1.53 mg /Lanzetta spray transdermal spray, estradiol solution
What Lenzetto Is And What It Is Used For?
Lanzetta is a preparation used for hormonal substitution therapy ( Hormone Replacement Therapy, HRT ). It contains the female sex hormone estrogen. Lanzetta is used for women whose menstruation has stopped ( menopause ), at least 6 months after their last natural menstruation.
Lanzetta can also be used by women whose ovaries have been removed, as this leads to the onset of menopause immediately.
Lanzetta spray solution contains small amounts of the drug estradiol. When sprayed on the skin according to the instructions, the drug penetrates through the skin into the bloodstream.
Lanzetta is used to:
Relieve Symptoms During And After Menopause
When menstruation ends ( menopause ), the woman’s estrogen decreases. It can cause problems such as sweating and hot flashes. Lanzetta relieves these symptoms after menopause. Lanzetta should only be used if the problems cause problems in daily life.
Lanzetta is indicated for the treatment of estrogen deficiency symptoms during menopause when menstruation has stopped after menopause. Symptoms of estrogen deficiency include hot flashes (sudden waves of heat and sweating throughout the body), sleep problems, irritation, and a dry vagina.
Experience in treating women over the age of 65 is limited.
Lanzetta is not a contraceptive.
Estradiol contained in Lenzetto may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What You Need To Know Before Using Lenzetto
Medical Background And Regular Check-ups
The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.
Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.
Before starting treatment (or resuming treatment), your doctor will ask about your own, and your family’s medical background. The doctor may perform a general medical and gynecological examination, which also includes the examination of the breasts.
Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.
Perform regular examinations of the breasts according to the doctor’s recommendations.
Do Not Take Lanzetta
if any of the following apply to you. If you are not sure, talk to your doctor before taking Lanzetta.
- If you have or have had breast cancer or if you suspect you may have it.
- If you have or have had estrogen-dependent cancer , such as cancer of the uterine lining (endometrium) or if there is a suspicion of such cancer.
- If you have unexpected genital bleeding that has not been investigated by a doctor.
- If you have endometrial hyperplasia(severe thickening of the uterine lining) and are not being treated for it.
- If you have or have had a blood clot in a vein (venous thromboembolism ) , in your legs (deep vein thrombosis) or in your lungs ( pulmonary embolism ) .
- If you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S or antithrombin) .
- If you have or have had a disease caused by blood clots in the arteries are as heart attack, stroke (stroke) or angina.
- If you have or have had any liver disease and still have abnormal liver values.
- If you have porphyria , a rare inherited blood disorder.
- If you are allergic to estradiol or any of the other ingredients of this medicine (listed in section 6).
If any of the above affects you the first time you use Lanzetta, stop taking Lenzetto and contact your doctor immediately.
Warnings And Cautions
Talk to your doctor or pharmacist before using Lanzetta.
Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Lanzetta. Should this occur, have more frequent check-ups with a doctor.
- If you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis or have had endometrial hyperplasia (severe thickening of the uterine lining)
- If you have an increased risk of blood clots (see below “Blood clots in a vein ( thrombosis )”)
- If a close relative has had breast cancer or other estrogen-dependent cancer
- High blood pressure
- Liver disease, e.g. liver adenoma (benign tumor )
- Diabetes
- Gallstone disease
- If you get a migraine or severe headache
- If you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- Epilepsy
- Asthma
- Otosclerosis (ossification of the middle ear leading to hearing loss)
- Hypertriglyceridemia (elevated blood lipids)
- Fluid retention due to heart or kidney disease.
You should contact a doctor immediately and discontinue treatment if any of the Lenzetto spray side effects occur:
- Some of what is mentioned in the section “Do not take Lenzetto”
- If skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
- If your blood pressure rises sharply (symptoms may include headache, fatigue or dizziness)
- If you are experiencing migraine-like headaches for the first time
- If you become pregnant
- If you get symptoms of blood clots like
- painful swelling and redness of the legs
- sudden chest pain
- breathing difficulties
For more information, see below “Blood clots in a vein ( thrombosis )”.
Note: Lenzetto is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.
HRT And Cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer).
The use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.
By taking progestogen as a supplement to estrogen for at least 12 days in each 28-day cycle, you are protected against this extra risk. The doctor will prescribe the progestogen if you have your uterus left.
