Rectogesic 4mg/G Rectal Ointment
Out of date information, search anotherRectogesic 4mg/g Rectal Ointment
Ref: LTT124/190214/1/F
(glyceryl trinitrate)
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* The information in this leaflet applies only to Rectogesic 4 mg/g Rectal Ointment.
* 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Rectogesic 4mg/g Rectal Ointment, throughout the rest of this leaflet it will be referred to as Rectogesic.
In this leaflet:
[2 What Rectogesic is and what it is used for ^2 Before you use Rectogesic How to use Rectogesic Possible side effects ^2 Storing Rectogesic [2 Further information
^ 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 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
* 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 trauma 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: 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), acetyl cysteine 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.
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.
Taking Rectogesic with 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.
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
* Acetyl cysteine 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 reduced 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 lower the therapeutic effect of Rectogesic
Taking Rectogesic with food and drink
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.
Important information about some of the ingredients of Rectogesic
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.
[2 How to use Rectogesic
Method of Administration
Rectogesic 4 mg/g Rectal Ointment is for Rectal Use.
Always use Rectogesic exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual 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.
(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 forgotten individual doses. Apply the next dose at the usual time.
If you have any further questions on the use of Rectogesic, ask your doctor or pharmacist
Possible side effects
Like all medicines, Rectogesic can have side effects, although not everybody gets them. Tell your doctor if you notice any of the following:
Very Common (occur in more than 1 patient in 10)
* 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 (occur in more than 1 in 100 patients, but less than 1 in 10 patients)
* Dizziness, faintness on standing, light-headedness, blurred vision and tiredness
* Nausea
Uncommon (occur in more than 1 in 1000 patients but less than 1 in 100 patients (potentially severe)
* Diarrhoea, anal discomfort, vomiting, rectal bleeding, rectal disorder
* Allergic skin reactions (potentially severe)
* 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.
* Itching or burning of the anal canal
* Fast heart beat or palpitations
* Chest pain (angina)
* Flush
* Methaemoglobinaemia (non-functional red blood cells leading to a decrease in blood oxygen content)
* Fainting
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
& Further information
What this medicine contains:
Each gram of rectal ointment contains 40mg of glyceryl trinitrate in propylene glycol corresponding to 4mg of glyeryl trinitrate. The recommended dose of 375mg of this formulation contains apprioximately 1.5mg GTN.
Also contains propylene glycol, lanolin, sorbitan sesquioleate, hard parrafin and white soft parrafin.
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: 19/02/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
rp 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 container 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.
* 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.
Patient Information Leaflet
Read all of this leaflet carefully before you start using this medicine.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* The information in this leaflet applies only to Glyceryl Trinitrate 4 mg/g Rectal Ointment.
* 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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Glyceryl Trinitrate 4mg/g Rectal Ointment, throughout the rest of this leaflet it will be referred to as Glyceryl Trinitrate.
In this leaflet:
[2 What Glyceryl Trinitrate is and what it is used for ^2 Before you use Glyceryl Trinitrate How to use Glyceryl Trinitrate Possible side effects ^2 Storing Glyceryl Trinitrate [2 Further information
^ 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 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
* 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 trauma 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: 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), acetyl cysteine 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.
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.
Taking Glyceryl Trinitrate with 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.
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
* Acetyl cysteine 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 reduced 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 lower the therapeutic effect of Glyceryl Trinitrate
Taking Glyceryl Trinitrate with food and drink
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.
Important information about some of the ingredients of Glyceryl Trinitrate
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 Glyceryl Trinitrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual 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.
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 forgotten individual doses. Apply the next dose at the usual time.
If you have any further questions on the use of Glyceryl Trinitrate, ask your doctor or pharmacist
Possible side effects
Like all medicines, Glyceryl Trinitrate can have side effects, although not everybody gets them. Tell your doctor if you notice any of the following:
Very Common (occur in more than 1 patient in 10)
* 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 (occur in more than 1 in 100 patients, but less than 1 in 10 patients)
* Dizziness, faintness on standing, light-headedness, blurred vision and tiredness
* Nausea
Uncommon (occur in more than 1 in 1000 patients but less than 1 in 100 patients (potentially severe)
* Diarrhoea, anal discomfort, vomiting, rectal bleeding, rectal disorder
* Allergic skin reactions (potentially severe)
* 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.
* Itching or burning of the anal canal
* Fast heart beat or palpitations
* Chest pain (angina)
* Flush
* Methaemoglobinaemia (non-functional red blood cells leading to a decrease in blood oxygen content)
* Fainting
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
& Further information
What this medicine contains:
Each gram of rectal ointment contains 40mg of glyceryl trinitrate in propylene glycol corresponding to 4mg of glyeryl trinitrate. The recommended dose of 375mg of this formulation contains apprioximately 1.5mg GTN.
Also contains propylene glycol, lanolin, sorbitan sesquioleate, hard parrafin and white soft parrafin.
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: 19/02/14
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
rp How to store Glyceryl Trinitrate
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 container 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.
* 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.