Strattera 4 mg/mL oral solution

XPIL (Text-only Patient Information Leaflet)

Source: Strattera_OS_PIL_ST051_Nov24_IE.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the user

Strattera® 4 mg/mL oral solution

atomoxetine

Important things you need to know about your medicine

This medicine is used to treat ADHD

- The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’.

- The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive.

- You need to have other help for ADHD as well as this medicine.

Read Section 1 for more information.

Before you take this medicine, talk to your doctor if you:

- have mental health problems

- have a problem with your heart or blood circulation

- have serious problems with the blood vessels in your brain such as a stroke

Read Section 2 for more information.

While taking this medicine:

- See your doctor regularly. This is because your doctor will want to check how the medicine is working.

- Do not stop taking the medicine without first talking to your doctor.

- Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year.

- The most common side effects in children and young people are: headache, stomach ache, not feeling hungry, feeling or being sick, feeling sleepy, increased blood pressure, increased heart rate (pulse).

- The most common side effects in adults are: feeling sick, dry mouth, headache, not feeling hungry, not being able to sleep, increased blood pressure, increased heart rate (pulse).

Read Sections 3 and 4 for more information.

Talk to your doctor straight away if any of the following happen:

- your mood and how you feel changes

- you feel any problems with your heart e.g. a fast or unusual heartbeat rhythm

Read Section 2 and 4 for more information.

The rest of this leaflet includes more detail and other important information on the safe and effective use of this medicine.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The leaflet has been written in sections:

Sections 1 to 6 are for parents and carers (sometimes called ‘your guardians’).

The last section is a special section for a child or young person to read.

However, all sections are written as though the child or young person taking the medicine is reading them.

What is in this leaflet:

1. What Strattera is and what it is used for

2. What you need to know before you take Strattera

3. How to take Strattera

4. Possible side effects

5. How to store Strattera

6. Contents of the pack and other information

Special section: Information for children and young people

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1. What Strattera is and what it is used for

What it is used for

Strattera contains atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD).

It is used

- in children over six years of age

- in young people

- in adults

It is used only as a part of the total treatment of the disease which also requires treatments which do not involve medicines, such as counselling and behavioural therapy.

It is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the drug works or is safe in 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 have had symptoms of the disease as a child.

How it works

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

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

About ADHD

Children and young people with ADHD find it:

- hard to sit still and

- hard to concentrate.

It is not their fault that they cannot do these things. Many children and young people struggle to do these things. However, with ADHD this can cause problems with everyday life. Children and young people with ADHD may have difficulty learning and doing homework. They find it hard to behave well at home, at school or in other places. ADHD does not affect the intelligence of a child or young person.

Adults with ADHD find it difficult to do all the things that children find difficult however this may mean they have problems with:

- work

- relationships

- low self esteem

- education

2. What you need to know before you take Strattera

Do not take Strattera if you

- are allergic (hypersensitive) to atomoxetine or any of the other ingredients of Strattera (listed in Section 6)

- have taken a medicine known as a monoamine oxidase inhibitor (MAOI) including phenelzine, tranylcypromine, moclobemide, selegiline or isocarboxazid in the last 14 days. MAOIs are medicines used to treat depression and other mental health problems. Taking Strattera with a MAOI could cause serious side effects or be life-threatening. You will need to wait at least 14 days after you stop taking an MAOI before you can take Strattera.

- have an eye disease called narrow-angle glaucoma (increased pressure in the eye).

- have serious problems with your heart which may be affected by increases in blood pressure and heart rate because Strattera can cause these effects.

- have serious problems with the blood vessels in your brain such as a stroke.

- have a tumour of your adrenal gland (phaeochromocytoma).

Do not take Strattera if any of the above apply to you. If you are not sure, talk to your doctor before you take Strattera.

Warnings and precautions

Talk to your doctor before taking Strattera if you have:

- high blood pressure

- fast heartbeat

- heart disease

- low blood pressure

- low blood pressure when you stand up

- a family history of sudden death from heart problems

- a family history of irregular heart beat

- had a stroke

- liver problems

Children and young people under 18 years old

Suicidal thoughts and behaviour

Suicidal thoughts and behaviour have been reported in patients treated with atomoxetine. In studies, suicidal thoughts were more often observed in children and adolescents. If you develop suicidal thoughts or behaviour, contact your doctor immediately.

Aggression, hostility, emotional lability

Aggressive behaviour, hostility and emotional lability (rapidly changing moods) have been reported in patients treated with atomoxetine. Strattera may not be suitable for you if you have history of these problems.

Growth

Strattera may cause reduced growth in some children and adolescents. Your doctor will monitor your height and weight.

Convulsions

Seizures have been reported in patients treated with atomoxetine. Tell your doctor if you have a history of seizures.

Psychotic symptoms

Psychotic symptoms including hallucinations (seeing or hearing things which are not real), delusional thinking or mania have been reported. Tell your doctor if you experience any of these.

Priapism

Priapism (a painful and long-lasting unwanted erection) has been reported in children and adolescents. If this happens, contact your doctor immediately.

Other medicines and Strattera

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines you have obtained without a prescription. Strattera may interact with some medicines.

Pregnancy and breast-feeding

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.

Driving and using machines

You may feel tired, sleepy or dizzy after taking Strattera. You should be careful when driving a car or operating machines.

Strattera contains sucrose and sodium benzoate

This medicine contains 40 mg of sucrose per ml of oral solution. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicine contains 0.7 mg sodium benzoate in each ml of oral solution. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

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3. How to take Strattera

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How to take

- Strattera is taken once or twice a day (in the morning and late afternoon/early evening).

- The solution should be swallowed. You may take it with food.

- The solution can be mixed with a small amount of water, orange juice, or other similar drinks. Do not mix with hot drinks.

- If you mix Strattera solution, drink it all straight away.

- If you spill any solution on the skin, wash the area straight away with soap and water.

- If you spill on clothing, wash the clothing straight away.

- The bottle has a child-resistant closure. Follow the instructions supplied with the pack to open it safely.

How much to take

Your doctor will work out how much Strattera you need to take according to your weight and your age.

Children and young people

- If you weigh up to 70 kg: you will usually start with 0.5 mg per kg each day. This will then be increased to 1.2 mg per kg each day.

- If you weigh over 70 kg: you will usually start with 40 mg each day. This will then be increased to 80 mg each day.

- The maximum dose is 100 mg each day.

Adults

- You will usually start with 40 mg each day. This will then be increased to 80 mg each day.

- The maximum dose is 100 mg each day.

If you take more Strattera than you should

Contact a doctor straight away if you take more than the prescribed dose. The symptoms of overdose include sleepiness, agitation, hyperactivity, abnormal behaviour, and stomach problems.

If you forget to take Strattera

- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue as normal.

- Do not take a double dose to make up for a forgotten dose.

If you stop taking Strattera

Do not stop taking Strattera without talking to your doctor first. You may still need to take this medicine even when you feel better.

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4. Possible side effects

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

Serious side effects – seek medical help straight away if you notice:

- allergic reactions such as rash, itching, swelling of face, lips or tongue, or difficulty breathing

- suicidal thoughts or behaviour

- liver problems (yellow skin/eyes, dark urine, pain in the upper right side of the stomach)

- seizures (fits)

- chest pain, fast or irregular heartbeat

Very common (may affect more than 1 in 10 people)

- headache

- sleepiness

- stomach ache

- decreased appetite

Common (may affect up to 1 in 10 people)

- dizziness, irritability, mood swings

- nausea, vomiting, dry mouth, constipation

- increased blood pressure, increased heart rate

- weight loss

- problems sleeping

Uncommon (may affect up to 1 in 100 people)

- liver problems (see above)

- suicidal thoughts

- aggressive behaviour, hostility

- seizures

- fainting

- abnormal liver function test results

- prolonged and painful erections (priapism)

Rare (may affect up to 1 in 1,000 people)

- psychotic symptoms including hallucinations (seeing or hearing things not real), mania

- severe allergic reactions (anaphylaxis)

- sudden death in patients with underlying heart problems

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance (www.hpra.ie). By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Strattera

- Keep this medicine out of the sight and reach of children.

- Do not use after the expiry date printed on the label and carton.

- Store in the original package to protect from light.

- Once opened, use within 6 weeks.

- Do not use if the solution is cloudy or contains particles.

- Do not throw away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.

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6. Contents of the pack and other information

What Strattera contains

- The active substance is atomoxetine hydrochloride. Each ml of oral solution contains 4 mg atomoxetine.

- The other ingredients are sucrose, sodium benzoate, sorbitol, hydroxyethylcellulose, citric acid monohydrate, sodium citrate dihydrate, strawberry flavour, purified water.

What Strattera looks like and contents of the pack

- Strattera oral solution is a clear, colourless liquid with strawberry flavour.

- It is supplied in a bottle with a child-resistant closure. Each pack includes a syringe for measuring doses accurately.

- Pack sizes may vary.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Eli Lilly and Company Limited, Basingstoke, UK.

For any information about this medicine, please contact:

Ireland: Eli Lilly and Company (Ireland) Limited, Tel: +353-(0)1 661 4377

This leaflet was last revised in November 2024

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Special section: Information for children and young people

This medicine is called Strattera. It helps people with ADHD.

- ADHD means Attention Deficit Hyperactivity Disorder.

- If you have ADHD, you may find it hard to sit still or concentrate.

- This is not your fault.

- Strattera can help you pay attention, concentrate better, and feel less impulsive.

- You may also get other help such as talking to someone about your problems or learning new skills.

Important things to know

- Take Strattera exactly as your doctor tells you.

- Do not share your medicine with anyone else.

- Tell an adult if you feel sad, worried, or if your feelings change in ways that worry you.

- Tell an adult if you have pain in your chest or an unusually fast heartbeat.

- You should see your doctor regularly while taking this medicine.

- Do not stop taking Strattera unless your doctor tells you to.

If you have any questions, ask your doctor, nurse or pharmacist.

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