Consists of Crataegus, Guaifenesin, Lupulus, Melissa, Passion Flower, Sambucus, St. John's Wort, Valerian
Crataegus (Novo-Passit) warnings
should be used with caution in pregnancy and lactation.
What happens if I overdose Guaifenesin (Novo-Passit)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Guaifenesin (Novo-Passit):
Store Guaifenesin (Novo-Passit) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin (Novo-Passit) out of the reach of children and away from pets.
Overdose of Guaifenesin (Novo-Passit) in details
The acute toxicity of Guaifenesin (Novo-Passit) is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when Guaifenesin (Novo-Passit) was administered by stomach tube in doses up to 5 grams/kg.
In massive over dosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.
What should I avoid while taking Guaifenesin (Novo-Passit)?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Ask a doctor or pharmacist before using any other cold, or cough medicine. Many combination medicines contain Guaifenesin (Novo-Passit). Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an expectorant.
Guaifenesin (Novo-Passit) warnings
DOLOPHINE® HYDROCHLORIDE CI/strong>(Guaifenesin (Novo-Passit) Hydrochloride Tablets), 5 mg and 10 mg Keep DOLOPHINE out of the reach of children. Accidental overdose by a child is a medical emergency and can result in death. If a child accidentally takes DOLOPHINE, get emergency help right away. Do not take a higher dose of DOLOPHINE or take it more often than prescribed. This can lead to an overdose and possible death. Read the Patient Information that comes with DOLOPHINE before you take it and each time you get a new prescription. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. Share the important information in this leaflet with members of your household. WARNINGS:
What Is The Most Important Information I Should Know About DOLOPHINE?
What is DOLOPHINE?
DOLOPHINE is a prescription medicine that contains methadone, which is a narcotic pain medicine similar to morphine. DOLOPHINE is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs.
- Prevent theft and misuse. Keep your DOLOPHINE tablets in a safe place to protect them from theft. Never give DOLOPHINE to anyone else even if they have the same symptoms you have. It may harm them and even cause death. Selling or giving away this medicine is dangerous and against the law.
DOLOPHINE is used:
- to treat moderate to severe pain in people that do not respond to non-narcotic pain medicines;
- to control withdrawal symptoms in patients being treated for narcotic drug addiction;
- for maintenance treatment of narcotic drug addiction along with other social and medical services. Stopping maintenance treatment of narcotic drug addiction with DOLOPHINE may result in a return to narcotic drug use.
Who Should Not Take DOLOPHINE?
Do not take DOLOPHINE if you:
- have severe asthma or severe lung problems.
- have a blockage or obstruction in your intestines.
- are allergic to methadone or anything else in DOLOPHINE. See the end of this leaflet for a complete list of ingredients.
What Should I Tell my Doctor Before I Start Taking DOLOPHINE?
DOLOPHINE may not be right for you. Before starting DOLOPHINE, tell your doctor about all your medical and mental conditions including a history of drug or alcohol abuse or addiction.
Tell your doctor if you:
- are pregnant or plan to become pregnant. DOLOPHINE may harm your unborn baby.
- are breast feeding. DOLOPHINE passes through your breast milk and may harm your baby. You should choose to use DOLOPHINE or breastfeed, but not both.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with DOLOPHINE. Be especially careful about other medicines that may make you sleepy, such as other pain medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers. Sometimes, the doses of certain medicines (including DOLOPHINE) may need to be changed if they are used together.
Do not take any medicine while using DOLOPHINE until you have first talked to your doctor or pharmacist. They will be able to tell you if it is safe to take other medicines while you are using DOLOPHINE.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist each time you get a new medicine.
How Should I Take DOLOPHINE?
- Take DOLOPHINE exactly as prescribed. Follow your doctors directions exactly. Your doctor may change your dose based on your reactions to the medicine. Do not change your dose unless your doctor tells you to change it. Do not take a higher dose of DOLOPHINE or take it more often than prescribed. This can lead to an overdose and possibly death.
- If you take too much DOLOPHINE or overdose, call 911 or your local emergency number right away.
- Review your medical conditions regularly with your doctor to determine if you still need DOLOPHINE, or if the dose needs to be adjusted.
- When starting treatment with DOLOPHINE for narcotic drug dependence, you should be aware that your dose of methadone will "hold" for longer periods of time as treatment goes on.
- Stopping DOLOPHINE. Ask your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms. You should not stop taking DOLOPHINE all at once if you have been taking it for more than a few days.
- Tell all health professionals that treat you that you take DOLOPHINE.
- After stopping treatment with DOLOPHINE, flush the unused tablets down the toilet.
