Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women (in women at least 6 months since last menses or surgical menopause, with or without a uterus).
The experience in treating women older than 65 years is limited.
Lenzetto is administered once daily, either as a monotherapy or as a continuous sequential treatment (when combined with a progestogen).
One metered-dose spray is administered once daily to the dry and healthy skin of the forearm as a starting dose. The dose may be increased to two metered-dose sprays daily to the forearm based on clinical response. Dose increase should be based on the degree of the woman’s menopausal symptoms and should be made only after at least 4 weeks of continuous treatment with Lenzetto. The maximum daily dose is 3 metered-dose sprays (4.59 mg/day) to the forearm. Dose increase should be discussed with the physician. For patients who have difficulty applying the prescribed dose to distinct, non-overlapping areas of the same forearm, {Invented name}may also be applied to sites on the alternate forearm, or to sites on the inner thigh.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.
When the degree of the woman’s menopausal symptoms is not reduced after a dose increase, the patient should be back-titrated to the previous dose.
Patients should be re-evaluated periodically as clinically appropriate (e.g. 3-month to 6-month intervals) to determine if treatment is still necessary (see section 4.4).
When oestrogen is prescribed for a postmenopausal woman with a uterus, a progestagen approved for addition to oestrogen treatment should also be initiated to reduce the risk of endometrial cancer. Only progestagens approved for addition to oestrogen treatment should be administered.
In women with an intact uterus, the product should be combined with a progestagen approved for addition to oestrogen treatment in a continuous – sequential dosing scheme: the oestrogen is dosed continuously. The progestagen is added for at least 12 to 14 days of every 28-day cycle, in a sequential manner.
Advice on how to initiate treatment should be given for treatment naive patients and for patients changing from other HRTs (cyclic, sequential or continuous combined).
In the period in which the oestrogen is combined with the progestagen, a withdrawal bleeding can occur. A new 28-day treatment cycle is started without a break.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add progestagen for women without a uterus.
There is some limited data that the rate and extent of absorption of Lenzetto can be reduced in overweight and obese women. During the treatment, the dose of Lenzetto may require adjustment. Dose modification should be discussed with the physician.
There is no relevant use of Lenzetto in the paediatric population.
If a dose is missed, the patient should make up for the missed dose as soon as she remembers and take the next dose at the usual time. If it is almost time for the next dose, she should skip the missed dose and take the next dose at the usual time. If one or more doses are missed one primer spraying with the cover on is needed. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
The container should be held upright and vertical for spraying. Before a new applicator is used for the first time, the pump should be primed by spraying three times into the cover.
The daily dose is one metered-dose spray on the inner forearm. If two or three sprays are prescribed as the daily dose, they should be applied to adjacent non-overlapping (side-by-side) 20 cm² areas on the inner surface of the arm between the elbow and the wrist and allowed to dry for approximately 2 minutes. Women should cover the application site with clothing if another person may come into contact with that area of skin after the spray dries. The site of application should not be washed for 60 minutes. Do not allow another person to touch the site of application within 60 minutes of application.
Do not allow children to come in contact with the area of the arm where Lenzetto was sprayed. If a child comes in contact with the part of the arm where Lenzetto was sprayed, wash the child’s skin with soap and water as soon as possible.
Do not allow pets to lick or touch the arm where Lenzetto was sprayed. Small pets may be especially sensitive to the oestrogen in Lenzetto. Contact a veterinarian if your pet exhibits mammary/nipple enlargement and/or vulvar swelling, or any other sign of illness.
Studies suggest that compared to applying it to the inner surface of the forearm, absorption of estradiol is similar when Lenzetto is applied to the skin of the thigh, but is lower when applied to the skin of the abdomen.
If the product is used according to the instructions, irrespective of different spray shape or pattern on the skin each puff will deliver the same amount of ingredient on the skin.
The effect of increased ambient temperature with Lenzetto has been studied and clinically relevant difference in the extent of absorption of Lenzetto was not observed. However, Lenzetto should be use with caution in extreme temperature conditions, such as sun bathing or sauna.
When sunscreen is applied about one hour following Lenzetto, estradiol absorption may be decreased by 10%. When sunscreen was applied about one hour prior to Lenzetto, no effect on absorption was observed (see section 5.2).
Effects have not been reported following acute ingestion of large doses of oestrogen-containing products. Overdosage of oestrogen may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Lenzetto together with institution of appropriate symptomatic care.
3 years.
Use within 56 days of first use.
Do not refrigerate or freeze.
Do not store above 25°C.
Contains ethanol which is flammable. Store away from heaters, open flames, and other sources of ignition.
The solution is packaged in a glass vial fitted with a metered dose pump. The unit is encased in a plastic housing with a conical bell opening that controls the distance, angle, and area of application of the metered dose spray.
One container is filled with 6,5 ml, transdermal spray solution and is designed to deliver 56 sprays after priming.
Pack sizes:
One plastic container 6,5 ml (56 sprays)
Three plastic containers 3x6,5 ml (3x56 sprays)
Not all pack sizes may be marketed.
After delivery of 56 sprays, the container must be discarded even if there is some leftover solution in it. The number of sprays made should be marked using the table on the carton. As drug residue will remain in the used up containers, they should not be disposed of via household waste. Empty containers should be returned to the pharmacy for destruction.
This medicinal product may pose a risk to the environment (see section 5.3).
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