Adco-Zolpidem Hemitartrate 5 mg Film-Coated Tablets

ADCO-ZOLPIDEM HEMITARTRATE contains a medicine called zolpidem tartrate and belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.

ADCO-ZOLPIDEM HEMITARTRATE is used to initiate sleep in adults with severe sleeping difficulties, also called insomnia, for a short-term only.

Do not take ADCO-ZOLPIDEM HEMITARTRATE

• If you are hypersensitive (allergic) to zolpidem hemitartrate or any of the other ingredients of ADCO-ZOLPIDEM HEMITARTRATE (listed in section 6) (Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue).
• If you have myasthenia gravis (a condition in which the muscles become weak and tire easily).
• If you have sleep apnoea (a condition where you temporarily stop breathing while you sleep).
• If you have severe lung problems.
• If you have serious liver problems.
• If you are a under the age of 18 years.
• If you are pregnant, intend to become pregnant or are breastfeeding.

Warnings and precautions

Take special care with ADCO-ZOLPIDEM HEMITARTRATE:

• The use of ADCO-ZOLPIDEM HEMITARTRATE may lead to the development of abuse and/or physical and psychological dependence. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or alcohol, illicit substance, or medicine abuse. Tell your health care provider if you have ever had a mental disorder or have abused or have been addicted to alcohol or other medicines.
• Please consult with your doctor if you notice that you cannot or do not want to stop taking ADCO-ZOLPIDEM HEMITARTRATE or if you feel that you need to take ADCO-ZOLPIDEM HEMITARTRATE more often than prescribed to you by your doctor.
• Use with caution if you have mild to moderate breathing or chest problems.
• If your sleep problems persist or worsen after a short period of treatment, consult your doctor.
• If your sleep problems return while you are taking ADCO-ZOLPIDEM HEMITARTRATE, consult your doctor. When medicines for sleep such as ADCO-ZOLPIDEM HEMITARTRATE are used for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as “tolerance”.
• You may have temporary memory loss (amnesia) when taking ADCO-ZOLPIDEM HEMITARTRATE. This can usually be avoided if you get a full night’s sleep (7 to 8 hours) before being active again.
• Some people taking ADCO-ZOLPIDEM HEMITARTRATE, may have changes in behaviour and thinking (see section 4). If you or your family notice any changes in your behaviour, or if you have any unusual or disturbing thoughts, consult your doctor immediately.
• If you ever had a history of sleep walking or other unusual behaviour (such as driving, eating, making a phone call or having sex etc.) while not being fully awake after taking ADCO-ZOLPIDEM HEMITARTRATE.
• Use with caution if you have mild to moderate liver problems.
• If you suffer from mental disorders (depression or schizophrenia).
• Next day psychomotor impairment (see also ‘Driving and using machines’)

Do not share medicines prescribed for you with any other person.

Always take ADCO-ZOLPIDEM HEMITARTRATE exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure.

Adults

The usual adult dose of ADCO-ZOLPIDEM HEMITARTRATE is 10 mg at night, immediately before bedtime or in bed. The dose of one tablet (10 mg) at night should not be exceeded.

Elderly

If you are over 65 years of age or have liver problems, the usual dose is 5 mg or half of a tablet (10 mg); this dose should not be exceeded except under special circumstances. The maximum daily dose is 10 mg in any patient.

ADCO-ZOLPIDEM HEMITARTRATE should only be used for a few days to 2 weeks with a maximum, including the tapering off (gradual reduction of your dose before stopping treatment over a period) process, of 4 weeks.

If you take more ADCO - ZOLPIDEM HEMITARTRATE than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre and tell them how many tablets have been taken. If you take too much ADCO-ZOLPIDEM HEMITARTRATE, your consciousness may be impaired, ranging from drowsiness to light coma.

If you forget to take ADCO - ZOLPIDEM HEMITARTRATE

ADCO-ZOLPIDEM HEMITARTRATE must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking ADCO - ZOLPIDEM HEMITARTRATE

Keep taking ADCO-ZOLPIDEM HEMITARTRATE until your doctor tells you to stop. Do not stop taking ADCO-ZOLPIDEM HEMITARTRATE 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. If you stop taking ADCO-ZOLPIDEM HEMITARTRATE suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below. See a doctor straight away if you experience any of the following effects:

• feeling anxious, restless, irritable or confused
• headache
• nightmares, seeing or hearing things that are not real (hallucinations)
• being more sensitive to light, noise and touch than normal
• relaxed grip on reality
• feeling distant from your body or feeling ‘puppet-like’
• numbness and tingling in your hands and feet
• aching muscles
• stomach problems
• sleep problems come back worse than before
• in rare cases fits (seizures) may also occur.
• Sweating

ADCO-ZOLPIDEM HEMITARTRATE can have side effects. Not all side effects reported for ADCO-ZOLPIDEM HEMITARTRATE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADCO-ZOLPIDEM HEMITARTRATE, please consult your health care provider for advice.

If any of the following happen, stop taking ADCO-ZOLPIDEM HEMITARTRATE and tell your doctor immediately or go to the causality department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing
• Lumpy rash (hives) or nettle rash (urticaria)

These are all very serious side effects. If you have them, you may have had a serious reaction to ADCO-ZOLPIDEM HEMITARTRATE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Discolouration of the skin or eyes, pain in the abdomen (stomach) or a bloated feeling, severe itching, pale or bloody stools, extreme weakness, nausea or loss of appetite. These may be signs of a problem with your liver
• Slower breathing or difficulty breathing (respiratory depression)
• ADCO-ZOLPIDEM HEMITARTRATE may cause sleep walking or other unusual behaviour (such as driving, eating, making a phone call or having sex etc.) while not being fully awake, some of which have been associated with serious injuries.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Drowsiness
• Dizziness
• Diarrhoea
• Nausea
• Vomiting
• Abdominal pain
• Headache
• Increased sleep problems
• Memory difficulties
• Hallucinations
• Agitation
• Nightmares
• Depression
• Tiredness
• Nose, throat or lung infections (respiratory infection)
• Back pain

Less frequent side effects:

• Confusion
• Irritability
• Restlessness
• Aggressiveness
• Delusion
• Libido disorders (changes in sex drive)
• Dependence (need to continue the sleep medicine associated with unpleasant symptoms when the sleep medicine is suddenly stopped)
• Double vision, blurred vision
• Decreased concentration
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
• Slower breathing (respiratory depression)
• Changes in the amount of liver enzymes – shown up in the results of blood tests
• Itching skin or skin rash
• Excessive sweating
• Unsteadiness, fall (mainly in older patients and when ADCO-ZOLPIDEM HEMITARTRATE is not taken in accordance with the prescribing recommendations)
• Muscle weakness, muscle spasms, limp or weak muscles, muscle pain, joint pain

Unknown frequency side effects:

• Rage (anger)
• Abnormal behaviour
• Feeling overly happy or confident (euphoric)
• A feeling of being out of touch with reality and being unable to think or judge clearly (psychosis)
• Anxiety
• Confusion
• Tolerance (loss of effectiveness of the sleep medicine)
• Puffy or swollen face, especially around your eyes and mouth, including lips and tongue.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ADCO-ZOLPIDEM HEMITARTRATE.

Store all medicines out of reach of children.

Store in the original package at or below 25 °C Protect from light and moisture. Keep the container well-closed. Do not take ADCO-ZOLPIDEM HEMITARTRATE after the expiry date shown on the carton and blister. Keep the blisters in the outer carton until required for use.