PATIENT INFORMATION LEAFLET

Zopiclona Qualigen 7.5 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.

- If you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1. What Zopiclona Qualigen is and what it is used for

2.What you need to know before you take Zopiclona Qualigen

3. How to take Zopiclona Qualigen

4. Possible side effects

5. Storage of Zopiclona Qualigen

6.Contents of the pack and other information

Zopiclona Qualigen belongs to a group of hypnotic and sedative (calming) medications.

Zopiclona Qualigen is a medication used for the treatment, of a transient and inducing type, of chronic or short-term insomnia situations. (including difficulty falling asleep, nocturnal awakening, and morning awakening) in adults.

Do not take Zopiclona Qualigen:

• if you are allergic (hypersensitive) to zopiclone or to any of the other components of Zopiclona Qualigen.
• if you have severe respiratory difficulties,
• if you have a severe liver problem,
• if you have a condition where you temporarily stop breathing while sleeping (sleep apnea syndrome)
• if you have severe myasthenia (fluctuating muscle weakness)
• if you are a child under 18 years old

In some patients, particularly in elderly patients, this medication may cause an opposite effect to the desired one:

• intensification of insomnia and nightmares
• nervousness, agitation, irritability, aggressiveness, episodes of anger
• sudden severe confusion (delirium), hallucinations, psychotic symptoms, behavioral disorders

If this occurs, contact your doctor. Your doctor will decide whether to discontinue the medication and how to do it.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Zopiclona Qualigen

if you have:

• any kidney problem
• chronic liver disease
• alcoholism or respiratory problems.

If you experience respiratory problems, special precautions should be taken, as this medication has the ability to depress respiratory function.

In this case, you need regular medical check-ups, especially because there is a risk of suicidal aptitude.

If insomnia continues after 4 weeks of treatment, talk to your doctor to review the diagnosis and treatment.

The risk of psychomotor disorders, including decreased ability to drive, is higher if:

• Zopiclona Qualigen is taken 12 hours before activities that require alertness;
• a higher dose than recommended is taken; or
• Zopiclona Qualigen is taken in combination with other central nervous system depressants (CNS), alcohol, or other medications that increase the level of zopiclone in the blood.

Especially, 12 hours after taking the medication, do not participate in hazardous activities that require complete attention or coordination of movements, such as operating machinery or driving.

If in doubt, do not hesitate to ask your doctor or pharmacist for advice.

This medication should not be used in combination with alcohol or during breastfeeding (see Pregnancy and breastfeeding)

Children and adolescents

This medication should not be used in children under 18 years old, as its safety and efficacy have not been established in this age group.

Taking Zopiclona Qualigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those obtained without a prescription. Zopiclona Qualigen may affect the way other medications work, and other medications may affect the mechanism of action of Zopiclona Qualigen.

Inform your doctor if you are taking any of the following medications:

• some pain medications called "narcotic analgesics" (codeine, morphine, methadone, pethidine, or tramadol),
• some cough medications (e.g. codeine),
• some medications for mental health problems (neuroleptics),
• antidepressants,
• sedating antihistamines such as chlorphenamine or promethazine,
• anxiety-reducing medications,
• clonidine (for high blood pressure) and similar medications,
• talidomide (for certain types of cancer),
• clozapine (for certain psychoses),
• erythromycin and clarithromycin (antibacterial medications used to treat infections),
• itraconazole or ketoconazole (used to treat fungal infections),
• ritonavir (protease inhibitor for HIV infections),
• antiepileptic medications (phenobarbital, carbamazepine, or phenytoin),
• rifampicin (antibiotic for infections),
• St. John's Wort (herbal medication for mood changes and depression).

Do not take alcohol or medications containing alcohol with Zopiclona Qualigen.

The concomitant use of Zopiclona Qualigen and opioids (strong pain medications, medication for substitution therapy, and some cough medications) increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes zopiclone with opioids, the dose and duration of concomitant treatment should be limited.

Inform your doctor about all the opioid medications you are taking and follow your doctor's recommended dosage strictly. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Use of Zopiclona Qualigen with food, drink, and alcohol

During treatment, do not consume alcoholic beverages.

Pregnancy, breastfeeding, and fertility

If you are pregnant or plan to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medication.

Pregnancy

The use of Zopiclona Qualigen is not recommended during pregnancy. If Zopiclona Qualigen is used during the last 3 months of pregnancy or during delivery, the newborn may be affected. Symptoms may include decreased body temperature, reduced muscle tone, respiratory disorders, withdrawal symptoms. Therefore, during this period, if possible, the use of Zopiclona Qualigen should be avoided.

Breastfeeding

Zopiclona Qualigen is excreted in breast milk, so it cannot be ruled out that it may have some effect on the infant; therefore, Zopiclona Qualigen should not be taken during breastfeeding.

Driving and operating machinery

The drowsiness, memory disturbances, difficulty concentrating, blurred vision, and muscle function alterations may affect the ability to drive or operate machinery that requires full attention, especially 12 hours after taking the medication. Concomitant use with alcohol may increase this risk. Therefore, it is not recommended to drive while taking Zopiclona Qualigen with alcohol.

The possibility of decreased alertness is higher if the patient does not get enough rest.

Zopiclona Qualigen contains lactose

The coating of the tablets contains small amounts of lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Zopiclona Qualigen contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for Zopiclona Qualigen as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again if you have any doubts.

Take the medication just before going to bed.Your doctor will prescribe the most effective low dose, which you should take only once. During the same night, you should not repeat the dose.

Adults up to 65 years:1 tablet (7.5 mg) once a day.

Patients over 65 years or with respiratory, liver, or kidney diseases:The recommended dose is½ tablet (3.75 mg) per day, which can be increased to 1 tablet (7.5mg) per day.

