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Strattera (Atomoxetine)

Strattera 10,18, 25, 40, 60 and 80 mg hard capsules

Atomoxetine

1. WHAT STRATTERA IS AND WHAT IT IS USED FOR

Strattera is a non-stimulant medicine used to treat attention-deficit and hyperactivity disorder (ADHD) in children over six years of age and in adolescents, as part of a comprehensive treatment programme which can include psychological, educational and social measures.

Strattera contains atomoxetine, which increases the amount of noradrenaline in the brain. This is a chemical in the brain that is produced naturally, which increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. Strattera has not been shown to be addictive.

It may take a few weeks after you start Strattera for your symptoms to fully improve.

When treatment has started already at a younger age it might be appropriate to continue taking Strattera when you become an adult. Your specialist will advise you about this.

2.BEFORE YOU TAKE STRATTERA

Do not take Strattera

  • if you are allergic (hypersensitive) to atomoxetine or any of the other ingredients of Strattera.
  • 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 Strattera with an MAOI could cause serious side effects or be life-threatening. (You also need to wait at least 14 days after you stop taking Strattera before you take an MAOI).
  • if you have an eye disease called narrow-angle glaucoma (increased pressure in your eye).

Strattera should not be used in children under six years of age.

Take special care with Strattera

Talk to your doctor before taking Strattera

  • if you have or had liver problems. You may need a lower dose, if you have high blood pressure. Strattera can increase blood pressure, if you have problems with your heart (including heart defects) or an increased heartbeat. Strattera can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
  • if you have low blood pressure. Strattera can cause dizziness or fainting in people with low blood pressure.
  • if you have a cardiovascular disease or past medical history of stroke, if you have a history of epilepsy or have had seizures for any other reason. Strattera might lead to an increase in seizure frequency.

There is a possibility of rare, serious psychiatric adverse effects including psychotic reactions (such as believing things that are not true or being suspicious), hallucinations (such as hearing voices or seeing things which are not there), mania (feeling elated or overexcited, which causes unusual behaviour) and agitation.

Taking other medicines

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or plan to take, including prescription and non-prescription medicines, dietary supplements and herbal remedies. Your doctor will decide if you can take Strattera with your other medicines.

Strattera should not be used with medicines called MAOI’s (monoamine oxidase inhibitors). See section “Do not take Strattera”.

If you take Strattera at the same time as some other medicines (see examples below), the treatment with these medicines or Strattera may be affected and so caution is needed.

  • medicines that increase blood pressure. Strattera can alter blood pressure.
  • medicines that alter noradrenaline such as antidepressants, for example imipramine, venlafaxine and mirtazapine, or decongestants such as pseudoephedrine or phenylephrine. Strattera also alters noradrenaline.
  • some medicines used to treat mental health conditions (such as antipsychotics, lithium for manic depression and tricyclic antidepressants), medicines used to control the rhythm of the heart (such as quinidine and amiodarone), medicines which change the concentration of salts in the blood (water pills such as thiazide diuretics), methadone, mefloquine (for malaria prevention and treatment) and some antibiotics (such as erythromycin and moxifloxacin). These medicines may lead to an increased risk of an abnormal rhythm of the heart when taken with Strattera.
  • medications that are known to increase the risk of seizures. These can include antidepressants, some antipsychotic medicines, bupropion (for smoking cessation), antimalarial tablets and some painkillers (such as tramadol). Taking Strattera might lead to an increase in seizure frequency.

The way in which Strattera is broken down in the body can be affected by other medicines and can mean that Strattera can stay in the body for longer than normal. Examples of medications that can do this include some antidepressants e.g fluoxetine and paroxetine or other medications such as quinidine and terbinafine. Your doctor may need to adjust your dose or increase your dose much more slowly.

Strattera may change the way your body reacts to salbutamol (a medicine to treat asthma) and other similar medicines. If you are taking salbutamol by a nebuliser, or by mouth (for example syrup or tablets), or having a salbutamol injection together with Strattera, you may feel as if your heart is racing, but this will not make your asthma worse. Talk to your doctor before taking Strattera if you are taking salbutamol by a nebuliser or by mouth, or having salbutamol injections. You do not need to worry if you are using only an inhaler.

strattera-60mg

Pregnancy and breast-feeding

If you think you might be pregnant or are planning to become pregnant, speak to your doctor or pharmacist before you take Strattera.

