ConZip

What is ConZip?

• ConZip is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not for use to treat pain that is not around-the-clock.

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

• Get emergency help right away if you take too much ConZip (overdose). When you first start taking ConZip, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking ConZip with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your ConZip. They could die from taking it. Selling or giving away CONZIP is against the law.
• Store ConZip securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Important Information Guiding Use in Pediatric Patients:

• Do not give ConZip to a child younger than 12 years of age.
• Do not give ConZip to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving ConZip to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

Who should not take ConZip?

Do not take ConZip if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What should I tell my healthcare provider before taking ConZip?

Before taking ConZip, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of ConZip during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended; it may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking ConZip with certain other medicines can cause serious side effects that could lead to death.

How should I take ConZip?

When taking ConZip:

• Do not change your dose. Take ConZip exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Swallow ConZip whole. Do not split, break, chew, crush, dissolve, snort, or inject ConZip because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking ConZip without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused ConZip by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of ConZip by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag and throwing the bag in your trash.

What should I avoid while taking ConZip?

While taking ConZip DO NOT:

• Drive or operate heavy machinery, until you know how ConZip affects you. ConZip can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with ConZip may cause you to overdose and die.

What are the possible side effects of ConZip?

The possible side effects of ConZip:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure.
  Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of ConZip. Call your doctor for medical advice about side effects. You may report side effects to Vertical Pharmaceuticals, LLC at (877) 958-3784 or FDA at 1-800-FDA-1088.

How should I store ConZip?

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Store ConZip securely and dispose of properly

What are the ingredients in ConZip?

Active ingredient: tramadol hydrochloride 100 mg

Inactive ingredients: gelatin, titanium dioxide, shellac, FD&C blue no. 2, lactos, starch, corn, magnesium stearate, hypromellose 2910 (6 mpa.s), talc, polysorbate 80, ethyl acrylate and methyl methacrylate copolymer.