TEMESTA 1MG TABLETS

Active substance: LORAZEPAM

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Temesta® 1mg Tablets/Lorazepam 1mg Tablets
(lorazepam)
Your medicine is known by the above names, but will be referred to as
Lorazepam Tablets throughout this:
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side-effects get serious, or if you notice any side-effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Lorazepam Tablets are and what they are used for
2) Before you take Lorazepam Tablets
3) How to take Lorazepam Tablets
4) Possible side-effects
5) How to store Lorazepam Tablets
6) Further information

1) What Lorazepam tablets are and what they are used for
The name of your medicine is Lorazepam Tablets. Lorazepam is a member
of a group of medicines called benzodiazepines. It can help to relieve
anxiety. Lorazepam is prescribed as short-term therapy for anxiety (2 -4
weeks), or sleeping difficulties due to anxiety. It may also be used as a
sedative before surgery or operative dental treatment.
Lorazepam Tablets are not to be used for longer than 4 weeks, to treat mild
or moderate anxiety in adults or for anxiety/insomnia in children.

2) Before you take Lorazepam tablets
Do not take Lorazepam Tablets:
 if you have severe breathing or chest problems
 if you are allergic to benzodiazepines or any of the other ingredients in
Lorazepam Tablets (see list under ‘What Lorazepam Tablets contain’)
 if you have myasthenia gravis (very weak or tired muscles)
 if you have serious liver problems
 if you suffer from sleep apnoea (breathing problems when you are asleep)
 if you are breast-feeding, since the drug may pass into breast milk.
 if you are planning a pregnancy or are pregnant.
If you have been only prescribed Lorazepam Tablets for anxiety and no
other medications, please consult with your doctor whether other
medications should also be prescribed.
When special care is required with Lorazepam Tablets:
Please consult your doctor if any of the following apply:
 if you abuse or have in the past abused drugs or alcohol
 if you have a personality disorder. If so, you have a greater chance of
becoming dependent on Lorazepam
 if you have any kidney or liver problems
 if you are suffering from depression, since Lorazepam may increase any
suicidal feelings which you may have
 if you have suffered from depression before, since it could re-occur during
treatment with Lorazepam
 if you suffer from breathing problems
 if you are suffering from an eye problem called glaucoma e.g. high
pressure within the eye.
Taking other medicines
Tell your doctor or pharmacist that you are taking Lorazepam Tablets
before taking any other medicine or if you enter hospital for treatment, or if
you are taking any other medicines, including those which have not been
prescribed by a doctor, since they may affect the way Lorazepam Tablets
work.
Lorazepam Tablets may also affect the way other drugs work. In particular,
you should tell your doctor if you are taking any other sedative (e.g.
barbiturates or antihistamines), anti-anxiety drugs, anti-depressants, strong
pain killers (e.g. methadone), drugs for epilepsy (e.g. phenobarbital or
valproate), antihistamines, or drugs for mood or mental disorders (e.g.
chlorpromazine, loxapine or clozapine), drugs for cataplexy; treating HIV; to
treat delusions or hallucinations; to help with indigestion (e.g. cisapride or
omeprazole); muscle relaxants (e.g. baclofen and tizanidine); drugs for
addiction treatment (e.g. lofexidine and disulfram); TB drugs such as
isazanid; antibiotics such as erthromycin; drugs to treat high blood

