Drug Ingredient Information
ESCITALOPRAM-10MG+CLONAZEPAM-0.5MG
ESCITALOPRAM
| Information for
patients
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| Drug Information |
Escitalopram is used to treat depression. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are thought to work by their actions on brain chemicals called amines which are involved in controlling mood.
Depression is longer lasting or more severe than the “low moods” everyone has from time to
time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in
parts of the brain. This imbalance affects your whole body and can cause emotional and
physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to
enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex
drive, lack of energy and feeling guilty over nothing.
Escitalopram corrects this chemical imbalance and may help relieve the symptoms of depression.
Escitalopram may also be used to treat patients who may avoid and/or are fearful of social
situations.
Escitalopram may also be used to treat patients who have excessive anxiety and worry.
Escitalopram may also be used to treat irrational fears or obsessional behaviour (obsessive-
compulsive disorder). Obsessive-compulsive disorder involves having both obsessions and
compulsions. Obsessions are unwanted thoughts that occur over and over again.
Compulsions are the ongoing need to repeat certain actions as a result of these thoughts.
Your doctor, however, may prescribe it for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is only available with a doctor’s prescription.
Escitalopram is not addictive. |
| Drug Alert |
| Alert |
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| Before Consuming
the Medicine
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| Avoid Drug |
Do not take Escitalopram if you are allergic to it, to any medicine containing citalopram, or
any of the ingredients listed in the contents
Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing, swelling of the face, lips, tongue or other parts of the body, or rash, itching or hives on the skin.
Do not take it after the expiry date printed on the pack.
If you take it after the expiry date has passed, it may not work as well. The expiry date refers to the last day of the month.
Do not take it if the packaging is torn or shows signs of tampering. |
| Drug Special Care |
Before you start to take it
Tell your doctor if:
1. you have allergies to any other substances such as foods, preservatives or dyes.
2. you are pregnant or intend to become pregnant.
3. you are breast-feeding or planning to breast-feed.
4. you have, or have had, the following medical conditions:
a tendency to bleed or bruise easily
diabetes
heart disease
kidney disease
liver disease
bipolar disorder (manic depression)
a history of seizures or fits
restlessness and/or a need to move often.
5. you are receiving electroconvulsive therapy.
Do not give Escitalopram to a child or adolescent.
There is no experience with its use in children or adolescents under 18 years old.
Escitalopram can be given to elderly patients over 65 years of age with a reduced dose.
The effects of Escitalopram in elderly patients are similar to that in other patients.
If you have not told your doctor about any of the above, tell them before you use Escitalopram.
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Escitalopram.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this
medicine.
Tell your doctor immediately if you have any suicidal thoughts or other mental or mood
changes. All mentions of suicide or violence must be taken seriously. Occasionally, the symptoms of
depression may include thoughts of suicide or self-harm. It is possible that these symptoms continue or get
worse until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur if you
are a young adult, i.e. 18 to 24 years of age, and you have not used antidepressant medicines before.
If you or someone you know demonstrates any of the following warning signs of
suicide-related behaviour while taking Escitalopram, contact a health care provider
immediately, or even go to the nearest hospital for treatment:
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
increase in aggressive behaviour, irritability or agitation.
Do not stop taking this medicine or change the dose without consulting your doctor,
even if you experience increased anxiety at the beginning of treatment.
At the beginning of treatment, some patients may experience increased anxiety which will
disappear during continued treatment.
Tell your doctor immediately if you experience symptoms such as restlessness or
difficulty in sitting or standing still. These symptoms can occur during the first weeks of treatment.
Contact your doctor as soon as possible if you suddenly experience an episode of
mania. Some patients with bipolar disorder (manic depression) may enter into a manic phase. This is
characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive
physical activity.
Sometimes you may be unaware of the above-mentioned symptoms and therefore you may
find it helpful to ask a friend or relative to help you to observe the possible signs of change in
your behaviour.
Things you must not do
Do not give the tablets to anyone else, even if they have the same condition as you.
Do not take Escitalopram to treat any other complaints unless your doctor tells you to.
Do not stop taking Escitalopram, or lower the dosage, without checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Suddenly stopping Escitalopram may cause unwanted discontinuation symptoms such as
dizziness, headache and nausea. Your doctor will tell you when and how Escitalopram should be
discontinued. Your doctor will gradually reduce the amount you are using, usually over a
period of one to two weeks, before stopping completely.
