PACKAGE LEAFLET : INFORMATION FOR THE USER
Calmax 0.25mg Tablets
Calmax 0.5mg Tablets
Calmax 1.0mg Tablets
Alprazolam
Read all of this leaflet carefully before you start taking this medicine.
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Keep this leaflet. You may need to read it again
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This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
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If you have any further questions, ask your doctor or pharmacist.
are the same as yours.
If any side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
IN THIS LEAFLET
1
What Calmax Tablets is and what it is used for
3.
How to take Calmax
2.
4.
5.
6.
Before you take Calmax
Possible side effects
How to store Calmax
Further information
1. WHAT IS CALMAX AND WHAT IT IS USED FOR
Calmax is used for the short-term treatment of severe/disabling anxiety.
Calmax contains the active ingredient alprazolam. Alprazolam belongs to a group of medicines called benzodiazepines. It
works by depressing activity in the part of the brain that controls emotion, by promoting the action of a chemical called
gamma-aminobutyric acid (GABA). Alprazolam is thought to increase the inhibitory effect of GABA on brain cells, thus
preventing excessive brain activity that causes anxiety.
2. BEFORE YOU TAKE CALMAX?
If the answer to any of the following questions is YES, DO NOT take this medicine without consulting your doctor.
Do not take Calmax if
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You have previously suffered an allergic reaction to a medicine containing alprazolam or other benzodiazepines.
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You are pregnant, planning to become pregnant or breast feeding.
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You are allergic to any of the other ingredients in this medicine. (See Section 6, Further Information).
You have the condition known as myasthenia gravis.
You suffer from a liver complaint.
You have breathing difficulties.
You suffer from sleep apnoea (a condition whereby your breathing stops at intervals while you are sleeping).
You had a problem with alcohol or drug abuse.
Take special care with Calmax
Use of alprazolam may lead to dependence on the drug and there is also a risk of withdrawal symptoms when you stop taking
it. Your doctor will advise you on this.
Tell your doctor if you:
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are under18 years old (treatment should only be started under the care of a specialist)
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have lung, liver or kidney problems
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Elderly patients should get a reduced dose (see section 3 How to take Calmax)
are suffering from depression
have a history of drug or alcohol dependence
Amnesia (Memory Loss)
Benzodiazepines may induce short term memory loss also known as anterograde amnesia. The condition occurs most often
several hours after taking the product and therefore to reduce the risk patients should ensure that they will be able to have an
uninterrupted sleep of 7-8 hours (see also section 4 Possible side effects).
Behavioural and Psychiatric reactions
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses,
inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this
occur, use of the drug should be discontinued.
They are more likely to occur in children and the elderly.
TAKING OTHER MEDICINES?
You should consult your doctor BEFORE taking any other medicine including:
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Medicines used to relieve anxiety, e.g. chlordiazepoxide.
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Medicines used for depression, e.g. amitriptyline.
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Sleeping tablets, e.g. temazepam.
Strong pain relieving medicines, e.g. morphine.
Medicines used to treat mental disorders e.g. thioridazine.
Medicines used to treat epilepsy, e.g. phenytoin.
Antihistamines, e.g. chlorpheniramine.
Drugs which affect liver enzymes (cytochrome P450), e.g. fluoxetine and paroxetine.
If you are to undergo surgery you should inform the surgeon or anaesthetist of your treatment with Calmax.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
TAKING CALMAX WITH FOOD AND DRINK
Do not drink alcohol while taking Calmax without first asking your doctor as the sedative effects of the drug may be increased.
PREGNANCY AND BREASTFEEDING
Calmax should only be used during pregnancy if considered essential by your doctor. Do NOT take this medicine during
pregnancy without first consulting your doctor. Calmax should NOT be taken by breastfeeding mothers.
DRIVING AND USING MACHINES
As this medicine may make you feel dizzy or drowsy or impair muscular function, you should not drive or operate
machinery until you know how the drug affects you.
3. HOW TO TAKE CALMAX?
You should take your medicine as directed by your doctor. The pharmacists label should tell you how much to take and how
often. If it does not or you are not sure ask your doctor or pharmacist.
