What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20046/0054 .


Temazepam Oral Solution BP

PACKAGE LEAFLET: INFORMATION FOR THE USER

Temazepam 10mg/5ml Oral Solution

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What is Temazepam Oral Solution and what is it used for

Temazepam belongs to a group of medicines known as Hypnotics. These are medicines which are used to help sleep. It may also be used in a hospital as pre-medication before minor surgery or other procedures.

2. What you need to know before you take Temazepam Oral Solution

Do not take Temazepam Oral Solution:

  • If you have a severe respiratory ailment
  • If you have ever had an unusual reaction to benzodiazepines (e.g. Diazepam, Temazepam) or to any of the ingredients listed in section 6 ‘Further information’
  • If you have liver problems
  • If you have been told that you have a condition where you tend to stop breathing temporarily while you are asleep (sleep apnoea)
  • If you have long term fatigue and muscle weakness
  • If you have any long term mental illness such as obsessions or phobias (irrational fears)
  • If you suffer from anxiety with or without depression, as temazepam may cause you to think about suicide
  • If you suffer from glaucoma.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Temazepam oral solution if:

  • You have a personality disorder (e.g. schizophrenia)
  • You have an addiction to alcohol or drugs
  • You have kidney problems
  • You have recently suffered a loss or bereavement as the medicine may affect the way you react to this.
  • You are taking any medicine from the group of medicines known as opioids: taking these medicines with Temazepam oral solution may result in sedation, difficulties in breathing (respiratory depression), coma and may be fatal. Even if opioids are prescribed, your doctor may need to change the dose, the duration of treatment or monitor you regularly.

Children and adolescents

This medicine should not be given to children under 18.

Other medicines and Temazepam oral solution

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines.

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

  • Narcotic painkillers (e.g. codeine, morphine)
  • Anti-depressants
  • Medicines to treat epilepsy
  • Medicines that help you relax and sleep
  • Anti-histamines (used to treat allergy) that cause drowsiness
  • Monoamine oxidase inhibitors (used to treat depression such as phenelzine)
  • Medicines to treat viral infections (including HIV, for example, ritonavir or zidovudine)
  • Medicines to treat high blood pressure (for example, moxonidine)
  • Disulfiram (used to treat alcoholism)
  • Lofexidine (used to treat drug dependence)
  • Nabilone (used to treat nausea and vomiting)
  • Medicines to treat mental illness (for example, clozapine)
  • Medicines that help you sleep
  • Medicines that relax your muscles (for example, baclofen or tizanidine)
  • Medicines used to treat Parkinson’s disease (for example, levodopa).

If you are having a general anaesthetic you should tell the doctor that you are taking temazepam.

If you are to receive this medicine as a pre-medication before surgery or investigative procedures, you should ensure that someone is with you to accompany you home.

At high doses taken for a long period of time, it is possible that you may become dependent on the medication. If this occurs you might experience withdrawal symptoms if the treatment stops too suddenly. If this is the case your doctor will advise you to cut down gradually.

You may develop tolerance to the effects of temazepam, this means you may notice that your medicine is less effective at relieving your symptoms.

If you take Temazepam for a long period of time, it may cause blood disorders and affect your liver. Your doctor may want to perform tests on your blood and liver function.

Concomitant use of Temazepam 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 Temazepam 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.

Temazepam with food, drink and alcohol

You should not drink alcohol while taking Temazepam. This is because alcohol can change the way Temazepam works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, speak to your doctor or pharmacist for advice before taking this medicine.

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. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.

Driving and using machines

Temazepam can cause side effects such as sleepiness, dizziness, confusion, reduced alertness, poor muscle coordination and blurring of vision. If you do get any of these side effects do not drive or use machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

  • 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.

Temazepam Oral Solution contains:

  • 2.250mg sorbitol per dose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
  • 10% ethanol (alcohol), i.e. up to 440mg per dose, equivalent to 10ml of beer, 4ml of wine per dose. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, you are pregnant or breast-feeding.
  • less than 1 mmol sodium (23 mg) per dosage unit that is to say essentially ‘sodium-free’.

3. How to take Temazepam Oral Solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

  • This medicine contains 10mg of Temazepam in each 5ml.
  • Take this medicine by mouth.

