Label: information for the user

Prolutex 25 mg injectable solution

Progesterone

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the package and additional information

Prolutex contains the active ingredient progesterone. Progesterone is a natural female sex hormone. The medication acts 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 Reproductive Techniques (ART) protocol, and who cannot use or tolerate vaginal preparations.

Do not use Prolutex

• if you are allergic to progesterone or any of the other components of this medication (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 have had an ectopic pregnancy;
• if you have severe liver problems;
• if you have or suspect breast cancer or genital tract cancer;
• if you have or have had blood clots in the legs, lungs, eyes, or any other part of the 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), intense itching, and/or skin blisters;
• if you are under 18 years of age.

Warnings and precautions

Be especially careful with Prolutex

If you experience any of the following conditions during treatment, inform your doctor immediately, as you may need to discontinue treatment. Also, inform 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 any other part of the body (eye pain or pain and swelling in the ankles, feet, and hands);
• worsening of depression symptoms.
• intense headache, changes in vision

Before starting treatment

Before starting treatment with Prolutex, consult 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 problems
• diabetes
• depression

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

Children and adolescents

The medication should not be used in children or adolescents

Use of Prolutex with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications or herbal medications. Some medications may interact with Prolutex. For example:

• carbamazepine (used to treat seizures)
• rifampicin (antibiotic)
• griseofulvin (antifungal medication)
• phenytoin and phenobarbital (used to treat epilepsy)
• herbal medications containing St. John's Wort
• ciclosporin (medication for some types of inflammation and for after organ transplants)
• diabetes medications
• ketoconazole (antifungal medication)

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

Pregnancy and breastfeeding

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

Prolutex may be used during the first trimester of pregnancy.

This medication should not be used during breastfeeding.

Driving and operating machinery

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

Prolutex contains Hidroxipropil betadex

If you have kidney problems, consult your doctor before taking this medication.

Prolutex contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The usual dose is one daily injection of 25 mg normally up to 12 weeks after confirmed pregnancy (for example, 10 weeks of treatment).

How to administer Prolutex

Prolutex can be administered under the skin (subcutaneous injection) or in the muscle (intramuscular injection).

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

Subcutaneous injection

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

• Practice of subcutaneous injection administration;
• Where to inject the medication;
• How to prepare the injectable solution;
• How to administer the medication.

Read the instructions below on the preparation and administration of Prolutex.

The steps to follow for correct self-administration are:

1. Preparation of the injection
2. Checking the material
3. Preparing the vial and syringe
4. Filling the syringe
5. Changing the injection needle
6. Removing air bubbles
7. Injecting by subcutaneous administration
8. Removing used materials

These steps are explained in detail below.

IMPORTANT: Each vial should only be used once. The solution must be used immediately after opening the vial. Do not store it in the syringe.

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. Select a clean area to prepare the medication:

• A vial containing Prolutex injectable solution

The following materialsARE NOTsupplied with your medication. Your doctor or pharmacist will provide these materials.

• A syringe
• A large needle (typically a green 21G needle; for intramuscular administration)
• A small fine needle (typically a grey 27G needle; for subcutaneous injection)
• Two alcohol wipes
• A sharps container (for safe disposal of needles, vials, etc.)

1. Checking the material

• The Prolutex vial, syringe, and needles have protective covers.

• Check that all the covers are in good condition and do not use them if they are damaged.
• Ensure that the expiration date is still valid on the Prolutex vial. Do not use the products past the expiration date.

1. Preparing the vial and syringe

1. Filling the syringe

1. Changing the injection needle

This step is only required if you administer a subcutaneous injection; if your doctor administers an intramuscular injection, you will proceed to setting the dose to administer the injection.

• Put the needle cover on the large green 21G needle and then gently remove the large needle from the syringe.
• Remove the small grey 27G needle from its packaging, keeping the needle cover on.
• Put the small grey 27G needle into the syringe and then remove the needle cover.

1. Removing air bubbles

1. Injecting by subcutaneous administration

• Your doctor or healthcare professional will have already shown you where to inject Prolutex (e.g., in the abdomen or the front of the thigh).
• Open the alcohol wipe and clean the skin area to be injected carefully, and let it dry.
• Hold the syringe in one hand. Use the other hand to pinch the skin at the injection site between your thumb and index finger.

• Insert the small grey 27G needle completely into the skin. Do not inject directly into a vein.
• Inject the solution by gently pushing the plunger in a slow and sustained motion until all the solution is injected under the skin. Inject all the prescribed solution.
• Release the skin and remove the needle directly.
• Clean the skin at the injection site with an alcohol wipe in a circular motion.

1. Removing used materials

• Once you have finished with the injection, put all the needles, empty vials, and syringes in a sharps container.
• Any unused solution must be discarded.

Intramuscular administration should only be performed by a doctor or healthcare professional

All intramuscular injections will be performed by a doctor or other healthcare professional.

The Prolutex injection will be administered in the thigh or buttock. Your doctor or healthcare professional will clean the skin area to be injected using an alcohol wipe and let it dry. Using a dart-like motion, they will insert the large needle into the muscle. They will inject the solution by gently pushing the plunger in a slow and sustained motion until all the solution is injected into the muscle. They will remove the needle directly and clean the skin at the injection site with an alcohol wipe.

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 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 medication and the amount used.

If you forget to use Prolutex

Do not use a double dose to compensate for the missed dose.

Use the dose as soon as you remember and then continue as before. Inform your doctor of what you have done.

If you interrupt treatment with Prolutex

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Prolutex may cause side effects, although not everyone will experience them.

Stop taking this medicine and seek medical help immediately if you have any of the following symptoms:

• Ovarian hyperstimulation (symptoms include lower abdominal pain, feeling of thirst and dizziness, and sometimes vomiting, passing small amounts of concentrated urine, and weight gain),
• Depression,
• Yellowing of the skin and the white part of the eyes (jaundice),
• Severe allergic reaction that can cause difficulty breathing, swelling of the face and throat, or 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 cramps,
• Vaginal bleeding.

Common:may affect up to 1 in 10 people

• Headache,
• Distended stomach,
• Abdominal pain,
• Constipation,
• Vomiting and feeling of dizziness,
• Mastalgia (breast pain) on palpation and/or breast pain,
• Vaginal discharge,
• Itching or irritation of the skin of the vagina and surrounding area,
• Hardening of the area around the injection site,
• Cardinal signs around the injection site,
• Fatigue (excessive tiredness, exhaustion, lethargy).

Rare:may affect up to 1 in 100 people

• Changes in mood,
• Dizziness,
• Insomnia,
• Gastrointestinal disorders (including stomach discomfort and/or pain on palpation, gas, painful spasms, and nausea),
• Skin rashes (including hot, red, swollen, itchy, or blistered skin, or dry, cracked, or blistered skin),
• Swelling and/or enlargement of the breast,
• Feeling of heat,
• General feeling of discomfort or "feeling unwell",
• Pain.

Unknown:frequency cannot be estimated from 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 adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 25 °C. Do not refrigerate or freeze.

Store in the original packaging to protect it from light.

The medication must be used immediately after the first opening.

Any remaining solution must be discarded.

Do not use this medication after the expiration date that appears on the packaging after CAD. If the expiration date is indicated as month/year, the expiration date is the last day of the month indicated.

Do not use this medication if you observe particles in the solution or if the solution is not transparent.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Prolutex

The active ingredient is progesterone. Each vial (1,112ml) contains 25mg of progesterone (theoretical concentration: 22.48mg/ml)

The other components are hydroxypropylbetadex, disodium phosphate, dihydrogen phosphate dihydrate of sodium and water for injectable preparations.

Appearance of the product and contents of the packaging

Prolutex is a colorless and transparent solution supplied in a colorless glass vial.

Each package contains 1, 7 or 14 vials.

Only some package sizes may be commercially marketed.

Marketing Authorization Holder:

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2

26900 Lodi

Italy

Responsible for Manufacturing:

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2

26900 Lodi

Italy

IBSA Pharma Limited (Only in the United Kingdom)

Units 4-6 Colonial Business Park, Colonial Way

Watford WD24 4PR

United Kingdom

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th Floor, Local 1,

08028 Barcelona (Spain)

This medication is authorized in the EEA member states with the following names: (The concentration and pharmaceutical form are identical in all countries, only the commercial name changes)

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: Lubion

Last review date of this leaflet: November 2023

If this leaflet is difficult to read or see, or you would like it in a different format, please contact IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy (telephone +39(0) 371 417354, email[email protected]).
Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/