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Introduction About FREEDASE 30 TABLET
FREEDASE 30 TABLET is a combination of Dienogest and Estradiol, which belongs to the group of medicines called Hormonal contraceptive agents. It is used to manage pregnancy. It is used to manage acne and heavy menstrual bleeding in women who take medicines to manage pregnancy. It works by managing unwanted or unplanned pregnancies.
Contraception, also known as birth control, is used to manage pregnancy, but there are also other options available other than contraceptives to manage pregnancy. Acne vulgaris is a condition where the hair follicles get blocked by dead cells, bacteria, and oil (sebum), causing blemishes, pimples, blackheads, whiteheads, and cysts.
Acne vulgaris, also commonly known as common acne, is most common in people around puberty and pregnant women. It is due to hormonal changes that increase oil secretion, thus causing acne.
FREEDASE 30 TABLET is not recommended for use in women with blood clots or a high risk of blood clots. FREEDASE 30 TABLET should be used with caution in patients with depression and varicose veins. Pregnant and breastfeeding women should not use FREEDASE 30 TABLET. If you are found to be pregnant, stop taking the medicine and consult your doctor immediately. Consult your doctor before taking it.
FREEDASE 30 TABLET should be used with caution in post-pubertal female children under the age of 18 years and should be used with caution in elderly women. Consult your doctor before taking it. The most common FREEDASE 30 TABLET side effects are unusual spotting or bleeding, nausea, breast tenderness, and headache.
Uses Of FREEDASE 30 TABLET
- Prevents pregnancy
- Manage heavy menstrual bleeding in women planning to manage pregnancy
- Manage acne in women who do not respond to other topical therapies or oral antibiotics
How FREEDASE 30 TABLET Works
FREEDASE 30 TABLET is an oral contraceptive medicine that works by managing unwanted or unplanned pregnancies. Dienogest and Estradiol are both synthetic forms of the female sex hormones progesterone and oestrogen that work together to manage egg release from the ovaries (ovulation) by suppressing the hormone responsible for ovulation and also promoting changes in the uterine thickening and mucus membrane. These changes make it difficult for the sperm to enter the uterus and implant the fertilised egg. Progestin, present in FREEDASE 30 TABLET, works by managing heavy menstrual bleeding. FREEDASE 30 TABLET reduces the male sex hormone (testosterone), which reduces oil secretion (sebum), managing acne formation.
How to use FREEDASE 30 TABLET
Take FREEDASE 30 TABLET strictly as advised by your physician. Do not miss any doses between the courses because the management may not be effective if any doses are missed. Swallow the medicine with a glass of water. FREEDASE 30 TABLET can be taken with or without food. Do not crush or chew the medicine. In case you have missed a dose, take it as soon as you remember it. Missing doses cause bleeding or spotting. Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition. If you have any doubts regarding the doses, consult your doctor.
Side Effects Of FREEDASE 30 TABLET
Common
- spotting or bleeding between menstrual periods
- nausea, headache, migraine
- stomach pain, acne
- absence of periods (amenorrhea), painful periods, irregular bleeding
- breast discomfort, tenderness
- weight gain
- difficulty wearing contact lenses
- vaginal irritation or infections
- urinary tract infection
- upper respiratory tract infections (colds, runny, stuffy nose)
- depression, trouble sleeping, nervousness
- back pain, fatigue, fever
- allergy, rash
- diarrhoea, flatulence
Uncommon
- decreased libido
- oedema, abnormal blood pressure
- blotchy darkening of the skin, face
- high blood sugar, and high-fat levels
- fungal infections, vaginal infection
- increased appetite
- hair loss, excessive sweating, itching, rash
- muscle cramps
- swollen breasts, lumps in the breast
- abnormal cell growth on the neck of the womb
- pain with intercourse, fibrocystic breast disease
- ovarian cyst, pelvic pain
- premenstrual syndrome
- abnormal growth, contractions in the uterus
- weight loss
Rare
- fungal infections
- oral infections, pelvic inflammatory disease
- eye disease
- urinary tract infection, bacterial infections
- aggression, anxiety
- increased libido
- nightmare, restlessness, stress
- reduced attention, numbness
- dry eye, eye swelling
- heart attack
Stop taking FREEDASE 30 TABLET and contact your doctor immediately if you experience any of the following side effects:
- deep vein thrombosis symptoms include persistent leg pain felt only when standing or walking, warmness in the leg, colour changes in the affected leg like pale, red or blue
- pulmonary embolism. symptoms include sudden breathlessness or rapid breathing, sudden cough with blood, chest pain on breathing, dizziness, irregular heartbeat, severe stomach pain
- retinal vein thrombosis (blood clot in eyes). symptoms include painless blurring of vision leading to sudden loss of vision
- chest pain, discomfort, heaviness, squeezing sensation or sensation of fullness in the chest, arms or below the breast, fullness, indigestion, choking feeling, pain in the upper body radiating towards back, jaw, throat, arm, stomach, sweating, nausea, vomiting, dizziness, extreme tiredness, anxiety, shortness of breath and irregular heartbeats
- symptoms of heart attack
- stroke. symptoms weakness or numbness in an arm or leg, trouble speaking, sudden confusion and trouble sleeping in one or both eyes, trouble walking, loss of balance, severe headache, fainting with or without seizures
- blood clots blocking other blood vessels symptoms include swelling and blue colour of legs or arms swelling and slight blue discolouration of legs or arms
- severe allergic reactions include swelling of the face, lips, mouth, tongue, or throat
- breast cancer symptoms include dimpling of the skin, changes in the nipple and lump formation
- signs of cancer of the cervix such as vaginal discharge with odour or blood, unusual bleeding, pelvic pain, painful sex
- severe liver problems. symptoms include severe stomach pain, yellow skin, or eyes (jaundice), inflammation of the liver (hepatitis), yellow skin or eyes (jaundice)
- gallbladder disease
How To Manage Side Effects
Diarrhea
Drinking plenty of water and other electrolyte-balanced fluids (like diluted fruit juices, broths, sports drinks, and caffeine-free sodas). Make sure to hydrate throughout the day. Do not consume any medicine on your own without consulting your doctor. If the symptom does not improve, contact your doctor.
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom does not improve.
Headache
Take a rest in a quiet place. Avoid using mobile phones and other electronic devices for a while. Headaches can be caused by a lack of water and dehydration. Consult your doctor if symptoms worsen.
Nausea And Vomiting
Drink clear or ice-cold drinks. Eat light, bland foods. Avoid fried, greasy, or sweet foods. Eat slowly and eat smaller, more frequent meals; drink gradually larger amounts of clear liquids; avoid solid food until the vomiting episode has passed; and take rest. Consult your doctor if symptoms worsen.
Warning & Precautions
Pregnancy
ContraindicatedFREEDASE 30 TABLET is not recommended for use in pregnant women and in women suspected to be pregnant. FREEDASE 30 TABLET is not recommended if have or ever had cholestasis of pregnancy (jaundice due to pregnancy). FREEDASE 30 TABLET should be used with caution in women who are in the postpartum period and patients with pregnancy patches (golden brown patches on the face). Consult your doctor before taking it.
Breastfeeding
ContraindicatedFREEDASE 30 TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking it.
Driving and Using Machines
Use with CautionDo not drive or handle heavy machines if you experience side effects like dizziness, drowsiness, tiredness, or if you have blurred vision while taking GBNKEYWORD].
Alcohol
ContraindicatedConsumption of alcohol is not recommended during management with FREEDASE 30 TABLET.
Kidney
ContraindicatedFREEDASE 30 TABLET is not recommended for use in patients with kidney diseases (kidney failure). Consult your doctor before taking it.
Liver
Consult your doctorFREEDASE 30 TABLET is not recommended for use in patients who have or ever had liver diseases (liver tumours) and hepatitis C. FREEDASE 30 TABLET should be used with caution in patients with gall bladder disease. Consult your doctor before taking it.
Allergy
ContraindicatedDo not take FREEDASE 30 TABLET if you are allergic to Dienogest or Ethinyl Estradiol.
