Zolpidem Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolpidem Normon 5 mg film-coated tablets EFG

zolpidem tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Zolpidem Normon is and what it is used for
2. What you need to know before taking Zolpidem Normon
3. How to take Zolpidem Normon
4. Possible side effects
5. How to store Zolpidem Normon
6. Contents of the pack and other information

1. What Zolpidem Normon is and what it is used for

Zolpidem is a compound belonging to a group of medicines known as benzodiazepine-related drugs. It is used for the short-term treatment of sleep disorders in adults.

Zolpidem is prescribed only for sleep disturbances that are severe, disabling, or causing the individual extreme distress.

2. What you need to know before taking Zolpidem Normon

Do not take Zolpidem Normon

• If you are allergic to zolpidem or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have experienced sleepwalking or other unusual behaviors during sleep (such as driving, eating, making phone calls, or having sexual intercourse, etc.) while not fully awake after taking zolpidem or other medicines containing zolpidem.
• If you suffer from severe muscle weakness (myasthenia gravis).
• If your breathing stops for short periods while you sleep (sleep apnea syndrome).
• If you have severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory failure).
• If you have severe liver damage (hepatic failure).

Children and young people under 18 years of age must not take zolpidem.

Do not take this medicine if you are in any of the situations listed above. If you are unsure, speak with your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• If you are elderly or frail: You should take a lower dose (see section 3, How to take Zolpidem Normon). Zolpidem has a muscle-relaxing effect. For this reason, elderly patients are especially at risk of falls and consequently hip fractures when getting up at night.
• If you have kidney failure. It may take longer to eliminate zolpidem from your body. Although dose adjustment is not required, caution is needed. Contact your doctor.
• If you have chronic (long-term) respiratory problems. Your condition may worsen.
• If you have ever had heart problems, including slow or irregular heartbeats.
• If you have ever had a mental disorder or have abused or been dependent on alcohol or drugs. You should be closely monitored by your doctor, as there is a risk of habituation and psychological dependence during treatment with zolpidem.
• If you have severe liver disease. You should not use zolpidem, as there is a risk of brain damage (hepatic encephalopathy). Contact your doctor.
• If you have delusions (psychosis), depression, or anxiety related to depression, zolpidem should not be your only treatment.
• If you have had another mental illness in the past.
• If you have or have ever had thoughts of harming yourself or committing suicide. Some studies have shown an increased risk of suicidal ideation, suicide attempt, and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for further medical advice.
• If you have recently taken zolpidem or similar medicines for more than four weeks.

Zolpidem may cause drowsiness and reduce your level of alertness. This could lead to falls and, occasionally, serious injuries.

General

Before starting treatment with this medicine:

• The cause of the sleep disturbance should be clearly identified.
• Underlying conditions should be treated.

If treatment does not improve the sleep problem after 7–14 days, it may be due to an underlying physical or psychiatric illness that needs to be evaluated. You should consult your doctor.

Next-day psychomotor impairment (see also “Driving and use of machines”)

The risk of next-day psychomotor impairment, including impaired ability to drive, may be increased the day after taking zolpidem if:

• You take this medicine with less than 8 hours remaining before performing activities requiring mental alertness.
• You take a higher dose than recommended.
• You take zolpidem together with another central nervous system depressant or another medicine that increases the concentration of zolpidem in your blood, combined with alcohol or illegal substances.

Take the dose all at once and immediately before going to bed at night. Do not take another dose during the same night.

Abuse and/or physical or psychological dependence

Physical or psychological dependence may develop.

The risk increases with dose and duration of treatment and is higher in patients with a history of mental disorders, alcoholism, illicit substance use, or drug abuse. If physical dependence has developed, abrupt discontinuation of treatment may lead to withdrawal syndrome.

Memory disturbances (amnesia)

Zolpidem may cause memory loss (amnesia). This usually occurs several hours after taking zolpidem. To minimize this risk, ensure you can sleep uninterrupted for at least 8 hours (see section 4, Possible side effects).

Psychiatric and “paradoxical” reactions

Reactions such as nervousness, restlessness, irritability, aggression, delusions (psychosis), rage, nightmares, hallucinations, sleepwalking, inappropriate behavior, worsening of sleep disturbances, and other adverse behavioral effects may occur.

If this happens, you should stop taking zolpidem and contact your doctor. These reactions are more likely to occur in elderly patients.

Sleepwalking and associated behaviors

Sleepwalking and associated behaviors such as "sleep-driving," preparing and eating food, making phone calls, or having sexual intercourse, with no memory of the episode, have been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other central nervous system depressants together with zolpidem appears to increase the risk of these behaviors, as does exceeding the maximum recommended dose. If you experience any of these events, inform your doctor immediately, as these sleep-related behaviors may place you and others at serious risk of injury. Your doctor may recommend discontinuing treatment.

Other medicines and Zolpidem Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines you buy without a prescription, including herbal medicines.

Zolpidem may affect other medicines. In turn, these medicines may affect the action of zolpidem.

If you take zolpidem with the following medicines, effects such as drowsiness or next-day psychomotor impairment, including impaired ability to drive, may be enhanced:

• Medicines for certain mental disorders (antipsychotics).
• Medicines for sleep problems (hypnotics).
• Medicines to relieve or reduce anxiety.
• Muscle relaxants (e.g., baclofen), as they may increase the muscle-relaxing effect.
• Medicines for depression.
• Medicines for moderate to severe pain (narcotic analgesics).
• Medicines for epilepsy.
• Anaesthetics.
• Medicines for seasonal allergic rhinitis, skin rashes, or other allergies that may cause drowsiness (sedating antihistamines).

Zolpidem may interact with medicines used to treat various fungal infections such as itraconazole and ketoconazole. Taking ketoconazole with zolpidem may increase the sedative effect.

The concomitant use of zolpidem and opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all opioid medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members to alert them to the signs and symptoms described above. Contact your doctor if you experience such symptoms.

If you take zolpidem with antidepressants, including bupropion, desipramine, fluoxetine, sertraline, and venlafaxine, you may see things that are not real (hallucinations).

It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

Medicines that strongly increase the activity of certain liver enzymes may possibly reduce the effect of zolpidem, e.g., rifampicin (an antibiotic used to treat infections), carbamazepine and phenytoin (medicines used to treat seizures), and St. John’s wort (a herbal medicine for mood changes and depression). Concomitant use is not recommended.

Taking Zolpidem Normon with alcohol

Do not drink alcohol during treatment. Alcohol can increase the effects of zolpidem, making you sleep deeply so that you do not breathe properly or have difficulty waking up.

Drinking alcohol during treatment may affect your ability to drive or operate machinery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Zolpidem should not be taken during pregnancy and breastfeeding, especially during the first three months of pregnancy, because there is insufficient information available to ensure the safety of this medicine during pregnancy and breastfeeding.

Reduced fetal movement and decreased variability in fetal heart rate may occur after taking zolpidem during the second and/or third trimester of pregnancy.

If zolpidem is taken towards the end of pregnancy or during childbirth, your baby may show muscle weakness, decreased body temperature, difficulty feeding, and breathing problems (respiratory depression).

However, if the benefit to the mother outweighs the risk to the baby, your doctor may decide to treat you with zolpidem. If zolpidem is taken for a prolonged period during the last months of pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Zolpidem passes into breast milk in small amounts; therefore, zolpidem should not be taken during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

Zolpidem has a major effect on the ability to drive and operate machinery. On days when you take zolpidem (as with other hypnotics), you should consider the following:

• You may feel drowsy, sleepy, dizzy, or confused.
• It may take you longer to make decisions.
• You may experience blurred or double vision.
• Your level of alertness may be reduced.

To reduce the effects mentioned above, a minimum interval of 8 hours between taking zolpidem and driving, operating machinery, or performing work at heights is recommended.

Do not consume alcohol or any other psychoactive substance while taking zolpidem, as this may increase the effects listed above.

For more information about possible adverse effects that could affect your ability to drive, see section 4 of this leaflet.

Zolpidem Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

Zolpidem Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; thus, it is essentially “sodium-free”.

3. How to take Zolpidem Normon

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Zolpidem should be taken:

• as a single dose;
• just before going to bed;
• ensure you have a period of at least 8 hours after taking this medicine before engaging in activities requiring alertness;
• do not exceed 10 mg within 24 hours;
• administer the medicine orally;
• swallow the tablet with a glass of water.

The recommended dose is:

Adults

The recommended dose is 10 mg every 24 hours. A lower dose may be prescribed for some patients.

Elderly patients, debilitated patients, or patients with hepatic impairment

A lower dose is recommended, such as 5 mg daily at the beginning of treatment (one 5 mg tablet). Your doctor may increase your dose to 10 mg (two 5 mg film-coated tablets of zolpidem tartrate) if the effect is insufficient and if the medicine is well tolerated.

Use in children and adolescents

Zolpidem must not be used in children or adolescents under 18 years of age.

Maximum dose

Do not take more than 10 mg (two 5 mg film-coated zolpidem tablets or one 10 mg film-coated zolpidem tablet) every 24 hours. Zolpidem tartrate 10 mg tablets are available.

Duration of treatment

The sleep-promoting (hypnotic) effect may be reduced after repeated treatment over several weeks.