Things to be careful of
Avoid alcohol while you are taking this medicine. It is not advisable to drink alcohol while you are being treated for depression. |
| Drug Drug Interactions |
Do not take Escitalopram at the same time as the following other medicines:
? pimozide, a medicine used to treat mental disorders
? monoamine oxidase inhibitors (MAOIs), which are also used for the treatment of depression.
Do not take Escitalopram when you are taking a MAOI or when you have been taking a MAOI
within the last 14 days. Taking Escitalopram with MAOIs may cause a serious reaction with a
sudden increase in body temperature, extremely high blood pressure and severe convulsions. Your
doctor will know when it is safe to start Escitalopram after the MAOI has been stopped.
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Escitalopram may interfere with each other. These include:
? bupropion, a medicine helping to treat nicotine dependence
? medicines used to treat reflux and ulcers, such as cimetidine, omeprazole, esomeprazole
? and lansoprazole
? medicines known to prolong bleeding, e.g. aspirin or other non-steroidal anti-inflammatory
? drugs (NSAIDs)
? ticlopidine and warfarin, medicines used to prevent blood clots
? mefloquine, an anti-malaria medicine
? sumatriptan, used to treat migraines
? tramadol, used to relieve pain
? medicines affecting the chemicals in the brain
? some heart medications, e.g. flecainide, propafenone, metoprolol
? tryptophan, an amino-acid
? lithium, used to treat mood swings and some types of depression
? antipsychotics, a class of medicines used to treat certain mental and emotional conditions, e.g. risperidone, thioridazine and haloperidol
? tricyclic antidepressants, e.g. imipramine, desipramine
? St John''s Wort (Hypericum perforatum), a herbal remedy
? any other medicines for depression, anxiety, obsessive-compulsive disorder or pre- menstrual dysphoric
disorder.
These medicines may be affected by Escitalopram, or may affect how well it works. You may need
to use different amounts of your medicines, or take different medicines. Your doctor will
advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid
while taking Escitalopram. |
| Drug Pregnancy Interaction |
Do not take Escitalopram if you are pregnant unless you and your doctor have discussed the
risks and benefits involved. If you take this medicine during the last three months of your
pregnancy, the general condition of your newborn baby might be affected.
Make sure your doctor and/or midwife know you are on Escitalopram. When taken during
pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your doctor and/or midwife immediately.
If used during pregnancy Escitalopram should never be stopped abruptly.
Ask your doctor or pharmacist for advice before taking any medicine. |
| Drug Breast feeding Interaction |
Do not take Escitalopram if you are breast-feeding unless you and your doctor have discussed
the risks and benefits involved. It is not recommended that you breast-feed while taking
Escitalopram as it is excreted in breast milk. |
| Drug Machinery Interaction |
Be careful driving or operating machinery until you know how Escitalopram affects you.
It may cause nausea, fatigue and dizziness in some people, especially early in the treatment.
If you have any of these symptoms, do not drive, operate machinery, or do anything else that
could be dangerous. |
| Drug More Information |
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| How to take the
Medicine
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| Consumption Info |
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| Drug quanitty |
Your doctor will decide what dose you will receive.
Follow the instructions they give you.
If you take the wrong dose, Escitalopram may not work as well and your condition may not
improve.
The standard dose for this medicine is 10 mg per day. This may be increased by your doctor to 20 mg per day.
The recommended maximum dose in elderly patients is 10 mg per day.
It is recommended that patients with liver disease receive an initial dose of 5 mg daily for the first two weeks. Your doctor may increase the dose to 10 mg daily.
Your doctor may have prescribed a different dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take. |
| Drug Dose |
How to take it
To remove tablet: - It is not recommended that you push the tablet through both layers of paper and foil. Peeling back the top layer of paper first, (as shown by an arrow on the corner of the blister), will expose the foil which when broken, will allow you to release the tablet from the blister bubble.
Swallow the tablets whole with a full glass of water.
Do not chew them.
When to take it
Take Escitalopram as a single dose either in the morning or in the evening.
Take Escitalopram with or without food.
How long to take it
Continue to take Escitalopram even if it takes some time before you feel any improvement in your condition. As with other medicines for the treatment of these conditions it may take a few weeks before
you feel any improvement. Individuals will vary greatly in their response to Escitalopram. Your doctor will
check your progress at regular intervals. The duration of treatment may vary for each individual, but is usually
at least 6 months. In some cases the doctor may decide that longer treatment is necessary.
