PACKAGE LEAFLET: INFORMATION FOR THE USER
®
SOMNOLS 7,5 mg film-coated tablets
Zopiclone
Read all of this leaflet carefully, before you start using 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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.
What SOMNOLS is and what it is used for
Before you use SOMNOLS
How to use SOMNOLS
Possible side effects
How to store SOMNOLS
Further information
1.
WHAT SOMNOLS IS AND WHAT IT IS USED FOR
SOMNOLS belongs to a group of medicines called hypnotics.
SOMNOLS is a medicine used to treat transient short-term insomnia for adults (including
difficulties in falling asleep, waking in the middle of the night and waking too early).
SOMNOLS is used as a support therapy for a limited period of time in the treatment
of chronic insomnia.
This medicine should only be used if your disorder is severe and limits your activity
or is subjecting you to extreme distress.
2.
BEFORE YOU USE SOMNOLS
Do not use SOMNOLS in the following cases
- if you are allergic (hypersensitive) to zopiclone or any of the other ingredients
of medicine SOMNOLS,
- if you have severe respiratory failure,
- if you have a severe liver disease,
- if you have a condition where you temporarily stop breathing while you sleep
(syndrome of sleep apnoea),
- if you have myasthenia gravis (fluctuating muscle weakness),
- for children till age of 18 years.
For some patients, particularly for elder people and children this medicine can cause opposite
effect to the desirable:
- intensifying of insomnia, nightmares,
-
nervousness, agitation, discomposure, aggressiveness, floods of anger,
sudden severe confusion (delirium), hallucinations, psychotic symptoms, behavioural
disorders.
If it happens, contact your doctor. He/she will then decide if you should discontinue
the treatment and how it should be done.
Take special care with SOMNOLS in the following cases
Before starting treatment tell your doctor if you have:
- any liver problems (see also Do not use SOMNOLS above). Your doctor may need to
give you a lower dose of SOMNOLS;
- any kidney problems. Your doctor may need to give you a lower dose of SOMNOLS;
- any problems with your lungs (see also Do not use SOMNOLS above). Your doctor
may need to give you a lower dose of SOMNOLS;
- a history of alcohol or drug abuse.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before
taking SOMNOLS.
This medicine is not recommended to use in combination with alcohol and during
the breast-feeding (see also Pregnancy and breast-feeding).
If insomnia continues after 2-4 weeks of treatment, please discuss it with the doctor so that
he/she could overview the diagnosis and the treatment.
Treatment with SOMNOLS is meant to be of only short duration or intermittent (i.e. it should
not be taken every day) in order to reduce symptoms that might appear after you have stopped
taking SOMNOLS, see under Dependence for description of possible symptoms.
Some loss of efficacy to the activity of SOMNOLS may develop. If after 2-4 weeks you
notice that the tablets are not working as well as they did when first starting treatment, you
should tell your doctor as an adjustment to your dosage may be required.
When taking this type of medicine there is a risk of dependence, which increases with dose
and length of treatment. There is a greater risk in patients with a history of alcohol or drug
abuse or personality disorders (see also How to use SOMNOLS), Dependence).
Some psychiatric unexpected reactions and strange behavior may also be observed when
using this medicine (see under Do not use SOMNOLS in the following cases and
Dependence).
On discontinuation of treatment with SOMNOLS a transient syndrome, where the symptoms
that led to treatment with zopiclone can recur in an enhanced form. It may be accompanied by
other reactions including mood changes, anxiety and restlessness. Treatment should be
gradually withdrawn. Your doctor will advice you on how this should be done.
SOMNOLS can cause memory loss. To reduce this risk you should ensure that you are able to
have a full night of uninterrupted sleep (see also How to use SOMNOLS ).
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This is because SOMNOLS
canaffect the way some other medicines work. Also some medicines can affect the way
SOMNOLS works.
