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drug-medicine : alprazolam

 

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Medicine: alprazolam

PATIENT INFORMATION LEAFLET

Alprazolam 250 microgram Tablets

Alprazolam 500 microgram Tablets

Please read this entire leaflet carefully before you start using this medicine.

If you have further questions, please ask your doctor or your pharmacist.

This medicine has been prescribed for you personally and you should not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

 

What is in your medicine?

The name of your medicine is Alprazolam Tablets. The tablets are available in 2 strengths.

Alprazolam 250 microgram Tablets: White, oblong, scored tablets. Each tablet contains 250 microgram alprazolam as the active ingredient.

Alprazolam 500 microgram Tablets: Pink, oblong, scored tablets. Each tablet contains 500 microgram alprazolam as the active ingredient.

The other ingredients are docosate sodium, sodium benzoate (E211), pregelatinised starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate and colloidal anhydrous silica. Alprazolam 500 microgram Tablets also contain erythrosine aluminium lake (E127) - which consists of erythrosine and aluminium hydroxide.

Alprazolam tablets are available in blister packs of 60 tablets.

 

Marketing Authorisation Holder:

What are Alprazolam Tablets and what are they used for?

Alprazolam belongs to a group of medicines known as anxiolytics that are used to treat severe anxiety. It has a rapid onset on anxiety symptoms such as agitation, restlessness and tension.

 

Before you take this medicine

Do not take Alprazolam Tablets if:

  • you are allergic to alprazolam or to any of the other ingredients (see section “What is in your medicine?”)
  • you suffer from a condition known as sleep apnoea - where your breathing stops or gets very shallow whilst you are sleeping
  • you suffer from a weakness of the muscles that often improves with rest and worsens with activity (Myasthenia Gravis)
  • you have severe breathing or liver problems
  • You have problems with alcohol or drugs that act upon the nervous system
  • you are pregnant or breast-feeding.

Take special care with Alprazolam Tablets and inform your doctor if:

  • you will be taking the medicine over a period of several weeks
  • you have a history of alcohol and drug abuse
  • you suffer loss of memory relating to events that occur after taking your medicine
  • you suffer from mood swings, insomnia, restlessness, agitation, fits of rage, nightmares or hallucinations
  • you suffer from a personality disorder
  • you suffer from difficulty in breathing or have breathing problems
  • you suffer from psychosis - a severe mental condition characterized by a loss of contact with reality.

Alprazolam Tablets should be withdrawn gradually. Alcohol should be avoided whilst being treated with Alprazolam Tablets since it will increase sedation, loss of memory and alter your concentration and muscular function.

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy

Alprazolam Tablets should not be taken if you are pregnant. If you are planning to become pregnant or have become pregnant, you should inform your doctor immediately.

 

Breast-feeding

Alprazolam Tablets should not be taken if you are breast-feeding since alprazolam passes into breast milk.

Driving and use of machines

Alprazolam Tablets may affect your ability to drive or operate machinery by causing sedation, loss of memory and alteration of concentration and muscular function during treatment. If affected, do not drive or operate machinery and consult your doctor.

Are you taking any other medicines?

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

You should especially inform your doctor if you are taking any of the following:

  • medicines affected by cytochrome P450 enzyme (e.g. Diltiazem)
  • medicines known as antifungals that treat fungal infections (e.g. Itraconazole and Ketoconazole)
  • medicines used to treat infection (e.g. Erythromycin or Troleandomycin)
  • medicine used to treat depression (e.g. Fluoxetine, Nefazodone, Fluvoxamine, Imipramine, Desipramine or Sertraline)
  • medicine used to lower the immune system in order to prevent organ rejection (e.g. Ciclosporin)
  • medicine used for the treatment of AIDS
  • medicine used to relieve mild pain (e.g. Dextropropoxyphen)
  • oral contraceptives
  • medicine used to treat epilepsy (e.g. Carbamazepine)
  • medicine used to treat ulcers (e.g. Cimetidine)
  • medicine used for schizophrenia (e.g. Clozapine)
  • medicine used for the treatment of heart failure and abnormal heart rhythms (e.g. Digoxin)
  • medicine used to prevent and treat wheezing, shortness of breath and difficulty in breathing caused by asthma and other breathing conditions (e.g. Theophylline)
  • medicines used to prevent blood clotting (e.g. Warfarin).

Caution should be exercised when taking Alprazolam Tablets with painkillers (known as narcotic analgesics), since this could bring an exaggerated feeling of mental and physical well-being and also lead to dependence.

There will be an increased muscle relaxing effect if Alprazolam Tablets are taken with a muscle relaxant.

Please read the back of this leaflet

 

How to take your medicine

Please take your tablets according to your doctor’s instructions. Your doctor will tell you how long your treatment will last.

Alprazolam Tablets are taken orally with some fluid. They can be taken with or without food. Your overall treatment should not last more than 8-12 weeks including the tapering off process.

Adults:

The initial dose is 250 microgram - 500 microgram three times a day.

The maintenance dosage is 500 microgram - 3mg per day in divided doses. The maximum daily dosage of 3mg per day must not be exceeded. If you experience side-effects, your doctor will prescribe a suitable dose for your specific condition.

Chronic alcoholism & those new to this kind of medicine:

Your doctor will prescribe the lowest effective dosage.

Children and adolescents:

Alprazolam Tablets are not recommended for children and adolescents under 18 years old.

Elderly, sensitive, weakened patients or patients with liver or kidney problems:

The initial dose is 250 microgram two to three times a day. If you experience side-effects, your doctor will prescribe a suitable dose for your specific condition.

The maintenance dosage is 500 microgram - 750 microgram per day taken in divided doses.

Your doctor may gradually increase the dosage by a maximum of 500 microgram every three days if needed. The maximum daily dose is 750 microgram - 1.5mg.

Discontinuation of treatment:

If your doctor feels that your treatment should be stopped, then your dose will be gradually reduced rather than being immediately stopped.

What if you forget to take your tablets?

If you miss a dose do not worry, just ignore it and take the next dose at the normal time. Do not take two doses together to make up for the one you have missed.

What if you have taken too many tablets?

If you or anyone else has taken too many tablets, call a doctor or go to the nearest Accident & Emergency department immediately. Take this leaflet and any remaining tablets with you to the hospital.

 

Possible side-effects

Like all medicines Alprazolam Tablets may cause some unwanted side-effects in some people. Please consult your doctor if you experience any of the following:

Common (occurring in more than 1% but less than 10% of patients):

  • drowsiness.

Uncommon (occurring in more than 0.1% but less than 1% of patients):

  • dizziness
  • uncoordination
  • skin reactions
  • constipation, diarrhoea
  • the sensation of feeling sick (nausea)
  • vomiting
  • blurred vision.

Rare (occurring in more than 0.01% but less than 0.1% of patients):

  • agitation, aggressiveness
  • hallucinations
  • fits of rage
  • nightmares
  • loss of memory (amnesia)
  • sleep disorders.

Very rare (occurring in less than 0.01% of patients):

  • increased pressure within the eye.

Further unwanted effects have been reported which include: reduced alertness, confusion, fatigue, headache, muscle weakness, lack of appetite for food, weight gain, difficulty in swallowing, low blood pressure, a decreased sexual drive, dry mouth, increased salivation, nasal congestion, rapid heartbeat, difficulty in concentration, muscle tone abnormality, speech disturbances, difficulty in passing urine, inability to control excretion (incontinence), liver problems and a yellowing of the whites of the eyes & skin (jaundice).

 

How you should store this medicine

Do not store above 30°C.

Store in the original package.

Do not take the tablets after the expiry date printed on the carton and blister.

Please return any tablets you have not used to the pharmacist.

Keep all medicines out of the reach and sight of children.

Remember: this medicine has been prescribed for you personally. Please do not give it to anyone else. It may harm them, even if they have the same symptoms as you.

 

Medicamentweb.com, the website for Patient Information Leaflets, is dedicated to share information about pharmaceutical products with the general public, and is particularly interested in making PILs available online. Of course, this information cannot replace the advice of your GP, doctor or pharmacist. If you should be worried in any way about your health, we urge you to see a doctor.

 

 

 

 

 

 

 

 

 

 

 

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