Lungs
ContraindicatedFREEDASE 30 TABLET is not recommended for use in patients with blood clots in the lungs (pulmonary embolism). Consult your doctor before taking it.
Heart Disease
ContraindicatedFREEDASE 30 TABLET is not recommended for use in patients with heart diseases like heart attack, stroke, angina, mini-stroke, uncontrolled high blood pressure and high cholesterol levels Consult your doctor before taking it.
Others
FREEDASE 30 TABLET is not recommended for use if you:
- have or had blood clots in legs (deep vein thrombosis) and eyes (retinal thrombosis)
- have high risks of having blood clots such to obesity, family history, planned surgeries, age (above 35 years), new mothers who delivered four weeks ago
- have diabetes associated with blood vessel damage
- have a disorder affecting your blood clotting (protein C deficiency
protein S deficiency, antithrombin-III deficiency, and antiphospholipid antibodies in blood which cause immediate blood clots - have or ever had migraine headaches
- have hyperhomocysteinaemia (an increase in the levels of an amino acid called homocysteine in the blood)
- have or ever had breast cancer or other cancers
- have unexplained bleeding from the vagina
- have any pre-planned surgery
- have adrenal (when the body does not produce enough aldosterone hormone)
Before taking FREEDASE 30 TABLET inform your doctor if you:
- have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
- have systemic lupus erythematosus (disease affecting your immune system)
- have haemolytic uraemic syndrome (blood clotting disorder causing kidney failure)
- have sickle cell anaemia (an inherited red blood cell disease)
- have an inflammation in the veins under the skin (superficial thrombophlebitis)
- have varicose veins (enlarged or twisted veins)
- have a family history of breast cancer
- have depression
- have epilepsy
- you smoke. Your doctor may advise you to stop smoking. If you’re older than 35 and you are unable to quit smoking, your doctor may advise you to use another medicine
- are obese (BMI more than 30)
- have a lab test
- have any pre-planned surgery
Use in paediatrics:
FREEDASE 30 TABLET should be used with caution in post-pubertal female children under the age of 18 years. FREEDASE 30 TABLET it is not intended for use in male children and in female children who have not attained puberty. Consult your doctor before taking it.
Use in geriatrics:
FREEDASE 30 TABLET is not indicated for use in elder women. Consult your doctor before taking it.
Interactions
A. Drug-Drug interactions:
Before taking FREEDASE 30 TABLET, inform your doctor if you are taking any of the following medicine:
- medicines used to manage epilepsy (Ex. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, lamotrigine)
- medicines used to manage tuberculosis (Ex. rifampicin)
- medicines used to manage HIV infection (Ex. ritonavir, nevirapine, efavirenz)
- medicines used to manage fungal infections (Ex. ketoconazole, griseofulvin)
- medicines used to manage arthritis, and osteoarthritis (Ex. etoricoxib)
- herbal remedy St. John’s wort used to manage mental illness
- medicines used to manage graft rejection in organ transplants (Ex. cyclosporin)
- medicines used to manage hepatitis C infections Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir
Overdosage:
If you or anyone else accidentally took more of FREEDASE 30 TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting and withdrawal bleeding. Withdrawal bleeding may occur in girl children even before their first menstruation who have taken it accidentally.
Synopsis
| Drug | : | Dienogest, Estradiol |
| Pharmacological Category | : | Oral contraceptives |
| Therapeutic Indication | : | contraception, acne, heavy menstrual flow |
| Dosage Forms | : | Tablet |
More Information
- Keep FREEDASE 30 TABLET out of reach from children
- Store at room temperature
FAQs About FREEDASE 30 TABLET
Q: Can I stop taking FREEDASE 30 TABLET once my acne gets better?
A: No, do not stop taking FREEDASE 30 TABLET unless your doctor advises you to do so because sudden termination of FREEDASE 30 TABLET will not provide any expected efficacy. Acne caused by hormonal changes may require long-term management. Please use FREEDASE 30 TABLET as advised by the doctor.
Q: Can FREEDASE 30 TABLET be used to manage acne in men?
