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INTRODUCTION
EVALON CREAM contains Estriol which belongs to a group of medicines called Hormone Replacement Therapy. EVALON CREAM is used to provide relief from menopausal symptoms in women affected with vaginal atrophy (thinning of vaginal walls).
EVALON CREAM is not recommended for use in patients allergic (hypersensitive) to estriol. It is also not recommended for use in patients who have/had/suspected of breast/endometrial cancer or thrombosis (blood clot in vein). The medicine is also not indicated for use in patients who suffer from unusual vaginal bleeding, untreated endometrial hyperplasia (excessive thickening of the womb lining), lung disease (such as pulmonary embolism), heart disease (such as heart attack/heart block), and/or liver disease (such as benign liver tumor, Hepatitis C).
Before applying EVALON CREAM, inform your doctor if you have fibroids (non-cancerous growths inside womb), endometriosis (growth of womb lining outside womb)/endometrial hyperplasia (excessive growth of the womb lining), and/or suffer from epilepsy, otosclerosis (disease affecting eardrum and hearing), and/or lung problems (such as asthma).
EVALON CREAM is generally not recommended for use during pregnancy and in women planning for pregnancy since it may affect the fetus. It is also not recommended for use in breastfeeding women.
EVALON CREAM is also not recommended for use in children and adolescents since it is intended to be used only in postmenopausal women and is advised to be used in elderly patients (aged 65 years and above) after consulting the doctor.
The most common side effects of applying EVALON CREAM are breast tenderness, stomach cramps, bloating, nausea, vomiting, headache, and/or vaginal itching. Consult your doctor if any of these symptoms worsens.
USES OF EVALON CREAM
- Provides relief from menopausal symptoms in women affected with vaginal atrophy
HOW EVALON CREAM WORKS
EVALON CREAM works by maintaining the estrogen levels in the body in menopausal women that prevents the vaginal wall from becoming thin and dry thereby reducing inflammation and providing relief from menopausal symptoms due to vaginal atrophy in affected individuals.
DIRECTIONS FOR USE
Always apply EVALON CREAM as directed by your physician. It is for intravaginal use only. Remove cap from the tube and screw nozzle end of the applicator onto the tube. Gently squeeze the tube to fill the applicator with required quantity of medicine. Unscrew the applicator from the tube and lie back with knees drawn up and gently insert the applicator deep into the vagina and press plunger downward to its original position to deliver the medication. After application, pull the plunger to remove it from the barrel and wash with mild soap and warm water. Your doctor will decide the correct dose and duration for your child depending upon the age, body weight and disease condition.
SIDE EFFECTS OF EVALON CREAM
COMMON
- breast tenderness
- stomach cramps, bloating, nausea, vomiting
- headache
- weight gain
- hyperpigmentation of skin
- hair loss
- vaginal itching, abnormal uterine bleeding
RARE
Stop applying EVALON CREAM and contact your doctor if you experience any of the following side effects:
- signs of liver disease such as yellowing of skin or whites of eyes (jaundice)
- signs of high blood pressure such as headache, tiredness, and/or dizziness
- migraine-like headaches (happening for the first time)
- signs of blood clot such as painful swelling & redness of the legs, sudden chest pain, and/or difficulty in breathing
- unexplained vaginal bleeding
- signs of endometrial hyperplasia (excessive thickening of the womb lining) such as heavy menstrual bleeding, anemia, bleeding between menstrual periods
- thrombosis (blood clot in a vein) such as deep venous thrombosis
- blood clots in arteries such as heart attack, stroke, and/or angina
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take EVALON CREAM with/just after a meal. Stick to simple meals. Avoid eating oil rich/spicy foods, sugary snacks and drinks. Avoid drinking too much liquid along with your meals, and drink slowly in between meals. Consult your doctor if the condition worsens.
Headache:
If EVALON CREAM causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking EVALON CREAM. If it lasts more than a week or becomes severe, then consult and inform your doctor.
WARNING & PRECAUTIONS
PREGNANCY
EVALON CREAM is generally not recommended for use during pregnancy and in women planning for pregnancy since it may affect the fetus. Consult your doctor before applying the medicine.
BREASTFEEDING
EVALON CREAM is not recommended for use in breastfeeding women. Consult your doctor before applying the medicine.
DRIVING AND USING MACHINES
EVALON CREAM is unlikely to affect your ability to drive/operate machines. Consult your doctor before applying the medicine.
KIDNEY
EVALON CREAM should be used with caution in patients with kidney problems. Consult your doctor before applying EVALON CREAM.
LIVER
EVALON CREAM is not recommended for use in patients with/history of liver disease (such as benign liver tumor, Hepatitis C), and in patients who have abnormal liver function. Consult your doctor before applying EVALON CREAM.
ALLERGY
Do not apply EVALON CREAM if you are allergic (hypersensitive) to estriol, and/or any other ingredients of this medicine.
LUNGS
EVALON CREAM is not recommended for use in patients with lung disease such as pulmonary embolism (blood clot in lungs). It should be used with caution in patient with other lung problems such as asthma. Consult your doctor before applying EVALON CREAM.
