ATOMAKTIN contain atomoxetine. ATOMAKTIN is used to treat Attention-Deficit/ Hyperactivity Disorder (ADHD) in children 6 years of age or older, adolescents and adults.
1. What ATOMAKTIN is and what it is used for
2. What you need to know before you take or give ATOMAKTIN
Do not take or give ATOMAKTIN :
- If you are allergic to atomoxetine or any of the other ingredients of this medicine.
- If you 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 ATOMAKTIN with an MAOI could cause serious side effects or even be life-threatening
- If you have an eye disease called narrow-angle glaucoma (increased pressure in your eye)
- If you have a condition called pheochromocytoma (tumour of your adrenal gland)
- If you have uncontrolled high blood pressure
- If you have serious problems with your heart which may be affected by an increase in heart rate and or blood pressure.
Warnings and precautions
Talk to your doctor before taking ATOMAKTIN if you have
- thoughts about killing yourself or trying to kill yourself.
- problems with your heart (including heart defects) or an increased heartbeat. ATOMAKTIN can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
- high blood pressure. ATOMAKTIN can increase blood pressure.
- low blood pressure. ATOMAKTIN 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. ATOMAKTIN 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.
- Possible allergic reactions including severe allergic reactions known as anaphylaxis
- Poor circulation which makes fingers and toes, numb and pale (Raynauds disease)
- If your child is not growing or gaining weight as expected.
- Problems passing urine.
Other medicines and ATOMAKTIN
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)
Do not take ATOMAKTIN with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 “Do not take ATOMAKTIN”.
Tell your doctor or pharmacist if you are taking any of the following medicines:
- 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 ATOMAKTIN 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
3. How to take ATOMAKTIN
Do not share medicines prescribed for you with any other person. Always take ATOMAKTIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. Swallow your capsules whole with a drink of water.
- Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition.
- If you are taking this medicine for a long time, your doctor will want to monitor you.
- You can take ATOMAKTIN with or without food.
If you have the impression that the effect of ATOMAKTIN is too strong or too weak, talk to your doctor or pharmacist.
If you take more ATOMAKTIN than you should
In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
If you forget to take ATOMAKTIN
It is important to take your ATOMAKTIN regularly at the same time each day. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take two doses at the same time, to make up for a missed dose.
If you stop taking ATOMAKTIN
If ATOMAKTIN is stopped earlier than your doctor has prescribed, your symptoms of may return or worsen. Always take ATOMAKTIN for as long as your doctor has prescribed.
4 Possible side effects
ATOMAKTIN can have side effects. Not all side effects reported for ATOMAKTIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ATOMAKTIN, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop taking ATOMAKTIN and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Allergic reactions – the signs may include: sudden swelling of your face, lips or tongue, difficulty breathing, hives (small raised, itchy patches of skin)
- Dark urine (hepatitis)
- Yellow skin or eyes (jaundice)
- Stomach pain which is sore when you press it (tenderness) on the right side just below the ribs.(Abdominal pain)
- A feeling of sickness (nausea) that is unexplained.
- Tiredness(Fatigue)
- Itching (Dermatitis)
These are all very serious side effects. If you have them, you may have had a serious reaction to ATOMAKTIN. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- feeling or having a very fast heartbeat, abnormal rhythms of the heart
- thinking about or feeling like killing yourself (Suicide-related events)
- feeling aggressive (agitation)
- feeling unfriendly and angry (hostility)
- mood swings or mood changes
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following side effects:
- Frequent Headache
- Pain in the stomach (Abdominal pain)
- Decreased appetite (not feeling hungry)
- feeling sick (nausea)
- Being sick (vomiting)
- Sleepiness (somnolence)
- Increased blood pressure
- Increased heart rate (pulse)
- Being irritable or agitated
- Problems sleeping including waking early
- Depression
- Large pupils (the dark centre of the eye)
- Dizziness
- Constipation
- Loss of appetite (Anorexia)
- Upset stomach, indigestion
- Swollen, reddened and itchy skin (Dermatitis)
- Rash
- Tiredness
- Weight loss
- Mood swings
- Fainting (somnolence)
- Lack of strength or energy (Lethargy)
- Decreased sex drive
- Tremor
- Dry mouth
- Headache
- Hot flushes
- Less frequent
- Blurred vision
- Problems going to the toilet such as frequent or hesitant urination
- Abnormal skin sensation, such as burning, prickling, itching or tingling
- Menstrual cramps
- Painful, prolonged erection
- Ejaculation failure
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Should your general health worsen or if you experience any untoward effects while taking ATOMAKTIN, please consult your healthcare provider for advice.
5. How to store ATOMAKTIN
Store at or below 25 °C. KEEP OUT OF THE REACH OF CHILDREN. Keep the blisters in the carton until required for use.