Combivent nebuliser liquid 2.5ml UDVs

Main information

  • Trade name:
  • Combivent nebuliser liquid 2.5ml UDVs
  • Dosage:
  • 1mg/ 1ml ; 200microgram/ 1ml
  • Pharmaceutical form:
  • Nebuliser liquid
  • Administration route:
  • Inhalation
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Combivent nebuliser liquid 2.5ml UDVs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 03010400; GTIN: 5012816000124

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00015/0197
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

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, pharmacist or practice nurse.

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 of the side effects gets troublesome

or serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or

pharmacist.

In this leaflet:

1. What COMBIVENT UDVs is and what it is

used for

2. Before you use COMBIVENT UDVs

3. How to use COMBIVENT UDVs

4. Possible side effects

5. How to store COMBIVENT UDVs

6. Further information

1. WHAT COMBIVENT UDVs IS AND WHAT IT IS

USED FOR

The name of your medicine is COMBIVENT

UDVs. You use it with a device called a

‘nebuliser’. This changes your medicine into a

mist for you to breathe in. COMBIVENT contains

two different medicines called:

Ipratropium bromide and

Salbutamol sulfate

Both belong to a group of medicines called

bronchodilators. They are used to make

breathing easier in an illness called ‘chronic

obstructive pulmonary disease’ or COPD. They

work by opening up your airways.

2. BEFORE YOU USE COMBIVENT UDVs

Do not use COMBIVENT if:

You are allergic (hypersensitive) to ipratropium

or salbutamol or any of the other ingredients

in COMBIVENT. (Listed in section 6: Further

information)

You are allergic to similar medicines which

contain atropine or medicines like atropine

You have a heart problem called ‘hypertrophic

obstructive cardiomyopathy’.

This is where the wall between the two sides of

the heart gets bigger and blocks the blood flow

You have a very fast heart beat (called

‘tachyarrythmia’)

You are pregnant, likely to get pregnant or are

breast-feeding

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or

pharmacist before using COMBIVENT.

Take special care with COMBIVENT

A condition known as lactic acidosis has been

reported in association with high therapeutic

doses of salbutamol, mainly in patients being

treated for an acute bronchospasm (see Section

3 and 4). Increase in lactate levels may lead to

shortness of breath and hyperventilation even

though there may be improvement in your

wheezing. If you feel that your medicine is not

working as well as usual and you need to use

the nebuliser more than your doctor has

recommended, immediately talk to a doctor.

Check with your doctor or pharmacist before

using this medicine if:

You have glaucoma, or have been told that you

may develop it

You have heart or circulation problems, or

have had a recent heart attack

You have diabetes

You have an over-active thyroid gland

You have problems passing water (urine)

You are a man who has prostate problems

You have cystic fibrosis

You have ever had something called

‘pheochromocytoma’. This is a rare tumour

which is not malignant. Using your inhaler

can make the symptoms of this worse

If you are not sure if any of these apply to you,

talk to your doctor or pharmacist before using

COMBIVENT.

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. This includes herbal

medicines. This is because COMBIVENT can

affect the way some other medicines work. Also

some other medicines can affect the way

COMBIVENT works.

In particular, tell your doctor or pharmacist if

you are taking any of the following medicines:

Steroid medicines such as prednisolone

Water tablets (also called ‘diuretics’)

Medicines for depression

Medicines to help your breathing

Medicines called ‘anti-cholinergics’. These

can be used to treat colic pain, Parkinson’s

Disease, problems passing water or lack of

control of your bladder or bowels

Medicines called ‘beta blockers’ such as

propanolol. These can be used to treat heart

problems, high blood pressure, anxiety or

migraine

Medicines called ‘beta mimetics’ such as

fenoterol for breathing problems

Digoxin - used for a fast heart beat or heart

failure

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

using COMBIVENT.

Operations

Some gases used in operations (anaesthetic

gases) may affect how your medicine works. If

you are about to have surgery, make sure you

mention that you are taking COMBIVENT to the

doctor, dentist or anaesthetist.

Tests

If you have to provide an urine sample as part

of a routine sport drug test, tell the person

giving the test that you are taking this medicine.

This is because COMBIVENT contains

salbutamol and this may lead to a positive

result.

Pregnancy and breast-feeding

Do not use COMBIVENT if you are pregnant,

likely to get pregnant or are breast-feeding.

Driving and using machines

You may feel dizzy, or have difficulty in

focusing, or blurred vision whilst taking

COMBIVENT. If this happens do not drive or use

tools or machines.

3. HOW TO USE COMBIVENT UDVs

Always use COMBIVENT exactly as your

doctor has told you. You should check with your

doctor or pharmacist if you are not sure. Follow

these instructions to get the best results. If

anything is unclear after reading this leaflet, ask

your doctor, pharmacist or practice nurse.

How many dose units

The usual dose is the contents of 1 single dose

unit, three or four times a day for:

Adults (including the elderly) and children over

12 years.

COMBIVENT is not recommended for

children under 12 years.

Do not swallow or give this medicine by

injection.

Do not use more than your doctor has told you

See your doctor straight away if:

You feel that your medicine is not working as

well as usual

You need to use the nebuliser more than your

doctor has recommended

Your doctor may need to check how well

your medicine is working.

In some cases your doctor may need to change

your medicine.

How to use your nebuliser

Read through numbers 1 to 6 first, before

starting to use your nebuliser.

1. Get your nebuliser ready by following the

manufacturer’s instructions. Ask your doctor

if you are not sure how to use it.

2.