If your uterus has undergone surgery ( hysterectomy ), you should consult your doctor if you can take the medicine without a progestogen.
For women with the uterus left who do not take HRT, an average of 5 out of 1,000 women aged 50-65 will be diagnosed with endometrial cancer.
For women aged 50-65 who have the uterus left and who take HRT with estrogen alone, between 10 and 60 women out of 1,000 users will be diagnosed with endometrial cancer (ie between 5 and 55 extra cases), depending on dose one and how as long as it is taken.
Lanzetta higher dose of estrogen than other HRT -preparation only estrogen. The risk of endometrial cancer when used with progestogens is unknown.
Unexpected Bleeding
You will have bleeding once a month (so-called dropout bleeding) when you take Lenzetto if the medicine is taken in combination with a sequential progestogen preparation. But if you get unexpected bleeding or splashing bleeding in addition to your monthly bleeding, and these:
- Lasts longer than 6 months
- Begins after taking Lenzetto for 6 months
- Continues after you stop taking Lenzetto
you should see a doctor as soon as possible.
Breast cancer
Data show that hormone replacement therapy ( HRT ) with combined estrogen-progestogen or with estrogen alone increases the risk of breast cancer. The increased risk depends on how long you use HRT. The increased risk is seen within 3 years. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
Comparison:
Among women aged 50–54 who do not take HRT, an average of 13–17 out of 1,000 will be diagnosed with breast cancer over 5 years.
In women who are 50 years old and start taking HRT with estrogen alone for 5 years, 16‑17 cases per 1,000 users (ie 0–3 extra cases) will occur.
In women who are 50 years old who start taking HRT with estrogen-progestogen for 5 years, 21 out of 1,000 users will be diagnosed (ie 4 – 8 extra cases).
Among women aged 50–59 who do not use HRT, an average of 27 out of 1,000 will be diagnosed with breast cancer over 10 years.
In women who are 50 years old and start taking HRT with estrogen alone for 10 years, 34 cases per 1,000 users (ie 7 extra cases) will occur.
In women who are 50 years old and start taking HRT with estrogen-progestogen for 10 years, 48 cases per 1,000 users (ie 21 extra cases) will occur.
Check your breasts regularly. Contact a doctor if you notice changes such as:
- Indentations or pits
- Changes of the nipple
- Nodules you can see or feel.
It is also recommended that you participate in a mammogram when you are called. At the mammogram, you must tell the nurse/healthcare professional who performs the examination that you are using HRT, as this medicine may increase the density of the breasts. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.
Ovarian cancer ( ovarian cancer )
Ovarian cancer is rare – much more rare than breast cancer. Use of HRT with estrogen alone or combined estrogen – progestogens has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 between the ages of 50 and 54 who do not take HRT for 5 years. For women who have taken HRT for 5 years, there will be about 3 cases per 2000 users (ie about 1 extra case).
How HRT Affects The Heart And Blood Circulation
Blood clots in a vein ( thrombosis )
The risk of blood clots in the veins is 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.
You are more likely to get a blood clot in a vein if any of the following apply to you. Tell your doctor if any of the following apply to you:
- You have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
- You are severely overweight ( BMI over 30 kg / m 2 )
- You have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
- If a close relative has had a blood clot in the bone, lung or other organ
- You have SLE (systemic lupus erythematosus)
- You have cancer.
The symptoms of a blood clot are described in the section “You should contact a doctor immediately and discontinue treatment”.
For women in their 50s, who do not take HRT, over 5 years, an average of 4-7 out of 1,000 are expected to get a blood clot in a vein.
For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9-12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases).
For women in their 50s without a uterus who take estrogen alone for more than 5 years, 5-8 out of 1,000 users are expected to get a blood clot in a vein (ie 1 extra case).
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks.
For women over 60 who take HRT with estrogen-progestogen, the risk of developing heart disease is slightly higher than those who do not take HRT.
For women without a uterus who take estrogen alone, there is no increased risk of developing heart disease.
Stroke (apoplexy)
The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.
Comparison: For women in their 50s who do not take HRT, an average of 8 out of 1,000 people are expected to have a stroke over 5 years. For women in their 50s who have taken HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases).
Other conditions
Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.
Children:
Lenzetto Spray Side Effects
After the spray has dried, the area sprayed should be covered with a garment in case other people may come into contact with that area. The estrogen in the Lenzetto spray can be inadvertently transferred to other people from the skin area where it was sprayed.
