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 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.

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

What Atomoxetine Actavis is and what it is used for

What is it used for

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

  • 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 used to treat 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 Actavis 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 Actavis 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 Actavis 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 use Atomoxetine Actavis

Do not take Atomoxetine Actavis 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 that belongs to the group of monoamine oxidase inhibitors ( MAOIs ), such as phenelzine. MAO inhibitors are used, among other things, to treat depression and other mental problems. Concomitant use of Atomoxetine Actavis and an MAOI may cause serious side effects or be life-threatening. At least 14 days must have elapsed after stopping treatment with Atomoxetine Actavis 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 Actavis
  • 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 Actavis if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atomoxetine Actavis. This is because Atomoxetine Actavis 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 Actavis if you have:

  • thoughts of taking your life or trying to take your life.
  • heart problems (including heart defects) or increased heart rate. Atomoxetine Actavis may increase your heart rate ( heart rate ). Sudden death has been reported in patients with heart failure.
  • high blood pressure. Atomoxetine Actavis may cause high blood pressure.
  • low blood pressure. Atomoxetine Actavis 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
  • aggressive emotions.
  • unfriendly and angry (hostile) feelings.
  • epilepsy or have had seizures for some other reason. Atomoxetine Actavis 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 Actavis 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 Actavis

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

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 Actavis 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 Actavis

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

If you are taking other medicines, Atomoxetine Actavis 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 Actavis:

  • 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 Actavis 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 Actavis:

  • drugs used to treat arrhythmias in the heart,
  • drugs that alter the concentration of salts in the blood,
  • medicines 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 Actavis.

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 if you are breast-feeding or avoid breast-feeding while you are being treated with Atomoxetine Actavis.

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, drowsy, or dizzy after taking Atomoxetine Actavis. Do not drive or use any tools or machines until you know how Atomoxetine Actavis 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. The description 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.

How to use Atomoxetine Actavis

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 Actavis once daily and get tired or nauseous, your doctor may change your prescription to Atomoxetine Actavis 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.

Use in children and adolescents

If you are a child or teenager (6 years or older): 
Your doctor will tell you how much Atomoxetine Actavis 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 Actavis 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 Actavis 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.

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

If you forget to take Atomoxetine Actavis

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 taking Atomoxetine Actavis

If you stop taking Atomoxetine Actavis, 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 Actavis 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
  • If you are taking Atomoxetine Actavis, have any problems or side effects that get worse.

Long-term treatment

Atomoxetine Actavis does not need to be taken forever. If you have been taking Atomoxetine Actavis for more than a year, your doctor will review your treatment to see if it 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 Actavis 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 people) for 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 cases (may affect up to 1 in 1,000 people), 

  • liver damage

You should stop taking Atomoxetine Actavis 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.

Children and adolescents over 6 years of age

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

  • headache
  • magont
  • decreased appetite (no feelings of hunger)
  • nausea or vomiting
  • somnolence
  • high blood pressure
  • elevated heart rate ( heart rate )

These side effects may go away after a while in most patients.

Common side effects (may affect up to 1 in 10 people)

  • to be easily irritated
  • sleep problems, waking up early
  • Depression
  • feel sad or hopeless
  • feel anxious
  • tics
  • large pupil er (the dark part in the center of the eye)
  • dizziness
  • constipation
  • loss of appetite
  • digestive disorders
  • swollen, red, and itchy skin
  • rash
  • feel lethargic (state of weakness)
  • chest pain
  • fatigue
  • weight loss

Uncommon side effects (may affect up to 1 in 100 people)

  • to faint
  • tremors
  • migraine
  • dimsyn
  • abnormal sensations in the skin such as burning sensation, tingling, itching, or ant crawling
  • tingling or numbness in the hands or feet
  • cramps (seizures)
  • a feeling of or having very fast heartbeats ( QT prolongation)
  • respiratory distress
  • increased sweating
  • itchy skin
  • feeling weak

