PATIENT INFORMATION LEAFLET

Ephedrine 1% w/v Nasal Drops

(ephedrine hydrochloride)

In this leaflet:

1.    What Ephedrine Nasal Drops is and what it is used for?

2.    Before Ephedrine Nasal Drops is used

3.    How will Ephedrine Nasal Drops be used?

4.    Possible Side effects

5.    Storing Ephedrine Nasal Drops

6.    Further information

1.    WHAT EPHEDRINE NASAL DROPS ARE AND WHAT THEY ARE USED FOR?

Ephedrine belongs to a group of medicines called sympathomimetics. A sympathomimetic is a medicine which has a wide range of effects, in this case it reduces nasal congestion (blocked noses).

Ephedrine Nasal Drops are used to treat congestion in the nose otherwise known as a blocked nose.

2.    BEFORE EPHEDRINE NASAL DROPS ARE USED

DO NOT use Ephedrine Nasal Drops if:

You are allergic (hypersensitive) to Ephedrine or to the ingredients present in the product (see section 6).

TAKE SPECIAL CARE with Ephedrine if:

•    You are pregnant, planning to become pregnant or are breast feeding

•    You suffer from diabetes, glaucoma, an over-active thyroid gland, prostate gland enlargement and any cardiovascular disease or heart condition.

If any of the above applies to you or your child, please consult your doctor.

Taking other medicines

Tell you’re your doctor if you are taking anti-depressants including any monoamine oxidase inhibitors or recently stopped taking, within the last 2 weeks.

If you are going to have an operation or medical procedure using an anaesthetic agent you should tell your doctor or anaesthetist if you are using ephedrine nasal drops

Pregnancy and breast-feeding:

This medicine should not be given to you if you are pregnant, trying to become pregnant or are breast-feeding, unless your doctor has recommended it.

Driving and using machines:

This medicine does not affect your ability to dive or operate machinery.

3.    HOW WILL EPHEDRINE NASAL DROPS BE USED?

•    Always follow the instruction of your doctor or pharmacist.

•    For nasal use only.

•    These drops are used by tilting back the head and carefully squeezing the bottle so that the required number of drops are applied to each nostril.

•    You may find it easier to get someone to help you.

Adults (including the elderly) and children over 12 years

•    1 or 2 drops to be put into each nostril as required up to 4 times a day Children under 12 years (including infants)

•    Not recommended.

You should not continue to take this medicine for more than 7 days without seeking medical advice.

If you forget to take Ephedrine Nasal Drops

Try not to miss a dose, do not worry, just carry as normal. Do not use extra drops to make up.

If you use more Ephedrine Nasal Drops than you should

If you suspect someone has swallowed any Ephedrine Nasal Drops, contact your doctor or go to the accident and emergency department of your hospital at once. Always take the container with you, if possible, even if empty.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Ephedrine Nasal Drops can sometimes cause side effects, although not every body gets them.

They may include:

•    Anxiety

•    Restlessness

•    Headache

•    Nausea

•    Weakness and trembling

•    Irritation of the nose

•    Sweating and thirst

•    Effects on the heart and circulation e.g. high blood pressure

•    Inflammation of the skin

People with difficulty in passing urine may find that the condition gets worse.

Use of the drops for more than 7 days may make your congestion worse and the effectiveness of the drops will decrease.

If you notice these or any side other effects not included above, stop use and tell your doctor or pharmacist. They will tell you what to do.

5.    STORING EPHEDRINE NASAL DROPS

•    This product has an expiry date printed on the bottle label. The expiry date refers to the last day of the month.

•    If you have any unused drops 2 months after first opening they should be discarded. Medicines should not be disposed of via wastewater or house hold water. Ask your pharmacist how to dispose of the medicines no longer required. The measures will help protect the environment.

•    Do not store above 25°C, protect from light.

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

6. FURTHER INFORMATION What Ephedrine Nasal Drops contains

The active ingredient is Ephedrine Hydrochloride 1%w/v

Other ingredients are Purified Water, Sodium Chloride and Benzalkonium Chloride 0.01% w/v. Contents of the pack.

Ephedrine nasal drops are a clear colourless liquid. Each bottle contains 10ml.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Ltd. Bampton Road, Romford, RM3 8UG, England

Product Licence No.: PL 00156/0052

Date of approval: 01/2010

© Martindale Pharmaceuticals Ltd c*****