Aromasin 25 mg coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Exemestane
Available from:
Originalis B.V.
ATC code:
L02BG06
INN (International Name):
Exemestane
Dosage:
25 milligram(s)
Pharmaceutical form:
Coated tablet
Therapeutic area:
exemestane
Authorization number:
PPA2306/015/001
Authorization date:
2019-07-19

What is in this leaflet

What Seroquel XR is and what it is used for

What you need to know before you take Seroquel XR

How to take Seroquel XR

Possible side effects

How to store Seroquel XR

Contents of the pack and other information

1.

What Seroquel XR is and what it is used for

Seroquel XR contains a substance called quetiapine. This belongs to a group of medicines called anti-

psychotics. Seroquel XR can be used to treat several illnesses, such as:

Bipolar depression and major depressive episodes in major depressive disorder: where you may feel

sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.

Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor

judgement including being aggressive or disruptive.

Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or

feel unusually suspicious, anxious, confused, guilty, tense or depressed.

When Seroquel XR is being taken to treat major depressive episodes in major depressive disorder, it will

be taken in addition to another drug being used to treat this illness.

Your doctor may continue to prescribe Seroquel XR even when you are feeling better.

2.

What you need to know before you take Seroquel XR

Do not take Seroquel XR:

if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).

if you are taking any of the following medicines:

Some medicines for HIV

Azole medicines (for fungal infections)

Erythromycin or clarithromycin (for infections)

Nefazodone (for depression).

If you are not sure, talk to your doctor or pharmacist before taking Seroquel XR.

Warnings and precautions

Talk to your doctor or pharmacist before taking Seroquel XR:

if you, or someone in your family, have or have had any heart problems, for example heart rhythm

problems, weakening of the heart muscle or inflammation of the heart or if you are taking any

medicines that may have an impact on the way your heart beats.

if you have low blood pressure.

if you have had a stroke, especially if you are elderly.

if you have problems with your liver.

if you have ever had a fit (seizure).

if you have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood

sugar levels while you are taking Seroquel XR.

if you know that you have had low levels of white blood cells in the past (which may or may not have

been caused by other medicines).

if you are an elderly person with dementia (loss of brain function). If you are, Seroquel XR should not

be taken because the group of medicines that Seroquel XR belongs to may increase the risk of stroke,

or in some cases the risk of death, in elderly people with dementia.

if you are an elderly person with Parkinson’s disease/parkinsonism

if you or someone else in your family has a history of blood clots, as medicines like these have been

associated with formation of blood clots.

if you have or have had a condition where you stop breathing for short periods during your normal

nightly sleep (called “sleep apnoea”) and are taking medicines that slow down the normal activity of

the brain (“depressants”).

if you have or have had a condition where you can’t completely empty your bladder (urinary

retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your

eye. These conditions are sometimes caused by medicines (called “anti-cholinergics”) that affect the

way nerve cells function in order to treat certain medical conditions.

if you have a history of alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after taking Seroquel XR:

A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness

(a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.

Uncontrollable movements, mainly of your face or tongue.

Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in

elderly patients.

Fits (seizures).

A long-lasting and painful erection (Priapism).

These conditions can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

A fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low

white blood cell count, which may require Seroquel XR to be stopped and/or treatment to be given.

Constipation along with persistent abdominal pain, or constipation which has not responded to

treatment, as this may lead to a more serious blockage of the bowel.

Thoughts of suicide and worsening of your depression

If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be

increased when first starting treatment, since these medicines all take time to work, usually about

two weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking

your medication. You may be more likely to think like this if you are a young adult. Information from

clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young

adults aged less than 25 years with depression. If you have thoughts of harming or killing yourself at

any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative

or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you

if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).

Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia),

enlarged lymph nodes and other body organs involvement (Drug Rash with Eosinophilia and

Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).

Stop using Seroquel XR if you develop these symptoms and contact your doctor or seek medical

attention immediately.

Weight gain

Weight gain has been seen in patients taking Seroquel XR. You and your doctor should check your weight

regularly.

