Zolnoxs 10 mg Tablets

ZOLNOXS 10 mg TABLETS contains the active substance zolpidem tartrate 10 mg. ZOLNOXS 10 mg TABLETS is used to initiate sleep in adults with severe sleeping difficulties, also called insomnia, for a short-term only.

Do not take ZOLNOXS 10 mg TABLETS:

• if you are hypersensitive (allergic) to zolpidem or any of the other ingredients of ZOLNOXS 10 mg TABLETS.
• 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 heart problems.
• if you have experienced complex sleep behaviour where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking medicines to help you sleep (eszopiclone, zaleplon or zolpidem).
• if you have lung problems.
• if you have liver problems.
• if you have any psychotic illness.
• if you are a child under 18 years of age due to an incidence risk of adverse effects.
• if you are pregnant, intend to become pregnant or are breastfeeding your baby.

Warnings and precautions

Take special care with ZOLNOXS 10 mg TABLETS:

• if the cause of your sleeplessness has not been determined.
• if you still suffer from sleeplessness after 7 to 14 days of taking ZOLNOXS 10 mg TABLETS.
• if you have recently taken ZOLNOXS 10 mg TABLETS or other similar medicines for which should not exceed 4 weeks, including the tapering off process.
• if sleep problems return while you are taking ZOLNOXS 10 mg TABLETS, consult your doctor.
• When medicines for sleep such as ZOLNOXS 10 mg TABLETS 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 ZOLNOXS 10 mg TABLETS. This can usually be avoided if you get a full night sleep (8 hours) before being active again.
• you may have changes in behaviour and thinking. 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 may be at risk of getting into a regular pattern or habit of taking ZOLNOXS 10 mg TABLETS.
• if you are elderly.
• if you suffer from depression or have had another mental illness in the past.
• if you have a history of alcohol or drug abuse.
• if you feel sleepy even the next day, this may lead to falls and severe injuries.
• use with caution if you have mild to moderate breathing or chest problems.
• next day decreased mental alertness (see also Driving and using machines).

Do not share medicines prescribed for you with any other person. Always take ZOLNOXS 10 mg TABLETS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Males

The usual dose is one tablet (10 mg) at night, immediately before bedtime.

Women

If you are a woman, the usual dose is half a tablet (5 mg) immediately before bedtime.

Elderly patients and patients with liver problems

If you are over 65 years of age or have liver problems, the usual dose is half a tablet (5 mg). A total dose of 10 mg should not be exceeded in these populations.

Children

You should not use this medicine if you are younger than 18 years of age. ZOLNOXS 10 mg TABLETS should only be used for a few days to 2 weeks with a maximum including the tapering off process of 4 weeks.

Swallow the tablet with a full glass of water. Your doctor will tell you how long your treatment with ZOLNOXS 10 mg TABLETS will last. If you have the impression that the effect of ZOLNOXS 10 mg TABLETS is too strong or too weak, tell your doctor or pharmacist.

ZOLNOXS 10 mg TABLETS can have side effects. Not all side effects reported for ZOLNOXS 10 mg TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZOLNOXS 10 mg TABLETS, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking ZOLNOXS 10 mg TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ZOLNOXS 10 mg TABLETS. 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:

• liver problems with symptoms such as skin and eyes that appear yellowish (jaundice), dark urine, stomach pain and swelling, swelling in the legs and ankles and a tendency to bruise easily,
• respiratory depression (slower breathing),
• suicidal thoughts and behaviours,
• falls and 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:
• hallucinations (seeing or hearing things that are not real), agitation, nightmares (bad dreams), depression (low mood),
• somnolence (sleepiness), headache, dizziness, exacerbated insomnia (worsening of sleeplessness), anterograde amnesia (loss of memory),
• diarrhoea, nausea (feeling sick), vomiting, abdominal pain (stomach ache),
• back pain,
• upper and lower respiratory tract infection (infection of the nose, throat or chest),
• fatigue (tiredness).

Less frequent side effects:

• changes in appetite or behaviour concerning appetite,
• confusional state, irritability, restlessness, aggression, delusion (thinking things that are not true), unrealistic feeling of well-being (euphoric mood), anger, psychosis (being unable to think or judge clearly), abnormal behaviour, somnambulism (sleep walking), dependence, libido disorder (sex drive disorder), insomnia (inability to sleep),
• numbness and tingling in the skin (paraesthesia), tremor, lack of concentration, speech disorder, low level of consciousness, day time drowsiness, vertigo (dizziness), light-headedness,
• vision abnormalities (inability to see properly), blurred vision, diplopia (double vision),
• liver enzymes elevated (changes in amount of liver enzymes shown in blood tests),
• increased sweating,
• muscle pain, muscle spasms, muscular weakness,
• gait disturbance (problem whilst walking), medicine tolerance (needing more medicine to get the same effect), fall, malaise (general feeling of being unwell).

Side effects with frequency unknown:

• Sleep behaviours which include: sleepwalking, sleep driving and engaging in other activities while not fully awake.

Store all medicines out of reach of children. Store in a dry place at or below 25 ̊ C. Protect from light. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).