Zolpidem XR Tablets

ZOLPIDEM XR 12,5 ADCO 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.

ZOLPIDEM XR 12,5 ADCO is used to initiate sleep in adults below the age of 65 years with sleeping difficulties, also called insomnia, for a short-term only.

Do not take ZOLPIDEM XR 12,5 ADCO

• if you are hypersensitive (allergic) to zolpidem tartrate or any of the other ingredients of ZOLPIDEM XR 12,5 ADCO (listed in section 6).
• if you are a child under 18 years of age.
• if you have sleep apnoea (a condition where you temporarily stop breathing while you sleep).
• if you have myasthenia gravis (a condition in which the muscles become weak and tire easily).
• if you have serious liver problems.
• if you have severe lung problems.
• if you are pregnant or are breastfeeding.

Warnings and precautions

Take special care with ZOLPIDEM XR 12,5 ADCO

• Use with caution if you have mild to moderate breathing or chest problems.
• You may have temporary memory loss (amnesia) when taking ZOLPIDEM XR 12,5 ADCO. This can usually be avoided if you get a full night’s of sleep (7 to 8 hours) before being active again.
• Symptoms like restlessness, irritability, agitation, aggression, delusion, anger, nightmares, hallucinations, abnormal behaviour are known to occur when taking ZOLPIDEM XR 12,5 ADCO. Should these occur stop taking ZOLPIDEM XR 12,5 ADCO and consult your health care provider immediately.
• If you have a history or are experiencing the following symptoms while taking ZOLPIDEM XR 12,5 ADCO: sleep walking, sleep driving, preparing and eating food, making phone calls or having sex, with no memory of these events. Consult your health care provider immediately if you experience any of the above symptoms.
• If your sleep problems return while you are taking ZOLPIDEM XR 12,5 ADCO, consult your doctor. When medicines for sleep such as ZOLPIDEM XR 12,5 ADCO are used for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as tolerance.
• The use of ZOLPIDEM XR 12,5 ADCO may lead to the development of abuse and/or physical and mental dependence. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or alcohol, illegal 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.
• If your sleep problems persist or worsen after a short period of treatment, consult your doctor.
• If you have mild to moderate liver problems.
• Some people taking ZOLPIDEM XR 12,5 ADCO 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 have heart problems.

Children and adolescents

Do not give ZOLPIDEM XR 12,5 ADCO to children or adolescents under 18 years of age.

Other medicines and ZOLPIDEM XR 12,5 ADCO

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Tell your doctor or pharmacist if you are currently taking:

• Other medicines that work on the brain such as:
• medicines used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants),
• medicines used for strong pain relief (narcotic analgesics, opioids),
• medicines used for the treatment of seizures/fits (antiepileptic medicines),
• anaesthetics,
• medicines used in the treatment of allergies (antihistamines that cause sleepiness).

The combination of these medicines with ZOLPIDEM XR 12,5 ADCO may make you drowsier than it should and may increase the next-day psychomotor impairment effects, including impaired driving ability. In addition, you may be euphoric (increase of well-being) if narcotic analgesics (morphine and opiates) are combined with ZOLPIDEM XR 12,5 ADCO.

• Medicine used to treat fungal infections (ketoconazole) increases the effect of ZOLPIDEM XR 12,5 ADCO.
• The following medicines may increase the effect of ZOLPIDEM XR 12,5 ADCO and it is not recommended to take them together:
• medicine used to treat depression (fluvoxamine)
• medicine used to treat bacterial infections (ciprofloxacin).

The following medicines may decrease the effect of ZOLPIDEM XR 12,5 ADCO and it is not recommended to take them together:

• medicine used to treat tuberculosis (TB) (rifampicin)
• herbal medicine used for mood swings and depression (St John’s Wort).

ZOLPIDEM XR 12,5 ADCO with food, drink, and alcohol

ZOLPIDEM XR 12,5 ADCO should not be administered with or immediately after a meal, for faster onset of sleep.

ZOLPIDEM XR 12,5 ADCO should not be taken with alcohol.

