Package Insert: Information for the User

1.5 mg EFG tablet

Levonorgestrel

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

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

• 1. What is Cumbran and for what it is used
• 2. What you need to know before starting to take Cumbran
• 3. How to take Cumbran
• 4. Possible adverse effects
• 5. Storage of Cumbran

6. Contents of the package and additional information

Cumbran is an emergency contraceptive pill.

What is emergency contraception?

Emergency contraception is a last resort method to prevent pregnancy after having unprotected sex or when a contraceptive method has failed.

When should emergency contraception be used?

Take Cumbran as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after having unprotected sex or when a contraceptive method has failed. Levonorgestrel is more effective if taken as soon as possible after unprotected sex. This medication can only prevent pregnancy if taken at most 72 hours after unprotected sex. It will not work if you are already pregnant. If you have unprotected sex after taking this medication, it will not prevent pregnancy.

Take this medication if you suspect you are pregnant because:

• You have had unprotected sex.

• You forgot to take your birth control pill on time.

• Your partner's condom broke, slipped off, or came off.

• You think your IUD (intrauterine device) has come out.

• You moved your diaphragm out of place or removed it too early.

• You are concerned because you think coitus interruptus or the Ogino method did not work.

• In case of rape.

The exact mechanism of action of levonorgestrel is unknown. It is likely that it prevents the ovaries from releasing an egg. There may be other processes involved, including preventing the implantation of a fertilized egg in the uterus. It is not effective once implantation has begun.

This tablet is only indicated for emergency contraception, not as an ordinary contraceptive method, as it is less effective than regular birth control pills ("the pill").

Cumbran is not indicated for use before the first menstrual bleeding (menarche).

Do not take Cumbran

If you are allergic to levonorgestrel or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

This medication is not recommended in the following cases:

• If you have had an ectopic pregnancy.
• If you have had pelvic inflammatory disease (salpingitis).
• If you or a family member have a known risk factor for thrombosis (blood clot formation).
• If you have a severe digestive disorder that alters the absorption of food and medications.
• If you have a severe liver disease or a severe small intestine disease, such as Crohn's disease.

Previous ectopic pregnancy and a previous infection of the Fallopian tubes increase the risk of having another ectopic pregnancy. Therefore, if you have had a previous ectopic pregnancy or a previous infection of the Fallopian tubes, you should consult your doctor before taking this medication.

If you have had unprotected sex more than 72 hours ago, it may already be too late for the treatment with levonorgestrel to be effective in preventing pregnancy.

Emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that levonorgestrel may be less effective in women with increased weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, levonorgestrel is recommended for all women, regardless of their weight or BMI.

You are advised to consult a healthcare professional if you are concerned about any problem related to emergency contraception.

This medication is not recommended for repeated administration in the same menstrual cycle, as it may interrupt the cycle.

This medication is not as effective as regular contraceptive methods (the pill or condoms). Your doctor may advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

After taking this medication, it is mandatory to exclude the possibility of pregnancy by performing a pregnancy test:

• When the next menstrual period is delayed by more than five days

• In case of abnormal bleeding, even on the date of the expected period

If you do not use condoms during sex (or if one breaks or slips off), you may have contracted a sexually transmitted disease (STD) or HIV. The use of emergency contraceptive pills does not offer protection against STDs or HIV infection and cannot replace the necessary precautions to be taken in case of risk of transmission of a disease (see "Additional information" later in this prospectus).

Mental health disorders:

Some women who use hormonal contraceptives like Cumbran have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Other medications and Cumbran

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications or herbal medications.

Some medications may prevent Cumbran from working effectively.

If you have used any of the following medications in the last 4 weeks, Cumbran may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), such as a copper intrauterine device (IUD-Cu). If this does not work for you or if you cannot see your doctor quickly, you may take a double dose of Cumbran:

• Barbiturates and other medications used to treat epilepsy (e.g. phenobarbital, phenytoin, primidone, and carbamazepine)
• Medications used to treat HIV (ritonavir, efavirenz)
• Medications used to treat tuberculosis (rifabutin, rifampicin)
• A medication to treat fungal infections (griseofulvin)
• Herbal medications containing St. John's Wort (Hypericum perforatum)

This medication should not be used in conjunction with emergency contraceptives containing ulipristal acetate.

Consult your doctor or pharmacist if you need additional information on the correct dosage for you

Consult your doctor as soon as possible after taking the pills, to inform you about reliable methods of regular contraception and avoid pregnancy (see also section 3 "How to take Cumbran" for more information).

Cumbran may also affect the proper functioning of other medications.

• A medication called cyclosporine (inhibits the immune system)

Pregnancy and breastfeeding

If you are pregnant:

If you are pregnant, this medication will not cause the abortion of an ongoing pregnancy.

If you are taking this medication and become pregnant, the studies conducted to date do not show any risk of fetal malformations. However, you should not take this medication if you are pregnant. If you become pregnant after taking levonorgestrel, you should consult your doctor. Your doctor may check if you have an ectopic pregnancy (if the fetus develops in some place other than the uterus). This is especially important if you have had severe abdominal pain after taking this medication, if you have had a previous ectopic pregnancy, or if you have undergone surgery on your Fallopian tubes or have had pelvic inflammatory disease.

If you are breastfeeding:

Breastfeeding is possible, but since levonorgestrel is excreted in breast milk, you should breastfeed your baby immediately before taking this medication and suspend breastfeeding for at least 8 hours after taking levonorgestrel.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

After taking levonorgestrel, some women experience fatigue and dizziness (see section 4, "Possible side effects"): do not drive or operate machines if you experience these symptoms.

No studies have been conducted on the effects of levonorgestrel on the ability to drive and operate machines.

This medication contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medication.

