Zolpidem normon 10 mg comprimidos recubiertos con pelicula efg

Package Leaflet: Information for the user

Zolpidem Normon 10 mg film-coated tablets EFG

zolpidem tartrate

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet.See section 4.

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

2. What you need to know before you start taking Zolpidem Normon

3. How to take Zolpidem Normon

4. Possible side effects

5. Storage of Zolpidem Normon

6. Contents of the pack and additional information

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

Zolpidem Normon is only prescribed for severe, debilitating, or extremely distressing sleep disturbances.

Do not take Zolpidem Normon

• If you are allergic to zolpidem or any of the other ingredients of this medication (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 while sleeping (such as driving, eating, calling, or having sex, etc.) without being fully awake after taking zolpidem or other medications containing zolpidem.
• If you have severe muscle weakness (myasthenia gravis).
• If you have interrupted breathing during short periods of time while sleeping (sleep apnea syndrome).
• If you have severe respiratory weakness (in which the lungs cannot take in enough oxygen) (respiratory insufficiency).
• If you have severe liver damage (liver insufficiency).

Children and young people under 18 years old should not take zolpidem.

Do not take this medication if you are in any of the above situations. If you are unsure, talk to your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

-If you are an elderly patient or are weak: 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 in particular are at risk of falls and subsequent fractures when getting up from bed at night.

-If you have kidney insufficiency. It may take longer to eliminate zolpidem. Although no dose adjustment is required, caution is required. Contact your doctor.

Zolpidem may cause drowsiness and decrease your level of alertness. This could cause a fall and, in some cases, cause serious injuries.

General

Before starting treatment with this medication:

If the treatment does not improve the sleep problem after 7-14 days of treatment, it may be a physical or psychiatric disease that needs to be checked. You should consult your doctor.

Altered psychomotor function the next day (see also “Driving and operating machines”)

The next day after taking zolpidem, there may be an increased risk of altered psychomotor function, including altered ability to drive, if:

• You take this medication with less than 8 hours of margin before performing activities that require a state of mental alertness.
• You take a higher dose than recommended.
• You take zolpidem at the same time as another central nervous system depressant or another medication that increases the concentration of zolpidem in your blood, combined with alcohol or with illicit substances.

Take the dose 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 the dose and duration of treatment and is high in patients with a history of mental disorders, alcoholism, illicit substances, or drug use. If physical dependence has developed, abrupt discontinuation of treatment is accompanied by withdrawal syndrome.

Memory impairments (amnesia)

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

Psychiatric and “paradoxical” reactions

It is known that reactions such as nervousness, restlessness, irritability, aggression, delirium (psychosis), anger, nightmares, hallucinations, sleepwalking, inappropriate behavior, increased sleep disturbances, and other adverse effects on behavior can occur.

If this occurs, you should discontinue taking zolpidem and contact your doctor. It is more likely that these reactions will occur in elderly patients.

Sleepwalking and associated behaviors

Sleepwalking and associated behaviors such as “driving while asleep”, preparing food and eating, making phone calls, or having sex, without remembering the episode in patients who had taken zolpidem and were not fully awake have been reported. The use of alcohol and other central nervous system depressants with zolpidem appears to increase the risk of these behaviors, or if you exceed the maximum recommended dose. If you experience any of these events, inform your doctor immediately as these sleep behaviors can put you and others at risk of serious injuries. Your doctor may recommend discontinuing treatment.

Other medications and Zolpidem Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications you buy without a prescription, including herbal medications.

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

If you take zolpidem with the following medications, the effects may be potentiated, such as drowsiness or altered psychomotor function the next day, including altered ability to drive.

Zolpidem may interact with medications to treat a variety of 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, medication for substitution therapy, and some medications for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not 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 the opioid medications you are taking and follow your doctor's recommended dose strictly. It may be helpful to inform friends or family members to alert them to the symptoms described above. Contact your doctor if you experience these symptoms.

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

Zolpidem should not be taken with fluvoxamine or ciprofloxacin.

Medications that significantly increase the activity of certain liver enzymes may reduce the effect of zolpidem, such as rifampicin (an antibiotic used to treat infections), carbamazepine, and phenytoin (medications used to treat seizures) and St. John's Wort (a plant-based medication for mood changes and depression). Concomitant use is not recommended.

Taking Zolpidem Normon with alcohol

You should not drink alcoholduring treatment. Alcohol may increase the effects of zolpidem and make you sleep deeply, so you may not breathe correctly or have difficulty waking up.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Zolpidem Normon during pregnancy and breastfeeding, especially during the first three months of pregnancy because there is not enough information available to guarantee the safety of this medication during pregnancy and breastfeeding.

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

If you take zolpidem at the end of pregnancy or during delivery, your baby may show muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

However, if the benefit to the mother is greater than the risk to the baby, your doctor may decide to treat you with zolpidem. If you take zolpidem for a longer 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 baby should be closely monitored during the postnatal period.

Zolpidem passes into breast milk in small amounts, so you should not take zolpidem during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Zolpidem has a significant effect on your ability to drive and operate machines. The days you take zolpidem (as with other hypnotics) you should be aware of the following:

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

To reduce the effects mentioned above, it is recommended to have a minimum of 8 hours between taking zolpidem and driving, operating machines, or any work that is performed at height.

