INSOMA
Nitrazepam 5mg Tablets
What is in this leaflet
This leaflet answers some common questions about INSOMA. It does not contain
all the information available on this medicine. 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 using INSOMA against the benefits expected
it will have for you. If you have any concerns about using this medicine, ask
your doctor or pharmacist.
Keep this leaflet. You may want to read it again.
What INSOMA is used for and how it works
Your INSOMA tablets contain the active ingredient nitrazepam. Nitrazepam
belongs to a group of medicines known as benzodiazepines. They are thought to
work by changing the amounts of certain chemicals found in the brain
INSOMA is used as short term treatment in patients that have problems
sleeping (insomnia).
Your doctor, however, may have prescribed INSOMA for another reason. Ask your
doctor if you have any questions about why INSOMA has been prescribed for you.
INSOMA is available on prescription from your doctor.
Before you take INSOMA
When you must not take it
Do not take INSOMA if:
- You are allergic to Nitrazepam or any other related benzodiazepine
- You are allergic to any of the other ingredients listed at the end of
this leaflet - You have severe and chronic lung disease or other breathing problems
(eg. respiratory depression) - You have certain psychological disorders involving phobic or
obsessional states or psychosis
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; rash, itching or hives on the skin.
Before you take it
Tell your doctor:
- If you have allergies to any other medicines or other substances including
foods and dyes - If you have lung problems
- If you have or have had depression or anxiety associated with depression
- If you have a liver or kidney problem
- If you have a history of alcoholism or drug abuse
- If you are pregnant or plan on becoming pregnant
- If you are breastfeeding or plan to breastfeed
Taking other medicines
If you are taking any other medicines, including any you get without a
prescription from a pharmacy, supermarket or health food shop, tell your doctor
or pharmacist.
Medicines that may interfere with INSOMA include:
- Other sleeping tablets, sedatives or tranquilisers
- Medicines for depression, anxiety or mood disorders
- Cimetidine, a medicine used to treat reflux and ulcers
- Rifampicin, a medicine used to treat tuberculosis
- Medicines used to treat epilepsy
These medicines may be affected by INSOMA or may affect how well INSOMA
works. You may need different amounts of your medicines or you may need to take
different medicines.
Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking INSOMA.
How to take INSOMA properly
How much to take
Your doctor will tell you how much INSOMA you need to take each day. It is
important that you take INSOMA as directed by your doctor. Do not take more than
the recommended dose.
The usual dose of INSOMA for all patients is one 5mg tablet taken immediately
before going to bed at night. This dose may, if necessary, be increased to 10mg
(two 5mg tablets). Treatment should, if possible, be on an intermittent basis.
Treatment at full dose should not be continued for greater than four weeks.
Elderly or debilitated patients may need only half the normal recommended
dose.
How long to take it
INSOMA should be used for short periods only. Continuous long-term treatment
is not recommended unless advised by your doctor. Long-term use may lead to
dependence on the medicine.
If you forget a dose
If you forget to take INSOMA before you go to bed and you wake up late in the
night or early in the morning, do not take INSOMA as you may have trouble waking
in the morning.
While you are taking INSOMA
Tell all doctors, dentists and pharmacists who are treating you that you are
taking INSOMA.
Tell your doctor or pharmacist that you are taking INSOMA before you start
any new medicine.
Tell your doctor if you develop a skin rash or hives, or you become pregnant
while taking INSOMA.
If you are going to have surgery, tell the surgeon or anaesthetist that you
are taking INSOMA.
If you are going to have any blood tests, tell your doctor that you are
taking INSOMA.
Do not take INSOMA to treat any other complaints unless your doctor tells you
to.
Do not give this medicine to anyone else, even if they have the same
condition as you.
INSOMA may cause drowsiness or dizziness in some people. Even if you take
INSOMA at night, you may still be drowsy or dizzy the next day. Be careful
when driving, operating machinery or performing jobs that need you to be alert,
until you are certain that INSOMA is not affecting your performance.
Try to avoid alcohol while taking INSOMA. Drinking alcohol will affect how
well INSOMA works and can make you more sleepy, dizzy or lightheaded.
Do not stop taking INSOMA without first checking with your doctor. Stopping
this medicine suddenly may cause some unwanted effects.
Side effects
Tell your pharmacist or doctor as soon as possible if you do not feel well
while you are taking INSOMA.
All medicines can have some unwanted 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.
Tell your doctor or pharmacist if you notice any of the following and they
worry you:
- Drowsiness, tiredness
- Unsteadiness, difficulty with coordination
These side effects are usually mild and are dose related.
- Headache
- Nausea, vomiting, diarrhoea
- Lightheadedness
- Skin rashes
- Visual problems
- Confusion, memory loss
- Changes in sex drive
If any of the following happen, stop taking INSOMA and tell your doctor
immediately, or go to accident and emergency at your nearest hospital:
- Sudden anxiety or excitement
- Hallucinations or delusions
- Swelling of the face, lips, mouth or throat which may cause difficulty in
swallowing or breathing
The list of side effects mentioned above is not complete. If you should
suffer from any of these side effects or any other undesired effect please tell
your doctor or pharmacist.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
In case of overdose
You should only take the number of tablets that you have been told.
Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any INSOMA by mistake. Do this even if there are no signs of discomfort or
poisoning. You may need urgent medical attention. Take the container of
INSOMA with you if you can.
Keep telephone numbers for these places handy.
Storage conditions
Do not take this medicine after the expiry date shown on the label or if the
packaging shows signs of tampering.
Keep your INSOMA tablets in the container until it is time to take them.
Store below 30°C and out of reach of children. Avoid exposure to heat, light
and moisture.
Do not store INSOMA, or any other medicine, in the bathroom or near a sink.
Disposal
If your doctor tells you to stop taking INSOMA or if the tablets have passed
the expiry date, ask your pharmacist what to do with the remaining medicine.
Product Description
What INSOMA tablets look like
INSOMA 5mg tablets are white round tablets marked "NM" breakline "5" on one
side and "G" on the other.
Each INSOMA tablet contains the active ingredient, nitrazepam.
Each INSOMA tablet also contains the ingredients lactose, magnesium stearate,
maize starch, pregelatinised maize starch, purified talc and colloidal silicon
dioxide.