COLPOGYN 0.5 MG Pessarium

Treść ulotki

1. COLPOGYN 0.5 mg pessary, 1 mg pessary
   1. What is COLPOGYN and what is it used for
   2. What you need to know before using COLPOGYN
   3. How to use COLPOGYN
   4. Possible side effects
   5. How to store COLPOGYN
   6. Contents of the pack and other information

COLPOGYN 0.5 mg pessary, 1 mg pessary

Estriol

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is COLPOGYN and what is it used for

COLPOGYN is a vaginal medicine containing estriol, a sex hormone belonging to the
family of estrogens and naturally produced by the female body. Estriol helps to keep the
cells lining the vagina (mucosa) elastic and more resistant to mechanical stimuli, reducing the risk
of developing an infection.
COLPOGYN is used for:

• the treatment of pathologies of the female genital tract (both internal and external) caused by a lack of estrogens, such as senile vaginitis or vulvo-vaginitis, vulvar itching;
• the treatment before and after an operation on the vagina or via the vaginal route, performed shortly before or after the onset of menopause (climacteric);
• the prevention of inflammation of the cervix (the lower part of the uterus) of unclear cause (erosive exocervicitis).

Contact your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using COLPOGYN

Do not use COLPOGYN if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you suffer from severe impairment of liver function;
• you have or have had, or suspect you have breast cancer, unless specifically indicated by your doctor;
• you have or have had in the past blood vessel clots (thrombi or emboli), for example in the lower limbs (thrombophlebitis), in the eye (retinal thrombosis), in the heart vessels (coronary thrombosis), in the brain (cerebral thrombosis), in the lungs (pulmonary embolism);
• you have vaginal bleeding of which you do not know the cause;
• you are pregnant or think you might be.

Warnings and precautions
Talk to your doctor or pharmacist before taking COLPOGYN
Before prescribing COLPOGYN to you, your doctor will perform a general and gynecological examination; they will also ask you
questions about your personal and family medical history.
Talk to your doctor before using COLPOGYN if:

• there is a history of cancer in your family;
• you have isolated or widespread breast nodules (fibrocystic mastopathy);
• you have experienced repeated yellowish discoloration of the skin or persistent itching during pregnancy;
• you have problems with your kidneys, liver or heart;
• you suffer or have suffered from high blood pressure (hypertension);
• you suffer from epileptic seizures;
• you suffer from severe depression;
• you suffer from asthma;
• you have diabetes;
• you have a decrease in hearing caused by a thickening of the tissues inside the ear (otosclerosis);
• you have a disease of the nervous system called multiple sclerosis;
• you have a connective tissue disease called systemic lupus erythematosus that causes joint pain, skin changes and disorders of various organs;
• hereditary and acquired angioedema.

Stop taking Colpogyn and consult your doctor immediately.
If you notice any of the following symptoms while taking HRT:

• swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with difficulty breathing, which are symptoms of angioedema;

During therapy with COLPOGYN, you will need to see your doctor for regular check-ups; your doctor
will determine when and what tests to perform (e.g. breast exams and/or mammograms). During these
check-ups, your doctor may discuss with you whether or not to continue using COLPOGYN.
Breast cancer
Evidence shows that taking hormone replacement therapy (HRT) based on estrogens and
combined progestogens or based on estrogen alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk manifests within 3 years of
use. After stopping HRT, the additional risk will decrease over time, but this risk may
persist for 10 years or more if HRT is used for more than 5 years.
Comparison
In women aged between 50 and 54 who are not taking HRT, breast cancer will be
diagnosed on average in about 13-17 women out of 1000 over a period of 5 years.
In women aged 50 who start taking HRT based on estrogen alone for a period of 5 years, 16-17 cases will occur out of 1000 users (i.e. 0-3 more cases).
In women aged 50 who start taking HRT based on estrogens and combined progestogens for 5 years,
there will be 21 cases out of 1000 women treated (i.e. 4 to 8 more cases).
In women aged between 50 and 59 who are not taking HRT, breast cancer will be
diagnosed on average in 27 women out of 1000 over a period of 10 years.
In women aged 50 who start taking HRT based on estrogen alone for 10 years, 34 cases will occur out of 1000 users (i.e. 7 more cases).
In women aged 50 who start taking HRT based on estrogens and combined progestogens for 10 years,
48 cases will occur out of 1000 users (i.e. 21 more cases).
COLPOGYN is used for local treatment and contains a very low dose of estriol. However, if you are
concerned about the risk of developing cancer, discuss this with your doctor.