Open the pouch and remove the

strip of unit dose vials

Carefully separate a new dose

unit from the strip

Do not use if it is already

open or if the liquid inside is

discoloured

3. Twist off the top

Always hold it upright while

you do this

4.

Squeeze all the contents of the

dose unit into the nebuliser

chamber

Your doctor will tell you if you

need to use a different amount

If your doctor has told you

that your medicine needs to

be diluted, you will be given

‘sterile sodium chloride 0.9%’

solution. Your doctor will tell

you how to do this

5. Use your nebuliser as directed by your doctor.

6. After you have finished, dispose of any

leftover medicine carefully

Follow the manufacturer’s instructions

on how to clean your nebuliser

It is important to keep your nebuliser

clean

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours

or lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at

any other time, talk to your doctor for advice.

If you use more COMBIVENT than you should

If you use more of this medicine than you should,

talk to a doctor or go to a hospital straight away.

If you forget to take COMBIVENT

If you forget a dose, take it as soon as you

remember it

However, if it is time for the next dose, skip

the missed dose

Do not take a double dose to make up for a

forgotten dose

If you have any further questions, ask your

doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, COMBIVENT can cause side

effects, although not everybody gets them.

Tell your doctor straight away if you notice any

of the following serious side effects - you may

need urgent medical treatment:

If after taking COMBIVENT you are wheezy or

have other difficulties in breathing, do not take

any more (unless you have been told to by

your doctor)

Allergic reactions - the signs may include skin

rash, itching and nettle rash. In severe cases

the signs include swelling of your tongue, lips

and face, sudden difficulties in breathing and

a fall in your blood pressure that may cause

dizziness.

See your doctor straight away if you have any of

these side effects.

The following side effect can also happen but

the frequency of this is not known:

A condition known as lactic acidosis which

may cause stomach pain, hyperventilation,

shortness of breath even though there may be

improvement in your wheezing, cold feet and

hands, irregular heartbeat or thirst.

The side effects described below have been

experienced by people taking COMBIVENT.

Uncommon (affects less than 1 in 100 people)

Feeling nervous, shaky or dizzy

Dry mouth

Cough, headache

Feeling sick (nausea)

Throat irritation

Increase in blood pressure

Increased heart rate or uneven heart beats

(palpitations)

Voice problems (‘dysphonia’)

Skin reactions

Rare (affects less than 1 in 1,000 people)

Irregular heart beat

Regular but abnormally fast heart rate

(supraventricular tachycardia)

Chest pain (due to heart problems such as

angina). Tell your doctor or pharmacist if this

occurs but do not stop taking this medicine

unless told to do so

Blurred vision, dilated pupils, glaucoma,

painful, stinging, or red eyes, swelling of the

eyes, see colours or lights

Increased sweating

Unexpected tightening of the chest

immediately after inhaling the medicine

Dry throat, swelling of the throat

Difficulty in breathing or speaking due to a

brief spasm of your vocal muscles

Diarrhoea, constipation, being sick (vomiting)

or other problems with your digestive system

Inflammation of the mouth

Muscle cramps, muscle weakness and pain

Difficulty in passing water (urine)

Feeling weak

Fall in blood pressure

Mood changes

You may also get unusually low levels of

potassium in your blood (called ‘hypokalemia’).

If this happens, your doctor will keep checking

your potassium levels.

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours or

lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at any

other time, talk to your doctor for advice.

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 COMBIVENT UDVs

Do not use this medicine after the expiry date

which is stated on the carton and the vial label.

The expiry date refers to the last day of the

month.

Store below 25°C. Do not freeze. Do not use if

the liquid is discoloured.

Keep vials in the outer carton in order to protect

from light.

Keep out of the sight and reach of children.

6. FURTHER INFORMATION

What COMBIVENT contains

COMBIVENT UDVs contain a nebuliser solution.

Each single dose unit contains ipratropium

bromide 500 micrograms and salbutamol

2.5 mg (as sulfate) in 2.5 ml of aqueous

solution.

The other ingredients are: sodium chloride, (1N)

hydrochloric acid and purified water.

What COMBIVENT looks like and contents of

the pack

Your medicine should be used with a nebuliser.

This changes COMBIVENT into a mist for you to

breathe in. COMBIVENT UDVs are available in

packs of 60 units.

Marketing Authorisation Holder and

Manufacturer

The Marketing Authorisation for

COMBIVENT UDVs is held by:

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell, Berks.,

RG12 8YS, United Kingdom.

COMBIVENT UDVs are manufactured by:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez - CS 28028

80084 Amiens Cedex 2

France

This leaflet was revised in January 2018.

© Boehringer Ingelheim Ltd 2018

ABCD

Combivent

UDVs

(ipratropium bromide and salbutamol sulfate)

65NOT1070/F

File information

Issue date of TD:

PPM SKU:

PPM SKU version:

Issue date of artwork:

Print colors:

PAN BLACK

19/JAN/2018

P014293

28/DEC/2017

Yes

Yes

No

Yes

No

Yes

No

Yes

No

No

Yes

Yes

TD

Printfile

Mandatory in

Mat. No. Pack. Site:

Min. font size:

65NOT1070/F

8.5pt

Legend case version:

Perigord No: 442302 p2

V4.0 01/OCT/2012 (please do not change or remove it)

a = Batch No.

Bottle pack :

b = Expiry date

4010/3-8-9-11

c = Manufacturing date

External dimension :

Weight and quality :

d = Price/Sample/Clinic

560 x 200 mm

40 g/m² - papier velin

35 x 200 mm (6 foldings)

Technical colors

Dimension of the leaflet after folding :

BI-Diecut-Legendcase

Free area

Gluepoints

Technical information

Additional information

MESSAGE TO OUR SUPPLIER :

Page 1 is always the front side. The text direction can be in landscape or portrait.

