10 mg & 18 mg & 25 mg & 40 mg & 60 mg & 80 mg & 100 mg hard capsules 
atomoxetine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atomoxetine STADA is and what it is used for 
2. What you need to know before you use Atomoxetine STADA 
3. How to use Atomoxetine STADA 
4. Possible side effects 
5. How to store Atomoxetine STADA 6. Contents of the pack 
and other information 

What Atomoxetine STADA is and what it is used for

What Atomoxetine Stada is used for

Atomoxetine Stada contains the active substance atomoxetine and is used to treat attention deficit hyperactivity disorder ( ADHD ). It is used in:

  • children from 6 years of age
  • young people
  • adults

It is used only as part of a complete treatment program of the disease which also includes treatment that does not involve drugs, such as talk and behavioral therapy.

In adults, Atomoxetine Stada is used to treat ADHD when the symptoms are very bothersome and affect your job or social life, and when you had symptoms of the disease as a child.

How Atomoxetine Stada works

Atomoxetine Stada increases the amount of norepinephrine in the brain. Noradrenaline is a naturally occurring neurotransmitter that increases attention span and reduces impulsivity and hyperactivity in patients with ADHD. This medicine helps control ADHD symptoms.

This medicine is not a stimulant.

It may take a few weeks after you start taking the medicine before the medicine reaches full effect.

About ADHD 
Children and adolescents with ADHD experience that it is:

  • difficult to sit still and
  • difficult to concentrate

It is not their fault that they can not do this. Many children and adolescents have difficulty with these things, but with ADHD, this can create problems in everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They find it difficult to behave at home, at school, or in other places. ADHD does not affect the intelligence of children and adolescents.

Adults with ADHD have difficulties with the same things that children experience as difficult, but this can mean that they have problems with:

  • work
  • relationships
  • low self-esteem
  • training

Atomoxetine contained in Atomoxetine Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Atomoxetine STADA

Do not use Atomoxetine STADA

  • is allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6)
  • during the last 14 days has taken a drug belonging to the group of monoamine oxidase inhibitors ( MAOIs ), e.g. fenelzin. MAO inhibitors are used, among other things, to treat depression and other mental problems. Concomitant use of Atomoxetine Stada and an MAOI may cause serious side effects or be life-threatening. At least 14 days must have passed after stopping treatment with Atomoxetine Stada before you can start taking an MAOI
  • have an eye disease called glaucoma with a narrow ventricular angle (increased pressure inside the eye)
  • have severe heart problems, which may be affected by an increase in heart rate and/or blood pressure, as it may be an effect of Atomoxetine Stada
  • have serious problems with the blood vessels in the brain – such as a stroke, swelling, and weakening of part of a blood vessel ( aneurysm ) or narrowing or blockage of blood vessels
  • has a tumor in the adrenal gland ( pheochromocytoma ).

Do not take Atomoxetine Stada if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atomoxetine Stada. This is because Atomoxetine Stada can make these problems worse.

Warnings and cautions

Both adults and children should be aware of the following warnings and precautions. Talk to your doctor or pharmacist before taking Atomoxetine Stada if you have:

  • thoughts of taking your life or trying to take your life
  • heart problems (including heart defects) or increased heart rate. Atomoxetine Stada can increase your heart rate ( heart rate ). Sudden death has been reported in patients with heart failure
  • high blood pressure. Atomoxetine Stada may cause high blood pressure
  • low blood pressure. Atomoxetine Stada may cause dizziness or fainting in people with low blood pressure
  • problems with sudden changes in blood pressure or heart rate
  • cardiovascular disease or have had a stroke
  • liver problem. You may then need a lower dose
  • of psychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing in things that are not true or being suspicious
  • mania (feeling elated and excited, causing unusual behavior) and agitation (a feeling of being both physically anxious and mentally aroused)
  • aggressive emotions
  • unfriendly and angry (hostile) feelings
  • epilepsy or have had seizures for some other reason. Atomoxetine Stada may increase the risk of seizures
  • different mood than usual (mood swings) or feel very unhappy
  • difficult to control, repeated twitches in any part of the body or that you repeat sounds and words.

Tell your doctor or pharmacist if any of the above apply to you before starting treatment. This is because Atomoxetine Stada can make these problems worse. Your doctor will want to follow up on how the medicine affects you.

