Prolutex

Leaflet accompanying the packaging: patient information

Prolutex, 25 mg, solution for injection

Progesterone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of contents of the leaflet:

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

1. What is Prolutex and what is it used for

Prolutex contains the active substance progesterone. Progesterone is a naturally occurring female sex hormone. The medicine works on the uterine lining and helps to become pregnant and maintain pregnancy.
Prolutex is intended for women who need additional doses of progesterone during assisted reproductive technology (ART) treatment and cannot use or do not tolerate vaginal products.

2. Important information before using Prolutex

When not to use Prolutex:

• If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
• If you have vaginal bleeding (of unknown origin) that has not been investigated by a doctor
• If you have had a miscarriage and there is a suspicion that dead tissue is still in the uterus
• If you are currently pregnant outside the uterus (ectopic pregnancy)
• If you have or have had severe liver disease
• If you have or have had breast or genital cancer
• If you have or have had blood clots in your legs, lungs, eyes, or other parts of your body
• If you have porphyria (a genetic or acquired disorder of certain enzymes)
• If you had jaundice (yellowing of the eyes and skin due to liver problems), severe itching, and (or) blisters on the skin during pregnancy
• In patients under 18 years of age

Warnings and precautions

Special care should be taken when using Prolutex

If any of the following conditions occur during treatment, you should immediately
tell your doctor, as there is a likelihood that treatment should be discontinued. You should inform your doctor if these conditions occur a few days after the last injection.

• Heart attack (chest pain, back pain, and (or) deep pain and pulsation in one or both arms, sudden shortness of breath, sweating, dizziness, nausea, palpitations)
• Stroke (sudden severe headache or vomiting, dizziness, fainting, vision and speech disturbances, weakness, numbness of the arm or leg)
• Blood clots in the eye or in any part of the body (eye pain or pain and swelling of the ankles, feet, and hands)
• Worsening of depression
• Sudden severe headache, vision disturbances

Before using Prolutex

Before using Prolutex, you should tell your doctor if you have or have had any of the following conditions, as this requires close monitoring during treatment:

• Liver disease (mild to moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney disease
• Diabetes
• Depression If any of the above points apply to you, your doctor will closely monitor your condition during treatment.

Children and adolescents

This medicine is not intended for use in children and adolescents.

Prolutex and other medicines

Tell your doctor about all the medicines you have taken recently, including those available without a prescription and herbal medicines. Some medicines may interact with Prolutex.
This is especially true for the following medicines:

• Carbamazepine (used to treat epilepsy)
• Rifampicin (an antibiotic)
• Griseofulvin (an antifungal medicine)
• Phenytoin and phenobarbital (used to treat epilepsy)
• Herbal products containing St. John's Wort (Hypericum perforatum)
• Cyclosporin (a medicine used to treat certain types of inflammation and after transplants)
• Antidiabetic medicines
• Ketoconazole (an antifungal medicine)

Do not administer Prolutex and other injectable medicines at the same time.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor.

• Prolutex may be used during the first three months of pregnancy.
• The medicine must not be used during breastfeeding.

Driving and using machines

Do not drive or operate machinery if you experience drowsiness and (or) dizziness while using Prolutex.

Prolutex contains hydroxypropylbetadex

If you have kidney disease, you should consult your doctor before using this medicine.

Prolutex contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to use Prolutex

This medicine should always be used exactly as your doctor has told you. Remember that Prolutex can only be used under the supervision of a doctor experienced in the treatment of infertility.

What dose of Prolutex should be used and for how long?

The usual dose is 25 mg per injection once a day. The treatment usually lasts until the 12th week of confirmed pregnancy (i.e., 10 weeks of treatment).

How to administer Prolutex

Prolutex can be administered subcutaneously (subcutaneous injection) in a dose of 25 mg or intramuscularly (intramuscular injection) in a dose of 25 mg.
The patient will be able to self-administer the subcutaneous injection of 25 mg of Prolutex after proper training by a doctor or nurse.

