Package Insert: Information for the User

Mifepristone Linepharma 200 mg Tablets

mifepristone

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Conserve this package insert,as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to otherswho have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor,even if they are not listed in this package insert.See section 4.

1. What is Mifepristone Linepharma and how is it used

2. What you need to know before starting to use Mifepristone Linepharma

3. How to use Mifepristone Linepharma

4. Possible adverse effects

5. Storage of Mifepristone Linepharma

6. Contents of the package and additional information

Mifepristona Linepharma is an antihormone that acts by blocking the effects of progesterone, a hormone necessary for the continuation of pregnancy.Mifepristona Linepharma can therefore cause termination of pregnancy.

Mifepristona Linepharma is recommended for medical termination of pregnancy:

- Up to a maximum of 63 days after the first day of your last menstrual period.

- In combination with another treatment called prostaglandin (a substance that increases uterine contraction) taken36 to48 hours after taking Mifepristona Linepharma.

Do not take Mifepristone Linepharma

• If you are allergic (hypersensitive) to mifepristone or to any of the other components of this medication (including those listed in section 6).
• If you have adrenal insufficiency.
• If you have uncontrolled asthma.
• If you have hereditary porphyria.

• If your pregnancy has not been confirmed by a biological test or ultrasound.
• If the first day of your last menstrual period was more than 63 days (9 weeks) ago.
• If your doctor suspects an ectopic pregnancy (the egg is implanted outside the uterus).
• Given the need to prescribe a prostaglandin in association with mifepristone, you should not receive this treatment if you are allergic to prostaglandins.

Warnings and precautions

Severe skin reactions, such as toxic epidermal necrolysis and acute generalized exanthematous pustulosis, have been reported associated with Mifepristone Linepharma treatment. Seek medical attention immediately if you experience any of the symptoms described in section 4. If you experience a severe skin reaction, you should not use mifepristone again in the future.

Be especially careful with Mifepristone Linepharma

Since in some other circumstances the treatment may be unsuitable for you, inform your doctor if:

• You have a heart problem.
• You have risk factors for heart disease, such as high blood pressure or high levels of cholesterol in the blood.
• You have asthma.
• You have a disease that may affect your blood clotting.
• You have liver or kidney disease.
• You have anemia or malnutrition.
• You have an infection.

Your doctor will be able to discuss with you whether you can receive the treatment.

You may have prolonged and/or heavy vaginal bleeding (an average of 12 days or more after taking Mifepristone Linepharma).The appearance of these bleeding is not related to the success of the treatment.

Other medications and Mifepristone Linepharma

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Specifically, inform your doctor if you are taking the following:

• Corticosteroids (used in the treatment of asthma and other inflammatory treatments).
• Ketoconazole, itraconazole (used as treatment for fungi).
• Erythromycin, rifampicin (antibiotics).
• St. John's Wort (natural remedy used in the treatment of mild depression).
• Phenytoin, phenobarbital, carbamazepine (used in the treatment of seizures and epilepsy).
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or diclofenac.

Taking Mifepristone Linepharma with food and drinks:

• Do not take grapefruit juice while you are being treated with Mifepristone Linepharma.

This method requires the participation of the woman, who must be informed of the requirements of the method:

• Necessity of combining the treatment with the administration of prostaglandins on a second visit.
• Necessity of a follow-up visit 14 to 21 days after taking Mifepristone Linepharma to check that the abortion is complete.
• The non-negligible risk of method failure, which may require interruption by another method; in very rare cases, may require surgical intervention.

Fertility, pregnancy, and breastfeeding

Pregnancy

There is little information on the risks to the fetus.If the pregnancy continues and you decide to continue it, talk to your doctor, who will prepare a careful prenatal check-up and ultrasounds.

Breastfeeding

Since Mifepristone Linepharma may pass into breast milk and may be ingested by your baby, you should stop breastfeeding once you have taken the treatment.

