Atomoxetine Glenmark - Atomoxetine uses, dose and side effects

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, Atomoxetine Glenmark 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 Glenmark works

Atomoxetine Glenmark 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 Glenmark 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 take Atomoxetine Glenmark

Do NOT take Atomoxetine Glenmark:

if you are 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 Glenmark and an MAOI may cause serious side effects or be life-threatening. At least 14 days must have elapsed after stopping treatment with Atomoxetine Glenmark 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 Glenmark
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 Glenmark if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atomoxetine Glenmark. This is because Atomoxetine Glenmark 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 Glenmark if you have:

thoughts of taking your life or trying to take your life
heart problems (including heart defects) or increased heart rate. Atomoxetine Glenmark may increase your heart rate ( heart rate ). Sudden death has been reported in patients with heart failure
high blood pressure. Atomoxetine Glenmark may cause high blood pressure
low blood pressure. Atomoxetine Glenmark 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 Glenmark may increase the risk of seizures
another 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 Glenmark 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 Glenmark

These studies are to determine if Atomoxetine Glenmark 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 Glenmark
your height and weight if you are a child or adolescent while taking Atomoxetine Glenmark

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 Glenmark 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 Glenmark

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

If you are taking other medicines, Atomoxetine Glenmark 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 Glenmark:

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 Glenmark to remain in the body for longer than normal (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 Glenmark:

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 Glenmark.

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.

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 Glenmark. Do not drive or use any tools or machines until you know how Atomoxetine Glenmark 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 Atomoxetine Glenmark 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.

How to take Atomoxetine Glenmark

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 Glenmark once a day and become tired or nauseous, your doctor may change your prescription to Atomoxetine Glenmark 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

Children or adolescents (6 years or older):

Your doctor will tell you how much Atomoxetine Glenmark 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 Glenmark 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 Glenmark should be initiated at 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 Glenmark

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 Glenmark

If you stop taking Atomoxetine Glenmark, 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 Glenmark 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 Glenmark, take note if you have any problems or side effects that got worse.

Long-term treatment

Atomoxetine Glenmark does not need to be taken forever. If you have been taking Atomoxetine Glenmark 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 Glenmark 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 1,000 users)

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 Glenmark 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 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
be annoyed or upsetsleep problems, waking up earlyDepressionfeel sad or hopelessfeel anxioustics (difficult to control, repeated twitches in any part of the body or that you repeat sounds and words)large pupil er (the dark part in the center of the eye)dizzinessconstipationloss of appetitedigestive disordersswollen, red and itchy skinrashfeeling lethargic (state of weakness) chest painfatigueweight loss.	feel upsetdecreased interest in sexsleep disordersDepressionfeel sad or hopeless feel 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 having a very fast pulseswollen, red and itchy skin increased sweatingrashproblems with toilet visits, having to urinate frequently or difficulty urinating, pain when urinatingprostatitis ( prostatitis)groin pain in meninability to get an erectiondelayed orgasm difficulty maintaining erection cramps 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 crawlingtingling or numbness in the hands or feetcramps (seizures)a feeling of having or having a very fast heart rate , ( 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 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 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 Glenmark. 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 Glenmark.

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 Glenmark

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 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 Glenmark 10 mg hard capsules

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

Other ingredients are: