CUMBRAN 1.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cumbran 1.5 mg tablet EFG

Levonorgestrel

Read 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the pack

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

1. Contents of the pack and further information

1. What is Cumbran and what is it used for

Cumbran is an emergency contraceptive pill.

What is emergency contraception?

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

When should emergency contraception be used?

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

If you suspect you are pregnant because:

• You have had unprotected sex without using a contraceptive method.
• You have missed a birth control pill.
• The condom your partner was using has broken, slipped, or been removed.
• You think your intrauterine device (IUD) has been dislodged.
• The diaphragm you were using has been moved out of place or removed too early.
• You are concerned that the withdrawal method or the rhythm method (Ogino) has not worked.
• 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. Other processes may be involved, including preventing the implantation of a fertilized egg in the uterus. It is not effective once implantation has begun.

This tablet is indicated only for emergency contraception, not as a regular contraceptive method, as it is less effective than the regular birth control pill.

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

2. What you need to know before you take Cumbran

Do not take Cumbran

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

Warnings and precautions

This medicine is not recommended for use 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 blood clots.
• If you have a severe digestive disorder that affects the absorption of food and drugs.
• If you have a severe liver disease or a severe disease of the small intestine, such as Crohn's disease.

A history of ectopic pregnancy and previous infection of the fallopian tubes increases the risk of having another ectopic pregnancy. Therefore, if you have had an ectopic pregnancy or an infection of the fallopian tubes, you should consult your doctor before taking this medicine.

Emergency contraception should be used only as an occasional method and should not replace any regular contraceptive method, because:

• It does not always prevent pregnancy.
• The risk of receiving an excess of hormones may disrupt the menstrual cycle.

Emergency contraception does not interrupt an existing pregnancy.

If you have had unprotected sex more than 72 hours ago, you may already be pregnant. Therefore, treatment with levonorgestrel after the second instance of unprotected sex may not be effective in preventing pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected sex. There is some evidence that levonorgestrel may be less effective with increasing body weight or body mass index (BMI), but these data were limited and not conclusive. 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 issues related to emergency contraception.

Repeated administration of levonorgestrel in the same menstrual cycle is not recommended because it may disrupt the cycle.

This medicine 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 using this medicine, it is mandatory to rule out a possible pregnancy by taking a pregnancy test:

• When the next menstrual period is delayed by more than five days
• In case of abnormal bleeding, even on the expected date of the period

If you do not use condoms during sex (or if the condom breaks or slips), you may have contracted a sexually transmitted disease (STD) or HIV. The use of emergency contraceptive pills does not provide protection against STDs or HIV and cannot replace the necessary measures and precautions that should be taken in case of risk of transmission of a disease (see "Further information" later in this leaflet).

Psychiatric 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 a doctor for additional medical advice as soon as possible.

Other medicines and Cumbran

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription or herbal medicines.

Some medicines may prevent Cumbran from working effectively. If you have used any of the following medicines in the last 4 weeks, Cumbran may be less suitable for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., 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).

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

This medicine should not be used in conjunction with emergency contraceptives that contain ulipristal acetate.

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

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

Cumbran may also affect the proper functioning of other medicines.

• A medicine called ciclosporin (which suppresses the immune system).

Pregnancy and breastfeeding

If you are pregnant:

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

If you are taking this medicine and become pregnant, studies to date have not shown any risk of malformations for the fetus. However, you should not take this medicine 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 is developing in a place outside the uterus). This is especially important if you have severe stomach pain after taking this medicine, if you have had an ectopic pregnancy before, or if you have had surgery on the 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 child immediately before taking this medicine and stop breastfeeding for at least 8 hours after administration of levonorgestrel.

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

Driving and using machines

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

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

This medicine contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Cumbran

Follow the instructions for administration of this medicine as described in the leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after unprotected sex.

Do not delay taking the tablet. The medicine works better the sooner it is taken after unprotected sex. It can only prevent pregnancy if taken within 72 hours after unprotected sex.

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

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

If you are using one of the medicines that may prevent Cumbran from working correctly (see section "Other medicines and Cumbran") or if you have used one of these medicines in the last 4 weeks, Cumbran may be less effective for you. Your doctor may prescribe another type of emergency contraception (non-hormonal), i.e., 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 contraceptive method (condom, diaphragm) until your next menstrual period. If you have had unprotected sex again after taking this medicine (even during the same menstrual cycle), the tablets will not have any contraceptive effect, and there is a risk of pregnancy. If you are using a regular contraceptive method like birth control pills, you can continue taking them as usual.

If you are using birth control pills ("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 a possible pregnancy. Your doctor may recommend long-term contraceptive methods that are effective in preventing pregnancy.

If you are using a regular hormonal contraceptive method like the pill and have not had any menstrual bleeding during the pill-free period, contact your doctor to check that you are not pregnant.

The next menstrual period after taking Cumbran

After taking this medicine, the menstrual period usually occurs normally and on the expected date, although it may be earlier or later by a few days. If your menstrual period is delayed by more than five days or is unusually light or heavy, or if you think you may be pregnant for any other reason, check by doing a pregnancy test. If you become pregnant even after taking this medicine, it is important that you consult your doctor.

If you take more Cumbran than you should

No cases of acute overdose or severe side 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 or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

4. Possible side effects

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

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

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

Common (affects 1 to 10 in 100 people)

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

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

The following side effects have been observed:

Very common side effects:

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

Common side effects:

• Diarrhea
• Vomiting

Frequency not known:

• Post-marketing reports of thromboembolic events (blood clots) have been noted.
• Skin hypersensitivity may occur after taking this medicine.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cumbran

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date is the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration; in this case, you should return the medicine to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Dispose of the packaging and any unused medicine in the SIGRE collection point. This will help protect the environment.

6. Container Content and Additional Information

Cumbran Composition

The active ingredient is levonorgestrel.

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

Levonorgestrel belongs to a class of medications called emergency contraceptives.

Product Appearance and Container Content

Round, white or almost white, flat, uncoated tablets with the inscription "145" on one side and smooth on the other side.

Each container contains one 1.5 mg levonorgestrel tablet.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

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 Last Revision of this Leaflet:February 2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

Additional Information

The Menstrual Cycle

The menstrual cycle is the period between two menstrual periods. Normally, the cycle lasts 28 days, but it can be different for each woman. Menstrual periods occur when a woman is not pregnant.

Fertilization

In the middle of each cycle, an egg is released from one of the two ovaries (this process is currently called "ovulation"). Ovulation typically occurs in the middle of the cycle, but it can happen at any other time.

After sexual intercourse, the man's sperm approaches the exposed egg and fertilizes it (i.e., a sperm fuses with the egg, and an embryo is formed). After a few days, the fertilized egg implants in the uterus, and pregnancy begins.

Contraceptives

Contraceptive methods serve, among other things, to prevent:

Ovulation: through the birth control pill.

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

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

Emergency Contraception

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

When a woman has unprotected sex, she cannot rule out the possibility of pregnancy. If she uses this medication but does not use any regular contraceptive method, it is strongly recommended that she seek medical advice or visit a 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 she has had unprotected sex, she is at risk of contracting a sexually transmitted disease, especially if she is unaware of her partner's sexual history or if she has sex with multiple partners. If she has any questions, she should consult her 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 she experiences any of these symptoms, she should consult her doctor immediately.

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