5 mg, 10 mg sublingual resoriblets
zolpidem tartrate
1. What Edluar is and what it is used for
Edluar tablets are sleeping pills that cause drowsiness by affecting the brain. The tablets can be used for short-term treatment of insomnia in adults that are severe, impaired, or cause severe anxiety. Insomnia is difficulty falling asleep or sleeping properly.
Zolpidem contained in Edluar may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Edluar
Do not take Edluar if you:
- is allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swollen face, lips, throat, or tongue.
- have severe liver problems.
- suffers from sleep apnea (a condition in which one stops breathing for very short moments during sleep).
- suffers from severe muscle weakness ( myasthenia gravis ).
- have acute and severe respiratory problems.
Warnings and cautions
Talk to your doctor or pharmacist before taking Edluar if you:
- is older or weak. If you step up at night, you need to be careful. Edluar can make your muscles relaxed. Because of this and the calming effect, the risk increases that you may fall and possibly break your femur.
- have kidney or liver problems.
- have or have had breathing problems. When you take Edluar, your breathing may become weaker.
- have or have had a mental illness, anxiety, or psychotic illness. Zolpidem may reveal or worsen symptoms.
- have or have had heart problems or a condition called long QT syndrome.
- have or have had depression (depression) or have suicidal thoughts.
- have or have had an addiction, or have a tendency to abuse alcohol or drugs. The risk of Edluar dependence (physical or mental effects induced by a compulsive need to continue taking the drug) increases with the dose and duration of treatment in these patients.
Children and young people
Edluar should not be used by children and adolescents under 18 years of age.
Problems with coordination the next day (see also driving ability and use of machines).
The day after you take Edluar, the risk of coordination problems, including reduced driving ability, may be greater if:
- You take this medicine less than 8 hours before performing activities that require alertness
- You are taking a higher dose than recommended
- You are taking zolpidem while taking other sedatives that affect the central nervous system, other medicines that increase zolpidem in the blood, drink alcohol, or use illicit drugs.
Take the tablet as a single dose just before going to bed.
Do not take any additional dose the same night.
Other things to consider
- Getting used to it – if after a few weeks you notice that your tablets do not work as well as they did when you started treatment, you should contact your doctor.
- Addiction – when taking this type of medicine there is a risk of addiction, which increases with dose and duration of treatment. The risk is greater if you have previously had a mental illness or been addicted to drugs, alcohol, other substances, or drug abuse. However, dependence can also occur at the normal doses given during treatment or if you do not show risk factors such as previous alcohol or drug abuse.
- End the treatment – the treatment should be gradually reduced. A short-term condition can occur when treatment is stopped, which means that the symptoms that led to you being treated with Edluar return in a strengthened form. It can be accompanied by other reactions such as mood swings, anxiety, and restlessness.
- Memory loss – Edluar can cause memory loss. To reduce this risk, make sure you sleep continuously for 8 hours.
- Psychiatric and “paradoxical” reactions – Edluar can cause behavioral side effects such as restlessness, agitation, irritability, aggression, delusions (misconceptions), outbursts of anger, nightmares, hallucinations, psychoses (hallucinations: something you do not see, hear or feel ) are there), inappropriate behavior and increased insomnia.
- Sleepwalking and other similar behaviors – Edluar can make people perform something in their sleep that they do not remember when they wake up. This includes going to sleep, driving a car to sleep, cooking and eating food in your sleep, making phone calls in your sleep, or having sex in your sleep. Alcohol and certain medications used to treat depression or anxiety, or taking doses of Edluar that exceed the maximum recommended dose may increase the risk of these side effects.
- Risk of falling and severe injuries- Edluar can cause drowsiness and decreased consciousness. This can increase the risk of falling and consequently cause severe injuries (see also section 4 Possible side effects ).
Other medicines and Edluar
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Edluar may affect the effect and/or side effects of other medicines. If you are going to have surgery and anesthesia, tell your doctor which medicines you are using.
The risk of drowsiness and coordination problems the next day, including impaired ability to drive, may increase when you take zolpidem at the same time as the following type of medicine:
- Drugs for certain mental problems (antipsychotics)
- Drugs for sleep problems ( hypnotics )
- Medicines that alleviate or reduce anxiety
- Antidepressants
- Drugs for moderate or severe pain (narcotic analgesics )
- Medicines for epilepsy
- Drugs used under anesthesia
- Medicines for hay fever, rashes, or other allergies that can make you sleepy (some antihistamines )
- Muscle relaxants
- Drugs that inhibit liver enzymes. Ask your doctor or pharmacist for advice on which medicines have this effect (eg ketoconazole, a medicine used to treat fungal infections).
