Ethinylestradiol + Levonorgestrel - Transdermal

Ethinylestradiol and Levonorgestrel are combined in this medicine.

Ethinylestradiol + Levonorgestrel is a combination transdermal contraceptive (birth control patch). This medicine is used to prevent pregnancy in women of reproductive age.

Apply Ethinylestradiol + Levonorgestrel patch on your skin exactly as directed by your doctor or according to the instructions on the label. Do not apply more or less than instructed by your doctor.

Do not cut the patch. The release pattern of the medicine will be affected if you cut the patch. Do not use it for a longer period than instructed by your doctor.

Instructions for application:

1. Remove the patch from the protective foil pouch and peel away half of the liner. Do not touch the sticky side with your fingers.
2. Apply the patch to a clean, dry, and hairless area on your upper torso, lower abdomen, or buttock. Make sure that the area of skin is not oily, cut, blistered, or irritated. The skin should be free of any powder, creams, or lotions. Do not put the patch near the waistline or where your belt or clothes may rub against it.
3. If the patch is not flat on the skin or if there are wrinkles, gently pull the patch off while holding the remaining half of the liner then reapply. Peel away the other half of the liner when the patch is flat with no wrinkles. Press firmly on the skin for 10 seconds to ensure that the patch stays on the skin. Check your patch every day to ensure that it is in the right place.
4. Wear the patch for 7 days (week one). Replace it on Day 8 (week two) and again on Day 15 (week three) on your usual "Patch Change Day". Do not wear a patch during the patch-free week from Day 22 to 28 (week four). The next four-week cycle will begin by applying a new patch on the usual "Patch Change Day", the day after Day 28. Remove the old patch before applying a new one. Change the site of application every week to avoid skin irritation. Do not apply the patch to the same area of skin as the previous patch.
5. If the patch starts to lift off your skin or is completely off for less than one day, try to put it on again or immediately replace it with a new patch (additional birth control is not necessary and your "Patch Change Day" will not change). If the patch starts to lift off your skin or is completely off for more than 1 day or if you are not sure how long, stop your current patch cycle and start over on a new patch cycle right away by putting on a new patch. The day you apply your new patch is now your new Day 1 and your new "Patch Change Day".
6. Throw away the used patch by folding the sticky sides together, put it back in the empty pouch, and place it in a rubbish bin. Do not throw it into the toilet bowl. Wash your hands after throwing the used patch.

If you forget to change your patch at the start of any patch cycle (Day 1/week one), apply the first patch of your new patch cycle as soon as you remember. This is now your new "Patch Change Day" and your new Day 1.

If you forget to change your patch in the middle of the patch cycle (Day 8/week two or Day 15/week three) for 1 or 2 days, you should apply a new patch right away. The next patch should be applied on your usual "Patch Change Day". If you forget to change your patch for more than 2 days, you should stop your current patch cycle and start a new 4-week patch cycle right away by putting on a new patch. This is now your new "Patch Change Day" and your new Day 1.

If you forget to remove your patch at the end of your patch cycle (Day 2/week 4), take it off as soon as you remember. Start your new cycle on your usual "Patch Change Day".

If you often forget to use your medicine, let your doctor and pharmacist know.

Alert your doctor if you have the following conditions:

• current or history of blood clot formation e.g. deep vein thrombosis (blood clots in your leg veins), pulmonary embolism (blood clots in a lung artery), history of heart attack or stroke
• with risk factors of blood clot formation e.g. severe or uncontrolled high blood pressure, high cholesterol level, prolonged immobilisation
• hereditary or acquired blood clotting disorders
• heart valve or heart rhythm disorders that may be associated with formation of blood clots
• unexplained vaginal bleeding
• current or history of breast cancer and other sex hormone-sensitive cancers
• current or history of pancreatitis (inflammation of the pancreas) with high cholesterol level
• liver disease e.g. liver tumours
• migraine (severe throbbing or pulsating sensation usually affecting one side of the head that is often accompanied by nausea, vomiting, and sensitivity to light and sound)
• obesity

as Ethinylestradiol + Levonorgestrel may not be suitable for you.

Do not use this medicine if you are pregnant or if you think that you are pregnant. If you become pregnant while being treated with this medicine, alert your doctor immediately. Ethinylestradiol + Levonorgestrel may cause harm to your unborn child.

Do not use this medicine with medicines used to treat hepatitis C. Please see the section "Can I use this with other medicines?" below for more information.

Inform your doctor if you have the following conditions:

• history of chloasma gravidarum (discolouration of the skin especially on the face or neck during pregnancy)
• risk factors for heart disease e.g. high cholesterol or triglyceride levels
• diabetes
• depression
• hereditary angioedema (an inherited disorder characterised by swelling of the limbs, face or airways)
• systemic lupus erythematosus (an autoimmune disease that causes inflammation)

Let your doctor know if you are breastfeeding.

Ethinylestradiol + Levonorgestrel does not lower the risk of getting HIV infection or any other sexually transmitted diseases. Ensure that you use proper precautions to avoid getting these diseases.

If you are going to have an operation, including minor surgery and dental work, inform your doctor or dentist that you are using this medicine.

If you are going for certain laboratory tests (e.g. liver, kidney, thyroid function test), inform your doctor that you are using Ethinylestradiol + Levonorgestrel.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests must be done before treatment to know if this medicine is suited for you to use.
• Routine tests (e.g. cholesterol/sugar levels) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Your blood pressure may rise to unsafe levels without you noticing it. Monitor your blood pressure before and during treatment.
• Regular monitoring of signs and symptoms of depression, unusual vaginal bleeding, and changes in vision may also be needed.

Ethinylestradiol + Levonorgestrel may cause any of the following side effects: headache, nausea, painful menstruation, and weight gain.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• pain, swelling and tenderness in your leg accompanied by redness and warmth
• breathlessness, chest pain, irregular heartbeat
• yellowing of the skin or eyes, fever, loss of appetite, dark coloured urine
• sudden partial or complete blurring or loss of vision
• recurrent, persistent, or severe migraine
• changes in the nipple, lumps in the breast, dimpling of the skin
• golden brown pigment patched on the skin especially on the face and neck
• unusual vaginal bleeding

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Do not use Ethinylestradiol + Levonorgestrel with medicines used in hepatitis C combination therapy such as ombitasvir, paritaprevir, ritonavir, dasabuvir, glecaprevir, pibrentasvir, sofosbuvir, velpatasvir, voxilaprevir.

Inform your doctor or pharmacist if you are taking or using any of these medicines:

• medicines for epilepsy (fits or seizures) e.g. topiramate, felbamate, primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, lamotrigine
• rifampicin (medicine to treat TB, lung infection known as tuberculosis)
• bosentan (medicine to treat high blood pressure in the blood vessels leading to the lungs)
• medicines for HIV infection e.g. nelfinavir, efavirenz, nevirapine
• aprepitant (medicine to treat nausea and vomiting caused by chemotherapy)
• medicines for fungal infection e.g. griseofulvin, voriconazole
• ciclosporin (medicine used in organ transplant or certain immune diseases)
• tizanidine (muscle relaxant)
• theophylline (asthma medicine)
• etoricoxib (medicine for pain and inflammation)
• erythromycin (antibiotic)
• medicine for heart disease e.g. diltiazem, verapamil
• vitamin C
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Ethinylestradiol + Levonorgestrel.

Always notify your doctor and pharmacist if you are taking or using any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice (more than 1 litre a day).

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.