PROLUTEX 25 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Prolutex 25 mg solution for injection in pre-filled syringe

progesterone

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.

Contents of the pack

1. What is Prolutex and what is it used for
2. What you need to know before you use Prolutex
3. How to use Prolutex
4. Possible side effects
5. Storage of 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 natural female sex hormone. The medicine works on the lining of the uterus and helps it to stay and remain pregnant.

Prolutex is indicated for women who need extra progesterone while undergoing treatment in an Assisted Reproduction Technique (ART) protocol, and who cannot use or tolerate vaginal preparations.

2. What you need to know before you use Prolutex

Do not use Prolutex

• if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6);
• if you have unusual vaginal bleeding that has not been evaluated by your doctor;
• if you have had a miscarriage and your doctor suspects that some tissue is still in the uterus;
• if you currently have an ectopic pregnancy (a pregnancy in which a fertilized egg implants outside the uterus);
• if you currently have or have had severe liver problems;
• if you have or suspect breast or genital tract cancer;
• if you currently have or have had blood clots in your legs, lungs, eyes, or anywhere else in your body;
• if you have porphyria (a group of inherited or acquired disorders of certain enzymes);
• if during pregnancy you have had jaundice (yellowing of the eyes and skin due to liver problems), severe itching, and/or blisters on the skin;
• if you are under 18 years of age.

Warnings and precautions

Be careful with Prolutex

If you experience any of the following disorders during treatment, tell your doctor immediately, as you may need to interrupt treatment. Also, tell your doctor immediately if you experience them a few days after the last dose:

• heart attack (chest or back pain, and/or deep, throbbing pain in one or both arms, sudden difficulty breathing, sweating, dizziness, fainting, nausea, palpitations);
• stroke (severe headache or vomiting, dizziness, fainting or changes in vision or speech, weakness or numbness in one arm or leg);
• blood clots in the eyes or anywhere else in the body (eye pain or pain and swelling in the ankles, feet, and hands);
• worsening of depression symptoms;
• severe headache, changes in vision.

Before treatment with Prolutex

Before treatment with Prolutex, tell your doctor if you have or have had any of the following health problems:

• Liver problems (mild or moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney disorders
• Diabetes
• Depression

If this is the case, your doctor will closely monitor you during treatment.

Children and adolescents

This medicine must not be used in children or adolescents.

Other medicines and Prolutex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription or herbal medicines. Some medicines may interact with Prolutex. For example:

• Carbamazepine (used to treat seizures/attacks)
• Rifampicin (antibiotic)
• Griseofulvin (antifungal medicine)
• Phenytoin and phenobarbital (used to treat epilepsy)
• Herbal medicines containing St. John's Wort
• Ciclosporin (medicine for some types of inflammation and after organ transplants)
• Medicines for diabetes
• Ketoconazole (antifungal medicine)

Do not administer Prolutex at the same time as another injectable medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• Prolutex may be used during the first trimester of pregnancy.

• This medicine must not be used during breastfeeding.

Driving and using machines

Do not drive or use tools or machines if you feel drowsy and/or dizzy while using Prolutex.

Prolutex contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

3. How to use Prolutex

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor again. Remember, Prolutex should only be used under the supervision of a doctor with experience in treating fertility problems.

What dose of Prolutex should you use and for how long?

The recommended dose is one daily injection of 25 mg, usually up to 12 weeks after confirmed pregnancy (i.e., 10 weeks of treatment).

How should Prolutex be administered

Prolutex should be administered under the skin (subcutaneous injection, i.e., SC).

You may self-administer 25 mg of Prolutex, subcutaneously, after receiving adequate advice and training from your doctor or healthcare professional.

Before self-administering an injection of Prolutex, you will receive the following training and advice:

• practice of subcutaneous injection administration;
• where to inject the medicine;
• how to administer the medicine.

Read the instructions below on preparing and administering Prolutex.

The steps to follow for correct self-administration are:

1. Preparation of the injection
2. Checking the packaging
3. Injection
4. Disposal of used materials

These steps are explained in detail below.

1. Preparation of the injection

It is essential to keep everything as clean as possible, so start by washing your hands thoroughly and drying them with a clean towel. Choose a clean area to prepare the injection.

The following materials are notsupplied with your medicine. Your doctor or pharmacist will provide these materials.

• Two alcohol swabs;
• A container for sharp objects and needles (to safely dispose of the pre-filled syringe, etc.).

1. Checking the packaging

• Do not use the product if the packaging is open or damaged.
• Make sure the pre-filled syringe of Prolutex contains the solution.
• Make sure the expiration date shown on the pre-filled syringe of Prolutex is still valid. Do not use the products if they are past the expiration date.

