PRONTOGEST 50 mg /Ml Injectable Solution

Зміст інструкції

1. PRONTOGEST 50 mg/ml injectable solution, 100 mg/ml injectable solution
   1. What is PRONTOGEST and what is it used for
   2. What you need to know before taking PRONTOGEST
   3. How to take PRONTOGEST
   4. Possible side effects
   5. How to store PRONTOGEST
   6. Contents of the pack and other information

PRONTOGEST 50 mg/ml injectable solution, 100 mg/ml injectable solution

Progesterone

Read this leaflet carefully before you start to take 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 they have the same symptoms as you, as it may 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 PRONTOGEST is and what it is used for
• 2. What you need to know before you take PRONTOGEST
• 3. How to take PRONTOGEST
• 4. Possible side effects
• 5. How to store PRONTOGEST
• 6. Contents of the pack and other information

1. What is PRONTOGEST and what is it used for

PRONTOGEST contains an active ingredient called progesterone. Progesterone is a
natural female sex hormone. This medicine acts on the lining of the uterus
promoting its normal functions; it also facilitates the onset and maintenance of pregnancy.
PRONTOGEST is used in women:

• with the following alterations of the menstrual cycle: heavy menstrual bleeding (hypermenorrhea), scanty menstrual bleeding (hypomenorrhea), frequent menstrual cycles (polymenorrhea), decreased menstrual cycles (oligomenorrhea), absence of menstruation (amenorrhea);
• with vaginal bleeding (metrorrhagia);
• with threatened miscarriage or a history of recurrent miscarriages;
• with threatened preterm labor;
• to prevent postpartum depression;
• who need progesterone supplementation because their body does not produce enough (in case of infertility or primary or secondary ovarian insufficiency);
• who are pregnant and need to undergo surgery;
• who suffer from premenstrual syndrome, a condition that manifests with: breast tension, headache, abdominal or leg swelling, mood instability.

2. What you need to know before taking PRONTOGEST

Do not take PRONTOGEST if:

• you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• you have bleeding (not due to menstruation) that has not been evaluated by your doctor;
• you have had a miscarriage and your doctor suspects that some tissue has remained inside the uterus (incomplete or internal miscarriage);
• you have or have had in the past blood clots (thrombi or emboli), for example in the limbs

lower (thrombophlebitis), in the lungs, in the eyes or in any other part of the body;

• you have suffered a ruptured blood vessel in the brain (cerebral haemorrhage);
• you have severe liver problems.

Warnings and precautions
Take special care with PRONTOGEST
If you experience any of the following conditions during treatment with PRONTOGEST, even some days after taking the dose, tell your doctor immediately
as it may be necessary to stop treatment or change your therapy:

• blood clots in the lungs. This condition manifests with difficulty breathing, chest pain and cough;
• blood clots in the brain resulting in stroke. This condition manifests with severe headache or vomiting, dizziness, fainting or changes in vision or speech, weakness or numbness of an arm or leg;
• blood clots in the limbs (peripheral vessels), especially in the legs. This condition manifests with pain, swelling, redness and increased temperature of the affected area;
• blood clots in the eyes. This condition manifests with changes in vision, such as total or partial loss of vision, double vision or blurred vision;
• changes in hormone levels or liver function tests.

If you need to undergo a histological examination of the uterus, remember to tell your doctor that you are being treated with PRONTOGEST.

Before treatment with PRONTOGEST
Consult your doctor before taking PRONTOGEST if you have or have had:

• epilepsy;
• headache (migraine);
• asthma;
• heart or kidney problems;
• diabetes;
• depression. In these cases, your doctor will carefully monitor your clinical condition during treatment.

Consult your doctor before taking PRONTOGEST also if you are currently in pre-
menopause.

Other medicines and PRONTOGEST
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your
doctor for advice before taking any medicine.

• PRONTOGEST can be used during pregnancy in the conditions listed in section
• 1.
• PRONTOGEST should not be used if you are breastfeeding.

Driving and operating machinery
PRONTOGEST can cause dizziness or drowsiness. Do not drive vehicles or operate machinery if you notice
any of these side effects.

PRONTOGEST contains benzyl alcohol
This medicine contains 200 mg of benzyl alcohol per 1 ml vial, equivalent to 200
mg/ml.
Benzyl alcohol can cause allergic reactions.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).
Ask your doctor or pharmacist if you have a liver or kidney disease. This
because large amounts of benzyl alcohol can accumulate in the body and cause adverse
effects (such as metabolic acidosis)

3. How to take PRONTOGEST

Take this medicine following exactly the instructions of your doctor, who will establish the correct dose and duration of treatment, based on your condition. If you have any doubts, consult your doctor or pharmacist.

Dose and duration of treatment with PRONTOGEST
The dose to be taken depends on the reason why you are taking PRONTOGEST:

• threatened miscarriage: the usual dose is 100-200 mg per day for at least 7 days to be administered during the first three months of pregnancy. Subsequently 50 mg on alternate days for another 20 days. From the fourth to the sixth month, the usual dose is 100-200 mg per day for at least 7 days. Subsequently 100 mg on alternate days for another 20 days;
• history of recurrent miscarriages: the usual dose is 50-100 mg per day two or three times a week, to be administered from the very first stages of pregnancy;
• hypermenorrhea - polymenorrhea - metrorrhagia: the dose should be higher than 50 mg per day, to be administered a few days before the start of menstruation. The doctor may consider the possibility of a curettage before starting therapy with PRONTOGEST;
• amenorrhea - hypomenorrhea - oligomenorrhea: the usual dose is 25 mg per day for 5 days a month. The doctor may consider the possibility of associating another medicine (for example estrogens) with the therapy with PRONTOGEST;
• during a surgical intervention performed during pregnancy: the usual dose is 100-200 mg per day;
• premenstrual syndrome: the usual dose is 50 mg per day to be administered from the 14th day to the beginning of menstrual flow or 100 mg per day to be administered 2-4 days before menstruation;
• to prevent postpartum depression: the usual dose is 200 mg per day for 7 days to be administered immediately after delivery. Subsequently 100 mg per day until the appearance of the first menstruation. After the first menstruation, the usual dose is 50-100 mg per day, to be administered from the 14th day of the menstrual cycle until the appearance of menstrual flow. The treatment will continue until the complete disappearance of the symptoms, gradually decreasing the dose;
• progesterone supplementation: the usual dose is 50-100 mg per day. In case of confirmed pregnancy, the treatment must be continued until reaching the 8th-12th week of gestation.