The folded leaflet will always be deliver with the 2 barcodes outside (front side

outside)

No gluepoint

direction of travel

Package leaflet: Information for the user

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, pharmacist or practice nurse.

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 of the side effects gets troublesome

or serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or

pharmacist.

In this leaflet:

1. What COMBIVENT UDVs is and what it is

used for

2. Before you use COMBIVENT UDVs

3. How to use COMBIVENT UDVs

4. Possible side effects

5. How to store COMBIVENT UDVs

6. Further information

1. WHAT COMBIVENT UDVs IS AND WHAT IT IS

USED FOR

The name of your medicine is COMBIVENT

UDVs. You use it with a device called a

‘nebuliser’. This changes your medicine into a

mist for you to breathe in. COMBIVENT contains

two different medicines called:

Ipratropium bromide and

Salbutamol sulfate

Both belong to a group of medicines called

bronchodilators. They are used to make

breathing easier in an illness called ‘chronic

obstructive pulmonary disease’ or COPD. They

work by opening up your airways.

2. BEFORE YOU USE COMBIVENT UDVs

Do not use COMBIVENT if:

You are allergic (hypersensitive) to ipratropium

or salbutamol or any of the other ingredients

in COMBIVENT. (Listed in section 6: Further

information)

You are allergic to similar medicines which

contain atropine or medicines like atropine

You have a heart problem called ‘hypertrophic

obstructive cardiomyopathy’.

This is where the wall between the two sides of

the heart gets bigger and blocks the blood flow

You have a very fast heart beat (called

‘tachyarrythmia’)

You are pregnant, likely to get pregnant or are

breast-feeding

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or

pharmacist before using COMBIVENT.

Take special care with COMBIVENT

A condition known as lactic acidosis has been

reported in association with high therapeutic

doses of salbutamol, mainly in patients being

treated for an acute bronchospasm (see Section

3 and 4). Increase in lactate levels may lead to

shortness of breath and hyperventilation even

though there may be improvement in your

wheezing. If you feel that your medicine is not

working as well as usual and you need to use

the nebuliser more than your doctor has

recommended, immediately talk to a doctor.

Check with your doctor or pharmacist before

using this medicine if:

You have glaucoma, or have been told that you

may develop it

You have heart or circulation problems, or

have had a recent heart attack

You have diabetes

You have an over-active thyroid gland

You have problems passing water (urine)

You are a man who has prostate problems

You have cystic fibrosis

You have ever had something called

‘pheochromocytoma’. This is a rare tumour

which is not malignant. Using your inhaler

can make the symptoms of this worse

If you are not sure if any of these apply to you,

talk to your doctor or pharmacist before using

COMBIVENT.

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. This includes herbal

medicines. This is because COMBIVENT can

affect the way some other medicines work. Also

some other medicines can affect the way

COMBIVENT works.

In particular, tell your doctor or pharmacist if

you are taking any of the following medicines:

Steroid medicines such as prednisolone

Water tablets (also called ‘diuretics’)

Medicines for depression

Medicines to help your breathing

Medicines called ‘anti-cholinergics’. These

can be used to treat colic pain, Parkinson’s

Disease, problems passing water or lack of

control of your bladder or bowels

Medicines called ‘beta blockers’ such as

propanolol. These can be used to treat heart

problems, high blood pressure, anxiety or

migraine

Medicines called ‘beta mimetics’ such as

fenoterol for breathing problems

Digoxin - used for a fast heart beat or heart

failure

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

using COMBIVENT.

Operations

Some gases used in operations (anaesthetic

gases) may affect how your medicine works. If

you are about to have surgery, make sure you

mention that you are taking COMBIVENT to the

doctor, dentist or anaesthetist.

Tests

If you have to provide an urine sample as part

of a routine sport drug test, tell the person

giving the test that you are taking this medicine.

This is because COMBIVENT contains

salbutamol and this may lead to a positive

result.

Pregnancy and breast-feeding

Do not use COMBIVENT if you are pregnant,

likely to get pregnant or are breast-feeding.

Driving and using machines

You may feel dizzy, or have difficulty in

focusing, or blurred vision whilst taking

COMBIVENT. If this happens do not drive or use

tools or machines.

3. HOW TO USE COMBIVENT UDVs

Always use COMBIVENT exactly as your

doctor has told you. You should check with your

doctor or pharmacist if you are not sure. Follow

these instructions to get the best results. If

anything is unclear after reading this leaflet, ask

your doctor, pharmacist or practice nurse.

How many dose units

The usual dose is the contents of 1 single dose

unit, three or four times a day for:

Adults (including the elderly) and children over

12 years.

COMBIVENT is not recommended for

children under 12 years.

Do not swallow or give this medicine by

injection.

Do not use more than your doctor has told you

See your doctor straight away if:

You feel that your medicine is not working as

well as usual

You need to use the nebuliser more than your

doctor has recommended

Your doctor may need to check how well

your medicine is working.

In some cases your doctor may need to change

your medicine.

How to use your nebuliser

Read through numbers 1 to 6 first, before

starting to use your nebuliser.

1. Get your nebuliser ready by following the

manufacturer’s instructions. Ask your doctor

if you are not sure how to use it.

2.

Open the pouch and remove the

strip of unit dose vials

Carefully separate a new dose

unit from the strip

Do not use if it is already

open or if the liquid inside is

discoloured

3. Twist off the top

Always hold it upright while

you do this

4.

