Atomoxetine Sandoz 100 mg capsules hard – patient leaflet, side effects, dosage

What it is used for Atomoxetine contains atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). It is used:

• in children over six years of age
• in adolescents
• in adults

It is used only as a part of the total treatment of the disease which also requires treatments which do not involve medicines, such as counselling and behavioural therapy. It is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the medicine works or is safe in these people.

In adults, this medicine is used to treat ADHD when the symptoms are very troublesome and affect your work or social life and when you have had symptoms of the disease as a child.

How it works

This medicine increases the amount of noradrenaline in the brain. This is a chemical that is produced naturally, and increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and is therefore not addictive.

It may take a few weeks after you start the medicine for your symptoms to fully improve.

About ADHD

Children and adolescents with ADHD find it:

• hard to sit still and
• hard to concentrate.

It is not their fault that they cannot do these things. Many children and adolescents struggle to do these things. However, with ADHD this can cause problems with everyday life. Children and adolescents with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places. ADHD does not affect the intelligence of a child or adolescent.

Adults with ADHD find it difficult to do all the things that children find difficult; however this may mean they have problems with:

• work
• relationships
• low self esteem
• education

2 What you need to know before you take

Atomoxetine

Do not take Atomoxetine if you:

• are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
• took a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine, in the last two weeks. An MAOI is sometimes used for depression and other mental-health problems; taking Atomoxetine with an MAOI could cause serious side effects or be life-threatening. You also need to wait at least 14 days after you stop taking this medicine before you take an MAOI.
• have an eye disease called narrow-angle glaucoma (increased pressure in your eye).
• have serious problems with your heart which may be affected by an increase in heart rate and/or blood pressure, as this may be an effect of Atomoxetine.
• have serious problems with the blood vessels in your brain - such as a stroke, swelling and weakening of part of a blood vessel (aneurysm) or narrow or blocked blood vessels.

• have a tumour of your adrenal gland

  (phaeochromocytoma).

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

Warnings and precautions

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

• thoughts about killing yourself or trying to kill yourself.
• problems with your heart (including heart defects) or an increased heartbeat. Atomoxetine can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
• high blood pressure. Atomoxetine can increase blood pressure.
• low blood pressure. Atomoxetine can cause dizziness or fainting in people with low blood pressure.
• problems with sudden changes in your blood pressure or your heart rate.
• cardiovascular disease or past medical history of stroke.
• liver problems. You may need a lower dose.
• psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious.
• mania (feeling elated or over-excited, which causes unusual behaviour) and agitation.
• aggressive feelings.
• unfriendly and angry (hostility) feelings.
• a history of epilepsy or have had seizures for any other reason. Atomoxetine might lead to an increase in seizure frequency.
• different moods than usual (mood swings) or feel very unhappy.
• hard-to-control, repeated twitching of any parts of the body or you repeat sounds and words.

Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Atomoxetine can make these problems worse. Your doctor will want to monitor how the medicine affects you. Serotonin syndrome

Serotonin syndrome is a potentially life-threatening condition which may occur when taking Atomoxetine in combination with some other medicines (see section 2 “Other medicines and Atomoxetine”). Signs and symptoms of serotonin syndrome may include a combination of the following: confusion, restlessness, incoordination and rigidity, hallucinations, coma, fast heart beat, increased body temperature, fast changes in blood pressure, sweating, flushing, tremor, overactive reflexes, nausea, vomiting, and diarrhoea. Contact a doctor or go to your nearest emergency department immediately if you think serotonin syndrome is happening to you.

Aggressive behaviour, hostility or emotional lability Treatment with Atomoxetine may make you feel aggressive, hostile or violent; or aggravate these symptoms if they were present before treatment. It may also cause you to have unusual changes in behaviour or mood (including physical assault, threatening behaviour and thoughts of harming others). If you or your family and/ or friends notice any of these reactions, talk to your doctor or pharmacist right away.

Checks that your doctor will make before you start to take Atomoxetine

These checks are to decide if Atomoxetine is the correct medicine for you.

Your doctor will measure your:

• blood pressure and your heart rate (pulse) before and during the time you take Atomoxetine
• your height and weight if you are a child or teenager during the time you take Atomoxetine

Your doctor will talk to you about:

• any other medicines you are taking
• whether there is any family history of sudden unexplained death

• any other medical problems (such as heart problems) you or your family may have

  It is important that you provide as much information as you can. This will help your doctor decide if Atomoxetine is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine.

  Important information about the content of the capsules Do not open Atomoxetine capsules because the contents of the capsule can irritate the eye. If the contents of the capsules come into contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any other part of the body that may have come into contact with the capsule contents should also be washed as soon as possible. Other medicines and Atomoxetine

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes non-prescription medicines. Your doctor will decide if you can take Atomoxetine with your other medicines and in some cases your doctor may need to adjust your dose or increase your dose much more slowly. Do not take Atomoxetine with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 “Do not take Atomoxetine”.

