Substandard, spurious, falsely labeled, falsified, and a counterfeit (SSFFC) medical products are each year becoming an increasing threat to consumers’ health and the problem remains largely underreported. SSFFC is a term defined by members of state which identify the products associated with the illicit trade. Although there is currently no agreed definition, counterfeit medicines were previously defined by the World Health Organisation (WHO) as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of ingredient(s), or with counterfeit packaging.
With the web, traffickers have found the opportunity to sell their forged goods on a large scale, directly to patients, circumventing all secure distribution channels. One of the main difficulties encountered in the fight against the distribution of counterfeit drugs through the Internet lies in the fact that some countries have already legalized trade in online drugs, sometimes including mandatory prescription drugs like tapentadol.
What is tapentadol?
Tapentadol is an opioid medication used to treat moderate to severe pain. The extended-release form of this medicine (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain. Tapentadol may also be used for purposes not listed in this medication guide.
How should I take tapentadol?
Follow the directions on your prescription label and read all medication guides. Never use tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine. Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law. Take this medicine with a full glass of water. Tapentadol can be taken with or without food.
Stop taking all other around-the-clock narcotic pain medications when you start taking tapentadol extended-release tablets.
Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.
Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.
Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using tapentadol.
Never crush or break a tapentadol pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of tapentadol and similar prescription drugs.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since tapentadol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.
Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.
What should I avoid while taking tapentadol?
Do not drink alcohol. Dangerous side effects or death could occur. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
What are the possible side effects of tapentadol?
Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat. Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.
- Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- a light-headed feeling, like you might pass out;
- agitation, feeling hot;
- seizure (convulsions);
- severe drowsiness or dizziness, confusion, problems with speech or balance;
- infertility, missed menstrual periods;
- impotence, sexual problems, loss of interest in sex; or
- low cortisol levels — nausea, vomiting, loss of appetite, dizziness, worsening tiredness, or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
- constipation, mild nausea, stomach pain;
- headache, tired feeling; or
- mild drowsiness or dizziness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
What other drugs will affect tapentadol?
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
- medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other narcotic medications –opioid pain medicine or prescription cough medicine;
- a sedative like Valium –diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
- drugs that make you sleepy or slow your breathing –a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
- drugs that affect serotonin levels in your body –a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
How to Avoid Counterfeit Medications
There are several things you can do to protect yourself from the risks associated with counterfeit drugs, including:
- Purchase your prescription medications from licensed drugstores. Although possible, it is rare for drugs purchased at a reputable pharmacy to be counterfeit.
- Be very careful when buying medications on the Internet. If you choose to buy medications online, look for websites that have the Verified Internet Pharmacy Practice Sites (VIPPS) seal. These are licensed pharmacies where FDA-approved medications can be purchased safely. Seventy-five online pharmacies carry the VIPPS seal.
- Know your medication. When you receive your medication, pay attention to the packaging, directions on how you should take it, and the appearance of the drug itself. Do not take the medication if you have any concerns.
- You also need to protect yourself from counterfeit drugs while traveling. The U.S. Centers for Disease Control and Prevention (CDC) recommends that you bring with you all the drugs that you think you will need during your trip, rather than buying them while you are traveling.
However, if you must buy drugs during your trip, there are things you can do to reduce your chances of buying counterfeit drugs:
- Bring a copy of your prescriptions, including the brand name or generic name and the manufacturer of any medicine that you take regularly or for a drug that has been prescribed for your trip.
- Buy medications only from licensed pharmacies and get a receipt. Do not buy drugs from open markets.
- Check with the pharmacist in the foreign drugstore whether the drug has the same active ingredient as the one that you were taking.
- Make sure that the medication is in its original packaging.
If you are in a developing country and are concerned about the regulation of medications, check with your country’s embassy to see if they can recommend a safe place to purchase medications.
Where can I get more information?
Your doctor or pharmacist can provide more information about tapentadol. SEE: AN 627 Pill