Nitrazepam 2.5 mg/5 ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Nitrazepam Oral Solution is and what it is used for
2. What you need to know before you take Nitrazepam Oral Solution
3. How to take Nitrazepam Oral Solution
4. Possible side effects
5. How to store Nitrazepam Oral Solution
6. Contents of the pack and other information

This medicine contains nitrazepam, which can cause dependence, tolerance and addiction. You can get withdrawal symptoms if you stop taking it or reduce the dose suddenly.

• are allergic (hypersensitive) to nitrazepam or any of the other ingredients of this medicine (listed in section 6).
• are allergic (hypersensitive) to any medicine known as a benzodiazepine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam).
• suffer from lung disease.
• suffer from difficulty breathing while awake or asleep.
• suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily).
• are suffering from a psychiatric illness or a personality disorder (severe mental problems).
• have a severe liver condition.

Nitrazepam Oral Solution is not for use in anyone under 18 years of age.

Take special care with Nitrazepam Oral Solution

Talk to your doctor or pharmacist before taking Nitrazepam Oral Solution if you:

• have a long-term lung, liver or kidney disease.
• suffer from depression or have recently suffered the death of a close friend or relative.
• are suffering or have suffered from a mental illness.
• are pregnant or breast-feeding.
• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake. You must not drink alcohol or use drugs while taking Nitrazepam Oral Solution.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Nitrazepam Oral Solution to get the same level of symptom control, this may mean you are developing tolerance to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is specific to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine.

Withdrawal symptoms can include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking this medicine suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Because Nitrazepam Oral Solution relaxes the muscles, elderly patients should take extra care when they get up at night as there is a risk of falls and consequently of injuries including hip fractures.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. In particular, tell your doctor if you are taking any of the following medicines:

• Antidepressants, barbiturates, antipsychotics, hypnotics, anxiolytics, tranquillisers or sleeping tablets, or other such medicines that act on the brain and nerves.
• Medicines used to relieve pain or anaesthetics.
• Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine).
• Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
• Medicines that affect the liver (e.g. the antibiotic rifampicin, Cimetidine, omeprazole; medicines used to treat stomach problems, disulfiram and St John’s wort).
• Sodium oxybate used in patients with narcolepsy.
• Theophylline or aminophylline; medicines to make breathing easier.

Concomitant use of Nitrazepam Oral Solution and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.

Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Nitrazepam Oral Solution together with opioids the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all opioid medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Do not drink alcohol for as long as you are taking Nitrazepam Oral Solution. Alcohol will increase the effects of this medicine and this can be dangerous.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will then decide whether you should take this medicine.

Tell your doctor before taking Nitrazepam Oral Solution if you are breast-feeding. Avoid taking this medicine if you are breast-feeding as nitrazepam passes into breast milk.

If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness and breathing and feeding difficulties. Also, your unborn baby may be at risk of developing dependency to this medicine and after birth may be at some risk of developing withdrawal symptoms.

Nitrazepam Oral Solution may cause side effects such as reduced alertness, confusion, tiredness, dizziness, poor muscle co-ordination and double vision. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects.

Nitrazepam Oral Solution can affect your ability to drive. Do not drive while taking this medicine until you know how it affects you.

It may be an offence to drive if your ability to drive safely is affected.

However, you would not be committing an offence if:

• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

If you take too much or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

Do not take a double dose to make up for a forgotten dose. Instead, you should simply continue with the next dose when it is due.

Your doctor will advise you when to stop taking this medicine.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your medicine suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

If you have taken benzodiazepines for a long time, the reduction in your dosage will be over a longer period of time than would normally be required when you stop taking this medicine. You may need additional help. Your doctor will be able to discuss this with you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

This medicinal product must be taken orally.

Use the measuring cup provided in the pack to deliver the required dose.

When you stop taking Nitrazepam Oral Solution, you may experience drug withdrawal symptoms, which include:

• headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your medicine suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiff and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

If you notice any of the following signs whilst taking Nitrazepam Oral Solution, it could be a sign that you have become addicted.

• You may feel the need to keep taking the medication for longer than your doctor recommended
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

If you are woken up soon after taking the medicine your memory may be temporarily affected.

If you are an elderly patient, you may be more susceptible to side effects. If this happens, tell your doctor and he/she may decide to change your dose.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is nitrazepam. Each 5 ml of solution contains 2.5 mg of nitrazepam.
• The other ingredients are medium-chain triglycerides and mint oil, partly dementholised.

Nitrazepam Oral solution is a clear, colourless to yellowish oily solution, with mint odour.

Nitrazepam Oral solution is packed in a 100 ml amber glass bottle with child resistant screw cap and comes with a 20 ml measuring cup with marked volume graduations at 2.5 ml, 5 ml, 10 ml, 15 ml and 20 ml.

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