Ovral-G (Marca)

Precautions

• Any allergies, especially estrogens (e.g. Ethinyl Estradiol, Mestranol) or progestins (e.g. Norethindrone, Desogestrel)
• A history of stroke or other blood clots (e.g. in the legs, eyes, lungs)
• Severe high blood pressure
• Abnormal breast exams
• Cancer (especially endometrial or breast cancer)
• Diabetes that has caused a disease of the kidneys, eyes, nerves or blood vessels
• Severe headaches or migraines
• A history of heart disease (e.g. heart attack, chest pain)
• Heart valve diseases
• Liver problems (e.g. liver tumor, active liver disease)
• A current or suspected pregnancy
• A recent major surgery
• Long periods of sitting or lying down (e.g. immobility such as being bedridden)
• A history of yellowing eyes or skin (jaundice) during pregnancy or while using hormonal birth control (e.g. pills, patch)
• Unexplained vaginal bleeding
• Heavy tobacco use (especially if 35 or over)
• High blood pressure
• High cholesterol or triglyceride (blood fat) levels
• Depression
• Swelling (edema)
• Gallbladder problems
• Kidney diseases
• Obesity
• Irregular, missed or very light periods
• A recent pregnancy
• Thyroid problems

If you currently have or used to have any of the above conditions, you may not be able to take this medication or you may need a dosage adjustment.

Medication containing female hormones combined with smoking, significantly increases the risk of strokes, blood clots, heart attacks or high blood pressure, especially when you're 35 years or over. Consult your doctor about an effective smoking cessation programme.

If you have diabetes, Ovral-G may make it more difficult to control your blood sugar levels. Monitor your blood sugar regularly. Your anti-diabetes medication and diet may have to be adjusted.

Ovral-G may cause blotchy, dark areas on your skin (melasma). This effect may be worsened by exposure to sunlight. Avoid prolonged sun exposure, sunlamps and tanning booths. Use an effective sunscreen or protective clothing when going outside into the sun.

Ovral-G is classed as Pregnancy Category X by the FDA. This means it is not safe to use during pregnancy and could be harmful to an unborn baby. If you are pregnant or think you may be pregnant, stop taking Ovral-G and contact your doctor immediately. If you have just given birth within the last 3 months or suffered a miscarriage or abortion, you should consult your doctor about reliable forms of birth control and find out when it is safe to start using birth control containing estrogen.

Ovral-G passes into breast milk. This may affect milk production and may be harmful for a nursing infant. It is not recommended to take this medication while breastfeeding a baby.

Drug Interactions

• Aromatase inhibitors (e.g. Anastrazole, Exemestane)
• Raloxifene
• Sodium Tetradecyl Sulfate
• Tamoxifen
• Medication for an underactive thyroid (hypothyroidism)
• Medicines that may increase blood levels of this drug (e.g. Acetaminophen, Ascorbic Acid/vitamin C, Atorvastatin, Azole antifungals such as Itraconazole, Ketoconazole or vaginal Miconazole)
• Certain antibiotics (e.g. Cephalosporins, Chloramphenicol, macrolides such as Erythromycin, Penicillins, Sulfas)
• Aprepitant
• Bexarotene
• Bosentan
• Dapsone
• Felbamate
• Griseofulvin
• Certain HIV protease inhibitors (e.g. Amprenavir, Nelfinavir, Ritonavir)
• Modafinil
• Nevirapine
• Phenylbutazone
• Rifamycins (e.g. Rifampin)
• Many seizure medications (e.g. barbiturates, Carbamazepine, Phenytoin, Lamotrigine, Topiramate)
• St. John's wort
• Acetaminophen
• Aspirin
• Certain beta blockers (e.g. Metoprolol)
• Clofibrate
• Cyclosporine
• Morphine
• Corticosteroids such as Prednisolone
• Certain benzodiazepines such as Lorazepam or Temazepam
• Theophylline

This is only a partial list and there may be other medication that interacts with Ovral-G. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and medication prescribed by other doctors. Do not start or stop using a new medication without telling your doctor first. 

The following common side effects of Ovral-G may occur:

• Nausea
• Vomiting
• Headache
• Stomach cramping or bloating
• Dizziness
• Vaginal discomfort or irritation
• Increased vaginal fluids
• Breast tenderness or enlargement
• Worsened acne
• Vaginal bleeding between periods (spotting) or missed, irregular periods

If any of the above effects persist or worsen, you should contact your doctor immediately.

Inform your doctor straightaway if you experience any of the following serious side effects:

• Changes in vaginal bleeding (e.g. continuous spotting, sudden heavy bleeding, missed periods)
• Problems wearing contact lenses
• Dark patches on the skin (melasma)
• Unwanted facial or body hair
• Swelling of the ankles or feet
• Weight changes (gain or loss)

In rare cases, Ovral-G may cause serious (sometimes fatal) problems from blood clots (e.g. pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience any of the following:

• Sudden shortness of breath
• Pain in the chest, jaw or left arm
• Confusion
• Coughing up blood
• Sudden dizziness or fainting
• Pain, swelling or warmth in the groin or calf
• Tingling, weakness or numbness in the arms or legs
• Headaches that are different from what you are used to (e.g. with other symptoms such as vision changes, lack of coordination, existing migraines becoming worse, sudden or very severe headaches)
• Slurred speech
• Weakness on one side of the body
• Vision problems or changes

Inform your doctor immediately if you notice any of the following rare but very serious side effects:

• Lumps in the breast
• Severe stomach, abdominal or pelvic pain
• Mental or mood changes (e.g. depression, suicidal thoughts, persistent trouble sleeping)
• Unusual tiredness
• Dark urine
• Yellowing eyes or skin (jaundice)

You are unlikely to incur an allergic reaction to Ovral-G, but seek emergency medical attention if you experience any of the following symptoms:

• Rash
• Itching or swelling (especially of the face, tongue or throat)
• Severe dizziness
• Trouble breathing

This is only a partial list of potential side effects and others may occur. Inform your doctor immediately if you experience any other side effects than the ones mentioned above, especially if they are bothersome.