10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 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 may harm them, even if they show symptoms 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.

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

What Atomoxetine Orion is and what it is used for

What is it used for

Atomoxetine Orion contains atomoxetine and is used to treat attention deficit hyperactivity disorder ( ADHD ). It uses:

  • in children from 6 years of age
  • in adolescents
  • in 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.

The drug is not for the treatment of ADHD in children under 6 years because it is not known if the treatment works or is safe for these people.

In adults, this drug 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 does it work

This drug 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 drug is not a central stimulant and is therefore not addictive.

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

What you need to know before you use Atomoxetine Orion

Do not take Atomoxetine Orion if you:

  • 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. feeling. MAO inhibitors are used, among other things, to treat depression and other mental problems. Concomitant use of Atomoxetine Orion and an MAOI may cause serious side effects or be life-threatening. At least 14 days must have passed after stopping treatment with this medicine 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 Orion.
  • 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 Orion 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 because this medicine may 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 Orion if you have:

  • thoughts of taking your life or trying to take your life
  • heart problems (including heart defects) or increased heart rate. Atomoxetine Orion may increase your heart rate ( heart rate ). Sudden death has been reported in patients with heart failure.
  • high blood pressure . Atomoxetine Orion may cause high blood pressure .
  • low blood pressure . Atomoxetine Orion 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 .
  • 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 Orion 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 Orion can make these problems worse. Your doctor will want to follow up on how the medicine affects you.

Tests that your doctor will do before you start taking Atomoxetine Orion

These tests are to determine if Atomoxetine Orion is the right drug for you.

Your doctor will measure:

  • your blood pressure and heart rate ( heart rate ) before and while you are taking Atomoxetine Orion
  • your height and weight if you are a child or teenager while taking Atomoxetine Orion.

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 Orion is the right medicine for you. Your doctor may decide that other medical check-ups are necessary before you start taking this medicine.

Other medicines and Atomoxetine Orion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor will decide if you can take Atomoxetine Orion 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 Orion with medicines belonging to the group MAO inhibitors (monoamine oxidase inhibitors) used in depression. See section 2. “Do not take Atomoxetine Orion if you:”.

If you are taking other medicines, Atomoxetine Orion 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 using Atomoxetine Orion:

  • drugs that increase blood pressure or are used to control blood pressure .
  • drugs such as antidepressants such as 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 Orion to stay in the body for 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 Orion:

  • 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 Orion.

Pregnancy and breastfeeding

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 while you are being treated with Atomoxetine Orion.

If you are:

  • pregnant or breastfeeding
  • think you may be pregnant or planning to have children
  • plan to breastfeed your baby

consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You may feel tired, sleepy or dizzy after taking Atomoxetine Orion. Do not drive or use any tools or machines until you know how Atomoxetine Orion 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.

Important information about the contents of the capsules

Do not open the 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 rinsed off as soon as possible.

Ingredients

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

3. How to use Atomoxetine Orion

  • Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Dose one is usually taken once or twice daily (in the morning and late afternoon / early evening).
  • Children should be helped by an adult to take this medicine.
  • If you take Atomoxetine Orion once daily and get tired or nauseous, your doctor may change your prescription to Atomoxetine Orion twice a day.
  • 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.
  • It is easier to remember to take the medicine if you take it at the same time each day.

How much to take

If you are a child or adolescent (6 years or older): 
Your doctor will tell you how much Atomoxetine Orion to take, dose one is calculated according to your body weight. Your doctor will normally ask you to start with a low dose and then increase the amount of Atomoxetine Orion 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.

Adults

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

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

If you forget to use Atomoxetine Orion

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 Orion

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

Steps your doctor will take when you are being treated

Your doctor will perform some checks

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

They will also be performed in case of a change of dose one. These controls include:

  • measurement of height and weight in children and adolescents.
  • measurement of blood pressure and heart rate .
  • be aware if you have any problems or side effects that get worse when you take Atomoxetine Orion.

