Zolpidem Tartrate 10 Mg Film-Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Zolpidem tartrate 5 mg film-coated tablets Zolpidem tartrate 10 mg film-coated tablets
Zolpidem tartrate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
even if leaflet,
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, their symptoms are same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this please tell your doctor or pharmacist.
In this leaflet:
1. What Zolpidem tartrate is and what it is used for
2. Before you take Zolpidem tartrate
3. How to take Zolpidem tartrate
4. Possible side effects
5. How to store Zolpidem tartrate Tablets
6. Further information
1. What Zolpidem tartrate is and what it is used for
Zolpidem is a hypnotic belonging to the group of benzodiazepine-like agents. It is used for short-term treatment of sleep disturbances.
Treatment with benzodiazepines and benzodiazepine-like agents is only indicated for serious sleep disturbances.
2. Before you take Zolpidem tartrate DO NOT take Zolpidem tartrate if
• you are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Zolpidem tartrate tablets
• you suffer from a condition in which your muscles are weak and tire easily (myasthenia gravis)
• you have difficulty breathing (respiratory insufficiency)
• you suffer from difficulty breathing while asleep (sleep apnoea syndrome)
• you suffer from severe liver damage (hepatic insufficiency).
• you are under the age of 18
Warnings and precautions
Next-day psychomotor impairment (see also Driving and using machines)
The day after taking Zolpidem tartrate, the risk of psychomotor impairment, including impaired driving ability may be increased if:
• You take this medicine less than 8 hours before performing activities that require your alertness
• You take a higher dose than the recommended dose
• You take zolpidem while you are already taking another central nervous system depressants or another medicines that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances
Take the single intake immediately at bedtime.
Do not take another dose during the same night.
Take special care with Zolpidem tartrate Please tell your doctor if:
• you suffer from chronic shortness of breath (dyspnoea)
• you have a history drug or alcohol abuse
• you have a history of psychotic illness
• you are depressed, think you are depressed or are being treated for depression. Zolpidem tartrate may unmask or worsen pre-existing symptoms
• you are elderly
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zolpidem tartrate.
If after a few weeks you notice that the tablets are not working as well as they did when you first started taking them, you should go and see your doctor as an adjustment to your dosage may be required.
When taking this medicine there is a risk of dependence (a need to keep taking the medicine). The risk increases with the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse.
When stopping this medicine you may experience side effects called withdrawal symptoms or experience a condition called rebound insomnia, see section 3 (If you stop taking Zolpidem tartrate).
Taking other medicines
Please tell to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is especially important to tell your doctor if you are taking the following medicines in combination with Zolpidem tartrate as they may increase the effect of both medications on the central nervous system:
• medicinal products to treat mental disorders (neuroleptics, antidepressants, antipsychotics)
• other medicinal products to treat sleep disturbances
• medicinal products against anxiety disorders, sedatives (anxiolytics/tranquillizers)
• highly effective analgesics (narcoanalgesics). Increased euphoria may occur which can result in increased psychological dependence.
• muscle relaxants
• medicinal products against seizures (antiepileptics)
• anaesthetics
• medicinal products to treat allergies or common colds with concurrent sedative effect (sedative antihistamines).
• ketoconazole (a potent CYP3A4 inhibitor)
While taking zolpidem with the following medicines, drowsiness and next-day psychomotor impairment effects, including impaired driving ability, may be increased.
• Medicines for some mental health problems (antipsychotics)
• Medicines for sleep problems (hypnotics)
• Medicines to calm or reduce anxiety
• Medicines for depressions
• Medicines for moderate to severe pain (narcotic analgesics)
• Medicines for epilepsy
• Medicines used for anesthesia
• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives antihistamines)
While taking 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.
It is especially important to tell your doctor if you are taking the following medicines in combination with Zolpidem tartrate as they may decrease the action of Zolpidem tartrate:
Medicinal products enhancing the activity of certain liver enzymes e. g. rifampicin (for treatment of tuberculosis).
Taking Zolpidem tartrate with food and drink
Do not use any alcohol during treatment, as this will change and intensify the effect of zolpidem tartrate in an unforeseeable way. The ability to perform tasks that demands an increased concentration is additionally impaired by this combination.
Pregnancy and breast-feeding
Do not take Zolpidem tartrate during pregnancy or if you are breast feeding
Please inform your doctor if you want to become pregnant during treatment with Zolpidem tartrate or if you suspect to be pregnant, so that he/she can decide whether treatment is to be continued or e.g. converted.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines while taking if you experience sleepiness, memory defects, impaired concentration or impaired muscular function . This applies to a higher degree if you are not getting enough sleep.
Zolpidem tartrate has major influence on the ability to drive and use machines such as “sleep driving”. On the day after taking Zolpidem tartrate (as other hypnotic medicines), you should be aware that:
• You may feel drowsy, sleepy, dizzy or confused
• Your quick decision-making may be longer
• Y our vision may be blurred or double
• You may be less alert
A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights to minimize the above listed effects.
Do not drink alcohol or take other psychoactive substances while you are taking Zolpidem tartrate, as it can increase the above listed effects
Important information about some of the ingredients of Zolpidem tartrate
Zolpidem tartrate tablet contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Zolpidem tartrate
Always take Zolpidem tartrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose per 24 hours is 10 mg of Zolpidem tartrate. A lower dose may be prescribed to some patients. Zolpidem tartrate should be taken:
• as a single intake,
• just before bedtime
Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness.