pressure; Parkinson's disease drugs e.g. levodopa; oestrogen-containing
contraceptives and drugs for asthma (theophylline). The dose of these
drugs may need to be reduced before you can take Lorazepam Tablets.
Using Lorazepam Tablets with food or drink
Grapefruit juice and drinks containing caffeine should be avoided as they
can affect the way that Lorazepam Tablets work.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, or might become pregnant,
without consulting your doctor. Benzodiazepines, including lorazepam, may
cause damage to the foetus if taken during early pregnancy.
If you take this medicine during late pregnancy or during labour, your baby,
when born, may be less active than other babies, have a low body
temperature, be floppy, or have breathing or feeding difficulties for a while.
Your baby’s response to the cold might be temporarily impaired. If this
medicine is taken regularly in late pregnancy, your baby may develop
withdrawal symptoms after birth.
Do not take this medicine if you are breast-feeding, since the drug may
pass into breast milk, and cause the baby to be less active and unable to
suckle.
Driving and using machines
Lorazepam tablets may make you feel dizzy, sleepy or forgetful during the
day, or may affect your concentration. This may affect your performance at
skilled tasks such as driving machinery or operating machinery by affecting
your vision or muscle function. You should not take part in any other
activities where this could put yourself or others at risk.
You should avoid alcohol while you are taking Lorazepam tablets, since this
may make you very drowsy and seriously affect your ability to drive or use
machines.
The medicine can affect your ability to drive as it may make you sleepy or
dizzy
 Do not drive while taking this medicine until you know how it affects you.
 It is an offence to drive if this medicine affects your ability to drive.
 However, you would not be committing an offence if:
 The medicine has been prescribed to treat a medical or dental
problem and
 You have taken it according to the instructions given by the prescriber
or in the information provided with the medicine and
 It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is safe for
you to drive while taking this medicine.
Important information about some of the ingredients of Lorazepam
Tablets. The 2.5mg Lorazepam Tablet contains the colour tartrazine
(E102) which can cause allergic reactions, including asthma, especially if
you are also allergic to aspirin.
Each tablet also contains the equivalent of 0.25mg of potassium. Too
much potassium may be harmful if you are on a low potassium diet.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3) How to take Lorazepam tablets
Always take Lorazepam Tablets exactly as your doctor has told you. The
label on your medicine should also tell you. You should check with your
doctor or pharmacist if you are not sure. Lorazepam Tablets should be
swallowed with water.
Adults (and children over 13 years of age)
- Anxiety: 1 to 4mg daily in divided doses. Your doctor will tell you how
often to take your tablets.
- Sleeping Problems: 1 to 2mg before going to sleep. You should make
sure that you will be able to sleep for 7 to 8 hours before taking your
tablets.
- Before Surgery: 2 to 3mg the night before your operation and 2 to 4mg 1
or 2 hours before your operation.

Children (between 5 and 13 years of age)
 Before Surgery: The dose is usually between 0.5 and 2.5mg (depending
on your child’s weight) at least 1 hour before your child’s operation.
 Lorazepam is not recommended for the treatment of anxiety or sleeping
problems in children. Nor is it recommended for children below 5 years of
age.
Elderly or patients with liver or kidney problems
- Older patients may be given lower doses. They may respond to half the
usual adult dose or less.
Lorazepam is usually prescribed for short courses of treatment, lasting from
a few days to 4 weeks including a dose reduction at the end. This reduces
the risk of becoming dependent on Lorazepam Tablets, or suffering
unpleasant effects when you stop taking them (See 'If you stop taking
Lorazepam Tablets' section).
The beneficial effect of Lorazepam Tablets may be less apparent after
several weeks of use. If you are given Lorazepam Tablets for more than 4
weeks, your doctor might want to take blood samples occasionally to check
your blood and liver, since drugs like Lorazepam Tablets have occasionally
affected blood and liver function.
If you take more Lorazepam Tablets than you should
If anyone has taken an overdose of Lorazepam Tablets (that is more than
the doctor has prescribed), seek medical help immediately, either by calling
your doctor, or going to the nearest casualty department. Always take the
labelled medicine container with you, even if there are no tablets left.
If you forget to take Lorazepam Tablets
Do not take a double dose to make up for a forgotten tablet. If you
forget to take a tablet for anxiety, you should take it as soon as you
remember if it is less than 3 hours since your usual time. If more than 3
hours has passed from when you usually take your tablet, just take your
next tablet when it is due.
If you forget to take a tablet for sleeping problems, only take it if you will be
able to sleep for 7 to 8 hours afterwards.
If you stop taking Lorazepam Tablets
 After you have finished your prescribed treatment with Lorazepam, your
doctor will decide if you need further treatment.
 The number of Lorazepam Tablets and how often you take them should
always be reduced slowly before stopping them. This allows your body to
get used to being without your tablets, and reduces the risk of unpleasant
effects when you stop taking them. Your doctor will tell you how to do this.
 On stopping lorazepam, you may experience symptoms such as
headaches, muscle pain, anxiety, tension, depression, restlessness,
sweating, confusion or irritability. Your original sleeplessness may also
return. If you suffer from any of these symptoms, ask your doctor for
advice.
 Do not stop taking your tablets suddenly. This could lead to more serious
symptoms such as loss of the sense of reality, feeling unreal or detached
from life, and unable to feel emotion. Some patients have also
experienced numbness or tingling of the arms or legs, tinnitus (ringing
sounds in the ears), oversensitivity to light, sound and touch, uncontrolled
or overactive movements, twitching, shaking, feeling sick, being sick,
stomach upsets or stomach pain, loss of appetite, agitation, abnormally
fast heartbeats, panic attacks, dizziness or feeling that you are about to
fall, memory loss, hallucinations, feeling stiff and unable to move easily,
feeling very warm, convulsions (sudden uncontrolled shaking or jerking of
the body).
 Patients taking anti-depressants and patients with seizure disorders may
be more likely to experience convulsions.
If you suffer from any of these symptoms, ask your doctor for advice
immediately.

