HYPNOVEL®
midazolam tablets 7.5 mg
What is in this leaflet
This leaflet answers some common questions about HYPNOVEL.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
your using HYPNOVEL against the benefits expected for you.
If you have any concerns about being given this medicine, ask your
doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What HYPNOVEL is used for
HYPNOVEL tablets are used for the short term treatment of insomnia.
HYPNOVEL tablets may be given to you before an operation to produce
sleepiness or drowsiness and to relieve anxiety.
HYPNOVEL belongs to a group of medicines called benzodiazepines. They are
thought to work by their action on brain chemicals. HYPNOVEL tablets will cause
sedation, and help you to sleep.
Your doctor, however, may have prescribed HYPNOVEL for another purpose.
Ask your doctor if you have any questions about why HYPNOVEL has been
prescribed for you.
If you will be receiving HYPNOVEL before minor surgery, your doctor will give
you the medicine and closely follow your progress.
This medicine is available only with a doctor's prescription.
Before you receive HYPNOVEL
Do not use HYPNOVEL tablets if
- you have had an allergic reaction to HYPNOVEL, any other
benzodiazepine medicine, or any of the ingredients listed at the end of this
leaflet - you have severe muscle weakness, also known as myasthenia gravis
- you have respiratory problems
- you have a condition called acute narrow angle glaucoma
- you have severe liver damage
- you are suffering from shock, coma or acute alcoholic intoxication
If you are not sure whether you should be given HYPNOVEL, talk to
your doctor.
Do not give HYPNOVEL tablets to children. An injection solution is
available which may be given by mouth for children who need sedation for minor
procedures.
Do not take Hypnovel if the expiry date printed on the pack has
passed. If the pharmacist has repacked the medicine for you, there may not be an
expiry date on the pack.
Before you receive it
Your doctor must know about all the following before you receive HYPNOVEL.
- if you are pregnant or plan to become pregnant
It is not known whether HYPNOVEL tablets are harmful to an unborn baby when
given to a pregnant woman. If there is a need to use HYPNOVEL when you are
pregnant, your doctor will discuss the risks and benefits to you and the
unborn baby. - if you are breastfeeding or plan to breastfeed
HYPNOVEL may pass into the breast milk and cause drowsiness and/or feeding
difficulties in the baby. HYPNOVEL tablets are not recommended for use while
breastfeeding. - if you have any other health problems including:
- liver, kidney or lung disease
- high or low blood pressure
- mental disorders including; depression, psychosis or schizophrenia
- epilepsy (fits or convulsions)
- if you drink alcohol regularly
Use of benzodiazepines may lead to the development of physical and
psychological dependence and the risk is increased with a history of alcohol
abuse. Tolerance to HYPNOVEL tablets may occur. - if you are allergic to any other medicines, foods, dyes or
preservatives.
Taking other medicines
Tell your doctor if you are taking any other medicines including any
that you have bought without a prescription from a pharmacy, supermarket or
healthfood shop.
Some medicines and HYPNOVEL tablets may interfere with each other. These
medicines include:
- other sleeping tablets, sedatives or tranquillisers
- medicines for depression
- medicines to control fits (Dilantin®, Epilim®,
Tegretol®, Teril®) - medicines for allergies or colds eg. antihistamines
- pain relievers (narcotics)
- cimetidine (Cytine®, Apo-cimetidine®, Duomet®,
Tagamet®), and ranitidine (Zantac®, Apo-ranitidine®)
medicine used to treat ulcers - disulfiram (Antabuse®), a medicine used in alcohol abuse
- erythromycin (ERYC®, ERA EMU-V®, EES®,
E-Mycin®), a common antibiotic - rifampicin, TB treatment
- diltiazem (Cardizem®, Apo-diltiazem®, Dilzem®,
Dilacor®, Dilcard®) - verapamil (Isoptin®, Civicor®)
- ketoconazole (Nizoral®) and itraconazole (Sporanox®)
- fluconazole (Diflucan®)
These medicines may be affected by HYPNOVEL or may affect how well HYPNOVEL
works. Your doctor or pharmacist can tell you what to do if you are taking any
of these medicines. They also know of other medicines to be careful with or
avoid while using HYPNOVEL.