Squeeze all the contents of the

dose unit into the nebuliser

chamber

Your doctor will tell you if you

need to use a different amount

If your doctor has told you

that your medicine needs to

be diluted, you will be given

‘sterile sodium chloride 0.9%’

solution. Your doctor will tell

you how to do this

5. Use your nebuliser as directed by your doctor.

6. After you have finished, dispose of any

leftover medicine carefully

Follow the manufacturer’s instructions

on how to clean your nebuliser

It is important to keep your nebuliser

clean

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours

or lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at

any other time, talk to your doctor for advice.

If you use more COMBIVENT than you should

If you use more of this medicine than you should,

talk to a doctor or go to a hospital straight away.

If you forget to take COMBIVENT

If you forget a dose, take it as soon as you

remember it

However, if it is time for the next dose, skip

the missed dose

Do not take a double dose to make up for a

forgotten dose

If you have any further questions, ask your

doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, COMBIVENT can cause side

effects, although not everybody gets them.

Tell your doctor straight away if you notice any

of the following serious side effects - you may

need urgent medical treatment:

If after taking COMBIVENT you are wheezy or

have other difficulties in breathing, do not take

any more (unless you have been told to by

your doctor)

Allergic reactions - the signs may include skin

rash, itching and nettle rash. In severe cases

the signs include swelling of your tongue, lips

and face, sudden difficulties in breathing and

a fall in your blood pressure that may cause

dizziness.

See your doctor straight away if you have any of

these side effects.

The following side effect can also happen but

the frequency of this is not known:

A condition known as lactic acidosis which

may cause stomach pain, hyperventilation,

shortness of breath even though there may be

improvement in your wheezing, cold feet and

hands, irregular heartbeat or thirst.

The side effects described below have been

experienced by people taking COMBIVENT.

Uncommon (affects less than 1 in 100 people)

Feeling nervous, shaky or dizzy

Dry mouth

Cough, headache

Feeling sick (nausea)

Throat irritation

Increase in blood pressure

Increased heart rate or uneven heart beats

(palpitations)

Voice problems (‘dysphonia’)

Skin reactions

Rare (affects less than 1 in 1,000 people)

Irregular heart beat

Regular but abnormally fast heart rate

(supraventricular tachycardia)

Chest pain (due to heart problems such as

angina). Tell your doctor or pharmacist if this

occurs but do not stop taking this medicine

unless told to do so

Blurred vision, dilated pupils, glaucoma,

painful, stinging, or red eyes, swelling of the

eyes, see colours or lights

Increased sweating

Unexpected tightening of the chest

immediately after inhaling the medicine

Dry throat, swelling of the throat

Difficulty in breathing or speaking due to a

brief spasm of your vocal muscles

Diarrhoea, constipation, being sick (vomiting)

or other problems with your digestive system

Inflammation of the mouth

Muscle cramps, muscle weakness and pain

Difficulty in passing water (urine)

Feeling weak

Fall in blood pressure

Mood changes

You may also get unusually low levels of

potassium in your blood (called ‘hypokalemia’).

If this happens, your doctor will keep checking

your potassium levels.

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours or

lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at any

other time, talk to your doctor for advice.

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 COMBIVENT UDVs

Do not use this medicine after the expiry date

which is stated on the carton and the vial label.

The expiry date refers to the last day of the

month.

Store below 25°C. Do not freeze. Do not use if

the liquid is discoloured.

Keep vials in the outer carton in order to protect

from light.

Keep out of the sight and reach of children.

6. FURTHER INFORMATION

What COMBIVENT contains

COMBIVENT UDVs contain a nebuliser solution.

Each single dose unit contains ipratropium

bromide 500 micrograms and salbutamol

2.5 mg (as sulfate) in 2.5 ml of aqueous

solution.

The other ingredients are: sodium chloride, (1N)

hydrochloric acid and purified water.

What COMBIVENT looks like and contents of

the pack

Your medicine should be used with a nebuliser.

This changes COMBIVENT into a mist for you to

breathe in. COMBIVENT UDVs are available in

packs of 60 units.

Marketing Authorisation Holder and

Manufacturer

The Marketing Authorisation for

COMBIVENT UDVs is held by:

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell, Berks.,

RG12 8YS, United Kingdom.

COMBIVENT UDVs are manufactured by:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez - CS 28028

80084 Amiens Cedex 2

France

This leaflet was revised in January 2018.

© Boehringer Ingelheim Ltd 2018

ABCD

Combivent

UDVs

(ipratropium bromide and salbutamol sulfate)

65NOT1070/F

File information

Issue date of TD:

PPM SKU:

PPM SKU version:

Issue date of artwork:

Print colors:

PAN BLACK

19/JAN/2018

P014293

28/DEC/2017

Yes

Yes

No

Yes

No

Yes

No

Yes

No

No

Yes

Yes

TD

Printfile

Mandatory in

Mat. No. Pack. Site:

Min. font size:

65NOT1070/F

8.5pt

Legend case version:

Perigord No: 442302 p2

V4.0 01/OCT/2012 (please do not change or remove it)

a = Batch No.

Bottle pack :

b = Expiry date

4010/3-8-9-11

c = Manufacturing date

External dimension :

Weight and quality :

d = Price/Sample/Clinic

560 x 200 mm

40 g/m² - papier velin

35 x 200 mm (6 foldings)

Technical colors

Dimension of the leaflet after folding :

BI-Diecut-Legendcase

Free area

Gluepoints

Technical information

Additional information

MESSAGE TO OUR SUPPLIER :

Page 1 is always the front side. The text direction can be in landscape or portrait.

The folded leaflet will always be deliver with the 2 barcodes outside (front side

outside)

No gluepoint

direction of travel

Package leaflet: Information for the user

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, pharmacist or practice nurse.