Long-term treatment

Atomoxetine Orion does not need to be taken forever. If you are taking Atomoxetine Orion for more than a year, your doctor will review your treatment to evaluate if the medicine is still needed.

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. Although some people experience side effects, most people find that Atomoxetine Orion helps them. Your doctor will talk to you about the side effects .

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

Uncommon (may affect up to 1 in 100 people)

  • a feeling of or having a very fast pulse, abnormal heart rhythm
  • thoughts of taking your life or wanting to take your life
  • feel aggressive
  • feel unfriendly and angry (hostile)
  • mood swings or mood swings
  • severe allergic reaction with symptoms of
    • swelling of the face and neck
    • difficulty breathing
    • hives (small raised, itchy spots on the skin)
  • cramps
  • psychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing in things that are not true or being suspicious.

Children and adolescents under the age of 18 have an increased risk  of side effects such as:

  • thoughts of taking your life or wanting to take your life (may affect up to 1 in 100 people)
  • mood swings or mood swings (may affect up to 1 in 10 people).

Adults have a reduced risk (may affect up to 1 in 1,000 users) of side effects such as:

  • cramps
  • psychotic symptoms including hallucinations (hearing voices or seeing things that do not exist), believing in things that are not true or being suspicious.

Rare (may affect up to 1 in 1,000 people) 

  • liver damage.

You should stop taking Atomoxetine Orion 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 .

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

Very common (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 (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 rednessfeeling of or having a very fast pulseswollen, red and itchy skinincreased sweatingrashdifficulty urinating, pain when urinatingprostatitis ( prostatitis )groin pain in meninability to get an erectiondelayed orgasmdifficulty maintaining an erectioncramps during menstruationfeeling weakfatiguefeel lethargic (state of weakness)overindulgefeel annoyed, shakenfeel thirstyweight loss

Uncommon (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 crawlingtingling or numbness in the hands or feetcramps (seizures)a feeling of or having very fast heartbeats ( QT prolongation)respiratory distressincreased sweatingitchy skinfeeling weak
restlessnessticsto faintmigrainedimsynabnormal heart rhythm ( QTprolongation)feeling cold in fingers and toeschest painrespiratory distressswollen, red and itchy skin (rash)muscle twitchingfrequent urinationabnormal or absent orgasmirregular menstruationinability to ejaculate

Rare (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 urinatingprolonged and painful erection ergroin pain in boys
poor blood circulation that causes toes and fingers to become numb and pale (Raynaud’s phenomenon)prolonged and painful erection er

Effect on growth

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

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase drug safety information.

Läkemedelsverket, Box 26, 751 03 Uppsala

www.lakemedelsverket.se

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 Orion

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 hydrochloride. Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg atomoxetine.
  • The other ingredients are pregelatinized corn starch and simethicone emulsion.- The capsule cover contains gelatin, sodium lauryl sulfate, and purified water. The capsule casing dyes are:
  • Titanium dioxide E171
  • Yellow iron oxide E172 (18 mg, 60 mg, 80 mg and 100 mg)
  • Indigo Carmine E132 (25 mg, 40 mg and 60 mg)
  • Red iron oxide E172 (80 mg and 100 mg)
  • Black ink (containing shellac E904 and black iron oxide E 172)

What the medicine looks like and the contents of the pack

10 mg: hard capsule, white, labeled AT / 10, length 11 mm.

18 mg: hard capsule, golden / white, marked AT / 18, length 14 mm.

25 mg: hard capsule, blue / white, labeled AT / 25, length 14 mm.

40 mg: hard capsule, blue, labeled AT / 40, length 18 mm.

60 mg: hard capsule, blue / golden, labeled AT / 60, length 19 mm.

80 mg: hard capsule, brown / white, labeled AT / 80, length 21 mm.

100 mg: hard capsule, brown, labeled AT / 100, length 23 mm.

Atomoxetine Orion capsules are available in blister packs of 7, 10, 14, 28, 30, 56, 98 or 100 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI – 02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

Muhammad Nadeem

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