount of Atofab you need to take depending on your body weight.

For body weights below 70 kg: the starting daily dose is a total of 0.5 mg per kilogram body weight for a minimum of 7 days. Your doctor may then decide to increase it to the usual maintenance dose of approximately 1.2 mg per kilogram of body weight per day.
For body weight over 70 kg: the starting daily dose is a total of 40 mg for a minimum of 7 days. Your doctor may then decide to increase it to the usual maintenance dose of 80 mg daily. The maximum daily dose your doctor can prescribe for you is 100 mg.

Adults
Atofab treatment should be started with a total daily dose of 40 mg for a minimum of 7 days. Your doctor may then decide to increase it to the usual maintenance dose of 80 mg - 100 mg daily. The maximum daily dose your doctor can prescribe for you is 100 mg.

If you have liver problems, your doctor may prescribe a lower dose.

Things your doctor will do while undergoing treatment
Your doctor will do some research

before you start - make sure that Atofab is safe and useful;
once you get started - research will be done at least once every 6 months, but it's possible and more common.
Investigations will also be made when the dose is changed. These studies include:

measuring height and weight in children and adolescents;
measurement of blood pressure and heart rate;
Check if you have any problems or if any side effects get worse while taking Atofab.
Long-term treatment
Atofab should not be taken forever. If you take Atofab for more than a year, your doctor will review your treatment to determine if you still need the medicine.

If you take more Atofab than you should, contact your doctor immediately or call the nearest hospital emergency department and tell them how many capsules you have taken. The most commonly reported symptoms accompanying overdose are gastrointestinal symptoms, drowsiness, dizziness, tremor and unusual behavior.

If you forget to take Atofab
If you miss a dose, you should take it as soon as possible, but you should not take more than your total daily dose for 24 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atofab
If you stop taking Atofab, there are usually no side effects, but the symptoms of ADHD can be reversed. Before stopping treatment, you must first tell your doctor.

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. Although some people get side effects, most patients find that Atofab helps them. Your doctor will notify you of these side effects.

Some side effects can be serious. If you get any of the side effects listed below, contact your doctor immediately.

Uncommon (may affect up to 1 in 100 patients):

feel or have a very fast heart rhythm, heart rhythm disorders;
thoughts or feelings of suicide;
feeling aggressive;
feelings of hostility and anger (hostility);
fluctuations or changes in mood;
severe allergic reaction with symptoms of:
swelling of the face and throat;
difficulty breathing;
nettle fever (small, raised, itchy skin patches);
seizures;
mental symptoms, including hallucinations (hearing voices or seeing things that do not exist), believe in things that are not true, or become suspicious.
Children and adolescents under the age of 18 are at increased risk of side effects such as:

thoughts or feelings of suicide (may affect up to 1 in 100 patients);
mood swings or changes (may affect up to 1 in 10 patients).
In adults, the risk of side effects is lower (may affect up to 1 in 1,000 patients), such as:

seizures;
psychotic symptoms, including hallucinations (hearing voices or seeing things that do not exist), believe in things that are not true, or become suspicious.
Rare (may affect up to 1 in 1,000 patients):

damage to the liver.
You should stop taking Atofab and contact your doctor immediately if you experience any of the following:

dark urine;
yellowing of the skin or yellowing of the eyes;
abdominal pain, which is painful when pressed on the right side just below the ribs;
you feel bad (nausea), which is inexplicable;
fatigue;
itching;
the feeling that you are getting the flu.
The following other side effects have also been reported. If these reactions
Uncommon side effects (may affect up to 1 in 100 patients):
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS ADULTS
seizures;
shaking;
migraine;
blurred vision;
an unusual sensation on the skin, such as burning, pricking, itching or tingling;
tingling or numbness of hands and feet;
seizures (seizures);
feel or have a very fast heart rate (QT prolongation);
shortness of breath;
increased sweating;
itchy skin;
lack of power or energy.
anxiety;
teak;
seizures;
migraine;
blurred vision;
abnormal heart rhythm (prolongation of QT interval);
feeling cold in the fingers and toes;
chest pain;
shortness of breath;
raised, red and itchy rash (nettle fever);
muscle spasms;
urges to urinate;
pathological orgasm or lack of orgasm;
irregular menstruation;
disturbances in ejaculation.


Rare side effects (may affect up to 1 in 1,000 patients):
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS ADULTS
poor dew on the fingers and toes, causing them to become stiff and pale (Raynaud's disease);
problems when going to the toilet, such as frequent or hesitant urination, pain when urinating;
prolonged and painful erections;
groin pain in men.

poor dew on the fingers and toes, causing them to become stiff and pale (Raynaud's disease);
prolonged and painful erections.

Effects on growth
Some children lag behind in height (weight and height) when they start taking Atofab. However, with prolonged treatment, children recover to the weight and height characteristic of their age group. Your doctor will measure your child's height and weight during treatment. If your child is not growing or gaining weight as expected, your doctor may change your child's dose or may decide to stop temporarily taking Atofab.

5. How to store Atofab

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Atofab contains
The active substance is atomoxetine.

Atofab 10 mg hard capsules
Each hard capsule contains 10 mg atomoxetine as 11.43 mg atomoxetine hydrochloride.

The other ingredients are:
Capsule Content: Pregelatinized corn starch, colloidal anhydrous silica and dimethicone.
Capsule shell composition: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), purified water.

Atofab 25 mg hard capsules
Each hard capsule contains 25 mg atomoxetine in the form of 28.57 mg atomoxetine hydrochloride.

The other ingredients are:
Capsule Content: Pregelatinized corn starch, colloidal anhydrous silica and dimethicone.
Capsule shell composition: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E 171), indigo carmine (E 132), purified water.

Atofab 40 mg hard capsules
Each hard capsule contains 40 mg atomoxetine in the form of 45.71 mg atomoxetine hydrochloride.

The other ingredients are:
Capsule Content: Pregelatinized corn starch, colloidal anhydrous silica and dimethicone.
Capsule shell composition: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E 171), indigo carmine (E132), purified water.

Atofab 60 mg Hard capsules
Each hard capsule contains 60 mg atomoxetine in the form of 68.57 mg atomoxetine hydrochloride.

The other ingredients are:
Capsule Content: Pregelatinized corn starch, colloidal anhydrous silica and dimethicone.
Composition of the capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E 171), indigo carmine (E132), yellow iron oxide (E172), purified water.

Print ink (black), consisting of: shellac gloss - 45% (20% esterified) in ethanol, ferric oxide - black (E 172), propylene glycol.

What Atofab looks like and contents of the pack
Atofab 10 mg hard capsules
White powder in hard gelatin capsule size 3 (length 15,7 ± 0,4 mm), with an opaque white cap, with a black inscription "10" and with an opaque white body, with a black inscription "mg".

Atofab 25 mg hard capsules
White powder in a hard gelatin capsule size 3 (length 15,7 ± 0,4 mm), with an opaque blue cap, with a black inscription "25" and with an opaque white body, with a black inscription "mg".

Atofab 40 mg hard capsules
White powder in hard gelatin capsule size 3 (length 15,7 ± 0,4 mm), with an opaque blue cap, with a black inscription "40" and with an opaque blue body, with a black inscription "mg".

Atofab 60 mg hard capsules
White powder in hard gelatin capsule size 2 (length 17.6 ± 0.4 mm), with opaque blue cap, with black overhang
Atofab is available in blisters in cartons.

Pack sizes: 7, 10, 14, 28, 30 and 56 hard capsules.

Not all pack sizes may be marketed.
€ 59.00
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