This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use RECTOGESIC 4 mg/g RECTAL OINTMENT

Introduction

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 symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

What Rectogesic is and what it is used for
What you need to know before you use Rectogesic
How to use Rectogesic
Possible side effects
Storage of Rectogesic
Contents of the pack and other information

1. What Rectogesic is and what it is used for

Rectogesic is a rectal ointment that contains glyceryl trinitrate as the active ingredient. Glyceryl trinitrate belongs to a group of medicines called organic nitrates.

The ointment will help to relieve the painful symptoms caused by chronic anal fissures. An anal fissure is a tear in the skin that lines the anal canal. Topical application of glyceryl trinitrate to the anal canal reduces anal pressure and increases blood flow, which reduces the sensation of pain.

2. What you need to know before you use Rectogesic

Do not use Rectogesic:

if you are allergic to glyceryl trinitrate or other similar medicines
if you are allergic to any of the other ingredients of this medicine (listed in section 6)
if you have low blood pressure
if you have heart or blood vessel disorders
if you have closed-angle glaucoma, a condition where the pressure inside the eyes increases rapidly and causes loss of vision

if you have migraine or recurrent headaches
if you have increased intracranial pressure or high cranial pressure (e.g. head trauma or cerebral hemorrhage; a hemorrhage caused by the rupture of a blood vessel in the brain that can be fatal without immediate medical treatment. It is usually considered as a type of stroke) or inadequate cerebral circulation (low blood flow in the brain)

if you have anemia (low iron content in the blood)
if you are taking any of the following medicines: medicines for erectile dysfunction such as sildenafil citrate, tadalafil, vardenafil; medicines for angina or heart pain, such as glyceryl trinitrate (NTG), isosorbide dinitrate, amyl nitrite or butyl nitrite; medicines for high blood pressure or depression (tricyclic antidepressants), acetylcysteine or alteplase

Be careful with Rectogesic:

if you have any liver or kidney disease
if you are going to be administered heparin, your blood parameters should be closely monitored as it may be necessary to modify the heparin dose. Talk to your doctor before stopping treatment with Rectogesic

if you also have hemorrhoids (piles) and you notice more bleeding than usual, you should stop treatment with Rectogesic. Talk to your doctor about this
if you experience severe headaches when using Rectogesic, inform your doctor. The doctor will decide if you need a different amount of Rectogesic, or if it is necessary to stop treatment altogether

Rectogesic can lower blood pressure. When getting up from a lying or sitting position, you should do so slowly to avoid dizziness. It is more likely that blood pressure will drop if you drink alcohol during treatment with Rectogesic.

Children and adolescents

Rectogesic is not suitable for children and adolescents under 18 years of age as it has not been evaluated in patients in this age group.

Taking Rectogesic with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The following medicines may increase the effect of lowering blood pressure of Rectogesic.

Medicines for depression (tricyclic antidepressants)
Medicines for the treatment of erectile dysfunction (male impotence) (sildenafil citrate, tadalafil, vardenafil)
Medicines for high blood pressure
Diuretics
Common sedatives
Medicines used for the treatment of heart problems (isosorbide dinitrate and amyl nitrite or butyl nitrite)

Other medicines

Acetylcysteine may increase the effects of Rectogesic on blood flow
May decrease the effects of heparin (used to control blood clots) when used with Rectogesic
May decrease the effects of alteplase (used for the treatment of heart problems) when used simultaneously with Rectogesic
The use of Rectogesic with dihydroergotamine (used to treat migraine) may increase the effects of dihydroergotamine and cause coronary vasoconstriction (a narrowing of the blood vessels of the heart that causes slower blood circulation)
Aspirin and non-steroidal anti-inflammatory drugs (certain types of painkillers) may alter the therapeutic effect of Rectogesic

Using Rectogesic with alcohol

Be careful with alcohol consumption as the ointment may have a greater effect than usual.

Pregnancy and breastfeeding

Do not use Rectogesic during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using a medicine during pregnancy or breastfeeding.

Driving and using machines

No studies have been conducted on the ability to drive and use machines with Rectogesic 4 mg/g Rectal Ointment. If you start to feel dizzy or sleepy or have blurred vision when you start using the ointment, do not drive or operate machinery until these effects have disappeared.

