RECTOGESIC 4 мг/мл Ректальная крем
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Инструкция по применению REKTOJESIK
Содержание инструкции
Rectogesic 4 mg/g Rectal Ointment
(trinitroglycerin)
Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 IS RECTOGESIC AND WHAT IS IT USED FOR
Rectogesic is a rectal ointment that contains nitroglycerin as the active ingredient. Nitroglycerin belongs to the family of medicines called organic nitrates.
The ointment helps to relieve the symptom of pain caused by chronic anal fissures. An anal fissure is defined as a lesion of the mucosa that lines the anal canal. Topical application of nitroglycerin to the site of the anal canal 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 nitroglycerin or 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 suffer from closed-angle glaucoma, a condition in which the pressure inside the eye increases rapidly causing loss of vision
- you suffer from migraine or recurrent headache
- you suffer from increased intracranial pressure or high pressure in the head (e.g. head injury or cerebral haemorrhage - bleeding due to the rupture of a blood vessel in the brain, which can be fatal without immediate medical treatment. Cerebral haemorrhage is commonly reported as a type of stroke) or inadequate cerebral circulation (low blood flow to the brain)
- you suffer from anaemia (low iron content in the 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 nitroglycerin (TNG), isosorbide dinitrate, amyl or butyl nitrite; medicines for high blood pressure or for depression (tricyclic antidepressants), acetylcysteine, or alteplase.
Take special care with Rectogesic especially:
- if you suffer from liver or kidney diseases
- in the case of heparin administration, strict blood monitoring must be performed as it may be necessary to change the dose of heparin. Consult your doctor before stopping treatment with Rectogesic
- in the presence of haemorrhoids and bleeding more than usual, stop using Rectogesic and consult your doctor
- if you experience a severe headache when using Rectogesic, inform your doctor who will decide whether to change the amount of Rectogesic or stop using the ointment altogether.
Rectogesic may cause a lowering of blood pressure. It is advisable to get up slowly from a
lying or sitting position otherwise you may feel faint. If you drink alcohol during treatment with
Rectogesic, you are more likely to experience a lowering of blood pressure.
Children and adolescents
Rectogesic is not indicated for children and adolescents under 18 years of age as it has not been tested
on subjects 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 those available without a prescription.
The following medicines can increase the effect of Rectogesic on lowering blood pressure
- Medicines for depression (tricyclic antidepressants)
- Medicines for erectile dysfunction (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 decrease if used with Rectogesic
- The effect of alteplase (used to treat heart problems) may decrease if 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 drugs (some types of painkillers) may alter the therapeutic effect of Rectogesic.
Rectogesic and alcohol
Be careful when drinking alcohol as the use of the ointment may cause alcohol to have a
greater effect than usual.
Pregnancy and breastfeeding
Rectogesic should not be used during pregnancy or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or
breastfeeding.
Driving and using machinery
There are no studies on the effect of using Rectogesic 4 mg/g rectal ointment on the ability
to drive vehicles and operate machinery. If you experience dizziness,
somnolence or blurred vision when you start using the ointment, 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.
Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. The recommended dose is approximately 375 mg of ointment (approximately 1.5 mg of
trinitroglycerin) applied into the anal canal every 12 hours.
To apply the ointment, you can use a finger protector, such as adhesive film or a finger cot. Finger cots can be
found at a pharmacy or surgical supply store, and adhesive film at your nearest supermarket. For dosage,
position your finger along the 2.5 cm line indicated on the outer carton and apply a strip of ointment the
length of the line onto the end of your finger by gently squeezing the tube. Gently insert the ointment into the
anal canal using your finger, which should be inserted up to the first joint of the finger (approximately 1 cm)
inside the anus.
Apply the ointment every twelve hours as directed by your doctor and do not exceed the dose. Wash your hands
after use and dispose of the finger cot or adhesive film (not in the toilet).
Continue treatment until the pain disappears or for a maximum of 8 weeks. If anal pain does not improve with
the use of Rectogesic, consult your doctor again to ensure that there are no other causes.
If you use more Rectogesic than you should
If you notice that you have applied more ointment than you should, you may experience dizziness and lightheadedness. You
may also have a fast heartbeat or palpitations. If you experience these symptoms, wash away the excess amount of
ointment and immediately inform your doctor or pharmacist.
If you forget to use Rectogesic
Do not use a double dose to make up for a missed dose. Apply the next dose
at the usual time.
If you have any questions about using 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 reactions (allergic reaction, potentially life-threatening that manifests with swelling of the face, lips, tongue or throat, difficulty breathing, shortness of breath or collapse). If you experienceany of these symptoms, stop using the ointment and consult your doctor immediately.
- Allergic skin reactions (potentially serious). If you experience an allergic skin reaction, stop using the ointment and consult your doctor immediately
Other side effects:
Very common (may affect more than 1 in 10 people)
- Headache, which may be severe. If you experience headache as a side effect, remove the ointment. If the headaches are bothersome, you may need to ask your doctor if it is appropriate to 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 1000 people)
- Feeling faint when standing up
Side effects with unknown frequency (frequency cannot be estimated from available data)
- Feeling of emptiness in the head, fainting
- Low blood pressure
- Irritation, rash or pain at the application site
Other known side effects associated with the use of medicines containing nitroglycerin (frequency
unknown)
- Hot flushes
- Unstable angina (chest pain)
- High blood pressure following discontinuation of treatment
- Methemoglobinemia (symptoms are a blue/purple discoloration of the skin and shortness of breath)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at the address
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects 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 which is stated on the tube and the 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 PACK AND OTHER INFORMATION
What Rectogesic contains
The active ingredient is nitroglycerin. One gram of rectal ointment contains 4 mg of nitroglycerin.
The usual dose of 375 mg of Rectogesic contains approximately 1.5 mg of nitroglycerin.
The other ingredients are: propylene glycol, lanolin, sorbitan sesquioleate, hard paraffin and
white soft paraffin.
Description of the appearance of Rectogesic and contents of the pack
Rectogesic is a whitish, homogeneous, opaque rectal ointment, distributed in aluminium tubes of 30 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Grünenthal Italia S.r.l.
Via Vittor Pisani, 16
20124 Milano
Manufacturer and Responsible for batch control and release
PHARBIL Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany
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- Страна регистрации
- Форма выпускаRectal cream, 4MG/ML
- Код АТХC05AE01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги REKTOJESIKФорма выпуска: Rectal cream, 0.3% + 1.5%Действующее вещество: other preparations, combinationsПроизводитель: NEOPHARMED GENTILI S.P.A.Отпускается по рецептуФорма выпуска: Cream, 1% + 1.5%Действующее вещество: ГидрокортизонОтпускается без рецептаФорма выпуска: Rectal cream, 0,1 MG/G + 10 MG/GДействующее вещество: Флуоцинолон ацетонидПроизводитель: RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.Отпускается без рецепта
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REKTOJESIK требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество REKTOJESIK — глицерил тринитрат. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
REKTOJESIK производится компанией GRUNENTHAL ITALIA S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения REKTOJESIK с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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