10, 18, 25, 40, 60, 80 and 100 mg hard capsules
Atomoxetine
What Strattera is and what it is used for
Strattera contains atomoxetine and is used to treat attention deficit hyperactivity disorder ( ADHD ). It is used
- in children from the age of 6
- in young people
- in adults
It is only used as part of a complete treatment program for the disorder that also includes treatment that does not involve drugs, such as talking and behavioral therapy. The medicine is not for the treatment of ADHD in children under 6 years of age because it is not known whether the treatment works or is safe for these people.
In adults, Strattera is used to treat ADHD when the symptoms are very troublesome and affect your work or social life, and when you had symptoms of the disorder as a child.
How does it work
Strattera increases the amount of norepinephrine in the brain. Noradrenaline is a naturally occurring signaling substance that increases attention and reduces impulsivity and hyperactivity in patients with ADHD. Strattera 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 for the medicine to reach its full effect.
About ADHD
Children and young people with ADHD feel that it is:
- difficult to sit still and
- difficult to concentrate
It is not their fault that they cannot do this. Many children and young people have difficulty with these things, but ADHD this can create problems in everyday life. Children and young people with ADHD may have difficulties with learning and doing homework. They find it difficult to behave at home, at school, or in other people’s places. ADHD does not affect the intelligence of children and adolescents.
Adults with ADHD have difficulty with the same things that children experience as difficult, but this may mean that they have problems with:
- work
- relationships
- low self-esteem
- training
What you need to know before you take Strattera
Do NOT take Strattera if you
- are allergic to atomoxetine or any of the other ingredients of this medicine (listed in section 6).
- in the last 14 days have taken a medicine that belongs to the group of monoamine oxidase inhibitors ( MAO inhibitors ). MAO inhibitors are used, among other things, to treat depression and other mental problems. Taking Strattera and an MAOI at the same time can cause serious or life-threatening side effects. At least 14 days must have passed after stopping treatment with Strattera before you can start taking an MAOI.
- have an eye disease called narrow-angle glaucoma (increased pressure inside the eye)?
- have serious problems with the heart, which may be affected by an increase in heart rate and/or blood pressure, as this may be an effect of Strattera.
- 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.
- have a tumor in the adrenal gland ( phaeochromocytoma ).
Do not take Strattera if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Strattera. This is because Strattera can make these problems worse.
Warnings and precautions
Both adults and children should be aware of the following warnings and precautions. Talk to your doctor or pharmacist before taking Strattera if you have:
- thoughts about taking your own life or trying to take your own life.
- heart problems (including heart failure) or increased heart rate. Strattera may increase your heart rate ( pulse ). Sudden death has been reported in patients with heart defects.
- high blood pressure. Strattera can cause increased blood pressure.
- low blood pressure. Strattera can cause dizziness or fainting in people with low blood pressure.
- problems with sudden changes in blood pressure et or heart rate.
- cardiovascular disease or have had a stroke.
- liver problems. You may then need a lower dose.
- psychotic symptoms include hallucinations (hearing voices or seeing things that aren’t there), believing things that aren’t true, or being suspicious.
- mania (feeling elated and excited, causing unusual behavior) and agitation (a feeling of being both physically restless and mentally excited).
- aggressive feelings
- unfriendly and angry (hostile) feelings.
- epilepsy or have had seizures for any other reason. Strattera may increase the risk of seizures.
- different mood than usual (mood swings) or feeling very unhappy.
- hard-to-control repeated jerks in any part of the body or repeating sounds and words.
Tell your doctor or pharmacist if any of the above apply to you before starting treatment. This is because Strattera can make these problems worse. Your doctor will want to monitor how the medicine affects you.
Tests your doctor will do before you start taking Strattera
These tests are to determine if Strattera is the right medicine for you.
Your doctor will measure:
- your blood pressure and heart rate ( pulse ) before and while you take Strattera
- your height and weight if you are a child or teenager while taking Strattera
Your doctor will talk to you about:
- other medicines you are taking
- if there is someone in the family who 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 Strattera is the right medicine for you. Your doctor may decide that other medical checks are necessary before you start taking this medicine.
Other medicines and Strattera
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including both prescription and over-the-counter medicines. Your doctor will decide if you can take Strattera 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 Strattera with medicines belonging to the group of MAO inhibitors (monoamine oxidase inhibitors) used for depression. See section 2. Do not take “Strattera”.