A: No, FREEDASE 30 TABLET is not intended for use by men. FREEDASE 30 TABLET contains a synthetic form of the female sex hormones oestrogen and progesterone, which work by reducing the male sex hormone testosterone. It is only for use by women and children under the age of 18 who have had their first menstrual cycle. FREEDASE 30 TABLET While used in men, it will reduce male sex hormones, which may cause fertility problems.
Q: How and when should I take FREEDASE 30 TABLET for acne and PMDD?
A: Do not take FREEDASE 30 TABLET without a doctor’s prescription. There are certain precautions and blood tests necessary before taking FREEDASE 30 TABLET. If your doctor has prescribed FREEDASE 30 TABLET to manage acne or PMDD, kindly follow the instructions given by your doctor.
Q: Does FREEDASE 30 TABLET cause any serious side effects?
A: The serious side effects of FREEDASE 30 TABLET are deep vein thrombosis, loss of eyesight, stroke, jaundice, pulmonary embolism, allergic reactions, breast cancer, cervical cancer, and inflammation of the liver.
Q: What precautions need to be followed while taking FREEDASE 30 TABLET?
A: FREEDASE 30 TABLET increases potassium levels in the blood, which affects the kidney and heart, so your doctor may advise you to do blood tests to check potassium levels. FREEDASE 30 TABLET is not recommended for use in women with blood clots or elevated risk of blood clots, kidney disease, heart disease, liver disease, or scheduled surgeries. FREEDASE 30 TABLET should be used with caution in patients with inflammatory bowel disease, anaemia, and depression. Do not discontinue use without consulting your doctor. Take the medicine without missing any doses. Avoid concomitant use of anti-viral drugs such as ritonavir, nevirapine, and efavirenz, along with FREEDASE 30 TABLET.
Q: Is it safe to take FREEDASE 30 TABLET immediately after delivery?
A: No, it is not safe to take FREEDASE 30 TABLET immediately after delivery. It is advisable to take it only after 4 weeks post-delivery. Consult your doctor before taking it.
Q: Can FREEDASE 30 TABLET be used by children?
A: FREEDASE 30 TABLET should be used with caution in postpubertal female children under the age of 18.It is not intended for use in boys or girls who have not reached puberty.Consult your doctor before taking it.
Q: Can FREEDASE 30 TABLET be used to manage acne in pregnant women?
A: FREEDASE 30 TABLET is not recommended for use in pregnant women or in women suspected to be pregnant. FREEDASE 30 TABLET is not recommended if you have or have ever had cholestasis of pregnancy (jaundice due to pregnancy). FREEDASE 30 TABLET should be used with caution in women who are in the postpartum period and in patients with pregnancy patches (golden brown patches on the face). Consult your doctor before taking it. While pregnant, do not take any medications without first consulting your doctor.
Q: Is FREEDASE 30 TABLET carcinogenic?
A: FREEDASE 30 TABLET does not cause breast cancer. If you have breast cancer or have had it in the past, do not use FREEDASE 30 TABLET because some breast cancers are sensitive to hormones. Women who use FREEDASE 30 TABLET may have a slightly higher chance of getting cervical cancer.
Q: Can the use of FREEDASE 30 TABLET cause unexpected bleeding?
A: No, it is not indicated to induce a menstrual cycle. Irregular vaginal bleeding or spotting may occur while you are taking FREEDASE 30 TABLET. Such bleeding may be temporary and usually does not indicate any serious problems. Consult your doctor if the condition worsens.
Q: How and when should I take FREEDASE 30 TABLET?
A: Take FREEDASE 30 TABLET strictly as advised by your physician. Do not miss any doses between the courses because the management may not be effective if any doses are missed. Swallow the medicine with a glass of water. FREEDASE 30 TABLET can be taken with or without food. Do not crush or chew the medicine. In case you have missed a dose, take it as soon as you remember it. Missing doses cause bleeding or spotting. Your doctor will determine the correct dose and duration for you depending upon your age, body weight, and disease condition. If you have any doubts regarding the doses, consult your doctor for advice.
Q: Can FREEDASE 30 TABLET cause abortion?