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

Always take ZOLPIDEM XR 12,5 ADCO exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual adult (< 65 years) dose is one tablet of ZOLPIDEM XR 12,5 ADCO at night, immediately before bedtime or in bed.

The maximum dose is 12,5 mg (one tablet of ZOLPIDEM XR 12,5 ADCO) at night. Do not exceed the maximum dose.

ZOLPIDEM XR 12,5 ADCO should be taken in a single intake and not taken again during the same night.

ZOLPIDEM XR 12,5 ADCO should only be used for a few days to 2 weeks with a maximum of 4 weeks, which including the tapering off (gradual reduction of your dose before stopping treatment over a period) process.

If you have the impression that the effect of ZOLPIDEM XR 12,5 ADCO is too strong or too weak, tell your doctor or pharmacist.

If you take more ZOLPIDEM XR 12,5 ADCO than you should

If you take more ZOLPIDEM XR 12,5 ADCO than you should, your consciousness may be impaired, ranging from sleepiness to coma. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take ZOLPIDEM XR 12,5 ADCO

ZOLPIDEM XR 12,5 ADCO must only be taken at bedtime. If you forget to take the tablet before you go to bed, do not take it if you wake up late in the night or very early in the morning. Take ZOLPIDEM XR 12,5 ADCO before bedtime the following day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking ZOLPIDEM XR 12,5 ADCO

Do not stop taking ZOLPIDEM XR 12,5 ADCO immediately. The dose must be reduced gradually over a period. You can experience headaches, muscle pain, extreme anxiety and tension, restlessness, confusion and irritability if you stop taking ZOLPIDEM XR 12,5 ADCO immediately.

ZOLPIDEM XR 12,5 ADCO can have side effects. Not all side effects reported for ZOLPIDEM XR 12,5 ADCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ZOLPIDEM XR 12,5 ADCO, please consult your health care provider for advice.

If any of the following happens, stop taking ZOLPIDEM XR 12,5 ADCO 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 reaction to ZOLPIDEM XR 12,5 ADCO. 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:

• Amnesia (memory loss),
• hallucination (seeing or hearing things that are not real), depersonalisation (your thoughts and feelings feel as though they belong to someone else),
• changes in the way your heart beats, for example, if you notice it beating faster than normal, abnormal heart rhythms, chest pain, blood clot, heart attack, excess fluid in the lungs,
• sleeping problems that get worse after taking this medicine,
• suicide attempts, suicidal thoughts.

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:

• Influenza (cough, congestion, runny nose),
• anxiety, slowed speech, disorientation,
• headache, dizziness, drowsiness, memory problems, attention problems, drugged feeling, dry mouth, light headedness, feeling overly happy/confident (euphoric), feeling sluggish,
• visual disturbances, double vision, eye redness,
• sinusitis,
• nausea (feeling sick), constipation, diarrhoea, stomach ache, indigestion, hiccups,
• muscle pain/cramps, neck pain, back pain,
• bladder or kidney infection
• tiredness.

Less frequent side effects:

