Lubion contains the active ingredient Progesterone. Progesterone is a naturally occurring female sex hormone. The medicine works on the lining of the womb and helps you to become pregnant and to stay pregnant.

Lubion is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme who are unable to use or tolerate vaginal preparations.

Do not use Lubion:

• If you are allergic (hypersensitive) to progesterone or any of the other ingredients of Lubion
• If you are suffering from vaginal bleeding (other than normal periods) that has not been evaluated by your doctor
• If you have had a miscarriage and your doctor suspects some tissue is still in the womb
• If you have had a pregnancy outside of the womb (ectopic pregnancy)
• If you currently have or have had severe liver problems
• If you have known or suspected breast cancer or cancer of the reproductive tract
• If you have or have had blood clots in the legs, lungs, eyes or elsewhere in the body
• If you have porphyria disorders (a group of inherited or acquired disorders of certain enzymes)
• If during pregnancy you have suffered from jaundice (yellowing of eyes and skin due to liver problems) severe itching and/or blisters on the skin
• If you are under 18 years of age.

Warnings and precautions

Take special care with Lubion

If you experience any of the following during treatment tell your doctor immediately as your treatment may need to be stopped. Also tell your doctor immediately if you experience these a few days after the last dosage:

• Heart attack (pains in the chest, or back pain and/or deep aching and throbbing in one or both arms, a sudden shortness of breath, sweating, dizziness, lightheadedness, nausea, palpitations)
• Stroke (severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg.)
• Blood clots in the eyes or anywhere in the body (pain in your eyes or pain and swelling in your ankles, feet and hands)
• Worsening of depression
• Severe headaches, changes in vision.

Before treatment with Lubion

Tell your doctor if you have had or have any of the following before using Lubion:

• Liver problems (mild or moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney problems
• Diabetes
• Depression

If any of the above applies to you, your doctor will monitor you carefully during treatment.

Children and adolescents

The product is not to be used by children or adolescents.

Other medicines and Lubion

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. Some medicines may interact with Lubion. For example:Carbamazepine (used to treat seizures/fits)

• Rifamipicin (an antibiotic)
• Griseofulvin (an antifungal medicine)
• Phenytoin and Phenobarbital (used to treat epilepsy)
• St. John’s Wort-containing herbal products.
• Ciclosporine (a medicine for some types of inflammation and after organ transplants)
• Diabetic medicines.
• Ketoconazole (an antifungal medicine)

Do not administer Lubion at the same time as any other injectable medicine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

• Lubion can be used during the first three months of pregnancy.
• This medicine should not be used during breast-feeding.

Driving and using machines

Do not drive or use any tools or machines if you feel drowsy and/or dizzy whilst taking Lubion.

Lubion contains hydroxypropylbetadex If you have a kidney disease, talk to your doctor before you receive this medicine.

Always use Lubion exactly as your doctor has told you. Remember Lubion should only be used under the supervision of a doctor experienced in treating fertility problems.

How much Lubion should you use and for how long?

The usual dose is a once daily injection of 25 mg usually until 12 weeks of confirmed pregnancy (i.e. 10 weeks of treatment).

How Lubion should be given

Lubion can be given either under your skin (subcutaneous injection) or into a muscle (intramuscular injection).

You will be able to administer 25 mg of Lubion subcutaneously after suitable advice and training by your doctor or healthcare professional.

Subcutaneous injection:

Before you inject Lubion you will receive the following training and advice:

• Practice giving subcutaneous injections
• Where to inject your medicine
• How to prepare your solution for injection
• How to administer your medicine.

Please read instruction below on preparation and administration of Lubion.

The steps for self administration are:

1. Preparing your injection
2. Checking pack
3. Preparing the vial and syringe
4. Filling the syringe
5. Changing the injecting needle
6. Removing air bubbles
7. Injection by subcutaneous administration
8. Disposal of used items.

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

Like all medicines, Lubion can cause side effects, although not everybody gets them.

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

• Overstimulation of the ovaries (symptoms include lower stomach pain, feeling thirsty and sick, and sometimes being sick, passing reduced quantities of concentrated urine and weight gain)
• Depression
• Yellowing of your skin and the whites of your 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
• Being sick and feeling sick
• Breast tenderness and/or pain
• Vaginal discharge
• A tingling or uneasy irritation or itching of the skin of the vagina and the surroundingarea
• Hardening of area around injection site
• Bruising around injection site
• Fatigue (excessive tiredness, exhaustion, lethargy).

Uncommon: may affect up to 1 in 100 people

• Changes in mood
• Dizziness
• Insomnia
• Stomach and intestinal disturbance (including stomach discomfort and/or tenderness, wind, painful spasms and retching)
• Skin rashes (including red warm skin, or raised, itchy bumps or wheals or dry, cracked or blistered or swollen skin)
• Breast swelling and/or enlargement
• Feeling hot
• General feeling of discomfort or “feeling out of sorts”
• Pain.

Not known: frequency cannot be estimated from the available data

The following disorders, although not reported by patients in clinical studies using Lubion , have been described with other progestins: inability to sleep (insomnia), premenstrual like syndrome and menstrual disturbances, hives, acne, excessive hairgrowth, hair loss (alopecia), weight gain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Store below 25oC. Do not refrigerate or freeze.

Store in the original package in order to protect from light.

This medicinal product must be used immediately after first opening.

Any remaining solution must be discarded.

Do not use Lubion after the expiry date which is stated on the label after Exp: The expiry date refers to the last day of that month.

Do not use Lubion if you notice particles in the solution or if the solution is not clear.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Lubion contains

The active substance is Progesterone. Each vial (1.112 ml) contains 25 mg progesterone (theoretical concentration 22.48 mg/ml).

The other ingredients are:

Hydroxypropylbetadex, Water for injections

What Lubion looks like and contents of the pack

Lubion is a clear colourless solution supplied in a colourless glass vial.

Each pack contains 1, 7 or 14 vials. Not all 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 (for UK), Units 4-6 Colonial Business Park, Colonial Way Watford, WD24 4PR, United Kingdom

This medicinal product is authorized in the Member States of the EEA under the following names: (The strength 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

Spain: Prolutex

The Netherlands: Prolutex

United Kingdom: Lubion