Tell you doctor if you are taking any of the following medicines:
- some medicines for moderate to severe pain called "narcotic analgesics" (codeine,
morphine, methadone, pethidine or tramadol),
- some cough drugs (e.g. codeine),
- medicines for mental problems (neuroleptics),
- medicines to treat depression,
- anti-allergic drugs that have a sedative effect (sedative antihistamines) such as
chlorphenamine or promethazine,
- medicines to reduce anxiety,
- clonidine (used to treat high blood pressure) and similar drugs,
- thalidomide (used to treat certain cancers),
- clozapine (for treating certain psychosis),
- erythromycin or chlarithromycin (antibacterial drugs – used for treating infections),
- itraconazole or ketoconazole (used to treat fungal infections),
- ritonavir (a protease inhibitor – used to treat HIV infections),
- medicines for epilepsy (phenobarbital, carbamazepine or phenytoin),
- rifampicin (an antibiotic – for treating infections),
- St. John’s wort (a herbal medicine – for mood swings and depression).
Alcohol
Do not use alcohol or drugs containing alcohol concomitantly with SOMNOLS.
Using SOMNOLS with food and drink
Do not drink alcohol when you are using this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use of SOMNOLS in pregnancy is not recommended. If SOMNOLS is used during the last 3
months of pregnancy or during labour, the newborn can be affected. Symptoms may include
reduced body temperature, reduced muscle tonus, respiratory disorders and withdrawal
symptoms. Therefore during this time, if possible, the use of SOMNOLS should be avoided.
Breast-feeding
SOMNOLS is excreted in breast milk. An effect on the suckling child cannot be excluded,
and SOMNOLS should therefore not be used during breast-feeding.
Driving and using machines
Drowsiness, memory disorders, difficulties to concentrate, blurred vision and disorder
of muscle function can influence the ability to drive or operate machines. If you feel any
of these symptoms do not drive or operate machines.
The possibility of vigilance worsening is greater if the person has not slept sufficiently.
Important information about some of the ingredients of SOMNOLS
The film coating of SOMNOLS tablets contains a small amount of lactose. If you have been
told by your doctor that you cannot tolerate some sugars (has intolerance to some sugars),
consult with your doctor before taking this medicine.
3.
HOW TO USE SOMNOLS
Always use SOMNOLS tablets exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Use just before bedtime.
Adults till age of 65: 1 tablet (7,5 mg) once per day.
Patients older than 65 and patients with liver or respiratory disorders: recommended dose
is ½ of tablet (3,75 mg) per day.
Patients with renal disorders are advised to start treatment with ½ of tablet (3,75 mg) per day.
Children (under the age of 18): SOMNOLS should not be used in children (see also section
Do not use SOMNOLS in the following cases).
This medicine may cause memory disorders (a person does not remember what has just
happened). Most often it happens during several hours after the medicine is taken,
particularly, if you wake up or you do not go to sleep just after the tablet is taken. Therefore
it is recommended to take the medicine right before going to sleep and to provide the
circumstances in which you are able to sleep for 7-8 hours.
Do not take more than 7,5 mg per day! Do not increase the dose, because the effect
of medicine has the tendency to decrease in the result of longer usage.
Treatment duration must be as short as possible – from some days till maximum 2-4 weeks.
Your doctor will tell you how to gradually lower the dose and eventually stop the treatment.
If insomnia continues for more than 4 weeks, please consult your doctor.
If it seems to you that effect of SOMNOLS is too strong or too weak, please consult your
doctor or pharmacist.
If you take more SOMNOLS than you should
In case of overdose or accidental poisoning you must consult a doctor immediately.
If you forget to take SOMNOLS
SOMNOLS must only be taken at bedtime. If you forget to take your tablet at bedtime, then
you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused
during the day. Do not take a double dose to make up for a forgotten tablet.
If you stop using SOMNOLS
Abrupt discontinuation of treatment may cause recurring insomnia: insomnia which is treated
by the prescribed medicine shall intensify. It is temporal – you just have to observe the
instructions given by the doctor.
Dependence
There is risk of physical and psychological dependence connected to the usage of this
medicine in case if the doses and/ or duration of treatment are not observed.
In case of physical dependence, the abrupt discontinuation of treatment may cause such
symptoms due to discontinuation of drug use (withdrawal): insomnia, headache, muscular
pain, anxiety, tension, confusion and irritability.
