Rectogesic

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rectogesic 4 mg/g Rectal Ointment

(trinitroglycerin)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Rectogesic is and what it is used for
2. What you need to know before using 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 containing glyceryl trinitrate as the active substance.
Glyceryl trinitrate belongs to a family of medicines known as organic nitrates.
The ointment helps relieve pain associated with chronic anal fissures.
An anal fissure is defined as a lesion of the mucous membrane lining the anal canal.
Topical application of glyceryl trinitrate to the anal canal area reduces anal pressure and increases blood flow, thereby reducing pain.

2. WHAT YOU NEED TO KNOW BEFORE USING RECTOGESIC

Do not use Rectogesic if:

• you are allergic to glyceryl trinitrate or to similar medicines
• you are allergic to any of the other ingredients of this medicine (listed in section 6)
• you suffer from low blood pressure
• you suffer from heart or vascular disorders
• you have closed-angle glaucoma, a condition in which pressure inside the eye rises rapidly, causing loss of vision
• you suffer from migraine or recurrent headaches
• you have increased intracranial pressure or high pressure in the head (e.g. head injury or cerebral haemorrhage – bleeding caused by rupture of a blood vessel in the brain, which can be fatal without immediate medical treatment. Cerebral haemorrhage is commonly referred to as a type of stroke) or inadequate cerebral circulation (low blood flow volume to the brain)
• you suffer from anaemia (low iron content in the blood)
• you are taking any of the following: erectile dysfunction medicines such as sildenafil citrate, tadalafil, vardenafil; medicines for angina or chest pain, such as glyceryl trinitrate (GTN), isosorbide dinitrate, amyl or butyl nitrite; medicines for high blood pressure or depression (tricyclic antidepressants), acetylcysteine, or alteplase.

Take special care with Rectogesic, especially:

• if you have liver or kidney disease
• if heparin is administered, close blood monitoring is required, as the dose of heparin may need to be adjusted. Consult your doctor before stopping treatment with Rectogesic
• if you have haemorrhoids or unusually heavy bleeding, stop using Rectogesic and consult your doctor
• if you experience a severe headache while using Rectogesic, inform your doctor, who will decide whether to adjust the dose of Rectogesic or discontinue use of the ointment completely.

Rectogesic may cause a drop in blood pressure. It is advisable to stand up slowly from a lying or sitting position, otherwise you may feel faint. If you consume alcohol during treatment with Rectogesic, you are more likely to experience a drop in blood pressure.
Children and adolescents
Rectogesic is not indicated for children and adolescents under 18 years of age, as it has not been tested in this age group.
Other medicines and Rectogesic
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
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
• Commonly used tranquillisers
• Medicines used to treat heart problems (isosorbide dinitrate, amyl or butyl nitrite) Other medicines
• Acetylcysteine may enhance the effect of Rectogesic on blood flow
• The effect of heparin (used to control blood clotting) may be reduced when used with Rectogesic
• The effect of alteplase (used to treat heart problems) may be reduced when administered together with 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 reduced blood flow)
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory medicines (some types of painkillers) may alter the therapeutic effect of Rectogesic.

Rectogesic and alcohol
Be cautious with alcohol consumption, as using the ointment may cause alcohol to have a stronger effect than usual.
Pregnancy and breastfeeding
Rectogesic must not be used during pregnancy or while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Driving and using machines
There are no studies on the effect of Rectogesic 4 mg/g rectal ointment on the ability to drive or use machinery. If, when starting treatment with the ointment, you experience dizziness, drowsiness, or blurred vision, do not drive or operate machinery until these effects have completely disappeared.
Rectogesic contains lanolin and propylene glycol
This medicine contains lanolin (wool fat) which may cause skin reactions (e.g. contact dermatitis). The 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 only.
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is approximately 375 mg of ointment (about 1.5 mg of glyceryl trinitrate) applied into the anal canal every 12 hours.
To apply the ointment, you may use a finger cover such as an adhesive film or a finger cot. Finger cots are available from pharmacies or surgical supply retailers, and adhesive film can be found at your nearest supermarket. For correct dosing, place your finger along the 2.5 cm mark indicated on the outer carton and squeeze a strip of ointment equal in length to the marked line onto the fingertip, gently pressing the tube. Gently insert the ointment into the anal canal using your finger, inserting it up 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 recommended dose. Wash your hands after use and dispose of the finger cot or adhesive film properly (not in the toilet).
Continue treatment until disappearance of pain or for a maximum of 8 weeks. If anal pain does not improve with the use of Rectogesic, consult your doctor again to rule out other possible causes.

If you use more Rectogesic than you should
If you accidentally apply more ointment than prescribed, you may experience dizziness or lightheadedness. You may also have a fast heartbeat or palpitations. If you experience these symptoms, wash off the excess ointment immediately and contact your doctor or pharmacist without delay.

If you forget to use Rectogesic
Do not apply a double dose to make up for a missed dose. Apply the next dose at the usual scheduled time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions:

• Anaphylactoid reactions (allergic reaction, potentially fatal, presenting with swelling of the face, lips, tongue or throat, difficulty breathing, shortness of breath or collapse). If you experience any of these symptoms, stop using the ointment and consult your doctor immediately.
• Allergic skin reactions (potentially severe). If you experience an allergic skin reaction, stop using the ointment and consult your doctor immediately

Other adverse reactions:
Very common (may affect more than 1 in 10 people)

• Headache, which may be severe. If you experience headache as an adverse reaction, remove the ointment. If headaches are troublesome, 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)

• Diarrhea
• Vomiting
• Rectal bleeding, rectal disorders
• Anal disorders, itching or burning of the anal canal
• Fast heartbeat or palpitations

Rare (may affect up to 1 in 1,000 people)

• Feeling faint when standing

Adverse reactions not known (frequency cannot be estimated from the available data)

• Feeling of emptiness in the head, fainting
• Low blood pressure
• Irritation, rash or pain at the application site

Other known adverse reactions associated with the use of trinitroglycerin-containing medicines (frequency not known)

• Flushing
• Unstable angina (chest pain)
• High blood pressure following treatment discontinuation
• Methaemoglobinaemia (symptoms are bluish/purple skin discoloration and shortness of breath)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 stated on the tube 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 tube tightly closed
• Once opened, use the ointment within 8 weeks.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Rectogesic contains
The active substance is glyceryl trinitrate. One gram of rectal ointment contains 4 mg of glyceryl trinitrate.
The usual dose of 375 mg of Rectogesic contains approximately 1.5 mg of glyceryl trinitrate.
The other components are: propylene glycol, lanolin, sorbitan sesquioleate, hard paraffin, and
white soft paraffin.
Description of the appearance of Rectogesic and contents of the package
Rectogesic is a whitish, homogeneous, opaque rectal ointment, supplied in 30 g aluminium tubes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Grünenthal Italia S.r.l.
Via Vittor Pisani, 16
20124 Milano
Italy
Manufacturer and Responsible Person for Batch Control and Release
PHARBIL Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany