Thursday, October 20, 2016

Librium 5 mg and 10 mg Capsules






Librium 5 mg and 10 mg Capsules



Chlordiazepoxide hydrochloride



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 you experience any side effect and this becomes serious, tell your doctor or pharmacist.



In this leaflet:


  • 1. What Librium is and what it is used for

  • 2. Before you take Librium Capsules

  • 3. How to take Librium Capsules

  • 4. Possible side effects

  • 5. How to store Librium Capsules

  • 6. Further information




What Librium Is And What It Is Used For


Librium belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect). Librium capsules are used for the short-term treatment of severe anxiety, which may occur alone or in association with sleeplessness (insomnia) or personality/behavioural disorders. Librium capsules may also be used to treat muscle spasms, and to relieve symptoms of sudden alcohol withdrawal.




Before You Take Librium Capsules



Do not take Librium if you:


  • are allergic (hypersensitive) to any of the ingredients of Librium Capsules (these are listed in section 6,“Further Information”).

  • are allergic (hypersensitive) to any medicine known as a benzodiazepine (e.g. nitrazepam, diazepam, chlordiazepoxide, or
    temazepam).

  • suffer from lung disease or breathing difficulties.

  • are suffering from a psychiatric illness or a personality disorder (severe mental problems).


Librium Capsules are not to be used in anyone under 18 years of age.




Take special care with Librium


Tell your doctor before you take these capsules if you:


  • have a long-term lung, liver or kidney disease.

  • suffer from depression or have recently suffered the death of a close friend or relative.

  • have suffered from mental illness.

  • have abused alcohol or drugs.

  • are pregnant or breast feeding.



Taking other medicines


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


  • Antidepressants, sleeping pills, other tranquillisers or other such medicines which act on the brain and nerves.

  • Medicines used to relieve pain or anaesthetics.

  • Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).

  • Medicines that affect the liver (e.g. the antibiotic rifampicin and cimetidine, a medicine used to treat stomach problems).

  • Medicines used to treat viral infections (e.g. ritonavir) as these medicines can potentiate the actions of benzodiazepines.



Taking Librium with food and drink


Take the medicine before or with your meals.


Do not drink alcohol for as long as you are taking Librium Capsules. Alcohol will increase the effects of the capsules and this can be dangerous.




Pregnancy and breast-feeding


Tell your doctor before taking Librium Capsules if you are pregnant, think that you are pregnant or intend to become pregnant during treatment.Your doctor will then decide whether you should take this medicine.


Tell your doctor before taking Librium Capsules if you are breast-feeding. Avoid use of Librium if you are breast-feeding, as Librium passes into breast-milk.


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. 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.




Driving and using machines


Librium Capsules may cause side effects such as drowsiness, tiredness, dizziness, confusion, poor muscle co-ordination and problems with your eyesight. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects.




Important information about some of the ingredients of Librium


Librium Capsules contain lactose. Therefore, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.





How To Take Librium Capsules


Your doctor will find the lowest dose to control your symptoms. The dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.


Always take Librium exactly as your doctor has told you. Do not change the prescribed dose yourself. You should check with your doctor or pharmacist if you are not sure how to take this medicine. If you think that the effect of your medicine is too weak or too strong, talk to your doctor.


Swallow the capsule(s) whole with a glass of water.



Dosage



For the treatment of: Anxiety Usual dosage: Up to 30 mg per day. The maximum dose is 100 mg per day, taken in divided doses throughout the day



For the treatment of: Sleeplessness (Insomnia) associated with anxiety Usual dosage: 10 to 30 mg before going to sleep.



For the treatment of: Symptoms of sudden alcohol withdrawal Usual dosage: 25 to 100 mg. This can be repeated 2 to 4 hours after the initial dose, if necessary



For the treatment of: Muscle spasms Usual dosage: 10 to 30 mg per day, taken in divided doses throughout the day.


If you are elderly or suffer from a lung, liver or kidney condition, or are generally unwell, your doctor will usually prescribe a lower dose.


Librium Capsules are not for use in children.


You will normally see an improvement in your symptoms after 10 to 15 days of taking Librium regularly.


Treatment will not normally be continued for more than 4 weeks. This is because Librium Capsules may become less effective if you take
them for more than four weeks. If you think that your medicine is no longer working, you should consult your doctor.


Also, you may become dependent on the capsules if you use them at high doses and for long periods. Therefore, Librium Capsules are not
suitable for long-term use and after a few weeks it is worth trying to get by without these capsules. This will help to prevent you becoming
used to Librium and reduce the risk of dependence.


Do not stop taking Librium Capsules without discussing with your doctor (refer to “When you stop taking Librium” below.)




If you take more Librium than you should


If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.




If you forget to take Librium


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 Librium


Your doctor will advise you when to stop taking the capsules. Do not stop taking Librium Capsules abruptly. You may experience withdrawal effects if your treatment is stopped suddenly. This is less likely if your dose is gradually reduced towards the end of your treatment.


Withdrawal symptoms may include:


  • a recurrence of sleep problems

  • depression

  • nervousness

  • irritability

  • sweating

  • diarrhoea

  • confusion

  • changes in behaviour

  • fits

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 have any further questions on the use of this product, ask your doctor or pharmacist.




Possible Side Effects


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


Changes in behaviour may occur rarely. These changes may include aggression, excitement, confusion and depression. If these
behavioural symptoms occur, you must inform your doctor. He/she may want you to stop taking this medicine.



Common side effects:


  • drowsiness and lightheadedness the next day

  • tiredness

  • unsteadiness

  • poor muscle co-ordination

  • dependence



Rare side effects:


  • forgetfulness

  • headache

  • dizziness

  • low blood pressure

  • stomach upsets

  • skin rashes

  • problems with your eyesight

  • changes in the level of sexual desire

  • inability to pass urine

  • incontinence

  • abnormality in the blood (blood dyscrasias)

  • yellowing of the eyes and skin (jaundice)


If you are an elderly patient, you may be more susceptible to side effects and may suffer from confusion. If this happens, tell your doctor and he/she may decide to change your dose.



If you are concerned about any of these side effects, or if you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.




How To Store Librium Capsules


  • Store Librium Capsules out of the reach and sight of children.

  • Store Librium Capsules below 30°C.

  • Do not use Librium Capsules after the expiry date which is stated on the bottle and outer carton after “EXP”. The expiry date refers to the last day of that month.

  • Medicines must 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.



Further Information



What Librium contains




Active substance:
Chlordiazepoxide hydrochloride. Each capsule contains 5 mg or 10 mg of chlordiazepoxide hydrochloride.




Other ingredients:
Starch maize white, talc purified, lactose, gelatine and the colouring agents yellow iron oxide
(E172), indigo carmine(E132) and titanium dioxide (E171). In addition, the 5 mg capsules also contain the colouring agents quinoline yellow (E104) and erythrosine (E127).




What Librium looks like and contents of the pack


  • Librium 5 mg Capsules are green and yellow with“LIB 5” printed on them.

  • Librium 10 mg Capsules are black and green with“LIB 10” printed on them.

  • Librium Capsules are available in pack sizes of 100.



Marketing Authorisation Holder



Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

UK




Manufacturer



Labiana Pharmaceuticals S.L.U.

Casanova 27-31

08757- Corbera de Llobregat (Barcelona)

Spain



For any information about this medicine, please contact the Marketing Authorisation Holder.




This leaflet was last revised in April 2010.



33750E0EU-C00


562104V7154UK01





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