Gerard Laboratories

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gerax 250 microgram tablets
Gerax 500 microgram tablets
Gerax 1mg tablets
(Alprazolam)

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 any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1 What Gerax is and what it is used for
2 Before you take Gerax
3 How to take Gerax
4 Possible side effects
5 How to store Gerax
6 Further information.

1. WHAT GERAX IS AND WHAT IT IS USED FOR

Gerax tablets contain the active ingredient alprazolam. Alprazolam is a tranquilliser which belongs to a group of medicines called benzodiazepines. Gerax is used to treat anxiety that is severe, disabling or causing the sufferer great distress. It should only be taken for a short time (up to 12 weeks treatment).

2. BEFORE YOU TAKE GERAX

Do not take Gerax

• if you are allergic (hypersensitive) to alprazolam, other benzodiazepines or any of the other ingredients of Gerax
• if you have myasthenia gravis (a muscle weakness disorder)
• if you have a severe lung disease e.g. bronchitis, emphysema
• if you have "sleep apnoea" where breathing temporarily stops during sleep
• if you have severe liver disease.

Take special care with Gerax

• if you suffer from epilepsy or have had fits in the past
• if you have kidney or liver disease
• if you have any breathing problems
• if you have ever suffered from any mental illness that required hospital treatment
• if you have a history of drug or alcohol abuse – your doctor may want to give you special help when you need to stop taking Gerax
• if you are under 18 years or over 60 years of age
• if you have ever experienced distressing thoughts of harming yourself or suicide. Tell your doctor straight away.Gerax may not be suitable for you. Your doctor may need to change your medicine.

Tell your doctor if any of the above applies to you.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or the following:

• other medicines to treat anxiety or depression eg. fluvoxamine, fluoxetine, nefazodone, or to help you sleep
• medicine to treat mental illness (antipsychotics)
• medicine to treat epilepsy
• medicine to treat a fungal infection, e.g. ketoconazole, itraconazole
• antihistamines to relieve allergies
• medicineto treat a heart problem e.g. diltiazem
• medicine to treat HIV/AIDS eg. ritonavir
• strong painkillers e.g. morphine, codeine
• oral contraceptives
• medicine for stomach ulcers e.g. cimetidine, ranitidine
• antibiotics e.g. erythromycin

If you are going to have an operation requiring a general anaesthetic, tell your doctor as your dose of Gerax may have to be altered.

Taking Gerax with food and drink
Gerax can be taken with or without food.
As with all benzodiazepines, it is advisable not to drink alcohol while being treated with Gerax.
Pregnancy and breast-feeding
You will not usually be given Gerax if you are pregnant. If you become pregnant while you are taking your tablets, then you should contact your doctor and discuss stopping your tablets. Sometimes for important medical reasons, your doctor will want you to continue taking your tablets during your pregnancy or during labour. Your baby will be examined carefully when it is born as your tablets can give the baby low body temperature, floppy muscles and make breathing more difficult for him or her. Your baby may also develop withdrawal symptoms after it is born.

You should not take Gerax if you are breast-feeding, as benzodiazepines, such as alprazolam, pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or operate machinery until you know that Gerax does not reduce your reaction time by making you sleepy or less alert.
Important information about some of the ingredients of Gerax
Gerax tablets contain a very small amount of sodium benzoate. Benzoates can cause mild irritation to eyes, skin and mucous membranes such as inside the mouth. Talk to your doctor or pharmacist if you notice any effects or if you are worried about this. Gerax contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, such as lactose monohydrate, contact your doctor before taking this medicinal product.

3. HOW TO TAKE GERAX

Always take Gerax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Do not take more of this medicine than you have been told to take.

• Swallow the tablets with a glass of water or milk. Do not drink alcohol.

Benzodiazepines can cause memory loss of events happening after the tablets are taken. To reduce the risk of this try to ensure that you are able to have an uninterrupted sleep of 7-8 hours.
If you have any distressing thoughts about committing suicide or harming yourself, go to your doctor at once. Your doctor will change your medicine.
If you feel drowsy during the day or you suffer side effects (refer to section ’Possible side effects’ in this leaflet), tell your doctor. He may want to change your dose.
Adults
The usual dose for anxiety is 250 micrograms or 500 micrograms of Gerax three times daily (750 micrograms to 1500 micrograms (1.5mg) a day). If necessary your doctor may decide to slowly increase the dose up to 3000 micrograms (3mg) a day in divided doses.

Elderly
The usual starting dose is 250 micrograms twice daily. Your doctor may decide to slowly increase this dose to best treat your symptoms.

