Prolutex

Patient Information Leaflet: Read this leaflet carefully before using the medicine as it contains important information for you.

Prolutex, 25 mg, solution for injection in pre-filled syringe
progesterone
Read the entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If any side effect worsens, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Prolutex is and what it is used for
2. Important information before using Prolutex
3. How to use Prolutex
4. Possible side effects
5. How to store Prolutex
6. Contents of the pack and other information

1. What Prolutex is and what it is used for

Prolutex contains the active substance called progesterone. Progesterone is a naturally occurring sex hormone in women. The medicine acts on the endometrium and helps achieve and maintain pregnancy.
Prolutex is intended for women who require additional progesterone during assisted reproductive technology (ART) treatments and who cannot use or do not tolerate vaginal formulations.

2. Important information before using Prolutex

When not to use Prolutex:

• If the patient is allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
• If there is vaginal bleeding (of unknown origin other than menstrual bleeding) that has not been investigated by a doctor
• If a miscarriage has occurred and there is suspicion that dead tissue remains in the uterus
• If the patient is currently experiencing an ectopic pregnancy
• If there are or have been severe liver diseases in the past
• If there is or has been a tumour or suspected tumour of the breast or reproductive organs
• If there are or have been thrombosis (blood clots) in the legs, lungs, eyes or other parts of the body, currently or in the past
• If the patient has porphyria (hereditary or acquired disorders of certain enzymes)
• If during pregnancy the patient experienced jaundice (yellowing of the eyes and skin due to liver problems), severe itching and (or) skin blisters
• In patients under 18 years of age

Warnings and precautions
Special caution is needed when using Prolutex
If any of the following conditions occur during treatment, the patient must immediately inform the doctor, as treatment may need to be discontinued. The doctor should also be informed if any of these conditions occur several days after the last dose.

• Heart attack (chest pain, back pain and (or) deep pain and throbbing in one or both arms, sudden shortness of breath, sweating, dizziness, nausea, palpitations)
• Stroke (sudden headache or vomiting, dizziness, fainting, visual or speech disturbances, weakness, numbness in arm or leg)
• Thrombosis in the eye or any part of the body (eye pain or pain and swelling in ankles, feet or hands)
• Worsening of depression
• Sudden severe headache, visual disturbances

Before using Prolutex
Before using Prolutex, the patient should inform the doctor if any of the following conditions have occurred in the past or are currently present, as careful monitoring during treatment will be required:

• Liver disease (mild to moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney disease
• Diabetes
• Depression
  If any of the above conditions apply, the doctor will closely monitor the patient during treatment.

Children and adolescents
This medicine is not intended for use in children and adolescents.

Prolutex and other medicines
The patient should tell the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use, including those available without a prescription and herbal medicines. Some medicines may interact with Prolutex. This is particularly true for the following medicines:

• Carbamazepine (used to treat epileptic seizures)
• Rifampicin (an antibiotic)
• Griseofulvin (an antifungal medicine)
• Phenytoin and phenobarbital (used to treat epilepsy)
• Herbal products containing St John's wort (Hypericum perforatum)
• Cyclosporine (a medicine used to treat certain inflammatory conditions and after organ transplants)
• Antidiabetic medicines
• Ketoconazole (an antifungal medicine)

Prolutex and other injectable medicines should not be administered at the same time.

Pregnancy and breastfeeding
Before taking any medicine, consult a doctor or pharmacist.

• Prolutex may be used during the first three months of pregnancy.
• Prolutex must not be used during breastfeeding.

Driving and operating machinery
Do not drive or operate machinery if drowsiness and (or) dizziness occur during treatment with Prolutex.

Prolutex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Prolutex

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult the doctor.
It is important to remember that Prolutex may only be used under the supervision of a physician experienced
in the treatment of infertility.

What dose of Prolutex should be used and for how long?
The recommended dose is 25 mg administered by injection once daily. Treatment usually lasts until
the 12th week of confirmed pregnancy (i.e. 10 weeks of treatment).

How should Prolutex be administered?
Prolutex may be administered subcutaneously (subcutaneous injection, i.e. sc.).
After appropriate training by a doctor or nurse, the patient may self-administer the 25 mg dose of Prolutex
by subcutaneous injection.

Before the first administration of Prolutex, the patient will receive training on the following points:

• Practical performance of subcutaneous injections
• Injection sites
• The method of administering the medicine

Please read the following instructions for preparing the solution and administering Prolutex
The following steps describe self-administration of the medicine:
A Preparation of the injection
B Checking the packaging
C Administration of the injection
D Disposal of waste
The above procedures are described below.

A Preparation of the injection
It is important to maintain hygiene and cleanliness. Before beginning, wash hands thoroughly and dry them
with a clean towel. Select a clean surface for preparing the injection.
The following items are not included in the medicine package. The doctor or pharmacist will provide
the patient with:

• Two antiseptic wipes
• A sharps container (for safe disposal of needles, vials, etc.)