Do not allow other people, especially children, to come into contact with the exposed skin area. If a child comes in contact with the area of the arm where Lenzetto has been sprayed, wash the child’s skin with soap and water as soon as possible.
Toddlers who have accidentally come in contact with the skin area with Lenzetto spray may show unexpected signs of puberty (eg budding breasts).
Contact your healthcare provider immediately if you notice signs and symptoms (breast development or other changes related to sexual maturity) in a child who may have been accidentally exposed to Lanzetta. In most cases, the baby’s breasts return to normal when the baby is no longer exposed to Lanzetta.
Pets
Do not allow pets to lick or touch the arm where Lenzetto has been sprayed. Small pets can be especially sensitive to the estrogen in Lanzetta.
Contact a veterinarian if your pet shows an enlargement of the breasts/nipples or swelling of the external genitalia or other signs of illness.
Other Drugs And Lenzetto
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect the effect of Lanzetta, which can lead to irregular bleeding. The following applies:
- Antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine)
- Medicines for tuberculosis (eg rifampicin and rifabutin)
- Drugs for HIV – infection (for example, nevirapine, efavirenz, ritonavir, and nelfinavir)
- (Traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum ).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal remedies.
Results from blood test analyze
If you need to take a blood sample, tell your doctor, or the person taking the blood sample, that you are taking Lanzetta, as this may affect the results of some tests.
Pregnancy And Breastfeeding
Lanzetta is intended for women whose menstruation has stopped. If you become pregnant, stop taking Lenzetto and consult a doctor.
Do not use Lenzetto if you are breastfeeding.
Driving And Using Machines
Lanzetta has no known effects on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
A description of these effects and side effects of Lenzetto can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lenzetto Contains Alcohol
This medicine contains 65.47 mg of alcohol ( ethanol ) in each dose, which corresponds to 72.74% w / v. It can cause a burning sensation on damaged skin.
Alcohol-based liquids are flammable. Avoid fire, flames, lighting cigarettes, or using certain hot appliances (eg hairdryers) when spraying the skin and until the spray has dried.
How To Take Lenzetto
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will strive to give you the lowest dose, which will give you relief of symptoms, and that you should use Lenzetto for the shortest possible time. Your doctor may adjust the dose one during treatment according to your individual needs.
Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.
If your uterus has not been surgically removed, your doctor will prescribe tablets that contain another hormone called progestin to reduce the effects of estrogen on your uterine lining. Your doctor will explain to you how to take these tablets. Dropout bleeding may occur at the end of the progestogen treatment period (see section Unexpected bleeding).
If you need surgery
If you are having surgery, tell your surgeon that you are taking Lanzetta. You may need to stop taking Lenzetto for 4 to 6 weeks before surgery to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when it is appropriate to start taking Lenzetto again.
Where to apply Lanzetta
The spray should be applied to dry and healthy skin on the inside of the forearm. If this is not possible, it should be applied to the inside of the thigh.
Do Not Apply Lenzetto To The Breasts Or The Skin Near The Breasts.
How to apply Lanzetta
Before using a new applicator for the first time, prepare the pump for use by spraying it three times with the cap on. The container should be held upright as in picture 1. With the lid on, press the button straight down three times with your thumb or forefinger. The drug is now ready for use.
DO NOT prepare the applicator before each dose; prepare the applicator only once before using a new container. If you forget to take one or more doses, prepare the applicator according to the instructions in the section “If you forget to use Lanzetta”.
Check that the skin at the place where you are going to apply the medicine 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 plastic cone tightly against the skin (Figure 2).
You may need to move the arm or move the cone-shaped part of the container on the arm so that the cone lies close to the skin and there is no gap between the cone and the skin.
Press the activation button at the bottom once. It must always be fully depressed and held down before being released again.
If a second spray is needed, move the cone along the arm so that it is next to the area you have already sprayed. Press the button at the bottom once.
If a third spray is needed, move the cone along the arm again and press the button at the bottom once.
If the second or third spray does not fit on the inside of the same forearm, you can also spray on the inside of the other forearm. If you have difficulty placing the cone on the inside of the forearm as in picture 3 or if it is difficult for you to spray on the forearms, you can also spray on the inside of the thigh.
When you have finished using Lanzetta, always place the lid back on the container (Fig. 4).
