Audalis 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Atomoxetine Film-Coated Tablets
1. What Audalis Is And What Audalis Used For?
What audalis used for:
Audalis contains atomoxetine and treats 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 treating 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 Audalis 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. Therefore, this drug is not a central stimulant and is not addictive. It may take a few weeks after you start taking 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, school, or elsewhere. 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 treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or healthcare professional if you have 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 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 unsure, 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 the following:
- 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 include hallucinations (hearing voices or seeing things that do not exist), believing in untrue, or being suspicious.
- Mania (feeling pleased and excited, which causes unusual behavior) and agitation (feeling 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 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 the following:
- 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
You must provide as much information as you can. This will help your doctor decide if Audalis is the right medicine. 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 take 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
- Are certain cough and cold 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 unsure if any medicines you are taking are listed above, ask your doctor or pharmacist before taking Audalis.
Pregnancy, Breastfeeding, And Fertility
It is unknown if this medicine affects the unborn baby or passes into breast milk.
- This medicine should not be taken during pregnancy without consulting your doctor.
- You should either stop taking this medicine or avoid breast-feeding when you are being treated with Audalis.
If you:
- 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 tools or machines until you know how Audalis affects you. Do not drive or use any tools or machines if you feel tired, sleepy, or dizzy.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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)
- An adult should help children to take this medicine.
- If you take Audalisen once a day and get tired or nauseous, your doctor may change the prescription to Audalis tablet twice daily.
- The tablets should be swallowed whole, with or without food
- It is easier to remember to take medicine if you take the tard simultaneously daily.
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 daily dose of 40 mg for at least 7 days. Your doctor can then decide to increase the dose to the daily maintenance dose of 80 mg. The maximum daily dose which your doctor will prescribe is 100 mg.
Adults
- Treatment with Audalis tablet 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 to the daily maintenance dose of 80 -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 daily dose over 24 hours. 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, 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 any problems or side effects worsen after taking Audalis.
Long-term treatment
Audalis does not have to be taken forever. If you take Audalis for over a year, your doctor will review your treatment to evaluate if the medicine is still needed. Ask your doctor or pharmacist if you have any further questions about using this product.
4. Possible Audalis Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Although some people experience side effects, most find that Audalis helps them. Your doctor will talk to you about the side effects.
Some side effects can be serious. Contact your doctor immediately if you get any of the side effects listed below.
Uncommon audalis side effects (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 early, Depressionfeel sad or hopelessfeel anxious, Tics large pupils (the dark part in the center of the eye), Dizziness, Constipation, Loss of appetite, Digestive disorder, Swollen, red and itchy ski, rashfeel lethargic (state of weakness)chest painfatigueweight loss. | Feel annoyed, Decreased interest in sex, Sleep disorders, Depressionfeel sad or hopelessfeel anxious, Dizziness, Abnormal taste or taste in the mouth that does not disappear, Tremorstingling or numbness in the hands or feet, 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, Inreased sweating, Rash, Difficulty urinating, Pain when urinating, Prostatitis ( prostatitis )groin pain in meninability to get an erection, Delayed orgasm, Difficulty maintaining an erection, Cramps during menstruation, Feeling weak, Fatigue, Feel lethargic (state of weakness) over indulge feel annoyed, Shaken feel, Thirsty, Weight loss. |
| Less common side effects (may affect up to1 AV100 users) | |
| CHILDREN AND YOUNG PEOPLE OVER 6 YEARS OLD | ADULTS |
| To faint, Tremors, Migrained, Imsynabnormal 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 sweating, itchy skin, feeling weak | Restlessness, ticsto faint, migrained, imsyn, abnormal heart rhythm (QT prolongation), feeling cold in fingers and toeschest painrespiratory 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) | |
| 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 decreased 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:
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 sight and reach of children.
- Do not use this medicine after the expiry date 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 that are 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