Librium 5 mg capsules – patient leaflet, side effects, dosage

1. 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 eff ect). 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.

You must talk to a doctor if you do not feel better or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIBRIUM CAPSULES

Do not take Librium:

• If you are allergic to chlordiazepoxide or any of the ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to any medicine known as a benzodi-azepine (e. g. nitrazepam, diazepam, fl urazepam, or temazepam).
• If you suff er from lung disease.
• If you suff er with breathing diffi culties while awake or asleep.
• If you suff er from myasthenia gravis (a condition in which the muscles become weak and tire easily).
• If you are suff ering from a psychiatric illness or a personality disorder (severe mental problems).
• If you have a severe liver condition.
• If you have spinal or cerebral ataxia

Warnings and precautions

Talk to your doctor or pharmacist before taking Librium if:

• You have a long-term lung, liver or kidney disease.
• You suff er from depression or have recently suff ered the death of a close friend or relative.
• You are suff ering or have suff ered from a mental illness.

• You have abused alcohol or drugs.

• You are pregnant or breast feeding.

• You have a decrease in mental function as you should receive a lower dose.

Librium capsules relax the muscles, therefore elderly patients should take extra care when they get up at night as there is a risk of falls and conse-quently of injuries including hip fractures.

Children and adolescents

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Th is is extremely important, as using more than one medicine at the same time can strengthen or weaken the eff ect of the medicines involved. In particular, tell your doctor if you are taking any of the following medicines:

• Antidepressants, sleeping tablets, neuroleptics, hypnotics, tranquilisers (may increase eff ects of relaxing muscles – higher risk of falling in elderly patients) or other such medicines which act on the brain and nerves.
• Medicines used to relieve pain or anaesthetics.
• Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine)
• Medicines for treating epilepsy (e.g. phenytoin and phenobarbital).
• Medicines that aff ect the liver (e.g. the antibiotic rifampicin and cimetidine, omeprazole, macrolide antibiotics (erythromycin); medicines used to treat stomach problems, disulfi ram and contraceptive agents).
• Medicines used to treat viral infections (e.g. ritonavir) as these medicines can potentiate the actions of benzodiazepines.

• Drugs to treat high blood pressure (e.g. beta blockers, anticoagulants, cardiac glycosides, moxonidine).

  • Drugs known as dopaminergics (e.g. levodopa, for

    Parkinson’s disease).

  • Sodium oxybate used in patients with narcolepsy

    (possible increase of respiratory depression)

  • Th eophylline; drug to make breathing easier

Concomitant use of Librium Capsules and opioids

(strong pain killers, medicines for substitution thera-

py and some cough medicines) increases the risk of

drowsiness, diffi culties in breathing (respiratory de-

pression), coma and may be life-threatening. Because of

this, concomitant use should only be considered when other treatment op-tions are not possible.

However if your doctor does prescribe Librium Capsules together with opi-oids 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 fol-low your doctor’s dose recommendation closely. It could be helpful to in-form friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Librium with food, drink and alcohol

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 eff ects of the capsules and this can be dangerous. Pregnancy, breast-feeding and fertility

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

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 tem-perature, fl oppiness and breathing and feeding diffi culties. Also, your un-born baby may be at risk of developing dependency to this medicine and aft er birth may be at some risk of developing withdrawal symptoms. Driving and using machines

Librium Capsules may cause side eff ects such as drowsiness, tiredness, diz-ziness, confusion, poor muscle co-ordination and problems with your eye-sight. Th is may aff ect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side eff ects. Th e medicine can aff ect your ability to drive. Do not drive while taking this medicine until you know how it aff ects you.

It may be an off ence to drive if your ability to drive safely is aff ected. How-ever, you would not be committing an off ence if:

Th e 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 aff ecting 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.

Th ere is further information for patients who are intending to drive in Great Britain – go to https://www.gov.uk/drug-driving-law Librium contains

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

3. HOW TO TAKE LIBRIUM CAPSULES

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 fi nd the lowest dose to control your symptoms. Th e dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.

If you think that the eff ect of your medicine is too weak or too strong, talk to your doctor.

Dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER Librium 5 mg and 10 mg Capsules

Chlordiazepoxide hydrochloride

Symptoms of sudden

alcohol withdrawal

25 to 100 mg. Th is can be repeated 2 to 4 hours aft er the initial dose, if necessary

Muscle spasms 10 to 30 mg per day, taken in divided dos-

es throughout the day.

If you are elderly or suff er from a lung, liver or kidney condition, or are generally unwell, your doctor will usually prescribe a lower dose. Use in children and adolescents

Librium Capsules are not to be used in anyone under 18 years of age. Swallow the capsule(s) whole with a glass of water.

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

Treatment will not normally be continued for more than 4 weeks. Th is is because Librium Capsules may become less eff ective if you take them for more than four weeks. If you think that your medicine is no longer work-ing, you should consult your doctor.

Also, you may become dependent on the capsules if you use them at high doses and for long periods. Th erefore, Librium Capsules are not suitable for long-term use and aft er a few weeks it is worth trying to get by without these capsules. Th is 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 “If 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. If 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 eff ects if your treatment is stopped suddenly. Th is 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
• Extreme anxiety
• Diarrhoea
• Confusion
• Restlessness
• Incontinence
• Headaches
• Muscle pain

In severe cases the following symptoms may occur:

• changes in behaviour or the way you are feeling
• numbness and tingling of the extremities
• over-sensitivity to light, noise and touch
• hallucinations
• fi ts

If you are woken up soon aft er taking the medicine your memory may be temporarily aff ected.

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 re-quired 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 medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side eff ects, although not every-body gets them.

It is very important that you immediately seek medical advice if you develop any of the following symptoms:

A severe allergic (anaphylaxis) or serious allergic reaction which causes swelling of your face or throat (angioedema), diffi culty breathing, thoughts of self-harm, yellowing of the eyes and skin (jaundice), abnormality in the blood (blood dyscrasias) with symptoms such as weakness, pale skin, bleed-ing problems, sore throat and frequent infections.

Changes in behaviour may occur rarely. Th ese changes may include aggres-sion, excitement, confusion and depression.

If these behavioural symptoms occur, you must inform your doctor. He/she may want you to stop taking this medicine.

Tell your doctor or pharmacist if you develop any of the following side eff ects:

Common:

• drowsiness and light headedness the next day
• tiredness
• sedation and dizziness
• loss of balance
• unsteadiness and clumsiness
• poor muscle co-ordination
• confusional states
• speech disorder

Rare:

• headache
• vertigo
• low blood pressure
• stomach upsets
• skin rashes
• problems with your eyesight
• emotional disturbances
• double vision
• changes in the level of sexual desire
• inability to pass urine
• incontinence
• impotence
• menstrual disorder

Th e following side eff ects have also been reported

(Frequency unknown):

• Forgetfulness, memory loss, hallucinations, dependence, depression, rest-lessness, agitation, irritability, aggression, delusion, nightmares, changes in salivation, increased liver enzymes, changes in the way you walk and muscle weakness.
• Paradoxical reactions (e.g. anxiety, sleep disorders, insomnia, suicide attempt, suicidal ideation).
• Tremor, stiff ness and slow movement. If you are woken up soon aft er taking the medicine your memory may be temporarily aff ected.
• Increased appetite

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

Reporting of side eff ects

If you get any side eff ects, talk to your doctor, pharmacist or nurse. Th is includes any possible side eff ects not listed in this leafl et. You can also re-port side eff ects 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 eff ects you can help provide more information on the safety of this medicine.

5. HOW TO STORE LIBRIUM CAPSULES

• Keep this medicine out of the sight and reach of children.
• Do not use Librium Capsules aft er the expiry date which is stated on the bottle and outer carton aft er “EXP”. Th e expiry date refers to the last day of that month.
• Store Librium Capsules below 30 °C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Th ese measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Librium contains

Active substance: Chlordiazepoxide hydrochloride. Each capsule con-tains 5 mg or 10 mg of chlordiazepoxide hydrochloride. Other ingredients: Starch maize white, talc purifi ed, 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 quinolone 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 and Manufacturer

Mylan Products Ltd,

Station Close, Potters Bar, Hertfordshire, EN6 1TL, 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 local repre-sentative of the Marketing Authorisation Holder.

Th is leafl et was last revised in August 2018.

52002640-03

56UK2006155-03

MANUFACTURER: Meda Pharma GmbH & Co. KG

PRODUCT: Librium 5 + 10 mg

MATERIAL-NO.: 56UK2006155-03

MFS-NO.: 52002640-03

PACK SIZE: 190 x 267 mm

COUNTRY: United Kingdom UK

LANGUAGE: English

CORRECTION: 3.

DATE: 31. 07. 2018 Studio Oberländer GmbH · Rubensstr. 33 · 60596 Frankfurt a. M. · Germany Phone: +49 69 631520-85 · Fax: -87 · E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet

5200264003