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GLYCERYL TRINITRATE 4MG/G RECTAL OINTMENT

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

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Package Leaflet: Information for the User

Rectogesic® 4 mg/g Rectal Ointment
(glyceryl trinitrate)
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.
• The name of your medicine is Rectogesic 4 mg/g Rectal Ointment but
it will be referred to as Rectogesic throughout the remainder of this
leaflet.
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.

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.

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.

Pregnancy and breast-feeding
You should not use Rectogesic during pregnancy or when breastfeeding.
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.
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 store above 25oC.
Do not freeze.
Keep the tube tightly closed.
Once opened use up the ointment within 8 weeks.
Do not use your medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information

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 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.

What Rectogesic contains
One gram of rectal ointment contains 4 mg glyceryl trinitrate (GTN).
The recommended dose of 375 mg of this formulation contains
approximately 1.5 mg GTN.
The other ingredients are propylene glycol, lanolin, sorbitan sesquioleate,
hard paraffin and white soft paraffin.
What Rectogesic looks like and contents of the pack
Rectogesic is an off-white smooth opaque ointment which comes in
tubes of 30 g.
Manufactured by
PHARBIL Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0712
POM
Leaflet dated 26th May 2016
Leaflet coded xxxxxxxxxxxx
Rectogesic® is a registered trademark of Strakan International Limited.

Package Leaflet: Information for the User

Glyceryl Trinitrate 4 mg/g Rectal Ointment
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.
• The name of your medicine is Glyceryl Trinitrate 4 mg/g Rectal
Ointment but it will be referred to as Glyceryl Trinitrate throughout the
remainder of this leaflet.
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 breastfeeding.
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.
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.

5. How to store Glyceryl Trinitrate







Keep out of the sight and reach of children.
Do not store above 25oC.
Do not freeze.
Keep the tube tightly closed.
Once opened use up the ointment within 8 weeks.
Do not use your medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information

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 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.

What Glyceryl Trinitrate contains
One gram of rectal ointment contains 4 mg glyceryl trinitrate (GTN).
The recommended dose of 375 mg of this formulation contains
approximately 1.5 mg GTN.
The other ingredients are propylene glycol, lanolin, sorbitan sesquioleate,
hard paraffin and white soft paraffin.
What Glyceryl Trinitrate looks like and contents of the pack
Glyceryl Trinitrate is an off-white smooth opaque ointment which comes
in tubes of 30 g.
Manufactured by
PHARBIL Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd.
PL: 33532/0712
POM
Leaflet dated 26th May 2016
Leaflet coded xxxxxxxxxxxx

Expand Transcript

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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