Examinations that your doctor will do before you start taking Atomoxetine Stada

Your doctor will perform some checks

  • before you start – to ensure that Atomoxetine Stada is safe and will help you.
  • once you start – they will be performed at least every 6 months, probably more often.
  • when does one change

Your doctor will measure

  • your blood pressure and heart rate ( heart rate ) before and while you are taking Atomoxetine Stada
  • your height and weight if you are a child or teenager while taking Atomoxetine Stada
  • if you have any problems or if side effects have worsened while you have been taking Atomoxetine Stada.

Your doctor will talk to you about:

  • other medicines you are taking
  • if there is someone in the family who has died a sudden unexplained death
  • other medical problems (such as heart problems) that you or someone in your family has.

It is important that you provide as much information as you can. This will help your doctor decide if Atomoxetine Stada is the right medicine for you. Your doctor may decide that other medical check-ups are necessary before you start taking this medicine.

Important information about the contents of the capsules

Do not open the Atomoxetine Stada capsules as the contents of the capsule may irritate the eyes. If the contents of a capsule come into contact with the eyes, the affected eye should be rinsed immediately with water, and medical advice should be sought. Hands and other parts of the body that may have come in contact with the capsule contents should be washed off as soon as possible.

Other medicines and Atomoxetine STADA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes both prescription and over-the-counter medications. Your doctor will decide if you can take Atomoxetine Stada with other medicines and in some cases, your doctor may need to adjust your dose or increase the dose much more slowly.

Do not take Atomoxetine Stada with medicines belonging to the group MAO inhibitors (monoamine oxidase inhibitors) used in depression. See section 2. “Do not take Atomoxetine Stada if you:”.

If you are taking other medicines, Atomoxetine Stada may affect how well they work or cause side effects.

If you are taking any of the following medicines, tell your doctor or pharmacist before taking Atomoxetine Stada:

  • drugs which increase blood pressure, et or used to control blood pressure et
  • drugs such as antidepressants e.g. imipramine, venlafaxine, mirtazapine, fluoxetine and paroxetine
  • certain cough and cold medicines that contain medicines that can affect blood pressure. It is important to check with the pharmacy staff when receiving these products
  • certain drugs used to treat mental illness
  • Drugs that are known to increase the risk of seizures
  • Some medicines may cause Atomoxetine Stada to stay in the body longer than usual (such as quinidine and terbinafine)
  • Salbutamol (an asthma medicine ) may give the feeling that your heart is racing when you take it by mouth or as an injection, but this will not aggravate your asthma.

The following medicines may lead to an increased risk of abnormal heart rhythm when taken with Atomoxetine Stada:

  • drugs used to treat arrhythmias in the heart
  • drugs that change the concentration of salts in the blood
  • drugs to prevent and treat malaria
  • certain antibiotics (such as erythromycin and moxifloxacin).

If you are not sure if any of the medicines you are taking are listed above, ask your doctor or pharmacist before taking Atomoxetine Stada.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if this medicine affects the unborn baby or passes into breast milk.

  • This medicine should not be taken during pregnancy without first consulting your doctor.
  • You should either stop taking this medicine or avoid breast-feeding.

Driving and using machines

You may feel tired, drowsy, or dizzy after taking Atomoxetine Stada. Do not drive or use any tools or machines until you know how Atomoxetine Stada affects you. If you feel tired, sleepy, or dizzy, do not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Atomoxetine STADA

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

Adults

Atomoxetine Stada treatment should be started with a total daily dose of 40 mg for at least 7 days. Your doctor may then decide that dose one should be increased up to the daily maintenance dose of 80 mg -100 mg. The maximum daily dose that your doctor will prescribe is 100 mg.

The capsules are usually taken once or twice daily (in the morning and late in the afternoon / early evening). It is easier to remember to take the medicine if you take it at the same time each day.

If you take Atomoxetine Stada once a day and get tired or nauseous, your doctor may change your prescription once or twice a day.

Liver problem

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

Method of administration

  • To be swallowed.
  • The capsules should be swallowed whole, with or without food.
  • The capsules must not be opened and the contents of the capsule must not be removed or otherwise ingested.
  • Children should not take this medicine without the help of an adult.

Treatment time

Atomoxetine Stada does not need to be taken forever. If you have been taking Atomoxetine Stada for more than a year, your doctor will review your treatment to see if it is still needed.

Use for children and adolescents

Children or adolescents (6 years or older):

Your doctor will tell you how much Atomoxetine Stada to take, dose one is calculated according to your body weight. He/she will normally ask you to start with a low dose and then increase the amount of Atomoxetine Stada you should take according to your body weight.

