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RECTOGESIC 4MG/G RECTAL OINTMENT

Active substance(s): GLYCERYL TRINITRATE 10% IN PROPYLENE GLYCOL

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Ref: LTT124/100516/1/F

®

Rectogesic 4mg/g Rectal Ointment
(glyceryl trinitrate)
Patient Information Leaflet
Read all of this leaflet carefully before you start using 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 for you only. Do not pass it on to
others. It may harm them even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
side effects not listed in this leaflet. See section 4.
Your medicine is called Rectogesic 4mg/g Rectal Ointment, throughout the
rest of this leaflet it will be referred to as Rectogesic.
What is in this leaflet
1

What Rectogesic is and what it is used for

2

What you need to know before you use Rectogesic

3

How to use Rectogesic

4

Possible side effects

5

How to store Rectogesic

6

Contents of the pack and other information

1

What Rectogesic is and what it is used for

Rectogesic is a rectal ointment which contains the active substance glyceryl
trinitrate. Glyceryl trinitrate belongs to a group of medicines called organic
nitrates.
The ointment will help to relieve the symptom of pain caused by chronic anal
fissures. An anal fissure is a tear in the skin lining the anal canal. Topical
application of glyceryl trinitrate to the anal canal reduces the anal pressure
and increases the blood flow, thereby reducing pain.

2

What you need to know before you use Rectogesic

Do not use Rectogesic:
* if you are allergic to glyceryl trinitrate or to similar medicines
* if you are allergic to any of the other ingredients in the product (listed in
section 6)
* if you suffer from low blood pressure
* if you suffer from heart or blood vessel disorders
* if you suffer from closed-angle glaucoma – a condition where pressure
inside the eye rises rapidly causing loss of vision
* if you suffer from migraine or recurrent headaches
* if you suffer from increased intracranial pressure or high pressure within
your skull (e.g. head injury or cerebral haemorrhage - bleeding from a
ruptured blood vessel in the brain that can be fatal without prompt medical
treatment. Cerebral haemorrhage is commonly referred to as a type
of stroke) or inadequate cerebral circulation (low volume of blood
circulation within your brain)
* if you suffer from anaemia (low iron content in your blood)
* if you are taking any of the following medicines for erectile dysfunction
such as sildenafil citrate, tadalafil, vardenafil; medicines for angina or heart
pain such as glyceryl trinitrate (GTN), isosorbide dinitrate, amyl or butyl
nitrite; medicines for high blood pressure or depression (tricyclic
anti-depressants), acetylcysteine or alteplase
Take special care with Rectogesic:
* if you suffer from liver or kidney disease
* if you are to be given heparin, close monitoring of your blood will be
required as your dose of heparin may need to be altered. Please discuss
with your doctor before stopping Rectogesic
* if you also have haemorrhoids (piles) and notice more bleeding than usual,
you should stop using Rectogesic and discuss this with your doctor
* if you get severe headaches when using Rectogesic, please tell your
doctor. Your doctor will decide if you need to use a different amount of
Rectogesic, or stop using it completely.
Rectogesic may lower your blood pressure. When getting up from a lying or
sitting position, you should get up slowly, otherwise you might feel faint. Your
blood pressure is more likely to be lowered if you drink alcohol whilst you are
using Rectogesic..

