Rectogesic

Rectogesic is a rectal ointment containing the active substance glyceryl trinitrate. Glyceryl trinitrate belongs to a group of medicines called organic nitrates.

Rectogesic is used to relieve pain caused by chronic anal fissures.

An anal fissure is a tear in the skin lining the anal canal.

When applied to the anal canal, glyceryl trinitrate reduces anal pressure and increases blood flow, which helps reduce pain.

Do not use Rectogesic if you:

• Are allergic to glyceryl trinitrate or to similar medicines
• Are allergic to any of the other ingredients in the product
• Suffer from low blood pressure
• Suffer from heart or blood vessel disorders
• Suffer from closed-angle glaucoma
• Suffer from migraine or recurrent headaches
• Suffer from increased intracranial pressure or high pressure within your skull, head trauma, cerebral haemorrhage, or inadequate cerebral circulation
• Suffer from anaemia
• Are taking sildenafil citrate, tadalafil, or vardenafil
• Are taking medicines for angina or heart pain such as glyceryl trinitrate, isosorbide dinitrate, amyl nitrite or butyl nitrite
• Are taking medicines for high blood pressure or depression such as tricyclic antidepressants
• Are taking acetyl cysteine or alteplase

Take special care with Rectogesic and talk to your doctor if you:

• Suffer from liver or kidney disease
• Are to be given heparin, as close monitoring of your blood may be required and your heparin dose may need to be altered
• Also have haemorrhoids and notice more bleeding than usual
• Get severe headaches while using Rectogesic

Rectogesic may lower your blood pressure. When getting up from lying or sitting, get up slowly to reduce the risk of feeling 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 18 years.

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 such as tricyclic antidepressants
• Medicines for erectile dysfunction such as sildenafil citrate, tadalafil, vardenafil
• Medicines for high blood pressure
• Diuretics
• Commonly used tranquillizers
• Medicines used to treat heart problems such as isosorbide dinitrate and amyl or butyl nitrite

Other interactions may include:

• Acetyl cysteine may increase the effect of Rectogesic on blood flow
• The effect of heparin may be decreased when used with Rectogesic
• The effect of alteplase may be reduced when given at the same time as Rectogesic
• Taking Rectogesic with dihydroergotamine may increase the action of dihydroergotamine and lead to coronary vasoconstriction
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs might lower the therapeutic effect of Rectogesic

You should not use Rectogesic during pregnancy or when breast-feeding.

If you feel dizzy, sleepy or have blurred vision when you start to use the ointment, do not drive or use machines until these effects have worn off.

This medicine contains lanolin which may cause a skin reaction such as contact dermatitis.

This medicine also contains propylene glycol which may cause skin irritation.

Rectogesic is for rectal use.

Always use Rectogesic exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is approximately 375 mg of ointment, corresponding to 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 used to apply the ointment.

Measure a strip of ointment using the 2.5 cm dosing line provided on the outside carton, then express a strip of ointment of that length onto the end of the covered finger by gently squeezing the tube.

Gently insert the ointment into the anal canal using the finger. The finger with ointment should be inserted to the first finger joint, approximately 1 cm, into the anus.

Apply every 12 hours as directed and do not exceed the dose.

Wash hands after use and dispose of the finger cot or plastic wrap.

Treatment may be continued until the pain goes away, or for up to a maximum of 8 weeks.

If your anal pain does not get better after using Rectogesic, talk to your doctor again to check that something else is not causing the pain.

If you use more Rectogesic than you should, you may feel dizzy or light-headed and may have fast heart beats or palpitations. Wipe away any extra ointment and 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.

Like all medicines, Rectogesic can have side effects, although not everybody gets them.

Very common side effects:

• Headaches, which may be severe

If you develop a headache as a side effect, wipe off any ointment. If headaches are unpleasant, ask your doctor whether you should stop using the medicine.

Common side effects:

• Dizziness
• Faintness on standing
• Light-headedness
• Blurred vision
• Tiredness
• Nausea

Uncommon side effects, potentially severe:

• Diarrhoea
• Anal discomfort
• Vomiting
• Rectal bleeding
• Rectal disorder
• Allergic skin reactions
• Anaphylactoid reaction with swelling of face, lips, tongue or throat, difficulty breathing, shortness of breath or collapse
• Itching or burning of the anal canal
• Fast heart beat or palpitations
• Chest pain (angina)
• Flush
• Methaemoglobinaemia
• Fainting

Stop using the ointment and seek medical attention immediately if you experience symptoms of a severe allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing, shortness of breath or collapse.

Tell your doctor or pharmacist if any side effect gets serious, or if you notice any side effects not listed in the leaflet.

• Keep out of the reach and sight of children
• Do not use Rectogesic after the expiry date stated on the label and carton
• Do not store above 25°C
• Do not freeze
• Keep the tube tightly closed
• Once opened, use up the ointment within 8 weeks

This leaflet summary does not replace the official patient information leaflet supplied with the medicine. Always read the full leaflet carefully before use and consult a doctor or pharmacist if you have any questions.