  • Bodyweight up to 70 kg: an initial total daily dose of 0.5 mg per kg bodyweight for at least 7 days. Your doctor may then decide that dose one should be increased up to the daily maintenance dose of approximately 1.2 mg per kg body weight.
  • Bodyweight over 70 kg: an initial total daily dose of 40 mg for at least 7 days. Your doctor may then decide to increase your dose to the 80 mg daily maintenance dose. The maximum daily dose one that your doctor will prescribe is 100 mg.

The capsules are usually taken once or twice daily (in the morning and late in the afternoon / early evening). It is easier to remember to take the medicine if you take it at the same time each day.

If you take Atomoxetine Stada once a day and get tired or nauseous, your doctor may change your prescription once or twice a day.

Atomoxetine Stada is not for the treatment of ADHD in children under 6 years of age as it is not known if the treatment works or is safe for these people.

Method of administration

  • To be swallowed.
  • The capsules should be swallowed whole, with or without food.
  • The capsules must not be opened and the contents of the capsule must not be removed or otherwise ingested.
  • Children should not take this medicine without the help of an adult.

Treatment time

Atomoxetine Stada does not need to be taken forever. If you have been taking Atomoxetine Stada for more than a year, your doctor will review your treatment to see if it is still needed.

If you forget to use Atomoxetine STADA

If you miss a dose, take it as soon as you remember, but do not exceed the total daily dose over a 24-hour period. Do not take a double dose to make up for a forgotten dose.

If you stop using Atomoxetine STADA

If you stop taking Atomoxetine Stada, there are usually no side effects, but your ADHD symptoms may return. You should talk to your doctor before stopping your treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should  stop taking Atomoxetine Stada  and contact your doctor immediately  if you have any of the following:

  • dark-colored urine
  • yellow skin or yellow eyes
  • abdominal pain and tenderness when pressing on the right side just below the ribs
  • unexplained nausea
  • fatigue
  • itching
  • flu-like symptoms
  • prolonged and painful erection er.

Some side effects can be serious. If you get any of the side effects listed below, seek medical advice immediately.

Common side effects (may affect up to 1 in 10 people)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
mood swings or mood swings. a feeling of or having a very fast pulse, abnormal heart rhythm.

Uncommon side effects (may affect up to 1 in 100 people)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
a feeling of or having a very fast pulse, abnormal heart rhythmthoughts of taking your life or wanting to take your lifefeel aggressivefeel unfriendly and angry (hostile)severe allergic reaction with symptoms ofswelling of the face and neckdifficulty breathinghives (small raised, itchy spots on the skin)crampspsychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing in things that are not true or being suspicious. thoughts of taking your life or wanting to take your lifefeel aggressivefeel unfriendly and angry (hostile)mood swings or mood swingssevere allergic reaction with symptoms ofswelling of the face and neckdifficulty breathinghives (small raised, itchy spots on the skin). 

Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
liver damage. crampspsychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing in things that are not true or being suspiciousliver damage.

Other reported side effects include the following. If they become serious, talk to your doctor or pharmacist.

Very common side effects (may affect more than 1 user in 10)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
headachemagontdecreased appetite (no feelings of hunger)nausea or vomitingsomnolencehigh blood pressureelevated heart rate ( heart rate ).These side effects may go away after a while in most patients. nauseadry mouthheadachedecreased appetite (no feelings of hunger)difficult to fall asleep, sleep and wake up earlyhigh blood pressureelevated heart rate ( heart rate ).

Common side effects (may affect up to 1 in 10 people)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
to be easily irritatedsleep problems, waking up earlyDepressionfeel sad or hopelessfeel anxiousticslarge pupil er (the dark part in the center of the eye)dizzinessconstipationloss of appetitedigestive disordersswollen, red and itchy skinrashfeel lethargic (state of weakness)chest painfatigueweight loss.
feel annoyeddecreased interest in sexsleep disordersDepressionfeel sad or hopelessfeel anxiousdizzinessabnormal taste or taste in the mouth that does not want to disappeartremorstingling or numbness in the hands or feetdrowsiness, drowsiness, fatigueconstipationmagontindigestiongas in the stomachvomitinghot flashes or rednessswollen, red and itchy skinincreased sweatingrashdifficulty urinating, pain when urinatingprostatitis ( prostatitis )genital pain in meninability to get an erectionproblems with ejaculationdifficulty maintaining an erectioncramps during menstruationfeeling weakfatiguefeel lethargic (state of weakness)overindulgefeel annoyed, shakenfeel thirstyweight loss.

