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PROXYDOLTM - Dextropropoxyphene HCL & Ibuprofen Capsules
 

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MEDICATION GUIDE

PROXYDOLTM
(Dextropropoxyphene HCL & Ibuprofen)

Capsules

Read this Medication Guide before you start taking PROXYDOLTM and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about PROXYDOLTM ?

PROXYDOLTM , and other medicines that contain propoxyphene can cause serious side effects, including:

Overdoses by accident or on purpose (intentional overdose). Overdoses with PROXYDOLTM may happen when it is taken by itself, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.

  • •    Death can happen within 1 hour of taking an overdose of PROXYDOLTM .

Many of the deaths that happen in people who take PROXYDOLTM happen in those who:

  • • have emotional problems
  • • have thoughts of suicide or attempted suicide, or
  • • also take antidepressants, sedatives, tranquilizers, muscle relaxants, or other medicines that affect your breathing and make you very sleepy. You should not use any of these medicines with PROXYDOLTM without talking to your doctor. 

• Before taking PROXYDOLTM tell your doctor if you:

  • • have a lung problem, such as COPD or cor pulmonale
  • • have liver or kidney problems
  • • have problems with your pancreas or gallbladder
  • • have a history of head injury
  • • are over age 65
  • • have a history of drug or alcohol abuse or addiction

Take PROXYDOLTM exactly as prescribed. Do not change your dose or stop taking PROXYDOLTM without first talking to your doctor.

  • • If you take PROXYDOLTM, do not take more than 5 capsules in one day.
  • • Before taking PROXYDOLTM , tell your doctor about all the medicines you take. PROXYDOLTM and many other medicines may interact with   each other and may cause serious side effects. Certain medicines can affect how your liver breaks down other medicines. See “What    should I tell my doctor before taking PROXYDOLTM ?”
  • • Do not drink grapefruit juice or eat grapefruit while you take PROXYDOLTM . Grapefruit juice may interact with PROXYDOLTM .
  • • Do not drink alcohol while using PROXYDOLTM . Using alcohol with PROXYDOLTM may increase your risk of having dangerous side effects.

What are PROXYDOLTM ?

  • • PROXYDOLTM is a prescription medicine used to treat mild to moderate cancer pain.
  • • PROXYDOLTM are federally controlled substances (C-IV) because they are strong opioid pain medicines that can be abused by people who abuse prescription medicines or street drugs.
  • • Prevent theft, misuse or abuse. Keep PROXYDOLTM in a safe place to protect it from being stolen. PROXYDOLTM can be a target for people  who misuse or abuse prescription medicines or street drugs.
  • • Never give PROXYDOLTM to anyone else, even if they have the same symptoms that you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.

It is not known if PROXYDOLTM are safe and effective in children younger than age 18.

Who should not take PROXYDOLTM ?

Do not take PROXYDOLTM if you:

  • • are allergic to propoxyphene. Ask your doctor if you are not sure. See the end of this Medication Guide for a list of the ingredients in PROXYDOLTM .
  • • are having an asthma attack or have severe asthma, trouble breathing, or have a lung problem
  • • have a bowel blockage called paralytic ileus

What should I tell my doctor before taking PROXYDOLTM ?

Before you take PROXYDOLTM, tell your doctor:

  • • if you have any of the conditions listed in the section “What is the most important information I should know about PROXYDOLTM ?”
  • • if you are allergic to propoxyphene
  • • if you plan to have surgery with general anesthesia
  • • if you are pregnant or plan to become pregnant.
  • • if you take PROXYDOLTM regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become used to the medicine. Symptoms of withdrawal in a newborn baby may include:
  • • irritability
  • • crying more than usual
  • • shaking (tremors
  • • jitteriness
  • • breathing faster than normal
  • • diarrhea or more stools than normal
  • • vomiting
  • • fever

• if you take PROXYDOLTM right before your baby is born, your baby could have breathing problems.

• if you are breast-feeding or plan to breast-feed. Some PROXYDOLTM passes into breast milk.

 Tell your doctor about all the medicines you take, including prescription, and non-prescription medicines, vitamins, and herbal   supplements. PROXYDOLTM interacts with many medicines and may lead to serious side effects. The doses of certain medicines may need   to be changed.