Continue taking your medicine for as long as your doctor tells you, even if you begin to feel better. The underlying illness may persist for a long time and if you stop your treatment too soon, your symptoms may return. |
| Excess Drug Consumption |
Immediately telephone your doctor, or the Poisons Information Centre or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Escitalopram. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.Symptoms of an overdose may include dizziness, low blood pressure,
nausea (feeling sick), vomiting, agitation, tremor (shaking) and rarely convulsions and coma. |
| Forgot Drug Consumption |
If you miss a dose and remember in less than 12 hours, take it straight away, and then go back to taking it as you would normally. Otherwise, if it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to. Do not take a double dose to make up for the dose you have missed.
If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering when to take your medicine, ask your pharmacist for
hints. |
| Stop Drug Consumption |
Do not stop taking this medicine suddenly.
If Escitalopram is stopped suddenly you may experience mild, but usually temporary, symptoms such as dizziness, pins and needles, electric shock sensations, sleep disturbances (vivid dreams, inability to sleep), feeling anxious or agitated, headaches, feeling sick (nausea), vomiting, sweating, tremor (shaking), feeling confused, feeling emotional or irritable, diarrhoea, visual disturbances, or fast or irregular heart beats.
When you have completed your course of treatment, the dose of Escitalopram is gradually reduced over a couple of weeks rather than stopped abruptly.
Your doctor will tell you how to reduce the dosage so that you do not get these unwanted effects. |
| Possible Side
Effects
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| General Information |
All medicines may have some unwanted side effects. Sometimes they are serious, but most
of the time they are not. Your doctor has weighed the risks of using this medicine against the
benefits he/she expects it will have for you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are
taking Escitalopram.
It helps most people with depression, social anxiety disorder (social phobia), generalised
anxiety disorder and obsessive-compulsive disorder, but it may have unwanted side effects in
a few people.
The side effects of Escitalopram are, in general, mild and disappear after a short period of time.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some people.
Do not be alarmed by this list of possible side effects.
You may not experience any of them. |
| Common Drug Side Effects |
Tell your doctor if you notice any of the following and they worry you:
? decreased appetite or loss of appetite
? dry mouth
? diarrhoea
? nausea (feeling sick)
? sleeplessness
? fatigue, sleepiness or drowsiness, yawning
? increased sweating
? sexual disturbances (decreased sexual drive; problems with ejaculation or erection; women may experience difficulties achieving orgasm). |
| Rare Drug Side Effects |
Tell your doctor as soon as possible if you notice any of the following:
? agitation, confusion, panic attacks, anxiety, restlessness
? dizziness
? dizziness when you stand up due to low blood pressure
? low sodium levels in the blood (the symptoms are feeling sick and unwell with weak muscles or feeling confused)
? abnormal liver function tests (increased amounts of liver enzymes in the blood)
? difficulties urinating
? unusual secretion of breast milk
? increased tendency to develop bruises
? rash, itching, patches of circumscribed swellings.
These may be serious side effects of Escitalopram. You may need urgent medical attention. |
| Very Rare Drug Side Effects |
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following:
? serious allergic reaction
? (symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat
? which may cause difficulty in swallowing or breathing, or hives)
? high fever, agitation, confusion, trembling and abrupt contractions of muscles
? (these symptoms may be signs of a rare condition called serotonin syndrome)*
? mania*, hallucinations
? seizures, tremors, movement disorders (involuntary movements of the muscles)*.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
*The side effects marked with an asterisk (*) are a number of rare side effects that are known to occur with medicines that work in a similar way to Escitalopram. |
| Drug Side Effects Symptoms |
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| How to Store the
Medicine
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| How to Store the Medicine |
Storage
Keep Escitalopram tablets in the blister pack until it is time to take them.
If you take the tablets out of the box or the blister pack they may not keep well.
Keep Escitalopram tablets in a cool dry place where the temperature stays below 30°C.
Keep Escitalopram oral solution in a cool dry place where the temperature stays below 25°C.
Discard Escitalopram oral solution 3 months after first opening.
Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.
Do not leave it in the car.
Heat and damp can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking Escitalopram, or the medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.