Rectogesic contains lanolin and propylene glycol

This medicine contains lanolin (wool fat), which may cause local skin reactions (such as contact dermatitis). This medicine 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.

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The recommended dose is approximately 375 mg of ointment (approximately 1.5 mg of glyceryl trinitrate) applied to the anal canal every 12 hours.

The finger can be covered with a plastic film or a finger stall before applying the ointment. Finger stalls can be obtained at your local pharmacy or a surgical supply provider, and plastic film at a local store. The covered finger is placed next to the 2.5 cm dosing line, which appears on the outer packaging, and a amount of ointment equivalent to the length of the line is extracted over the end of the finger with gentle pressure on the tube. Insert the ointment gently into the anal canal with your finger. The finger with ointment should be inserted up to the first knuckle (approximately 1 cm) inside the anus.

Apply the ointment every twelve hours as instructed by your doctor and do not exceed the indicated dose. Wash your hands after each use and dispose of the finger stall or plastic film (not down the toilet drain).

Treatment may continue until the pain disappears, or for a maximum of 8 weeks. If the pain is not relieved after using Rectogesic, you should consult your doctor again to rule out another cause of the pain.

If you use more Rectogesic than you should

If you use a larger amount of ointment than indicated, you may feel dizzy or lightheaded. You may also feel a rapid heartbeat or palpitations. If you experience these symptoms, clean the excess and talk to your doctor or pharmacist immediately.

If you forget to use Rectogesic

Do not apply a double dose to make up for forgotten doses. Apply the next dose at the usual time.

If you have any other questions about 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:

Anaphylactoid reaction (potentially life-threatening allergic reaction with swelling of the face, lips, tongue or throat, difficulty breathing, shortness of breath or fainting). If you experience any of these symptoms, stop using the ointment and consult a doctor immediately.
Severe skin allergic reactions (potentially serious). If you experience any skin allergic reaction, stop using the ointment and consult a doctor immediately.

Other side effects:

Very common (may affect more than 1 in 10 people)

Headaches, which can be severe. If you start to suffer from a headache as a side effect, clean any remaining ointment. If the headaches become bothersome, consult your doctor if 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)

Diarrhea
Vomiting
Rectal bleeding, rectal disorder
Anal discomfort, itching or burning in the anal canal
Rapid heartbeat or palpitations

Rare (may affect up to 1 in 1000 people)

Dizziness when standing up

Side effects of unknown frequency (frequency cannot be estimated from the available data)

Dizziness, fainting
Low blood pressure
Irritation, rash or pain at the application site

Other side effects known to be associated with glyceryl trinitrate products (frequency unknown)

Flushing
Unstable angina (chest pain)
High blood pressure when stopping treatment
Methemoglobinemia (symptoms are bluish discoloration of the skin and shortness of breath)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month stated.

Do not store above 25°C.
Do not freeze.
Keep the tube tightly closed.

Once opened, use the ointment within the next 8 weeks.

6. Contents of the pack and other information

Composition of Rectogesic

The active ingredient is glyceryl trinitrate. One gram of rectal ointment contains 4 mg of glyceryl trinitrate. The normal dose of 375 mg of Rectogesic contains approximately 1.5 mg of glyceryl trinitrate.

The other ingredients (excipients) are: propylene glycol, lanolin, sorbitan sesquioleate, hard paraffin and white soft paraffin.

Appearance of Rectogesic and pack size

Rectogesic is a white, smooth and opaque rectal ointment that is supplied in 30 g aluminum tubes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36

28027 Madrid

Spain

Manufacturer

PHARBIL Waltrop GmbH

Im Wirrigen 25

45731 Waltrop

Germany

Date of last revision of this leaflet:May 2015

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

How much does RECTOGESIC 4 mg/g RECTAL OINTMENT cost in Spain ( 2025)?

The average price of RECTOGESIC 4 mg/g RECTAL OINTMENT in December, 2025 is around 64.46 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

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RECTOGESIC 4 mg/g RECTAL OINTMENT

Dmytro Horobets

Karim BenHarbi

Dmytro Horobets

Karim BenHarbi