Hemocyte Oral

Estrogens and progestins are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness. Progestins help to regulate the effects of estrogens.

Estrogens are prescribed for several reasons:

• to provide additional hormone when the body does not produce enough of its own, such as during menopause. They can also help to relieve a genital skin condition called vaginal or vulvar atrophy.
• to help prevent weakening of bones (osteoporosis) in women past menopause.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens and progestins are available only with your doctor's prescription.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of estrogens and progestins in the elderly with use in other age groups.

Pregnancy

Estrogens and progestins are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Breast Feeding

Estrogens and progestins pass into the breast milk and can change the content or lower the amount of breast milk. Use of this medicine is not recommended in nursing mothers.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Boceprevir
• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anagrelide
• Aprepitant
• Boceprevir
• Bosentan
• Bupropion
• Carbamazepine
• Ceritinib
• Conivaptan
• Dabrafenib
• Darunavir
• Dasabuvir
• Dexamethasone
• Donepezil
• Efavirenz
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Griseofulvin
• Idelalisib
• Isotretinoin
• Lesinurad
• Lixisenatide
• Lumacaftor
• Mitotane
• Modafinil
• Netupitant
• Oxcarbazepine
• Paclitaxel
• Paclitaxel Protein-Bound
• Phenytoin
• Piperaquine
• Pitolisant
• Pixantrone
• Prednisone
• Rifabutin
• Rifampin
• St John's Wort
• Sugammadex
• Theophylline
• Tizanidine
• Topiramate
• Ulipristal
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Calcium, too much or too little in blood or
• Diabetes mellitus (sugar diabetes)
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Liver tumors, benign or
• Lupus erythematosus, systemic or
• Migraine headaches or
• Porphyria—Estrogens may worsen these conditions.

• Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

• Breast cancer or
• Bone cancer or
• Cancer of the uterus or
• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

• Endometriosis or
• Gallbladder disease or gallstones (or history of) or
• High cholesterol or triglycerides (or history of) or
• Liver disease or
• Pancreatitis (inflammation of pancreas)—Estrogens may worsen these conditions; while estrogens can improve blood cholesterol, they may worsen blood triglycerides for some people.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

• Vision changes, sudden onset including
• Bulging eyes or
• Double vision or
• Migraine headache or
• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

This section provides information on the proper use of a number of products that contain estrogen and progestin combination (ovarian hormone therapy). It may not be specific to Hemocyte. Please read with care.

Estrogens and progestins usually come with patient information or directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

For patients taking estrogens and progestins by mouth:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For 17 beta-estradiol and norgestimate
• For oral dosage forms (tablets):
  • For treating a genital skin condition (vaginal or vulvar atrophy), or vasomotor symptoms of menopause:
    • Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.
  • To prevent loss of bone (osteoporosis):
    • Adults—Oral, 1 mg estradiol for three days followed by 1 mg of estradiol combined with 0.09 mg of norgestimate for three days. The regimen is repeated continuously without interruption.

For ethinyl estradiol and norethindrone
• For oral dosage forms (tablets):
  • For treating vasomotor symptoms of menopause:
    • Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.
  • To prevent loss of bone (osteoporosis):
    • Adults—Oral, 2.5 mcg (0.025 mg) ethinyl estradiol and 0.5 mg norethindrone once daily.

For estradiol and norethindrone
• For oral dosage forms (tablets):
  • For treating vasomotor symptoms of menopause or treatment of vaginal or vulvar atrophy:
    • Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.
  • To prevent loss of bone (osteoporosis):
    • Adults—Oral, 1 mg estradiol and 0.5 mg norethindrone once daily.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer, and no need to take an estrogen and progestin combination.

It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.

Check with your doctor immediately if any of the following side effects occur:

Check with your doctor as soon as possible if any of the following side effects occur:

• Breast pain or tenderness
• dizziness or light-headedness
• headache
• rapid weight gain
• swelling of feet and lower legs
• vaginal bleeding

• Breast lumps
• change in vaginal discharge
• discharge from nipple
• nausea and vomiting
• pains in chest, groin, or leg, especially calf
• pains in stomach, side, or abdomen
• pain or feeling of pressure in pelvis
• severe or sudden headache
• sudden and unexplained shortness of breath
• sudden loss of coordination
• sudden slurred speech
• sudden vision changes
• weakness or numbness in arm or leg
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• bloating or gas
• dizziness
• general feeling of tiredness
• flu-like symptoms
• mental depression
• muscle aches
• nausea—taking tablet with food may decrease
• vaginitis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

This medication is an iron supplement used to treat or prevent low blood levels of iron (e.g., for anemia or during pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health.

How to use Hemocyte

Follow all directions on the product package, or take as directed by your doctor. Do not take more than the recommended dosage. If you have any questions, ask your doctor or pharmacist.

Iron is best absorbed on an empty stomach (usually if taken 1 hour before or 2 hours after meals). If stomach upset occurs, you may take this medication with food. See the instructions below for the liquid drops for infants/children. Avoid taking antacids, dairy products, tea, or coffee within 2 hours before or after this medication because they will decrease its effectiveness.

Take tablets or capsules with a full glass of water (8 ounces or 240 milliliters) unless otherwise directed by your doctor. Do not lie down for 10 minutes after taking your tablet or capsule dose.

Swallow extended-release capsules whole. Do not crush or chew extended-release capsules or tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split extended-release tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

If you are taking chewable tablets, chew the medication thoroughly, then swallow.

If you are taking a liquid suspension form of this medication, shake the bottle well before each dose.

If you are taking the liquid form for adults, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Mix the dose in a glass of water or juice, and drink the mixture through a straw to prevent staining the teeth.

If you are giving the liquid drops to an infant or child, use the dropper provided to carefully measure the dose. The dose may be placed directly into the mouth (towards the back of the tongue) or it may be mixed in formula (not milk), fruit juice, cereal, or other food as directed to increase your child's acceptance. It is best to give this medication right after a meal. Follow the directions on the product package for the brand that you use.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Before taking this medication, 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.

This medication should not be used if you have certain medical conditions. Before taking this medication, consult your doctor or pharmacist if you have: iron overload disorder (e.g., hemochromatosis, hemosiderosis).

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: use/abuse of alcohol, liver problems, stomach/intestinal problems (e.g., ulcer, colitis).

If your brand of iron supplement also contains folic acid, be sure to tell your doctor or pharmacist if you have vitamin B12 deficiency (pernicious anemia) before taking it. Folic acid may falsely improve certain laboratory tests for vitamin B12 deficiency without actually treating this anemia. Untreated vitamin B12 deficiency may result in serious nerve problems (e.g., peripheral neuropathy symptoms such as numbness/pain/tingling sensations). Consult your doctor or pharmacist for details.

Chewable tablets of this medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

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 using this product safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.