4 mg / g rectal ointment glyceryl trinitrate
WHAT KETOGENIC IS AND WHAT IT IS USED F
Rectogesic is a rectal ointment that contains the active substance glyceryl trinitrate.
Glyceryl trinitrate belongs to a group of medicines called organic nitrates.
The ointment helps relieve the pain caused by chronic anal fissures. An anal fissure is a crack in the skin that surrounds the anal canal. The topical application of glyceryl trinitrate in the anal canal reduces anal pressure and increases blood flow, reducing pain.
WHAT YOU NEED TO KNOW BEFORE USING RECTOGESIC
Do not use Rectogesic
- if you are allergic to glyceryl trinitrate or 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 a disease of the heart or blood vessels
- if you have narrow-angle glaucoma (an eye disease in which the eye pressure rises rapidly and causes impaired vision)
- if you have migraines or recurrent headaches
- if you have increased intracranial pressure or high pressure inside the skull (eg head injury or cerebral hemorrhage – hemorrhage from a ruptured blood vessel in the brain which can lead to death if medical treatment is not started immediately. Cerebral hemorrhage generally means a type of stroke ) or insufficient blood circulation in the brain (small amount of circulating blood in the brain).
- if you have anemia (low level of iron in your blood)
- if you are taking any of the following: medicines for erectile dysfunction such as sildenafil citrate, tadalafil, vardenafil; drugs for angina (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.
Take special care with Rectogesic
- if you have liver or kidney disease
- If you are going to receive heparin, a careful check of your blood is required as the dose of heparin may need to be changed. Talk to your doctor before stopping using Rectogesic
- if you also have hemorrhoids and notice that they bleed more than usual, stop using Rectogesic and discuss this with your doctor.
- If you get severe headaches while using Rectogesic, tell your doctor. Your doctor will decide if you need to take another dose of Rectogesic or stop using it altogether.
Rectogesic may lower your blood pressure. When you get up from lying down or sitting, you have to do it slowly, otherwise, you may feel dull / about to faint. Blood pressure is more likely to drop if you drink alcohol while using Rectogesic.
Children and adolescents
Rectogesic is not suitable for children and adolescents under 18 years of age as it has not been tested in people in this age group.
Other medicines and Rectogesic
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
- antidepressants ( tricyclic antidepressants )
- drugs for erectile dysfunction (male impotence ) (sildenafil citrate, tadalafil, vardenafil)
- medicines for high blood pressure
- diuretics (“diuretic”)
- commonly used sedatives
- drugs 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 capacity) can be reduced if used at the same time as Rectogesic
- The effect of alteplase (used to treat heart problems) can be reduced if given at the same time as Rectogesic
- If you take Rectogesic together with dihydroergotamine (used to treat migraines ) the effect of dihydroergotamine may increase and lead to contraction of the coronary arteries (blood vessels in the heart constrict so that blood flow is slower)
- Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (certain types of painkillers) may alter the effect of Rectogesic
Rectogesic with alcohol
Be careful with alcohol as alcohol may increase the effect of the ointment.
Pregnancy, breastfeeding, and fertility
Do not use Rectogesic during pregnancy or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breastfeeding.
Driving and using machines
No studies on the effects of Rectogesic 4 mg / g rectal ointment on the ability to drive and use machines have been performed. If you feel dizzy, sleepy, or have blurred vision when you start using the ointment, do not drive or use machines until these effects have disappeared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rectogesic contains lanolin and propylene glycol
This medicine contains lanolin (sheep wool fat) which may cause a skin reaction (eg contact dermatitis ). The product also contains propylene glycol which can cause skin irritation.
HOW TO USE RECTOGESIC
Method of administration
Rectogesic 4 mg / g rectal ointment is intended for use in the anal canal.
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The recommended dose is about 375 mg of ointment (about 1.5 mg of glyceryl trinitrate ) which is applied to the anal canal every 12 hours.
You can put a finger guard, e.g. plastic film or a fingertip, on the finger used to apply the ointment. Fingers can be bought at the pharmacy or health care retailers, and plastic film is available in grocery stores. The covered finger is placed along the 2.5 cm long dosing line located on the outside of the carton, and an ointment string as long as the line is squeezed onto the fingertip with light pressure on the tube. Carefully insert the ointment into the anal canal with your finger. The finger with the ointment should be inserted into the outermost finger joint (approximately 1 cm) in the anus.
Apply the ointment every twelve hours according to the doctor’s instructions and do not exceed dose one. Wash your hands after use and dispose of your fingertip or plastic wrap (except on the toilet seat).
The treatment can continue until the pain subsides, or for a maximum of 8 weeks. If the anal pain does not improve after using Rectogesic, talk to your doctor again so that you can check that nothing else is causing the pain.
If you use more Rectogesic than you should
If you may have used more ointment than you should, you may feel dizzy and faint. You may also have a fast heartbeat or palpitations. If you experience these symptoms, wipe off any extra ointment and then talk to a doctor or pharmacist immediately.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Rectogesic
Do not take a double dose to make up for a forgotten dose. Apply the next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
- Anaphylactoid reaction ( allergic reaction, which can be fatal with swelling of the face, lips, tongue, or throat, difficulty breathing, shortness of breath, or collapse). If you get any of these symptoms, stop using the ointment and seek medical advice immediately.
- Allergic skin reactions (which can be serious). If you get an allergic skin reaction, you must stop using the ointment and see a doctor.
Other side effects:
Very common (may affect more than 1 in 10 people)
- Headache, which can be severe. If you get a headache as a side effect, wipe off all ointment. If the headache is unpleasant, you may need to ask 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
- Bleeding in the rectum, disturbance in the rectum
- Anal discomfort, itching, or burning in the anal canal
- Fast heartbeat or palpitations
Rare (may affect up to 1 in 1,000 people)
- Weakness when you get up
Side effects of unknown frequency (frequency can not be calculated from the available data)
- Fainting sensation, fainting
- Low blood pressure
- Irritation, rash, or pain at the application site
Other known side effects associated with glyceryl trinitrate products (frequency unknown)
- Hemorrhoids
- Unstable angina (chest pain)
- High blood pressure when treatment is stopped
- Methemoglobinemia (symptoms are blue/purple discoloration of the skin and shortness of breath)
HOW TO STORE 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 expiration date is the last day of the specified month.
- Do not store above 25 ° C.
- Do not freeze
- Close the tube tightly
- The ointment should be used within 8 weeks after opening
CONTENTS OF THE PACKAGING AND OTHER INFORMATION
Content declaration
The active substance is glyceryl trinitrate. One gram of rectal ointment contains 4 mg of glyceryl trinitrate. There is approximately 1.5 mg of glyceryl trinitrate in the usual 375 mg dose of Rectogesic.
The other ingredients are propylene glycol, lanolin, sorbitan sesquiplane, hard paraffin, and white, soft paraffin.
What the medicine looks like and the contents of the pack
Rectogesic is an off-white, smooth, opaque rectal ointment found in 30 g aluminum tubes.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Kyowa Kirin Holdings BV
Bloemlaan 2
2132NP Hoofddorp
Netherlands
Local representative:
Kyowa Kirin AB
Kista
Tfn: +46 (0) 8-50 90 74 10
Manufacturer
PHARBIL Waltrop GmbH
I’m Wirrigen 25
45731 Waltrop
Germany