PL16133/0001

Package Leaflet: Information For The Patient

Diethylpropion Hydrochloride BP Tablets 25mg ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 to you. Do not pass it on to others.

•    If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.

What is in this leaflet?

1.    What Diethylpropion is and what it is used for

2.    What you need to know before you take Diethylpropion

3.    How to take Diethylpropion

4.    Possible side effects

5.    How to store Diethylpropion

6.    Contents of the pack and other information

1.    What Diethylpropion is and what it is used for

Your tablets are called Diethylpropion Hydrochloride BP. They are part of a group of drugs known as anorectic agents, used to reduce your appetite. They are used, for short periods of time, to assist with weight reduction in moderate to severely overweight adults.

This medicine should only be used in combination with a strict weight-reducing diet.

2.    What you need to know before you take Diethylpropion

Tell your doctor before you start taking your medication if you:

•    have ever had a bad reaction to any of the ingredients listed in section 6 or to sympathomimetic agents such as adrenaline or ephedrine

•    have ever had any problems with your heart or have high blood pressure

•    have ever had a stroke, glaucoma, thyroid trouble or epilepsy

•    have ever had a psychiatric problem including anorexia nervosa, depression, alcohol or drug abuse

•    are already taking drugs to reduce your appetite

•    are taking mono amino oxidase inhibitors (for depression) or have taken them within the past two weeks

•    are already taking medicines to lower your blood pressure, for diabetes, for mental disorders, sedatives or other sympathomimetic drugs such as ephedrine, phenylephrine or adrenaline

•    are taking other medicines including ones that you have bought for yourself without a prescription

Children and older people should not take Diethylpropion.

Do not drive or use machinery until you are sure that your tablets are not going to affect your reactions.

Do not drink alcohol while you are taking these tablets.

Pregnancy, breast feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, you should not take Diethylpropion. Talk to your doctor or pharmacist if you believe you may pregnant or are breast feeding and have taken Diethylpropion.

Information regarding Lactose

This product 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.

3.    How to take Diethylpropion

Always take Diethylpropion tablets exactly as your doctor has told you. If in doubt, check with your doctor or pharmacist.

•    The most common adult dose is 25mg two or three times a day, for 4 to 6 weeks. Very occasionally your doctor may tell you to take them for longer periods, but not for more than 3 months.

•    Tablets should be taken one hour before meals, but should not be taken in the evening as this may keep you awake at night. Swallow the tablets whole with water.

•    The score line is not intended for breaking the tablet.

If you take more Diethylpropion than you should or think that a child may have swallowed any then please contact your nearest hospital casualty department or a doctor immediately. Take this leaflet and any tablets that you still have, to show the doctor.

If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.

If you do not lose any weight or if you stop losing weight while you are taking your tablets you should see your doctor.

4. Possible side effects

Like all medicines, Diethylpropion tablets can cause side effects, although not everybody gets them.

The most serious side effect is an increase in blood pressure in the pulmonary artery, which leads from the heart to the lungs. The onset of which is characterised by shortness of breath. It is extremely important that if you feel more breathless than normal when you exercise or perform strenuous work, stop taking your medicine and see your doctor at once.

Should you have any of the following reactions stop taking your medicine immediately and seek urgent medical advice:

Rarely Diethylpropion can cause strokes, angina, heart attack and heart failure.

Less serious side effects can include: a dry mouth, constipation, feeling and being sick, skin rashes & breast enlargement in men.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diethylpropion

Store in cool dry conditions, away from light.

Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

•    Do not use this medicine if you notice any visible signs of deterioration.

•    Do not throw away any medicines via wastewater or household waste. Any tablets left at the end of your treatment should be returned back to your doctor or pharmacist.

6. Contents of the pack and other information

What Diethylpropion contains

The active substance (the ingredient that makes the tablets work) is Diethylpropion Hydrochloride BP 25mg. The other ingredients are lactose, magnesium stearate, pregelatinised starch, tartaric acid, E127 and E172.

What Diethylpropion looks like and contents of the pack

Diethylpropion tablets are round pink tablets with a slightly speckled appearance. Each tablet has been stamped with the code DPY25 and has a breakline on one side. They come in packs of 42 and 84.

Marketing authorisation holder and manufacturer:

For any information about this medicine, please contact the MA holder and manufacturer:

Essential Nutrition Ltd, Brough, East Yorkshire, HU15 1EG.

