Nitrazepam Mixture 2.5mg/5ml Oral Suspension BP

• 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.
• 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.

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

• if you are allergic to nitrazepam or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any medicines known as a benzodiazepine (e.g. temazepam, diazepam, flurazepam or chlordiazepoxide);
• if you suffer from lung disease;
• if you suffer from difficulty breathing while awake or asleep;
• if you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily);
• if you are suffering from psychiatric illness or a personality disorder (severe mental problems);
• if you have severe liver condition;
• if you have acute porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorder).

Take special care with Nitrazepam Mixture Oral Suspension

Talk to your doctor or pharmacist before taking Nitrazepam Mixture Oral Suspension

• if you have a long-term lung, liver or kidney disease;
• if you suffer from depression or worry caused by depression, or have recently suffered the death of a close friend or relative;
• if you are suffering or have suffered from a mental illness;
• if you notice that this medicine is not working as well as it did when first starting treatment;
• if you are not able to have 7 or 8 hours of unbroken sleep.
• If you are woken from sleep within this time you may suffer from a loss of memory for a short while;
• if you experience changes in behaviour such as aggression, confusion, restlessness, agitation, irritability, rages, delusion (a fixed irrational idea not shared by others), nightmares, hallucinations, psychoses (severe mental condition in which the person loses contact with reality and is unable to think and judge clearly) or inappropriate behaviour. If these behavioural changes occur your doctor may want you to stop taking this medicine;
• if you have abused alcohol or drugs. You must not drink alcohol or use drugs while taking nitrazepam;
• if you are pregnant or breast-feeding.
• if you 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.
• if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• if you feel you need to take more of Nitrazepam Mixture Oral Suspension 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 doctor 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 doctor 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 Nitrazepam Mixture Oral Suspension 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 doctor 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 doctor 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.

Nitrazepam Mixture Oral Suspension should only be used by those that it has been prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of nitrazepam may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Because nitrazepam 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.

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

Tell your doctor or pharmacist if you are taking or have recently taken 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.

Concomitant use of Nitrazepam Mixture 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 Mixture 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.

Also tell your doctor if you are taking any of the following medicines:

• Antidepressants, other tranquillisers or sleeping pills, or other such medicines that act on the brain and nerves.
• Medicines used to relieve pain (eg. codeine) or anaesthetics.
• Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine).
• Medicines for treating epilepsy (e.g. phenytoin, carbamazepine and phenobarbital).
• Medicines that affect the liver (e.g. the antibiotic rifampicin).
• Cimetidine used to treat stomach ulcers, (as this can cause nitrazepam to be removed more slowly than usual from the body).
• Probenecid used to treat gout (painful inflammation of the joints).
• Levodopa (to treat Parkinson’s disease) as nitrazepam may cause levodopa to not work as well as it should.

Do not drink alcohol when taking Nitrazepam Mixture Oral Suspension. Alcohol can increase the effects of nitrazepam 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 for advice before taking this medicine.

If you and your doctor decide that you should take this medicine towards the end of your pregnancy (or during labour) this may harm your baby. The baby may have a low temperature, floppiness, and breathing problems or difficulty in feeding.

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.

Tell your doctor before taking nitrazepam if you are breast-feeding. Avoid taking nitrazepam if you are breast-feeding as nitrazepam passes into breast-milk.

Nitrazepam Mixture Oral Suspension 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.

This medicine can affect your ability to drive.

Do not drive while taking this medicine until you know how it affects you.

It is an offence to drive if this medicine affects your ability to drive.

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.

There is further information for patients who are intending to drive in Great Britain – go to https://www.gov.uk/drug-driving-law.

This medicine contains 2 g of sucrose per 5 ml of oral suspension. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. May be harmful to teeth.

This medicine contains 7.5 mg sodium (main component of cooking/table salt) in each 5 ml. This is equivalent to 0.37% of the recommended maximum daily dietary intake of sodium for an adult.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your doctor 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 doctor 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 may 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).

Duration of treatment: Normally treatment lasts from a few days to two weeks with a maximum of 4 weeks. The total treatment period should not be any longer than 4 weeks (including any time that it takes to reduce the dose before stopping treatment).

If you take too much oral suspension or someone else accidentally takes your medicine, contact a doctor immediately.

Symptoms of overdose may be:

• Drowsiness
• Confusion
• Difficulty in speaking or unclear speech
• Lack of energy/tiredness
• Difficulties coordinating arms and legs
• Low muscle tone
• Low blood pressure
• Very slow and/or shallow breathing
• Rarely coma

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.

When you stop taking Nitrazepam Mixture Oral Suspension, you may experience drug withdrawal symptoms, which 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).

If you notice any of the following signs whilst taking Nitrazepam Mixture Oral Suspension, 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 that you talk to your doctor.

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. There are 2.5 mg of nitrazepam in each 5 ml.

The other ingredients are sucrose, microcrystalline cellulose, carboxymethyl cellulose sodium, a preservative (mixed esters of p-hydroxybenzoic acid), cherry flavour and water (see end of Section 2 for further information about sucrose and sodium).

Nitrazepam Mixture Oral Suspension is a white to off-white suspension with a cherry odour.

It is available in a 70 ml amber glass bottle with a tamper-evident child-resistant polypropylene (PP) cap with and a polyethylene (PE) liner and a 20 ml measuring cup (polypropylene) with increments in the range of 2.5 ml to 20 ml.

Marketing Authorisation Holder:

Manufacturer:

UK Marketing Authorisation Number: PL 00427/0288