B Checking the packaging

• Do not use the product if the packaging is open or damaged.
• Ensure that the Prolutex pre-filled syringe contains a solution.
• Check the expiry date printed on the Prolutex pre-filled syringe. Do not use the medicine if the expiry date has passed.

C Administration of the injection

• The doctor or nurse will indicate suitable injection sites for Prolutex (e.g. abdomen or front of the thigh).
• Open the antiseptic wipe package and thoroughly clean the injection site. Wait until the area is completely dry.
• Remove the cap. After removing the cap, do not touch anything with the needle. This ensures that the needle remains clean (sterile).
• Hold the syringe with the needle pointing upwards and slowly push the plunger until all air is expelled from the syringe and at least one drop of solution appears at the tip of the needle.
• Hold the syringe with one hand. With the other hand, pinch a fold of skin so that the injection site lies between the thumb and index finger.

Insert the needle quickly and firmly at a 90-degree angle

• Insert the entire needle into the skin. Do not inject the solution directly into a blood vessel.
• Inject the solution by gently pressing the plunger with a steady, slow motion until all the solution has been delivered under the skin.
• Release the skin fold and withdraw the needle.
• Wipe the injection site in a circular motion with a swab containing disinfectant.

Each pre-filled syringe is intended for single use only.
D Disposal of leftovers

• After completing the injection, dispose of the pre-filled syringe into a container for medical waste.

Use of a higher than recommended dose of Prolutex
Inform your doctor or pharmacist. Symptoms of overdose include drowsiness.
Missed dose of Prolutex
Take the missed dose as soon as possible, then continue as usual.
Do not use a double dose to make up for a missed dose. Consult your doctor for further advice.
Stopping treatment with Prolutex
Do not discontinue treatment with Prolutex without consulting your doctor or pharmacist. Abruptly stopping Prolutex may cause increased anxiety, mood swings, and a higher risk of seizures.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop using this medicine immediately and seek medical help if
the patient experiences any of the following symptoms:

• Ovarian hyperstimulation syndrome (symptoms include pain in the lower abdomen, feeling thirsty, malaise, sometimes vomiting, passing reduced amounts of concentrated urine, weight gain),
• Depression,
• Yellowing of the skin and eyes (jaundice),
• Severe allergic reaction which may cause difficulty breathing, swelling of the face and throat, or acute rash (anaphylactic reactions).

Very common (may affect more than 1 in 10 people)

• Pain, redness, itching, irritation or swelling at the injection site
• Uterine contractions
• Vaginal bleeding

Common (may affect up to 1 in 10 people)

• Headache
• Bloating
• Abdominal pain
• Constipation
• Nausea and vomiting
• Breast tenderness and (or) breast pain
• Vaginal discharge
• Irritation, tingling or itching of the vagina and surrounding skin
• Hardening at the injection site
• Bruising at the injection site
• Fatigue (excessive tiredness, exhaustion, drowsiness)

Uncommon (may affect up to 1 in 100 people)

• Mood changes
• Dizziness
• Drowsiness
• Gastrointestinal disturbances (feeling of discomfort in the stomach and (or) tenderness, excessive gas, painful spasms, nausea)
• Skin rash (including redness and increased warmth of the skin, itchy bumps or blisters, dry cracked skin, swelling of the skin)
• Breast swelling and (or) breast enlargement
• Feeling of warmth
• General feeling of discomfort
• Pain

Frequency not known: cannot be estimated from the available data
The following adverse reactions have not been reported for Prolutex during clinical trials,
but have been reported for other medicines containing progesterone: insomnia, symptoms resembling
premenstrual syndrome, menstrual disturbances, urticaria, acne, excessive hair growth, excessive hair loss, weight gain.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Prolutex

Keep this medicine out of sight and reach of children.
Do not store in the refrigerator 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 prefilled syringe label following EXP. If the expiry date is displayed as month/year, the expiry date refers to the last day of that month.
Do not use this medicine if floating particles are visible in the solution or if the solution is not clear.
Each prefilled syringe is for single use only.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Prolutex contains
The active substance is progesterone.
Each ampoule-syringe (1.112 ml) contains 25 mg of progesterone (22.48 mg/ml).
The other ingredients are: hydroxypropylbetadex, disodium phosphate, sodium dihydrogen phosphate dihydrate,
water for injections.

What Prolutex looks like and contents of the pack
Prolutex is a clear solution for injection contained in a glass syringe.
Each cardboard box contains 7 or 14 ampoule-syringes.
Not all 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:
IBSA Poland Sp. z o.o.
Al. Jana Pawła II 29, 00-867 Warsaw
00-078 Warsaw
Tel.: +48 22 653 68 60

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
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
Spain: Prolutex
Netherlands: Prolutex
United Kingdom (Northern Ireland): Lubion