Children and adolescents

Seroquel XR is not for use in children and adolescents below 18 years of age.

Other medicines and Seroquel XR

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

Do not take Seroquel XR if you are taking any of the following medicines:

Some medicines for HIV.

Azole medicines (for fungal infections).

Erythromycin or clarithromycin (for infections).

Nefazodone (for depression).

Tell your doctor if you are taking any of the following medicines:

Epilepsy medicines (like phenytoin or carbamazepine).

High blood pressure medicines.

Barbiturates (for difficulty sleeping).

Thioridazine or Lithium (other anti-psychotic medicines).

Medicines that have an impact on the way your heart beats, for example, drugs that can cause an

imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills)

or certain antibiotics (drugs to treat infections).

Medicines that can cause constipation.

Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain

medical conditions.

Before you stop taking any of your medicines, please talk to your doctor first.

Seroquel XR with food, drink and alcohol

Seroquel XR can be affected by food and you should therefore take your tablets at least one hour

before a meal or prior to bedtime.

Be careful how much alcohol you drink. This is because the combined effect of Seroquel XR and

alcohol can make you sleepy.

Do not drink grapefruit juice while you are taking Seroquel XR. It can affect the way the medicine

works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby ask your

doctor for advice before taking this medicine. You should not take Seroquel XR during pregnancy unless

this has been discussed with your doctor. Seroquel XR should not be taken if you are breast-feeding.

The following symptoms which can represent withdrawal may occur in newborn babies of mothers that

have used Seroquel in the last trimester (last three months of their pregnancy): shaking, muscle stiffness

and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby

develops any of these symptoms you may need to contact your doctor.

Driving and using machines

Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the

tablets affect you.

Seroquel XR contains lactose

Seroquel XR contains lactose which is a type of sugar. If you have been told by your doctor that you have

an intolerance to some sugars, talk to your doctor before taking this medicine.

Effect on Urine Drug Screens

If you are having a urine drug screen, taking Seroquel XR may cause positive results for methadone or

certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used,

even though you may not be taking methadone or TCAs. If this happens, a more specific test can be

performed.

3.

How to take Seroquel XR

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure. Your doctor will decide on your starting dose. The maintenance dose (daily dose) will

depend on your illness and needs but will usually be between 150 mg and 800 mg.

You will take your tablets once a day.

Do not split, chew or crush the tablets.

Swallow your tablets whole with a drink of water.

Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell

you when).

Do not drink grapefruit juice while you are taking Seroquel XR. It can affect the way the medicine

works.

Do not stop taking your tablets even if you feel better, unless your doctor tells you.

Liver problems

If you have liver problems your doctor may change your dose.

Elderly people

If you are elderly your doctor may change your dose.

Use in children and adolescents

Seroquel XR should not be used by children and adolescents aged under 18 years.

If you take more Seroquel XR than you should

If you take more Seroquel XR than prescribed by your doctor, you may feel sleepy, feel dizzy and

experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Keep the

Seroquel XR tablets with you.

If you forget to take Seroquel XR

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose,

wait until then. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Seroquel XR

If you suddenly stop taking Seroquel XR, you may be unable to sleep (insomnia), or you may feel sick

(nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability.

Your doctor may suggest you reduce the dose gradually before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

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

the following side effects get serious, or if you notice side effects not listed in this leaflet, please tell your

doctor or pharmacist.

Very common: may affect more than 1 in 10 people

Dizziness (may lead to falls), headache, dry mouth.

Feeling sleepy (this may go away with time, as you keep taking Seroquel) (may lead to falls).

Discontinuation symptoms (symptoms which occur when you stop taking Seroquel) include not being

able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness,

and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.

Putting on weight.

Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling

restless or muscle stiffness without pain.

Changes in the amount of certain fats (trigylcerides and total cholesterol).

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

Package leaflet: Information for the user

Seroquel XR

®

400 mg prolonged-release tablets

quetiapine

O0649A3-IE-4.0

Common: may affect up to 1 in 10 people

Rapid heartbeat.