Children and adolescents
Rectogesic is not suitable for children and adolescents under the age of 18
years because it has not been assessed in people in this age group.
Other medicines and Rectogesic
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines including medicines obtained without a prescription.
The following medicines may increase the blood pressure lowering effect of
Rectogesic
* Medicines for depression (tricyclic anti-depressants)
* Medicines for erectile dysfunction (male impotence) (sildenafil citrate,
tadalafil, vardenafil)
* Medicines for high blood pressure
* Diuretics ("water tablets")
* Commonly used tranquillizers
* Medicines used to treat heart problems (isosorbide dinitrate and amyl or
butyl-nitrite)
Other Medicines
* Acetylcysteine may increase the effect of Rectogesic on blood flow
* The effect of heparin (used to control blood clotting) may be decreased
when used with Rectogesic
* The effect of alteplase (used to treat heart problems) may be decreased
when given at the same time as Rectogesic
* Taking Rectogesic with dihydroergotamine (used to treat migraine) may
increase the action of dihydroergotamine and lead to coronary
vasoconstriction (narrowing of blood vessels in the heart causing slower
blood flow)
* Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs
(certain types of painkillers) might alter the therapeutic effect of Rectogesic
Rectogesic with alcohol
Be careful about drinking alcohol as the ointment may affect you more than
usual.
Pregnancy and breast-feeding
You should not use Rectogesic during pregnancy or when breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine when
pregnant or breast feeding.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been
performed with Rectogesic 4 mg/g Rectal Ointment. If you feel dizzy, sleepy
or have blurred vision when you start to use the ointment, do not drive or
work machinery until these effects have worn off.
Rectogesic contains lanolin and propylene glycol
This medicinal product contains lanolin (wool fat) which may cause a skin
reaction (e.g. contact dermatitis). The product also contains propylene glycol
which may cause skin irritation.

3

How to use Rectogesic

Method of Administration
Rectogesic 4 mg/g Rectal Ointment is for Rectal Use.
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. The recommended dose is
approximately 375 mg of ointment (approximately 1.5 mg glyceryl trinitrate)
applied to the anal canal every 12 hours.
A finger covering, such as cling film or a finger cot, may be placed on the
finger to be used to apply the ointment. Finger cots can be obtained from
your local pharmacy or surgical supplies retailer, or cling film from your local
store. The covered finger is placed alongside the 2.5 cm dosing line, which
is provided on the outside carton, and a strip of ointment the length of the
line is expressed onto the end of finger by gently squeezing the tube. Gently
insert the ointment into the anal canal using the finger. The finger with the
ointment must be inserted to the first finger joint (approximately 1 cm) into
the anus.
Apply the ointment every twelve hours as directed by your doctor and do not
exceed the dose. Wash hands after use and dispose of the finger cot or
plastic wrap (not down the toilet).
Treatment may be continued until the pain goes away, or for up to a
maximum 8 weeks. If your anal pain does not get better after using
Rectogesic you should talk to your doctor again to check that something
else is not causing the pain.

Ref: LTT124/100516/1/B

®

Rectogesic 4mg/g Rectal Ointment
(glyceryl trinitrate)
Patient Information Leaflet (continued)
If you use more Rectogesic than you should
If you may have used more ointment than you should you may feel dizzy
and light-headed. You may also have fast heart beats or palpitations. If you
feel these symptoms wipe away any extra ointment and then talk to your
doctor or pharmacist immediately.
If you forget to apply Rectogesic
Do not use a double dose to make up for a forgotten dose. Apply the next
dose at the usual time.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

5

How to store Rectogesic

Keep out of the sight and reach of children.
Do not use Rectogesic after the expiry date which is stated on the label and
carton after ‘Exp.’ The expiry date refers to the last day of that month.

