10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets 
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. See section 4.

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

1. What Audalis is and what it is used for

What is it used for

Audalis 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 for the disease that 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, Audalis 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

Audalis 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 . Audalis 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 Audalis 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 using Audalis

Do not use Audalis

Do not take Audalis if you:

– is allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).

during the last 14 days have taken a medicine belonging to the group monoamine oxidase inhibitors ( MAOIs ). MAO inhibitors are used, among other things, to treat depression and other mental problems. Concomitant use of Audalis and an MAOI may cause serious side effects or be life-threatening. At least 14 days must have elapsed after stopping treatment with Audalis before you can start taking an MAOI

– has 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 Audalis

– 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 Audalis if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Audalis. This is because Audalis 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 Audalis if you have:

thoughts of taking your life or trying to take your life.

– heart problems (including heart defects) or increased heart rate. Audalis can increase your heart rate ( heart rate ).

Sudden death has been reported in patients with heart failure.

– high blood pressure. Audalis can cause high blood pressure.

– low blood pressure . Audalis can 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, which causes unusual behavior) and agitation (a feeling of being both physically anxious and mentally excited).

– aggressive emotions.

– unfriendly and angry (hostile) feelings.

– epilepsy or have had seizures for some other reason. Audalis may increase the risk of seizures.

– mood other than usual (mood swings) or you feel very unhappy.

– difficult to control, repeated twitching 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 Audalis can make these problems worse. Your doctor will want to follow up on how the medicine affects you.

Examinations that your doctor will do before you start taking Audalis

These tests are to determine if Audalis is the right medicine for you.

Your doctor will measure

– your blood pressure and heart rate ( pulse ) before and during taking Audalis

– your height and weight if you are a child or teenager while taking Audalis

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 Audalis 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 Audalis

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

If you are taking other medicines, Audalis 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 Audalis:

– medicines that increase blood pressure or are used to control blood pressure.

– medicines such as antidepressants such as imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine

certain cough and cold medicines containing medicines that may affect blood pressure.

It is important to check with the pharmacy staff when receiving these products

– certain medicines used to treat mental illness

– drugs that are known to increase the risk of seizures

– some medicines can make Audalis 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 medicines below can lead to an increased risk of abnormal heart rhythm when taken with Audalis:

– medicines used to treat arrhythmias in the heart,

– drugs that change 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 Audalis.

Pregnancy, breastfeeding, and fertility

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 when you are being treated with Audalis.

If you:

• is pregnant or breastfeeding

• think you may be pregnant or planning to have a baby

• plan to breastfeed your baby

consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

3. How to use Audalis

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 Audalisen once a day and get tired or nauseous, your doctor may change the prescription to Audalis twice a day.
  • The tablets should be swallowed whole, with or without food
  • It is easier to remember to take the medicine if you take the tard at the same time every day.

How much to take

If you are a child or teenager (6 years or older):

Your doctor will tell you how much Audalis 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 Audalis you should take according to your body weight.

  • Body weight up to 70 kg: an initial total daily dose of 0.5 mg per kg body weight for at least 7 days. Your doctor may then decide to increase the dose up to it daily maintenance dose of approximately 1.2 mg per kg body weight.
  • Body weight over 70 kg: an initial total daily dose of 40 mg for at least 7 days. Your doctor can then decide that the dose should be increased up to the daily maintenance dose of 80 mg. The maximum daily dose which your doctor will prescribe is 100 mg.

Adults

  • Treatment with Audalis should be initiated with a total daily dose of 40 mg for at least 7 days. Your doctor can then decide that the dosage is increased up to the daily maintenance dose of 80 mg -100 mg. The maximum daily dose as 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 Audalis

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 Audalis

If you stop taking Audalis, 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 Treated Your doctor will perform certain checks

  • before you start – to ensure that Audalis 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
  • Pay attention if you have any problems or side effects that have worsened after taking Audalis.

Long-term treatment

Audalis does not have to be taken forever. If you are taking Audalis 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 Audalis 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, contact your doctor 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 one’s life or wanting to live one’s life
  • feel aggressive
  • feel unfriendly and angry (hostile)
  • mood swings or mood swings
  • severe allergic reaction with symptoms
    • 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 does not exist), believe in things that are not true or be 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 live your life (may affect up to 1 in 100 users)
  • 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)  of side effects such as:

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

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

  • liver damage

You should stop taking Audalis 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
to be easily irritatedsleep problems, waking up earlyDepressionfeel sad or hopelessfeel anxiousticslarge pupils (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 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

Less  common  side effects (may affect up to1 AV100 users)
CHILDREN  AND YOUNG PEOPLE OVER 6 YEARS OLD ADULTS
to fainttremorsmigrainedimsynabnormal sensations in the skin such as burning sensation, tingling, itching or ant crawlingtingling or numbness in the hands or feetcramps (seizures)a feeling of or having a very fast heartbeat (QT prolongation)respiratory distressincreased sweatingitchy skinfeeling weak
restlessnessticsto faintmigrainedimsynabnormal heart rhythm (QT prolongation)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 tears 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 erectionsgroin pain in boys
poor blood circulation that causes tears and fingers to become numb and pale (Raynaud’s phenomenon)prolonged and painful erections

Effect on growth

Some children may experience a decrease in growth (weight and height) at the beginning of treatment with Audallis. 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 or temporarily discontinue treatment with Audalis.

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 Audalis

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 and carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any 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 film-coated tablet contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg atomoxetine.

Other ingredients) are:

  • Calcium hydrogen phosphate,
  • Cellulose, microcrystalline,
  • Calcium phosphate,
  • Croscarmellose sodium,
  • Magnesium stearate,
  • Polyvinyl alcohol),
  • Macrogol 4000,
  • Talc,
  • Titanium dioxide (E171).

What the medicine looks like and the contents of the pack

  • 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets are white, oval-shaped film-coated tablets debossed with “10”, “18”, “25”, “40”, “60”, “80”, “100” on one side.

Audalis 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg film-coated tablets are packaged in PVC / PVDC-aluminum blisters.

Available in pack sizes of 7, 14, 28, 35, 49, 56 or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MEDICE Arzneimittel Pütter GmbH & Co. KG

Kuhloweg 37

58638 Iserlohn

Germany

Tel .: +49 (0) 2371 937-0

Fax: +49 (0) 2371 937-106

Email: info@medice.de

Muhammad Nadeem

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