HairfectRx Hair Capsules with Finasteride

Minoxidil + Hair Supplement Complex + Finasteride

Important Safety Information for 

HairfectRx Hair Capsules

(Minoxidil + Hair Supplement Complex + Finasteride OR Dutasteride)

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Minoxidil Prescription Information:

Contraindications and warnings:

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Minoxidil tablets contain a powerful antihypertensive agent which may

produce serious adverse effects. It can cause pericardial effusion, occasionally

progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum

therapeutic doses of a diuretic and two other antihypertensive agents.

In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects.

Minoxidil tablets must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and

increased myocardial workload. It must also usually be given with a diuretic, frequently

one acting in the ascending limb of the loop of Henle, to prevent serious fluid

accumulation. 

Patients with malignant hypertension and those already receiving

guanethidine should be hospitalized when Minoxidil is first

administered so that they can be monitored to avoid too rapid, or large orthostatic,

decreases in blood pressure.

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• Do not use Minoxidil if you have a pheochromocytoma tumor (adrenal gland tumor).
• Call your doctor and get medical care at once if you develop worsening or new chest pain, shortness of breath, pain upon breathing, or increased heart rate.
• Do not take Minoxidil if you are allergic to any of the ingredients in the tablet.
• You should weigh yourself regularly while taking Minoxidil, call your doctor if you gain 5 or more pounds very rapidly.
• Check your blood pressure and heart rate often while taking Minoxidil.
• Do not take Minoxidil in higher doses or more often than you are prescribed. Overdose symptoms may include dizziness or fainting.

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Before taking this medication:

You should not use Minoxidil if you are allergic to it, or:

• If you are a child.
• If you are a woman who is pregnant, may be pregnant, or breastfeeding. It is unknown whether Minoxidil may harm an unborn baby, and Minoxidil does pass into breast milk and may cause harm to a developing baby.

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Tell your healthcare provider about:

• Any health conditions that you have, including; high blood pressure, low blood pressure, congestive heart failure, chest pain (angina), a recent heart attack a recent stroke, blood vessel disease, kidney disease, if you require dialysis, asthma, migraine headaches, epilepsy, or other seizure disorders.
• All other medications that you take, including over-the-counter medications or vitamins and supplements.
• Keep a list of all the medications you take to show your healthcare provider and pharmacist.

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What you should avoid while taking Minoxidil:

• You may need to reduce or limit the amount of salt you intake while you are using Minoxidil. Also, avoid salt substitutes or potassium supplements unless directed otherwise by your doctor.
• You may feel dizzy if you get up too fast after sitting or lying down. Get up slowly and have something available to steady yourself to avoid potential falls.
• Talk to your doctor or pharmacist to see if decongestant medications found in cough and cold medications are a good fit for you.

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Side Effects:

Get emergency medical help if you have signs of an allergic reaction to Minoxidil:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
• A red or purple rash that spreads and causes blistering and peeling.

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Common Minoxidil side effects may include:

• Changes in the length, color, or thickness of face or body hair
• Rash
• Nausea and vomiting
• Breast tenderness or pain

Call your doctor at once if these side effects occur with Minoxidil use:

• Chest pain that is new or getting worse
• Chest pain that feels like it’s spreading to your shoulder or jaw
• Heartbeats that are fast or pounding
• Increased swelling of your ankles, legs, or feet
• Rapid weight gain, especially in your midsection or face
• A shortness of breath
• Feeling lightheaded or like you might pass out
• Signs of fluid build-up in your lungs; pain when taking a breath, feeling shortness of breath when lying down, gasping for breath, coughing up foaming mucus, or wheezing

Finasteride Prescription Information:

Contraindications and warnings:

• Finasteride is a medication approved for use in men only, children should never take Finasteride, and only women who are not of childbearing potential can potentially use Finasteride. Finasteride prescribing for women is based on the clinical judgment of your physician.
• Women who are pregnant or potentially may be pregnant should not handle whole or crushed Finasteride tablets due to the risk of birth defects in a male fetus. If a pregnant woman comes in contact with crushed or broken Finasteride tablets, wash the contact area with soap and water right away, and a healthcare provider should be contacted.
• Finasteride normally causes a decrease in PSA levels. If your PSA levels go up while you are taking Finasteride, it may signal the presence of prostate cancer and should be evaluated by a physician.
• 5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
• Do not take Finasteride if you are allergic to any of the ingredients in the tablet.

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Before taking this medication:

You should not use Finasteride if you are allergic to it, or:

• If you are a child.
• If you are a woman of childbearing potential.
• If you are a woman who is pregnant or may be pregnant. Finasteride may harm an unborn baby.

Tell your healthcare provider about:

• Any health conditions that you have, including liver or prostate problems.
• All other medications that you take, including over-the-counter medications or vitamins, and supplements.
• Keep a list of all medications you take to show your healthcare provider and pharmacist.