Feeling like your heart is pounding, racing or has skipped beats.

Constipation, upset stomach (indigestion).

Feeling weak.

Swelling of arms or legs.

Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).

Increased levels of sugar in the blood.

Blurred vision.

Abnormal dreams and nightmares.

Feeling more hungry.

Feeling irritated.

Disturbance in speech and language.

Thoughts of suicide and worsening of your depression.

Shortness of breath.

Vomiting (mainly in the elderly).

Fever.

Changes in the amount of thyroid hormones in your blood.

Decreases in the number of certain types of blood cells.

Increases in the amount of liver enzymes measured in the blood.

Increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin

could in rare cases lead to the following:

men and women to have swelling of breasts and unexpectedly produce breast milk

women to have no monthly period or irregular periods.

Uncommon: may affect up to 1 in 100 people

Fits or seizures.

Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the

mouth.

Unpleasant sensations in the legs (also called restless legs syndrome).

Difficulty swallowing.

Uncontrollable movements, mainly of your face or tongue.

Sexual dysfunction.

Diabetes.

Change in electrical activity of the heart seen on ECG (QT prolongation).

A slower than normal heart rate which may occur when starting treatment and which may be

associated with low blood pressure and fainting.

Difficulty in passing urine.

Fainting (may lead to falls).

Stuffy nose.

Decrease in the amount of red blood cells.

Decrease in the amount of sodium in the blood.

Worsening of pre-existing diabetes.

Rare: may affect up to 1 in 1,000 people

A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint

(a disorder called “neuroleptic malignant syndrome”).

Yellowing of the skin and eyes (jaundice).

Inflammation of the liver (hepatitis).

A long-lasting and painful erection (priapism).

Swelling of breasts and unexpected production of breast milk (galactorrhoea).

Menstrual disorder.

Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg),

which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.

If you notice any of these symptoms seek medical advice immediately.

Walking, talking, eating or other activities while you are asleep.

Body temperature decreased (hypothermia).

Inflammation of the pancreas.

A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the

following: an increase in fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an

increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your

blood sugar.

Combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood

cell count, a condition called agranulocytosis.

Bowel obstruction.

Increased blood creatine phosphokinase (a substance from the muscles).

Very rare: may affect up to 1 in 10,000 people

Severe rash, blisters, or red patches on the skin.

A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.

Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).

A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).

Inappropriate secretion of a hormone that controls urine volume.

Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

Skin rash with irregular red spots (erythema multiforme)

Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of

the skin (toxic epidermal necrolysis)

Symptoms of withdrawal may occur in newborn babies of mothers that have used Seroquel XR during

their pregnancy.

Stroke.

The class of medicines to which Seroquel XR belongs can cause heart rhythm problems, which can

be serious and in severe cases may be fatal. Some side effects are only seen when a blood test is taken.

These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the

blood, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreases

in the number of certain types of blood cells, decrease in the amount of red blood cells, increased blood

creatine phosphokinase (a substance in the muscles), decrease in the amount of sodium in the blood and

increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin could

in rare cases lead to the following:

Men and women to have swelling of breasts and unexpectedly produce breast milk.

Women to have no monthly period or irregular periods.

Your doctor may ask you to have blood tests from time to time.

Additional side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents.

The following side effects have been seen more often in children and adolescents or have not been seen in

adults:

Very common: may affect more than 1 in 10 people

Increase in the amount of a hormone called prolactin, in the blood. Increases in the hormone

prolactin could in rare cases lead to the following:

boys and girls to have swelling of breasts and unexpectedly produce breast milk

girls to have no monthly period or irregular periods.

Increased appetite.

Vomiting.

Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling

restless or muscle stiffness without pain.

Increase in blood pressure.

Common: may affect up to 1 in 10 people

Feeling weak, fainting (may lead to falls).

Stuffy nose.

Feeling irritated.

