Nitrazepam Mixture 2.5mg/5ml Oral Suspension Bp
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Nitrazepam Mixture 2.5mg/5ml Oral Suspension BP
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet in an alternative format, such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet:
1. What Nitrazepam Mixture Oral Suspension is and what it is used for
2. Before you take Nitrazepam Mixture Oral Suspension
3. How to take Nitrazepam Mixture Oral Suspension
4. Possible side effects
5. Howto store Nitrazepam Mixture Oral Suspension
6. Further information
1. What Nitrazepam Mixture Oral Suspension is and what it is used for
Nitrazepam Mixture Oral Suspension contains the benzodiazepine, nitrazepam. Benzodiazepines are a group of medicines known as sedatives, which have a calming effect and reduce anxiety and tension.
Nitrazepam Mixture Oral Suspension helps people who find it so difficult to sleep that their daily lives are affected or they are distressed.
2. Before you take Nitrazepam Mixture Oral Suspension Do not take Nitrazepam Mixture Oral Suspension if:
• You are allergic (hypersensitive) to nitrazepam or any other benzodiazepines, e.g. temazepam, or any of the other ingredients of Nitrazepam Mixture Oral Suspension.
• Your doctor has told you that you have myasthenia gravis (a disease causing severe muscle weakness) or sleep apnoea syndrome (difficulties in breathing whilst asleep).
• You have chronic Psychosis (long-standing mental illness with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.)
• You have acute porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorder)
• You have severe problems with your breathing
• You have severe liver problems
• You are breast-feeding
Make sure your doctor knows if you have or have had a drug or alcohol problem as you are more likely to become dependent on Nitrazepam Mixture Oral Suspension.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Examples of medicines that can affect Nitrazepam Mixture Oral Suspension are:-
• Some medicines used for mental illness such as anxiety or depression
• Other sleeping tablets
• Some strong painkillers, such as codeine may give you a heightened sense of well being when taken with nitrazepam. This can increase your desire to continue taking these medicines (dependency) or can make you very sleepy.
• Anaesthetics, used to put you to sleep during an operation
• Antihistamines, used for hayfever and other allergies which cause drowsiness.
• Medicines used for epilepsy such as phenytoin, carbamazepine or phenobarbital.
• Rifampicin, an antibiotic (commonly used in the treatment of tuberculosis as this can cause nitrazepam to be removed from the body more quickly than usual)
• 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.
Taking Nitrazepam Mixture Oral Suspension with food and drink
Do not drink alcohol when taking Nitrazepam Mixture Oral Suspension as it may make you excessively sleepy.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Nitrazepam Mixture Oral Suspension is not recommended during pregnancy except on the advice of a doctor.
Breast-feeding
Do not take Nitrazepam Mixture Oral Suspension whilst breast-feeding.
Driving and using machines
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Do not drive or use machinery when taking Nitrazepam Mixture Oral Suspension because the effect of your insomnia plus the possible sedative effects of Nitrazepam Mixture Oral Suspension the next day may make you unsafe.
Important information about some of the ingredients of Nitrazepam Mixture Oral Suspension
Nitrazepam Mixture Oral Suspension contains 2g of sucrose (sugar) in every teaspoon. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Nitrazepam Mixture Oral Suspension
Always take Nitrazepam Mixture Oral Suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
* Before you take Nitrazepam Mixture Oral Suspension make sure you have enough time for 7-8 hours sleep.
* The usual dose for adults is 10 ml (2 teaspoonfuls) just before bedtime.
Sometimes if this dose doesn't work, the doctor may increase it to 20 ml (4 teaspoonfuls).
* Older people and patients with liver, kidney or breathing problems should take half the adult dose - 5 ml (1 teaspoonful). Sometimes if this dose doesn't work, the doctor may increase it to 10 ml (2 teaspoonfuls).
* The doctor may tell you not to take the medicine every night.
* If you forget to take Nitrazepam Mixture Oral Suspension and remember too late for 7 to 8 hours sleep, do not take any Nitrazepam Mixture Oral Suspension until the next night.
Nitrazepam Mixture Oral Suspension is not recommended for children.
Duration of treatment: Normally treatment lasts from a few days to two weeks with a maximum of 4 weeks. To stop treatment, the doctor will probably advise you how to reduce your dose slowly until you stop.
If you take more Nitrazepam Mixture Oral Suspension than you should, contact a doctor immediately.
If you stop taking Nitrazepam Mixture Oral Suspension
* You should ask your doctor for advice before you stop taking Nitrazepam Mixture Oral Suspension.
* People can sometimes become addicted to benzodiazepines. This is why treatment should be for a short time, and why the dose should be gradually reduced at the end.
* Contact your doctor if you find it difficult to stop using this medicine, particularly if you have any unusual symptoms. These "withdrawal" symptoms might include difficulties in sleeping, headaches, muscle pain, numbness or tingling of the hands or feet, hallucinations or fits or feeling very anxious, tense, restless, confused, irritated, unreal or any other changes in mood or being very sensitive to light, noise or touch. These do not last. Sometimes patients feel that all the symptoms they had before treatment have returned in worse form.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Nitrazepam Mixture Oral Suspension can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Nitrazepam Mixture Oral Suspension if you get a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat.
* Sometimes people feel sleepy, unemotional, less alert, confused, tired, dizzy, and weak or are unsteady when they walk. They may get a headache or double vision. These effects happen more often at the start of treatment then usually wear off.
* People can become addicted to Nitrazepam Mixture Oral Suspension.
* There may be changes in mood and patients become restless, agitated, irritable, very angry or aggressive and any pre-existing depression may be revealed.
* Patients may get nightmares, delusions or hallucinations, become forgetful or show unusual behaviour. All these are more likely in the elderly.
* Other side effects include stomach upsets, low blood pressure, yellowing of the skin or whites of the eyes (jaundice), changes in sex drive or skin reactions, which happen occasionally.
* Blood disorders and difficulty passing water happens rarely.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Nitrazepam Mixture Oral Suspension
Keep all medicines out of the reach and sight of children.
Do not store above 25°C and protect from light. Do not freeze it.
Do not use Nitrazepam Mixture Oral Suspension after the expiry date which is printed or embossed on the carton and bottle label as month/year. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Nitrazepam Mixture Oral Suspension contains
The active substance of Nitrazepam Mixture Oral Suspension is nitrazepam. There are 2.5mg of nitrazepam in each 5 ml.
The other ingredients are sucrose, microcrystalline cellulose, carboxymethyl cellulose sodium, a preservative (mixed esters of p-hydroxybenzoic add), cherry flavour and water. What Nitrazepam Mixture Oral Suspension looks like and contents of the pack
Each pack consists of a carton with an amber glass bottle of Nitrazepam Mixture Oral Suspension containing 150 ml suspension.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Norgine Ltd, Norgine House, Moorhall Road, Harefield, Middlesex, UB9 6NS UK.
It is made by Norgine Ltd, Mid Glamorgan, CF82 8SJ UK.
NORGINE
UK Marketing Authorisation Number: PL 00322/0039 The leaflet was last revised in 07/2013