Follow exactly the administration instructions of this medication as described in the package insert or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered orally. The tablet should be swallowed with a glass of water and should not be chewed.

You can take Cumbran at any time during the menstrual cycle, except if you are already pregnant or think you may be pregnant.

If you vomit within three hours after taking the tablet, you should take another tablet.

Consult your doctor if more than 72hours have passed since unprotected sex.

If you are using one of the medications that can prevent Cumbran from working correctly (see section “Other medications and Cumbran”) or if you have used one of these medications in the last 4 weeks, Cumbran may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), that is a copper intrauterine device (IUD-Cu). If this is not an option for you or if you cannot see your doctor quickly, you can take a double dose of Cumbran (i.e., 2 tablets taken at the same time).

After taking levonorgestrel, use a barrier method of contraception (condom, diaphragm) until your next menstrual period begins. If you have had unprotected sex again after taking this medication (even during the same menstrual cycle), the tablets will have no contraceptive effect and there is a risk of pregnancy. If you use a regular method of contraception such as oral contraceptives, you can continue taking them at the same regularity.

If you use oral contraceptives (“the pill”), after taking levonorgestrel, simply continue taking the pill as you normally do. If you do not have any menstrual bleeding during the next pill-free period, you should have a pregnancy test to rule out possible pregnancy. Your doctor may recommend effective long-term contraceptive methods to prevent pregnancy.

If you continue using a regular hormonal method of contraception such as the pill and do not have any menstrual bleeding during the pill-free period, contact your doctor to check if you are pregnant.

The next menstrual period after taking Cumbran

After taking this medication, the menstrual period usually occurs normally and on the expected day, although in some cases it may be delayed or advanced by a few days. If your menstrual period is delayed by more than five days or is unusually light or heavy or if you suspect you may be pregnant for any other reason, check it by doing a pregnancy test. If you become pregnant even after taking this medication, it is essential to consult your doctor.

If you take more Cumbran than you should

No cases of acute poisoning or severe adverse effects have been reported after taking too many doses of levonorgestrel at once. However, you may experience nausea, vomiting, or vaginal bleeding. Consult your doctor or pharmacist for advice.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequency of occurrence of the possible adverse effects listed below is defined as follows:

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

Frequent (affect between 1 and 10 in 100 people)

Very rare (affect less than 1 in 10,000 people)

Not known (the frequency cannot be estimated from the available data).

The following adverse effects have been observed:

Very frequent adverse effects:

• Dizziness, headache
• Nausea, abdominal pain
• Mammary tenderness, delayed menstrual period, heavy menstrual periods, bleeding
• Fatigue

Frequent adverse effects:

• Diarrhea
• Vomiting

Unknown frequency:

• Post-marketing cases of thromboembolic episodes (blood clots) have been reported.
• Skin hypersensitivity may occur after taking this medication.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse 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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration; in that case, you must return the medication to your pharmacist.

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

Composition of Cumbran

The active ingredient is levonorgestrel.

The other components (excipients) are lactose monohydrate, povidone (E-1201), cornstarch, anhydrous colloidal silica (E-551) and magnesium stearate (E-572).

Levonorgestrel belongs to a class of medications called emergency contraceptives.

Appearance of the product and contents of the package

Round, white or almost white, flat and uncoated tablets with the inscription “145” on one face and smooth on the other face.

Each package contains a tablet of 1.5mg of levonorgestrel.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Accord Healthcare Limited

Sage House,

319 Pinner Road,

North Harrow,

Middlesex- HA1 4HF

United Kingdom

or

Aristo Pharma GmbH

Wallenroder Straße 8-10,

13435, Berlin

Germany

or

Laboratorios Medicamentos Internacionales S.A.

C/Solana 26

28850-Torrejón de Ardoz (Madrid)

Spain

Date of the last review of this leaflet:February 2019

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

Additional information

Menstrual cycle

The menstrual cycle is the period existing between two menstrual periods. Normally the cycle lasts 28días, but it may be different in each woman. Menstrual periods occur when a woman is not pregnant.

Fertilization

In the middle of each cycle, an ovum is released from one of the two ovaries (currently this process is called “ovulation”). Ovulation typically occurs in the middle of the cycle, but it may occur at any other time.

After sexual intercourse, the sperm of the man approaches the exposed ovum and fertilizes it (i.e., the fusion of a sperm with the ovum and the formation of an embryo). After a few days, the fertilized ovum implants in the uterus and pregnancy begins.

Contraceptives

Contraceptives serve, among other things, to prevent:

Ovulation: through the contraceptive pill.

Fertilization (the fusion of a sperm with an ovum): through a condom.

Implantation of a fertilized ovum in the uterus: through an IUD.

Emergency contraception

Emergency contraception acts by inhibiting ovulation or preventing the implantation of the ovum after sexual intercourse. It is not effective if implantation has already begun.

If a woman has sexual intercourse without using a contraceptive method, the possibility of pregnancy cannot be ruled out. If she uses this medication but does not use any ordinary contraceptive method, it is strongly recommended that she seek medical advice or visit the public health service. She will be informed about the most suitable contraceptive method for her.

Warning about the risk of contracting a sexually transmitted disease

If you have had unprotected sex, you are at risk of contracting a sexually transmitted disease, especially if you are unaware of your partner's sexual history or if you have had sex with multiple partners. If you have any questions, consult your doctor, pharmacist or family planning service.

GLOSSARY

• Ectopic pregnancy: a pregnancy that develops outside the uterus, usually in the fallopian tubes. Symptoms include persistent abdominal pain, amenorrhea, vaginal bleeding or signs of pregnancy (nausea, breast tenderness). If you experience any of these symptoms, consult your doctor immediately.

Salpingitis: infection of the fallopian tubes. Symptoms include abdominal pain, fever and intense vaginal discharge.