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

For more information on possible side effects that may affect your ability to drive, see section 4 of this prospectus.

Zolpidem Normon contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Zolpidem should be taken:

• as a single dose;
• just before going to bed;
• make sure to have a period of at least 8 hours after taking this medication before performing activities that require being alert;
• do not exceed 10 mg per 24 hours;
• administer the medication orally;
• swallow the tablet with a glass of water.

The recommended dose is:

Adults

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

Older adults, debilitated patients, or patients with liver insufficiency

A lower dose of 5 mg per day is recommended at the beginning of treatment (half a 10 mg zolpidem tablet). Your doctor may increase your dose to 10 mg if the effect is insufficient and if the medication is well tolerated.

Use in children and adolescents

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

Maximum dose

Do not take more than 10 mg (2 coated tablets of Zolpidem Normon 5 mg or 1 coated tablet of Zolpidem Normon 10 mg) every 24 hours.

Zolpidem tartrate 5 mg tablets are available.

Treatment duration

The hypnotic effect may be reduced after repeated treatment for several weeks.

The treatment duration should be as short as possible. It may range from a few days to 2 weeks, and should not exceed 4 weeks.

In certain situations, zolpidem may need to be taken for a longer period. Your doctor will inform you when and how to discontinue treatment.

If you take more Zolpidem Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Do not go to the hospital alone, ask someone to accompany you. Bring this leaflet with you and any remaining tablets to show to your doctor.

This is so that your 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 suffering a fatal coma.

If you forgot to take Zolpidem Normon

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

If you interrupt treatment with Zolpidem Normon

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

If you stop taking zolpidem suddenly, your sleep problems may recur and you may experience withdrawal effects. If this happens, you may experience some of the following effects.

Consult a doctor immediately if you experience any of the following effects:

• Feeling anxious, restless, irritable, or confused.
• Headache.
• Increased or irregular heartbeats (palpitations).
• Nightmares, seeing or hearing things that are not real (hallucinations).
• Being more sensitive to light, noise, and touch than normal.
• 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.
• Your sleep problems become worse than before.
• In rare cases, seizures (convulsions) may also occur.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These side effects appear to be related to individual sensitivity and seem to be more frequent after the first hour of taking the tablet if you do not go to bed or sleep immediately.

Side effects occur more frequently in elderly patients.

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

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

Other side effects are:

Frequent(may affect up to 1 in 10 people)

• Perception of things that are not real (hallucinations), agitation, nightmares,
• depression,
• Daytime drowsiness, emotional numbness, reduced alertness, attention alteration, fatigue, headache, dizziness, difficulty remembering things, which may be associated with inappropriate behavior (see section 2, Warnings and precautions), memory decline, inability to remember recent past (anterograde amnesia), ataxia (loss of muscle coordination), worsening of insomnia,
• Sensation of dizziness with loss of balance (vertigo),
• Pulmonary or respiratory tract infection (respiratory infection),
• Diarrhea, feeling of discomfort (nausea), vomiting, stomach pain,
• Back pain,
• Fatigue.

Less frequent(may affect up to 1 in 100 people)

• Confusion, irritability,
• Somnambulism, feeling of intense euphoria or confidence (euphoria), feeling restless or angry,
• Difficulty speaking, attention alteration, tremor,
• Dual vision, blurred vision,
• Change in appetite (appetite disorder),
• Increased liver enzymes,
• Unusual or tingling sensation in the skin, skin itching or rash, excessive sweating,
• Pain in the joints or muscles, muscle spasms, weak muscles, neck pain.

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

• Change in sexual desire (libido),
• Liver damage (hepatocellular, cholestatic, or mixed),
• Rashes,
• Abnormal gait (abnormal gait).

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

• Visual impairment (visual disability)
• Physical or psychological dependence. If you stop taking Zolpidem Normon suddenly, you may experience withdrawal symptoms (see section 2, Warnings and precautions),
• Thinking things that are not true (delusions)
• Slower breathing (respiratory depression)

Frequency unknown(the frequency cannot be estimated from available data)

• Rapid inflammation under the skin in areas such as the face, throat, arms, and legs that can be life-threatening if the throat inflammation blocks the airways (angioedema),
• A drug effect that is contrary to what is normally expected (paradoxical reaction), abnormal behavior, mental disorders (psychosis), anger, these reactions are more likely in the elderly,
• Abuse of zolpidem by drug addicts, being less aware of your surroundings,
• Drug tolerance, falls (mainly in elderly patients and when zolpidem was not taken as prescribed),
• Delirium (a sudden and severe change in mental state that makes a person appear confused or disoriented).

Communication 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 for the Vigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions. Store in the original packaging.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Zolpidem Normon

• The active ingredient is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.
• The other components (excipients) are:
• Tablet core: lactose monohydrate, microcrystalline cellulose, carboxymethylstarch sodium type A (from potato), hypromellose, and magnesium stearate.
• Coating with film of the tablets: hypromellose, titanium dioxide (E 171), talc, and macrogol 6000.

Appearance of the product and contents of the packaging

Zolpidem Normon 10 mg are white or almost white, round, biconvex, tablets with a Z imprint on one face and scored on the other. They are presented in packaging containing 28, 30, and 500 (clinical packaging) tablets.

Holder of the marketing authorization and responsible for manufacturing.

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:September 2024

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.