Method of administration
Take PRONTOGEST by injection into a muscle (intramuscular route), following the

If you take more PRONTOGEST than you should
Contact your doctor.

If you forget to take PRONTOGEST
Take the forgotten dose as soon as you remember, then continue the treatment regularly. Do not use a double dose to compensate for the forgotten dose. However, inform your doctor of what happened.

If you stop taking PRONTOGEST
Do not stop the treatment with PRONTOGEST without first consulting your doctor or pharmacist.
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.
During treatment with medicines containing progesterone, such as PRONTOGEST, the following side
effects have been reported:

• blood clots in the eyes, limbs, lungs, or brain leading to stroke ( seesection 2 - “Special care with PRONTOGEST”);
• changes in tests evaluating liver function (alkaline phosphatase, transaminases) ( see section 2 - “Special care with PRONTOGEST”);
• increased blood pressure or changes in coagulation parameters;
• premenstrual syndrome, which manifests with breast tenderness, headache, abdominal or leg
  swelling, mood instability. These symptoms occur before each menstruation;
• changes in sexual desire;
• bleeding between periods;
• changes or absence of menstrual flow, changes in uterine secretions, breast pain (mastodynia);
• weight gain or loss;
• headache, dizziness, difficulty falling asleep (insomnia), drowsiness, nervousness, depression;
• skin reactions such as the appearance of tan-like spots (chloasma), urticaria with or without
  itching;
• abnormal hair growth (hirsutism), patchy hair loss (alopecia);
• yellowing of the eyes and skin, signs of cholestatic jaundice.

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 PRONTOGEST

Keep this medicine out of the sight and reach of children.
Do not store PRONTOGEST at temperatures above 25 °C.
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.
Do not dispose of any medicine in wastewater 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 PRONTOGEST contains
The active ingredient is: progesterone.
Each vial of PRONTOGEST 50 mg/ml injectable solution contains 50 mg of progesterone.
Each vial of PRONTOGEST 100 mg/ml injectable solution contains 100 mg of progesterone.
The other ingredients are: benzyl alcohol, ethyl oleate.

Description of the appearance of PRONTOGEST and contents of the pack
PRONTOGEST 50 mg/ml injectable solution is available in packs of 3 vials of 1 ml.
PRONTOGEST 100 mg/ml injectable solution is available in packs of 3 or 7 vials of 1 ml.

Marketing Authorisation Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi.

Manufacturer
Biologici Italia Laboratories S.r.l., Via Filippo Serpero, 2, 20060 Masate (Milano)
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi
INSTRUCTIONS FOR USE OF PRONTOGEST
To use PRONTOGEST, follow these steps:
A Preparation of the injection
B Verification of the administration material
C Preparation of the vial
D Filling the syringe
E Elimination of air bubbles
F Intramuscular injection
G Disposal of used components.
Below is a detailed description of each individual step.

• A. Preparation of the injectionIt is important to ensure maximum cleanliness. Begin by washing your hands thoroughly and drying them with a clean towel. Choose a clean area where you can prepare the injection with:
• one vial of PRONTOGEST.

You must also have the following components available, which are notsupplied in the pack
of the medicine:

• a syringe with a needle
• a swab soaked in alcohol
• a sharps container (for the safe disposal of needles, vials, etc.)
• B. Verification of the administration material
• The syringe and needle are provided with a protective cap.
• Verify that the cap is securely in place. If not, or if it is damaged, do not use the syringe and needle.
• Make sure that the expiry date on the PRONTOGEST vial is still valid. Do not use the medicine if it is expired.

• C. Preparation of the vial
• There is a coloured line on the neck of the vial.
• Gently tap the top of the vial to remove any liquid residue present in the tip.
• Press firmly on the tip of the vial to break it near the coloured line.
• D. Filling the syringe
• Make sure that the plunger is at the bottom of the syringe.
• Insert the needle into the vial and gently tilt the vial together with the syringe.
• Make sure that the tip of the needle is below the level of the liquid and gently pull the syringe plunger to draw all the solution contained in the vial into the syringe.
• E. Elimination of air bubbles
• Holding the syringe in a vertical position with the needle pointing upwards, slightly retract the plunger and tap the syringe so as to facilitate the rise of air bubbles to the top.
• Slowly press the plunger until all the air has been removed from the syringe and a drop of solution comes out of the tip of the needle.
• F. Intramuscular injection
• Take the swab soaked in alcohol and thoroughly clean the area of skin where you will administer the injection, then let it dry.
• Hold the syringe in one hand.
• With a quick vertical movement, insert the needle into the muscle.
• Do not inject directly into a vein.
• Inject the solution by applying slight pressure on the plunger with a slow and steady movement until the solution has been completely injected. Inject all the prescribed solution.
• Withdraw the needle keeping it in a vertical position.
• Clean the injection site with a swab soaked in alcohol with a circular movement.
• G. Disposal of used componentsOnce the injection is finished, replace the needle, empty vial and syringe in the sharps container. Any unused solution must be disposed of.