Lenzetto 1.53 mg/dose solution for transdermal spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lenzetto 1.53 mg/dose, solution for transdermal spray

estradiol

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lenzetto is and what it is used for
2. What you need to know before using Lenzetto
3. How to use Lenzetto
4. Possible side effects
5. How to store Lenzetto
6. Contents of the pack and other information

1. What Lenzetto is and what it is used for

Lenzetto is a Hormone Replacement Therapy (HRT). It contains the female hormone estrogen. Lenzetto is used in postmenopausal women when at least 6 months have passed since their last natural menstrual period.

Lenzetto may also be used in women who have undergone surgery to remove their ovaries, as this causes an immediate menopause.

Lenzetto is a spray solution containing small amounts of a medicine called estradiol. When sprayed on the skin as directed, it passes through the skin into the bloodstream.

Lenzetto is used for:

Relief of symptoms occurring after menopause

During menopause, the amount of estrogen produced by a woman's body decreases. This can cause symptoms such as heat in the face, neck, and chest ("hot flashes"). Lenzetto relieves these postmenopausal symptoms. You will be prescribed Lenzetto only if your symptoms seriously affect your daily life.

Lenzetto is indicated for the treatment of estrogen deficiency symptoms after menopause, when menstruation has ceased following menopause. Symptoms of estrogen deficiency include hot flashes (sudden waves of heat and sweating throughout the body), sleep disturbances, irritability, and vaginal dryness.

Experience with treatment in women over 65 years of age is limited.

Lenzetto is not a contraceptive.

2. What you need to know before using Lenzetto

Medical history and regular check-ups:

HRT carries risks that must be considered when deciding whether to start or continue treatment.

Experience in treating women with premature menopause (due to ovarian failure or surgery) is limited. If you have premature menopause, the risks of using HRT may differ. Please consult your doctor.

Before starting (or resuming) HRT, your doctor will ask about your personal and family medical history. Your doctor may decide to perform a physical examination, which may include a breast examination and/or an internal examination, if necessary.

Once you have started treatment with Lenzetto, you should visit your doctor for periodic check-ups (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing Lenzetto.

Have regular breast examinations as recommended by your doctor.

Do not use Lenzetto

If any of the following apply to you. If you are unsure about any of the points below, consult your doctor before using Lenzetto.

Do not use Lenzetto

• if you have or have had breast cancer, or suspect you may have it;
• if you have estrogen-sensitive cancer, such as cancer of the inner layer of the uterus (endometrium), or suspect you may have it;
• if you have any unexplained vaginal bleeding;
• if you have excessive thickening of the inner layer of the uterus (endometrial hyperplasia) that is not being treated;
• if you have or have had a blood clot in a vein (thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if you have a blood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency);
• if you have or have recently had a disease caused by blood clots in the arteries, such as heart attack, stroke, or angina;
• if you have, or have ever had, a liver disease and your liver function tests have not returned to normal;
• if you have a rare inherited blood disorder called "porphyria";
• if you are allergic to estradiol or any of the other ingredients of Lenzetto (listed in section 6).

If any of the above conditions develop for the first time while using this medicine, stop treatment immediately and consult your doctor without delay.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lenzetto.

Inform your doctor if you have ever had any of the following conditions before starting treatment, as they may reappear or worsen during treatment with Lenzetto. In such cases, you should visit your doctor more frequently for check-ups:

• fibroids in your uterus;
• growth of the inner lining of the uterus outside the uterus (endometriosis) or history of excessive growth of the inner lining of the uterus (endometrial hyperplasia);
• increased risk of developing blood clots (see “Blood clot in a vein (thrombosis)”);
• increased risk of developing estrogen-dependent cancer (such as having a mother, sister, or grandmother who had breast cancer);
• high blood pressure;
• a liver disorder, such as benign liver tumor;
• diabetes;
• gallstones;
• migraine or severe headache;
• an autoimmune disease affecting multiple organs of the body (systemic lupus erythematosus, SLE);
• epilepsy;
• asthma;
• a disease affecting the eardrum and ear (otosclerosis);
• very high levels of fat in your blood (triglycerides);
• fluid retention due to heart or kidney problems;
• hereditary or acquired angioedema.

Stop treatment with Lenzetto and seek medical advice immediately

If you experience any of the following symptoms while using HRT:

• any of the conditions listed in the section “DO NOT use Lenzetto”;
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of liver disease;
• swelling of the face, tongue, or throat, difficulty swallowing, or hives accompanied by breathing difficulties, suggesting angioedema;
• a significant increase in your blood pressure (symptoms may include headache, fatigue, dizziness);
• new-onset migraine-type headaches;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
  • painful swelling and redness in the legs
  • sudden chest pain
  • difficulty breathing.

