Document: Gelistrol vaginal gel ENG PL change

• Gelistrol vaginal gel PL
• Gelistrol vaginal gel ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gelistrol 50 micrograms/g vaginal gel

Estriol

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

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

Gelistrol contains estriol, a female hormone that is identical to a hormone that your body makes naturally called oestrogen. Estriol helps to keep the cells lining the vagina (mucosa) elastic and more resistant to mechanical influence and makes you less likely to develop an infection.

Gelistrol is used for the treatment of vaginal dryness, which is due to lack of oestrogen after menopause.

Do not use Gelistrol

• if you are allergic (hypersensitive) to estriol or any of the other ingredients of this medicine (listed in the section 6).

• if you have, have had or it is suspected that you have a breast cancer or a cancer of the womb

• if you are pregnant or you think you may be pregnant

• if you have unexpected vaginal bleeding

• if you have abnormal growth of the lining of your womb (endometrial hyperplasia)

• if you have or have previously had blood clots in the veins of the legs (deep venous thrombosis) or in the lungs (lung embolism)

• if you have or have recently had heart problems such as angina or heart attack

• if you have an acute liver disease or have previously had liver disease and your liver function has not returned to normal

• if you have porphyria (a rare metabolic disease)

Warnings and precautions

The medicine is given by inserting an applicator into the vagina. This may cause discomfort or soreness in women who have severe vaginal atrophy (thinning or inflammation of the vaginal walls).

Medical check-ups

Before treatment with Gelistrol, your doctor should ask you about your own and your family’s medical history. Your doctor may decide to examine your breasts and/or your abdomen, and may do an internal examination - but only if these examinations are necessary for you, or if you have any special concerns.

Once you have started to use Gelistrol, you should see your doctor for regular check-ups (at least once a year). At these check-ups, your doctor may discuss with you the need to continue using Gelistrol.

Please tell your doctor if you have or have had any of the following disease/conditions, that in rare cases can return or become worse during treatment with Gelistrol:

• any disease of the heart or circulation

• too much cholesterol or other fatty substances in the blood

• changes in your breast

• endometriosis (abnormal growth of the inner lining of your womb outside the womb)

• benign tissue lump in your womb (myoma)

• high blood pressure

• diabetes

• gallstones

• migraine or severe headache

• a rare disease of the immune system called systemic lupus erythematosus (SLE)

• epilepsy (fits)

• asthma

• otosclerosis (deafness caused by thickened ear tissue)

• kidney disease

Reasons to contact your doctor immediately

• you get jaundice (your eyes and skin go yellow) or problems with your liver function

• a sudden increase in blood pressure

• if you get migraine or severe headache, for the first time

• you become pregnant

• if anything under the heading “Do not use Gelistrol” occurs.

If any of the above occurs, your doctor may need to stop treatment and give you an alternative.

Treatment with higher dose oestrogen preparations that can raise your blood levels of oestrogen (such as tablets or stick on patches) increases the risk for abnormal growth of the lining of your womb (endometrial hyperplasia), certain types of cancer such as breast and endometrial cancer and blood clots in the veins. Gelistrol is a vaginal gel for local treatment and contains a very low dose of estriol, therefore your risk of developing these conditions is very low. Nevertheless, if you are concerned about these risks, you should discuss it with your doctor.

Other medicines and Gelistrol

Gelistrol contains a low dose of estriol and is for local treatment, therefore it is not expected to affect or be affected by taking other medicines.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

You should not use Gelistrol if you are pregnant.

If you do become pregnant during treatment, tell your doctor immediately and do not use Gelistrol.

You should not use Gelistrol during breast-feeding.

Driving and using machines

Gelistrol has no effect on your ability to drive and use machines.

Gelistrol contains

Sodium methyl parahydroxybenzoate (E 219) and sodium propyl parahydroxybenzoate (E 217). They may

cause allergic reactions (possibly delayed).

Do not use this medicine if you are allergic to any of the ingredients.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for the first 3 weeks of treatment is one applicator-dose per day, preferably before going to bed. After 3 weeks of use, your discomfort should have decreased and the dose should be lowered. You may only need one dose twice a week.

How to apply the gel

Inside the cardboard box you will find a tube containing 10g of Gelistrol and one blister containing 10 disposable tubes (cannulas) with a filling mark and a reusable plunger.

Inside the cardboard box you will find a tube containing 10g of Gelistrol and one bag containing 1 reusable tube (cannula) with a filling mark and a reusable plunger.

Inside the cardboard box you will find a tube containing 30 gof Gelistrol and three blisters eachcontaining 10disposable tubes (cannulas) with a filling mark and a reusable plunger.