HEART DISEASE
EVALON CREAM is not recommended for use in patients with heart disease such as heart attack/heart block. Consult your doctor before applying the medicine.
OTHERS
EVALON CREAM is not recommended for use if you:
- have/had/suspected of breast cancer
- have/suspected of endometrium cancer
- have unusual vaginal bleeding
- suffer from untreated endometrial hyperplasia (excessive thickening of the womb lining)
- have/had thrombosis (blood clot in a vein) such as deep venous thrombosis
- have blood clotting disorder such as protein C/protein S/antithrombin deficiency
- have/recently had blood clots in arteries such as stroke
- suffer from inherited porphyria (rare blood disorder)
Before applying EVALON CREAM, inform your doctor if you:
- have fibroids (non-cancerous growths) inside womb
- suffer from endometriosis (growth of womb lining outside womb) or have a history of endometrial hyperplasia (excessive growth of the womb lining)
- have an increased risk of developing blood clots
- have an increased risk of developing estrogen-sensitive cancer such as mother, sister/ grandmother who has/had breast cancer
- suffer from high blood pressure, diabetes, gallstones, migraine/severe headaches
- suffer from systemic lupus erythematosus (disease of the immune system that affects many organs of the body)
- suffer from epilepsy
- otosclerosis (disease affecting eardrum and hearing)
- are scheduled for any surgery
Use in Pediatrics:
EVALON CREAM is not recommended for use in children and adolescents since it is intended to be used only in postmenopausal women. Consult your doctor before using the medicine.
Use in Geriatrics:
EVALON CREAM should be used with caution in elderly women (aged 65 years and above). Consult your doctor before applying EVALON CREAM.
INTERACTIONS
A. Drug-Drug Interactions:
Before applying EVALON CREAM, inform your doctor, if you are applying any of the following medicine:
- medicine used to treat epilepsy such as barbiturates (Ex. amobarbital, phenobarbital), hydantoins (Ex. phenytoin), carbamezapine
- medicines used to treat infections (Ex. griseofulvin, rifamycin)
- medicines used to treat viral infections (Ex. nevirapine, efavirenz, ritonavir, nelfinavir)
- St John’s wort (herbal medicine used to treat depression)
- corticosteroids (used to reduce inflammation) Ex. prednisone, prednisolone
- succinylcholine (muscle relaxant)
- theophylline (used to treat asthma)
- troleandomycin (used to treat bacterial infection)
- ombitasvir, paritaprevir, ritonavir, dasabuvir (medicines used to treat Hepatitis C)
Overdosage:
If you or anyone else accidentally applies too much of EVALON CREAM, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, and/or vaginal bleeding.
SYNOPSIS
| Drug | : | Estriol |
| Pharmacological Category | : | Estradiol Congeners |
| Therapeutic Indication | : | Vaginal atrophy |
| Dosage Forms | : | Tablet, Cream |
MORE INFORMATION
- Keep EVALON CREAM out of reach from children
- Do not store EVALON CREAM above 25°C
FAQs ABOUT EVALON CREAM
Q. What is EVALON CREAM and why is it used?
A. EVALON CREAM contains Estriol which belongs to a group of medicines called Hormone Replacement Therapy. It is used to provide relief from menopausal symptoms in women affected with vaginal atrophy (thinning of vaginal walls).
Q. What are the side effects of EVALON CREAM?
A. The most common side effects of applying EVALON CREAM are breast tenderness, stomach cramps, bloating, nausea, vomiting, headache, and/or vaginal itching. Consult your doctor if any of these symptoms worsens.
Q. How EVALON CREAM is applied?
A. Always apply EVALON CREAM as directed by your physician. It is for intravaginal use only. Remove cap from the tube and screw nozzle end of the applicator onto the tube. Gently squeeze the tube to fill the applicator with required quantity of medicine. Unscrew the applicator from the tube and lie back with knees drawn up and gently insert the applicator deep into the vagina and press plunger downward to its original position to deliver the medication. After application, pull the plunger to remove it from the barrel and wash with mild soap and warm water. Your doctor will decide the correct dose and duration for your child depending upon the age, body weight and disease condition.
Q. What happens if EVALON CREAM is applied more than its required dosage?
A. If you or anyone else accidentally applies too much of EVALON CREAM, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, and/or vaginal bleeding.
Q. How EVALON CREAM works?
A. EVALON CREAM works by maintaining the estrogen levels in the body in menopausal women that prevents the vaginal wall from becoming thin and dry thereby reducing inflammation and providing relief from menopausal symptoms due to vaginal atrophy in affected individuals.
REFERENCES
1. KD. Tripathi. Estrogens, Progestins and Contraceptives. Seventh edition. 2013. Page – 310.
2. Benjamin J. Delgado; Wilfredo Lopez-Ojeda. Estrogen. NIH National Library of Medicine. National center for biotechnology information. StatPearls. June 2022. [Accessed on 2nd June 2022] https://www.ncbi.nlm.nih.gov/books/NBK538260/
3. Aspen Pharma Trading Limited. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 2nd June 2022] https://www.medicines.org.uk/emc/files/pil.5384.pdf
USEFUL DIAGNOSTIC TESTS
- Blood test
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