- glyceryl trinitrate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16508/0037.
Rectogesic 4 mg/g Rectal Ointment
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rectogesic® 4 mg/g Rectal Ointment
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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:
Take special care with Rectogesic:
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
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.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Other Side Effects:
Very Common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Side effects of unknown frequency (frequency cannot be estimated from the available data)
Other known side effects associated with glyceryl trinitrate products (frequency unknown)
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:
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE RECTOGESIC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton after ‘Exp.’ The expiry date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Rectogesic contains
The active substance is glyceryl trinitrate. One gram of rectal ointment contains 4 mg glyceryl trinitrate. Approximately 1.5 mg glyceryl trinitrate is contained in the usual 375 mg dose of Rectogesic.
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 rectal ointment supplied in 30g aluminium tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised: May 2016
Galabank Business Park, Galashiels, TD1 1QH
+ 44 (0)1896 664 000