4) Possible side-effects
Like all medicines, Lorazepam Tablets can cause side-effects, although not
everybody gets them. These are usually not serious and do not last long.
If you experience any of the following more rare unwanted effects, you
should tell your doctor immediately (these effects are more likely to occur in
children and elderly patients):
Restlessness, agitation, irritability, aggressiveness, violent anger, sleeping
difficulties, nightmares, hallucinations, personality changes, sexual arousal,
abnormal behaviour or false beliefs.

Unexplained bleeding and/or bruising; increased risk of infections e.g.
frequent sore throats, mouth ulcers, weakness and pale skin as these are
symptoms of blood dyscrasia.
Severe allergic reactions e.g. difficulty in breathing, swelling of the lips,
mouth, tongue, throat, hands, feet and /or severe faintness or dizziness.
Jaundice e.g. yellowing of the skin, eyes, nose, mouth, pale coloured stools
(faeces) and dark coloured urine.
However, you should tell your doctor if any of the following symptoms are
severe or become troublesome:
Daytime drowsiness, dizziness, reduced alertness, poor muscle control,
muscle weakness, fatigue, hypersensitivity including anaphylaxis (allergic
reactions), confusion, depression, numbed emotions, difficulty controlling
urges and impulses to speak, act or show emotions, a feeling of well-being
for no reason, appetite changes, sleep problems, changes in sex drive,
decreased orgasm, thoughts of harming or killing yourself, becoming
dependent on Lorazepam tablets, headache, slurred speech, memory loss
or forgetfulness, trembling or shaking, impaired consciousness (ultimately
coma), problems with vision including double vision or blurred vision,
worsening of sleep apnoea e.g. loud snoring, restlessness and
choking/gasping during the night, breathing difficulties, stomach upsets,
nausea, constipation, changes in the amount of saliva in the mouth, skin
problems such as rashes and inflammation, erectile dysfunction.
Other rare unwanted effects, which you may not be aware of whilst taking
Lorazepam tablets, include blood or liver function changes, or low blood
pressure, or low body temperature.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5) How to store Lorazepam tablets
 Keep out of the sight and reach of children.
 Do not take Lorazepam Tablets after the expiry date which is stated on
the carton after EXP.
 The expiry date refers to the last day of the month.
 Do not store above 25°C. Store in the original package.
 Return any unused tablets to your pharmacist. Only keep them if your
doctor tells you to.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
 Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.

6) Further information
What Lorazepam Tablets contain
Each tablet contains 1mg of Lorazepam.
The other ingredients are lactose monohydrate, lactose anhydrous,
cellulose microcrystalline, polacrilin potassium and magnesium stearate.
What Lorazepam Tablets look like and the contents of the pack
Lorazepam Tablets are white capsule-shaped tablets, with 'L Z' on one face
and with a break bar on the other face.
Lorazepam Tablets are available in blister packs of 30 tablets.
PL 10383/1786

Temesta 1mg Tablets/Lorazepam 1mg Tablets POM

Who makes and repackages your medicine?
Your medicine is manufactured by Sanofi Winthrop Industrie, Compiegne,
France. Procured from within the EU and repackaged by the Product
Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 28.04.2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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