Subcutaneous injection:

Before the first administration of Prolutex, the patient will be trained in the following points:

• Practical performance of subcutaneous injections
• Where to inject the medicine
• How to prepare the solution for injection
• How to administer the medicine

Please read the following instructions for preparing the solution and administering Prolutex

Next steps for self-administration of the medicine:
A
Preparing the injection
B
Checking the packaging
C
Preparing the vial and syringe
D
Filling the syringe
E
Changing the needle to an injection needle
F
Removing air bubbles
G
Administering the medicine by subcutaneous injection
H
Disposing of waste
The above actions are described below
NOTE: Each vial is for single use only.
The solution should be used immediately after opening the vial. Do not store it in the syringe.

A Preparing the injection

It is essential to maintain hygiene and cleanliness. When starting preparations, wash your hands thoroughly and dry them with a clean towel. Choose a clean surface for preparing the medicine:

• One vial of Prolutex containing the solution for injection

The following items are notincluded in the packaging of the medicine. The doctor or pharmacist will provide them to the patient:

• One syringe
• One large green needle (21G, for intramuscular injection)
• One small gray needle (27G, for subcutaneous injection)
• Two swabs impregnated with a disinfectant
• A container for medical waste (for safe disposal of needles, vials, etc.)

B Checking the packaging

• The Prolutex vial, syringe, and needles have protective covers
• Check that all covers are factory-fitted; if they are improperly fitted or damaged, do not use these products
• Make sure what the expiry date of Prolutex is. If it is after the expiry date, do not use this medicine.

C Preparing the vial and syringe

Remove the plastic cap from the Prolutex vial by gently pushing it upwards Wipe the rubber stopper with a swab impregnated with a disinfectant and wait until it dries Unpack the syringe Take the large green needle 21G; do not remove the needle cover Holding the syringe in your hand, put the large green needle 21G on it, remove the needle cover

D Filling the syringe

E Changing the needle to an injection needle

These actions are required only for subcutaneous injection; if the doctor performs an intramuscular injection, they will prepare the appropriate dose and perform the injection.

• Put the needle cover on the large green needle 21G and gently remove the needle from the syringe
• Take the smaller gray needle 27G out of the packaging, do not remove the cover
• Put the small gray needle 27G on the syringe and then remove the cover from the needle.

F Removing air bubbles

Insert the large green needle 21G through the rubber stopper into the Prolutex vial With the needle inserted, turn the vial upside down. The needle should hold the vial by itself Make sure the tip of the needle is below the level of the liquid Gently pull the plunger to fill the syringe Withdraw the needle from the vial

Holding the syringe straight up with the small gray needle 27G pointing towards the ceiling, slowly pull back the plunger and gently tap the syringe to make all air bubbles rise Slowly press the plunger until all the air is out of the syringe, and a small drop of solution appears on the tip of the gray needle 27G.

G Administering the medicine by subcutaneous injection

• The doctor or nurse will show you the areas where you can inject Prolutex (e.g., abdomen or front of the thigh)
• Open the packaging of the swab impregnated with a disinfectant, thoroughly wipe the injection site, and wait until it dries
• Holding the syringe with one hand, use the fingers of the other hand to pinch the skin fold, so the injection site is between the thumb and index finger

With a quick, firm motion, insert the small gray needle 27G at a right angle

• Insert the entire gray needle 27G into the skin. Do not inject the solution directly into a blood vessel
• Inject the solution by gently pressing the plunger with a smooth, slow motion until the entire solution is injected under the skin.
• Release the skin fold and withdraw the needle.
• With a circular motion, wipe the skin at the injection site with a swab impregnated with a disinfectant.

H Disposing of waste

• After the injection, put the needles, empty vial, and syringe into a container for medical waste.
• Any unused solution should also be disposed of.

Intramuscular injection may only be performed by a doctor or nurse

The intramuscular injection will be performed by a doctor or nurse.
The injection of Prolutex may be done from the side or from the bottom of the thigh. The doctor or nurse will wipe the injection site with a swab impregnated with a disinfectant and wait until it dries. With a quick, firm motion, they will insert the needle into the muscle. The solution will be injected by gently pressing the plunger with a smooth, slow motion. Then the needle will be withdrawn, and the skin at the injection site will be wiped with a swab impregnated with a disinfectant.