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 of the side effects gets troublesome

or serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or

pharmacist.

In this leaflet:

1. What COMBIVENT UDVs is and what it is

used for

2. Before you use COMBIVENT UDVs

3. How to use COMBIVENT UDVs

4. Possible side effects

5. How to store COMBIVENT UDVs

6. Further information

1. WHAT COMBIVENT UDVs IS AND WHAT IT IS

USED FOR

The name of your medicine is COMBIVENT

UDVs. You use it with a device called a

‘nebuliser’. This changes your medicine into a

mist for you to breathe in. COMBIVENT contains

two different medicines called:

Ipratropium bromide and

Salbutamol sulfate

Both belong to a group of medicines called

bronchodilators. They are used to make

breathing easier in an illness called ‘chronic

obstructive pulmonary disease’ or COPD. They

work by opening up your airways.

2. BEFORE YOU USE COMBIVENT UDVs

Do not use COMBIVENT if:

You are allergic (hypersensitive) to ipratropium

or salbutamol or any of the other ingredients

in COMBIVENT. (Listed in section 6: Further

information)

You are allergic to similar medicines which

contain atropine or medicines like atropine

You have a heart problem called ‘hypertrophic

obstructive cardiomyopathy’.

This is where the wall between the two sides of

the heart gets bigger and blocks the blood flow

You have a very fast heart beat (called

‘tachyarrythmia’)

You are pregnant, likely to get pregnant or are

breast-feeding

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or

pharmacist before using COMBIVENT.

Take special care with COMBIVENT

A condition known as lactic acidosis has been

reported in association with high therapeutic

doses of salbutamol, mainly in patients being

treated for an acute bronchospasm (see Section

3 and 4). Increase in lactate levels may lead to

shortness of breath and hyperventilation even

though there may be improvement in your

wheezing. If you feel that your medicine is not

working as well as usual and you need to use

the nebuliser more than your doctor has

recommended, immediately talk to a doctor.

Check with your doctor or pharmacist before

using this medicine if:

You have glaucoma, or have been told that you

may develop it

You have heart or circulation problems, or

have had a recent heart attack

You have diabetes

You have an over-active thyroid gland

You have problems passing water (urine)

You are a man who has prostate problems

You have cystic fibrosis

You have ever had something called

‘pheochromocytoma’. This is a rare tumour

which is not malignant. Using your inhaler

can make the symptoms of this worse

If you are not sure if any of these apply to you,

talk to your doctor or pharmacist before using

COMBIVENT.

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. This includes herbal

medicines. This is because COMBIVENT can

affect the way some other medicines work. Also

some other medicines can affect the way

COMBIVENT works.

In particular, tell your doctor or pharmacist if

you are taking any of the following medicines:

Steroid medicines such as prednisolone

Water tablets (also called ‘diuretics’)

Medicines for depression

Medicines to help your breathing

Medicines called ‘anti-cholinergics’. These

can be used to treat colic pain, Parkinson’s

Disease, problems passing water or lack of

control of your bladder or bowels

Medicines called ‘beta blockers’ such as

propanolol. These can be used to treat heart

problems, high blood pressure, anxiety or

migraine

Medicines called ‘beta mimetics’ such as

fenoterol for breathing problems

Digoxin - used for a fast heart beat or heart

failure

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

using COMBIVENT.

Operations

Some gases used in operations (anaesthetic

gases) may affect how your medicine works. If

you are about to have surgery, make sure you

mention that you are taking COMBIVENT to the

doctor, dentist or anaesthetist.

Tests

If you have to provide an urine sample as part

of a routine sport drug test, tell the person

giving the test that you are taking this medicine.

This is because COMBIVENT contains

salbutamol and this may lead to a positive

result.

Pregnancy and breast-feeding

Do not use COMBIVENT if you are pregnant,

likely to get pregnant or are breast-feeding.

Driving and using machines

You may feel dizzy, or have difficulty in

focusing, or blurred vision whilst taking

COMBIVENT. If this happens do not drive or use

tools or machines.

3. HOW TO USE COMBIVENT UDVs

Always use COMBIVENT exactly as your

doctor has told you. You should check with your

doctor or pharmacist if you are not sure. Follow

these instructions to get the best results. If

anything is unclear after reading this leaflet, ask

your doctor, pharmacist or practice nurse.

How many dose units

The usual dose is the contents of 1 single dose

unit, three or four times a day for:

Adults (including the elderly) and children over

12 years.

COMBIVENT is not recommended for

children under 12 years.

Do not swallow or give this medicine by

injection.

Do not use more than your doctor has told you

See your doctor straight away if:

You feel that your medicine is not working as

well as usual

You need to use the nebuliser more than your

doctor has recommended

Your doctor may need to check how well

your medicine is working.

In some cases your doctor may need to change

your medicine.

How to use your nebuliser

Read through numbers 1 to 6 first, before

starting to use your nebuliser.

1. Get your nebuliser ready by following the

manufacturer’s instructions. Ask your doctor

if you are not sure how to use it.

2.

Open the pouch and remove the

strip of unit dose vials

Carefully separate a new dose

unit from the strip

Do not use if it is already

open or if the liquid inside is

discoloured

3. Twist off the top

Always hold it upright while

you do this

4.

Squeeze all the contents of the

dose unit into the nebuliser

chamber

Your doctor will tell you if you

need to use a different amount

If your doctor has told you

that your medicine needs to

be diluted, you will be given

‘sterile sodium chloride 0.9%’

solution. Your doctor will tell

you how to do this

5. Use your nebuliser as directed by your doctor.

6. After you have finished, dispose of any

leftover medicine carefully

Follow the manufacturer’s instructions

on how to clean your nebuliser

It is important to keep your nebuliser

clean

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours

or lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at

any other time, talk to your doctor for advice.