For more information, see ‘Blood clot in a vein (thrombosis)’.

Note: Lenzetto is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you may still need additional contraceptive measures to prevent pregnancy. Seek advice from your doctor.

HRT and cancer

Excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and cancer of the inner lining of the uterus (endometrial cancer)

HRT with estrogen alone increases the risk of excessive thickening of the inner lining of the uterus (endometrial hyperplasia) and of endometrial cancer.

Taking a progestogen in addition to estrogen for at least 12 days of each 28-day cycle protects against this additional risk. Therefore, your doctor will prescribe a progestogen separately if you still have your uterus. If your uterus has been removed (hysterectomy), consult your doctor whether you can safely use this medicine without a progestogen.

In women with a uterus who are not treated with HRT, on average, 5 out of 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65.

In women aged 50 to 65 with a uterus who are on estrogen-only HRT, between 10 and 60 out of 1,000 will be diagnosed with endometrial cancer (i.e., between 5 and 55 additional cases), depending on the dose and duration of treatment.

Lenzetto contains a higher dose of estrogen than other estrogen-only HRT products. The risk of endometrial cancer when using Lenzetto in combination with a progestogen is unknown.

Unexpected bleeding

You will have a monthly bleed (called withdrawal bleeding) while using Lenzetto if combined with a sequential-dose progestogen. However, if you experience unexpected bleeding or spotting in addition to your monthly bleed that:

• continues beyond the first 6 months;
• starts after using Lenzetto for more than 6 months;
• continues after stopping Lenzetto;

contact your doctor as soon as possible.

Breast cancer

It is well established that combined estrogen-progestogen hormone replacement therapy (HRT) or estrogen-only HRT increases the risk of breast cancer. The additional risk depends on how long HRT is used. The additional risk becomes evident within 3 years of use. After stopping HRT, the additional risk decreases over time, but may persist for 10 years or more if HRT was used for more than 5 years.

Comparison

In women aged 50 to 54 who do not use HRT, on average, 13 to 17 out of 1,000 will be diagnosed with breast cancer over a 5-year period.

In women aged 50 who start using estrogen-only HRT for 5 years, there will be 16–17 cases per 1,000 users (i.e., 0 to 3 additional cases).

In women aged 50 who start using estrogen-progestogen HRT for 5 years, there will be 21 cases per 1,000 users (i.e., 4 to 8 additional cases).

In women aged 50 to 59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over a 10-year period.

In women aged 50 who start using estrogen-only HRT for 10 years, there will be 34 cases per 1,000 users (i.e., 7 additional cases).

In women aged 50 who start using estrogen-progestogen HRT for 10 years, there will be 48 cases per 1,000 users (i.e., 21 additional cases).

Examine your breasts regularly. Contact your doctor if you notice any changes, such as:

• skin dimpling
• changes in the nipple
• any lump you can see or feel.

Additionally, you are advised to participate in mammography screening programs when offered. For mammography, it is important to inform the nurse/healthcare professional performing the X-ray that you are using HRT, as this medication may increase breast density, which can affect the mammogram result. When breast density increases, a mammogram may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare, much less common than breast cancer. The use of estrogen-only HRT or combined estrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 who do not use HRT, about 2 cases of ovarian cancer are observed per 2,000 women over a 5-year period. In women on HRT for 5 years, about 3 cases per 2,000 patients are observed (i.e., about 1 additional case).

Effect of HRT on the heart and circulation

Blood clots in a vein (thrombosis)

The risk of venous blood clots is approximately 1.3 to 3 times higher in HRT users than in non-users, especially during the first year of treatment.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, difficulty breathing, fainting, or even death.

Your likelihood of developing a venous blood clot increases with age and if you have any of the following conditions. Inform your doctor if you have any of the following:

• inability to walk for long periods due to major surgery, injury, or illness (see also section 3, “If you need surgery”);
• severe obesity (BMI >30 kg/m²);
• a blood clotting disorder requiring long-term treatment with a medication used to prevent blood clots;
• a close family history of blood clots in the leg, lung, or other organs;
• systemic lupus erythematosus (SLE);
• cancer.

For signs of blood clots, see “Stop treatment with Lenzetto and seek medical advice immediately”.

Considering women aged 50 who do not use HRT, on average, 4 to 7 out of 1,000 are expected to have a venous blood clot over a 5-year period.

In women aged 50 who have been using combined estrogen-progestogen HRT for 5 years, there will be 9 to 12 cases per 1,000 users (i.e., 5 additional cases).

In women aged 50 who have had a hysterectomy and have been using estrogen-only HRT for 5 years, there will be 5 to 8 cases per 1,000 users (i.e., 1 additional case).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks.

Women over 60 years of age who use combined estrogen-progestogen HRT are slightly more likely to develop heart disease than those who do not use HRT.

In women who have had a hysterectomy and use only estrogen therapy, there is no increased risk of developing heart disease.

Stroke

The risk of stroke is about 1.5 times higher in women treated with HRT than in untreated women. The number of additional stroke cases due to HRT use increases with age.

Comparison: In women aged 50 who do not use HRT, on average, 8 out of 1,000 are expected to have a stroke over a 5-year period. In women aged 50 using HRT, there will be 11 cases per 1,000 users over 5 years (i.e., 3 additional cases).

Other conditions

HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start using HRT after age 65. Consult your doctor.

Children

Estradiol spray may be accidentally transferred from the skin where it was sprayed to other people. Do not allow others, especially children, to come into contact with the sprayed area of your skin. Cover the area if necessary after the spray has dried. If a child comes into contact with the area of skin sprayed with estradiol Lenzetto, wash the child’s skin with water and soap as soon as possible. Due to estradiol transfer, young children may show signs of unexpected puberty (e.g., breast development). In most cases, symptoms will disappear once children are no longer exposed to the estradiol spray.

Contact your doctor if you observe any signs or symptoms (breast development or other sexual changes) in a child who may have been accidentally exposed to the estradiol spray.

Other medicines and Lenzetto

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interfere with the effect of Lenzetto. This may cause irregular bleeding. This occurs with the following medicines:

• Medicines for epilepsy (such as phenobarbital, phenytoin, and carbamazepine)
• Medicines for tuberculosis (such as rifampicin, rifabutin)
• Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• Herbal medicines containing St. John’s wort (Hypericum perforatum)

HRT may affect how other medicines work:

• An epilepsy medicine (lamotrigine), as it could increase the frequency of seizures;

• Combined regimens for hepatitis C virus (HCV) – ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir – may cause elevations in blood liver function tests (increase in liver enzyme ALT) in women using HRT containing ethinylestradiol. Lenzetto contains estradiol instead of ethinylestradiol. It is unknown whether an increase in liver enzyme ALT may occur when Lenzetto is used with these HCV regimens.

Inform your doctor or pharmacist if you are taking or have recently taken other medicines, including over-the-counter medicines, herbal remedies, or other natural products.

Laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are using Lenzetto, as this medicine may affect the results of certain tests.

Pregnancy and breastfeeding

Lenzetto is for use only in postmenopausal women. If you become pregnant, stop treatment with Lenzetto and contact your doctor.

Do not use Lenzetto while breastfeeding.

Driving and using machines

Lenzetto has no known effects on the ability to drive or use machines.

Lenzetto contains alcohol

This medicine contains 65.47 mg of alcohol (ethanol) per dose, equivalent to 72.74% p/v. It may cause a burning sensation on damaged skin.

Alcohol-based products are flammable. Keep away from fire. Avoid open flames, lit cigarettes, or using devices that generate heat (e.g., hair dryers) while applying the spray to your skin, until the medication spray has dried completely.

3. How to use Lenzetto

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will prescribe the lowest effective dose to treat your symptoms for the necessary duration.

During treatment, your doctor may adjust the dose according to your individual needs. Speak with your doctor if you feel the dose is too strong or insufficient.

If you have not undergone a hysterectomy (surgical removal of the uterus), your doctor will prescribe tablets containing another hormone called a progestogen to counteract the effects of estrogen on the uterine lining. Your doctor will explain how to take these tablets. At the end of the progestogen treatment period, withdrawal bleeding may occur (see section "unexpected bleeding").

If you need surgery

If you are scheduled for surgery, inform your surgeon that you are using Lenzetto. You may need to stop using Lenzetto approximately 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, Blood clots in a vein). Ask your doctor when you can resume using Lenzetto.

Where to apply Lenzetto

The spray should be applied to dry, healthy skin on the inner surface of the forearm. If this is not possible, it should be applied to the inner surface of the thigh.

Do not apply Lenzetto to the breasts or any area near the breasts.