Tel: 01482 667634

labs@essentialnutrition.co.uk    This leaflet was last revised in August 2014

Diethylpropion Hydrochloride BP Tablets 25mg

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 to you. Do not pass it on to others.

•    If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.

What is in this leaflet?

1.    What Diethylpropion is and what it is used for

2.    What you need to know before you take Diethylpropion

3.    How to take Diethylpropion

4.    Possible side effects

5.    How to store Diethylpropion

6.    Contents of the pack and other information

1.    What Diethylpropion is and what it is used for

Your tablets are called Diethylpropion Hydrochloride BP. They are part of a group of drugs known as anorectic agents, used to reduce your appetite. They are used, for short periods of time, to assist with weight reduction in moderate to severely overweight adults.

This medicine should only be used in combination with a strict weight-reducing diet.

2.    What you need to know before you take Diethylpropion

Tell your doctor before you start taking your medication if you:

•    have ever had a bad reaction to any of the ingredients listed in section 6 or to sympathomimetic agents such as adrenaline or ephedrine

•    have ever had any problems with your heart or have high blood pressure

•    have ever had a stroke, glaucoma, thyroid trouble or epilepsy

•    have ever had a psychiatric problem including anorexia nervosa, depression, alcohol or drug abuse

•    are already taking drugs to reduce your appetite

•    are taking mono amino oxidase inhibitors (for depression) or have taken them within the past two weeks

•    are already taking medicines to lower your blood pressure, for diabetes, for mental disorders, sedatives or other sympathomimetic drugs such as ephedrine, phenylephrine or adrenaline

•    are taking other medicines including ones that you have bought for yourself without a prescription

Children and older people should not take Diethylpropion.

Do not drive or use machinery until you are sure that your tablets are not going to affect your reactions.

Do not drink alcohol while you are taking these tablets.

Pregnancy, breast feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, you should not take Diethylpropion. Talk to your doctor or pharmacist if you believe you may pregnant or are breast feeding and have taken Diethylpropion.

Information regarding Lactose

This product 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.

3.    How to take Diethylpropion

Always take Diethylpropion tablets exactly as your doctor has told you. If in doubt, check with your doctor or pharmacist.

•    The most common adult dose is 25mg two or three times a day, for 4 to 6 weeks. Very occasionally your doctor may tell you to take them for longer periods, but not for more than 3 months.

•    Tablets should be taken one hour before meals, but should not be taken in the evening as this may keep you awake at night. Swallow the tablets whole with water.

•    The score line is not intended for breaking the tablet.

If you take more Diethylpropion than you should or think that a child may have swallowed any then please contact your nearest hospital casualty department or a doctor immediately. Take this leaflet and any tablets that you still have, to show the doctor.

If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.

If you do not lose any weight or if you stop losing weight while you are taking your tablets you should see your doctor.

4. Possible side effects

Like all medicines, Diethylpropion tablets can cause side effects, although not everybody gets them.

The most serious side effect is an increase in blood pressure in the pulmonary artery, which leads from the heart to the lungs. The onset of which is characterised by shortness of breath. It is extremely important that if you feel more breathless than normal when you exercise or perform strenuous work, stop taking your medicine and see your doctor at once.

Should you have any of the following reactions stop taking your medicine immediately and seek urgent medical advice:

Rarely Diethylpropion can cause strokes, angina, heart attack and heart failure.

Less serious side effects can include: a dry mouth, constipation, feeling and being sick, skin rashes & breast enlargement in men.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Diethylpropion

Store in cool dry conditions, away from light.

Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

•    Do not use this medicine if you notice any visible signs of deterioration.

•    Do not throw away any medicines via wastewater or household waste. Any tablets left at the end of your treatment should be returned back to your doctor or pharmacist.

6.    Contents of the pack and other information

What Diethylpropion contains

The active substance (the ingredient that makes the tablets work) is Diethylpropion Hydrochloride BP 25mg. The other ingredients are lactose, magnesium stearate, pregelatinised starch, tartaric acid, E127 and E172.

What Diethylpropion looks like and contents of the pack

Diethylpropion tablets are round pink tablets with a slightly speckled appearance. Each tablet has been stamped with the code DPY25 and has a breakline on one side. They come in packs of 42 and 84.

Marketing authorisation holder and manufacturer:

For any information about this medicine, please contact the MA holder and manufacturer:

Essential Nutrition Ltd, Brough, East Yorkshire, HU15 1EG.

Tel: 01482 667634 labs@essentialnutrition.co.uk