IMPORTANT SAFETY INFORMATION

PROPOXYPAIN®(DEXTROPROPOXYPHENE HCL ) is not for everyone. PROPOXYPAIN® may cause serious, even life-threatening, allergic reactions. Stop taking PROPOXYPAIN® and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck, if you have any trouble breathing, or have a rash, hives, or blisters.

Drugs used to treat pain through CNS mechanism increase the risk of suicidal thoughts or behavior. If you have a history of any suicidal ideation or PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL) may cause suicidal thoughts or actions in a very small number of people. Patients, family members, or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self-harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, headache, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop PROPOXYPAIN® without first talking to your doctor.

Serious breathing problems can occur when PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL) is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting PROPOXYPAIN® or when the dose is increased. Get help right away if breathing problems occur.

PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL) may cause swelling of your hands, legs, and feet, which can be serious for people with heart problems. PROPOXYPAIN® may cause dizziness and sleepiness. You should not drive or work with machines until you know how PROPOXYPAIN® affects you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight, including blurry vision or if you have any kidney problems or get dialysis.

Tell your doctor immediately if you are taking opioid painkillers (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with PROPOXYPAIN®(DEXTROPROPOXYPHENE HCL). Taking PROPOXYPAIN® with opioid pain medicines may lead to death.

Some of the most common side effects of PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL) are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores.

You may have a higher chance for swelling and hives if you are also taking angiotensin-converting enzyme (ACE) inhibitors, so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on PROPOXYPAIN®(DEXTROPROPOXYPHENE HCL). You may have a higher chance for dizziness and sleepiness if you take PROPOXYPAIN® with alcohol, narcotic pain medicines, or medicines for anxiety.

Before you start PROPOXYPAIN®(DEXTROPROPOXYPHENE HCL), tell your doctor if you are planning to father a child, if you are pregnant, or plan to become pregnant. Breastfeeding is not recommended while taking PROPOXYPAIN®. If you have had a drug or alcohol problem, you may be more likely to misuse PROPOXYPAIN®.

Do not stop taking PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL) without talking to your doctor. If you stop suddenly, you may have headaches, nausea, diarrhoea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.

Do not adjust the daily dosage without consultation of your doctor, protect your medicine supply and do not give it to anyone other than the individual to whom it was prescribed.

Report any pain or adverse event to your prescribing doctor, do not increase the daily dosage without consulting your doctor. PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL) is available in dosage of 65 mg.

INDICATIONS

PROPOXYPAIN®(DEXTROPROPOXYPHENE HCL ) is indicated to treat Cancer Pain Please see full Prescribing Information. and Medication Guide.

This site is intended only for Indian residents. The products discussed in this site may have different product labeling in different countries. The health information in this site is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report adverse events related to PROPOXYPAIN® (DEXTROPROPOXYPHENE HCL ) 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).