How to apply Lenzetto

Before using a new dispenser for the first time, prime the pump by spraying three times with the cap in place: Hold the container in an upright position as shown in Figure 1. With the cap on, press the button down three times using your thumb or index finger.

The medication is now ready for use.

DO NOT prime the dispenser before each dose; prime it only once before starting a new container. If you have missed one or more doses, prime the dispenser according to the instructions in the section “If you forget to use Lenzetto”.

Ensure the skin where you intend to spray the medication is healthy, clean, and dry.

How to apply your daily dose.

To apply your daily dose, remove the plastic cap, hold the container upright, and place the flat plastic cone against the skin (Figure 2).

You may need to move your arm or adjust the cone so that it lies flat against the skin with no gaps between the cone and the skin.

Press the button down once. Press it fully and hold it down before releasing.

If a second spray is needed, move the cone along your arm so that it is adjacent to the area already sprayed. Press the button down once.

If a third spray is needed, move the cone again along your arm and press the button down once.

If the second or third spray does not fit on the same inner forearm area, you may also spray on the inner surface of the other forearm. If you have difficulty placing the cone on the inner forearm as shown in Figure 3, or if using it on the forearms is difficult, you may also spray on the inner surface of the thigh.

After using Lenzetto, always replace the cap on the container (Figure 4).

If the medication is used as instructed, regardless of the different forms or patterns of application on the skin, each spray will release the same amount of active ingredient.

Allow the spray to dry for at least 2 minutes before dressing and at least 60 minutes before bathing or washing. If Lenzetto spray comes into contact with another area of skin, such as the hands, wash that area immediately with water and soap.

Lenzetto must not be used on damaged or broken skin.

Do not massage or rub Lenzetto into the skin.

Do not allow other people to touch the area of skin where the spray has been applied until it has dried completely, and cover it with clothing 2 minutes after application if necessary. If another person (especially a child) accidentally touches the area of skin where you have sprayed Lenzetto, instruct them to wash the affected skin area immediately with water and soap.

How much Lenzetto to use

Your doctor will likely initially recommend the lowest dose (one spray per day), and you should discuss with your doctor how well the medication is working for you. If necessary, your doctor may increase the dose to two sprays per day. The maximum daily dose is 3 sprays.

How often to use Lenzetto

Apply the total number of sprays (dose) prescribed by your doctor at the same time every day.

How long to use Lenzetto

Discuss with your doctor every 3–6 months how long you should continue using Lenzetto. You should only use Lenzetto for as long as needed to relieve menopausal hot flushes.

Additional useful information

Sunscreen may alter the absorption of estrogen from Lenzetto.

Avoid applying sunscreen to the area of skin where you intend to spray. However, if you need to use sunscreen, apply it at least one hour before using Lenzetto.

Lenzetto should be used with caution under extreme temperature conditions, such as in saunas or while sunbathing.

Limited data suggest that the rate and extent of absorption of Lenzetto may be reduced in overweight and obese women. Consult your doctor. During treatment, your doctor may adjust the dose according to your individual needs.

If you use more Lenzetto than you should

If you use more Lenzetto than prescribed, or if children have accidentally used the medicine, contact your doctor or hospital for advice on the risk and measures to be taken.

If you use more Lenzetto than prescribed, you may feel unwell, vomit, and experience withdrawal bleeding (abnormal vaginal bleeding).

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone 91 562 04 20, stating the medication and the amount used.

If you forget to use Lenzetto

If you forget to use Lenzetto at your usual time, apply it as soon as you remember, and the next day, use it as usual. If it is almost time for your next dose, wait and apply the next dose as usual. If you miss one or more doses, you will need to prime the pump with the protective cap in place. Do not use a double dose to make up for missed doses.

Missing a dose may increase the likelihood of intermenstrual bleeding and spotting.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you stop using Lenzetto

Your doctor will explain how to discontinue treatment with this medicine when your treatment is complete.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following conditions have been reported more frequently in women using HRT compared to women not using HRT:

• breast cancer;
• abnormal growth or cancer of the inner layer of the uterus (endometrial hyperplasia or cancer);
• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• heart disease;
• stroke;
• gallbladder disease;
• high blood pressure;
• liver problems;
• high blood sugar levels;
• possible memory loss if HRT is started after the age of 65.

For more information about these adverse effects, see section 2.

Some adverse effects may be serious

The following symptoms require immediate medical attention:

• sudden chest pain;
• chest pain spreading to the arm or neck;
• difficulty breathing;
• painful swelling and redness in the legs;
• yellowing of the eyes and skin (jaundice);
• unexpected vaginal bleeding (intermenstrual bleeding) or spotting after using Lenzetto for some time or after stopping treatment;
• changes in the breasts including skin dimpling, changes in the nipple, lumps that you can see or feel;
• painful menstrual periods;
• dizziness and fainting;
• changes in speech;
• changes in vision;
• migraine-type headaches without known cause.

If any of the adverse effects you experience worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

The following adverse effects have been reported with Lenzetto:

Frequent adverse effects (may affect up to 1 in 10 people)

Headache, abdominal pain, nausea, rash, pruritus (itching), irregular uterine bleeding or vaginal bleeding including spotting, breast tenderness, breast pain, weight gain or weight loss.

Uncommon adverse effects (may affect up to 1 in 100 people)

Hypersensitivity reactions, depressed mood, insomnia (difficulty sleeping), dizziness, vertigo (sensation of dizziness or spinning), visual disturbances, palpitations (awareness of heartbeats), diarrhea, dyspepsia (indigestion), increased blood pressure, erythema nodosum (characterized by painful red skin nodules), urticaria (rash or localized or generalized hives), skin irritation, swelling due to fluid retention (edema), muscle pain, breast discoloration, galactorrhea (milk secretion from the breasts), polyps (small cell growths) in the uterus or cervix, endometrial hyperplasia, ovarian cyst, genital inflammation (vaginitis), increased liver enzymes and blood cholesterol, armpit pain.

Rare adverse effects (may affect up to 1 in 1,000 people)

Anxiety, increased or decreased sexual desire, migraine, intolerance to contact lenses, abdominal distension, vomiting, increased body hair, acne, muscle cramps, painful menstruation, premenstrual syndrome, breast enlargement, fatigue.

Other adverse effects have been reported with Lenzetto at a frequency of "not known" (frequency cannot be estimated from available data) during post-marketing surveillance: hair loss (alopecia), chloasma (golden-brown patches, known as "pregnancy mask," especially on the face), skin discoloration.

The following adverse effects have been reported with other HRTs:

Severe allergic reaction causing swelling of the face or throat (angioedema), anaphylactoid/anaphylactic reactions (severe allergic reactions causing difficulty breathing or dizziness), glucose intolerance, depression, mood disturbances, irritability, exacerbation of chorea (Huntington's chorea), exacerbation of epilepsy, dementia, exacerbation of asthma, gallbladder disease, yellowing of the skin (jaundice), pancreatitis, benign neoplasm of the uterine smooth muscle, various skin disorders: skin discoloration, especially on the face or neck, known as "pregnancy mask" (chloasma); painful red skin nodules (erythema nodosum); rash with target-like redness or sores (erythema multiforme), hemorrhagic rash, hair loss, joint pain, milk secretion from the breasts, breast lumps, enlargement of benign uterine smooth muscle neoplasms, changes in cervical secretion and the inner layer of the cervix, vaginal inflammation, fungal infections of the vagina (vaginal candidiasis), abnormally low levels of calcium in the blood.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lenzetto

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and label following EXP. The expiry date refers to the last day of the month indicated.

Use within 56 days of first use.

Do not refrigerate or freeze this medicine.

Do not store above 25 °C.

Contains ethanol, which is flammable. Keep away from heaters, open flames, and other sources of ignition.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lenzetto

• The active substance is estradiol (as estradiol hemihydrate). Each spray contains 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate).
• The other components are octisalate and 96% ethanol.

Nature of the product and contents of the container

Lenzetto is a transdermal aerosol containing a solution of estradiol and octisalate in ethanol. It is supplied with a metered-dose pump.

Lenzetto is presented in a plastic-packaged container. Inside is a glass bottle containing 6.5 ml of solution, designed to deliver 56 sprays of 90 microlitres each after priming the metering pump. Mark each spray administered in the table on the carton.

Each spray contains 1.53 mg of estradiol.

Use only the number of sprays indicated on the label of each Lenzetto container, even if the container is not completely empty.

Pack sizes:

1 container of 6.5 ml (56 sprays).

3 containers of 3 x 6.5 ml (3 x 56 sprays).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

Manufacturer

Gedeon Richter România S.A.

Cuza Voda Street 99-105

Târgu-Mures

Romania - 540306

or

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest

Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Gedeon Richter Ibérica S.A.

Sabino Arana nº 28, 4º 2ª

08028 Barcelona, Spain

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/