Dormicum ® 7,5 mg Tablets

DORMICUM contains a medicine called midazolam. This belongs to a group of medicines called “benzodiazepines”.

DORMICUM is used in adults:

• For the short-term to treatment of insomnia (inability to sleep).
• Before a medical test or operation to produce sleepiness or drowsiness and to relieve anxiety.

Do not take DORMICUM:

• If you are allergic (hypersensitive) to benzodiazepines or to any other ingredients of the product.
• If you have severe muscle weakness, also known as myasthenia gravis.
• If you have severe liver disease.
• If you have difficulties with your breathing.
• If you suffer from sleeping disorders, such as difficulty breathing while asleep.
• If you are taking antifungal medicines including ketoconazole, itraconazole, voriconazole.
• If you are taking HIV protease inhibitors including ritonavir boosted protease inhibitors formulations.
• If you are taking medicines for the hepatitis C virus (HCV) protease inhibitors, boceprevir or telaprevir.
• If you suffer from galactose intolerance.
• DORMICUM tablets are not recommended for use in children.

You must not take DORMICUM if any of the above apply to you. If you are not sure, talk to your pharmacist, doctor or nurse before you take DORMICUM.

Warnings and precautions

Before you take DORMICUM tell your doctor or nurse if you:

• are over 60 years of age,
• take any benzodiazepine medicines, as these may lead to the development of physical and psychological dependence and the risk is increased with a history of alcohol or drug abuse. Tolerance to DORMICUM may occur,
• regularly take recreational drugs or drink large amounts of alcohol or have had problems with alcohol or drug abuse in the past,
• have other health problems including breathing problems or kidney, liver, lung or heart problems.
• have high or low blood pressure, or heart disease,
• suffer from mental disorders including depression, psychosis or schizophrenia,
• are, or plan to become pregnant.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you take DORMICUM.

Other medicines and DORMICUM

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) DORMICUM can affect the way some other medicines work. Also, some medicines can affect the way DORMICUM works.

In particular tell your doctor or nurse if you are taking any of the following medicines:

• Medicines for hepatitis C, such as boceprevir and telaprevir. You must not take these medicines with DORMICUM.
• Medicines for depression.
• Hypnotic medicines (to make you sleep).
• Sedatives (to make you feel calm or sleepy).
• Tranquilliser medicines (for anxiety or to help you sleep).
• Carbamazepine or phenytoin (these may be used for fits or seizures).
• Rifampicin (for tuberculosis).
• Medicines for HIV called “protease inhibitors” (such as saquinavir, delavirdine).
• Antibiotics called “macrolides” (such as erythromycin or clarithromycin).
• Medicines to treat fungal infections (such as ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole).
• Strong pain killers.
• Antihistamines (for allergic reactions).
• Herbal medicines such as St John’s Wort, berberine, goldenseal, Echinacea purpurea root, quercetin or Panax ginseng.
• Medicines for high blood pressure called “calcium channel blockers” (such as diltiazem, verapamil).
• Medicines used in the treatment of leukaemia and other cancers, such as imatinib, lapatinib, idelalisib, mitotane or enzalutamide.
• Oestrogen receptor modulators such as raloxifene.
• Oral contraceptive medicines such as ethinylestradiol combined with norgestrel or gestodene.
• Neurokinin-1 receptor antagonists such as aprepitant, netupitant, casopitant.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you take DORMICUM.

DORMICUM with food and drink

Drinking alcohol: Do not drink alcohol if you are taking DORMICUM. This is because alcohol may make you feel very sleepy and cause problems with your breathing.

Pregnancy and breastfeeding

You must tell your doctor or dentist if you are pregnant, or if you think you are pregnant, they can then decide if DORMICUM is suitable for you. Taking DORMICUM during the first three months of pregnancy and cause your baby to be born with birth defects. If your doctor decides you should be given DORMICUM during late pregnancy, labour or Caesarean section, your baby may have an irregular heartbeat, a low body temperature, floppiness, difficulty in sucking, or breathing difficulties and may have developed physical dependence and suffer withdrawal symptoms. DORMICUM may pass into breast milk therefore you should not breastfeed your baby while taking it.

