Rectogesic

Rectogesic is a medicine used for the treatment of tears in the anus or back passage called anal fissures. These tears are typically caused when someone attempts to pass a hard stool when they are suffering from constipation. Usually, the tear can be quite painful, and may also bleed which leads to further discomfort for the patient. The tear in some cases can be caused by a tightening in the muscles around the anus. These spasms can happen because of pain and other issues. When the spasms happen, the blood supply to the anus is restricted, which might slow the healing process and prevent the anus from healing properly. In most cases, when a doctor attempts to treat anal fissures, they will provide you with solutions that are intended to resolve or prevent constipation. This is because there are many problems that can occur as a result of attempting to pass large and hard stools. In most cases, like any cut or injury, an anal fissure will actually heal by itself within a few weeks. However, in some cases, the issue can be ongoing. This can lead to chronic conditions.

• Used to treat anal fissures
• Rectal ointment with painkilling effect
• Not to be used while pregnant or breastfeeding

Rectogesic contains the active substance glyceryl trinitrate. The ointment helps relieve pain caused by anal fissures (a tear in the skin lining in the anal canal). Anal fissures can be caused by various factors, including constipation, and are very painful.

Rectogesic reduces the anal pressure and increases the blood flow, thereby reducing pain.

The ointment should be applied every 12 hours to the anal canal. A finger covering, such as cling film or a finger cot, may be placed on the finger to be used to apply the ointment. 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. 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 eight weeks. If your anal pain does not get better after using Rectogesic you should talk to your doctor again.

Do not use the ointment after eight weeks of opening.

Alcohol/driving

Be careful about drinking alcohol as the ointment may affect you more than usual.

No studies on the effect on the ability to drive and use machines have been performed with Rectogesic. 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.

If you use more than you should/forget to use Rectogesic

If you have used more ointment than you should, you may feel dizzy and light-headed. You may also have fast heartbeats 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, apply the next dose at the usual time. Do not use a double dose to make up for a forgotten dose.

Rectogesic is not suitable for everyone. Do not use this medicine if:

• You are allergic to glyceryl trinitrate or to similar medicines.
• You are allergic to any of the other ingredients in the product (see section ‘What Rectogesic contains').
• You have low blood pressure.
• You suffer from heart or blood vessel disorders.
• You suffer from closedangle glaucoma – a condition where pressure inside the eye rises rapidly causing loss of vision.
• You suffer from migraine or recurrent headaches.
• 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).
• You suffer from anaemia (low iron content in your blood).
• 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 antidepressants), acetylcysteine or alteplase.

When should this medicine be used with caution?

Take special care with Rectogesic:

• If you have a 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.

Pregnancy and breastfeeding

Do not use Rectogesic if you are pregnant or breastfeeding.

Other medicines and Rectogesic

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, herbal medicines or other natural products.

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

• Medicines for depression (tricyclic antidepressants).
• 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 nonsteroidal anti-inflammatory drugs (certain types of painkillers) might alter the therapeutic effect of Rectogesic.

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.
• Faster than normal heartbeat, palpitations.

For a complete list of possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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.