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Home » Antianxiety

Centrax®10mg Tablets

Submitted by on November 10, 2016 – 6:41 pm | 40 views
anxiety

®10mg Tablets

Package Leaflet: Information for the user

Centrax®10mg Tablets

prazepam

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

Centrax is a tranquilliser containing the active ingredient prazepam. It belongs to a group of medicines called benzodiazepines. Benzodiazepines affect chemical activity in the brain and may help to reduce anxiety and stress.

It is used for short term relief of severe or disabling anxiety or when anxiety is causing great distress.

The overall length of your treatment should not be more than 4 to 6 weeks including a period where the dose is gradually reduced.

It is not suitable for children and adolescents under 18 years.

  1. What you need to know before you take Centrax

Do not take Centrax:

 If you have are allergic to prazepam or other similar benzodiazepine medicines, or any of the other ingredients of this medicine (listed in section 6 )

 If you suffer from an autoimmune disease called ‘myasthenia gravis’ where you suffer from very weak and tired muscles

 If you have

 If you have severe liver problems

 If you have ‘sleep apnoea’- this is a condition where your breathing becomes irregular, even stopping for short periods, while you are asleep

Warning and precautions

Talk to you doctor or pharmacist before taking Centrax.

Your doctor will assess your condition before and throughout your treatment with this medicine. Centrax tablets are for short term use only for over a period of 4 to 6 weeks. Your condition will be reviewed if you need more than the recommended duration of treatment. Your dose will be lowered gradually as you progress through the course of this treatment. If you take Centrax for a long period of time, you may need to have regular blood tests.

Centrax may cause memory loss in some patients several hours after taking the tablets. If you believe that you could have suffered memory loss after taking Centrax tell your doctor. To reduce this risk your doctor may recommend that you take this medicine at a time which ensures you have 7 to 8 hours of .

Tell your doctor immediately if you notice a change in your behaviour, for example agitation, rage, aggressiveness, false beliefs and hallucinations, inappropriate actions and restlessness, as your treatment may need to be discontinued.

History of

If you have a history of alcohol or drugs abuse. Your doctor may want to give you special help when you need to stop taking these tablets.

Tell your doctor if you start to experience the following during your treatment with this medicine:

 a decrease in the effects of the medicine

 feeling of dependence on your treatment (withdrawal symptoms) if you delay or miss taking your tablets

 lack of sleep and increased anxiety.

Centrax needs to be gradually reduced towards the end of your treatment. Do not stop taking your tablets suddenly, especially if you have been taking a high dose. You may experience withdrawal symptoms (“rebound effects”) like headache, depression, nervousness, feeling stressed or worried, difficulty in sleeping, restlessness, irritability, tension and muscle pain.( see section 4 – Dependence and withdrawal symptoms).

Elderly Patients

Centrax may cause the muscles to feel relaxed or weak, therefore elderly patients taking Centrax are more at risk of falling, which may lead to hip fractures. Elderly patients should therefore take care when moving around if they experience any muscles problems.

Other medicines and Centrax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, in particular any of the following medicines, as the effect of Centrax may be stronger when taken at the same time. Sometimes it may be necessary to reduce the dose of Centrax if you are taking:

 any other medicines to treat anxiety or depression or to help you sleep

(e.g. or codeine)

 antipsychotic medicines such as clozapine – used to treat mental illnesses like schizophrenia which affects the way you think and feel

 medicines to treat epilepsy

for relief of allergies that also make you sleepy

 oral contraceptives (‘the pill’)

 anaesthetics (medicines that aid loss of sensation to prevent pain during surgery).

Centrax with food and drink

Do not drink any alcohol whilst you are taking Centrax, as alcohol increases the effects of this medicine.

Pregnancy and Breast-feeding

Pregnancy

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

If you do become pregnant while taking this medicine, your doctor will advise you of the risks involved and may advise you to stop taking the tablets. Occasionally, your doctor may assess your condition and it may be necessary to give you Centrax during late pregnancy or during labour. In these cases babies may have a low body temperature, floppiness, withdrawal symptoms, breathing and feeding difficulties.

Breast-feeding

Do not breast-feed while taking Centrax, as the drug may pass into breast milk.

Driving and using machines

Centrax can cause blurred vision, drowsiness during the day, lack of coordination, forgetfulness and loss of concentration. It is very important you do not drive or operate machinery until you know how the tablets affect you.

Centrax contains

Centrax contains an ingredient known as lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

  1. How to take Centrax

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many tablets to take and when to take them. This information is also on the label on the carton of the tablets. Do not take your tablets with alcohol.