Return any unused medicine to your pharmacist. |
CLONAZEPAM
| Information for
patients
|
| Drug Information |
It contains a medicine called clonazepam. This belongs to a group of medicines called ‘benzodiazepines’.
Clonazepam is used to treat epilepsy in infants, children and adults.
•It lowers the number of fits (seizures) that you have.
•Any fits that you do have will be less serious. |
| Drug Alert |
| Alert |
•Clonazepam or any of the other ingredients of Clonazepam.
•Other ‘benzodiazepine’ medicines. These include diazepam, flurazepam and temazepam. Do not take Clonazepam if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Clonazepam. |
| Before Consuming
the Medicine
|
| Avoid Drug |
•You have breathing problems or lung disease.
•You have severe liver problems.
•You have a condition called ‘myasthenia gravis’ (where your muscles become weak and get tired easily).
•You have a condition called ‘sleep apnoea syndrome’ (where your breathing stops when you are asleep). Do not take Clonazepam if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Clonazepam. |
| Drug Special Care |
A small number of people being treated with anti-epileptics such as clonazepam have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Check with your doctor or pharmacist before taking Clonazepam if:
•You have liver, kidney or lung problems.
•You have ever had depression.
•You have ever tried to kill yourself.
•A close friend or relative has recently died.
•You regularly drink alcohol or take recreational drugs or you have had problems with alcohol or drug use in the past.
•You have spinal or cerebellar ataxia (where you may become shaky and unsteady, have slurred speech or rapid eye movements).
•You have a rare, inherited blood problem called ‘porphyria’.
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Clonazepam. |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Clonazepam can affect the way some other medicines work. Also some other medicines can affect the way Clonazepam works.In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
•Other medicines to treat epilepsy, such as carbamazepine, hydantoins, phenobarbital, phenytoin, primidone or sodium valproate.
•Cimetidine (used to treat stomach problems and heartburn).
•Rifampicin (an antibiotic used to treat infections).
•Medicines used to make you sleep (hypnotics).
•Medicines that help with anxiety (tranquillisers).
•Pain-killers (analgesics) and medicines to relax your muscles (muscle relaxants).
Operations
If you are going to have an anaesthetic for an operation or for dental treatment, it is important to tell your doctor or dentist that you are taking Clonazepam. |
| Drug Pregnancy Interaction |
Do not take Clonazepam if you are pregnant, might become pregnant or are breast-feeding, unless your doctor tells you to. This is because Clonazepam will affect your baby. |
| Drug Breast feeding Interaction |
Do not take Clonazepam if you are pregnant, might become pregnant or are breast-feeding, unless your doctor tells you to. This is because Clonazepam will affect your baby. |
| Drug Machinery Interaction |
Talk to your doctor about driving and using machines or tools, whilst you are taking Clonazepam. This is because it can slow down your reactions, particularly when you start taking it. If you are in any doubt about whether you can do a particular activity, talk to your doctor |
| Drug More Information |
Do not drink alcohol while you are taking Clonazepam. This is because it may cause side effects or cause your fits to return. |
| How to take the
Medicine
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| Consumption Info |
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| Drug quanitty |
Adults and children over 12 years
•The usual starting dose is 1 mg a day, or less.
•This will be increased gradually (usually to between 4 mg and 8 mg a day). The maximum dose is 20 mg a day.
The elderly
•The usual starting dose is 0.5 mg a day, or less.
•This will be increased gradually (usually to between 4 mg and 8 mg a day). The maximum dose is 20 mg a day.
Infants (aged 0 to 1 year)
•The usual starting dose is 0.25 mg a day, or less.
•This will be increased gradually (usually to between 0.5 mg and 1 mg a day).
Small children (aged 1 to 5 years)
•The usual starting dose is 0.25 mg a day, or less.
•This will be increased gradually (usually to between 1 mg and 3 mg a day).
Older children (aged 5 to 12 years)
•The usual starting dose is 0. 5 mg a day, or less.
•This will be increased gradually (usually to between 3 mg and 6 mg a day). |
| Drug Dose |
Always take Clonazepam exactly as your doctor has told you. You should check with your doctor if you are not sure.
•Your doctor will start you on a low dose of Clonazepam and gradually increase it over 2 to 4 weeks until the right dose has been found for you.
•Your doctor will usually tell you to split your daily dose into three equal amounts which you will take at evenly spaced times throughout the day.
