NEXTSTELLIS is a new medicine used by women to prevent pregnancy, often referred to as 'The Pill'. This leaflet provides important information about using NEXTSTELLIS and its potential side effects. Because this medicine is new, it is subject to additional monitoring to quickly identify new safety information. It's crucial to report any side effects you experience.
What is NEXTSTELLIS?
NEXTSTELLIS contains estrogen and has selective activity. E4 has highly selective action on estrogen receptors in the body. For more information, see Section 1 of the full CMI.
Important Considerations Before Using NEXTSTELLIS
Before starting NEXTSTELLIS, carefully consider the following:
Increased Risk of Blood Clots: You should not use NEXTSTELLIS if you have or are concerned about an increased risk of blood clots. Serious blood clots can happen, especially if you smoke or are obese, and may even be fatal. Be aware that factors for blood clotting include prolonged or temporary immobilisation (e.g. travel), particularly in women with other risk factors. Also, a procedure that would require a significant period of immobilisation will increase the risk of blood clots temporarily. Talk to your doctor if you will be immobilised for an extended period of time.
Other Medical Conditions: NEXTSTELLIS may not be suitable if you have certain medical conditions such as:
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- Cancer that may grow under the influence of sex hormones (e.g. breast or uterine cancer).
- Antiphospholipid antibodies e.g. lupus anticoagulant.
- Are depressed or have been depressed in the past. (Depression is a well-known risk factor for suicidal behaviour.)
- Are breastfeeding or plan to breastfeed.
Surgery: If you are scheduled for surgery, discuss with your doctor when to stop and restart NEXTSTELLIS. Your doctor may advise you to stop taking NEXTSTELLIS several weeks before surgery and not restart until at least two weeks after surgery, since the risk of blood clots is temporarily increased in this situation.
How to Use NEXTSTELLIS
- Dosage: Take one tablet every day at the same time, as indicated on your blister pack. Both the pink tablets and white tablets should be swallowed whole. Tablet-taking should start on the first day of your period.
- Consistency: Do not skip your tablets, even if you do not have sex often. Missing tablets (starting the pack late) could lead to pregnancy.
- Missed Tablets: If you miss a tablet, take it as soon as you remember. Take the next tablet at your regular time. Discard the other missed tablet(s). If you are more than 24 hours late, take only the last missed tablet as soon as you remember, even if it means taking two tablets in the one day. Discard the other missed tablet(s).
- What if you miss two periods? If you miss two periods in a row or feel like you may be pregnant, call your doctor.
- Stopping NEXTSTELLIS: If you want to become pregnant, you may stop taking the Pill whenever you wish.
Potential Side Effects of NEXTSTELLIS
All medicines can have side effects. Sometimes they are serious, most of them are minor and temporary.
Common side effects associated with NEXTSTELLIS include:
- Weight gain
- Breast tenderness
- Decreased sex drive
- Nausea
- Mood changes
While weight loss is not explicitly listed as a common side effect, individual reactions to medications can vary. It's essential to pay attention to your body and report any unexpected changes to your doctor.
Serious Side Effects
Be vigilant for signs of serious side effects, including those related to blood clots. Seek immediate medical attention if you experience:
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- Severe pain or swelling in the abdomen
- Swelling or pain in the leg
- Sudden change in eyesight
- Severe chest pain, sudden cough or shortness of breath
- Change in colour of the skin on the leg e.g. turning blue, pale or red
- Unusual, severe or prolonged headache
- Focal neurological symptoms
If you notice anything else that is making you feel unwell, consult your doctor, pharmacist or nurse.
Interactions with Other Medicines
Some medicines may interfere with NEXTSTELLIS and affect how it works. Be particularly cautious if you are taking:
- Products containing St. John's Wort
- ACE inhibitors (e.g. captopril, enalapril)
- Angiotensin-II receptor antagonists (e.g. candesartan, irbesartan, losartan)
- Potassium-sparing diuretics (e.g. amiloride, spironolactone, triamterene)
Inform your doctor or pharmacist about all medications, vitamins, and herbal supplements you are taking before starting NEXTSTELLIS.
Additional Information
- An Information Card for women is available at nextstellis.com.au.
- NEXTSTELLIS contains 24 pink (active) tablets and 4 white (inactive) tablets. Aust R 341876.
- Do not give NEXTSTELLIS to anyone else.
- Avoid spending long periods in direct sunlight, tanning booths or under sun lamps while taking NEXTSTELLIS.
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