If you use more COMBIVENT than you should

If you use more of this medicine than you should,

talk to a doctor or go to a hospital straight away.

If you forget to take COMBIVENT

If you forget a dose, take it as soon as you

remember it

However, if it is time for the next dose, skip

the missed dose

Do not take a double dose to make up for a

forgotten dose

If you have any further questions, ask your

doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, COMBIVENT can cause side

effects, although not everybody gets them.

Tell your doctor straight away if you notice any

of the following serious side effects - you may

need urgent medical treatment:

If after taking COMBIVENT you are wheezy or

have other difficulties in breathing, do not take

any more (unless you have been told to by

your doctor)

Allergic reactions - the signs may include skin

rash, itching and nettle rash. In severe cases

the signs include swelling of your tongue, lips

and face, sudden difficulties in breathing and

a fall in your blood pressure that may cause

dizziness.

See your doctor straight away if you have any of

these side effects.

The following side effect can also happen but

the frequency of this is not known:

A condition known as lactic acidosis which

may cause stomach pain, hyperventilation,

shortness of breath even though there may be

improvement in your wheezing, cold feet and

hands, irregular heartbeat or thirst.

The side effects described below have been

experienced by people taking COMBIVENT.

Uncommon (affects less than 1 in 100 people)

Feeling nervous, shaky or dizzy

Dry mouth

Cough, headache

Feeling sick (nausea)

Throat irritation

Increase in blood pressure

Increased heart rate or uneven heart beats

(palpitations)

Voice problems (‘dysphonia’)

Skin reactions

Rare (affects less than 1 in 1,000 people)

Irregular heart beat

Regular but abnormally fast heart rate

(supraventricular tachycardia)

Chest pain (due to heart problems such as

angina). Tell your doctor or pharmacist if this

occurs but do not stop taking this medicine

unless told to do so

Blurred vision, dilated pupils, glaucoma,

painful, stinging, or red eyes, swelling of the

eyes, see colours or lights

Increased sweating

Unexpected tightening of the chest

immediately after inhaling the medicine

Dry throat, swelling of the throat

Difficulty in breathing or speaking due to a

brief spasm of your vocal muscles

Diarrhoea, constipation, being sick (vomiting)

or other problems with your digestive system

Inflammation of the mouth

Muscle cramps, muscle weakness and pain

Difficulty in passing water (urine)

Feeling weak

Fall in blood pressure

Mood changes

You may also get unusually low levels of

potassium in your blood (called ‘hypokalemia’).

If this happens, your doctor will keep checking

your potassium levels.

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours or

lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at any

other time, talk to your doctor for advice.

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 COMBIVENT UDVs

Do not use this medicine after the expiry date

which is stated on the carton and the vial label.

The expiry date refers to the last day of the

month.

Store below 25°C. Do not freeze. Do not use if

the liquid is discoloured.

Keep vials in the outer carton in order to protect

from light.

Keep out of the sight and reach of children.

6. FURTHER INFORMATION

What COMBIVENT contains

COMBIVENT UDVs contain a nebuliser solution.

Each single dose unit contains ipratropium

bromide 500 micrograms and salbutamol

2.5 mg (as sulfate) in 2.5 ml of aqueous

solution.

The other ingredients are: sodium chloride, (1N)

hydrochloric acid and purified water.

What COMBIVENT looks like and contents of

the pack

Your medicine should be used with a nebuliser.

This changes COMBIVENT into a mist for you to

breathe in. COMBIVENT UDVs are available in

packs of 60 units.

Marketing Authorisation Holder and

Manufacturer

The Marketing Authorisation for

COMBIVENT UDVs is held by:

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell, Berks.,

RG12 8YS, United Kingdom.

COMBIVENT UDVs are manufactured by:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez - CS 28028

80084 Amiens Cedex 2

France

This leaflet was revised in January 2018.

© Boehringer Ingelheim Ltd 2018

ABCD

Combivent

UDVs

(ipratropium bromide and salbutamol sulfate)

65NOT1070/F

File information

Issue date of TD:

PPM SKU:

PPM SKU version:

Issue date of artwork:

Print colors:

PAN BLACK

19/JAN/2018

P014293

28/DEC/2017

Yes

Yes

No

Yes

No

Yes

No

Yes

No

No

Yes

Yes

TD

Printfile

Mandatory in

Mat. No. Pack. Site:

Min. font size:

65NOT1070/F

8.5pt

Legend case version:

Perigord No: 442302 p2

V4.0 01/OCT/2012 (please do not change or remove it)

a = Batch No.

Bottle pack :

b = Expiry date

4010/3-8-9-11

c = Manufacturing date

External dimension :

Weight and quality :

d = Price/Sample/Clinic

560 x 200 mm

40 g/m² - papier velin

35 x 200 mm (6 foldings)

Technical colors

Dimension of the leaflet after folding :

BI-Diecut-Legendcase

Free area

Gluepoints

Technical information

Additional information

MESSAGE TO OUR SUPPLIER :

Page 1 is always the front side. The text direction can be in landscape or portrait.

The folded leaflet will always be deliver with the 2 barcodes outside (front side

outside)

No gluepoint

direction of travel

Package leaflet: Information for the user

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, pharmacist or practice nurse.

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 of the side effects gets troublesome

or serious, or if you notice any side effects not

listed in this leaflet, please tell your doctor or

pharmacist.

