RECTIV—for chronic anal fissure pain

It's more common than you think.

Talk to your doctor about your symptoms
and how RECTIV may help.

RECTIV is FDA-approved

RECTIV is the only FDA-approved medication used to treat
moderate to severe pain associated with chronic anal fissure.

What is RECTIV?

  • RECTIV (nitroglycerin) Ointment 0.4% 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 studied in this age group.

IMPORTANT RISK INFORMATION

Who should not use RECTIV?

Do not use RECTIV if you:
  • Are taking a medicine for erectile dysfunction (male impotence), such as Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil), or for pulmonary hypertension. If you have questions, consult your pharmacist or healthcare provider
  • Have been told by your doctor that you have severe anemia (low numbers of red blood cells)
  • Have increased intracranial pressure or high pressure within your skull (eg, following a head injury or bleeding in your brain)
  • Are allergic to any of the ingredients in RECTIV, or have had an allergic reaction to similar medications in the past

What should I tell my healthcare provider before using RECTIV?

Tell your healthcare provider about all of your medical conditions, including if you:
  • Have low blood pressure
  • Have recently had a heart attack
  • Have heart or blood vessel disorders
  • Suffer from migraine or recurrent headaches
  • Are pregnant or plan to become pregnant. It is not known if RECTIV or the components of RECTIV will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if RECTIV or the components of RECTIV will harm your child if you breastfeed

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 doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor if you are taking other products that contain nitroglycerin, a medicine for erectile dysfunction, medicines used to treat high blood pressure, aspirin, ergotamine (used to treat migraine), tissue-type plasminogen activator (used to help dissolve blood clots in the heart, lungs, and brain), or are to be given heparin.

What should I avoid while using RECTIV?

  • Do not drive or operate machinery immediately after applying RECTIV. If you feel dizzy or light-headed after applying the ointment, do not drive or operate machinery until the dizziness has stopped.
  • Avoid consuming alcohol while you are using 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 allergic reactions, including swelling of the face, lips, tongue, or throat, or difficulty breathing. If you have an allergic reaction, stop using RECTIV and seek immediate medical attention.
  • The most common side effects of RECTIV are:
    •  Headaches, which can be severe. If you have a headache, you may take over-the-counter painkillers (such as acetaminophen), or ask your doctor whether you should stop taking RECTIV.
    •  Dizziness, faintness on standing, or light-headedness

These are not all the possible side effects of RECTIV. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep RECTIV out of the reach of children.

Please also see the Patient Information within the full Prescribing Information.

RECTIV® is a registered trademark of Actavis, Inc. or its affiliates.

© Actavis 2014. All rights reserved.REC1913611/14

What is RECTIV?

  • RECTIV (nitroglycerin) Ointment 0.4% 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 studied in this age group.

IMPORTANT RISK INFORMATION

Who should not use RECTIV?

Do not use RECTIV if you:
  • Are taking a medicine for erectile dysfunction (male impotence), such as Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil), or for pulmonary hypertension. If you have questions, consult your pharmacist or healthcare provider
  • Have been told by your doctor that you have severe anemia (low numbers of red blood cells)
  • Have increased intracranial pressure or high pressure within your skull (eg, following a head injury or bleeding in your brain)
  • Are allergic to any of the ingredients in RECTIV, or have had an allergic reaction to similar medications in the past

What should I tell my healthcare provider before using RECTIV?

Tell your healthcare provider about all of your medical conditions, including if you:
  • Have low blood pressure
  • Have recently had a heart attack
  • Have heart or blood vessel disorders
  • Suffer from migraine or recurrent headaches
  • Are pregnant or plan to become pregnant. It is not known if RECTIV or the components of RECTIV will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if RECTIV or the components of RECTIV will harm your child if you breastfeed

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 doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor if you are taking other products that contain nitroglycerin, a medicine for erectile dysfunction, medicines used to treat high blood pressure, aspirin, ergotamine (used to treat migraine), tissue-type plasminogen activator (used to help dissolve blood clots in the heart, lungs, and brain), or are to be given heparin.

What should I avoid while using RECTIV?

  • Do not drive or operate machinery immediately after applying RECTIV. If you feel dizzy or light-headed after applying the ointment, do not drive or operate machinery until the dizziness has stopped.
  • Avoid consuming alcohol while you are using 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 allergic reactions, including swelling of the face, lips, tongue, or throat, or difficulty breathing. If you have an allergic reaction, stop using RECTIV and seek immediate medical attention.
  • The most common side effects of RECTIV are:
    •  Headaches, which can be severe. If you have a headache, you may take over-the-counter painkillers (such as acetaminophen), or ask your doctor whether you should stop taking RECTIV.
    •  Dizziness, faintness on standing, or light-headedness

These are not all the possible side effects of RECTIV. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep RECTIV out of the reach of children.

Please also see the Patient Information within the full Prescribing Information.

RECTIV® is a registered trademark of Actavis, Inc. or its affiliates.

© Actavis 2014. All rights reserved.REC1913611/14