Adults

Your doctor will have decided on the most suitable dose for you. The usual dose is 3 tablets a day, either as a single dose or divided into several doses. Your doctor may decide that a different dose is right for you; this will normally be between 1 and 6 tablets a day.

The elderly

You may be given half the adult dose if you are elderly (over 65), run down, or have kidney or liver problems.

Children

Centrax is not recommended for the treatment of children or adolescents under 18 years.

If you take more Centrax than you should

It is important that you do not take more tablets than you are told to. If you do accidentally take too many tablets, seek medical attention straight away.

If you forget to take Centrax

If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose, take your next dose as usual. If you think you have missed more than one dose contact your doctor for more advice.

Length of treatment and stopping treatment with Centrax tablets

 Centrax tablets are only used for short-term treatment (not more than 6 weeks). You will be given a prescription for this medicine for a minimum of 4 weeks. Your doctor will assess your condition after this time and may put you on a further 2 weeks of treatment.

 Always see your doctor before you stop taking your tablets as the dose needs to be reduced gradually. If you stop taking the tablets or reduce the dose suddenly you can get ‘rebound’ effects (see section 2) which might cause you to become temporarily more anxious or restless or to have difficulty sleeping. These symptoms will go away as your body re-adjusts. If you are worried, your doctor can tell you more about this.

  1. Possible side effects

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

Reasons to see your doctor immediately

 Very occasionally treatment with this medicine may cause serious behavioural or psychiatric effects – for example agitation, restlessness, aggressiveness, irritability, violent anger, false beliefs, nightmares or vivid dreams and hallucinations or other inappropriate behaviour.

If you get any of these symptoms see your doctor straight away as treatment will need to be discontinued. Your doctor will then advise how treatment will be stopped.

Dependence and withdrawal symptoms

 It is possible to become reliant (‘dependent’) on medicines like Centrax while you are taking them which increase the likelihood of getting withdrawal symptoms when you stop treatment. Tell your doctor if you start to feel dependence on your treatment.

 Withdrawal symptoms are more common if you stop treatment suddenly, have been taking high doses, have been taking Centrax for longer than recommended or have a history of alcohol or drug abuse. This can cause effects such as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, mood changes, difficulty sleeping and irritability.

 In severe cases of withdrawal you can also get the following symptoms: nausea (feeling sick), vomiting, sweating, , muscle cramps, a feeling of unreality or detachment, being unusually sensitive to sound, light or physical contact, numbness and tingling of the feet and hands, hallucinations (seeing or hearing things which are not there while you are awake), shaking or epileptic fits.

Please see your doctor as soon as you can if any withdrawal symptoms get worse or don’t go away.

Other side effects

You can also get the following side effects – but you do not need to stop taking the tablets unless your symptoms are very bad. Talk to your doctor if you are at all concerned about any side effects.

 drowsiness during the day

 numbed emotions

 confusion

 memory loss. Tell your doctor if you think you could have suffered this. Your doctor may recommend that you take this medicine at a time which ensures you have 7 to 8 hours uninterrupted sleep.

 loss of alertness or concentration

 tiredness

 headache

 dizziness

 light-headedness

 muscle spasms or muscle weakness

 double or blurred vision

 shakiness or trembling

 slurred speech

 awareness of your heartbeat (palpitations)

 hyperactivity

 dry mouth

 sweating

 itching or skin reactions

 swollen feet

 joint pains

 fainting

 difficulty urinating or bladder control problems

 difficulty in controlling movements (ataxia)

 stomach or intestinal problems

 low blood pressure

 increase in weight

 abnormal liver function tests

Reporting of side effects

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 IMB Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:

www.imb.ie; e-mail: imbpharmacovigilance@imb.ie. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Centrax

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

Do not use this medicine after the expiry date printed on the carton and blister strip. The expiry date refers to the last day of that month.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Centrax contains

The active substance is prazepam. Each tablet contains 10mg of prazepam

The other ingredients are lactose monohydrate (see section 2 Centrax contains lactose), microcrystalline cellulose, maize starch, magnesium stearate and colloidal anhydrous silica.

What Centrax looks like and contents of the pack

Centrax are round white tablets with a breakline. They are available in PVC/Aluminium blister packs of 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24, Ireland.

Manufacturer:

Goedecke GmBH

Mooswaldallee 1

D-79090

Freiburg

Germany.

Company contact address:

For further information on your medicine contact Medical Information at the following address:

Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Telephone 1800 633 363.

This leaflet was last revised in 01/2014

Ref: CE 11_0

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