PATIENT INFORMATION LYMEPAK (LIME-pac) (doxycycline) Tablets, for oral use
Read this Patient Information before you start taking LYMEPAK and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
What is LYMEPAK?
LYMEPAK is a prescription medicine used for the treatment of early Lyme disease due to a bacteria known as Borrelia burgdorferi in adults and children 8 years of age and older weighing 99 pounds (lbs) (45 kg) and above.
It is not known if LYMEPAK is safe and effective in children less than 8 years of age or weighing under 99 lbs (45 kg).
Do not take LYMEPAK if you:
- are allergic to doxycycline or any of the ingredients in LYMEPAK. See the end of this Patient Information leaflet for a complete list of ingredients in LYMEPAK.
- have diarrhea or watery stools.
- have vision problems.
- have or had a yeast or fungal infection in your vagina.
- are pregnant or plan to become pregnant. LYMEPAK may harm your unborn baby. Taking LYMEPAK while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking LYMEPAK and call your doctor right away if you become pregnant while taking LYMEPAK.
- are breastfeeding or plan to breastfeed. LYMEPAK can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take LYMEPAK. You and your doctor should decide if you will take LYMEPAK or breastfeed. You should not do both. After the last dose you should not breastfeed for 5 days
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYMEPAK and other medicines can affect each other causing serious side effects.
Especially tell your doctor if you take:
- a blood thinner medicine.
- a penicillin (antibacterial medicine).
- antacids that contain aluminum, calcium, or magnesium.
- products containing iron or bismuth subsalicylate.
- birth control pills. LYMEPAK may reduce the effectiveness of birth control pills. Talk to your doctor about what types of birth control you can use to prevent pregnancy during treatment with LYMEPAK.
- a medicine taken by mouth that contains isotretinoin or acitretin.
- a medicine to treat seizures, such as carbamazepine or phenytoin.
How should I take LYMEPAK?
- Take LYMEPAK exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your risk of side effects, including the risk that bacteria will become resistant to LYMEPAK.
- Take 1 LYMEPAK tablet every 12 hours
- Take LYMEPAK with enough fluid to completely swallow the tablet and avoid taking LYMEPAK less than 30 minutes before going to bed to lower your risk of getting irritation or ulcer in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
- If irritation of the stomach happens, LYMEPAK may be taken with food or milk.
- If you took too much LYMEPAK stop taking LYMEPAK and call your doctor right away or go to the nearest hospital emergency room.
- Your doctor may do blood tests during treatment with LYMEPAK to check for side effects.
What should I avoid while taking LYMEPAK?
Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear clothes that cover your skin while out in sunlight. Stop taking LYMEPAK and tell your doctor right away if you get sunburn.
What are the possible side effects of LYMEPAK?
LYMEPAK may cause serious side effects, including:
- Harm to an unborn baby. See ” What should I tell my doctor before taking LYMEPAK?”
- Harm to infants and children under 8 years of age:
- Permanent teeth discoloration. LYMEPAK may permanently turn a baby or child’s teeth yellow-gray-brown during tooth development.
- Slow bone growth. LYMEPAK may slow bone growth in infants and children. Slow bone growth is reversible after stopping treatment with LYMEPAK.
- Diarrhea. Diarrhea can happen with most antibiotics, including LYMEPAK. This diarrhea may be caused by an infection ( Clostridium difficile) in your intestines. Call your doctor right away if you get watery or bloody stools, this can happen anytime while on LYMEPAK, or even two or more months after taking your last dose.
- Severe Skin Reactions Stop taking LYMEPAK and tell your doctor right away if you get any of the following symptoms during treatment with LYMEPAK:
- rash with red, purple, blue or gray discoloration with fever
- trouble breathing
- feeling uneasy
- itching or burning eyes
- sensitivity to light
- joint pain
- painful skin with blisters
- skin peeling (chest, face, palms of the hands or soles of the feet)
- sores or ulcers (mouth, eyes, vagina or penis)
- swollen lymph nodes
- Jarisch-Herxheimer Reaction. This reaction can happen in people with early Lyme Disease and begins one to two hours after the first dose of LYMEPAK and disappears within 12 to 24 hours. The reaction may include fever, chills, muscle pain, headache, worsening of skin lesions, fast heart rate, fast breathing, flushing of skin, and increase in blood pressure. Tell your doctor if you have any of these symptoms.
- Increased pressure around the brain (intracranial hypertension). This condition may lead to vision changes and permanent vision loss. You may be more likely to get intracranial hypertension if you are female of childbearing age and are overweight or have a history of intracranial hypertension. Stop taking LYMEPAK and call your doctor right away if you have blurred or double vision, vision loss, or unusual headaches.
If you have any of the above serious side effects during treatment with LYMEPAK, your doctor may stop your treatment.
Common side effects of LYMEPAK include:
- loss of appetite
- skin sensitivity to sunlight
- reversible discoloration of the surface of adult teeth
- lower than normal amount of red blood cells
These are not all the possible side effects of LYMEPAK.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LYMEPAK?
- Store LYMEPAK at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep LYMEPAK inside blister dose card and out of light.
- Keep LYMEPAK away from moisture
Keep LYMEPAK and all medicine out of the reach of children.
General information about the safe and effective use of LYMEPAK
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take LYMEPAK for a condition for which it was not prescribed. Do not give LYMEPAK to other people, even if they have the same symptoms you have. It may harm them. You can also ask your doctor or pharmacist for information that is written for health professionals.
What are the ingredients in LYMEPAK?
Active ingredient: doxycycline
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C yellow #6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.
Chartwell Pharmaceuticals, LLC.
Congers, NY 10920 USA
Lifsa Drugs LLC
New Brunswick, NJ 08901 USA
Made in USA
For more information, go to www.lymepak.com or call 1-845-232-1683.
This Patient Information has been approved by the U.S. Food and Drug Administration.
(doxycycline hyclate tablets)
14 Tablets | 7 Day Supply
R x Only
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