10, 18, 25, 40, 60, 80 and 100 mg hard capsules
atomoxetine
1. What Atomoxetine Accord is and what it is used for
Atomoxetine Accord contains the active substance atomoxetine and is used to treat attention deficit hyperactivity disorder ( ADHD ). It uses:
- in children over 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.
In adults, this drug is used to treat ADHD when the symptoms are very bothersome and affect your job or social life, and when you have had symptoms of the disease as a child.
How does it work
This drug 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 the Atomoxetine Accord 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 take Atomoxetine Accord
Do not take Atomoxetine Accord if you:
- is allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
- have taken a medicine called monoamine oxidase inhibitor (MAOI), e.g. phenelzine, during the last two weeks. MAO inhibitors are sometimes used to treat depression and other mental health problems. Concomitant use of Atomoxetine Accord and an MAOI can cause serious side effects or be life-threatening. You must wait at least 14 days after stopping this medicine 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 Atomoxetine Accord.
- 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 Accord if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. This is because this medicine 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 Accord if you have:
- thoughts of taking your life or trying to take your life.
- heart problems (including heart defects) or increased heart rate. Atomoxetine Accord may increase your heart rate ( heart rate ). Sudden death has been reported in patients with heart failure.
- high blood pressure. Atomoxetine Accord may increase blood pressure.
- low blood pressure. Atomoxetine Accord 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, which causes unusual behavior) and agitation(a feeling of being both physically anxious and mentally excited).
- aggressive emotions.
- unfriendly and angry (hostile) feelings.
- previous epilepsy or if you have had seizures for any other reason. Atomoxetine Accord may increase the risk of seizures.
- another mood than usual (mood swings) or if you 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 Accord 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 Atomoxetine Accord
These tests are to determine if Atomoxetine Accord is the right drug for you.
The doctor will measure:
- blood pressure and heart rate ( heart rate ) before and while you are taking Atomoxetine Accord
- height and weight if you are a child or teenager while taking Atomoxetine Accord
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 Accord is the right medicine for you. Your doctor may decide that other medical examinations are necessary before you start taking this medicine.
Important information about the contents of the capsules
Do not open the Atomoxetine Accord capsules as the contents of the capsule may irritate the eyes. If the contents of a capsule come in contact with the eyes, the affected eye should be immediately rinsed with water, and consult a healthcare professional for advice. Hands and other parts of the body that may have come in contact with the capsule contents should be washed as soon as possible.
Children
Atomoxetine Accord should not be used for the treatment of ADHD in children under 6 years of age as it is not known if this medicine works or is safe for these people.
Other medicines and Atomoxetine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medications. Your doctor will decide if you can take Atomoxetine Accord with 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 Accord with medicines belonging to the group MAO inhibitors ( monoamine oxidase inhibitors ) used in depression. See section 2 “Do not take Atomoxetine Accord”.
If you are taking other medicines, Atomoxetine Accord may affect how well they work or cause side effects.
If you are taking any of the following medicines, check with your doctor or pharmacist before taking Atomoxetine Accord:
- Drugs that increase blood pressure or are used to control blood pressure.
- Drugs such as antidepressants e.g. imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine.
- Some cough and cold medicines contain medicines that can affect blood pressure. It is important to check with the pharmacy staff when receiving these products
- Some drugs used to treat mental illness.
- Drugs that are known to increase the risk of seizures.
- Some medicines may cause Atomoxetine Accord to stay in the body longer than usual (such as quinidine and terbinafine).
- Salbutamol (a medicine for asthma ) may give the feeling that the heart is rushing when taken 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 Accord:
- Drugs used to treat arrhythmias in the heart.
- Drugs that change the concentration of salts in the blood.
- Drugs to prevent and treat malaria.
- Some 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 Accord.
Pregnancy and breastfeeding
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.
It is not known if this medicine affects the unborn baby or passes into breast milk.
- This medicine should not be taken during pregnancy unless your doctor has advised you to do so.
- You should either stop taking this medicine or avoid breast-feeding while you are being treated with Atomoxetine Accord.
Driving and using machines
You may feel tired, drowsy, or dizzy after taking Atomoxetine Accord. Be careful if you drive and use tools or machines until you know how Atomoxetine Accord 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.
How to take Atomoxetine Accord
- 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 Accord once a day and get tired or nauseous, your doctor may change your prescription to Atomoxetine Accord twice a day.
- Oral use.
- 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 taken in any other way.
- It is easier to remember to take the medicine if you take it at the same time each day.
How much to take
If you are a child or adolescent (6 years or older):
Your doctor will tell you how much Atomoxetine Accord to take and will calculate the dose according to your body weight. He/she will normally ask you to start with a low dose and then increase the amount of Atomoxetine Accord 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. The doctor can then increase the dose to the usual maintenance dose of approximately 1.2 mg per kg of body weight daily.
- Bodyweight over 70 kg: an initial total daily dose of 40 mg for at least 7 days. Your doctor may then increase your dose to the usual 80 mg daily maintenance dose. The maximum daily dose that your doctor will prescribe is 100 mg.
