PACKAGE LEAFLET INFORMATION FOR THE USER

Ephedrine Hydrochloride 15mg, 30mg and 60mg Tablets

Ephedrine Hydrochloride

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor

or 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.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Ephedrine Hydrochloride 15mg, 30mg or 60mg Tablets. In the rest of this leaflet it is called Ephedrine Tablets.

In this leaflet:

1.    What Ephedrine Tablets are and what they are used for

2.    Before you take Ephedrine Tablets

3.    How to take Ephedrine Tablets

4.    Possible side effects

5.    How to store Ephedrine Tablets

6.    Further information

1. WHAT EPHEDRINE TABLETS ARE AND WHAT THEY ARE USED FOR

The active ingredient in Ephedrine Tablets is ephedrine hydrochloride, which belongs to a group of medicines called bronchodilators, which open up the airways in your lungs and prevent or relieve wheezing.

Ephedrine Tablets are used to prevent or relieve wheezing associated with asthma.

2. BEFORE YOU TAKE EPHEDRINE TABLETS

Do not take Ephedrine Tablets if you:

• are allergic to ephedrine hydrochloride or any of the other ingredients contained in Ephedrine Tablets (see list under

heading ‘What Ephedrine Tablets contain' in section 6)

•    have coronary heart disease with narrowing of the blood vessels that supply blood and oxygen to the heart

•    suffer from high blood pressure

•    have an overactive thyroid gland

•    have an enlarged prostate gland

•    are being treated for depression with monoamine oxidase inhibitors (MAOIs) or have only recently stopped taking them (within the last two weeks)

If any of the above statements apply to you, you should not take Ephedrine Tablets.

The tablets are not recommended for children under one year of age.

Speak to your doctor before taking Ephedrine Tablets if you:

•    suffer from diabetes

•    have glaucoma (a disease in which the pressure inside the eyeball is too high)

•    have kidney problems.

If any of the above statements apply to you, you should speak to your doctor before taking Ephedrine Tablets.

Taking other medicines

Taking another medicine while you are taking Ephedrine Tablets can affect how it or the other medicine works.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products, including those you may have bought yourself without a prescription.

Please check with your doctor if you are taking any of the following (or any other medication):

•    Theophylline, a similar drug used to treat severe asthma and other conditions causing obstruction of the airways in your lungs

•    Tricyclic antidepressants, such as amitriptyline or dosulepin, or monoamine oxidase inhibitors, such as phenelzine, isocarboxazid or tranylcypromine, used to treat depression

• Drugs used to treat high blood pressure, such as propranolol or atenolol

• Dexamethasone, a steroid

•    Anaesthetics, such as halothane

•    Methysergide or ergotamine, used to treat migraine

•    Drugs used to treat heart failure or abnormal heart rhythm, such as digoxin

•    Oxytocin, used to induce labour and prevent bleeding

•    Agents used to make the urine more alkaline (such as potassium citrate or sodium bicarbonate), or more acid (such as ammonium chloride or ascorbic acid).

If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

Pregnancy and breast-feeding

You should not take Ephedrine Tablets if you are pregnant or wish to become pregnant. Taking Ephedrine Tablets whilst pregnant can affect your baby's heartbeat.

Ephedrine can enter breast milk. You should not breast-feed whilst taking Ephedrine Tablets. Irritability and disturbed sleep patterns have been reported in breast-fed infants.

Driving and operating machines

Ephedrine Tablets do not affect the ability to drive or operate machinery.

Important information for patients who have an intolerance to some sugars

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains lactose. You should not take Ephedrine Tablets if you have certain types of intolerance.

3. HOW TO TAKE EPHEDRINE TABLETS

Your doctor will decide the dose which is best for you. Always follow your doctor's instructions completely and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless instructed differently, take your tablets with a glass of water.

Adults

The usual dose for adults is 15-60mg three times daily.

Elderly

Smaller doses are required. For the elderly the starting dose should be half the adult dose.

Children one to five years

For children one to five years old the usual dose is 15mg three times daily.

Children six to 12 years

For children six to 12 years old the dose is usually 30mg three times daily.

The tablets are not recommended for children under one year of age.

If you take more Ephedrine Tablets than you should

If you accidentally take too many tablets contact your doctor, pharmacist or nearest hospital casualty department. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist. Symptoms of an overdose include being sick or feeling sick, high blood pressure, fever, rapid heart beat, restlessness, difficulty breathing and convulsions. Hallucinations and delusions may also occur.

If you miss a dose of Ephedrine Tablets

If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

Stopping Ephedrine Tablets

You should continue to take Ephedrine Tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.

4. POSSIBLE SIDE EFFECTS

•    fast or irregular heart beat (these are more likely to occur if you are elderly)

•    trembling

•    headaches

•    high blood pressure

•    poor circulation in your fingers and toes

•    heart attack (this is a very rare side effect)

Side effects specific to children

In children ephedrine may cause bed-wetting, sleeplessness or drowsiness.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist immediately.

If you take Ephedrine Tablets for a long time

If you have been taking Ephedrine Tablets for a long time you may become dependent on them.

5. HOW TO STORE EPHEDRINE TABLETS

Keep out of the reach and sight of children.

Do not take this medicine if the expiry date on the label has passed. The expiry date refers to the last day of that month.

Ephedrine Tablets should not be taken if they show signs of deterioration such as discoloration.

Do not store above 25°C.

Store in the original container or package in order to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to disppse of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Ephedrine Tablets look like and contents of the pack

Ephedrine Hydrochloride 15mg Tablets are white circular tablets marked E15 on one face and CP on the reverse.

Ephedrine Hydrochloride 30mg Tablets are white circular tablets marked E30 on one face and CP on the reverse.

Ephedrine Hydrochloride 60mg Tablets are white circular tablets marked E60 on one face and CP on the reverse.

Ephedrine Hydrochloride Tablets are available in polypropylene (plastic) containers of 28 tablets.

Marketing Authorisation Holder:

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

This is a service provided by the Royal National Institute of Blind People.

Date of leaflet preparation: July 2008

Like many medicines Ephedrine Tablets may cause side effects in some patients, although not everybody gets them.

Side effects include:

•    feeling sick

•    restlessness

•    insomnia (difficulty in sleeping)

•    anxiety

•    dry mouth

What Ephedrine Tablets contain

The active ingredient in Ephedrine Tablets is ephedrine hydrochloride. The tablets are available in three strengths, 15mg, 30mg and 60mg.

The other ingredients in Ephedrine Tablets are lactose, maize starch, acacia (spray-dried), stearic acid and magnesium stearate