Fertility

Studies of the use of mifepristone in animals do not indicate direct or indirect harmful effects with respect to fertility.

It is recommended that you avoid becoming pregnant again during your next menstrual period after taking Mifepristone Linepharma.

Consult with your doctor or pharmacist before using any medication.

Driving and operating machinery

No studies have been published on the effects on the ability to drive vehicles and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor again.

Mifepristone Linepharma is for oral use.

Administration method: 200mg of mifepristone (1 tablet) should be taken, followed, 36 to 48 hours later, by the administration of a prostaglandin analogue (1 capsule containing 1mg of gemeprost placed in the vagina).

If you are taking other medications, you may need a higher dose of mifepristone. It is essential that you inform your doctor if you are taking other medications. See Section 2 “Other medications and Mifepristone Linepharma”.

You should swallow the Mifepristone Linepharma tablet with a little water in the presence of a doctor or a member of your medical team.

In the case of a pregnancy with an intrauterine device in place, it should be removed.

Expulsion may occur before the administration of the prostaglandin (in approximately a 3% of cases).This does not exclude a follow-up visit to check that the abortion has been completed.

After the administration of Mifepristone Linepharma, you will return home.Uterine bleeding usually begins 1 to 2 days after taking Mifepristone Linepharma.

In rare cases, expulsion may occur before taking the prostaglandin.It is essential that you undergo a check-up to confirm that complete expulsion has occurred; you must return to the center.

Two days later, the prostaglandin will be administered to you.You should remain at rest for 3 hours after receiving the prostaglandin.The embryo may be expelled a few hours after administration of prostaglandin or in the following days.Bleeding lasts an average of 12 days or more.In case of heavy or prolonged bleeding, you should consult your doctor immediately, in order to schedule a visit before the scheduled date.

You should return to the center for the follow-up visit within 14 to 21 days after taking Mifepristone Linepharma.If the pregnancy continues or expulsion is incomplete, you will be offered an alternative method to interrupt the pregnancy.

It is recommended that you do not travel far from the center where you were prescribed the medication until then.

In case of emergency or if you are concerned for any reason, you can contact your center by phone or visit it before the scheduled date for your next appointment.You will be provided with the phone number for emergency consultations or any problems.

The use of Mifepristone Linepharma requires taking measures to prevent sensitization to the Rh factor(if you are Rh-negative)in addition to the general measures taken during any abortion.

You may become pregnant again immediately after the abortion.

As some effects of Mifepristone Linepharma may still persist, it is recommended that you avoid becoming pregnant again before your next menstrual period after taking Mifepristone Linepharma.

Use in children

No information is available about treatments in women under 18years.

If you take more Mifepristone Linepharma than you should

Since you will be under medical supervision during the administration of the medication, it is unlikely that you will take more than you should.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Mifepristone Linepharma

If you forgot to complete any part of the treatment, it is likely that the method will not be fully effective. Inform your doctor if you forgot to take the treatment.

If you have any other doubts about the use of this product, consult your doctor.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, go to your doctor or the nearest hospital immediately:

• Heavy vaginal bleeding (frequency: frequent). See also section 2, “Warnings and precautions”
• Infections: cases of fatal toxic shock caused by endometritis due to infection byClostridium sordellii. It may cause symptoms such as the following: fever accompanied by muscle pain, rapid heart rate, dizziness, diarrhea, vomiting, or feeling weak. It may also occur without fever or other obvious signs of infection (frequency: rare or very rare)
• Severe allergic reactions (angioedema and anaphylaxis) swelling of the face, tongue, or throat, difficulty swallowing, rashes (skin eruption), difficulty breathing (frequency: rare or very rare)
• Cardiovascular accidents: heart attack, cardiac arrhythmias (frequency: rare or very rare)
• Significant drop in blood pressure, caused by the loss of a large amount of blood (hemorrhagic shock) (frequency: infrequent).
• Red patches on the trunk. These patches are macules in the shape of a target or circular red spots, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis; frequency: rare or very rare).
• Generalized red exfoliative rash, with lumps under the skin and blisters accompanied by fever. These symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis; frequency: unknown).