  If you are taking other medicines, Atomoxetine may affect or be affected by other medicines

  If you are taking any of the following medicines, check with your doctor or pharmacist before taking

  Atomoxetine:

  • medicines that increase blood pressure or are used to control blood pressure
  • medicines such as antidepressants, for example imipramine, venlafaxine, mirtazapine, fluoxetine and paroxetine
  • some cough and cold remedies which contain medicines that can affect blood pressure. It is important to check with your pharmacist when you get any of these products.
  • some medicines used to treat mental health conditions
  • medicines that are known to increase the risk of seizures
  • some medicines that cause Atomoxetine to stay in the body for longer than normal (such as quinidine and terbinafine)
  • salbutamol (a medicine to treat asthma) when taken by mouth or injected may make you feel as if your heart is racing, but this will not make your asthma worse
  • some anti-depressants, opioids as tramadol, and medicines used to treat migraine called triptans. These medicines may interact with Atomoxetine and can lead to serotonin syndrome, a potentially life-threatening condition. (See section 2, Warnings and Precautions, Serotonin Syndrome).

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

• medicines used to control the rhythm of the heart
• medicines which change the concentration of salts in the blood
• medicines for malaria prevention and treatment
• some antibiotic medicines (such as erythromycin and moxifloxacin)

If you are not sure about whether any medicines you are taking are included in the list above, ask your doctor or pharmacist before taking Atomoxetine.

Pregnancy and breast-feeding

It is not known if this medicine can affect an unborn baby or pass into breast milk.

• This medicine should not be used during pregnancy, unless your doctor has advised you to do so.
• You should either avoid taking this medicine if you are breast-feeding or discontinue breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby or planning to breast-feeding your 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. You should be careful if you are driving a car or operating machinery until you know how Atomoxetine affects you. If you feel tired, sleepy or dizzy you should not drive or operate machinery.

Atomoxetine contains sodium

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

3 How to take Atomoxetine

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. This is usually one or two times a day (morning and late afternoon or early evening).
• Children should not take this medicine without the help from an adult.
• If you are taking Atomoxetine once a day and experience sleepiness or feel sick, your doctor may change your treatment schedule to twice a day.
• Oral use.

• The capsules should be swallowed whole, either with or without food.

• The capsules should not be opened and the contents inside the capsules should not be removed and taken in any other way.
• Taking the medicine at the same time each day may help you remember to take it.

How much to take

If you are a child or adolescent (6 years or older): Your doctor will tell you how much Atomoxetine you should take and will calculate this according to your weight. Your doctor will normally start you on a lower dose before increasing the amount of Atomoxetine you need to take according to your body weight.

• Body weight up to 70 kg: a starting total daily dose of 0.5 mg per kg of body weight for a minimum of 7 days. Your doctor may then decide to increase this to the usual maintenance dose of about 1.2 mg per kg of body weight daily.
• Body weight over 70 kg: a starting total daily dose of 40 mg for a minimum of 7 days. Your doctor may then decide to increase this to the usual maintenance dose of 80 mg daily. The maximum daily dose your doctor will prescribe is 100 mg.

Adults

• Atomoxetine should be started at a total daily dose of 40 mg for a minimum of 7 days. Your doctor may then decide to increase this to the usual maintenance dose of 80 mg-100 mg daily. The maximum daily dose your doctor will prescribe is 100 mg.

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

Things your doctor will do when you are on treatment Your doctor will do some tests

• before you start - to make sure that Atomoxetine is safe and will be of benefit.
• after you start - they will be done at least every 6 months, but possibly more often.

They will also be done when the dose is changed. These tests will include:

• measuring height and weight in children and adolescents
• measuring blood pressure and heart rate
• checking whether you have any problems or if side effects have got worse while taking Atomoxetine. Long-term treatment

Atomoxetine does not need to be taken for ever. If you take Atomoxetine for more than a year, your doctor will review your treatment, to see if the medicine is still needed.

If you take more Atomoxetine than you should contact your doctor or the nearest hospital casualty department immediately and tell them how many capsules you have taken. The most commonly reported symptoms accompanying overdoses are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behaviour. Very rarely, serotonin syndrome has also been reported, a potentially life-threatening condition. (See section 2, Warnings and precautions, Serotonin Syndrome). If you forget to take Atomoxetine

If you miss a dose, you should take it as soon as possible, but you should not take more than your total daily dose in any 24-hour period. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atomoxetine

If you stop taking Atomoxetine there are usually no side effects but your ADHD symptoms may return. You should talk to your doctor first before you stop treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some people get side effects most people find that Atomoxetine helps them. Your doctor will talk to you about these side effects. Some side effects could be serious. If you have any of the side effects below, see a doctor straight away. Uncommon (may affect up to 1 in 100 people)

