ZOLPIDEM 5 MG TABLETS

Active substance: ZOLPIDEM TARTRATE

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PATIENT INFORMATION LEAFLET

Zolpidem 5mg Tablets
Zolpidem 10mg Tablets
(Zolpidem tartrate)

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 Zolpidem Tablets are and what they are used for
2. Before you take Zolpidem Tablets
3. How to take Zolpidem Tablets
4. Possible side effects
5. How to store Zolpidem Tablets
6. Further information

1.

WHAT ZOLPIDEM TABLETS ARE AND WHAT
THEY ARE USED FOR



if you have ever been addicted to or have abused drugs or
alcohol.

Taking other medicines
When Zolpidem Tablets are taken with the following medicines, they
may make you more drowsy than normal. Tell your doctor if you are
taking:

medicines to correct abnormal behaviour (antipsychotics),

medicines to help you sleep (hypnotics),

medicines to prevent anxiety (anxiolytics),

medicines to make you feel calmer (sedatives),

medicines for depression,

strong painkillers (narcotic analgesics),

medicines for epilepsy,

antihistamines (allergy treatments).
Tell your doctor or dentist that you are taking Zolpidem tablets if you
are going to be given an anaesthetic.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

Your tablets contain zolpidem tartrate, which belongs to a
group of medicines called hypnotics (sleep producers). These
medicines work by acting on the brain to cause sedation.

Taking Zolpidem Tablets with food and drink
Swallow your tablets whole and take with a small glass of water.

Your doctor has prescribed Zolpidem Tablets to help you
sleep. Sleeping problems do not usually last long and most
people only need a short course of treatment.

Do not drink alcohol while you are being treated with Zolpidem
Tablets. Alcohol can increase the side effects of any sleeping
medicine.

2.

Pregnancy and breast-feeding
Zolpidem Tablets should only be taken if your doctor decides that it is
absolutely necessary. Tell your doctor if you are pregnant, trying to
become pregnant or think you may be pregnant.

BEFORE YOU TAKE ZOLPIDEM TABLETS

Do not take Zolpidem Tablets

if you are allergic (hypersensitive) to zolpidem tartrate

if you are allergic to any of the other ingredients of
Zolpidem Tablets (these are listed in section 6, Further
Information)

if you have breathing difficulties

if you have sleep apnoea (stopping breathing for short
periods while asleep)

if you have liver disease

if you have a muscle disease called “myasthenia
gravis”
Take special care with Zolpidem Tablets
Talk to you doctor before taking the tablets if any of the
following apply to you:

if you are pregnant or intend to become pregnant, or if
you are breast feeding (see section on Pregnancy and
breast-feeding, below).

This medicine can be passed into breast milk. You should not take
Zolpidem Tablets whilst breast-feeding, unless you are told by your
doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
After taking Zolpidem Tablets you may feel drowsy the following
morning. If you are affected in this way, you should avoid driving or
using machines.
Important information about some of the ingredients of Zolpidem
Tablets
These tablets contain lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3.

HOW TO TAKE ZOLPIDEM TABLETS

Always take Zolpidem Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure.
Zolpidem Tablets work quickly and should be taken when you
are ready to get into bed and go to sleep. Your tablets should
be taken by mouth and swallowed whole (do not chew), with
Elderly or infirm adults:
The usual daily dose is one 5mg tablet.
Your doctor will tell you what dose you should be taking.
Do not use Zolpidem Tablets or any other sleeping medicine
for longer than your doctor tells you to.
Zolpidem Tablets are not recommended for children.
If you take more Zolpidem Tablets than you should
If you (or someone else), has taken too many tablets, contact
your doctor or hospital casualty department immediately for
advice.
If you have taken too many tablets, you will become
increasingly drowsy very quickly. If you go to the hospital or
doctors surgery, do not go on your own – ask someone to
take you and take the container and the remaining tablets
with you.
If you forget to take Zolpidem Tablets
Do not take the missed dose unless you have a full 7-8 hours
before you have to wake up. Do not take a double dose to
make up for the one you missed.
If you stop taking Zolpidem Tablets
Do not stop taking your Zolpidem Tablets without speaking to
your doctor first. You may experience side affects if you stop
your medication suddenly.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Zolpidem Tablets can cause side effects,
although not everybody gets them.
Side effects can include:

day-time drowsiness

dizziness/vertigo (feeling of “spinning”)

diarrhoea

headache

weakness

nausea and/or vomiting (feeling or being sick).
In rare cases you may experience:

memory difficulties,

nightmares,

restlessness at night,

tremor (shaking),

depression,

unsteadiness and/or falls,

double vision or other sight problems,


confusion,

agitation,

irritability,

aggressiveness,

delusions (having false or unusual ideas or beliefs),

rages,

hallucinations

inappropriate behavior

other mental problems
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.

5.

HOW TO STORE ZOLPIDEM TABLETS

Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package to
protect from light.
Do not use after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
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 Zolpidem Tablets contain

The active substance in is Zolpidem tartrate 5 mg or 10
mg.

The other ingredients are lactose monohydrate,
microcrystalline cellulose, sodium starch glycolate,
magnesium
stearate,
hypromellose,
hydroxypropylcellulose, titanium dioxide (E171) and
talc.
What Zolpidem Tablets look like and contents of the pack
Your medicine is in the form of a film-coated tablet. There are
two strengths available in blister strip packs of 28 tablets:
Zolpidem 5mg Tablets are round white tablets, embossed on
one face with the number “5”.
Zolpidem 10mg Tablets are white, capsule-shaped tablets,
embossed on one face with the letter “Z” and the number “10”
either side of a score line.
Marketing Authorisation Holder
Arrow Generics Limited, Unit 2, Eastman Way, Stevenage,
Hertfordshire SG1 4SZ
Manufacturer
Lacer SA, Sardenya 350, 08025 Barcelona, Spain
This leaflet was revised in: October 2009

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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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