Adults
- Atomoxetine Accord treatment should be started with a total daily dose of 40 mg for at least 7 days. The doctor can then increase the dose to the usual maintenance dose of 80‑100 mg daily. The maximum daily dose that your doctor will prescribe is 100 mg.
If you have liver problems, your doctor may choose to prescribe a lower dose.
Steps your doctor will take when you are being treated
Your doctor will perform some checks
- before you start – to ensure that Atomoxetine Accord 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
- any problems or side effects that have been aggravated while taking Atomoxetine Accord.
Long-term treatment
You do not need to take the Atomoxetine Accord forever. If you have been taking Atomoxetine Accord for more than a year, your doctor will review your treatment to evaluate if the medicine is still needed.
If you forget to take Atomoxetine Accord
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 Accord
If you stop taking Atomoxetine Accord, there are usually no side effects, but your ADHD symptoms may return. You should talk to your doctor before stopping your treatment.
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. Your doctor will talk to you about the side effects.
You should stop taking Atomoxetine Accord and contact a doctor immediately if you get 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.
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 such as
- 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.
Rare (may affect up to 1 in 1,000 people)
- liver damage.
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.
Other reported side effects include the following. If you become serious, consult a doctor or pharmacist.
| Very common side effect are (can occur in more than 1 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 pupil er (the dark part in the center of the eye)dizzinessconstipationloss of appetiteupset stomach, indigestionswollen, 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 want to disappeartremorstingling or numbness in the hands or feetdrowsiness, drowsiness, fatigueconstipationmagontdigestive disordersgas in the stomachvomitinghot flashes or rednessfeeling of having a very fast pulseswollen, red and itchy skinincreased sweatingrashdifficulty urinating, frequent urination, 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. |
| 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 or having very fast heartbeats ( QT ‑extension)respiratory distressincreased sweatingitchy skinfeeling weak. | restlessnessticsto faintmigrainedimsynabnormal heart rhythm ( QT‑extension)feeling cold in fingers and toeschest painrespiratory distressswollen, red and itchy skin ( hives )muscle twitchingurinary incontinenceabnormal or absent orgasmirregular menstruationinability to ejaculate. |
| Rare side effects (may affect up to 1 in 10,000 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 frequent urination or difficulty urinating, pain when urinatingprolonged or 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 Accord. 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 Accord.
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 Accord
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.
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 Accord 10 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 10 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium laurilsulfate (E487), titanium dioxide (E171).
- Atomoxetine Accord 18 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 18 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), yellow iron oxide (E172).
- Atomoxetine Accord 25 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 25 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), indigo carmine (E132).
- Atomoxetine Accord 40 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 40 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), indigo carmine (E132).
- Atomoxetine Accord 60 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 60 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172).
- Atomoxetine Accord 80 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 80 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
- Atomoxetine Accord 100 mg hard capsules one hard capsule contains atomoxetine hydrochloride equivalent to 100 mg atomoxetine.
- Other ingredients are Capsule contents: Pregelatinized maize starch, colloidal anhydrous silica, dimethicone. Capsule shell: Gelatin, sodium lauryl sulfate (E487), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
- Ink (black) consisting of shellac glaze 45% (20% esterified), black iron oxide (E172), propylene glycol.
What the medicine looks like and the contents of the pack
Atomoxetine Accord 10 mg hard capsules
White powder in a hard gelatin capsule of size No. 3 (length 15.7 ± 0.4 mm), opaque white top embossed with “10” in black ink, and opaque white bottom embossed with “mg” in black ink.
Atomoxetine Accord 18 mg hard capsules
White powder in a hard gelatin capsule of size No. 3 (length 15.7 ± 0.4 mm), opaque yellow upper part imprinted with “18” in black ink and opaque white lower part imprinted with “mg” in black ink.
Atomoxetine Accord 25 mg hard capsules
White powder in a hard gelatin capsule of size no. 3 (length 15.7 ± 0.4 mm), opaque blue upper part embossed with “25” in black ink and opaque white lower part embossed with “mg” in black ink.
Atomoxetine Accord 40 mg hard capsules
White powder in a hard gelatin capsule of size 3 (length 15.7 ± 0.4 mm), opaque blue upper part imprinted with “40” in black ink and opaque blue lower part embossed with “mg” in black ink.
Atomoxetine Accord 60 mg hard capsules
White powder in a hard gelatin capsule of size 2 (length 17.6 ± 0.4 mm), opaque blue upper part imprinted with “60” in black ink and opaque yellow lower part imprinted with “mg” in black ink.
Atomoxetine Accord 80 mg hard capsules
White powder in a hard gelatin capsule of size 2 (length 17.6 ± 0.4 mm), opaque brown upper part imprinted with “80” in black ink, and opaque white lower part embossed with “mg” in black ink.
Atomoxetine Accord 100 mg hard capsules
White powder in a hard gelatin capsule of size 1 (length 19.1 ± 0.4 mm), opaque brown upper part imprinted with “100” in black ink, and opaque brown lower part imprinted with “mg” in black ink.
Atomoxetine Accord is supplied in blisters in a carton.
Pack sizes: 7, 28, 50, 56, 60, and 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Pharmathen International SA
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
Pharmathen SA
6, Dervenakion str.
Pallini, Attiki, 153 51
Greece
Paradox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta