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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0273.
Atomoxetine Glenmark 10-18-25-40-60-80-100 mg hard capsules
Atomoxetine Glenmark 10 mg hard capsules
Atomoxetine Glenmark 18 mg hard capsules
Atomoxetine Glenmark 25 mg hard capsules
Atomoxetine Glenmark 40 mg hard capsules
Atomoxetine Glenmark 60 mg hard capsules
Atomoxetine Glenmark 80 mg hard capsules
Atomoxetine Glenmark 100 mg hard capsules
Atomoxetine
1. What Atomoxetine Glenmark is and what it is used for
2. What you need to know before you take Atomoxetine Glenmark
3. How to take Atomoxetine Glenmark
4. Possible side effects
5. How to store Atomoxetine Glenmark
6. Contents of the pack and other information
Atomoxetine Glenmark contains atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). It is used
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, Atomoxetine Glenmark 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.
Atomoxetine Glenmark 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.
Children and young people with ADHD find it:
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:
Do not take Atomoxetine Glenmark if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take Atomoxetine Glenmark. This is because Atomoxetine Glenmark can make these problems worse.
Both adult and children should be aware of the following warnings and precautions. Talk to your doctor or pharmacist before taking Atomoxetine Glenmark if you have:
Tell your doctor or pharmacist if any of the above applies to you before starting treatment. This is because Atomoxetine Glenmark can make these problems worse. Your doctor will want to monitor how the medicine affects you.
These checks are to decide if Atomoxetine Glenmark is the correct medicine for you.
Your doctor will measure your
Your doctor will talk to you about:
It is important that you provide as much information as you can. This will help your doctor decide if Atomoxetine Glenmark is the correct medicine for you. Your doctor may decide that other medical tests are needed before you start taking this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes non-prescription medicines. Your doctor will decide if you can take Atomoxetine Glenmark with your 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 Glenmark with medicines called MAOIs (monoamine oxidase inhibitors) used for depression. See section 2 “Do not take Atomoxetine Glenmark”.
If you are taking other medicines, Atomoxetine Glenmark may affect how well they work or may cause side effects. If you are taking any of the following medicines, check with your doctor or pharmacist before taking Atomoxetine Glenmark:
The medicines below may lead to an increased risk of an abnormal rhythm of the heart when taken with Atomoxetine Glenmark:
If you are not sure about whether any medicines you are taking are included in the list above, ask your doctor or pharmacist before taking Atomoxetine Glenmark.
It is not known if this medicine can affect an unborn baby or pass into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby or planning to breast-feeding your baby, ask your doctor or pharmacist for advice before taking this medicine.
You may feel tired, sleepy or dizzy after taking Atomoxetine Glenmark. You should be careful if you are driving or operating machinery until you know how Atomoxetine Glenmark affects you. If you feel tired, sleepy or dizzy you should not drive or operate machinery.
Do not open Atomoxetin Glenmark capsules because the contents of the capsule can irritate the eye.
If the contents of the capsules come 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.
If you are a child or teenager (6 years or older):
Your doctor will tell you how much Atomoxetine Glenmark 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 Atomoxetine Glenmark you need to take according to your body weight.
Adults
If you have problems with your liver your doctor may prescribe a lower dose.
If you take more Atomoxetine Glenmark 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 are gastrointestinal symptoms, sleepiness, dizziness, tremor, and abnormal behaviour.
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 a forgotten dose.
If you stop taking Atomoxetine Glenmark there are usually no side effects but your ADHD symptoms may return. You should talk to your doctor first before you stop treatment.
Your doctor will do some tests
They will also be done when the dose is changed. These tests will include:
Atomoxetine Glenmark does not need to be taken for ever. If you take Atomoxetine Glenmark for more than a year, your doctor will review your treatment, to see if the medicine is still needed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Although some people get side effects most people find that Atomoxetine Glenmark helps them. Your doctor will talk to you about these side effects.
Some side effects could be serious. If you have any of the side effects below, see a doctor straight away.
Uncommon (may affect up to 1 in 100 people)
Children and young people aged under 18 have an increased risk of side effects such as:
Adults have a reduced risk (rare - may affect up to 1 in 1,000 people) of side effects such as:
Rare (may affect up to 1 in 1,000 people)
Very common side effects (may affect more than 1 in 10 people)
CHILDREN and YOUNG PEOPLE over 6 years
These effects may disappear after a while in most patients.
