Zoltab Film-Coated Tablets

ZOLTAB contains a medicine called zolpidem tartrate. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep. ZOLTAB is used for temporary sleep problems in adults that are causing you severe distress or that are affecting your everyday life. This includes sleep problems in adults such as:

• Difficulty falling asleep.
• Waking in the middle of the night.
• Waking too early.

Your doctor will identify your sleep problem wherever possible and the underlying factors before prescribing ZOLTAB for you. The failure of your sleep problems to stop after a 7 – 14 - day course of treatment may indicate you have an underlying disorder; your doctor will assess you at regular intervals. ZOLTAB is used for short - term treatment of insomnia in adults. Do not use long - term. Treatment should be as short as possible because the risk of dependence increases with the duration of treatment. Ask your doctor for advice if you are unsure.

Do not take ZOLTAB if:

• you are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6).
• you have signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• you have a problem where you stop breathing for short periods at night (sleep apnoea).
• you have a problem that causes severe muscle weakness (myasthenia gravis).
• you have breathing difficulties (hypoventilate).
• you have severe liver problems.
• you are under the age of 18.
• safe in pregnancy and breastfeeding has not been established.

Do not take ZOLTAB if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking ZOLTAB.

Take special care with ZOLTAB if:

• you have a history of alcohol or drug abuse.
• your lungs do not work properly.
• you have any liver problems.
• you have depression or have had another mental illness in the past.
• you have recently taken zolpidem or other similar medicines for more than 4 weeks.

Use of ZOLTAB may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence is greater when ZOLTAB is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substances, or drug abuse. Tell your healthcare provider if you have ever had a mental disorder or have abused or have been dependent on alcohol, illicit substances, or medicines. ZOLTAB can cause drowsiness and decrease your level of alertness. This could cause you to fall, sometimes leading to severe injuries. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking ZOLTAB.

Do not share medicines prescribed for you with any other person. Always take ZOLTAB exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. ZOLTAB is taken by mouth. Swallow the tablet whole with a drink of water. ZOLTAB 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.

Adults over 18 years of age:

• The recommended dose is one 10 mg tablet (or two 5 mg tablets) just before bedtime.
• A lower dose may be prescribed to some patients. Do not exceed 10 mg per 24 hours.

Elderly:

• The usual dose is one 5 mg tablet just before bedtime.

Patients with liver problems:

• The usual starting dose is one 5 mg tablet just before bedtime. This may be increased to two 5 mg tablets (or one 10 mg tablet) by your doctor if necessary.

The usual length of treatment is 2 days to 4 weeks.

ZOLTAB can have side effects. Not all side effects reported for ZOLTAB are included in this leaflet. Should your general health worsen while taking ZOLTAB please consult your doctor, pharmacist, or other healthcare professional for advice. If any of the following happens, stop taking ZOLTAB and tell your doctor immediately or go to the casualty department at your nearest hospital: Severe allergic reaction, including an itchy, lumpy rash (hives) or nettle rash (urticaria), swelling of the hands, feet, ankles, face, lips or throat and difficulty in swallowing or breathing. These are all serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following:

• Frequent side - effects:
• Poor memory while taking ZOLTAB (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 ZOLTAB 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).
• Diarrhoea.
• Feeling sick (nausea) or being sick (vomiting).
• Abdominal pain.
• Respiratory infection.
• Headache.
• Feeling tired or agitated.
• Nightmares.
• Depression.
• Feeling dizzy.
• Feeling sleepy or drowsy.
• Back pain.

Less frequent side - effects:

• Any changes in vision such as blurred eyesight or ‘seeing double’, loss of vision.
• Being less aware of your environment.
• Falling, especially in the elderly.
• Sleep - driving and other sleep - related behaviour.
• Itching skin or skin rash.
• Excessive sweating.

Feeling restless, aggressive, confused, or irritable.

Feeling overly happy/confident (euphoric).

Unusual skin sensations such as numbness, tingling, pricking, burning, or creeping on the skin (paraesthesia).

Tremor.

Lack of concentration.

Speech problems.

Changes in the amount of liver enzymes – shown up in the results of blood tests.

Changes in appetite or behaviour concerning appetite.

Muscle pain, muscle spasms and limp or weak muscles.

Itchy, lumpy rash (urticaria).

Thinking things that are not true (delusions).

Changes in sex drive (libido).

You have 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. This could be caused by an infection or injury to the liver.

An illness where removal of bile from the liver is blocked (cholestasis). Signs include jaundice, rash or fever and the colour of your water (urine) becomes darker.

Changes in the way you walk.

Slower breathing (respiratory depression).

Becoming dependent on ZOLTAB.

Frequency unknown:

A feeling of being out of touch with reality and being unable to think or judge clearly (psychosis).

Feeling angry or showing unusual behaviour.

Needing to take more ZOLTAB in order to sleep.

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, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ZOLTAB. Alternatively, all adverse events can be reported to Alkem Laboratories via the e-mail: [email protected].

Store at or below 25 °C. Protect from light and moisture. Keep sealed blister in outer container until required for use. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and the blister. Do not throw away any medicines in drains or sewage systems. Return all unused medicine to the pharmacist.