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking DORMICUM.

Driving and using machines

After being given DORMICUM, do not drive or use tools or machines until your doctor says you can. This is because DORMICUM may make you sleepy, forgetful or affect your concentration and co-ordination, these effects can be worsened if you take alcohol at the same time. This may affect your performance at skilled tasks such as driving or operating machinery. Your doctor will let you know when it is safe for you to drive or use machines again.

DORMICUM contains lactose: If you suffer from the rare hereditary condition of lactose/fructose or galactose intolerance e.g. galactosaemia, lactase deficiency or glucose-galactose malabsorption or fructose intolerance, you must not take DORMICUM.

Always take DORMICUM exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Do not share medicines prescribed for you with another person. DORMICUM must be taken for short-term treatment only.

Your doctor will tell you how many tablets to take before you go to bed. If you are having DORMICUM tablets before a minor surgical procedure, this will be administered by a doctor, dentist or a nurse. The dose is normally 15 mg. The normal dosage for insomnia is 7,5 mg to 15 mg.

Swallow the tablets whole with a glass of water. Do not break or crush tablets unless instructed to do so.

If you have the impression that the effect of DORMICUM is too strong or too weak, talk to your doctor, dentist, nurse or pharmacist.

If you take more DORMICUM than you should

Symptoms of overdose may include feeling sick (nausea), vomiting, dizziness, slowing of breathing, drowsiness or coma, slurred speech, loss of balance, slow reactions. If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take DORMICUM

If you forget to take your DORMICUM and your sleep is all right, do not take a dose until the next evening. If you miss a dose and wake up to have it, you require 7 to 8 hours uninterrupted sleep for the effects to wear off. You should never make up for missing a dose by doubling it the next time. Instead, you should simply continue with the next dose when it is due.

If you stop taking DORMICUM

Effects when treatment with DORMICUM is stopped: If you take DORMICUM for a long time, you may:

• Become tolerant to DORMICUM. The medicine becomes less effective and does not work as well for you.
• Become dependent upon DORMICUM and get withdrawal symptoms (see below). Your doctor will reduce your dose gradually to avoid these effects happening to you.

Withdrawal symptoms

If you stop treatment with DORMICUM suddenly, or lower the dose too quickly, you may get withdrawal symptoms. These can include:

• Headache.
• Diarrhoea.
• Muscle pain.
• Feeling very worried (anxious), tense, restless, confused or bad tempered (irritable).
• Mood changes.
• Seeing and possible hearing things that are not really there (hallucinations).
• Sensitivity to light, noise or physical contact.
• Fits (convulsions).
• Problems with sleeping (insomnia).

DORMICUM can cause side effects. Stop taking DORMICUM and see a doctor straight away if you notice any of the following side effects. They can be life-threatening and you may need urgent medical treatment:

• Heart attack. The signs may include chest pain.
• Breathing problems, sometimes causing the breathing to stop.

Other possible side effects:

• Hypersensitivity and an allergic skin disease characterised by patches of confined swelling involving the skin, the layers beneath the skin and/or the mucous membranes (angioedema).
• Feeling confused, disoriented, and emotional with mood swings.
• Feeling very happy or excited (euphoria).
• Loss of libido.
• Feeling depressed.
• Other reactions such as restlessness, agitation, hyperactivity, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis or inappropriate behaviour.
• Feeling tired or sleepy or being sedated for a long time.
• Headache.
• Feeling dizzy.
• Difficulty co-ordinating muscles.
• Temporary loss of memory.
• Seeing double.
• Stomach upsets.
• Skin reactions including rash.
• Muscle weakness.
• Fatigue.
• An increased risk of falling and fractures, the risk being increased when sedatives and/or alcohol are taken at the same time.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. Not all side effects reported for DORMICUM are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking DORMICUM, please consult your doctor, pharmacist or other healthcare professional for advice.

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 DORMICUM.

Store at or below 30 °C, protect from light and moisture. Store in original pack until required for use. DORMICUM should not be used after the expiry date shown on the container. Store out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).