If you use the product according to the instructions, each spray will release the same amount of the ingredient on the skin, regardless of the shape of the spray or how it lands on the skin.
Let the spray dry for at least 2 minutes before dressing and at least 60 minutes before bathing or washing. If you get Lenzetto spray on any other skin area such as your hands, wash your skin area immediately with soap and water.
Lanzetta must not be used on damaged skin.
Do not massage or rub Lenzetto into the skin.
Do not allow other persons or pets to touch the skin area where the spray was applied for at least 60 minutes afterward.
If another person (especially a child) accidentally touches the skin area where you sprayed Lanzetta, ask the person to immediately wash the exposed skin area with soap and water.
Therefore, the sprayed skin area should be covered with clothing 2 minutes after the spray has been applied.
How much Lenzetto to use
Your doctor will probably start treatment with the lowest dose (one spray daily) and you should discuss with your doctor how well the medicine works for you. If necessary, the doctor may increase the dose one to two sprays daily. The maximum daily dose is 3 sprays.
How often to use Lanzetta
The total number of sprays ( doses ) prescribed by your doctor should be applied at the same time each day.
How long does Lenzetto take to work
Discuss with your doctor every 3 to 6 months how long you should take Lanzetta. You should only use Lenzetto for as long as you need it to relieve hot flashes associated with menopause.
Other useful information
Sunscreens can affect the absorption of estrogen from Lanzetta.
Avoid using sunscreen on the skin area where you are going to spray Lanzetta. If you need to use sunscreen, apply it for at least one hour before using Lanzetta.
Lanzetta should be used with caution in extreme temperature conditions, e.g. for sunbathing or sauna baths.
There are limited data to suggest that Lenzetto’s absorption rate and ‑ degree may be lower in overweight or obese women. Discuss the matter with your doctor. Your doctor may adjust the dose one during treatment according to your individual needs.
Possible Lenzetto Side Effects
Like all medicines, this medicine can cause side effects, like lenzetto spray weight loss although not everybody gets them.
The following diseases are more common in women who take HRT than those who do not:
- Breast cancer
- Severe thickening of the uterine lining ( endometrial hyperplasia ) or cancer of the uterine lining (endometrial cancer)
- Does lenzetto cause weight gain?
- Ovarian cancer ( ovarian cancer )
- Blood clots in veins in bones or lungs (venous thromboembolism )
- Heart disease
- Stroke (apoplexy)
- Gallbladder disease
- High blood pressure
- Liver problem
- High blood sugar
- Probable memory loss, if treatment with HRT is started after the age of 65.
See section 2 for more information on these side effects.
Some lenzetto side effects can be serious.
The following symptoms require immediate medical attention:
- Sudden chest pain
- Chest pain that spreads to arms and neck
- Breathing difficulties
- Painful swelling and redness of the legs
- Yellowing of the eyes and face (jaundice)
- Unexpected vaginal bleeding (breakthrough bleeding) or splashing bleeding after using Lenzetto for a while or after stopping treatment
- Breast changes such as pits in the skin of the breasts, changes in the nipples, lumps that you see or feel
- Painful menstruation
- Dizziness and fainting
- Speech disorders
- Visual disturbances
- Unexplained migraine-like headache.
If any of the Lenzetto side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The following side effects have been reported with Lanzetta:
Common Side Effects of Lenzetto are (may affect up to 1 in 10):
- Headache
- Abdominal pain
- Nausea
- Rash
- Itching
- Irregular bleeding from the uterus or bleeding from the vagina (eg spotting)
- Sore breasts
- Chest pain
- Weight gain
- Lenzetto spray weight loss
Less Common Side Effects are (may affect up to 1 in 100):
- Hypersensitivity reactions
- Depressed state
- Insomnia
- Dizziness
- Visual disturbances
- Palpitations
- Diarrhea
- Indigestion
- High blood pressure
- Tuberculosis (characterized by painful red bumps on the skin)
- Hives (scattered or locally raised rash, rash, mumps, rash) of the breasts
- Secretion from the breasts, polyps (small growths) in the uterus or cervix
- Endometrial hyperplasia
- Ovarian cyst, inflammation of the vagina
- Elevated liver enzymes and high cholesterol in the blood
- Pain in the forearm.
