Lutigest 100 mg vaginal tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 the doctor.
• if you have a miscarriage and your physician suspects some tissue is still in the uterus or pregnancy outside of the womb.
• if you currently have or have had severe liver problems.
• if you have known or suspected breast or genital tract cancer.
• 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)

Take special care and tell your doctor straight away if you experience any of these symptoms during treatment or even few days after the last dosage:

• pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs
• severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg indicating possible clots in the brain or eye
• worsening symptoms of depression

Before starting treatment with Lutigest tell your doctor if you have had or have any of the following health problems:

• Epilepsy
• Migraine
• Asthma
• Cardiac or renal dysfunction
• Diabetes

There is no relevant use of Lutigest in children.

Tell your doctor if you are using, have recently used or might use any other medicines.

Some medicines may interact with vaginal progesterone tablets. For example, carbamazepine, rifampin as well as St. John’s wort-containing herbal products may decrease the effectiveness, whereas products containing ketoconazole and vaginal antifungal creams may alter the actions of progesterone.

Lutigest can be used during the first trimester of pregnancy for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.

The risks of congenital (conditions present at birth) anomalies, including genital abnormalities in male or female infants, from exposure to exogenous progesterone during pregnancy have not been fully established.

This medicine should not be used during breast feeding.

Lutigest has minor or moderate influence on the ability to drive and use machines. It may cause drowsiness and/or dizziness; therefore caution is advised in drivers and users of machines.

Lutigest is to be placed directly into your vagina by using the applicator provided.

1. Remove one blister from the strip by tearing along the perforations.
2. To remove the foil seal on the back of the blister, start in the corner of the blister pack that has a printed arrow
3. Unwrap the applicator.
4. Put one tablet in the space provided at the end of the applicator. The tablet should fit securely and not fall out.
5. The applicator with the tablet may be inserted into the vagina while you are standing, sitting, or when lying on your back with your knees bent. Gently insert the thin end of the applicator well into the vagina.
6. Push the plunger to release the tablet.

Remove the applicator and rinse it thoroughly in warm running water, wipe dry with a soft tissue and keep the applicator for subsequent use.

Please consult your doctor or pharmacist if you have used more Lutigest than your doctor has told you.

Take the dose as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.

Please consult your doctor or pharmacist for advice if you intend to stop or have stopped using Lutigest. Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.

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

The active substance is progesterone.

Each vaginal tablet contains 100 mg progesterone.

The other ingredients are:

• Hydrophobic colloidal silica
• Lactose monohydrate
• Pregelatinized maize starch
• Povidone
• Adipic acid
• Sodium hydrogen carbonate
• Sodium laurilsulfate
• Magnesium stearate

This medicine is a vaginal tablet. It is a white to off-white convex and oblong tablets debossed with “FPI” on one side and “100” on the other side.

Pack sizes: 21 or 90 vaginal tablets, supplied with one polyethylene vaginal applicator. Not all pack sizes may be marketed.

PL 03194/0103