Ragwitek 12 AMB 3x10 Sublingual Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

POLLEN ALLERGEN EXTRACT - SUBLINGUAL

(POL-uh-n)

WARNING: Rarely, this medication can cause a serious (rarely fatal) allergic reaction. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: flushing/rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, fast/weak heartbeat, or trouble breathing. To be sure that you do not have a serious reaction, you will need to stay in a health care setting for 30 minutes after taking this drug for the first time so your doctor can carefully monitor you and provide medical help if needed. Your doctor will also prescribe another medication (epinephrine) to use if you have a serious allergic reaction outside the health care setting. Read the Patient Information Leaflet for this medication provided by your pharmacist. Learn ahead of time when and how to use your brand of epinephrine, and get medical help right away if you have to use it. Certain medical conditions may increase the seriousness of an allergic reaction or your risk for an allergic reaction. These include high blood pressure, breathing disorders such as asthma, or heart problems such as angina/irregular heartbeat/previous heart attack. Also, some medications (including beta blockers such as atenolol) may make epinephrine or other rescue medications not work as well or increase your risk for side effects from these medications. Be sure to tell your doctor about all the drugs you use (including prescription/nonprescription drugs and herbal products).

USES: This medication is used to treat certain allergies that may occur seasonally or year round. It is an extract of certain plant pollens that can cause allergies. Before prescribing this medication, your doctor must do laboratory/medical tests (such as skin or IgE tests) to learn what you are allergic to. This pollen allergen extract works by making your body less sensitive to the pollens (such as ragweed, grasses) that cause your allergies. This medication will not work right away to relieve allergy symptoms. When taken as directed, it may help relieve symptoms such as sneezing, runny/stuffy nose, cough, or itchy/watery eyes that are caused by allergies.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth without food as directed by your doctor, usually once daily. With dry hands, remove one tablet from the package just before taking. Place the tablet under the tongue and allow it to dissolve for at least 1 minute before swallowing. Do not chew or swallow the tablet. Do not eat or drink while the tablet is dissolving in your mouth and for 5 minutes after taking it. Wash your hands after handling the tablet. If needed, an adult should help a child take this medication properly. Watch the child for at least 30 minutes after each dose to make sure the child does not have an allergic reaction to the medication. For some brands of this medication, your doctor may direct you to start this medication at a low dose and gradually increase your dose to reduce your risk of side effects. Follow your doctor\'s instructions carefully. Usually, your doctor will direct you to start taking this medication about 4 months before the expected start of allergy season, and continue taking it throughout the season. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Mild mouth/eye/ear/throat itching, throat dryness/irritation, cough, mouth/tongue swelling, or mouth blisters may occur, especially during the first few days of treatment. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Get medical help right away if you have any very serious side effects, including: throat tightness/swelling, trouble swallowing/breathing, chest pain, voice changes. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction (see also Warning Section). This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning Section. Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other allergen extracts; 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. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing disorders (such as asthma, chronic obstructive pulmonary disease-COPD), heart problems (such as angina, irregular heartbeat, previous heart attack), high blood pressure, mouth irritation (such as due to cold sore, ulcer, infection), a certain esophagus problem (eosinophilic esophagitis), previous allergic reaction, other current allergy treatments (such as allergy shots, other allergen extracts). Before having surgery or a dental procedure, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may direct you to temporarily stop treatment with this medication after dental surgery or a procedure (such as tooth extraction). Ask your doctor or dentist for details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning Section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.

OVERDOSE: 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.

NOTES: Do not share this medication with others. It may harm them, even if their symptoms are the same as yours. Your doctor may direct you to also use other medications for allergy symptoms or mild side effects (such as antihistamines, nasal sprays for allergies). Ask your doctor for details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

Information last revised March 2022. Copyright(c) 2022 First Databank, Inc.