Rare Side Effects Of Lenzetto are (may affect up to 1 in 1000 people):
- Anxiety decreased or increased sex drive
- Migraine, contact lens intolerance
- Bloating
- Vomiting
- Increased body hair
- Acne
- Muscle cramps
- Painful menstruation
- PMS-like syndrome
- Breast enlargement
- Fatigue.
Other Lenzetto side effects are of unknown frequency (frequency can not be estimated from available data) have been reported with Lenzetto from post-marketing surveillance:
- Alopecia
- Chloasma (golden brown pigment patches, so-called pregnancy spots,
- Especially in the face),
- Skin discoloration.
The following side effects have been reported with other HRTs:
- Severe allergic reaction causing swelling of the face or pharynx ( angioedema )
- Anaphylactoid/anaphylactic reactions (severe allergic reaction causing difficulty breathing or dizziness)
- Glucose intolerance,
- Depression, mood disorders
- Irritation,
- Worsening of dance sickness ( Epilepsy, Aggravated, Gallbladder disease, Yellowing of the skin (Jaundice)
- Pancreatitis,
- Benign tumor in the smooth muscles of the uterus, various skin diseases: discoloration of the skin especially on the face and neck, so-called “pregnancy spots” (chloasma)
- Painful reddish-purple lumps on the skin (erythema nodosum)
- Annular redness or sore rash (erythema multiforme)
- Skin rash with bleeding
- Hair loss
- Joint pain, secretion of milk from the breasts
- Lumps in the breasts
- Enlarged benign tumors in the smooth muscle of the uterus
- Changes in the secretion and inner lining of the cervix
- Inflammation of the vagina
- Fungal infection of the vagina (candidiasis of the vagina)
- Unusually low calcium
How To Store Lenzetto
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and container label. The expiration date is the last day of the specified month.
- Use within 56 days after first use.
- Store in a cold place. Do not freeze.
- Do not store above 25 ° C.
- Contains flammable ethanol. Do not store near heat sources, open flames, or other ignition sources.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is estradiol (as estradiol hemihydrate). One spray contains 1.53 mg of estradiol (equivalent to 1.58 mg of estradiol hemihydrate).
- The other ingredients are octisalate and 96% ethanol .
What The Medicine Looks Like And Contents Of The Pack
Lanzetta is a transdermal spray that contains a solution of estradiol and octisalate in ethanol. The medicine is in a pump for divided doses.
Lanzetta is sold in a plastic container with a plastic lid. Inside there is a glass container. A container is filled with 6.5 ml of solution and is designed to deliver 56 sprays of 90 microliters after the pump has been prepared. Mark the number of sprays performed in the table on the box.
One Lenzetto spray contains 1.53 mg of estradiol.
Do not use a Lenzetto container longer than the specified number of sprays, even though the container may not be empty.
Pack sizes:
- A plastic container 6.5 ml (56 sprays)
- Three plastic containers 3×6.5 ml (3×56 sprays)
- Not all pack sizes may be marketed.
This medicinal product is authorized under the European Economic Area under the names:
| HU | Lenzetto |
| ASK | Lenzetto |
| BG | Lenzetto |
| CY | Lenzetto |
| CZ | Lenzetto |
| THE | Lenzetto |
| DK | Lenzetto |
| EE | Lenzetto |
| EL | Lenzetto |
| ES | Lenzetto |
| FI | Lenzetto |
| HR | Lenzetto |
| IE | Lenzetto |
| IS | Lenzetto |
| IT | Lenzetto |
| LT | Lenzetto |
| LU | Lenzetto |
| LV | Lenzetto |
| MT | Lenzetto |
| NL | Lenzetto |
| NO | Lenzetto |
| PL | Lenzetto |
| RO | Lenzetto |
| SEE | Lenzetto |
| SI | Lenzetto |
| SK | Lenzetto |
| UK | Lenzetto |
Marketing Authorization Holder And Manufacturer
- Gedeon Richter Plc.
- Gyömrői out 19-21.
- 1103 Budapest, Hungary
Manufacturer
- Gedeon Richter România SA
- Cuza Voda street 99-105
- Târgu-Mureş, 540306 Romania
- Gedeon Richter Plc.
- Gyömrői out 19-21.
- 1103 Budapest, Hungary
For Further Information On This Medicine, Please Contact:
- Gedeon Richter Nordics AB
- Barnhusgatan 22
- 111 23 Stockholm, Sweden