• 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.

What is in this leaflet:

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.

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.

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.

Stopping Nitrazepam Mixture Oral Suspension and Withdrawal Symptoms:

This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly. If you stop taking this medicine suddenly you may experience the following withdrawal effects:

• a recurrence of sleep problems,
• depression,
• nervousness,
• extreme anxiety,
• tension,
• restlessness,
• confusion,
• mood changes,
• irritability,
• sweating,
• diarrhoea,
• headaches,
• muscle weakness.

In severe cases the following symptoms may occur:

• changes in behaviour,
• numbness and tingling of the extremities,
• fits,
• over-sensitivity to light, noise and touch,
• hallucinations.

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 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