Uncommon side effects (may affect up to 1 in 100 people)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
to fainttremorsmigrainedimsynabnormal sensations in the skin such as burning sensation, tingling, itchingor ant crawling tingling or numbness in the hands or feetrespiratory distressincreased sweatingitchy skinfeeling weak. restlessnessticsto faintmigrainedimsynfeeling cold in fingers and toeschest painrespiratory distressswollen, red and itchy skin (rash)muscle twitchingfrequent urinationabnormal or absent orgasmirregular menstruationinability to ejaculate.

Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
poor blood circulation that causes toes and fingers to become numb and pale (Raynaud’s phenomenon)problems with toilet visits such as having to urinate frequently or difficulty urinating, pain when urinatinggenital pain in boys. poor blood circulation that causes toes and fingers to become numb and pale (Raynaud’s phenomenon).

Effect on growth

Some children may experience a decrease in growth (weight and height) at the beginning of treatment with Atomoxetine Stada.

On the other hand, it has been seen that with long-term treatment, the child then returns to the normal weight and height for children of the same age. Your doctor will monitor your child’s height and weight continuously. If your child does not grow or gain weight as expected, your doctor may change the dose one or temporarily stop treatment with Atomoxetine Stada.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Atomoxetine STADA

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 expiration date is the last day of the specified month.

No special storage instructions.

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

6. Contents of the packaging and other information

Content declaration

The active substance is atomoxetine.

Atomoxetine Stada 10 mg hard capsules

Each hard capsule contains 10 mg of atomoxetine equivalent to 11.43 mg of atomoxetine hydrochloride.

Atomoxetine Stada 18 mg hard capsules

Each hard capsule contains 18 mg of atomoxetine equivalent to 20.57 mg of atomoxetine hydrochloride.

Atomoxetine Stada 25 mg hard capsules

Each hard capsule contains 25 mg of atomoxetine equivalent to 28.58 mg of atomoxetine hydrochloride.

Atomoxetine Stada 40 mg hard capsules

Each hard capsule contains 40 mg of atomoxetine equivalent to 45.72 mg of atomoxetine hydrochloride.

Atomoxetine Stada 60 mg hard capsules

Each hard capsule contains 60 mg of atomoxetine equivalent to 68.58 mg of atomoxetine hydrochloride.

Atomoxetine Stada 80 mg hard capsules

Each hard capsule contains 80 mg of atomoxetine equivalent to 91.44 mg of atomoxetine hydrochloride.

Atomoxetine Stada 100 mg hard capsules

Each hard capsule contains 100 mg of atomoxetine equivalent to 114.3 mg of atomoxetine hydrochloride.

Other ingredients are:

Capsule contents:

Pregelatinized starch

Dimethicone

Capsule shell:

Titanium dioxide

Gelatine

Indigotine (Atomoxetine Stada 25 mg, 40 mg, 60 mg)

Yellow iron oxide (Atomoxetine Stada 18 mg, 60 mg, 80 mg, 100 mg)

Red iron oxide (Atomoxetine Stada 80 mg, 100 mg)

What the medicine looks like and the contents of the pack

Atomoxetine Stada 10 mg hard capsules:

hard gelatin capsules size 4 (approx. 14.3 ± 0.3 mm length), white opaque base and top.

Atomoxetine Stada 18 mg hard capsules:

hard gelatin capsules size 3 (approximately 15.9 ± 0.3 mm in length), white opaque base and yellow opaque top.

Atomoxetine Stada 25 mg hard capsules:

hard gelatin capsules size 4 (approx. 14.3 ± 0.3 mm length), white opaque base, and light blue opaque top.

Atomoxetine Stada 40 mg hard capsules:

hard gelatin capsules size 3 (approx. 15.9 ± 0.3 mm length), light blue opaque lower part and upper part.

Atomoxetine Stada 60 mg hard capsules:

hard gelatin capsules size 2 (approx. 18.0 ± 0.3 mm length), yellow opaque base, and light blue opaque top.

Atomoxetine Stada 80 mg hard capsules:

hard gelatin capsules size 2 (approximately 18.0 ± 0.3 mm long), white opaque base, and orange opaque top.

Atomoxetine Stada 100 mg hard capsules:

hard gelatin capsules size 1 (approx. 19.4 ± 0.3 mm length), orange opaque base and top.

Atomoxetine Stada 10 mg and 18 mg hard capsules are available in pack sizes of 7, 28, and 30 capsules.

Atomoxetine Stada 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg hard capsules are available in pack sizes of 7, 28, 30, and 56 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Vienna

Austria

Centrafarm Services BV

Nieuwe Donk 9, 4879 AC Etten-Leur

Netherlands

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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