A: No, it does not cause abortion; it just works by suppressing ovulation and fertilization. FREEDASE 30 TABLET is not recommended for use during pregnancy. Consult your doctor before taking it.
Q: Can the use of FREEDASE 30 TABLET cause depression?
A: Yes, the use of FREEDASE 30 TABLET can cause depression. Exercise will increase the production of hormones, which improve our mood. Drinking alcohol or misusing substances may make you feel better for a short time, but after a long time, these substances can make depression symptoms even worse and even cause severe other health problems. So please avoid using alcohol and drugs to overcome depression. Self-care is particularly important to overcome depression. This includes getting good sleep, eating a healthy diet, avoiding negativity, and participating in other activities. If you still feel depressed or low, contact your doctor.
Q: What should I do if I forget to take FREEDASE 30 TABLET?
A: If you miss a dose, take it as soon as you remember. If you have missed a dose, use proper safety measures like condoms to avoid pregnancy. Do not take double doses to compensate for the missed ones. Spotting or sudden bleeding can occur in the case of missed doses.
Q: Will the use of GBNKEYWORD change the length of the menstrual cycle?
A: Because FREEDASE 30 TABLET is a common side effect, there are modifications for sudden spotting or vaginal bleeding. However, no evidence of long menstrual cycles has been reported.
Q: Will the use of FREEDASE 30 TABLET produce complete protection from pregnancy?
A: Yes, FREEDASE 30 TABLET will produce complete protection from pregnancy when all the doses are taken correctly every day. If you miss any dose, it will not be effective, and you will have a high chance of getting pregnant.
Q: Is the use of condemn necessary while using FREEDASE 30 TABLET?
A: No, it is not required to use condemn while using FREEDASE 30 TABLET. But if you miss any dose and you do not want to be pregnant, then you should use condoms to manage an unwanted pregnancy.
References
1. KD Tripathi Hormones and Related drugs, Essentials of Pharmacology seventh edition 2013 Page no: 308, Joseph. T. Dipero Gynaecologic and obstetric disorders, Pharmacotherapy handbook ninth edition 2012 page no – 272.
2. Goodman & Gilman’s Estrogens and progestins, the pharmacological basis of therapeutics, eleventh edition Page no – 1559.
3. laura M. Borgelt, PharmD. Estradiol Valerate/Dienogest: A Novel Combined Oral Contraceptive, December 2011. [Accessed on 31st May 2022] https://www.clinicaltherapeutics.com/article/S0149-2918(11)00723-5/references#secd33342776e529
4. Sally Rafie Laura M Borgelt Erin R Koepf Mary E Temple Katherine Lehman Novel oral contraceptive for heavy menstrual bleeding: Estradiol valerate and dienogest Dove press journal, June 2013. [Accessed on 31st May 2022] https://www.researchgate.net/publication/240310164_Novel_oral_contraceptive_for_heavy_menstrual_bleeding_Estradiol_valerate_and_dienogest
5. Slopien, R., Milewska, E., Rynio, P., & Meczekalski, B. (2018). Use of oral contraceptives for management of acne vulgaris and hirsutism in women of reproductive and late reproductive age NCBI: National Library of Medicine, PubMed articles. April 2018. [Accessed on 31st May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5925193/
6. Bayer HealthCare Pharmaceuticals Inc. Inc U.S. Food and drug Administration. [Revised on February 2012] [Accessed on 31st May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022252s001lbl.pdf
7. Bayer HealthCare Pharmaceuticals Inc. U.S. Food and drug Administration. [Revised on August 2015] [Accessed on 31st May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022252s004lbl.pdf
8. Bayer HealthCare Pharmaceuticals Inc health Canada. [Revised on March 2015] [Accessed on 31st May 2022] https://pdf.hres.ca/dpd_pm/00030046.PDF
9. Laboratories Leon Farma, S.A. Health products Regulatory Association. [Revised on January 2022] [Accessed on 31st May 2022] https://www.hpra.ie/img/uploaded/swedocuments/Licence_PA1474-011-001_28012022203227.pdf
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