Using more Prolutex than prescribed

Tell your doctor or pharmacist. Symptoms of overdose include drowsiness.

Missing a dose of Prolutex

Take the missed dose as soon as possible, and then proceed as usual.
Do not take a double dose to make up for the missed dose. Consult your doctor for further action.

Stopping the use of Prolutex

Do not stop using Prolutex without consulting your doctor or pharmacist. Stopping Prolutex abruptly may cause increased anxiety, mood swings, and increased susceptibility to seizures.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prolutex can cause side effects, although not everybody gets them

You should stop using this medicine and seek medical help immediately if you experience any of the following symptoms:

• Ovarian hyperstimulation syndrome (symptoms include abdominal pain, thirst, malaise, sometimes vomiting, decreased urine output, weight gain),
• Depression,
• Yellowing of the skin and eyes (jaundice),
• Severe allergic reaction, which can cause difficulty breathing, swelling of the face and throat, or acute rash (anaphylactic reactions).

Very common(may affect more than 1 in 10 people)

• Pain, redness, itching, irritation, or swelling at the injection site
• Uterine contractions
• Vaginal bleeding

Common(may affect up to 1 in 10 people)

• Headache
• Bloating
• Abdominal pain
• Constipation
• Nausea and vomiting
• Breast tenderness and (or) breast pain
• Vaginal discharge
• Irritation, tingling, or itching of the vagina and surrounding skin
• Hardening at the injection site
• Bruising at the injection site
• Fatigue (excessive tiredness, exhaustion, drowsiness)

Uncommon(may affect up to 1 in 100 people)

• Mood changes
• Dizziness
• Insomnia
• Gastrointestinal disorders (discomfort in the stomach and (or) tenderness, excessive gas, painful cramps, nausea)
• Skin rash (including redness and increased skin temperature, itching bumps or blisters, dry, cracked skin, skin swelling)
• Breast swelling and (or) breast enlargement
• Feeling of heat
• General feeling of discomfort
• Pain

Frequency not known: cannot be estimated from the available data
The following side effects have not been described for Prolutex during clinical trials, but for other progesterone-containing medicines: insomnia, symptoms similar to premenstrual syndrome, menstrual disorders, hives, acne, excessive hair growth, hair loss, weight gain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prolutex

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Store in the original packaging to protect from light.
This medicine must be used immediately after opening the packaging.
Any remaining solution should be disposed of.
Do not use this medicine after the expiry date stated on the label after: EXP. If the expiry date is given as a month/year, the expiry date refers to the last day of the given month.
Do not use Prolutex if you notice any particles in the solution or if the solution is not clear.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Prolutex contains

The active substance of Prolutex is progesterone.
One vial (1.112 ml) contains 25 mg of progesterone (theoretical concentration 22.48 mg/ml).
The other ingredients are: Hydroxypropylbetadex, Disodium phosphate, Sodium dihydrogen phosphate dihydrate, Water for injections

What Prolutex looks like and contents of the pack

Prolutex is a colorless solution in a transparent vial.
Each pack contains 1, 7, or 14 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

IBSA Farmaceutici Italia Srl
Via Martiri di Cefalonia 2
26900 Lodi
Italy
biuro@ibsagroup.com
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
(The strength and pharmaceutical form are the same in all countries, only the trade name differs).
Austria:
Progedex
Belgium:
Inprosub
Bulgaria:
Prolutex
Cyprus:
Prolutex
Czech Republic:
Prolutex
Denmark: Prolutex
Estonia:
Lubion
Finland:
Prolutex
France:
Progiron
Germany:
Prolutex
Greece:
Prolutex
Hungary:
Prolutex
Italy:
Pleyris
Lithuania:
Lubion
Latvia:
Lubion
Luxembourg:
Inprosub
Norway:
Prolutex
Poland:
Prolutex
Portugal:
Prolutex
Romania:
Prolutex
Slovakia :
Prolutex
Sweden:
Prolutex
Spain:
Prolutex
Netherlands:
Prolutex
United Kingdom:
Lubion

Date of last revision of the leaflet: September 2024