• feeling or having a very fast heartbeat, abnormal rhythms of the heart
• thinking about or feeling like killing yourself
• feeling aggressive
• feeling unfriendly and angry (hostility)
• mood swings or mood changes

• serious allergic reaction with symptoms of

  • swelling of the face and throat
  • difficulty breathing
  • hives (small raised, itchy patches of skin)
• seizures
• psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious Children and adolescents aged under 18 have an increased risk of side effects such as:
• thinking about or feeling like killing yourself (may affect up to 1 in 100 people)
• mood swings or mood changes (may affect up to 1 in 10 people)

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

• seizures
• psychotic symptoms including hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious Rarely (may affect up to 1 in 1,000 people)
• liver injury

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

• dark urine
• yellow skin or yellow eyes
• tummy pain which is sore when you press it (tenderness) on the right side just below your ribs
• a feeling of sickness (nausea) that is unexplained
• tiredness
• itching
• feeling that you are coming down with flu Other side effects reported include the following. If they get serious, tell your doctor or pharmacist.

Frequency not known (frequency cannot be estimated

from the available data)

CHILDREN and ADOLESCENTS over

6 years

• Involuntary teeth grinding (bruxism)

  Effects on growth

  Some children experience reduced growth (weight and height) when they start taking Atomoxetine. However, with long-term treatment, children recover to the weight and height for their age range. Your doctor will watch your child’s height and weight over time. If your child is not growing or gaining weight as expected, your doctor may change your child’s dose or decide to stop Atomoxetine temporarily.

  Reporting of side effects

  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Atomoxetine

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 expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other

information

What Atomoxetine contains

• The active substance is Atomoxetine.

• Atomoxetine 10 mg Capsules, hard

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

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), Purified water

• Atomoxetine 18 mg Capsules, hard

  Each hard capsule contains 18 mg atomoxetine as 20.57 mg atomoxetine hydrochloride.

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), iron oxide yellow (E172), Purified water

• Atomoxetine 25 mg Capsules, hard

  Each hard capsule contains 25 mg atomoxetine as 28.57 mg atomoxetine hydrochloride.

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), indigo carmine (E132), Purified water

• Atomoxetine 40 mg Capsules, hard

  Each hard capsule contains 40 mg atomoxetine as 45.71 mg atomoxetine hydrochloride.

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), indigo carmine (E132), Purified water

• Atomoxetine 60 mg Capsules, hard

  Each hard capsule contains 60 mg atomoxetine as 68.57 mg atomoxetine hydrochloride.

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172), Purified water

• Atomoxetine 80 mg Capsules, hard

  Each hard capsule contains 80 mg atomoxetine as 91.42 mg atomoxetine hydrochloride.

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), Purified water

• Atomoxetine 100 mg Capsules, hard

  Each hard capsule contains 100 mg atomoxetine as 114.28 mg atomoxetine hydrochloride.

• The other ingredients are

  Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.

  Capsule shell: Gelatin, Sodium Lauryl Sulfate (E487), Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), Purified water

• Printing ink (black) consisting of: Shellac Glaze-45% (20% Esterified) in Ethanol, Iron Oxide Black (E172), Propylene Glycol

What Atomoxetine looks like and contents of the pack

• Atomoxetine 10 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque white cap imprinted in black ink with ‘10’ and opaque white body imprinted in black ink with ‘mg’.

• Atomoxetine 18 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque rich yellow cap imprinted in black ink with ‘18’ and opaque white body imprinted in black ink with ‘mg’.

• Atomoxetine 25 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque blue cap imprinted in black ink with ‘25’ and opaque white body imprinted in black ink with ‘mg’.

• Atomoxetine 40 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), opaque blue cap imprinted in black ink with ‘40’ and opaque blue body imprinted in black ink with ‘mg.’

• Atomoxetine 60 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), opaque blue cap imprinted in black ink with ‘60’ and opaque rich yellow body imprinted in black ink with ‘mg’.

• Atomoxetine 80 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), opaque Brown cap imprinted in black ink with ‘80’ and opaque white body imprinted in black ink with ‘mg’.

• Atomoxetine 100 mg Capsules, hard

  White powder in a hard gelatin capsule of size No 1 (length of 19.1 ± 0.4 mm), opaque brown cap imprinted in black ink with ‘100’ and opaque brown body imprinted in black ink with ‘mg’.

Atomoxetine is supplied in blisters in a cardboard box. Pack sizes:

7, 14, 28, 56 and 84 hard capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer

LEK farmacevtska družba d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia or Pharmathen S.A.

6, Dervenakion str., Pallini

153 51, Greece or Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA3000

Malta or Pharmathen International S.A.

Industrial Park Sapes, Block No.5

Rodopi Prefecture,

69300, Greece or Salutas Pharma GmbH

Otto-von-Guericke-Allee 1 39179

Barleben

Germany

This leaflet was last revised in 06/2025

SZ96301LT02A