If you are taking zolpidem at the same time as antidepressants such as 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.
Edluar can increase the effect of muscle relaxants. The risk of falling may therefore increase, especially in elderly patients and at higher doses.
Rifampicin (a medicine used to treat tuberculosis ), carbamazepine (a medicine used to treat epilepsy ), phenytoin (a medicine used to treat epilepsy ), and (traditional) herbal medicines containing St. John’s wort may reduce the effect of Edluar. Concomitant use is therefore not recommended.
Edluar with food, drink, and alcohol
Do not drink alcohol while taking Edluar, as alcohol may increase the sedative and sedative effects.
Grapefruit juice may affect the effectiveness of this medicine. Talk to your doctor for more information.
Pregnancy and breastfeeding
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.
Edluar should not be taken during pregnancy, especially during the first three months. If you need to take Edluar for acute medical reasons at the end of pregnancy or during labor, your baby may suffer from low body temperature, weak muscles, and difficulty breathing, and the baby may experience withdrawal symptoms after birth due to. physically dependent.
Do not breast-feed your baby as small amounts of zolpidem may pass into the breast milk.
Driving and using machines
Edluar has a great impact on your ability to drive and use machines, for example so-called “sleep-driving”. The day after you take Edluar (as with other medicines for sleep problems), you should be aware that:
- You may feel drowsy, sleepy, dizzy, or confused
- It takes longer for you to make a quick decision
- You may see blurred or double
- You may be less attentive
A period of at least 8 hours is recommended between taking zolpidem and driving, using machines, or working at high altitudes to minimize the effects mentioned above.
Do not drink alcohol or take other psychoactive substances while taking Edluar, as it may increase the effects mentioned above.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to take Edluar
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The tablet should be placed under the tongue and kept there until it has dissolved. Because the tablet works quickly, you should take Edluar immediately before going to bed or when you are already in bed. Do not take Edluar during or shortly after a meal.
Adults: The recommended dose of Edluar is 10 mg per 24 hours. Some patients may be prescribed a lower dose. Edluar to be taken:
- as a single dose,
- in connection with bedtime
Make sure that there is a period of at least 8 hours after you have taken this medicine before performing activities that require you to be awake/alert.
Never take more than 10 mg per 24 hours.
Elderly (over 65 years) or debilitated patients: The recommended dose is 5 mg. The recommended dose should not be exceeded.
Patients with liver problems: The usual starting dose is 5 mg. Your doctor may decide to increase this dose to 10 mg if it is safe.
Do not take Edluar if you have severe liver problems.
Patients with respiratory problems: A lower dose is recommended for patients with respiratory problems.
Use for children and adolescents:
Edluar should not be used by children and adolescents under 18 years of age.
If after a few weeks you notice that your tablets do not work as well as they did when you started treatment, you should contact your doctor as your dosage may need to be adjusted.
Length of treatment
The treatment period should be as short as possible. It usually varies from a few days to two weeks. The maximum treatment period is four weeks, including a tapering process where the dose is gradually reduced.
Your doctor will decide on a step-by-step reduction program for you based on your individual needs. In some situations, you may need to take Edluar for a period longer than four weeks.
If you take more Edluar than you should
If you (or someone else) has ingested too much medicine, or if e.g. a child has accidentally ingested the medicine, contact a doctor, hospital, nearest emergency department, or the Poison Information Center immediately for assessment of the risk and advice. Bring the pack and the remaining tablets. Do not go unaccompanied when seeking medical attention. If you have taken an overdose, you may become drowsy very quickly, and high doses are likely to lead to coma or even death.
If you forget to take Edluar
If you forget to take a dose immediately before going to bed but remember it during the night, you should only take the missed dose if you still have the opportunity to sleep continuously for 8 hours. If this is not possible, take the next dose before going to bed the following evening. Do not take a double dose to make up for a forgotten dose. If you have any further questions, ask your doctor or pharmacist.
If you stop taking Edluar
The treatment should be phased out gradually, otherwise, the symptoms you are being treated for may return more intense than before. Anxiety, restlessness, and mood swings can also occur. These effects eventually disappear.