In severe cases may occur: contact loss with the real world, personality disorders,
hallucinations, seizures, hypersensitivity to light, noise or touch, numbness and tingling of the
extremities.
These symptoms may occur within few days after you stop taking SOMNOLS.
Sleep walking and other and similar behaviours such as "sleep driving", preparing and eating
food, or making phone calls, with amnesia for the event, have been reported in patients who
have taken SOMNOLS and were not fully awake. The use of alcohol and other central
nervous system (CNS) depressants with zopiclone appears to increase the risk of such
behaviours, as well as the use of SOMNOLS at doses exceeding the maximum recommended
dose. If you experience such behaviour, contact your doctor. He/she will then decide if you
should discontinue the treatment and how it should be done.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, SOMNOLS can cause side effects, although not everybody gets them.
A bitter after-taste in mouth is the most frequently reported side effect. Other side effects also
can occur, particularly within one hour after medicine taking. Therefore the medicine should be
taken just before going to bed in order to reduce this risk of reaction.
Very common (for more than 1 of 10 patients):
- A bitter taste in the mouth
Common (for more than 1 of 100 patients, but for less than 1 of 10 patients):
- Drowsiness during daytime, impaired vigilance, cognition disorder
- Dry mouth
- Fatigue
Uncommon (for more than 1 of 1 000 patients, but for less than 1 of 100 patients):
- Vertigo, headache, dizziness
- Nausea, indigestion
- Muscle weakness
Rare (for more than 1 of 10 000 patients, but for less than 1 of 1 000 patients):
- Itch and rashes
- Changes in sexual desire
- Restlessness, agitation, rages, psychosis, nightmarish dreams, hallucinations, delirium,
irritability, confusion, aggressiveness, inadequate behaviour which possibly
is connected with amnesia (poor memory since taking SOMNOLS, therefore it is
important to ensure uninterrupted sleep during 7-8 hours), memory disorders, sleep
walking
Very rare (for less than 1 of 10 000 patients):
-
-
Anaphylactic reactions and/or angioedema (severe allergic reactions; the signs may
include a rash, swallowing or breathing problems, swelling of your lips face, throat or
tongue). If you get any of these symptoms you must stop taking SOMNOLS and
contact a doctor immediately.
Mild to moderate increases in liver enzymes
Not known (the frequency cannot be estimated from the available data):
- Decreased muscle tonus (muscular hypotonia)
Double vision and decreased ability to coordinate movements (ataxia) has been reported.
The use of this medicine may cause physical and psychological dependence. Insomnia,
anxiety, tremor, sweating, irritation, confusion, headache, palpitation, tachycardia, delirium,
nightmarish dreams, hallucinations and irritability. In very rare cases seizures also may occur.
In case of psychiatric disorders, which are mostly characteristic for elderly people, treatment
should be discontinued.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.
HOW TO STORE SOMNOLS
Keep out of the reach and sight of children.
Do not store above 25 °C.
Store in the original package in order to protect from light and moisture.
Do not use SOMNOLS after the expiry date which is stated on the blister and carton after
EXP. 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 to protect
the environment.
6.
FURTHER INFORMATION
What SOMNOLS contains
The active substance is zopiclone (Zopiclone).
One tablet contains 7,5 mg zopiclone.
The other ingredients are:
Tablets core: calcium hydrogen phosphate (anhydrous), potato starch, magnesium stearate,
sodium starch glycolate (type A), silicon dioxide (Syloid 244 FP).
Tablets film-coating: Opadry 33G28707 White (hydroxypropylmethylcellulose (Hypromellose),
titanium dioxide (E 171), lactose monohydrate, polyethylene glycol 3000 (Macrogol), triacetin).
What SOMNOLS looks like and contents of the pack
White round, film-coated biconvex tablets with single breakline on one side. The tablet can be
divided into equal halves.
10 tablets are packed per blister, 1, 2 or 3 blisters are packed per cardboard box.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia
Phone: +371 67083205
Fax: +371 67083505
E-mail: grindeks@grindeks.lv
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last approved in
03/2011