Do not crush or chew the tablets.

Use in children and adolescents:Zopiclona Qualigen should not be used in children under 18 years (see section Do not use Zopiclona Qualigen).

This medication may cause memory loss (the person does not remember what just happened). This occurs more frequently during the following hours after taking the medication, particularly if you wake up or do not go to sleep just after taking the tablet. Therefore, it is recommended to take this medication just before going to bed and provide all the conditions that allow you to sleep for several hours.

Do not take more than 7.5mg per day. Do not increase the dose because the effect of this medication tends to decrease as a result of prolonged use.

The treatment duration should be as short as possible – from a few days to several weeks, including the time of dose reduction. If insomnia continues for more than 4 weeks, talk to your doctor.

If you estimate that the action of Zopiclona Qualigen is too strong or too weak, talk to your doctor or pharmacist.

Use in children and adolescents:

Zopiclona Qualigen should not be used in children under 18 years (see section Do not use Zopiclona Qualigen).

If you take more Zopiclona Qualigen than you should

In case of overdose or accidental ingestion, you should consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

You may experience additional risk factors, such as other diseases and a general poor state of health, as well as the concomitant use of other central nervous system depressants, including alcohol, which may worsen symptoms and, in rare cases, cause death.

If you forgot to take Zopiclona Qualigen

Do not take a double dose to compensate for the missed doses. Take the medication the next day at the usual time.

If you interrupt treatment with Zopiclona Qualigen

Abrupt withdrawal of treatment may cause recurrent insomnia: the insomnia for which the prescribed medication is used intensifies. It is temporary and you should follow your doctor's instructions.

Dependence

There is a risk of physical or psychological dependence related to the use of this medication if you do not follow the prescribed dose or treatment duration.

In case of physical dependence, abrupt withdrawal of treatment may cause withdrawal symptoms (due to interruption of medication intake): insomnia, headache, muscle pain, anxiety, tension, agitation, confusion, and irritability.

In severe cases, it may appear: loss of contact with reality, personality alterations, hallucinations, convulsions, hypersensitivity to light, sound, or touch, tingling, and cramps in the limbs.

Cases of walking while asleep and other similar behaviors such as "driving while asleep", preparing food and eating or making phone calls under a state of amnesia have been reported in patients who took zopiclone and were not fully awake. The use of alcohol and other central nervous system depressants with zopiclone increases the risk of these behaviors, as well as the use of Zopiclona Qualigen at doses higher than the recommended maximum dose. If you experience this behavior, contact your doctor, who will decide whether to interrupt treatment and how to do it.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, Zopiclona Qualigen can cause side effects, although not everyone will experience them.

The most common side effect is a bitter taste. Other side effects may occur, especially within the hour after taking the medication, That is why and in order to reduce this risk, it should be taken just before going to bed.

Frequent(may affect up to 1 in 10 patients):

• Disgeusia (alterations in taste),residual somnolence
• Dry mouth

Possibly frequent(may affect up to 1 in 100 patients):

• Nightmares, agitation
• Dizziness, headache
• Nausea
• Fatigue

Rare(may affect up to 1 in 1,000 patients):

• Confusion, changes in sexual desire, irritability, aggression, hallucinations
• Anterograde amnesia (inability to remember recent events)
• Dyspnea (shortness of breath, difficulty breathing)
• Itching and rash
• Falls (more common in older people)

Very rare(may affect up to 1 in 10,000 patients):

• Angioedema(hinchazón of the face, tongue, and larynx), anaphylactic reactions (allergic reactions).
• Mild or moderate elevation of liver enzymes.

Unknown(cannot be established from available data)

• Anxiety, delirium, abnormal behavior (with possible memory deterioration), somnambulism (sleepwalking), dependence, withdrawal syndrome.
• Ataxia (decreased ability to coordinate movements), paresthesia (tingling, pins and needles, burning sensation, skin crawling), cognitive disorders such as memory impairment, concentration impairment, speech disorder.
• Diplopia (double vision)
• Respiratory depression
• Dyspepsia (indigestion)
• Muscle weakness

The use of this medication may cause physical or psychological dependence. After stopping treatment with Zopiclona Qualigen, withdrawal symptoms may occur: insomnia, anxiety, tremors, sweating, irritability, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, irritability. In very rare cases, seizures may also occur.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 25 °C.

Store in its original packaging to protect it from light and humidity.

Keep this medication out of sight and reach of children.

Do not use Zopiclona Qualigen after the expiration date that appears on the box after EXP.

The expiration date refers to the last day of the month.

Medicines should not be disposed of through drains or into wastewater or trash.Deposit empty containers and unused medications at the SIGRE point of your pharmacy.In case of doubt, ask your pharmacist how to dispose of empty containers and unused medications.This will help protect the environment.

Composition of Zopiclona Qualigen

• The active ingredient is zopiclone.

Each tablet contains 7.5mg of zopiclone.

• The other components are:

Tablet core: calcium hydrogen phosphate (anhydrous), potato starch, magnesium stearate, potato starch glycolate sodium (typeA), silicon dioxide (Siloide 244FP).

Coating: Opadry 33G28707 White: hypromellose, titanium dioxide (E171), lactose monohydrate, Macrogol 3000, triacetin.

Appearance of the product and content of the packaging

Coated tablets with a film, biconvex, white in color, round, scored on one side.

The tablet can be divided into two equal halves.

Zopiclona Qualigen is packaged in blisters of 10 tablets, made from aluminum foil and a polyvinyl chloride film coated with polyvinylidene chloride.

Each box contains 1, 2, 3 or 10 blisters (10, 20, 30 or 100 tablets).

Some package sizes may not be commercially available.

7. HOLDER OF THE MARKETING AUTHORIZATION NUMBER

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69 i

08970 – Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:

February 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/