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 Mylan is and what it is used for 
2. What you need to know before you take Atomoxetine Mylan 
3. How to take Atomoxetine Mylan 
4. Possible side effects 
5. How to store Atomoxetine Mylan 
6. Package contents and other information 

1. What Atomoxetine Mylan is and what it is used for

Atomoxetine Mylan hard capsules contain the active substance atomoxetine which 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 of age because it is not known if the treatment works or is safe for these people.

In adults, Atomoxetine Mylan 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

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

What you need to know before you take Atomoxetine Mylan

Do not take Atomoxetine Mylan 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. phenelzine. MAO inhibitors are used, among other things, to treat depression and other mental problems. Concomitant use of atomoxetine and an MAOI may cause serious side effects or be life-threatening. At least 14 days must elapse after stopping treatment with Atomoxetine Mylan 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 Mylan
  • 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 or has had a tumor in the adrenal gland ( pheochromocytoma ).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atomoxetine Mylan. This is because atomoxetine can aggravate these problems.

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 Mylan if you have:

  • heart problems (including heart defects) or increased heart rate. Atomoxetine may increase your heart rate ( heart rate ). Sudden death has been reported in patients with heart failure.
  • high blood pressure. Atomoxetine may cause high blood pressure.
  • low blood pressure. Atomoxetine 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.
  • epilepsy or have had seizures for some other reason. Atomoxetine may increase the risk of seizures.
  • depression, anxiety, or “tics” (uncontrolled movements or twitching or uncontrolled speech) – see also “Changed behavior” below.

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

Changed behavior

Atomoxetine may cause changes in behavior during treatment, or aggravate certain conditions. If you have any of the following and notice that it gets worse, or if you notice any of the following for the first time during treatment, tell your doctor immediately:

  • thoughts of taking your life or harming yourself, or trying to take your life
  • 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 or excited, causing unusual behavior) and agitation (a feeling of being both physically anxious and mentally aroused)
  • aggressive emotions
  • unfriendly and angry (hostile) feelings
  • mood other than usual (mood swings) or feeling very unhappy (depression) or anxious (anxiety).

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

These tests are to determine if atomoxetine 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 Mylan
  • your height and weight if you are a child or teenager while taking Atomoxetine Mylan.

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

Children under 6 years

Atomoxetine should not be used in children under 6 years of age as it is not known if it is effective or safe in this age group.

Important information about the contents of the capsules

Do not open the Atomoxetine Mylan 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.

Other medicines and Atomoxetine Mylan

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

If you are taking other medicines, Atomoxetine Mylan 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 Mylan:

  • drugs which increase blood pressure, et or used to control blood pressure et
  • antidepressants e.g. imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine
  • drugs used to treat other mental disorders
  • 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.
  • quinidine (a medicine used to treat abnormal heart rhythms)
  • terbinafine (a medicine used to treat fungal infections)
  • Salbutamol (an asthma medicine ) may give the feeling that the heart is rushing when taken by mouth or as an injection, but this will not aggravate your asthma.
  • drugs used to treat arrhythmias in the heart
  • drugs that change the concentration of salts in the blood
  • mefloquine or chloroquine (medicines to treat and prevent malaria )
  • methadone (a drug used to treat addiction to certain substances)
  • certain antibiotics (such as erythromycin and moxifloxacin)
  • cisapride (a medicine used to treat digestive problems)
  • tramadol (a strong painkiller).

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

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 Mylan.

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.

Driving and using machines

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

Atomoxetine Mylan contains sodium

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

How to take Atomoxetine Mylan

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 Mylan once a day and get tired or nauseous, your doctor may change your prescription once or 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 taken in any other way (see section 2 “Important information about the contents of the capsules”).
  • It is easier to remember to take the medicine if you take it at the same time each day.

Children and adolescents (6 years or older)

Your doctor will tell you how much medicine 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 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 that your doctor will prescribe is 100 mg.

Adults

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

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

Steps your doctor will take when taking this medicine

Your doctor will perform some checks

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

Some checks will also be performed when your dose changes. These controls include:

  • measurement of height and weight in children and adolescents
  • measurement of blood pressure and heart rate
  • to check if you have any problems or if side effects have worsened when you have taken atomoxetine.

Long-term treatment

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

If you forget to take Atomoxetine Mylan

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

If you stop taking Atomoxetine Mylan

If you stop taking atomoxetine, 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. Although some people experience side effects, most people find that atomoxetine 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 throat, 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

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

  • liver damage that causes yellowing of the skin and eyes, fever with abdominal pain, dark-colored urine, or pale stools
  • a prolonged and painful erection lasting longer than 4 hours

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

  • mood swings or mood swings (may affect up to 1 in 10 users)

Adults have a reduced risk (may affect up to 1 in 1,000 users) of side effectssuch 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

You should stop taking Atomoxetine Mylan 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 a doctor or pharmacist.