Children
COLPOGYN is not suitable for pediatric use.

Other medicines and COLPOGYN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
HRT can affect how some other medicines work:

• A medicine for epilepsy (lamotrigine), as it may increase the frequency of seizures.
• Medicines for the hepatitis C virus (HCV) (such as the ombitasvir/paritaprevir/ritonavir and dasabuvir regimens with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir can cause increases in blood test results for liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. COLPOGYN contains estriol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using COLPOGYN with this combination regimen against HCV.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk
(as small doses of estrogens pass into breast milk), ask your doctor or pharmacist for advice before
taking this medicine.
Colpogyn should not be used during pregnancy.

Driving and using machines
COLPOGYN does not impair the ability to drive vehicles or use machines.

3. How to use COLPOGYN

Use this medicine following the instructions of your doctor or pharmacist exactly.
The doctor will establish the correct dose and duration of treatment, based on your condition. If you have any doubts, consult
your doctor or pharmacist.
The daily doserecommended is 1 ovule (equivalent to 0.5 or 1 mg of estriol), to be applied deeply into the
vagina, preferably in the evening before going to bed.
The durationof treatment depends on the reason why you are using COLPOGYN: always follow the instructions
of your doctor.
If you are using COLPOGYN before an operation on the vagina or vaginally: your doctor will tell you to
start treatment a few weeks before the operation and continue it until 10 days before
the surgery.

INSTRUCTIONS FOR USE OF COLPOGYN
OVULE
Wash your hands thoroughly and take an ovule from the package.
Lie down with your knees bent and spread apart (as shown in figure 1).
Gently insert the ovule into the vagina as deeply as possible.

If you use more COLPOGYN than you should
If you use high doses of COLPOGYN, you may notice: breast pain (mastodynia), feeling of breast tension,
excessive mucus production from the vagina or vaginal bleeding (menometrorrhagia). In this case, contact
your doctor as it may be necessary to modify your therapy (e.g. reduce the dosage or
space out the applications).

If you forget to use COLPOGYN
Do not use a double dose to make up for a missed dose

If you stop using COLPOGYN
Do not stop treatment without consulting your doctor.
If you have any doubts 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.
Stop taking COLPOGYN and contact your doctor immediately if you notice the appearance of:

• itching and/or redness and/or skin lesions (possible sensitization reactions);
• swelling, redness and pain in a leg or arm (thrombophlebitis);
• severe headache;
• difficulty breathing (dyspnea);
• problems with understanding or speaking (aphasia);
• altered consciousness;
• altered voluntary movements;
• altered vision;
• yellowing of the eyes and skin (jaundice);
• abnormal vaginal bleeding (vaginal hemorrhage).

Other side effects that may occur with the use of COLPOGYN are:

• headache (cephalalgia, migraine);
• dizziness;
• involuntary, sudden and irregular muscle movements (chorea);
• high blood pressure (hypertension);
• nausea;
• vomiting;
• abdominal pain;
• slight vaginal bleeding;
• vaginal fungal infection (vaginal candidiasis);
• change in vaginal discharge;
• breast pain (mastodynia);
• breast enlargement or secretion;
• swelling (edema);
• weight gain;
• worsening of endometriosis (gynaecological disease in which cells of the uterus implant outside of it);
• worsening of porphyria (disease with alterations of red blood cell enzymes).

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
https://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 COLPOGYN

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 packaging. The expiry date refers to the last day of that month.
COLPOGYN vaginal suppositories: store in the original packaging at a temperature not exceeding 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

What COLPOGYN contains
The active ingredient is: estriol.
COLPOGYN vaginal tablets
Each 1 and 0.5 mg vaginal tablet contains 1 and 0.5 mg of estriol.
The other ingredients are: polyethylene glycol; semi-synthetic solid glycerides.

Description of the appearance of COLPOGYN and contents of the pack
COLPOGYN vaginal tabletsis available in packs of 10 or 20 white vaginal tablets, 0.5 mg or 1 mg.

Marketing Authorisation Holder
Angelini Pharma S.p.A. - Viale Amelia, 70, 00181 Rome

Manufacturer
A.C.R.A.F. S.p A. - Via Vecchia del Pinocchio, 22, 60131 Ancona