Prolutex 25 mg solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Prolutex 25 mg injectable solution
Progesterone
Read this 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Prolutex is and what it is used for
- What you need to know before using Prolutex
- How to use Prolutex
- Possible side 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 become and remain pregnant.
Prolutex is indicated for women who require additional progesterone while undergoing treatment as part of 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 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 cancer of the breast or 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 developed jaundice (yellowing of the eyes and skin due to liver problems), severe itching, and/or skin blistering;
- if you are under 18 years of age.
Warnings and precautions
Exercise special caution with Prolutex
If you experience any of the following conditions during treatment, inform your doctor immediately, as treatment may need to be stopped. Also inform your doctor immediately if you experience any of these conditions a few days after your 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 symptoms of depression;
- severe 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 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.
Use of Prolutex with other medicines
Tell 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 remedies. 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 remedies containing St. John’s wort
- Cyclosporine (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 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 operate tools or machinery if you experience drowsiness and/or dizziness while using Prolutex.
Prolutex contains Hydroxypropyl betadex
If you have renal impairment, consult your doctor before taking this medicine.
Prolutex contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.
3. How to use Prolutex
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in 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, typically up to 12 weeks after confirmed pregnancy (e.g., 10 weeks of treatment).
How Prolutex should be administered
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 appropriate advice and training from your doctor or healthcare professional.
Subcutaneous injection
Before self-administering a Prolutex injection, you will receive training and advice on:
- Practicing subcutaneous injection techniques;
- Where to inject the medicine;
- How to prepare the injectable solution;
- 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 materials
- Preparing the vial and syringe
- Filling the syringe
- Changing the injection needle
- Removing air bubbles
- Administering the subcutaneous injection
- Disposal of used materials
These steps are explained in detail below.
IMPORTANT: Each vial must only be used once. The solution must be used immediately after opening the vial. It must not be stored in the syringe.
- 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 medicine:
- A vial containing Prolutex injectable solution
The following materials are NOT supplied 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 grey 27G needle; for subcutaneous injection)
- Two alcohol swabs
- A sharps container (for the safe disposal of needles, vials, etc.)
- Checking the materials
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The Prolutex vial, syringe, and needles are equipped with protective caps.
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Check that all caps are intact and do not use if they are damaged.
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Ensure that the expiry date on the Prolutex vial is still valid. Do not use the product beyond the expiry date.
- Preparing the vial and syringe
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- Filling the syringe
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- Changing the injection needle
This step is only required if you are administering the injection subcutaneously; if your doctor is giving an intramuscular injection, proceed directly to setting the dose for administration.
- Place the needle cap onto the large green 21G needle and then gently remove the large needle from the syringe.
- Remove the smaller grey 27G injection needle from its packaging, keeping the needle cap in place.
- Attach the small grey 27G needle to the syringe, and then remove the needle cap.
- Removing air bubbles
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- Subcutaneous injection administration
- Your doctor or healthcare professional will have already shown you where to inject Prolutex (e.g., in the abdomen or the front part of the thigh).
- Open the alcohol wipe and carefully clean the skin area to be injected, then allow it to dry.
- Hold the syringe in one hand. Use the other hand to gently pinch the skin at the injection site between your thumb and forefinger.
| With a dart-like motion, insert the small 27G fine-grade gray needle into the skin so that the skin and the needle form a right angle. |
- 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 steady motion until all the solution has been delivered under the skin. Inject the entire prescribed amount of 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.
- Disposal of used materials
- Once you have finished the injection, place all needles, empty vials, and syringes into a sharps container.
- Any unused solution must be discarded.
Intramuscular administration must be performed only by a doctor or healthcare professional
All intramuscular injections will be administered by a doctor or other healthcare professional.
Prolutex injection will be given in the outer side of the thigh or buttock. Your doctor or healthcare professional will clean the injection site with an alcohol wipe and allow it to dry. Using a dart-like motion, they will insert the large needle into the muscle. The solution will be injected by gently pushing the plunger in a slow and steady motion until all the solution has been delivered into the muscle. The needle will then be removed straight out, and the injection site will be cleaned with an alcohol wipe.
If you use more Prolutex than you should
If you have used more Prolutex than prescribed, contact your doctor or pharmacist immediately. Symptoms of overdose may include numbness.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, stating the medication and the amount taken.
If you forget to use Prolutex
Do not use a double dose to make up 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 stop using Prolutex
Do not stop using Prolutex without first consulting your doctor or pharmacist. Suddenly stopping Prolutex may cause increased anxiety, irritability, and an increased risk of seizures (attacks).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Prolutex may cause adverse effects, although not everyone experiences them.
Stop taking this medicine and seek immediate medical help if you experience any of the following symptoms:
- Ovarian hyperstimulation (symptoms include lower abdominal pain, 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 spasm,
- vaginal bleeding.
Common: may affect up to 1 in 10 people
- headache,
- bloated stomach,
- stomach pain,
- constipation,
- vomiting and feeling nauseous,
- breast tenderness and/or breast pain,
- vaginal discharge,
- 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,
- insomnia,
- stomach and intestinal disorders (including stomach discomfort and/or tenderness, gas, painful spasms, and retching),
- skin rashes (including hot, red skin, raised itchy bumps or hives, or dry, cracked, blistered, or swollen skin),
- swelling and/or increase in breast size,
- 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 progestogens: inability to sleep (insomnia), pseudopremenstrual syndrome or menstrual disorders, urticaria, acne, excessive hair growth, hair loss (alopecia), and weight gain.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 sight and reach of children.
Store below 25 °C. Do not refrigerate or freeze.
Keep in the original packaging to protect from light.
The medicine should be used immediately after first opening.
Any unused solution must be discarded.
Do not use this medicine after the expiry date stated on the container after EXP. If the expiry date is given as month/year, the expiry date refers to the last day of that month.
Do not use this medicine if you see particles in the solution or if the solution is not clear.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Prolutex
The active substance 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 injections.
Appearance of the product and contents of the container
Prolutex is a colourless and clear solution supplied in a colourless glass vial.
Each pack contains 1, 7 or 14 vials.
Only certain pack sizes may be marketed.
Marketing Authorisation 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 (UK only)
Units 4-6 Colonial Business Park, Colonial Way
Watford WD24 4PR
United Kingdom
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, premises 1,
08028 Barcelona (Spain)
This medicinal product is authorised in the EEA Member States 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: Lubion
Date of latest review of this leaflet: September 2024
If this leaflet is difficult to see 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 (telephone +39(0) 371 417354, e-mail [email protected]). Detailed and up-to-date 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/