In this leaflet:

1. What COMBIVENT UDVs is and what it is

used for

2. Before you use COMBIVENT UDVs

3. How to use COMBIVENT UDVs

4. Possible side effects

5. How to store COMBIVENT UDVs

6. Further information

1. WHAT COMBIVENT UDVs IS AND WHAT IT IS

USED FOR

The name of your medicine is COMBIVENT

UDVs. You use it with a device called a

‘nebuliser’. This changes your medicine into a

mist for you to breathe in. COMBIVENT contains

two different medicines called:

Ipratropium bromide and

Salbutamol sulfate

Both belong to a group of medicines called

bronchodilators. They are used to make

breathing easier in an illness called ‘chronic

obstructive pulmonary disease’ or COPD. They

work by opening up your airways.

2. BEFORE YOU USE COMBIVENT UDVs

Do not use COMBIVENT if:

You are allergic (hypersensitive) to ipratropium

or salbutamol or any of the other ingredients

in COMBIVENT. (Listed in section 6: Further

information)

You are allergic to similar medicines which

contain atropine or medicines like atropine

You have a heart problem called ‘hypertrophic

obstructive cardiomyopathy’.

This is where the wall between the two sides of

the heart gets bigger and blocks the blood flow

You have a very fast heart beat (called

‘tachyarrythmia’)

You are pregnant, likely to get pregnant or are

breast-feeding

Do not use if any of the above apply to you.

If you are not sure, talk to your doctor or

pharmacist before using COMBIVENT.

Take special care with COMBIVENT

A condition known as lactic acidosis has been

reported in association with high therapeutic

doses of salbutamol, mainly in patients being

treated for an acute bronchospasm (see Section

3 and 4). Increase in lactate levels may lead to

shortness of breath and hyperventilation even

though there may be improvement in your

wheezing. If you feel that your medicine is not

working as well as usual and you need to use

the nebuliser more than your doctor has

recommended, immediately talk to a doctor.

Check with your doctor or pharmacist before

using this medicine if:

You have glaucoma, or have been told that you

may develop it

You have heart or circulation problems, or

have had a recent heart attack

You have diabetes

You have an over-active thyroid gland

You have problems passing water (urine)

You are a man who has prostate problems

You have cystic fibrosis

You have ever had something called

‘pheochromocytoma’. This is a rare tumour

which is not malignant. Using your inhaler

can make the symptoms of this worse

If you are not sure if any of these apply to you,

talk to your doctor or pharmacist before using

COMBIVENT.

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. This includes herbal

medicines. This is because COMBIVENT can

affect the way some other medicines work. Also

some other medicines can affect the way

COMBIVENT works.

In particular, tell your doctor or pharmacist if

you are taking any of the following medicines:

Steroid medicines such as prednisolone

Water tablets (also called ‘diuretics’)

Medicines for depression

Medicines to help your breathing

Medicines called ‘anti-cholinergics’. These

can be used to treat colic pain, Parkinson’s

Disease, problems passing water or lack of

control of your bladder or bowels

Medicines called ‘beta blockers’ such as

propanolol. These can be used to treat heart

problems, high blood pressure, anxiety or

migraine

Medicines called ‘beta mimetics’ such as

fenoterol for breathing problems

Digoxin - used for a fast heart beat or heart

failure

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

using COMBIVENT.

Operations

Some gases used in operations (anaesthetic

gases) may affect how your medicine works. If

you are about to have surgery, make sure you

mention that you are taking COMBIVENT to the

doctor, dentist or anaesthetist.

Tests

If you have to provide an urine sample as part

of a routine sport drug test, tell the person

giving the test that you are taking this medicine.

This is because COMBIVENT contains

salbutamol and this may lead to a positive

result.

Pregnancy and breast-feeding

Do not use COMBIVENT if you are pregnant,

likely to get pregnant or are breast-feeding.

Driving and using machines

You may feel dizzy, or have difficulty in

focusing, or blurred vision whilst taking

COMBIVENT. If this happens do not drive or use

tools or machines.

3. HOW TO USE COMBIVENT UDVs

Always use COMBIVENT exactly as your

doctor has told you. You should check with your

doctor or pharmacist if you are not sure. Follow

these instructions to get the best results. If

anything is unclear after reading this leaflet, ask

your doctor, pharmacist or practice nurse.

How many dose units

The usual dose is the contents of 1 single dose

unit, three or four times a day for:

Adults (including the elderly) and children over

12 years.

COMBIVENT is not recommended for

children under 12 years.

Do not swallow or give this medicine by

injection.

Do not use more than your doctor has told you

See your doctor straight away if:

You feel that your medicine is not working as

well as usual

You need to use the nebuliser more than your

doctor has recommended

Your doctor may need to check how well

your medicine is working.

In some cases your doctor may need to change

your medicine.

How to use your nebuliser

Read through numbers 1 to 6 first, before

starting to use your nebuliser.

1. Get your nebuliser ready by following the

manufacturer’s instructions. Ask your doctor

if you are not sure how to use it.

2.

Open the pouch and remove the

strip of unit dose vials

Carefully separate a new dose

unit from the strip

Do not use if it is already

open or if the liquid inside is

discoloured

3. Twist off the top

Always hold it upright while

you do this

4.

Squeeze all the contents of the

dose unit into the nebuliser

chamber

Your doctor will tell you if you

need to use a different amount

If your doctor has told you

that your medicine needs to

be diluted, you will be given

‘sterile sodium chloride 0.9%’

solution. Your doctor will tell

you how to do this

5. Use your nebuliser as directed by your doctor.

6. After you have finished, dispose of any

leftover medicine carefully

Follow the manufacturer’s instructions

on how to clean your nebuliser

It is important to keep your nebuliser

clean

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours

or lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at

any other time, talk to your doctor for advice.