Drug Interactions:

• Propecia/Proscar: Do not take Finasteride if you are also taking Propecia or Proscar, these medications contain the same active ingredient, and you would be taking too much. 
• Cytochrome P450-Linked Drug Metabolizing Enzyme System: No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.
• Other Concomitant Therapy: Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.

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Side Effects:

Get emergency medical help if you have signs of an allergic reaction to Finasteride:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

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Potential side effects of Finasteride:

• Decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Finasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.
• Potential increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of Finasteride for hair loss.

Common Finasteride side effects may include:

• Decrease in sex drive
• Trouble getting or keeping an erection
• Decrease in the amount of semen

The following less common side effects have been reported with Finasteride use:

• Breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• Depression
• Decrease in sex drive that continued after stopping the medication
• Allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face
• Problems with ejaculation that continued after stopping medication
• Testicular pain
• Difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen
• In rare cases, male breast cancer

Tell your healthcare provider if you have any side effect that bothers you or does not go away. 

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Dutasteride Prescription Information:

Contraindications and warnings:

• Dutasteride is a medication for men only, women and children should never take Dutasteride.
• Dutasteride is not indicated for use in women or pediatric patients.
• Women who are pregnant or potentially may be pregnant should not handle whole or crushed Dutasteride capsules due to the risk of birth defects in a male fetus. If a pregnant woman comes in contact with crushed or broken Dutasteride capsules, wash the contact area with soap and water right away, and a healthcare provider should be contacted.
• Dutasteride normally causes a decrease in PSA levels. If your PSA levels go up while you are taking Dutasteride, it may signal the presence of prostate cancer and should be evaluated by a physician.
• 5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.
• Do not take Dutasteride capsules if you are allergic to any of the ingredients in the capsule.

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Before taking this medication:

You should not use Dutasteride if you are allergic to it, or:

• If you are a woman or a child.
• If you are a woman who is pregnant or may be pregnant. Dutasteride may harm an unborn baby.

Tell your healthcare provider about:

• Any health conditions that you have, including liver or prostate problems.
• All other medications that you take, including over-the-counter medications or vitamins, and supplements.
• Keep a list of all medications you take to show your healthcare provider and pharmacist.

Drug Interactions:

• Avodart/Propecia/Proscar: Do not take Dutasteride if you are also taking Avodart, Propecia, or Proscar, these medications contain the same active ingredient or an ingredient in the same class, and you would be taking too much. 
• Dutasteride has no known serious or severe interactions with other drugs.
• Moderate interactions with Dutasteride include: carbamazepine, cimetidine, clarithromycin, erythromycin, isoniazid, itraconazole, ketoconazole, nefazodone, rifabutin, rifampin, and St.John’s wort.

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Side Effects:

Get emergency medical help if you have signs of an allergic reaction to Dutasteride:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

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Potential side effects of Dutasteride capsules:

• Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.

Dutasteride capsule side effects may include:

Less common side effects not requiring immediate medical attention:

These side effects may occur during treatment with Dutasteride. These side effects may not require immediate medical attention and may reduce or go away as your body adjusts to the medication with time. Your doctor may be able to help you find ways to reduce or relieve these side effects. Always talk with your doctor about side effects that do not go away or that are bothersome to you.

• Abnormal ejaculation
• Impotence
• Decreased sexual interest
• Decreased sexual performance or desire
• Inability to develop or keep an erection
• Discharge, swelling, soreness, or pain from the breast or breasts

Side effects requiring immediate medical attention:

The following side effects are rare, but if they occur you need to seek immediate medical attention.

• Discomfort or pain in the chest
• Dilated neck vessels
• Irregular breathing or heartrate
• Extreme fatigue
• Swelling of the face, fingers, feet, or lower legs
• Trouble breathing
• Unexpected weight gain
• Decrease in your blood Prostate Specific Antigen (PSA) levels. Dutasteride may lower your PSA levels. If your PSA levels increase during the time that you are taking Dutasteride, this may be a sign of the presence of prostate cancer and should be evaluated, even if this increase is still within normal limits.

The following potential side effects have an unknown incidence, but if they do occur you should seek immediate medical attention.

• Blistering, flaking, or peeling skin
• Cough
• Trouble swallowing
• Dizziness
• Rapid heart rate
• Itching, rash, hives, or welts
• Hive-like swelling of the face, eyes, lips, tongue, throat, hands, legs, feet, or sex organs
• Puffiness or swelling of the eyelids, face, eyes, lips, tongue
• Skin redness
• Chest tightness
• Unusual weakness or tiredness

5 Alpha-Reductase Inhibitors may increase the risk of high-grade prostate cancer.

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Tell your health care provider if you have any side effect that bothers you or does not go away. 

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This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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