Gerax is only for short term treatment. This means that you will not normally be given Gerax for more than 8 to 12 weeks without your doctor reviewing your condition. This is because taking benzodiazepines for too long and at too high a dose can become habit-forming. This risk of dependence is greater in patients with a history of alcohol or drug abuse. Talk to your doctor if you are worried about this.

It is possible that when you finish your course of Gerax that your symptoms may return or you may suffer from some new symptoms. This is quite normal and may not mean you need more tablets.

Due to the muscle relaxant effect there is a risk of falls and consequently of hip fractures in elderly patients.

Patients with liver or kidney problems may be given a lower dose of Gerax

If you take more Gerax than you should
If you take more Gerax than you should contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose include uncontrollable movement and sleepiness. Take the container and any remaining tablets with you.

If you forgot to take Gerax
If you forget to take a dose of Gerax take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gerax
Do not stop taking your medicine without telling your doctor as he may wish to reduce your dose of Gerax slowly before stopping treatment completely. This reduces the likelihood of unpleasant withdrawal effects including feeling unhappy, headaches, difficulty sleeping, abdominal cramps, being sick, sweating, muscle pain or cramps, extreme anxiety, tension, restlessness, tremor, confusion and irritability. In severe cases you may feel that the world has become "unreal" or feel detached from the world, numbness and tingling of the fingers and toes, sensitive to light, noise or sounds or physical contact, hallucinations, or fits.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gerax can cause side effects, although not everybody gets them.
If you get any of the following, tell your doctor as soon as you can:

• memory loss of events that happened a few hours after you took your tablets
• depression
• restlessness – being unable to sit still or settle down to anything
• irritability – easily annoyed by things that would not normally bother you
• very excited, with possible aggressive outbursts
• delusions – you may start believing or thinking things that are obviously untrue
• rage – extreme anger when you lose control of yourself, when you would not normally do so
• nightmares
• hallucinations – seeing or hearing things that are not there, while you are awake
• behaving in a way that is either inappropriate or not how you would normally behave in that situation
• any other changes in your mental state
• severe sedation, slurred speech and loss of co-ordination –a condition similar to that seen when drinking too much alcohol.

The following side effects are usually seen at the start of treatment and often disappear on their own. They are more common in the elderly or young patients. Tell your doctor if you have any of the following:

• feeling sleepy during the day
• lightheaded or less alert
• numbed emotions
• confusion
• tiredness
• headaches
• dizziness
• tremor
• feeling nervous or anxious
• weight change
• muscle weakness
• lack of co-ordination and clumsiness
• problems sleeping
• double or blurred vision.

Occasionally some people have suffered from stomach pain or upset, loss of appetite and nausea, jaundice (yellowing of the skin or whites of the eyes), liver changes, urinary problems, breasts starting to produce milk (in women), menstrual changes in women, enlargement of breast (in men), skin reactions, sexual problems or changes in sex drive. If you suffer from these or any other unwanted effects, tell your doctor.
Rarely patients may suffer from raised pressure in the eye. Withdrawal symptoms can occur in patients who stop taking Gerax suddenly or reduce the dose too quickly (refer to the section ‘If you stop taking Gerax’ of this leaflet).
Patients prone to depression are more likely to suffer from this condition when taking a benzodiazepine. If you are worried speak to your doctor.
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE GERAX

Keep out of the reach and sight of children.
Do not use Gerax after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. In order to protect from light keep container in the outer carton.

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 protect the environment.

6. FURTHER INFORMATION

What Gerax contains
The active substance is alprazolam.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, sodium benzoate (E211), docusate sodium, povidone, anhydrous colloidal silica, sodium starch glycollate (Type A), magnesium stearate. The tablet coating includes
Gerax 500 microgram tablets: indigo carmine (E132), erythrosine (E127)
Gerax 1mg tablets: indigo carmine (E132)

What Gerax looks like and contents of the pack
Your medicine comes as a tablet.
Gerax 250 micrograms: White, oval tablets, scored and marked "AL 0.25" on one side and marked "G" on the other.
Gerax 500 microgram: Pale pink, oval tablets scored and marked "AL 0.50" on one side and "G" on the other.
Gerax 1 mg: Light blue, oval tablets scored and marked "AL 1.0 on one side and "G" on the other.

Gerax is available in plastic bottles or blister packs of 100 tablets.

Marketing Authorisation Holder and Manufacturer

McDermott Laboratories Limited, t/a Gerard Laboratories, Baldoyle, Dublin 13

This leaflet was last approved in January 2007