Strattera should not be used during pregnancy, unless your doctor has advised you to do so.

It is not known if Strattera can pass into breast milk. Therefore you should either avoid taking Strattera if you are breastfeeding or discontinue breastfeeding. If you are breast feeding or planning to breastfeed your baby, ask your doctor or pharmacist for advice before taking Strattera.

Driving and using machines

You may feel tired or sleepy after taking Strattera. You should be careful if you are driving a car or operating heavy machinery until you know how Strattera affects you. If you feel tired or sleepy you should not drive or operate hazardous machinery.

Important information about the content of the capsules

Strattera capsules are not intended to be opened. Strattera can irritate the eye. In the event of the contents of the capsules coming into contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any other part of the body that may have come into contact with the capsule contents should also be washed as soon as possible.

3. HOW TO TAKE STRATTERA

You should take Strattera as your doctor has instructed you. This is usually one or two times a day (morning and late afternoon or early evening).

Strattera is for oral use and you can take Strattera with or without food.

Taking Strattera at the same time each day may help you remember to take it.

Your doctor will tell you how much Strattera you should take and will calculate this according to your weight. He/she will normally start you on a lower dose before increasing the amount of Strattera you need to take according to the instructions below:

Children (6 years of age and older) and adolescents:

Body weight up to 70kg: Strattera should be started at a total daily dose of approximately 0.5mg per kilogram of body weight. This dose should be continued for a minimum of 7 days. Your doctor may then decide to increase this to a usual maintenance dose of approximately 1.2mg per kilogram of body weight daily.

Body weight over 70kg: Strattera should be started at a total daily dose of 40 mg. This dose should be continued for a minimum of 7 days. Your doctor may then decide to increase this to a usual maintenance dose of 80mg daily. The maximum daily dose your doctor will prescribe is 100 mg.

  • If you have problems with your liver your doctor may prescribe a smaller dose.

A child taking Strattera may start to lose a little weight after starting treatment. Your doctor will watch your child’s height and weight. If your child is not growing or gaining weight as expected, your doctor may change your child’s dose or decide to stop Strattera temporarily.

If you take more Strattera than you should contact your doctor or the nearest hospital casualty department immediately and tell them how many capsules you have taken. The most commonly reported symptoms accompanying overdoses were sleepiness, agitation, hyperactivity, abnormal behaviour and gastrointestinal symptoms.

  • If you forget to take Strattera

If you miss a dose, you should take it as soon as possible, but you should not take more than your total daily dose in any 24-hour period. Do not take a double dose to make up for forgotten doses.

  • If you stop taking Strattera

If you stop taking Strattera there are not normally any side effects, but you should talk to your doctor first before you stop treatment.

strattera-40mg

4. POSSIBLE SIDE EFFECTS

Like all medicines, Strattera can cause side effects, although not everybody gets them.

Although uncommon (affects 1 to 10 users in 1,000) Strattera can cause a serious allergic reaction. You should stop taking Strattera and call your doctor or hospital immediately if you have any of the following:

  • swelling of the face and throat
  • difficulty breathing
  • hives (small raised, itchy patches of skin)

Very rarely (affects less than 1 user in 10,000), there have been reports of liver injury. You should stop taking Strattera and call your doctor immediately if you have any of the following:

  • dark urine
  • yellow skin or yellow eyes
  • tummy pain which is sore when you press it (tenderness) on the right side just below your ribs
  • a feeling of sickness (nausea) that is unexplained tiredness itching
  • feeling that you are coming down with flu. These symptoms should not be ignored as they may be the start of something more serious.

Patients under 18 have an increased risk of side effects such as:

  • suicidal thoughts
  • hostility (predominantly aggression, oppositional behaviour and anger)
  • emotional lability

You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun. Also you should know that as with other psychotropic medication, there is a possibility of rare, serious psychiatric adverse effects.   The long-term effects on growth, maturation and cognitive and behavioural development of Strattera in this age group have not yet been demonstrated.