Very common (may affect more than 1 user in 10)

Children and adolescents over 6 years of age Adults
decreased appetite (no feelings of hunger)headachesomnolencemagontnausea or vomiting high blood pressure elevated heart rate ( heart rate )
These side effects may go away after a while in most patients.
decreased appetite (no feelings of hunger)difficult to fall asleep, sleep and wake up earlyheadachedry mouthnauseahigh blood pressure elevated heart rate ( heart rate )

Common (may affect up to 1 in 10 people)
Children and adolescents over 6 years of age Adults
to be easily irritated or upsetsleep problems, including waking up earlyDepressionfeel sad or hopelessfeel anxiousinvoluntary muscle twitches ( tics )large pupil er (the dark part in the center of the eye)dizzinessconstipationloss of appetiteupset stomach, indigestionswollen, red and itchy skinrashfeel lethargic (state of weakness)chest painfatigueweight loss feel annoyeddecreased interest in sexsleep disordersDepressionfeel sad or hopelessfeel anxiousdizzinessabnormal taste or altered taste in the mouth that does not want to disappearabnormal sensation in the skin such as burning sensation, tingling, itchingor ant crawlingdrowsiness, drowsiness, fatiguetremorsconstipationmagontindigestiongas in the stomachvomitinghot flashes or rednessswollen, red and itchy skin increased sweatingrashproblems with toilet visits, such as difficulty urinating, frequent urination, difficulty emptying the bladder, pain when urinatingprostatitis ( prostatitis )groin pain in inability to get an erectiondelayed ejaculation difficulty getting or maintaining an erection cramps during menstruationfeeling weak or tiredfeel lethargic (state of weakness)overindulgefeel annoyed, shakenfeel thirsty weight loss

Uncommon (may affect up to 1 in 100 people)
Children and adolescents over 6 years of age Adults
to fainttremorsmigrainedimsynabnormal sensations in the skin such as burning sensation, tingling, itchingor ant crawlingtingling or numbness in the hands or feetrespiratory distressincreased sweatingitchy skinfeeling weak or tired restlessnessinvoluntary muscle twitches ( tics )to faintmigraineimpaired sensation or numbness in the skindimsynfeeling cold in fingers and toesgeneral feeling of coldchest painrespiratory distressswollen, red and itchy skin ( hives )muscle twitchingurinary incontinenceabnormal or absent orgasmirregular menstruationinability to ejaculate

Rare (may affect up to 1 in 1,000 people)
Children and adolescents over 6 years of age 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 emptying the bladder, pain when urinatinggroin 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 atomoxetine treatment. 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 Mylan.

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 Mylan

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 blister or carton 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. One capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg atomoxetine.
  • Other ingredients are:

Capsule contents: maize starch, pregelatinized maize starch, dimethicone, and sodium starch glycolate

Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (only 18 mg, 60 mg, 80 mg, 100 mg capsules), black iron oxide (E 172) (only 25 mg, 40 mg, 60 mg capsules) , red iron oxide (E 172) (only 80 mg, 100 mg capsules), indigo carmine (E 132) (only 25 mg, 40 mg, 60 mg capsules)

Ink: shellac, propylene glycol, black iron oxide (E 172), potassium hydroxide

See section 2, ‘Atomoxetine Mylan contains sodium’

What the medicine looks like and the contents of the pack

Atomoxetine Mylan 10 mg hard capsules are hard gelatin capsules with white upper and lower part, marked “A910” on the upper and lower part with black ink.

Atomoxetine Mylan 18 mg hard capsules are hard gelatin capsules with a gold-colored top and white bottom, marked “A918” on the top and bottom with black ink.

Atomoxetine Mylan 25 mg hard capsules are hard gelatin capsules with a blue top and white bottom, marked “A925” on the top and bottom with black ink.

Atomoxetine Mylan 40 mg hard capsules are hard gelatin capsules with the blue upper and lower body, marked “A940” on the upper and lower part with black ink.

Atomoxetine Mylan 60 mg hard capsules are hard gelatin capsules with a blue top and a gold-colored bottom, marked “A960” on the top and bottom with black ink.

Atomoxetine Mylan 80 mg hard capsules are hard gelatin capsules with a brown top and white bottom, marked “A980” on the top and bottom with black ink.

Atomoxetine Mylan 100 mg hard capsules are hard gelatin capsules with a brown top and bottom, marked “A900” on the top and bottom with black ink.

This medicine is supplied in blisters containing 7, 28, or 56 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Manufacturer

McDermott Laboratories Limited trading as Gerard

Laboratories trading as Mylan Dublin

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Mylan Hungary Kft

H-2900 Komárom, Mylan UTC 1

Hungary

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str

Dupnitsa 2600

Bulgaria

Actavis UK Limited

Whiddon Valley,

Barnstable, North Devon,

EX32 8NS

United Kingdom



Muhammad Nadeem

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