ATROCOM 0.03 MG Vaginal suppository

Зміст інструкції

1. Atrocom 0.03 mg vaginal suppositories
   1. What is Atrocom and what is it used for
   2. What you need to know before using Atrocom
   3. How to use Atrocom
   4. Possible side effects
   5. How to store Atrocom
   6. Contents of the pack and other information

Atrocom 0.03 mg vaginal suppositories

Estriol

important information for you

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What Atrocomis and what it is used for
• 2. What you need to know before you use Atrocom
• 3. How to use Atrocom
• 4. Possible side effects
• 5. How to store Atrocom
• 6. Contents of the pack and other information

1. What is Atrocom and what is it used for

Atrocombelongs to a group of medicines called vaginal hormone replacement therapy (HRT).
It is used to relieve symptoms of menopause in the vagina such as dryness or irritation. In medical terms
this is known as "vaginal atrophy". This is caused by a decrease in estrogen levels in the body.
This happens naturally after menopause.

Atrocomworks by replacing the estrogen that is normally produced in women's ovaries. It is inserted
into your vagina, so the hormone is released where it is needed. This can relieve discomfort in the
vagina.

2. What you need to know before using Atrocom

Medical history and regular check-ups
The use of HRT involves risks that must be considered when deciding whether to start or continue using it.
Experience in treating women with early menopause (due to ovarian insufficiency or surgery) is limited. If you have early menopause, the risks associated with HRT may be different.
Talk to your doctor.
Before starting (or restarting) hormone replacement therapy, your doctor will ask you about your personal and family medical history. Your doctor may decide to perform a check-up. This may include a breast exam and/or a pelvic exam, if necessary.
Once you have started Atrocom, you should consult your doctor for regular check-ups (at least once a year).
During these check-ups, discuss with your doctor the benefits and risks of continuing therapy with Atrocom.
As recommended by your doctor, undergo regular breast cancer screening.
Before starting treatment with Atrocom, vaginal infections must be treated with appropriate medications.

Do not useAtrocom
If anything in the following list applies to you. If you are unsure about any of the points below, talk to your doctorbefore using Atrocom.
Do not use Atrocom

• if you have, have ever had, or suspect you have breast cancer;
• if you have or suspect you have a cancer sensitive to estrogen, such as cancer of the uterine lining (endometrium);
• if you have unexplained vaginal bleeding;
• if you have excessive thickening of the uterine lining(endometrial hyperplasia) that has not been treated;
• if you have or have had in the past blood clots in the veins(thrombosis) of the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• if you have a blood clotting disorder(such as protein C, protein S or antithrombin deficiency);
• if you have or have recently had disorders caused by blood clots in the arteries, such as heart attack, strokeor angina;
• if you have or have had in the past a liver diseaseand your liver function has not yet returned to normal;
• if you have a rare blood disorder called “porphyria” that is inherited (familial);
• if you are allergic to estriol or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions appear for the first time during the use of Atrocom, stop using it immediately and consult your doctor immediately.

Warnings and precautions
Tell your doctor if you have ever had any of the following problems, before starting treatment, as these may return or worsen during treatment with Atrocom. In this case, you should consult your doctor more often for check-ups:

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

Stop using Atrocom and contact your doctor immediately
If you notice any of the following while using HRT:

• If you experience any of the events listed under “Do not use Atrocom”.
• yellowing of the skin or eyes (jaundice) these may be signs of a liver disease;
• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives, along with difficulty breathing suggesting angioedema;
• a sharp increase in blood pressure (symptoms may include headache, fatigue, dizziness);
• migraine or headache, for the first time;
• if you become pregnant;
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs;
• sudden chest pain;
• difficulty breathing. For more information, see "Blood clots in a vein (thrombosis)".

Note:Atrocom 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 to use additional contraception to prevent pregnancy. Contact your doctor for advice.