* Do not store above 25°C.
* Do not freeze
* Keep the tube tightly closed
* Once opened use up the ointment within 8 weeks.
* If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious side effects:
* Anaphylactoid reaction (allergic reaction, potentially fatal with face, lip,
tongue or throat swelling, difficulty breathing, shortness of breath or
collapse). If you experience any of these symptoms stop using the
ointment and seek medical attention immediately.
* Allergic skin reactions (potentially severe). If you have an allergic skin
reaction stop using the ointment and seek medical attention.
Other Side Effects:
Very Common (may affect more than 1 in 10 people)
* Headaches, which may be severe. If you develop a headache as a side
effect, wipe off any ointment. If the headaches are unpleasant, you may
need to ask your doctor whether you should stop using the medicine.
Common (may affect up to 1 in 10 people)
* Dizziness
* Nausea
Uncommon (may affect up to 1 in 100 people)
* Diarrhoea
* Vomiting
* Rectal bleeding, rectal disorder
* Anal discomfort, itching or burning of the anal canal
* Fast heart beat or palpitations
Rare (may affect up to 1 in 1,000 people)
* Faintness on standing up
Side effects of unknown frequency (frequency cannot be estimated
from the available data)
* Light-headedness, fainting
* Low blood pressure
* Irritation, rash or pain at area of application
Other known side effects associated with glyceryl trinitrate products
(frequency unknown)
* Flushing
* Unstable angina (chest pain)
* High blood pressure on stopping treatment
* Methaemoglobinaemia (symptoms are blue/purple colouration of the skin
and shortness of breath)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via:
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

* Medicines should not be disposed of via waste water or household waste.

Ask your pharmacist how to dispose of medicines you no longer require or
medicines that have expired. These measures will help to protect the
environment.

6

Contents of the pack and other information

What this medicine contains:
One gram of rectal ointment contains 4 mg of glyceryl trinitrate (GTN).
The recommended dose of 375 mg of this formulation contains
approximately 1.5 mg GTN.
The other ingredients are: white soft paraffin, lanolin, propylene glycol, hard
paraffin and sorbitan sesquioleate.
What this medicine looks like and contents of the pack
Rectogesic is an off-white smooth opaque ointment formulation.
It comes in a 30g tube.
Manufacturer and Licence Holder
This medicine is manufactured by PHARBIL Waltrop GmbH, Im Wirrigen 25,
45731 Waltrop, Germany and is procured from within the EU. Product
Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 33723/0124

Rectogesic is a registered trademark of Strakan International Limited.
Revision date: 10/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT124/100516/2/F

Glyceryl Trinitrate 4mg/g Rectal Ointment
Patient Information Leaflet
Read all of this leaflet carefully before you start using 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 for you only. Do not pass it on to
others. It may harm them even if their signs of illness are the same as
yours.
* If you get any side effects, talk to your doctor or pharmacist. This includes
side effects not listed in this leaflet. See section 4.
Your medicine is called Glyceryl Trinitrate 4mg/g Rectal Ointment, throughout the rest of this leaflet it will be referred to as Glyceryl trinitrate.
What is in this leaflet
1

What Glyceryl Trinitrate is and what it is used for

2

What you need to know before you use Glyceryl Trinitrate

3

How to use Glyceryl Trinitrate

4

Possible side effects

5

How to store Glyceryl Trinitrate

6

Contents of the pack and other information

1

What Glyceryl Trinitrate is and what it is used for

Glyceryl Trinitrate is a rectal ointment which contains the active substance
glyceryl trinitrate. Glyceryl Trinitrate belongs to a group of medicines called
organic nitrates.
The ointment will help to relieve the symptom of pain caused by chronic anal
fissures. An anal fissure is a tear in the skin lining the anal canal. Topical
application of glyceryl trinitrate to the anal canal reduces the anal pressure
and increases the blood flow, thereby reducing pain.