What Should I Avoid While Taking DOLOPHINE?
- Do not drive, operate heavy machinery, or do other possible dangerous activities until you know how DOLOPHINE affects you. DOLOPHINE can make you sleepy. Ask your doctor when it is okay to do these activities.
- Do not drink alcohol while using DOLOPHINE. It may increase the chance of having dangerous side effects.
- Do not take other medicines with DOLOPHINE without first talking with your doctor.
What are the Possible Side Effects of DOLOPHINE?
- DOLOPHINE can cause life threatening breathing and heart problems which can lead to death See "What Is The Most Important Information I Should Know About DOLOPHINE?"
- Call your doctor or get medical help right away if you:
- have trouble breathing
- have extreme drowsiness and breathing slows down
- have slow shallow breathing (little chest movement with breathing)
- fast or slowed heartbeat
- feel faint, very dizzy, confused, have palpitations (irregular heart beat) or any other unusual symptoms
- Call your doctor or get medical help right away if you:
These can be symptoms that you have taken too much (overdose of) DOLOPHINE, or the dose is too high for you. They can also be symptoms of a serious heart reactionstrong>These symptoms can lead to serious problems or death if not treated right away.
- DOLOPHINE can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down.
- DOLOPHINE can cause physical dependence. Do not stop taking DOLOPHINE or any other opioid without first talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Talk to your doctor about slowly stopping DOLOPHINE to avoid getting sick with withdrawal symptoms. Physical dependency is not the same as drug addiction.
- For patients using DOLOPHINE for pain treatment, there is a chance of abuse or addiction with DOLOPHINE. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
Some common side effects of DOLOPHINE are lightheadedness, dizziness, drowsiness, nausea, vomiting and sweating. Other side effects include weakness, headache, constipation, itching, and dry mouth.
Talk to your doctor about any side effects that bother you or that do not go away.
These are not all the possible side effects of DOLOPHINE. For a complete list, ask your doctor or pharmacist.
How Should I Store DOLOPHINE Tablets?
- Keep DOLOPHINE in a safe place away from children. Accidental use by a child is a medical emergency that can result in death. If a child accidentally takes DOLOPHINE, get emergency help right away.
- Keep DOLOPHINE at room temperature, 59 to 86°F (15 to 30°C).
- Always keep DOLOPHINE in a secure place to protect from theft.
- Dispose of any unused DOLOPHINE remaining from a prescription as soon as they are no longer needed. Unused tablets should be flushed down the toilet.
General Information About DOLOPHINE.
Medicines are sometimes prescribed for purposes other than those listed in patient information leaflet. Do not use DOLOPHINE for a condition for which it was not prescribed. Do not give DOLOPHINE to other people, even if they have the same symptoms you have. DOLOPHINE can harm other people and even cause death. Sharing DOLOPHINE is against the law.
This leaflet summarizes the most important information about DOLOPHINE. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about DOLOPHINE that is written for healthcare professionals, or you can visit www. Roxane.com or call 1-800-962-8364.
What are the Ingredients in DOLOPHINE?
Active Ingredient: methadone hydrochloride, USP
Inactive Ingredients: magnesium stearate, microcrystalline cellulose, and starch.
What should I discuss with my healthcare provider before taking Guaifenesin (Novo-Passit)?
Some medical conditions may interact with Guaifenesin (Novo-Passit). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a chronic cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if your cough occurs with large amounts of mucus
Some MEDICINES MAY INTERACT with Guaifenesin (Novo-Passit). Tell your health care provider if you are taking any other medicines. However, no specific interactions with Guaifenesin (Novo-Passit) are known at this time.
Ask your health care provider if Guaifenesin (Novo-Passit) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Guaifenesin (Novo-Passit) precautions
Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.
Pregnancy:
Teratogenic Effects—Pregnancy Category C: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.
Nursing Mothers: It is not known whether Guaifenesin (Novo-Passit) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Laboratory Test Interactions: Guaifenesin (Novo-Passit) or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.
What happens if I miss a dose of Guaifenesin (Novo-Passit)?
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Lupulus (Novo-Passit) warnings
What has to be considered in children?
The use of this medicine in children are no adequate studies. Nervenruh sedative tablets should therefore not be used.
Nervenruh sedative tablets should not be used because of insufficient studies in pregnancy and lactation.
Melissa (Novo-Passit) warnings
Limit alcohol intake while using this product, as it may intensify certain side effects (e.g., drowsiness). Use caution when performing tasks requiring mental alertness (e.g., driving). Liquid preparations of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence or liver disease. Ask your doctor or pharmacist about the safe use of this product. Lemon balm is not recommended for use during pregnancy. Consult your doctor before using this product. Because of the potential risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.