1. Injection

• Your doctor or healthcare professional will have already shown you where to inject Prolutex (e.g., in the abdomen or in the front of the thigh).
• Open the alcohol swab, carefully clean the skin area to be injected, and let it dry.
• Remove the cap. Once the cap is removed, do not let the needle touch anything. This is to ensure the needle remains clean (sterile).
• Hold the syringe with the needle facing upwards and slowly press the plunger until all the air has been removed from the syringe and at least one drop of the solution comes out of the needle tip.
• Hold the syringe in one hand. Use your other hand to gently pinch the skin at the injection site between your thumb and index finger.

• Insert the needle completely into the skin. Do not inject directly into a vein.
• Inject the solution by slowly and steadily pushing the plunger until all the solution is injected under the skin. Inject all the solution.
• Release the skin and withdraw the needle directly.
• Clean the skin at the injection site with an alcohol swab using a circular motion.

Each pre-filled syringe is for single use only.

1. Disposal of used materials

• Once you have finished the injection, put the pre-filled syringe in a container for sharp objects and needles.

If you use more Prolutex than you should

If you have used more Prolutex than you should, consult your doctor or pharmacist immediately. Symptoms of an overdose include numbness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount used.

If you forget to use Prolutex

Use the dose as soon as you remember and then proceed as before. Do not use a double dose to make up for the forgotten dose. Inform your doctor of what you have done.

If you stop treatment with Prolutex

Do not stop using Prolutex without consulting your doctor or pharmacist first. Stopping Prolutex suddenly may cause an increase in anxiety, irritability, and increase the risk of having seizures (attacks).

If you have any other questions about using 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 this medicine and seek medical help immediately if you have any of the following symptoms:

• Ovarian hyperstimulation (symptoms include pain in the lower abdomen, feeling of thirst and dizziness, and sometimes vomiting, passing small amounts of concentrated urine, and weight gain),
• Depression,
• Yellowing of the skin and the whites of the eyes (jaundice),
• Severe allergic reaction that can cause difficulty breathing, swelling of the face and throat, or a severe rash (anaphylactoid reactions).

Very common:may affect more than 1 in 10 people

• pain, redness, itching, irritation, or swelling at the injection site,
• uterine spasm,
• vaginal bleeding.

Common:may affect up to 1 in 10 people

• headache,
• bloating,
• stomach pain,
• constipation,
• vomiting and feeling of nausea,
• breast tenderness on palpation and/or breast pain,
• vaginal discharge,
• tingling or irritating discomfort or itching of the skin of the vagina and surrounding area,
• hardening of the area around the injection site,
• bruising around the injection site,
• fatigue (excessive tiredness, exhaustion, lethargy).

Uncommon:may affect up to 1 in 100 people

• mood changes,
• dizziness,
• numbness,
• gastrointestinal disorders (including stomach upset and/or pain on palpation, gas, painful spasms, and retching),
• skin rashes (including red, hot skin, and/or itching, bumps, or hives),
• breast swelling and/or enlargement,
• feeling of heat,
• general feeling of discomfort or "feeling unwell",
• pain.

Rare:frequency cannot be estimated from the available data

The following disorders, although not reported by patients in clinical studies using Prolutex, have been described with other progestins: insomnia, premenstrual syndrome or menstrual disorders, urticaria, acne, excessive hair growth, hair loss (alopecia), and weight gain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prolutex

Keep this medicine out of the sight and reach of children.

Do not refrigerate or freeze.

Store in the original packaging to protect from light.

Do not use this medicine after the expiration date shown on the carton and on the label of the pre-filled syringe after EXP.

Do not use this medicine if you notice particles in the solution or if the solution is not clear.

Each pre-filled syringe is for single use only.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prolutex

The active substance is progesterone. Each pre-filled syringe (1.112 ml) contains 25 mg of progesterone (22.48 mg/ml).

The other ingredients are hydroxypropylbetadex, disodium phosphate, sodium dihydrogen phosphate dihydrate, and water for injections.

Appearance and packaging of the product

Prolutex is a clear and transparent solution for injection in a pre-filled syringe, supplied in a glass syringe.

Each carton contains 7 or 14 pre-filled syringes. Only certain pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2

26900 Lodi

Italy

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

Planta 8, Local 1,

08028 Barcelona (Spain)

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names (the concentration and pharmaceutical form are identical 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

Netherlands: Prolutex

United Kingdom (Northern Ireland): Lubion

Date of last revision of this leaflet:May 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).