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LUTIGEST 100 MG VAGINAL TABLETS

Active substance(s): PROGESTERONE

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1.

Lutigest 100 mg

This medicine is provided as a vaginal tablet that
contains the natural female sex hormone progesterone.

Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.










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.

What is in this leaflet:
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

What Lutigest is and what it is used for

Lutigest is for women who need extra progesterone
while undergoing treatment in an Assisted Reproductive
Technology (ART) programme.
Progesterone acts on the lining of the womb and it
helps you to become and to stay pregnant when you are
treated for infertility.
2. What you need to know before you use
Lutigest
Lutigest can be used only in women who are undergoing
infertility treatment in an Assisted Reproductive
Technology (ART) programme. The treatment is started
on the day of egg retrieval. Your doctor will tell you when
the treatment is started.
Do not use Lutigest
• 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)

Children
There is no relevant use of Lutigest in children.
Other medicines and Lutigest
Tell your doctor if you are using, have recently used or
might use any other medicines.

Warnings and precautions

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.

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

3. How to use Lutigest
Always use this medicine exactly as your doctor has
told you. You should check with your doctor if you are
not sure.
The usual dose is 100 mg placed directly into your
vagina three times daily starting on the day of egg
retrieval. The administration of Lutigest should be
continued for 30 days if pregnancy has been confirmed.
Instructions for use
Lutigest is to be placed directly into your vagina by the
applicator provided.

Pregnancy and breast-feeding
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.

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

4. 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.

1. Unwrap the applicator.

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

This medicine should not be used during breast feeding.
Driving and using machines
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.

3. 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.

2. Put one tablet in the space provided at the end of the
applicator. The tablet should fit securely and not fall out.

If you forget to use Lutigest
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.

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Package leaflet: Information for the user

Vaginal tablets
Progesterone

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4.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The most common side effects are headache, vaginal
disorders and uterine cramping.

The following uncommon side effects affect between
1 and 10 of every 1000 patients treated:
-
Dizziness
-
Insomnia
-
Diarrhoea
-
Constipation
-
Urticaria (allergic rash)
-
Rash

Vaginal disorders (e.g. vaginal discomfort, burning
sensation, discharge, dryness, and bleeding)
Fungal infection in vagina
Breast disorders (e.g. breast pain, breast swelling
and breast tenderness)
Itching in the genital area
Peripheral edema (swelling due to the build up
of fluid)

The following side effects have been seen after the
product was marketed. Frequency is not known (cannot
be estimated from the available data):
-
Fatigue
-
Vomiting
-
Allergic reactions
Reporting of side effects
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.
5. How to store Lutigest

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

What Lutigest looks like and contents of the pack
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.

This medicinal product does not require any special
temperature storage conditions.

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

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.

Marketing Authorisation Holder
PL 03194/0103
Ferring Pharmaceuticals Ltd.
Drayton Hall, Church Road
West Daryton UB7 7PS
UK

6. Contents of the pack and other
information
What Lutigest contains
The active substance is progesterone.

Manufacturer
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany

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 medicinal product is authorised in the Member
States of the EEA under the following names:
Bulgaria, Czech Republic, Denmark, Finland, Germany,
Greece, Hungary, Iceland, Ireland, the Netherlands,
Norway, Poland, Slovak Republic, Spain and Sweden:
Lutinus
Portugal: Luferti
Romania: Lutinus 100 mg, comprimate vaginale
Slovenia: Lutinus 100 mg vaginalne tablete
United Kingdom: Lutigest

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.

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The following common side effects affect between 1
and 10 of every 100 patients treated:
-
Headache
-
Abdominal distension (swelling in the abdomen)
-
Abdominal pain
-
Nausea
-
Uterine cramping

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-
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If you stop using Lutigest
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.

This leaflet was last revised in September 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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