If you use more COMBIVENT than you should

If you use more of this medicine than you should,

talk to a doctor or go to a hospital straight away.

If you forget to take COMBIVENT

If you forget a dose, take it as soon as you

remember it

However, if it is time for the next dose, skip

the missed dose

Do not take a double dose to make up for a

forgotten dose

If you have any further questions, ask your

doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, COMBIVENT can cause side

effects, although not everybody gets them.

Tell your doctor straight away if you notice any

of the following serious side effects - you may

need urgent medical treatment:

If after taking COMBIVENT you are wheezy or

have other difficulties in breathing, do not take

any more (unless you have been told to by

your doctor)

Allergic reactions - the signs may include skin

rash, itching and nettle rash. In severe cases

the signs include swelling of your tongue, lips

and face, sudden difficulties in breathing and

a fall in your blood pressure that may cause

dizziness.

See your doctor straight away if you have any of

these side effects.

The following side effect can also happen but

the frequency of this is not known:

A condition known as lactic acidosis which

may cause stomach pain, hyperventilation,

shortness of breath even though there may be

improvement in your wheezing, cold feet and

hands, irregular heartbeat or thirst.

The side effects described below have been

experienced by people taking COMBIVENT.

Uncommon (affects less than 1 in 100 people)

Feeling nervous, shaky or dizzy

Dry mouth

Cough, headache

Feeling sick (nausea)

Throat irritation

Increase in blood pressure

Increased heart rate or uneven heart beats

(palpitations)

Voice problems (‘dysphonia’)

Skin reactions

Rare (affects less than 1 in 1,000 people)

Irregular heart beat

Regular but abnormally fast heart rate

(supraventricular tachycardia)

Chest pain (due to heart problems such as

angina). Tell your doctor or pharmacist if this

occurs but do not stop taking this medicine

unless told to do so

Blurred vision, dilated pupils, glaucoma,

painful, stinging, or red eyes, swelling of the

eyes, see colours or lights

Increased sweating

Unexpected tightening of the chest

immediately after inhaling the medicine

Dry throat, swelling of the throat

Difficulty in breathing or speaking due to a

brief spasm of your vocal muscles

Diarrhoea, constipation, being sick (vomiting)

or other problems with your digestive system

Inflammation of the mouth

Muscle cramps, muscle weakness and pain

Difficulty in passing water (urine)

Feeling weak

Fall in blood pressure

Mood changes

You may also get unusually low levels of

potassium in your blood (called ‘hypokalemia’).

If this happens, your doctor will keep checking

your potassium levels.

If any of the liquid or mist accidentally gets into

your eyes you may get painful, stinging or red

eyes, dilated pupils, blurred vision, see colours or

lights. If this happens, talk to your doctor for

advice. If you get problems with your eyes at any

other time, talk to your doctor for advice.

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 COMBIVENT UDVs

Do not use this medicine after the expiry date

which is stated on the carton and the vial label.

The expiry date refers to the last day of the

month.

Store below 25°C. Do not freeze. Do not use if

the liquid is discoloured.

Keep vials in the outer carton in order to protect

from light.

Keep out of the sight and reach of children.

6. FURTHER INFORMATION

What COMBIVENT contains

COMBIVENT UDVs contain a nebuliser solution.

Each single dose unit contains ipratropium

bromide 500 micrograms and salbutamol

2.5 mg (as sulfate) in 2.5 ml of aqueous

solution.

The other ingredients are: sodium chloride, (1N)

hydrochloric acid and purified water.

What COMBIVENT looks like and contents of

the pack

Your medicine should be used with a nebuliser.

This changes COMBIVENT into a mist for you to

breathe in. COMBIVENT UDVs are available in

packs of 60 units.

Marketing Authorisation Holder and

Manufacturer

The Marketing Authorisation for

COMBIVENT UDVs is held by:

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell, Berks.,

RG12 8YS, United Kingdom.

COMBIVENT UDVs are manufactured by:

Laboratoire Unither

Espace Industriel Nord

151 rue André Durouchez - CS 28028

80084 Amiens Cedex 2

France

This leaflet was revised in January 2018.

© Boehringer Ingelheim Ltd 2018

ABCD

Combivent

UDVs

(ipratropium bromide and salbutamol sulfate)

65NOT1070/F

File information

Issue date of TD:

PPM SKU:

PPM SKU version:

Issue date of artwork:

Print colors:

PAN BLACK

19/JAN/2018

P014293

28/DEC/2017

Yes

Yes

No

Yes

No

Yes

No

Yes

No

No

Yes

Yes

TD

Printfile

Mandatory in

Mat. No. Pack. Site:

Min. font size:

65NOT1070/F

8.5pt

Legend case version:

Perigord No: 442302 p2

V4.0 01/OCT/2012 (please do not change or remove it)

a = Batch No.

Bottle pack :

b = Expiry date

4010/3-8-9-11

c = Manufacturing date

External dimension :

Weight and quality :

d = Price/Sample/Clinic

560 x 200 mm

40 g/m² - papier velin

35 x 200 mm (6 foldings)

Technical colors

Dimension of the leaflet after folding :

BI-Diecut-Legendcase

Free area

Gluepoints

Technical information

Additional information

MESSAGE TO OUR SUPPLIER :

Page 1 is always the front side. The text direction can be in landscape or portrait.

The folded leaflet will always be deliver with the 2 barcodes outside (front side

outside)

No gluepoint

direction of travel