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

  • 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 urinating
  • prolonged and painful erection er
  • groin pain in boys

Adults

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

  • nausea
  • dry mouth
  • headache
  • decreased appetite (no feelings of hunger)
  • difficult to fall asleep, sleep and wake up early
  • high blood pressure
  • elevated heart rate ( heart rate )

Common side effects (may affect up to 1 in 10 people)

  • feel annoyed
  • decreased interest in sex
  • sleep disorders
  • Depression
  • feel sad or hopeless
  • feel anxious
  • dizziness
  • abnormal taste or taste in the mouth that does not want to disappear
  • tremors
  • tingling or numbness in the hands or feet
  • drowsiness, drowsiness, fatigue
  • constipation
  • magont
  • indigestion
  • gas in the stomach
  • vomiting
  • hot flashes or redness
  • feeling of or having a very fast pulse
  • swollen, red, and itchy skin
  • increased sweating
  • rash
  • difficulty urinating, pain when urinating
  • prostatitis ( prostatitis )
  • groin pain in men
  • inability to get an erection
  • delayed orgasm
  • difficulty maintaining an erection
  • cramps during menstruation
  • feeling weak
  • fatigue
  • feel lethargic (state of weakness)
  • overindulge
  • feel annoyed, shaken
  • feel thirsty
  • weight loss

Uncommon side effects (may affect up to 1 in 100 people)

  • restlessness
  • tics
  • to faint
  • migraine
  • dimsyn
  • abnormal heart rhythm ( QT prolongation)
  • feeling cold in fingers and toes
  • chest pain
  • respiratory distress
  • swollen, red, and itchy skin (rash)
  • muscle twitching
  • frequent urination
  • abnormal or absent orgasm
  • irregular menstruation
  • inability to ejaculate

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

  • 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 Actavis. 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 Actavis.

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 Actavis

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.

Jar: Used within 6 months after the jar is first opened.

Store below 30 ° C.

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

What Atomoxetine Actavis contains

  • 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.
  • Other ingredients are:Capsule: processed maize starch (containing maize starch and pregelatinized starch ), dimethicone 350 cs, Sodium starch glycolate (type A) Capsule shell: gelatin, titanium dioxide (E171), black ink (containing shellac, propylene glycol, ammonia, black hydroxide, and potassium oxide) *

* Dyes:

10 mg: No additional dyes

18 mg: Yellow iron oxide (E172)

25 mg and 40 mg: Indigo carmine (E132) and yellow iron oxide (E172)

60 mg: Indigo carmine (E132), black iron oxide (E172), and yellow iron oxide (E172)

80 mg and 100 mg: Yellow iron oxide (E172) and red iron oxide (E172)

What the medicine looks like and the contents of the pack

10 mg: Opaque white, hard capsules, size 4 (14.3 mm x 5.31 mm), marked “A910” with black ink.

18 mg: Opaque, hard capsules with gold and white base, size 3 (15.9 mm x 5.82 mm), marked “A918” with black ink.

25 mg: Opaque, hard capsules with blue top and white bottom, size 3 (15.9 mm x 5.82 mm), marked “A925” with black ink.

40 mg: Opaque blue, hard capsules, size 2 (18 mm x 6.35 mm), marked “A940” with black ink.

60 mg: Opaque, hard capsules with blue top and bottom in gold, size 2 (18 mm x 6.35 mm), marked “A960” with black ink.

80 mg: Opaque, hard capsules with brown upper and white lower part, size 1 (19.4 mm x 6.91 mm), marked “A980” with black ink.

100 mg: Opaque brown, hard capsules, size 0 (21.7 mm x 7.65 mm), marked “A900” with black ink.

Atomoxetine Actavis is available as blister packs of 7 (strengths 10 mg, 18 mg, 25 mg and 40 mg), 28, 30, 56 and 60 capsules.

Atomoxetine Actavis is also available in jars of 28 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður, Iceland

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa, Bulgaria

Muhammad Nadeem

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