HRT and cancer
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial carcinoma)
Taking HRT tablets containing only estrogen for a long period may increase the risk of developing cancer of the uterine lining (the endometrium).
It is not clear whether there is a similar risk when Atrocom is used for repeated or long-term treatments (more than one year). However, Atrocom has been shown to have very low absorption into the blood, so the addition of a progestin is not necessary.
If you bleed or have spotting, it is usually nothing to worry about, but you should make an appointment to see your doctor. It may be a sign that your endometrium has become thicker.

The following risks apply to medicines for hormone replacement therapy (HRT) that circulate in the blood.

However, Atrocom is indicated for local treatment in the vagina and absorption into the blood is very low. It is

less likely that the conditions indicated below will worsen or recur during treatment with

Atrocom, however contact your doctor if you have any doubts.

Breast cancer
Evidence suggests that the use of Atrocom does not increase the risk of breast cancer in women who have not had this type of cancer in the past. It is not known whether Atrocom can be used safely in women who have had breast cancer in the past.

• Check your breasts regularly. See your doctor if you notice changes such as:
• dimpling of the skin;
• changes in the nipple;
• any lumps you can see or feel.

In addition, it is advisable to join breast cancer screening programs when they are offered to you.

Ovarian cancer
Ovarian cancer is rare - much rarer than breast cancer. The use of HRT with only estrogen has been associated with a slight increase in the 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 out of 1000 will be diagnosed with ovarian cancer over a 5-year period. For women who have used HRT for 5 years, there will be about 3 cases out of 1000 users (i.e. about 1 extra case).

Effect of HRT on the heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veinsis 1.3 to 3 times higher in users of HRT compared to non-users, especially during the first year of use.
Blood clots can be serious, and if one reaches the lungs, it can cause chest pain, shortness of breath, fainting or even death.
You are more likely to have a blood clot in the veins as you get older and if one of the following conditions applies to you. Tell your doctor if any of these situations apply to you:

• you are unable to walk for a long time due to surgery, injury or serious illness (see also section 3, "If you need surgery");
• you are seriously overweight (BMI > 30 kg/m²);
• you have a blood clotting problem that requires long-term treatment with a medicine used to prevent blood clots from forming;
• someone in your close family has ever had a blood clot in the leg, lung or another organ;
• you have systemic lupus erythematosus (SLE);
• you have cancer. For signs of a blood clot, see "Stop using Atrocom and contact your doctor immediately".

Comparison
Considering women aged 50 who do not use HRT, on average, 4 to 7 out of 1000 will have a blood clot in a vein over a 5-year period.
For women aged 50 who have used HRT with only estrogen for more than 5 years, there will be 5 to 8 cases out of 1000 users (i.e. 1 extra case).

Heart disease (heart attack)
For women who take estrogen-only therapy, there is no increased risk of developing heart disease.

Stroke
The risk of stroke is about 1.5 times higher in users of HRT compared to non-users. The number of extra cases of stroke due to the use of hormone replacement therapy will increase with age.

Comparison
Considering women aged 50 who are not taking HRT, on average, 8 out of 1000 may have a stroke over a 5-year period. For women aged 50 who are taking HRT, there will be 11 cases out of 1000 users, over 5 years (i.e. 3 extra cases).

Other conditions
Hormone replacement therapy does not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Talk to your doctor for advice.

Other medicines and Atrocom
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use other medicines.
Atrocom is used for local treatment in the vagina and is unlikely to interact with other medicines.
Atrocom may affect other treatments applied vaginally, but it is unlikely to interact with other medicines.
If Atrocomis used at the same time as latex condoms, it may reduce their tensile strength and therefore compromise the safety of the condoms themselves.

Pregnancy and breastfeeding
Atrocom is intended only for postmenopausal women. If you become pregnant, stop taking Atrocom and contact your doctor.

Driving and using machines
Atrocom does not affect the ability to drive vehicles and use machines.