Do not exceed 10mg per 24 hours.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablet whole with a drink of water
• Take just before bedtime. Make sure you have at least 7-8 hours for sleep after taking this medicine
• The usual length of treatment is 2 days to 4 weeks Adults
The recommended daily dose is 10 mg zolpidem tartrate, just before bedtime.
Elderly and debilitated patients
A dose of 5 mg zolpidem tartrate/day is recommended. This dosage should be exceeded only in exceptional cases.
Patients with impaired liver function
In patients with impaired liver function a dose of 5 mg zolpidem tartrate/day is recommended.
Children and adolescents
Zolpidem tartrate must not be used in children and adolescents of less than 18 years of age.
A daily dose of 10 mg should not be exceeded.
If you take more Zolpidem tartrate than you should
In case of overdose, a doctor's advice is to be asked without delay.
In case of overdose of Zolpidem tartrate alone, depression of consciousness has been reported which was in the range from extreme sleepiness up to light coma.
Besides visual disturbances, twisting and repetitive movements or abnormal posture due to involuntary muscle contractions and spasm, movement disorders and paradoxical reactions (restlessness, hallucinations) may occur.
If you forget to take Zolpidem tartrate
DO NOT take a double dose to make up for a forgotten dose. Continue intake of Zolpidem tartrate as prescribed by your doctor.
If you stop taking Zolpidem tartrate
Keep taking Zolpidem tartrate until your doctor tells you to stop. Do not stop taking Zolpidem tartrate suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.
When stopping this medicine you may experience side effects called withdrawal symptoms.
These include:
• headache or muscle pain
• extreme anxiety and tension
• restlessness
• mood changes
• confusion
• irritability
• sleep disturbances
In severe cases
• a feeling of things being unreal (derealisation or depersonalization)
• sounds seeming louder than usual that can be painful (hyperacusis)
• numbness and tingling of extremities
• hypersensitivity to light, noise and physical contact
• hallucinations
• epileptic seizures
You may also experience a condition called rebound insomnia when stopping this medicine. This is an inability to sleep which may be worse than the insomnia you had before you started treatment. You may also experience mood changes, anxiety and restlessness.
The risk of withdrawal symptoms and rebound insomnia is greater if you stop taking this medicine suddenly. Therefore your doctor may decide to gradually reduce the dose you take before you stop taking this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Zolpidem tartrate can cause side effects, although not everybody gets them.
Stop taking Zolpidem tartrate and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Tell your doctor as soon as possible if you have any of the following side effects:
Common (affects less than 1 in 10 people)
• Poor memory while taking Zolpidem tartrate (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 7-8 hours sleep after taking Zolpidem tartrate, this is less likely to cause you a problem.
• Sleeping problems that get worse after taking this medicine
• Seeing or hearing things that are not real (hallucinations)
Uncommon (affects less than 1 in 100 people)
• Blurred eyesight or ‘seeing double’
Frequency unknown
• Being less aware of your environment
• Falling, especially in the elderly
Sleep-Driving and other strange behaviour
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine.
This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
• Diarrhoea
• Headache
• Feeling tired or agitated
• Nightmares
Uncommon (affects less than 1 in 100 people)
• Feeling confused or irritable
Frequency unknown
• Itching skin or skin rash
• Weak muscles
• Feeling restless, aggressive, angry or showing unusual behaviour
• Thinking things that are not true (delusions)
• Changes in sex drive (libido)
• Change in the amount of liver enzymes - shown up in the results of blood tests
• Changes in the way you walk
• Zolpidem tartrate having less effect than normal
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet
5. How to store Zolpidem tartrate Tablets
Keep out of the reach and sight of children.
Do not use Zolpidem tartrate after the expiry date, which is stated on the blister/bottle and the carton after EXP. The expiry date refers to the last date of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment.
6. Further information
What Zolpidem tartrate contains
- The active substance is zolpidem tartrate.
One film-coated tablet contains 5 mg zolpidem tartrate equivalent to 4.02 mg zolpidem.
One film-coated tablet contains 10 mg zolpidem tartrate equivalent to 8.04 mg zolpidem.
- The other ingredients are:
Tablet core: Lactose monohydrate, cellulose microcrystalline, sodium starch glycolate (Type A), magnesium stearate.
Tablet film-coating: hypromellose, macrogol 400, titanium dioxide (E 171)
What Zolpidem tartrate looks like and contents of the pack
Film-coated tablet.
Zolpidem tartrate 5 mg film-coated tablets are white to off-white, circular, biconvex, debossed with ‘E’ on one side and ‘78’ on other side.
Zolpidem tartrate 10 mg film-coated tablets are white to off-white, oval shaped, biconvex, debossed with ‘E’ on one side and ‘80’ with a score line between ‘8’ and ‘0’ on other side. The tablet can be divided into equal halves.
Blister
Pack sizes: 4, 5, 7, 8, 10, 14, 15, 20, 25, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, 98, 100, 105, 112, 150, 250 and 500 film-coated tablets.
HDPE bottle:
Pack sizes: 30, 50, 100, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta