(Nitroglycerin) Ointment 0.4%
IMPORTANT: For intra-anal use only
Read the Patient Information
that comes with RECTIV before you start using the product and each time you get
a refill because there may be new information. This information does not take
the place of talking to your healthcare provider about your medical condition
or your treatment. If you have any questions about RECTIV, ask your healthcare
What is RECTIV?
RECTIV is a prescription
medicine used to treat moderate to severe pain caused by chronic anal fissures.
An anal fissure is a tear in the skin lining the anal canal.
RECTIV is not suitable for
children and adolescents under the age of 18 years because it has not been
assessed in people in this age group.
Who should not use RECTIV?
Do not use RECTIV if you:
- are taking a medicine for
erectile dysfunction (male impotence), for example Viagra (sildenafil), Cialis
(tadalafil) or Levitra (vardenafil).
- have been told by your doctor
that you have severe anemia (low numbers of red blood cells in your blood)
- have increased intracranial
pressure or high pressure within your skull e.g. following head trauma or
bleeding in your brain
- are allergic to any of the ingredients
in RECTIV or if you have had allergic reactions to similar medicines in the
past. See the end of this leaflet for a list of ingredients in RECTIV.
What should I tell my
healthcare provider before using RECTIV?
Tell your healthcare
provider about all your medical conditions, including if you:
- have low blood pressure
- have recently had a heart
- have heart or blood vessel
- suffer from migraine or
- are pregnant or plan to become
pregnant. It is not known if RECTIV will harm your unborn baby.
- are breast-feeding or plan to
breast-feed. It is not known if the components of RECTIV will harm your child
if you breast-feed.
RECTIV may lower your blood
pressure. When getting up from a lying or sitting position, you should get up
slowly, otherwise you might feel faint.
Tell your healthcare
provider about all the medicines you take,
including prescription and nonprescription medicines, vitamins and herbal
supplements. Other medicines may affect how RECTIV works. RECTIV may also
affect how other medicines work.
Specifically, tell your doctor
if you are taking any of the following:
- other nitroglycerin containing
- a medicine for erectile
dysfunction (male impotence), for example sildenafil, tadalafil or vardenafil
(see the section above 'Who should not use RECTIV')
- medicines used to treat high
- are taking aspirin, ergotamine
(used to treat migraine) or are receiving tissue-type plasminogen activator
(used to help dissolve blood clots formed in blood vessels in the heart, lungs
- are to be given heparin. If so,
close monitoring of your blood will be required as your dose of heparin may
need to be altered. Please discuss with your doctor before stopping RECTIV.
How should RECTIV be used?
Use RECTIV exactly as
prescribed. See detailed Patient
Instructions for Applying RECTIV at the end of this Patient Information
Treatment may be continued
for up to 3 weeks. If your anal pain does
not get better after using RECTIV you should talk to your doctor.
What should I avoid while
Do not drive or operate
machinery immediately after applying RECTIV. If you feel dizzy or lightheaded after
applying the ointment do not drive or operate machinery until the dizziness has
Avoid consuming alcohol while
you are being treated with RECTIV as your blood pressure is more likely to be
affected if you consume alcoholic beverages.
What are the possible side
effects of RECTIV?
RECTIV can cause serious
side-effects: Stop using the ointment and seek medical attention immediately if
you have an allergic reaction. You may have swelling of the face, lips, tongue
or throat, or difficulty breathing.
Common side-effects of RECTIV
- Headaches, which can be severe.
You could take painkillers for this (such as acetaminophen). If the headaches
are unpleasant, you may need to ask your doctor whether you should stop using RECTIV.
- Dizziness, faintness on
standing, or light-headedness
These are not all the possible
side effects of RECTIV. Tell your healthcare provider if you have any side
effect that bothers you or that does not go away. For more information, ask
your healthcare provider or pharmacist.
Call your doctor for medical
advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store RECTIV?
- Store at 20°-25°C (68°-77°F);
excursions permitted between 15°-30°C (59°-86°F). [See USP Controlled Room
- Keep the tube tightly closed.
- Use within 8 weeks of first
Keep RECTIV out of the reach
Do not use RECTIV after the
expiry date which is stated on the label and carton after 'EXP.' The expiry
date refers to the last day of that month.
General information about RECTIV
Medicines are sometimes
prescribed for conditions that are not mentioned in Patient Information leaflets.
Do not use RECTIV for a condition for which it is not prescribed. Do not give
RECTIV to other people, even if they have the same symptoms you have. It may
This Patient Information
leaflet summarizes the most important information about RECTIV. If you would
like more information, talk to your healthcare provider. You can ask your
pharmacist or healthcare provider for information about RECTIV that is written
for health professionals.
For more information call 1-800-472-2634 or visit www.RECTIV.com.
Patient Instructions for Use
When do I apply the
Apply the ointment every 12
hours exactly as your doctor has told you to.
How do I apply the ointment?
Cover your finger with
plastic-wrap, a disposable surgical glove or a finger cot.
Lay the covered finger
alongside the 1 inch dosing line marked on the side of the medicine box (see figure
below) so that the tip of your finger is at one end of the dosing line.
Starting at the tip of the finger, squeeze the ointment onto your finger for
the same length marked on the box.
Refer to carton for accurate dosage guide.
Gently insert the finger with the ointment into the anal
canal, up to the first finger joint. Carefully smear the ointment around the
inner sides of the anal canal. If this cannot be achieved due to pain, application
of the ointment should be made directly to the outside of the anus.
What do I do after I have applied the ointment?
Throw away the finger covering in the garbage, out of the
reach of children and pets. Wash your hands.
What are the ingredients in RECTIV?
Active ingredient: nitroglycerin
Inactive ingredients: propylene glycol, lanolin, sorbitan
sesquioleate, paraffin wax and white petrolatum.