Atrocomcontains butylhydroxytoluene
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use Atrocom

Use this medicine exactly as your doctor has told you.
If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:
During the first 3 weeks of treatment, one ovule (corresponding to 0.03 mg of estriol) administered
daily. Subsequently, as a maintenance dose, 1 ovule 2 times a week is recommended.
Your doctor will prescribe the lowest dose to treat your symptoms for the shortest possible time. Talk to your
doctor if you think this dose is too strong or not strong enough.

Method of administration
The ovule must be inserted deeply into the vagina, preferably in the evening before going to bed.
To administer an ovule, tear the film on the top until
the ovule can be easily removed.

If you use moreAtrocomthan you should
If you use too many ovules at any time, you should not worry. You may, however, consult a doctor
for advice. You may feel unwell or be sick, and some women may experience
some vaginal bleeding after a few days.

If you forget to useAtrocom

• - During daily use in the first 3 weeks of treatment: If you do not realize a missed dose before the next day, you should skip the missed dose. In this case, you should resume with the usual dosage schedule.
• During use twice a week: If you have forgotten to take Atrocomon the scheduled date, take the missed dose as soon as possible.

If you stop using Atrocom
Even if your symptoms improve significantly, you should continue treatment until the end. However, if you
wish to stop or end treatment early, consult your doctor.

If you need surgery
If you are planning to have surgery, tell the surgeon that you are using Atrocom. It may
be necessary to stop using Atrocom 4 to 6 weeks before the operation to reduce the
risk of blood clots (see paragraph 2, "Blood clots in a vein (thrombosis)"). Ask your
doctor when you can start using Atrocom again.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following conditions are reported more frequently in women using hormone replacement therapy (HRT) that circulate in the
blood than in women who do not use HRT. The aforementioned risks are less relevant for treatments
administered via the vaginal route such as Atrocom:

• ovarian cancer;
• blood clots in the veins of the legs or lungs (venous thromboembolism);
• stroke;
• possible memory loss if HRT is started over the age of 65. For further information on these side effects, see paragraph 2. Local irritations may occur at the beginning of treatment.

Common(may affect up to 1 in 10 users)

• vulvovaginal burning, itching and pain;
• discomfort during urination (dysuria).

Uncommon(may affect up to 1 in 100 users)

• vaginal discharge;
• anorectal disorders.

The following side effects have been reported with other HRT:

• gallbladder disease;
• various skin disorders:
• skin discoloration, especially on the face or neck, known as "chloasma" or "pregnancy mask" (cloasma),
• painful reddish skin nodules (erythema nodosum),
• skin rash with redness or target-shaped sores (erythema multiforme).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Atrocom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package and on the blister after “Exp.”
The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatAtrocomcontains
The active ingredient is estriol.
1 ovule contains 0.03 mg of estriol.
The other ingredients are: butylhydroxytoluene, glyceryl ricinoleate, saturated fatty acids, macrogol
cetostearyl ether.

Description of the appearance ofAtrocomand contents of the pack

Atrocomis presented as white ovules.

Atrocomis available in packs containing 10, 15, 20, 24 and 30 ovules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmitalia srl
Viale Alcide De Gasperi 165/B
95127 Catania

Manufacturer
DR. KADE Pharmazeutische Fabrik GmbH
Rigistraße 2
12277 Berlin (Germany)

This medicinal product is authorised in the member states of the European Economic Area and in the United Kingdom
(Northern Ireland) with the name of:
Germany – OeKolp Ovula 0.03 mg
Denmark, Finland, Norway, and Sweden – Estrokad
Hungary - Estrokad 0.03 mg hüvelykúp
Belgium, Luxembourg – Oekolp 0.03 mg ovule/ovules/Vaginalzäpfchen
Italy – Atrocom 0.03 mg ovuli
United Kingdom, Ireland – IMVAGGIS 0.03 mg pessary
Netherlands – Estriol DR. KADE 0.03 mg ovules
Austria – Estrokad 0.03 mg Vaginalzäpfchen
United Kingdom (Northern Ireland) – IMVAGGIS 0.03 mg pessary