The usual doses are as follows:
Adults only
The usual starting dose is 0.25mg to 0.5mg twice times daily. If required, your doctor may increase the dose gradually up to a
total daily dose of 3 to 4mg in divided doses.
Frail or elderly patients
0.25mg twice daily. If required, your doctor may increase the dose gradually to suit individual requirements.
Treatment with Calmax should not normally be more than 8-12 weeks. In certain cases your doctor may prescribe Calmax
beyond the usual maximum treatment period.
The tablets should be swallowed with a drink of water.
Calmax is not recommended for children.
IF YOU TAKE MORE CALMAX THAN YOU SHOULD?
If you accidentally take too many tablets you should contact your doctor or nearest hospital casualty department immediately.
IF YOU FORGET TO TAKE CALMAX
If you forget to take a dose, take it as soon as you remember. If your next dose is due within two hours, take a single dose
now and omit the next dose.
IF YOU STOP TAKING CALMAX
Do not stop taking your medicine abruptly, you should follow your doctor’s advice carefully.
Use of alprazolam may lead to dependence on the drug and there is also a risk of withdrawal symptoms when you stop taking
it. Your doctor will advise you on this.
4. POSSIBLE SIDE EFFECTS?
Like most other medicines may cause unwanted effects although not everybody gets them.
The following unwanted effects may occur at the start of treatment and usually disappear with time.
Drowsiness
Dizziness
Double vision
Feeling exhausted
Numbed emotions
Muscle weakness
Headache
Reduced alertness
Confusion
Unsteadiness
Other unwanted effects which may occur include stomach or bowel upset, skin rash, changes in sexual desire, depression,
amnesia, restlessness, agitation, irritability, aggressiveness, delusion, rages, mental disorders (psychoses), nightmares,
hallucinations and inappropriate behaviour.
Treatment with alprazolam may lead to dependence and abuse, with withdrawal symptoms after stopping treatment. You
should contact your doctor without delay if you experience these symptoms.
If any of the side effects gets serious, or if you notice any side effects not list in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CALMAX?
KEEP ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.
Do not store above 25°C.
Keep blisters in the outer carton.
The tablets are sensitive to light and moisture and you should keep them stored in the blister strips in the outer carton.
Do not use this medicine after expiry date or ‘Use before’ date stated on the carton or blister. The expiry date, or ‘Use before’,
refers to the last day of that month.
6. FURTHER INFORMATION
WHAT CALMAX CONTAINS
Calmax 0.25mg tablets:
White, oblong tablets marked with ‘apzm 0.25’ and a breakline.
Calmax 0.5mg tablets:
Pink, oblong tablets marked with ‘apzm 0.5’ and a breakline.
Calmax 1.0mg tablets:
Pack Size: 100 tablets
Each tablet contains 0.25 mg alprazolam.
Each tablet contains 0.5mg alprazolam.
Light blue, oblong tablets marked with ‘apzm 1’ and a breakline.
Each tablet contains 1.0mg alprazolam.
The tablets also contain the following other ingredients:
Docusate Sodium
Pregelatinised starch
Lactose monohydrate
Sodium benzoate (E211)
Colloidal silicon dioxide
Microcrystalline cellulose
Magnesium stearate
The 0.5mg tablets contain the colour erythrosine aluminium lake (E127); the 1.0mg tablets contain the colour indigotine blue
(E132).
P.A Holder:
Helsinn Birex Therapeutics Ltd.,
Mulhuddart,
Manufacturer: Damastown,
Dublin 15
Marketed in Ireland by: Ergha Healthcare, Damastown, Mulhuddart, Dublin 15.
Calmax 0.25mg tablets
PA915/25/1
Calmax 1.0mg tablets
PA915/25/3
Calmax 0.5mg tablets
PA915/25/2
Date leaflet last revised: August 2010
PMCALTPIL/03
Toll Manufacturing Services SL,
C/ Aragoneses 2,
28108 Alcobendas,
Madrid, Spain.