If you take other medicines, Strattera can 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 Strattera:
- drugs that increase blood pressure et or are used to control blood pressure et
- medicines such as anti-depressants eg imipramine, venlafaxine, mirtazapine, fluoxetine, and paroxetine
- certain cough and cold remedies that contain drugs that can affect blood pressure. It is important to check with a pharmacist when receiving these products
- certain medicines used to treat mental disorders
- medicines that are known to increase the risk of seizures
- some medicines can cause Strattera to stay in the body longer than normal (such as quinidine and terbinafine)
- salbutamol (an asthma medicine ) can make your heart feel like it is racing when taken by mouth or as an injection, but this will not make your asthma worse
The medicines below may lead to an increased risk of abnormal heart rhythms when taken with Strattera:
- medicines used to treat heart rhythm disorders
- medicines 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 included in the list above, ask your doctor or pharmacist before taking Strattera.
Pregnancy and breastfeeding
It is not known whether 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 breastfeeding while you are being treated with Strattera.
If you:
- are pregnant or breastfeeding
- think you may be pregnant or planning to have a baby
- planning to breastfeed your baby
consult your doctor or pharmacist before taking this medicine
Driving ability and use of machinery
You may feel tired or sleepy after taking Strattera. Do not drive or use tools or machines until you know how Strattera affects you. If you feel tired or sleepy, you should not drive or use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Discuss with your doctor or pharmacist if you are unsure
Important information about the contents of the capsules
Do not open the 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 immediately flushed with water, and medical advice sought. Hands and other parts of the body that may have come into contact with the capsule contents should be washed off as soon as possible.
How to take Strattera
- Always take this medicine as directed by your doctor or pharmacist. 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 Strattera once a day and become tired or nauseous, your doctor may change your prescription to Strattera 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 taken out and ingested in any other way.
- It is easier to remember to take the medicine if you take it at the same time every day.
How much to take
If you are a child or teenager (age 6 or older):
Your doctor will tell you how much Strattera to take, the dose 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 Strattera you 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 that dose one should be increased up to the daily maintenance dose of approximately 1.2 mg per kg of body weight.
- Body weight over 70 kg: an initial 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. The maximum daily dose that your doctor will prescribe is 100 mg.
Adults
- Treatment with Strattera should be initiated with a total daily dose of 40 mg for at least 7 days. Your doctor may then decide that the dose 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 have taken too much Strattera
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Tell me how many capsules you have taken. The most common symptoms of overdose are stomach/intestinal symptoms, sleepiness, dizziness, tremors, and abnormal behavior.
If you forget to take Strattera
If you have forgotten a dose, take it as soon as you remember, but do not exceed the total daily dose of one in 24 hours. Do not take a double dose to make up for missed dose.
If you stop taking Strattera
If you stop taking Strattera, there are usually no side effects, but your ADHD symptoms may return. You should talk to your doctor before stopping your treatment.
Actions your doctor will take when you are treated
Your doctor will carry out certain checks:
- before you start – make sure Strattera is safe and will help you.
- when you started – they will be carried out at least every 6 months, probably more often.
They will also be carried out 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 pulse
- Pay attention if you have any problems or side effects that got worse while taking Strattera.
Long-term treatment
Strattera does not need to be taken forever. If you take Strattera for more than a year, your doctor will review your treatment to assess whether the medicine is still needed.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some people experience side effects, the vast majority find that Strattera helps them. Your doctor will talk to you about the side effects.
Some side effects can be serious. If you experience any of the side effects below, see a doctor immediately.
Uncommon (may affect up to 1 in 100 users)
- a feeling of or having a very fast pulse, abnormal heart rhythm
- thoughts about taking their own life or wanting to take their own life
- feel aggressive
- feeling unfriendly and angry (hostile)
- mood swings or changes in mood
- 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 aren’t there), believing things that aren’t true, or being suspicious
Children and young people under the age of 18 have an increased risk of side effects such as:
- suicidal thoughts or wanting to take their own life (may affect up to 1 in 100 users)
- mood swings or changes in mood (may affect up to 1 in 10 people)
Adults have a reduced risk (which 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 aren’t there), believing things that aren’t true, or being suspicious
Rare cases (may affect up to 1 in 1,000 users),
- liver damage
You should stop taking Strattera and contact your doctor immediately if you have any of the following:
- dark colored urine
- yellow skin or yellow eyes
- stomach pain and tenderness when you press 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 severe, talk to your doctor or pharmacist.