 Especially tell your doctor if you take:

See “What is the most important information I should know about PROXYDOLTM

  • • certain medicines that can affect how your liver breaks down other medicines
  • • a monoamine oxidase inhibitor (MAOI) medicine
  • • other medicines that make you sleepy, such as: other medicines for pain, including other opioid medicines, anti-depressant medicines,   sleeping pills, anti-anxiety medicines, muscle relaxants, anti-nausea medicines, or tranquilizers
  • • a blood pressure medicine
  • • a blood-thinner medicine. You may have an increased risk of bleeding while also taking PROXYDOLTM .

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How should I take PROXYDOLTM ?

See “What is the most important information I should know about PROXYDOLTM ?”

  • • Take PROXYDOLTM exactly as prescribed.
  • • If you take too much PROXYDOLTM , or take it with alcohol or other medicines, you may overdose. See “What is the most important information I should know about PROXYDOLTM ?” You will need medical help right away if you think you have taken an overdose of  PROXYDOLTM . A large overdose could cause you to become unconscious and die.

Signs and symptoms of an overdose of PROXYDOLTM include:

  • • you are very sleepy or do not respond to others
  • • confusion
  • • have trouble breathing or stop breathing
  • • changes in blood pressure and heart rate

What are the possible side effects of PROXYDOLTM

PROXYDOLTM can cause serious side effects, including:

See “What is the most important information I should know about PROXYDOLTM ?”

• Serious breathing problems that can become life-threatening. This is especially true if you already have a serious lung or breathing   problem, or your body is not used to opioid pain medicines. This can happen even if you take PROXYDOLTM exactly as prescribed by    your doctor. Call your doctor or get medical help right away if:

  • o your breathing slows down
  • o you have shallow breathing (little chest movement with breathing)
  • o you feel faint, dizzy, confused, or
  • o you have any other unusual symptoms

• PROXYDOLTM can cause your blood pressure to drop.This can make you feel dizzy and faint if you get up too fast from sitting or lying   down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe   low blood pressure can happen if you lose blood or take certain other medicines.

• Sleepiness. PROXYDOLTM can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive,   operate heavy machinery, or do other dangerous activities until you know how PROXYDOLTM affects you.

• PROXYDOLTM can cause physical dependence if you take it for more than a few weeks. Do not stop taking PROXYDOLTM all of a sudden. You could become sick with uncomfortable withdrawal symptoms (for example,   nausea, vomiting, diarrhea, anxiety, and shivering) because your body has become used to the medicine. Physical dependence is not   the same as drug addiction. Your doctor can   tell you more about the differences between physical dependence and drug addiction.

Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking PROXYDOLTM . You may need to stop PROXYDOLTM more slowly.

Common side effects of PROXYDOLTM include:

  • • dizziness
  • • feeling sleepy
  • • nausea and vomiting
  • • constipation
  • • stomach area (abdominal) pain
  • • skin rashes
  • • lightheadedness
  • • headache
  • • weakness
  • • feeling of excitement (elation) or discomfort
  • • seeing, hearing, or sensing things that are not really there (hallucinations)
  • • blurred vision

Call your doctor for medical advice about side effects.

You may also report side effects to MG Lifecare LLP .

How should I store PROXYDOLTM ?

  • Store PROXYDOLTM at room temperature.

Keep PROXYDOLTM and all medicines out of the reach of children.

General information about PROXYDOLTM

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROXYDOLTM for a purpose for which it was not prescribed. Do not give PROXYDOLTM to others even if they have the same symptoms you have. It may harm them and is against the law.

This Medication Guide summarizes the most important information about PROXYDOLTM . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about PROXYDOLTM that is written for health professionals. For more information, go to www.proxydol.com.

What are the ingredients in PROXYDOLTM ?

PROXYDOLTM :

Active ingredient: Dextropropoxyphene HCl & Ibuprofen
PROXYDOLTM is a registered trademark of PRG Pharma Pvt. Ltd.

Marketed by :

MG Lifecare LLP .

 

You are encouraged to report adverse events related to PROXYDOLTM (DEXTROPROPOXYPHENE HCL & IBUPROFEN) by calling 011-45137698, connect@mglifecare.com. If you prefer, you may contact the Pharmacovigilance Programme of India (PvPI) directly. Visit https://www.ipc.gov.in/PvPI/pv_home.html or call 1800-180-3024 (9:00 AM to 5:30 PM, Monday-Friday).