2

What you need to know before you use Glyceryl
Trinitrate

Do not use Glyceryl Trinitrate:
* if you are allergic to glyceryl Trinitrate or to similar medicines
* if you are allergic to any of the other ingredients in the product (listed in
section 6)
* if you suffer from low blood pressure
* if you suffer from heart or blood vessel disorders
* if you suffer from closed-angle glaucoma – a condition where pressure
inside the eye rises rapidly causing loss of vision
* if you suffer from migraine or recurrent headaches
* if you suffer from increased intracranial pressure or high pressure within
your skull (e.g. head injury or cerebral haemorrhage - bleeding from a
ruptured blood vessel in the brain that can be fatal without prompt medical
treatment. Cerebral haemorrhage is commonly referred to as a type
of stroke) or inadequate cerebral circulation (low volume of blood
circulation within your brain)
* if you suffer from anaemia (low iron content in your blood)
* if you are taking any of the following medicines for erectile dysfunction
such as sildenafil citrate, tadalafil, vardenafil; medicines for angina or heart
pain such as glyceryl trinitrate (GTN), isosorbide dinitrate, amyl or butyl
nitrite; medicines for high blood pressure or depression (tricyclic
anti-depressants), acetylcysteine or alteplase
Take special care with Glyceryl Trinitrate:
* if you suffer from liver or kidney disease
* if you are to be given heparin, close monitoring of your blood will be
required as your dose of heparin may need to be altered. Please discuss
with your doctor before stopping Glyceryl Trinitrate
* if you also have haemorrhoids (piles) and notice more bleeding than usual,
you should stop using Glyceryl Trinitrate and discuss this with your doctor
* if you get severe headaches when using Glyceryl Trinitrate, please tell your
doctor. Your doctor will decide if you need to use a different amount of
Glyceryl Trinitrate, or stop using it completely.
Glyceryl Trinitrate may lower your blood pressure. When getting up from a
lying or sitting position, you should get up slowly, otherwise you might feel
faint. Your blood pressure is more likely to be lowered if you drink alcohol
whilst you are using Glyceryl Trinitrate.

Children and adolescents
Glyceryl Trinitrate is not suitable for children and adolescents under the age
of 18 years because it has not been assessed in people in this age group.
Other medicines and Glyceryl Trinitrate
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines including medicines obtained without a prescription.
The following medicines may increase the blood pressure lowering effect of
Glyceryl Trinitrate
* Medicines for depression (tricyclic anti-depressants)
* Medicines for erectile dysfunction (male impotence) (sildenafil citrate,
tadalafil, vardenafil)
* Medicines for high blood pressure
* Diuretics ("water tablets")
* Commonly used tranquillizers
* Medicines used to treat heart problems (isosorbide dinitrate and amyl or
butyl-nitrite)
Other Medicines
* Acetylcysteine may increase the effect of Glyceryl Trinitrate on blood flow
* The effect of heparin (used to control blood clotting) may be decreased
when used with Glyceryl Trinitrate
* The effect of alteplase (used to treat heart problems) may be decreased
when given at the same time as Glyceryl trinitrate
* Taking Glyceryl Trinitrate with dihydroergotamine (used to treat migraine)
may increase the action of dihydroergotamine and lead to coronary
vasoconstriction (narrowing of blood vessels in the heart causing slower
blood flow)
* Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs
(certain types of painkillers) might alter the therapeutic effect of Glyceryl
Trinitrate
Glyceryl Trinitrate with alcohol
Be careful about drinking alcohol as the ointment may affect you more than
usual.
Pregnancy and breast-feeding
You should not use Glyceryl Trinitrate during pregnancy or when
breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine when
pregnant or breast feeding.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been
performed with Glyceryl Trinitrate 4 mg/g Rectal Ointment. If you feel dizzy,
sleepy or have blurred vision when you start to use the ointment, do not
drive or work machinery until these effects have worn off.
Glyceryl Trinitrate contains lanolin and propylene glycol
This medicinal product contains lanolin (wool fat) which may cause a skin
reaction (e.g. contact dermatitis). The product also contains propylene glycol
which may cause skin irritation.