There have been reports in some patients of abnormal rhythms of the heart, which can be serious, and also seizures. You should contact your doctor if you suspect a heart problem or have a seizure.

Side effects reported in clinical trials of Strattera in teenagers and children over six years old

Very common side effects (affects more than 1 user in 10) are:

  • headache
  • decreased appetite (not feeling hungry)
  • being sick (vomiting)
  • feeling sick (nausea)
  • pain in the stomach (abdomen)
  • sleepiness These effects may disappear after a while.

Other common side effects (affects 1 to 10 users in 100) may be:

  • loss of appetite being irritable mood swings problems sleeping dizziness lethargy constipation upset stomach
  • swollen, reddened and itchy skin rash
  • tiredness weight loss increased blood pressure

Side effects which have been seen, but are uncommon (affects 1 to 10 users in 1,000), are:

  • feeling or having a very fast heartbeat.
  • suicidal thoughts or suicidal attempt
  • aggression
  • hostility
  • emotional lability

Please see the advice above on what to do if these side effects should occur.

Other uncommon side effects may be: waking early fainting tremor migraine

large pupils (the dark centre of the eye) itchy skin increased sweating feeling of weakness allergic reactions

Side effects reported in clinical trials of Strattera in adults

Very common side effects ( affects more than 1 user in 10) are: decreased appetite (not feeling hungry) problems sleeping dry mouth feeling sick (nausea)

Other common side effects (affects 1 to 10 users in 100) may be: decreased interest in sex sleep disturbance dizziness headaches

tingling or numbness in the hands or feet tremor constipation stomach ache indigestion flatulence hot flushes

feeling or having a very fast heartbeat swollen, reddened and itchy skin increased sweating rash

problems going to the toilet (urinating) inflammation of the prostate gland (prostatitis) groin pain in men failure to obtain an erection difficulty maintaining an erection abnormal orgasm

menstrual cramps and irregular menstruation tiredness lethargy chills weight loss

Side effects which have been seen, but are uncommon (affects 1 to 10 users in 1,000), are:

  • waking early fainting
  • migraine
  • cold fingers and toes absence of orgasm increased blood pressure allergic reactions

Other possible side effects:

psychotic symptoms including hallucinations (such as hearing voices or seeing things which are not there), believing things that are not true or being suspicious agitation

problems going to the toilet (urinating) in teenagers and children groin pain in male teenagers and children prolonged and painful erections poor blood circulation which makes toes and fingers numb and pale (Raynaud’s)

If you experience any of these side effects and they become troublesome or get worse, or if you notice any side effects not mentioned in this post, please tell your doctor or pharmacist.

strattera-10mg

5. HOW TO STORE STRATTERA

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the carton and blister after ‘Exp’. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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. FURTHER INFORMATION

What Strattera 10,18, 25, 40, 60 and 80 mg hard capsules contain

The active substance in Strattera capsules is atomoxetine hydrochloride. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg or 80 mg of atomoxetine.

The other ingredients are pregelatinised starch and dimeticone.

The capsule shells contain sodium laurilsulfate, gelatin and edible black ink (containing shellac and black iron oxide El72). The capsule shell colourants are:

Yellow iron oxide El72 (18 mg, 60 mg and 80 mg)

Titanium dioxide E171 (10 mg, 18 mg, 25 mg, 40 mg, 60 mg and 80 mg)

FD&C blue 2 (indigo carmine) El32 (25 mg, 40 mg and 60 mg)

Red iron oxide El72 (80 mg)

What Strattera looks like and contents of the pack

Capsule, hard, 10 mg (white, imprinted Lilly 3227/10 mg) Capsule, hard, 18 mg (gold/white, imprinted Lilly 3238/18 mg) Capsule, hard, 25 mg (blue/white, imprinted Lilly 3228/25 mg) Capsule, hard, 40 mg (blue, imprinted Lilly 3229/40 mg) Capsule, hard, 60 mg (blue/gold, imprinted Lilly 3239/60 mg) Capsule, hard, 80 mg (brown/white, imprinted Lilly 3250/80 mg)

Strattera capsules are available in packs of 7, 14, 28 or 56 capsules but not all pack sizes may be marketed.

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