• Lower and upper respiratory tract infections, ear infection with discharge from the ear (inner, middle and outer), shingles (a viral infection) (herpes simplex), abscess,
• anaemia, abnormal blood test results, low white blood cell count, thrombosis (blood clot),
• intestinal infection marked by diarrhoea and cramps, middle ear infection, outer ear infection, abscess, shingles,
• appetite disorder, high blood glucose levels, thirst, gout, high cholesterol, puffy eyes, abnormal blood test results, higher appetite weight loss,
• depression, confusion, lack of interest, mood swings, binge eating, nightmares, feeling very happy, stress symptoms, a sensation of impending threat, feelings of suffocation, and sensations of floating, spinning or falling when falling asleep,
• hallucination (seeing and hearing things that are not real),
• an extreme, unrealistic feeling of physical and emotional well-being,
• depersonalisation (a state in which one's thoughts and feelings seem unreal or not to belong to oneself),
• unsteadiness/tendency to fall, numbness, pins and needles, a lack of muscle control or coordination of voluntary movements, such as walking or picking up objects, burning sensation, dizziness when standing up, altered taste, muscle spasm, tremor, agitation, trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life, feeling detached, slurred speech, exaggerated mood swings (uncontrollable laughing or crying, or heightened irritability or temper), poor concentration, nervousness, abnormal thinking, memory loss/forgetfulness, illusion, leg cramps, migraine, sleeping (after daytime dosing), yawning, increased sweating, unhealthy pale appearance,
• speech disorder, a state of near-unconsciousness or insensibility, unable to walk in the usual way, aggressive reaction, lack of interest, enthusiasm, or concern, lower sex drive, a belief of altered reality, memory loss, feeling that you're observing yourself from outside your body, a stabbing, burning, and often severe pain due to an irritated or damaged nerve, inflammation of a nerve, damage to the nerves, poor ability to adapt to your environment, panic attacks, weakened muscle movements, personality disorder, sleepwalking, involuntary muscle contractions, fainting, hot flushes, cramping rectal pain with a feeling that bowel needs to be emptied even if you already had complete bowel movement, increased or altered saliva, weakness, loss of movement, impotence (sexual dysfunction),
• foul, salty or metallic taste in your mouth,
• red eyes, blurred vision, altered visual depth perception, tired eyes, eye irritation, eye pain, eye inflammation, conjunctivitis (pink eye), abnormal secretion of tears, seeing flashes of light, increased pressure in the eye, a problem with focusing, an open sore in the eye,
• vertigo (sensation of spinning or swaying), ringing or buzzing noise in both ears,
• rapid heartbeats, low blood pressure (including when getting up from a lying down), position conditions that affect blood flow and the blood vessels in the brain, high blood pressure and worsening of high blood pressure, artery or vein inflammation, varicose veins,
• cough, dry irritated throat, bronchitis (inflammation of the lining of bronchial tubes), laryngitis (throat infection), pneumonia (lung infection), difficulty or shallow breathing, nose bleeds,
• vomiting (being sick), stomach pain, excessive gas in your stomach, frequent bowel movements,a burning sensation in your chest (heartburn) usually after eating which might be worse at night, inflammation of the small intestine, burping, inflammation of the stomach, haemorrhoids, obstruction in the intestines, bleeding from your rectum, tooth cavities,
• b lood disorders, including low blood cell count, abnormal lymph node size, unusual large red blood cells, purple-coloured spots and patches that occur on the skin, and in mucus membranes, including the lining of the mouth, porphyria (a rare hereditary blood disease),
• wrinkling of your skin, skin rashes, hives, contact eczema, acne, light sensitivity, skin wrinkles, itching skin, forming of blisters, boils,
• pain in a joint, arthritis (joint inflammation), sciatica (compressed nerve in the lower back causing back, leg and hip pain), osteoarthritis, tendon inflammation,
• painful or difficult urination, bladder infection, passing more or less urine than is normal for you, inability to pass urine, frequent urination at night, kidney infection, kidney pain,
• heavy menstrual flow, itchy and sore in and around your vagina (women), breast pain, painful menstruation, breast tumour,
• abnormal physical weakness or lack of energy, feeling of tiredness, drowsiness, pain, fever, chest discomfort, feeling drunk, influenza-like illness, swelling, falling, general discomfort, trauma, swelling in the face, hot flashes, restless legs, higher tolerance to medicines,
• higher body temperature, higher heart rate, abnormal blood test results.

Frequency unknown side effects:

• Sleep walking, restlessness, aggression, delusion, anger, abnormal behaviour, dependence/addiction,
• liver injury,
• muscle weakness.

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. 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 ZOLPIDEM XR 12,5 ADCO.

• Store at or below 30 °C.
• Store all medicines out of reach of children.
• Keep the tablets in the bottle and the blister strip in the outer carton until required for use.
• Do not take ZOLPIDEM XR 12,5 ADCO after the expiry date shown on the bottle or blister.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).