If you have become physically addicted to Edluar, sudden discontinuation of treatment will lead to side effects such as headache, muscle aches, anxiety, tension, restlessness, confusion, irritability, and insomnia. In severe cases, another side effect may occur, e.g. hypersensitivity to light, noise and physical touch, abnormally sensitive hearing and painful sensitivity to sound, hallucinations, numbness and tingling in the arms and legs, derealization (a feeling that the world is not real), depersonalization (a feeling that your mind is separated from the body) or epileptic seizures (violent convulsions or tremors). These symptoms can also be experienced between doses, especially if dose one is high.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur, stop taking Edluar and contact your doctor immediately or go to the nearest emergency room:
- allergic reactions such as rash or itching with swelling of the face, lips, throat, or tongue and difficulty breathing or swallowing ( angioedema )These side effects are serious, but the frequency is not known (can not be calculated with the available data). You need medical attention.
Tell your doctor or pharmacist if any of the following side effects occur or get worse:
Common side effects are (may affect up to 1 in 10 people):
- hallucinations, agitation, nightmares, stunning emotions, confusion
- drowsiness, headache, dizziness, increased insomnia, cognitive disturbances such as memory loss (which may be linked to inappropriate behaviors), drowsiness during the following day
- “spinning” feeling
- double vision
- diarrhea, nausea, vomiting, stomach pain
- skin reactions
- fatigue
- back pain
The risk of memory loss increases at higher doses. Ensuring that you can sleep continuously for 8 hours reduces the risk of memory loss.
Less common side effects are (may affect up to 1 in 100 people):
- irritability
- coordination disorders, tingling or numbness, tremors, muscle weakness, muscle pain, muscle cramps, joint pain, neck pain
- dimsyn
Rare side effects are (may affect up to 1 in 1000 people):
- altered sex drive ( libido )
- paradoxical reactions (restlessness, agitation, irritability, aggression, delusions (false perceptions), outbursts of anger, nightmares, hallucinations, psychosis, inappropriate behavior, and other negative behavioral effects) The probability of this happening is higher for older people.
No known frequency (cannot be calculated from the available data)
- loss of consciousness, impaired attention, speech disorders
- restlessness, aggression, delusions (false perceptions), outbursts of anger, psychosis (hallucinations: when you see, hear or feel something that is not there), inappropriate behavior, sleepwalking, depression (depression), euphoria
- physical dependence: use (even at the doses given during treatment) can lead to physical dependence, sudden discontinuation of treatment can result in withdrawal effects and recurrence of problems.
- Psychologically addicted: in this case, you do not think you will ever be able to sleep without taking Edluar
- increased levels of certain liver enzymes (which should be detected by your doctor during blood sampling), liver damage
- skin rash, itching, hives
- heavy sweating
- changed way of walking
- the need to take ever-higher doses of a drug to achieve the same effect
- cases (falling over), especially for the elderly
- shortness of breath ( respiratory depression )
5. How to store Edluar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the blister pack after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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. Contents of the packaging and other information
Content declaration
The active substance is zolpidem tartrate.
Edluar 5 mg:
One sublingual travel tablet contains 5 mg zolpidem tartrate.
Edluar 10 mg:
One sublingual travel tablet contains 10 mg zolpidem tartrate.
The other ingredients are mannitol (E421), silicified microcrystalline cellulose (a mixture of microcrystalline cellulose and colloidal anhydrous silica), colloidal anhydrous silica, croscarmellose sodium, saccharin sodium, magnesium stearate.
What the medicine looks like and the contents of the pack
5 mg:
Your medicine comes in the form of white, round, flat tablets with beveled edges that are approximately 7.5 mm in diameter and have a V engraved on one side.
10 mg:
Your medicine comes in the form of white, round, flat tablets with beveled edges that are approximately 7.5 mm in diameter and have an X engraved on one side.
It is available in blister packs containing 10, 14, 20, 28, 30, 60, 100, or 150 sublingual resoriblets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Meda AB
Box 906
170 09 Solna
e-mail: info@medasverige.se
tel: 08-630 19 00
or
MEDA Pharma GmbH & Co. KG
Benztrasse 1
61352 Bad Homburg
Germany
This medicinal product is authorized under the European Economic Area under the names:
Austria, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, United Kingdom: Edluar
Belgium, Italy, Luxembourg: Zolpeduar