|
Zimovane - DATOLÁN 7,5mg ® Zopiclone Zimovane
- Datolan, 7,5 mg. Tablets:
Zopiclone (Zimovane - Datolan)
- The active ingredient in these Tablets is zopiclone.
- The other ingredients are wheat starch (gluten content
0,1 mg.), lactose, calcium hydrogen phosphate, sodium
carboxymethyl starch and magnesium stearate. Film-coating:
hydroxypropyl methylcellulose and titanium dioxide.
Each pack contains 30 Tablets.
1. WHAT IS ZOPICLONE (Zimovane - Datolan)
Zopiclone (Zimovane - Datolan) is a sleep-inducing agent.
It has been found to reduce the time to onset sleep
and the frequency of nocturnal awakenings, increasing
the quality of sleep and quality of awakening in the
morning. Likewise zopiclone is a drug with sedative,
anxiolytic, anti-convulsant and muscle-relaxant properties.
Doctors prescribe Zopiclone (Zimovane - Datolan) to treat
sleeping disorders and all types of insomnia, especially
when it's difficult to fall asleep, either initially
or after early awakening. In most cases only short-term
treatment with Zimovane is necessary (generally treatment
should not exceed 2 weeks). Treatment should be initiated
with the minimum recommended dosage. Do not exceed the
maximum recommended dosage
2. BEFORE TAKING ZOPICLONE (Zimovane - Datolan)
Carefully read the instructions provided in section
3 (see "How to take Zopiclone (Zimovane - Datolan).")
Do not take Zopiclone (Zimovane - Datolan) if,
- you are allergic to or sensitive to any of the ingredients
of these Tablets or to benzodiazepines in general.
- you suffer respiratory difficulties, either sleep
related or not, muscular problems or severe hepatic
insufficiency.
- you suffer drug or alcohol dependence, you must not
take Zimovane unless formally indicated by your doctor.
If you have any doubts consult your doctor.
- And remember that Zopiclone (Zimovane - Datolan) must
not be administered to children.
Take special care with Zimovane:
Before you take Zopiclone (Zimovane - Datolan) inform
your doctor if:
- you have any liver or kidney problems
- you suffer myasthenia gravis.
- you have other diseases.
- you have allergies.
The use of zopiclone can lead to the development of
dependence. This mainly occurs after taking the medication
uninterruptedly during a long period of time. In order
to reduce the risk of dependence to the maximum take
these precautions into account:
- only take zopiclone when prescribed to you by a doctor
(never because it has been effective with other patients)
and never if recommended to you by other people.
- do not increase the doses prescribed by your doctor
and do not prolong treatment more than the recommended
period.
- consult your doctor regularly in order for him/her
to decide whether you should continue treatment.
After taking this medication make sure that you can
rest without being woken for 7 hours.
Zopiclone (Zimovane - Datolan) can affect the elderly
more than younger patients. If you are an elderly patient
your doctor may prescribe a lower dose and check your
response to the treatment. Please carefully follow your
doctor's instructions. If you have impaired liver or
kidney function or suffer myasthenia gravis, your doctor
will decide whether it is convenient for you to take
a lower dose of Zopiclone (Zimovane - Datolan) or if
you should not take it at all.
Pregnancy
Consult your doctor or pharmacist before taking any
medication. Before starting the treatment, inform your
doctor if you are or suspect that you are pregnant or
intend to become pregnant. Your doctor will decide whether
it is convenient for you to take Zopiclone (Zimovane
- Datolan). Lactation
Consult your doctor or pharmacist before taking any
medication. Zopiclone is excreted in breast milk; therefore
you should consult your doctor about the convenience
of taking Zopiclone (Zimovane - Datolan) while you are
breastfeeding.
Driving and using machines
Depending on your individual response, your ability
to drive or operate machinery may be adversely affected;
therefore before carrying out these activities make
sure that your performance is not impaired.
Important information about some of Zopiclone's (Zimovane
- Datolan) ingredients:
This medication contains the excipient, wheat starch.
Patients with celiac disease must consult their doctor
before taking this medication. Taking other medications:
Inform your doctor if you are taking any other medicines
- even over-the-counter medication before commencing
treatment. This is extremely important because the simultaneous
administration of some medicines can increase or decrease
its effect. Therefore, you must not take other medications
concomitantly with Zimovane unless your doctor is informed
and approves. For example, tranquillizers, sleep inducers
and similar medications act on the brain and nerves
and may enhance the effect of Zopiclone (Zimovane - Datolan).
During treatment avoid alcoholic beverages. Concomitant
intake with alcohol is not recommended since the sedative
effect of Zopiclone (Zimovane - Datolan) may be enhanced
and this may affect the ability to drive or use machines.
If you require more information about this, ask your
doctor. The simultaneous treatment of erythromycin (an
antibiotic used to treat infections) and Zopiclone (Zimovane
- Datolan) may enhance the effect of Zopiclone (Zimovane
- Datolan).
3. HOW TO TAKE ZOPICLONE (Zimovane - Datolan)
Always take Zopiclone (Zimovane - Datolan) as recommended
by your doctor. Depending on the condition of your illness,
your age and weight, your doctor will prescribe the
appropriate dosage for you. Doctors will prescribe lower
doses for elderly patients and those with liver or kidney
problems, or with myasthenia gravis. Take Zopiclone
(Zimovane - Datolan) just before going to sleep
by swallowing the tablet, without chewing it, with some
water or another non-alcoholic beverage. In normal conditions
it should not take more than 20 minutes to fall asleep
after taking Zopiclone (Zimovane - Datolan), it is convenient
that you make sure that you are able to sleep without
being woken during at least 7 hours. If not, it is possible
that you won't remember what occurred while you were
awake (this only occurs on rare occasions). In order
to avoid symptoms of abstinence, do not stop taking
Zopiclone (Zimovane - Datolan) abruptly, especially if
you have been taking it during a long period of time.
Remember to take your medication. Each individual dose
must not exceed the limit indicated; neither should
the total daily dose, unless your doctor has prescribed
a higher dose for you. The usual dosages are as follows:
- in adults: 1 tablet (7,5 mg of zopiclone) - in the
elderly and in patients with liver or kidney problems
or chronic respiratory insufficiency, a dose of ˝ tablet
(3,75 mg. of zopiclone) is recommended initially, this
may be increased to 1 tablet if necessary. You should
never alter the prescribed dosage yourself. If you think
that the medication is too strong or too weak for you
consult your doctor.
If you take more Zopiclone (Zimovane - Datolan) than
you should: call your doctor, pharmacist or nearest
hospital immediately. In the case of an overdose or
accidental ingestion, consult your local poison centre.
If you forget to take Zopiclone (Zimovane - Datolan):
Never take a double dose to make up for the missed dose,
just take your next dose at the usual time.
Effects of ceasing Zopiclone (Zimovane - Datolan)
treatment: upon cessation of this medication you
may experience restlessness, anxiety, insomnia, lack
of concentration, headache and suffocation. The abrupt
discontinuation of this medication is generally not
recommended, it is therefore advised to decrease the
dosage gradually in accordance with your doctor's instructions.
4. POSSIBLE SIDE EFFECTS
As well as benefits, Zopiclone (Zimovane - Datolan) may
have unwanted effects in some patients, even when the
medication is being taken appropriately. Bitter taste
is the most common side effect observed with zopiclone.
Zopiclone (Zimovane - Datolan) is well tolerated by most
patients, but some patients may feel tired and sleepy
during the day, in particular at the beginning of treatment.
Anterograde amnesia may occur, this happens when
the patient does not remember what occurred while they
were awake after having taken the medication, therefore
the patient should ensure that they are able to sleep
during at least 7 hours without being disturbed. On
rare occasions Zopiclone (Zimovane - Datolan) may cause
sudden anxiety, hallucinations, excitation and sleep
disorders. If this occurs consult your doctor immediately.
If you notice any other reactions not mentioned in this
patient information leaflet, inform your doctor or pharmacist
immediately.
5. STORAGE OF ZOPICLONE (Zimovane - Datolan)
No special precautions for storage are required.
Expiry: You must not take these Tablets after
the expiry date on the carton.
ALL MEDICATIONS MUST BE KEPT
OUT OF THE REACH OF CHILDREN
|