The duration of treatment should be as short as possible. It may range from a few days to 2 weeks, and must not exceed four weeks.

In certain situations, zolpidem treatment for a longer period may be required. Your doctor will inform you when and how to stop the treatment.

If you take more Zolpidem Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Do not go to the hospital alone; ask someone else to accompany you. Bring this leaflet and any remaining tablets with you to show the doctor.

This is so the doctor knows what you have taken. Taking too much zolpidem can be very dangerous. The following effects may occur: feeling drowsy, confused, sleeping deeply, and possibly experiencing a fatal coma.

If you forget to take Zolpidem Normon

Do not take a double dose to make up for missed doses. Take the tablet only if you will be able to sleep for 8 hours. If this is not possible, do not take the tablet until the next night when you go to bed.

If you stop taking Zolpidem Normon

Continue taking zolpidem until your doctor tells you to stop. Do not stop taking zolpidem suddenly, but inform your doctor if you wish to discontinue treatment. Your doctor should gradually reduce your dose and discontinue your tablets over a period of time.

If you stop taking zolpidem suddenly, your sleep problems may return and you may experience a "withdrawal effect." If this happens, you may suffer some of the effects listed below.

Contact a doctor immediately if you experience any of the following:

• Feeling anxious, restless, irritable, or confused.
• Headache.
• Faster or irregular heartbeats (palpitations).
• Nightmares, seeing or hearing things that are not real (hallucinations).
• Increased sensitivity to light, noise, and touch.
• Loss of contact with reality.
• Feeling detached from your body or feeling "like a puppet."
• Numbness and tingling in hands and feet.
• Muscle pain.
• Stomach problems.
• Sleep problems returning worse than before.
• In rare cases, seizures (convulsions) may also occur.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

These effects appear to be related to individual sensitivity and seem to occur more frequently within the first hour after taking the tablet if the person does not go to bed or sleep immediately.

Adverse effects occur more frequently in elderly patients.

Stop taking zolpidem and consult a doctor or go to hospital immediately if:

• You have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Other adverse effects are:

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

• perception of things that are not real (hallucinations), agitation, nightmares;
• depression;
• drowsiness the following day, emotional numbness, reduced alertness, attention disturbance, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behaviour (see section 2, Warnings and precautions), memory impairment, inability to recall recent events (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia;
• sensation of dizziness with loss of balance (vertigo);
• lung or airway infection (respiratory infection);
• diarrhoea, feeling of discomfort (nausea), vomiting, stomach pain;
• back pain;
• fatigue.

Uncommon (may affect up to 1 in 100 people):

• confusion, irritability;
• sleepwalking, sensation of intense euphoria or confidence (euphoria), feeling restless or angry;
• difficulty speaking, attention disturbance, tremor;
• double vision, blurred vision;
• change in appetite (appetite disorder);
• increased liver enzymes;
• unusual sensation or tingling in the skin, skin itching or rash, excessive sweating;
• joint or muscle pain, muscle spasms, weak muscles, neck pain.

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

• change in sexual desire (libido);
• liver injury (hepatocellular, cholestatic or mixed);
• hives;
• abnormal posture while walking (abnormal gait).

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

• reduced ability to see (visual impairment);
• physical or psychological dependence. If you stop taking zolpidem suddenly, you may experience withdrawal symptoms (see section 2, Warnings and precautions);
• thinking things that are not true (delusions);
• slower breathing (respiratory depression).

Frequency not known (frequency cannot be estimated from available data):

• rapid swelling beneath the skin in areas such as the face, throat, arms and legs, which may be life-threatening if swelling of the throat blocks the airways (angioedema);
• a drug effect that is opposite to what is normally expected (paradoxical reaction), abnormal behaviour, mental disorders (psychosis), anger; these reactions are more likely in the elderly;
• misuse of zolpidem by drug addicts, reduced awareness of surroundings;
• drug tolerance, falls (mainly in elderly patients and when zolpidem is not taken as prescribed);
• delirium (a sudden and severe change in mental state causing a person to appear confused or disoriented).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolpidem Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the carton after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Zolpidem Normon

• The active substance is zolpidem tartrate. Each tablet contains 5 mg of zolpidem as zolpidem tartrate.
• The other components (excipients) are:

Tablet core: lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch type A (from potato), magnesium stearate.

Film coating of the tablets: hypromellose, talc, and macrogol 6000.

Appearance of the product and contents of the container

Zolpidem Normon is presented as film-coated tablets, round biconvex, white, printed with the letter "Z" on one side and unmarked on the other, with a diameter of 5.1 mm.

Zolpidem Normon is available in packaging containing 30 tablets in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: August 2024

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