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Introduction About EVALON CREAM

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, unmanageed 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 manages the vaginal wall from becoming thin and dry thereby reducing inflammation and providing relief from menopausal symptoms due to vaginal atrophy in affected individuals.

How to use EVALON CREAM

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 unmanageed 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 manage epilepsy such as barbiturates (Ex. amobarbital, phenobarbital), hydantoins (Ex. phenytoin), carbamezapine
medicines used to manage infections (Ex. griseofulvin, rifamycin)
medicines used to manage viral infections (Ex. nevirapine, efavirenz, ritonavir, nelfinavir)
St John’s wort (herbal medicine used to manage depression)
corticosteroids (used to reduce inflammation) Ex. prednisone, prednisolone
succinylcholine (muscle relaxant)
theophylline (used to manage asthma)
troleandomycin (used to manage bacterial infection)
ombitasvir, paritaprevir, ritonavir, dasabuvir (medicines used to manage 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 used for?

A. Evalon Cream is used to provide relief from menopausal symptoms (vaginal itching, painful sex, burning sensation or irritation in vagina) 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. Gently squeeze the tube to fill the applicator with required quantity of medicine. 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?

Evalon Cream works by replacing the deficient estrogen levels in women’s body which is normally produced in the ovaries of women. It is administered into the vagina, facilitating the release of the hormone directly to the targeted area. This action can alleviate vaginal discomfort.

Q: Is Evalon Cream advised to be used in pregnancy?

A: Do not use Evalon Cream without consulting your doctor if you are pregnant or think you may be pregnant.

Q: Who should avoid applying Evalon Cream?

A: 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).

Q: Can I stop applying Evalon Cream without consulting your doctor?

A: No. You should not stop applying Evalon Cream without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using Evalon Cream, consult your doctor for advice.

Q: How do you insert Evalon Cream?

A: Always apply Evalon Cream as directed by your physician. Gently squeeze the tube to fill the applicator with required quantity of medicine. 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.

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

Author Details

Written By Srilekha. R - B.Pharm

Reviewed For Accuracy By Dr. Pushpraj Singh - MBBS

Last updated on 06 Apr 2024 | 07:07 PM(IST)