Inside the cardboard box you will find a tube containing 30g of Gelistrol and one bag containing 1 reusable tube (cannula) with a filling mark and a reusable plunger.

Use the applicator to insert the gel in the vagina (it is recommended before going to bed).

The following instructions explain how the gel should be used.

In the picture below you can see different elements of the tube and the applicator.

1. Remove the tube cap, turn it upside down and use the sharp point to pierce the seal on the neck of the tube.

2. Take out a cannula and the plunger. Insert the white plunger all the way into the cannula. Screw the cannula on the neck of tube.

3.Squeeze the tube to fill the applicator with the gel up to the filling mark

4.Unscrew the cannulafrom the tubeand replace the cap on the tube.

5. To apply the gel, lie down, insert the end of the applicator deep into the vagina and slowly push the plunger all the way down.

6 . After use,

Pack size of 10g – 1 Blister containing 10 disposable tubes (cannulas) and a reusable plunger.

Pack size of 30g – 3 Blisters containing 30 disposable tubes (cannulas) and a reusable plunger.

Pull the plunger out of the cannula, dispose of the cannula and rinse the plunger well with clean water so it can be reused for the next application.

Pack size of 10g – Bag containing 1 reusable tube (cannula) and a reusable plunger.

Pack size of 30g – Bag containing 1 reusable tube (cannula) and a reusable plunger.

Pull the plunger out of the cannula. Rinse both cannula and plunger well with clean water so it can be reused for the next application.

If you use more Gelistrol than you should

If too much gel is applied at any time or someone has swallowed some gel accidentally, there is no need to worry. However, you should consult a doctor for advice. You might feel sick or be sick and some women may have some vaginal bleeding after a few days.

If you forget to use Gelistrol

Do not use a double dose to make up for a forgotten dose.

Apply the missed dose when you remember, unless you are more than 12 hours late. If you are more than 12 hours late just skip the missed dose.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately if any of the conditions that are listed in the section “What you need to know before you use Gelistrol” occur, such as vaginal bleeding. Your doctor may need to stop treatment and give you an alternative.

At the beginning of treatment local irritation or itching may occur. In most patients these side effects go away with continued use. Tell your doctor if vaginal bleeding occurs, or if any of the following side effects become troublesome or continue.

Common side effects (occur in less than 1 in 10 patients):

Itching, local irritation in or around the vagina

Uncommon side effects (occur in less than 1 in 100 patients):

Low abdominal pain, skin irritation, genital rash, headache, Candidiasis (vaginal ‘thrush’)

Other very rare side effects may occur when higher dose oestrogen preparations that can raise blood levels of oestrogen (such as tablets or stick on patches) are taken for a long time:

- Certain types of tumours such as endometrial cancer and breast cancer

- Blood clots in the veins

- Heart attack and stroke

- Gall bladder disease

- Skin problems such as rashes or red patches on the skin

- Dementia (brain disease)

As Gelistrol is a vaginal gel for local treatment and contains a very low dose of estriol, your risk of developing these side effects is very low.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 label. The expiry date refers to the last day of that month.

Store below 25ºC.

Do not throw away any medicinesvia wastewater or household waste. Ask your pharmacist how tothrow away medicines you no longer use. These measures will help protect the environment.

What Gelistrol contains

The active substance is estriol.

One applicator filled to the mark delivers a dose of 1 g vaginal gel that contains 50 micrograms estriol.

The other ingredients are: Glycerol (E422), sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), polycarbophil, carbopol, sodium hydroxide, hydrochloric acid, purified water.

What Gelistrol looks like and content of the pack

This medicinal product is presented as a colourless, clear to slightly translucent vaginal gel, pack size of 1 aluminium tube 10g or 30 g.

Cardboard box containing 10g of Gelistrol and one blister containing 10 disposable tubes (cannulas) with a filling mark and a reusable plunger.

Cardboard box containing 10g of Gelistrol and one bag containing 1 reusable tube (cannula) with a filling mark and a reusable plunger.

Cardboard box containing 30 gof Gelistrol and three blisters eachcontaining 10disposable tubes (cannulas) with a filling mark and a reusable plunger.

Cardboard box containing 30g of Gelistrol and one bag containing 1 reusable tube (cannula) with a filling mark and a reusable plunger.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

ITALFARMACO S.A.

San Rafael, 3 -28108 Alcobendas

(Madrid)- Spain

Manufacturer responsible for batch release

ITALFARMACO S.A.

San Rafael, 3 -28108 Alcobendas

(Madrid)- Spain

This medicinal product is authorized in the Member States of the EEA under the following names:

To be completed nationally.

This leaflet was last revised in 2015-05-12