PROLUTEX 25 mg INJECTABLE SOLUTION

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 checked by your doctor;
• if you have had a miscarriage and your doctor suspects that some tissue is still in the womb;
• 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 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 blistering of 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 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 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 starting treatment

Before 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 the case, your doctor will closely monitor you during treatment.

Children and adolescents

This medicine must not be used in children or adolescents

Using Prolutex with other medicines

Tell your doctor or pharmacist that 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, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 Hydroxypropyl betadex

If you have kidney failure, consult your doctor before taking this medicine.

Prolutex contains sodium

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

3. How to use Prolutex

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

What dose 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 (e.g., 10 weeks of treatment).

How to administer Prolutex

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

You may 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 medicine;
• how to prepare the injectable solution;
• how to administer the medicine.

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 of materials
3. Preparation of the vial and syringe
4. Filling of the syringe
5. Changing the injection needle
6. Elimination of air bubbles
7. Injection by subcutaneous administration
8. Elimination of used materials

These steps are explained in detail below.

IMPORTANT: each vial should only be used once. The solution should be used immediately after opening the vial. It should not be stored in the syringe.

1. Preparation of the injection

It is important 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 medicine:

• A vial containing Prolutex injectable solution

The following materials ARE NOTsupplied with your medicine. 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 gray 27G needle; for subcutaneous injection)
• Two alcohol swabs
• A container for sharp objects (for safe disposal of needles, vials, etc.)

1. Checking of materials

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

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

1. Preparation of the vial and syringe

1. Filling of the syringe

1. Changing the injection needle

This step is only required if you perform a subcutaneous administration; if your doctor performs an intramuscular injection, you will proceed to fix the dose for administration.

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

1. Elimination of air bubbles

1. Injection by subcutaneous administration

• 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 an alcohol swab and carefully clean the skin area to be injected, and let it dry.
• Hold the syringe in one hand. Use your other hand to gently pinch the skin in the injection area between your thumb and index finger.

• Insert the small gray 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 steady motion until all the solution is injected under the skin. Inject all the prescribed solution.
• Release the skin and withdraw the needle directly.
• Clean the skin at the injection site with a cotton ball with alcohol using a circular motion.

1. Elimination of used materials

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

Intramuscular administration must be performed only 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 into one side of the thigh or buttock. Your doctor or healthcare professional will clean the skin area to be injected using an alcohol swab and let it dry. By a darting motion, they will insert the large needle into the muscle. They will inject the solution by gently pushing the plunger in a slow and steady motion until all the solution is introduced into the muscle. They will withdraw the needle directly and clean the skin at the injection site with an alcohol swab.

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, telephone 915 620 420, indicating the medicine and the amount used.

If you forget to use Prolutex

Do not use a double dose to make up for the forgotten dose.

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

If you stop using Prolutex

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

If you have any further questions on 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.

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,
• nausea and vomiting,
• breast tenderness and/or breast pain,
• vaginal discharge,
• a tingling or irritating sensation 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,
• insomnia,
• stomach and intestinal disorders (including stomach upset and/or pain on palpation, gas, painful spasms, and retching),
• skin rashes (including hot, red, raised patches, itching, or hives, or dry, cracked, or blistered skin),
• swelling and/or enlargement of the breast,
• feeling of heat,
• general feeling of discomfort or "feeling unwell",
• pain.

Rare: 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: inability to sleep (insomnia), premenstrual syndrome or menstrual disorders, hives, 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, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: 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.

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

Store in the original packaging to protect it from light.

The medicine should be used immediately after the first opening.

Any remaining solution should be discarded.

Do not use this medicine after the expiration date stated on the packaging after EXP. If the expiration date is indicated as month/year, the expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Prolutex

The active ingredient is progesterone. Each vial (1,112 ml) contains 25 mg of progesterone (theoretical concentration: 22,48 mg/ml)

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

Appearance of the product and package contents

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 marketed.

Marketing authorization holder:

IBSA Farmaceutici Italia Srl

Via Martiri di Cefalonia 2

26900 Lodi

Italy

Manufacturer:

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,

Planta 8, Local 1,

08028 Barcelona (Spain)

This medication is authorized in the EEA member states under the following names: (The concentration and pharmaceutical form are identical in all countries, only the trade 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

Date of the last revision of this prospectus: September 2024

If this prospectus is difficult to view or read, or if you would like it in a different format, please contact IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy (phone +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 Health Products (AEMPS) http://www.aemps.gob.es/