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 (see details below). By reporting side effects

you can help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL – Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

5.

How to store Seroquel XR

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

Do not use this medicine after the expiry date which is 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 protect the environment.

6.

Contents of the pack and other information

What Seroquel XR contains

The active substance is quetiapine. Each prolonged-release tablet contains 400 mg of quetiapine (as

quetiapine fumarate).

The other ingredients are:

Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate,

hypromellose.

Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171).

What Seroquel XR looks like and contents of the pack

Seroquel XR 400 mg prolonged-release tablets are white, capsule shaped and marked with XR 400.

Pack size: 60 prolonged-release tablets.

Parallel Product Authorisation Holder and manufacturer

Product procured from within the EU by the Parallel Product Authorisation Holder:

Originalis B.V., Joop Geesinkweg 901, 1114 AB Amsterdam-Duivendrecht, The Netherlands

Repackaged by: Originalis B.V., Diamantweg 4, 1812RC Alkmaar, The Netherlands

Manufacturer:

AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Germany

Parallel Product Authorisation Number:

PPA2306/011/001

Seroquel XR® is a registered trademark of AstraZeneca UK Limited.

This medicinal product is authorised in the Member States of the EEA under the following names:

COUNTRY

TRADE NAME

Austria

Seroquel XR

Belgium

Seroquel XR

Croatia

Seroquel XR

Cyprus

Seroquel XR

Denmark

Seroquel Prolong

Estonia

Seroquel XR

Finland

Seroquel Prolong

France

Xeroquel LP

Germany

Seroquel Prolong® 50 mg Retardtabletten

Seroquel Prolong® 150 mg Retardtabletten

Seroquel Prolong® 200 mg Retardtabletten

Seroquel Prolong® 300 mg Retardtabletten

Seroquel Prolong® 400 mg Retardtabletten

Greece

Seroquel XR

Hungary

Seroquel XR

Iceland

Seroquel Prolong

Ireland

Seroquel XR

Italy

Seroquel compresse a rilascio prolungato

Latvia

Seroquel XR

Lithuania

Seroquel XR

Luxembourg

Seroquel XR

Netherlands

Seroquel XR

Quetiapine XR AstraZeneca

Norway

Seroquel Depot

Portugal

Seroquel SR

Slovakia

Seroquel XR

Slovenia

Seroquel SR

Spain

Seroquel Prolong

Sweden

Seroquel Depot

United Kingdom

Seroquel XL

This leaflet was last revised in 05/2020.

Blind or partially sighted?

Is this leaflet hard to see or read?

Write to info@originalis.eu

to obtain the leaflet in a format

suitable for you.

Health Products Regulatory Authority

22 July 2019

CRN008VL3

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Aromasin 25 mg coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains 25 mg of exemestane.

Excipients with known effect

Sucrose

Methyl parahydroxybenzoate (E218)

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Coated tablet

Product imported from Lithuania

Round, biconvex, off-white coated tablet marked 7663 on one side.

4 CLINICAL PARTICULARS

As per PA0822/111/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0822/111/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica, colloidal hydrated (E551)

Crospovidone

Hypromellose (E464)

Magnesium stearate (E572)

Mannitol (E421)

Microcrystalline cellulose (E460)

Sodium starch glycolate (type A)

Polysorbate 80 (E433)

Polyvinyl alcohol

Simeticone

Macrogol 6000

Sucrose

Magnesium carbonate, light (E504)

Methyl Parahydroxybenzoate (E218)

Cetyl esters wax

Talc

Carnauba wax

Ethyl alcohol

Shellac

Titanium Dioxide (E171)

Black Iron Oxide (E172)

Health Products Regulatory Authority

22 July 2019

CRN008VL3

Page 2 of 2

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product as marketed

in the country of origin

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Blisters of 30 coated tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Originalis B.V.

Joop Geesinkweg 901

1114 AB Amsterdam-Duivendrecht

Netherlands

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA2306/015/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19

July 2019

10 DATE OF REVISION OF THE TEXT

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