•If the daily dose cannot be split equally, take the largest dose at bedtime.
•Once your doctor has found the right dose for you, they may tell you to take Clonazepam as a single dose in the evening. |
| Excess Drug Consumption |
•If you take more Clonazepam than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
•If you take too many tablets, you may feel drowsy, sleepy, light-headed, have a lack of co-ordination or be less responsive than normal. |
| Forgot Drug Consumption |
•If you forget to take a dose, skip the missed dose. Then take the next dose when it is due.
•Do not take a double dose (two doses at the same time) to make up for a forgotten dose. |
| Stop Drug Consumption |
•Do not stop taking your tablets without talking to your doctor. If you do, your fits may return and you may get withdrawal symptoms (see Section 4: Possible side effects).
•If the dose of Clonazepam you take has to be reduced, or stopped, this must be done gradually. Your doctor will let you know how to do this.If someone else takes your Clonazepam tablets by mistake, they should talk to a doctor or go to a hospital straight away.If you have any further questions on the use of this medicine, ask your doctor or pharmacist. |
| Possible Side
Effects
|
| General Information |
•Poor concentration, confusion and a feeling of being lost (disorientation).
•Feeling restless.
•Difficulty remembering new things.
•Headache.
•Depression.
•Slowing or slurring of speech.
•Poor co-ordination, including feeling unsteady when walking.
•An increase in how often you have fits.
Liver, kidney and blood
•Changes in how well your liver is working (shown by blood tests).
•Loss of bladder control.
•Blood problems. The signs include feeling tired, bruising easily, being short of breath and nose bleeds. Your doctor may want you to have blood tests from time to time.
Stomach and gut
•Feeling sick (nausea).
•Stomach upset.
Eyes
•Double vision.
•Jerky movements of the eyes (nystagmus).
Skin and hair
•Skin rashes and itchy skin.
•Changes to the colour of your skin.
•Hair loss (the hair usually grows back).
Sexual
•Loss of sex drive.
•Difficulty getting or keeping an erection (erectile dysfunction). |
| Common Drug Side Effects |
Allergic reactions
If you get an allergic reaction, see a doctor straight away.
The signs may include:
•Sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
•Sudden swelling of the hands, feet and ankles.
•Skin rash or itching.
Effects on the heart
If you notice any of the following effects, see a doctor straight away.The signs may include:
•Breathlessness, swelling of the ankles, cough, tiredness and a racing heart.
•Chest pain which may spread to your neck and shoulders and down your left arm.
Effects on behaviour
If you notice any of the following effects, talk to your doctor as they may want you to stop taking Clonazepam. The signs may include:
•Being aggressive, excited, irritable, nervous, agitated, or anxious.
•Problems sleeping, nightmares and vivid dreams.
•Mental problems such as seeing or hearing things that are not really there (hallucinations), delusions (believing in things that are not real) and problems with your speech.
•Types of fits (seizures) that you have not had before.
Infants and children
•If an infant or small child is taking Clonazepam, watch them carefully. This is because they could develop breathing problems, coughing or choking. This can be caused by too much saliva being made.
•Early puberty in children. This is reversible after stopping treatment with Clonazepam.
Elderly patients
Older patients taking benzodiazepine medicines have a higher risk of falling and breaking bones. |
| Rare Drug Side Effects |
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| Very Rare Drug Side Effects |
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| Drug Side Effects Symptoms |
Using benzodiazepines like Clonazepam may make you dependent on the medicine. This means that if you stop treatment quickly, or reduce the dose too quickly, you may get withdrawal symptoms. The symptoms can include:
•Problems sleeping.
•Muscle pain, shaking (tremor) and feeling restless.
•Feeling very anxious, tense, confused, irritable or agitated, or changes in your mood.
•Increased sweating.
•Headache.
•Feeling sensitive to light, noise and physical contact.
•Seeing or hearing things that are not really there (hallucinations).
•Tingling and feeling numb in your arms and legs.
•A feeling of losing contact with reality. |
| How to Store the
Medicine
|
| How to Store the Medicine |
•Keep Clonazepam tablets in their original bottle and in the outer carton to protect from light.
•Clonazepam tablets do not need special storage conditions.
•Keep out of the reach and sight of children.
•Do not use Clonazepam after the expiry date printed on the pack.
•Do not throw away any left over tablets. Instead, return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to. |
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