Other side effects that may occur:

The following side effects have been observed:

Very frequent side effects(may affect more than 1 in 10 people):

• Headaches.
• Vaginal bleeding.
• Side effects related to prostaglandin use, such as nausea, vomiting, diarrhea, dizziness, abdominal discomfort, abdominal pain, uterine cramps, fatigue, and chills or fever.
• Uterine contractions or cramps in the hours following administration of the prostaglandin.

Frequent side effects(may affect up to 1 in 10 people):

• Prolonged bleeding after abortion.
• Spotting.
• Severe bleeding.
• Endometritis (uterine inflammation).
• Breast tenderness.
• Fainting.
• Cramps.

Rare side effects (may affect up to 1 in 100 people):

• Salpingitis (infection of the Fallopian tubes).
• Infection.
• Hypotension.

Rare side effects (may affect up to 1 in 1000 people) and very rare side effects (may affect up to 1 in 10,000 people):

• Ectopic pregnancy.
• Bilateral adnexal mass (enlargement of the Fallopian tubes).
• Intrauterine adhesions, uterine rupture, hematosalpinge (hemorrhage in the Fallopian tubes).
• Ovarian cyst rupture.
• Mammary abscess.
• Hydatidiform mole, trophoblastic tumor, elevated alpha-fetoprotein, elevated carcinoembryonic antigen, amniotic band syndrome, uteroplacental apoplexy.
• Urticarial reaction, periorbital edema.
• Bronchospasm, asthma.
• Abnormal liver function tests.
• Liver insufficiency.
• Gastric hemorrhage.
• Epilepsy.
• Tinnitus (ringing in the ear).
• Mania.
• Superficial thrombophlebitis.
• Purpura thrombocytopenic thrombosis (coagulation disorder).
• Thrombocytopenia
• Induced systemic lupus erythematosus
• Renal insufficiency.
• Muscle spasms.
• Ophthalmoplegia.
• Erhythema.
• Neuralgic symptoms (headaches, skin eruptions/itching).
• General discomfort.

In a very small number of women,especially those who have undergone surgery on the uterus or a cesarean delivery, there is a risk of uterine rupture or tear during another pregnancy.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store the blister pack in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Mifepristone Linepharma

• The active ingredient is mifepristone. Each tablet contains 200 mg of mifepristone.
• The other components are cornstarch, povidone, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of Mifepristone Linepharma and contents of the packaging

White or almost white, round tablet, 11 mm in diameter, with MF engraved on one side of the tablet.

PVC-PVDC-aluminum blister with 1 tablet and 30 tablets (clinical packaging).

Only some packaging sizes may be commercially available

Holder of the marketing authorizationand manufacturer

Holder of the marketing authorization

LINEPHARMA

216 boulevard Saint-Germain

75007 Paris

FRANCE

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate

C/ La Vallina, s/n

24193 Villaquilambre, León

SPAIN

or

Delpharm Lille S.A.S.

Roubaix Est Business Park

22 Rue de Toufflers

Cs 50070

59452 Lys Lez Lannoy Cedex

FRANCE

Local representative

Mifepharma, S.L.

C/ Venezuela, nº 28, planta EN

36203 Vigo – Pontevedra

SPAIN

This medicine is authorized in the member states of the European Economic Area with the following names:

France: MIFFEE®200 mg tablet

Spain: Mifepristone Linepharma 200 mg tablets

Ireland: Mifepristone Linepharma 200 mg tablet

Sweden: Mifepristone Linepharma 200 mg tablet

United Kingdom: Mifepristone Linepharma 200 mg tablet

This leaflet has been approved inSeptember 2022

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/