If you have not told your doctor about any of the above, tell them
before you receive HYPNOVEL.
How to take HYPNOVEL
How much to take
Take HYPNOVEL tablets exactly as your doctor has prescribed.
Your doctor will tell you how many tablets to take each evening.
If you are having HYPNOVEL tablets before a minor surgical procedure this
will be administered by a doctor or nurse.
The normal dosage for insomnia is 7.5 to 15 mg (one to two tablets). The dose
for sedation before procedures is normally 15mg (two tablets).
How to take it
Swallow the tablets whole with a glass of water.
Take the tablets with or without food.
Do no break or crush tablets unless instructed to do so.
How long to take HYPNOVEL
HYPNOVEL is used for short term treatment of sleeping difficulty (insomnia)
or as instructed by your doctor.
Continue take HYPNOVEL tablets until your doctor tells you to stop.
If you forget to take HYPNOVEL
If you forget to take your HYPNOVEL and your sleep is all right, do not take
a dose until the next evening. If you miss a dose and wake up to have it, you
require 7 or 8 uninterrupted sleeps for the effects to wear off.
If you are not sure whether to skip the dose, talk to your doctor or
pharmacist.
In case of an overdose
Immediately telephone your doctor or National Poisons Information Centre
(telephone 0800 POISON or 0800 764 766) for advice or go to Accident and
Emergency at your nearest hospital if you think that you or anyone else may have
taken too much HYPNOVEL. Do this even if there are no signs of discomfort or
poisoning. You may need urgent medical attention. Keep telephone numbers for
these places handy.
Symptoms of overdosage may include feeling sick (nausea), vomiting,
dizziness, slowing of breathing, drowsiness and coma.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking HYPNOVEL
Things you must do
Do not take any other medicines whether they require a prescription
or not without first telling your doctor.
Tell your doctor if you feel HYPNOVEL tablets are not helping you.
Things you must not do
Do not drive or operate machinery until you know how HYPNOVEL affects
you.
HYPNOVEL may cause drowsiness or dizziness in some people and therefore may
affect alertness. Make sure you know how you react to HYPNOVEL before you drive
a car or operate machinery, or do anything else that could be dangerous if you
are drowsy, dizzy or not alert.
Do not have any alcohol for at least 12 hours after you have been
given HYPNOVEL.
Things to be careful of
Be careful if you are elderly, unwell or taking other medicines.
Some people may experience side effects such as drowsiness, confusion,
dizziness and unsteadiness, which may increase the risk of a fall.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel
well after you have received HYPNOVEL tablets.
In addition to the beneficial effects of HYPNOVEL it is possible that
unwanted effects will occur during treatment, even when it is used as intended.
All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects.
All medical procedures which involve the use of an anaesthetic have a very
small risk which your doctor will discuss with you.
In elderly, or high risk patients, death has resulted rarely due to a
slowdown of the heart and lungs.
Tell your doctor if you notice any of the following and they worry
you:
- dizziness, unsteadiness
- loss of memory, inattentiveness, confusion, lack of concentration
- headache, hangover feeling in the morning
- slurred speech
- unpleasant dreams
- blurred vision
- headache, hiccups
- feeling sick with or without vomiting
- worse sleep once you stop treatment
Tell your doctor immediately or go to casualty at your nearest
hospital if you notice any of the following:
- sudden anxiety or excitation
- hallucinations or delusions
- severe sleep disturbances
These are serious side effects. You may need urgent medical attention.
Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in
some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel
unwell, even if it is not on this list.
Ask your doctor or pharmacist if you do not understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After taking HYPNOVEL
Storage
HYPNOVEL tablets must be kept in a cool dry place where the temperature stays
below 25°C. They should be protected from light.
Hypnovel tablets given before a procedure will be kept at the clinic and
given by a nurse or doctor.
Product Description
What HYPNOVEL tablets look like
HYPNOVEL tablets are white oval with an imprint 'ROCHE 7.5' on one side.
Ingredients
Active ingredient - midazolam
Tablets containing midazolam maleate equivalent to 7.5 mg midazolam.
Inactive ingredients
- lactose
- microcrystalline cellulose
- pregelatinised starch
- magnesium stearate
- methyl hydroxypropyl cellulose
- talc
- colourant titanium dioxide (E171)