Keep all regular medical and laboratory appointments.
Passion Flower (Novo-Passit) warnings
Pregnancy and breast-feeding: Don
What happens if I overdose St. John's Wort (Novo-Passit)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of St. John's Wort (Novo-Passit):
Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep St. John's Wort (Novo-Passit) out of the reach of children and away from pets.
What should I avoid while taking St. John's Wort (Novo-Passit)?
Avoid prolonged exposure to sunlight. St. John's Wort (Novo-Passit) may increase the sensitivity of your skin to the sun. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.
St. John's Wort (Novo-Passit) may increase the effects of other drugs that cause drowsiness or dizziness, including antidepressants, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, muscle relaxants, other antihistamines, and topical medications that contain an antihistamine (e.g., anti-itch creams). Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.
What should I discuss with my healthcare provider before taking St. John's Wort (Novo-Passit)?
Some medical conditions may interact with St. John's Wort (Novo-Passit). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to become pregnant or breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of bipolar disorder (manic-depressive illness) or infertility
Some MEDICINES MAY INTERACT with St. John's Wort (Novo-Passit). Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aldosterone blockers (eg, eplerenone), blood thinners (eg, warfarin), benzodiazepines (eg, alprazolam), cancer chemotherapy medicines, digoxin, HIV medicines (eg, delavirdine, efavirenz, indinavir), HMG-CoA reductase inhibitors (eg, simvastatin), immunosuppressants (eg, cyclosporine, tacrolimus), selective serotonin reuptake inhibitors (SSRIs; eg, fluoxetine), or verapamil because the effectiveness may be decreased by St. John's Wort (Novo-Passit)
This may not be a complete list of all interactions that may occur. Ask your health care provider if St. John's Wort (Novo-Passit) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
What happens if I miss a dose of St. John's Wort (Novo-Passit)?
No information is available regarding a missed dose of St. John's Wort (Novo-Passit). Consult your doctor, pharmacist, or health care professional if you require further information.
What happens if I overdose Valerian (Novo-Passit)?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include blurred vision; chest tightness; hand tremor; lightheadedness; paralysis; stomach cramping; weak heartbeat.
Proper storage of Valerian (Novo-Passit):
Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Valerian (Novo-Passit) out of the reach of children and away from pets.
Overdose of Valerian (Novo-Passit) in details
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusual tiredness, stomach cramping, chest tightness, shaking of hands/feet.
Notes
Keep all regular medical and laboratory appointments. Liver function tests should be performed if this product is used for an extended time.
Missed Dose
Not applicable.
Storage
Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all medications and herbal products away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
What should I avoid while taking Valerian (Novo-Passit)?
Valerian (Novo-Passit) may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid using Valerian (Novo-Passit) with other herbal/health supplements that can cause drowsiness. This includes 5-HTP (5-hydroxytryptophan), California poppy, catnip, chamomile, gotu kola, Jamaican dogwood, kava, melatonin, Valerian (Novo-Passit), skullcap (or scullcap), yerba mansa, and others.
Avoid drinking alcohol. It can increase drowsiness caused by Valerian (Novo-Passit).
Valerian (Novo-Passit) warnings
Avoid during pregnancy and lactation.
What should I discuss with my healthcare provider before taking Valerian (Novo-Passit)?
You should not use Valerian (Novo-Passit) if you are allergic to it.
Before using Valerian (Novo-Passit), talk to your healthcare provider. You may not be able to use Valerian (Novo-Passit) if you have certain medical conditions.
It is not known whether Valerian (Novo-Passit) will harm an unborn baby. Do not use this product without medical advice if you are pregnant.
It is not known whether Valerian (Novo-Passit) passes into breast milk or if it could harm a nursing baby. Do not use this product without medical advice if you are breast-feeding a baby.
Do not give any herbal/health supplement to a child without medical advice.
Valerian (Novo-Passit) precautions
Before taking Valerian (Novo-Passit), tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this product: liver problems.
Liquid forms of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.
This product may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This product is not recommended for use during pregnancy. Consult your doctor before using this product.
It is unknown if this product passes into breast milk. Consult your doctor before breast-feeding.
What happens if I miss a dose of Valerian (Novo-Passit)?
Since Valerian (Novo-Passit) is used when needed, you are not likely to miss a dose.
References
- DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "Valerian - DrugBank". http://www.drugbank.ca/drugs/DB13196 (accessed September 17, 2018).
- DrugBank. "Guaifenesin". http://www.drugbank.ca/drugs/DB00874 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
