Prolutex 25 mg solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Prolutex 25 mg solution for injection in pre-filled syringe
progesterone
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Prolutex is and what it is used for
- What you need to know before using Prolutex
- How to use Prolutex
- Possible adverse effects
- How to store Prolutex
- Contents of the pack and other information
1. What Prolutex is and what it is used for
Prolutex contains the active substance progesterone. Progesterone is a natural female sex hormone. The medicine acts on the lining of the uterus and helps you to become and remain pregnant.
Prolutex is indicated for women who require additional progesterone while undergoing treatment within an Assisted Reproductive Technology (ART) protocol, and who cannot use or tolerate vaginal preparations.
2. What you need to know before using Prolutex
Do not use Prolutex
- if you are allergic to progesterone or to 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 remains in the uterus;
- if you currently have an ectopic pregnancy (pregnancy outside the uterus);
- if you currently have or have had severe liver problems;
- if you have or suspect you have breast cancer or cancer of the genital tract;
- if you currently have or have had blood clots in the legs, lungs, eyes, or elsewhere in the body;
- if you have porphyria (a group of inherited or acquired disorders affecting certain enzymes);
- if during pregnancy you experienced jaundice (yellowing of the eyes and skin due to liver problems), severe itching, and/or skin blisters;
- if you are under 18 years of age.
Warnings and precautions
Take special care with Prolutex
If you experience any of the following conditions during treatment, contact your doctor immediately, as treatment may need to be stopped. Also inform your doctor immediately if you experience them within a few days after the last dose:
- heart attack (chest or back pain, and/or deep, throbbing pain in one or both arms, sudden shortness of breath, 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 elsewhere 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 starting treatment with Prolutex, inform your doctor if you have or have had any of the following health conditions:
- Liver problems (mild or moderate)
- Epilepsy
- Migraine
- Asthma
- Heart or kidney disorders
- Diabetes
- Depression
If any of these apply to you, your doctor will monitor you closely during treatment.
Children and adolescents
This medicine must not be used in children or adolescents.
Other medicines and Prolutex
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines or herbal medicines. Some medicines may interact with Prolutex. For example:
- Carbamazepine (used to treat seizures)
- Rifampicin (an antibiotic)
- Griseofulvin (an antifungal medicine)
- Phenytoin and phenobarbital (used to treat epilepsy)
- Herbal medicines containing St. John’s wort
- Ciclosporin (a medicine used for certain inflammatory conditions and after organ transplantation)
- Medicines for diabetes
- Ketoconazole (an 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 might 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 operate tools or machinery if you experience drowsiness and/or dizziness while using Prolutex.
Prolutex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., essentially “sodium-free”.
3. How to use Prolutex
Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor again. Remember, Prolutex should only be used under the supervision of a doctor experienced in the treatment of 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 Prolutex should be administered
Prolutex must be administered under the skin (subcutaneous injection, i.e., SC).
You may self-administer 25 mg of Prolutex subcutaneously after receiving appropriate advice and training from your doctor or healthcare professional.
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 administer the medicine.
Read the instructions below regarding the preparation and administration of Prolutex.
The steps for correct self-administration are:
- Preparation of the injection
- Checking the packaging
- Injection
- Disposal of used materials
These steps are explained in detail below.
- Preparation of the injection
It is important to keep everything as clean as possible, so begin by thoroughly washing your hands and drying them with a clean towel. Select a clean area to prepare the injection.
The following materials are NOT supplied with your medicine. Your doctor or pharmacist will provide these materials.
- Two alcohol wipes;
- A sharps container (for the safe disposal of the pre-filled syringe, etc.).
- Checking the packaging
- Do not use the product if the packaging is open or damaged.
- Ensure that the pre-filled syringe of Prolutex contains the solution.
- Check that the expiry date printed on the pre-filled syringe of Prolutex has not passed. Do not use the product if it is past the expiry date.
- Injection
- 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 an alcohol wipe, carefully clean the skin area to be injected, and allow it to dry.
- Remove the cap. Once the cap is removed, do not let the needle touch anything. This ensures the needle remains clean (sterile).
- Hold the syringe with the needle pointing upwards and slowly press the plunger until all air has been expelled from the syringe and at least one drop of the solution appears at the tip of the needle.
- Hold the syringe in one hand. Use the other hand to gently pinch the skin at the injection site between your thumb and index finger.
| With a dart-like motion, insert the needle into the skin so that the skin and the needle form a right angle. |
- Insert the 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 has been injected under the skin. Inject all the solution.
- Release the skin and remove the needle straight out.
- Clean the skin at the injection site with an alcohol swab using a circular motion.
Each pre-filled syringe is for single use only.
- Disposal of used materials
- After completing the injection, place the pre-filled syringe in a sharps container.
If you use more Prolutex than you should
If you have used more Prolutex than you should, contact your doctor or pharmacist immediately. Symptoms of overdose include numbness.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount used.
If you forget to use Prolutex
Take the missed dose as soon as you remember, and then continue as before. Do not use a double dose to make up for a forgotten dose. Inform your doctor of what you have done.
If you stop using Prolutex
Do not stop using Prolutex without first consulting your doctor or pharmacist. Suddenly stopping Prolutex may cause increased anxiety, irritability, and increase the risk of seizures (attacks).
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Stop taking this medicine and seek immediate medical help if you have any of the following symptoms:
- Ovarian hyperstimulation (symptoms include pain in the lower abdomen, feeling thirsty and dizzy, and sometimes vomiting, passing small amounts of concentrated urine, and weight gain),
- Depression,
- Yellowing of the skin and whites of the eyes (jaundice),
- Severe allergic reaction which may 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 cramping,
- Vaginal bleeding.
Common: may affect up to 1 in 10 people
- Headache,
- Bloating of the stomach,
- Stomach pain,
- Constipation,
- Vomiting and nausea,
- Breast tenderness and/or breast pain,
- Vaginal discharge,
- Uncomfortable tingling, irritation, 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,
- Stomach and intestinal disorders (including stomach discomfort and/or tenderness, gas, painful spasms, and retching),
- Skin rashes (including red, hot skin, itchy bumps or hives, dry, cracked, blistered or swollen skin),
- Swelling and/or enlargement of the breast,
- Feeling of warmth,
- General feeling of discomfort or "feeling unwell",
- Pain.
Not known: 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: inability to sleep (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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the carton and on the label of the pre-filled syringe after EXP.
Do not use this medicine if you see 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 containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. 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 components are hydroxypropylbetadex, disodium phosphate, sodium dihydrogen phosphate dihydrate, and water for injections.
Nature of the product and pack contents
Prolutex is a clear, colourless 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Instituto Bioquímico Ibérico IBSA S.L.
Avenida Diagonal 605,
8th floor, Local 1,
08028 Barcelona (Spain)
This medicinal product 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 brand 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 the most recent review of this leaflet: May 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).