PRODUCT INFORMATION FOR THE USER

Rectogesic 4 mg/g Rectal Ointment

Glyceryl Trinitrate

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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. Storage of Rectogesic

6. Contents of the pack and additional information

RECTOGESIC is a rectal ointment that contains as its active ingredient glyceryl trinitrate. Glyceryl trinitrate belongs to a group of drugs known as organic nitrates.

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

Do not use Rectogesic:

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

• if you have migraines or recurrent headaches
• if you have increased intracranial pressure or high cranial pressure (for example, 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. Cerebral hemorrhage is often considered a type of stroke)

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

Be especially careful with Rectogesic:

• if you have liver or kidney disease
• if you are to be administered heparin, closely monitor blood parameters as it may be necessary to modify the heparin dose. Consult your doctor before interrupting treatment with Rectogesic

• if you also have hemorrhoids (piles) and observe more bleeding than usual, discontinue treatment with Rectogesic. Consult your doctor about this
• if you experience severe headaches when using Rectogesic, inform your doctor. The doctor will decide if you need a different dose of Rectogesic or if you need to discontinue treatment completely

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

Children and adolescents

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

Use of Rectogesic with other medicines

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

The following medicines may increase the effect of Rectogesic to lower blood pressure:

• Depression medicines (tricyclic antidepressants)
• Erectile dysfunction medicines (impotence) (sildenafil citrate, tadalafil, vardenafil)
• High blood pressure medicines
• Diuretics
• Frequent tranquilizers
• Medicines used to treat heart problems (isosorbide dinitrate and amylnitrite or butylnitrite)

Other medicines

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

Use of Rectogesic with alcohol

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

Pregnancy and breastfeeding

You should not use Rectogesic during pregnancy or breastfeeding.

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

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery with Rectal Cream Rectogesic 4 mg/g. If you start to feel dizzy or sleepy or have blurred vision when you start using the cream, 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.

Administration Method

Rectal Rectogesic 4 mg/g Ointment is for rectal use.

Follow exactly the administration instructions for this medication as 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 plastic film or a finger cot before applying the ointment. Finger cots can be obtained from your local pharmacy or a surgical supply provider and plastic film from a local store. The covered finger is placed next to the 2.5 cm dosing line, which appears on the outer packaging, and a quantity of ointment equivalent to the length of the line is taken from the tube with a light pressure. Insert the ointment gently into the anal canal with your finger. The finger with ointment must be inserted up to the first knuckle (approximately 1 cm) inside the anus.

Apply the ointment every 12 hours as instructed by your doctor and do not exceed the indicated dose. Wash your hands after each use and dispose of the finger cot or plastic film (not down the toilet).

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

If you use more Rectogesic than you should

If you use a quantity of ointment greater than indicated, you may feel dizzy or lightheaded. You may also feel a rapid heart rate or palpitations. If you experience these symptoms, clean off the excess and speak immediately with your doctor or pharmacist.

If you forgot to use Rectogesic

Do not apply a double dose to compensate for missed doses. Apply the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

• Anaphylactic reaction (allergic reaction, potentially fatal with swelling of the face, lips, tongue, or throat, difficulty breathing, lack of air, or lightheadedness).If you experience any of these symptoms, discontinue use of the ointment and consult a doctor immediately.
• Severe skin allergic reactions (potentially life-threatening). If you experience any skin allergic reaction,discontinue use of the ointment and consult a doctor immediately.

Other side effects:

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

• Headaches, which may become severe. If you start experiencing a headache as a side effect, clean any remaining ointment. If headaches become bothersome, consult your doctor to see if you should discontinue use of the medication.

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
• Fast heart rate 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 available data)

• Drowsiness, fainting
• Low blood pressure
• Irritation, hives, or pain at the application site

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

• Hot flashes
• Unstable angina (chest pain)
• High blood pressure when treatment is discontinued
• Methemoglobinemia (symptoms include blue or purple discoloration of the skin and lack of air)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the tube and the box after CAD. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C.
• Do not freeze.
• Keep the tube perfectly closed.

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

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

Appearance of Rectogesic and packaging size

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

Holder of the marketing authorization and Responsible for manufacturing.

Holder of the Marketing Authorization

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36

28027 Madrid

Spain

Responsible for manufacturing

PHARBIL Waltrop GmbH

Im Wirrigen 25

45731 Waltrop

Germany

Last review date of this leaflet:May 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/