RECTOGESIC 4 mg/g RECTAL OINTMENT
How to use RECTOGESIC 4 mg/g RECTAL OINTMENT
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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/
- Country of registration
- Average pharmacy price64.46 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to RECTOGESIC 4 mg/g RECTAL OINTMENTDosage form: RECTAL SEMISOLID, 0.25 mg; 8 mg; 1 mg/gActive substance: fluocinonideManufacturer: Anotaciones Farmaceuticas, S.L.Prescription not requiredDosage form: RECTAL SEMISOLID, 0.1 mg/g + 10 mg/g + 20 mg/gActive substance: other preparations, combinationsManufacturer: Lacer S.A.Prescription not requiredDosage form: RECTAL SEMISOLID, 25 mg; 5 mg; 15 mg; 10 mgActive substance: hydrocortisoneManufacturer: Laboratorios Cinfa S.A.Prescription required
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