ADULTS
Common side effects (may affect up to 1 in 10 people)
CHILDREN and YOUNG PEOPLE over 6 years
ADULTS
Uncommon side effects (may affect up to 1 in 100 people)
CHILDREN and YOUNG PEOPLE over 6 years
ADULTS
Rare side effects (may affect up to 1 in 1,000 people)
CHILDREN and YOUNG PEOPLE over 6 years
ADULTS
Some children experience reduced growth (weight and height) when they start taking Atomoxetine Glenmark. However, with long-term treatment, children recover to the weight and height for their age range.
Your doctor will watch your child’s height and weight over time. If your child is not growing or gaining weight as expected, your doctor may change your child’s dose or decide to stop Atomoxetine Glenmark temporarily.
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after ‘Exp’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is Atomoxetine.
Atomoxetine Glenmark 10 mg hard capsules
Each hard capsule contains 10 mg atomoxetine as 11.43 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate , Titanium dioxide (E171)
Atomoxetine Glenmark 18 mg hard capsules
Each hard capsule contains 18 mg atomoxetine as 20.57 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate, Titanium dioxide (E171), iron oxide yellow (E172)
Atomoxetine Glenmark 25 mg hard capsules
Each hard capsule contains 25 mg atomoxetine as 28.57 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate, Titanium dioxide (E171), indigo carmine (E132)
Atomoxetine Glenmark 40 mg hard capsules
Each hard capsule contains 40 mg atomoxetine as 45.71 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate, Titanium dioxide (E171), indigo carmine (E132)
Atomoxetine Glenmark 60 mg hard capsules
Each hard capsule contains 60 mg atomoxetine as 68.57 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate, Titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172)
Atomoxetine Glenmark 80 mg hard capsules
Each hard capsule contains 80 mg atomoxetine as 91.42 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate, Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Atomoxetine Glenmark 100 mg hard capsules
Each hard capsule contains 100 mg atomoxetine as 114.28 mg atomoxetine hydrochloride.
The other ingredients are
Capsule content: Pregelatinized maize starch, silica colloidal anhydrous and dimeticone.
Capsule shell: Gelatin, Sodium Lauryl Sulfate, Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Printing ink (black) consisting of: Shellac Glaze-45% (20% Esterified), Iron Oxide Black (E172), Propylene Glycol
Atomoxetine Glenmark10 mg hard capsules
Hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), Opaque White cap imprinted in black ink with ‘10’ and opaque white body imprinted in black ink with ‘mg’
Atomoxetine Glenmark 18 mg hard capsules
Hard gelatin capsule of size No 3 (length of 15.7±0.4 mm), Opaque Rich yellow cap imprinted in black ink with ‘18’ and Opaque White body imprinted in black ink with ‘mg’
Atomoxetine Glenmark 25 mg hard capsules
Hard gelatin capsule of size No 3 (length of 15.7±0.4 mm) , Opaque Blue cap imprinted in black ink with ‘25’ and Opaque White body imprinted in black ink with ‘mg'
Atomoxetine Glenmark 40 mg hard capsules
Hard gelatin capsule of size No 3 (length of 15.7±0.4 mm) , Opaque Blue cap imprinted in black ink with ‘40’ and Opaque Blue body imprinted in black ink with ‘mg’
Atomoxetine Glenmark 60 mg hard capsules
Hard gelatin capsule of size No 2 (length of 17.6±0.4 mm) , Opaque Blue cap imprinted in black ink with ‘60’ and Opaque Rich yellow body imprinted in black ink with ‘mg’
Atomoxetine Glenmark 80 mg hard capsules
Hard gelatin capsule of size No 2 (length of 17.6±0.4 mm), Opaque Brown cap imprinted in black ink with ‘80’ and Opaque White body imprinted in black ink with ‘mg’
Atomoxetine Glenmark 100 mg hard capsules
Hard gelatin capsule of size No 1 (length of 19.1 ± 0.4 mm), Opaque Brown cap imprinted in black ink with ‘100’ and Opaque Brown body imprinted in black ink with ‘mg’
Atomoxetine Glenmark 10 mg, 18 mg, 25 mg, 40 mg and 60 mg are available in packs of 7, 28, 30 or 56 capsules.
Atomoxetine Glenmark 80 mg and 100 mg are available in packs of 28, 30 or 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Manufacturer
This leaflet was last revised in May 2022.