3

How to use Glyceryl Trinitrate

Method of Administration
Glyceryl Trinitrate 4 mg/g Rectal Ointment is for Rectal Use.
Always use this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. The recommended dose is
approximately 375 mg of ointment (approximately 1.5 mg glyceryl trinitrate)
applied to the anal canal every 12 hours.
A finger covering, such as cling film or a finger cot, may be placed on the
finger to be used to apply the ointment. Finger cots can be obtained from
your local pharmacy or surgical supplies retailer, or cling film from your local
store. The covered finger is placed alongside the 2.5 cm dosing line, which
is provided on the outside carton, and a strip of ointment the length of the
line is expressed onto the end of finger by gently squeezing the tube. Gently
insert the ointment into the anal canal using the finger. The finger with the
ointment must be inserted to the first finger joint (approximately 1 cm) into
the anus.
Apply the ointment every twelve hours as directed by your doctor and do not
exceed the dose. Wash hands after use and dispose of the finger cot or
plastic wrap (not down the toilet).
Treatment may be continued until the pain goes away, or for up to a
maximum 8 weeks. If your anal pain does not get better after using Glyceryl
Trinitrate you should talk to your doctor again to check that something else is
not causing the pain.

Ref: LTT124/100516/2/B

Glyceryl Trinitrate 4mg/g Rectal Ointment
Patient Information Leaflet (continued)
If you use more Glyceryl Trinitrate than you should
If you may have used more ointment than you should you may feel dizzy
and light-headed. You may also have fast heart beats or palpitations. If you
feel these symptoms wipe away any extra ointment and then talk to your
doctor or pharmacist immediately.
If you forget to apply Glyceryl Trinitrate
Do not use a double dose to make up for a forgotten dose. Apply the next
dose at the usual time.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

How to store Glyceryl trinitrate

5

Keep out of the sight and reach of children.
Do not use Glyceryl Trinitrate after the expiry date which is stated on the
label and carton after ‘Exp.’ The expiry date refers to the last day of that
month.

* Do not store above 25°C.
* Do not freeze
* Keep the tube tightly closed
* Once opened use up the ointment within 8 weeks.
* If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious side effects:
* Anaphylactoid reaction (allergic reaction, potentially fatal with face, lip,
tongue or throat swelling, difficulty breathing, shortness of breath or
collapse). If you experience any of these symptoms stop using the
ointment and seek medical attention immediately.
* Allergic skin reactions (potentially severe). If you have an allergic skin
reaction stop using the ointment and seek medical attention.
Other Side Effects:
Very Common (may affect more than 1 in 10 people)
* Headaches, which may be severe. If you develop a headache as a side
effect, wipe off any ointment. If the headaches are unpleasant, you may
need to ask your doctor whether you should stop using the medicine.
Common (may affect up to 1 in 10 people)
* Dizziness
* Nausea
Uncommon (may affect up to 1 in 100 people)
* Diarrhoea
* Vomiting
* Rectal bleeding, rectal disorder
* Anal discomfort, itching or burning of the anal canal
* Fast heart beat or palpitations
Rare (may affect up to 1 in 1,000 people)
* Faintness on standing up
Side effects of unknown frequency (frequency cannot be estimated
from the available data)
* Light-headedness, fainting
* Low blood pressure
* Irritation, rash or pain at area of application
Other known side effects associated with glyceryl trinitrate products
(frequency unknown)
* Flushing
* Unstable angina (chest pain)
* High blood pressure on stopping treatment
* Methaemoglobinaemia (symptoms are blue/purple colouration of the skin
and shortness of breath)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via:
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

* Medicines should not be disposed of via waste water or household waste.

Ask your pharmacist how to dispose of medicines you no longer require or
medicines that have expired. These measures will help to protect the
environment.

6

Contents of the pack and other information

What this medicine contains:
One gram of rectal ointment contains 4 mg of glyceryl trinitrate (GTN).
The recommended dose of 375 mg of this formulation contains
approximately 1.5 mg GTN.
The other ingredients are: white soft paraffin, lanolin, propylene glycol, hard
paraffin and sorbitan sesquioleate.
What this medicine looks like and contents of the pack
Glyceryl Trinitrate is an off-white smooth opaque ointment formulation.
It comes in a 30g tube.
Manufacturer and Licence Holder
This medicine is manufactured by PHARBIL Waltrop GmbH, Im Wirrigen 25,
45731 Waltrop, Germany and is procured from within the EU. Product
Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 33723/0124

Revision date: 10/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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