The usual doses are given below. These may be changed by your doctor.

Adults

Insomnia

The recommended dose is between 5 – 20ml before going to bed.

Pre-medication

The recommended dose is between 10 – 15ml half an hour to one hour before surgery or other procedures.

Elderly or patients with disease of the blood vessels i.e. hardening of the arteries

The recommended dose is between 5 – 10ml.

The medicine should only be taken for a maximum of 4 weeks at a time.

Your doctor may advise you to take this medicine only when necessary.

If you take more Temazepam Oral Solution than you should

Talk to your doctor or go to your nearest hospital straight away. Common symptoms of Temazepam overdose are drowsiness, loss of coordination of movement, confusion and slurred speech. Occasionally low blood pressure (symptoms such as tiredness, light-headedness and fainting), breathing problems and coma may occur.

If you forget to take Temazepam Oral Solution

Do not take a double dose (two doses at the same time) to make up for the forgotten dose. Wait until the next dose is due and then take only that dose.

If you stop taking Temazepam Oral Solution

You should only stop taking this medicine when the doctor tells you. Do not stop it abruptly. If the medicine is stopped quickly the following symptoms may occur: nervousness, sleeplessness, depression, irritability, sweating, shaking, vomiting, confusion, psychosis, fits, headaches, muscle pain, restlessness, anxiety, tension, tingling in the hands or feet, hallucinations, an increased sensitivity to light, noise or physical contact, feeling detached from yourself or your surroundings.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following side effects, contact your doctor immediately or go to hospital straight away and stop taking this medicine.

  • Thoughts of suicide or other behavioural side effects that may include aggressive outbursts, excitement, confusion, depression, restlessness, agitation, irritability, hallucinations, delusions, mental disorders or inappropriate behaviour.
  • Severe allergic reactions that may include a red and lumpy skin rash, difficulty breathing, swelling of the face, mouth, lips and eyelids. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
  • Jaundice which may include yellowing of the skin or whites of the eyes.

Other side effects are:

Common: may affect up to 1 in 10 people

  • Numbed emotions
  • Aggression
  • Confusion state
  • Restlessness
  • Difficulty in speaking
  • memory loss (amnesia)
  • Dizziness
  • Difficulty in controlling movements
  • Blurry vision
  • Muscle weakness

Rare: may affect up to 1 in 1,000 people

  • Exaggerated feeling of physical and emotional well-being
  • Anger
  • Abnormal thinking and perceptions
  • Nightmare
  • Changes in vision
  • A feeling of dizziness or “spinning”
  • Inability to empty the bladder completely
  • Changes in libido
  • Breathing problems such as hypoventilation
  • Stomach upset
  • Dry mouth
  • Rash

Very rare: may affect up to 1 in 10,000 people

  • Sleeping difficulty
  • Shaking
  • Difficulty in passing urine
  • Increase in saliva production

Not known: frequency cannot be estimated from the available data

  • A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

These side effects are more likely to occur if alcohol is taken with this medicine or if you are elderly.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5. How to store Temazepam Oral Solution

Keep this medicine out of the sight and reach of children.

The product should be stored at or below 25°C and protected from light.

Do not use this medicine after the expiry date which is stated on the bottle.The expiry date refers to the last day of that month.

If it is out of date or you no longer want it, take it back to the pharmacy.

Do not use Temazepam Oral Solution if you notice something wrong with the medicine. Talk to your pharmacist.

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. Contents of the pack and other information

What Temazepam Oral Solution contains

  • The active substance is Temazepam.
  • The other ingredients are povidone 25, polyethylene glycol 400, ethanol, glycerol, sodium phosphate, anhydrous citric acid, chlorophyll, sorbitol solution 70%, peppermint oil, lemon flavour and purified water.

What Temazepam Oral Solution looks like and contents of the pack

Temazepam Oral Solution is a clear green lemon and mint flavoured liquid.

It comes in a brown glass bottle holding 300ml of solution.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited
Capital House
85 King William Street
London
EC4N 7BL
UK
Tel: 01283 495 280
Fax: 01283 495 290

Manufacturer

Penn Pharmaceutical Services Ltd
Tredegar
Gwent
NP22 3AA

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone 01283 495 280 or email [email protected]

This leaflet was last revised in July 2018.