| Very common side effects (may affect more than 1 in 10 users) | |
|---|---|
| CHILDREN and YOUNG PEOPLE over the age of 6 | ADULTS |
| headache stomach ache decreased appetite (no feelings of hunger)nausea or vomitingsomnolenceelevated blood pressure increased heart rate ( pulse ) These side effects can disappear after a while in most patients. | nausea dry mouthheadachedecreased appetite (no feelings of hunger)difficulty falling asleep, sleeping, and waking up early elevated blood pressure increased heart rate ( pulse ) |
| Common side effects (may affect up to 1 in 10 users) | |
|---|---|
| CHILDREN and YOUNG PEOPLE over the age of 6 | ADULTS |
| to be easily irritated sleep problems, early awakeningDepressionfeeling sad or hopeless feeling anxiousticslarge pupils (the dark part in the center of the eye)dizziness-constipation loss of appetite digestive disordersswollen, red and itchy skin rash feeling lethargic (state of listlessness)chest pain fatigue weight loss | feel irritateddecreased interest in sex sleep disordersDepressionfeeling sad or hopeless feeling anxiousdizzinessabnormal taste or taste in the mouth that does not want to go awaytremorstingling or numbness in the hands or feel sleepiness, drowsiness, fatigue-constipation stomach acheindigestiongas in the stomachvomitinghot flashes or rednessfeeling of or having a very fast pulseswollen, red and itchy skin increased sweatingrashdifficulty urinating, pain when urinating prostate inflammationgroin pain in an inability to get an erection delayed orgasm difficulty maintaining an erectioncramping during menstruationfeeling of weaknessfatiguefeeling lethargic (state of listlessness)overindulgefeel irritated, shaky feel thirsty weight loss |
| Uncommon side effects (may affect up to 1 in 100 users) | |
|---|---|
| CHILDREN and YOUNG PEOPLE over the age of 6 | ADULTS |
| to fainttremorsmigraineblurred vision abnormal sensations in the skin such as burning, tingling, itching or crawling tingling or numbness in the hands or feetconvulsions (seizures)a feeling of or having very fast heartbeats ( QT prolongation)respiratory distress increased sweatingitchy skin feeling of weakness | restlessnessticsto faintmigraineblurred vision abnormal heart rhythm ( QT prolongation)coldness in fingers and toes chest pain respiratory distressswollen, red and itchy skin (rash)muscle twitchingfrequent urge to urinate abnormal or absent orgasmirregular menstruationinability to ejaculate |
| Rare side effects (may affect up to 1 in 1,000 users) | |
|---|---|
| CHILDREN and YOUNG PEOPLE over the age of 6 | ADULTS |
| poor blood circulation causing toes and fingers to become numb and pale (Raynaud’s phenomenon)problems with going to the toilet such as having to urinate often or difficulty urinating, pain when urinatingprolonged and painful erections grown pain in boys | poor blood circulation causing toes 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 start of treatment with Strattera. However, 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 is not growing or gaining weight as expected, the doctor may change the dose or temporarily stop treatment with Strattera.
How to store Strattera
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the box after Issue. dat. and pressure packaging according to Exp. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment
Packaging contents and other information
Contents declaration
What Strattera 10, 18, 25, 40, 60, 80, and 100 mg hard capsules contain
The active substance is atomoxetine hydrochloride. Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine.
- Other ingredients are pregelatinized starch and dimethicone.
- The capsule shell contains sodium lauryl sulfate and gelatin. Dyes in the capsule shell are:
- yellow iron oxide E172 (18 mg, 60 mg, 80 mg and 100 mg)
- titanium dioxide E171 (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg)
- indigo carmine E132 (25 mg, 40 mg and 60 mg)
- red iron oxide E172 (80 mg and 100 mg).
- Edible black ink (containing shellac and black iron oxide E172).
Appearance and package sizes of the medicine
Capsule, hard 10 mg (white, marked Lilly 3227/10 mg, approximately 15.5-16.1 mm long)
Capsule, hard 18 mg (gold-colored/white, marked Lilly 3238/18 mg, approximately 15.5-16.1 mm long)
Capsule, hard 25 mg (blue/white, marked Lilly 3228/25 mg, approximately 15.5-16.1 mm long)
Capsule, hard 40 mg (blue, marked Lilly 3229/40 mg, approximately 15.5-16.1 mm long)
Capsule, hard 60 mg (blue/gold colored, marked Lilly 3239/60 mg, approximately 17.5-18.1 mm long)
Capsule, hard 80 mg (brown/white, marked Lilly 3250/80 mg, approximately 17.5-18.1 mm long)
Capsule, hard 100 mg (brown, marked Lilly 3251/100 mg, approximately 19.2-19.8 mm long)
Strattera capsules are available in pack sizes of 7, 14, 28, or 56 capsules. Not all pack sizes will be marketed.
Manufacturer
Lilly SA
Abda. De la Industria 30
28108 Alcobendas
Madrid
This medicine is approved in the European Economic Area under the name: Strattera
Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and Great Britain: