Package leaflet: Information for the user

Hana 75 microgram film coated tablets
75 microgram
film coated tablets

Desogestrel

Using Hana:
summary of
key points

If this is your first time using Hana, you must read all of this leaflet carefully before you start taking it.

If you have already used Hana, you must check this medicine is still right for you.

Here are some key points to consider before taking Hana:



  • Hana is a contraceptive pill for women who want to prevent pregnancy.
  • Take one tablet at the same time every day, without any break between packs. Always read “When and how to take the tablets” before starting Hana.
  • If you forget to take Hana,
    • If you are less than 12 hours late, take the delayed pill straight away and take your further pills as usual. Hana will still protect you from pregnancy.
    • If you are more than 12 hours late, take the most recently missed pill straight away and leave any earlier missed pills in the strip. Take your further pills as usual. Use extra contraception (e.g. condoms) for the next 7 days. Missing tablets at any time in the cycle can reduce the efficacy of Hana and risk pregnancy but if you have missed one or more tablets in the first week of taking Hana and had sex in the week before missing the tablets, the risk you may get pregnant is higher. Ask your pharmacist for advice.

    For full details, see the chart in section 3, under “If you forget to take Hana”.

  • It is common for women taking Hana to have bleeding patterns which are different from their usual periods, or to have no periods at all (see section 4, “Changes to your periods”).
  • In some circumstances it may not be appropriate to take Hana or it may be necessary to consult a doctor before taking Hana (see section 2.1 “Do not take Hana” and section 2.2 “Warnings and precautions”).
  • Some medicines may reduce the efficacy of Hana. Tell your pharmacist if you are taking, or may start taking, any other medicines (see section 2.4 “Taking other medicines”).
  • Now read the rest of this leaflet. It includes other key points on the safe and effective use of this medicine that might be especially important for you.

    This Leaflet was last revised in July 2021.

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

    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

    1 What Hana is and what it is used for

    Hana is a daily contraceptive used to prevent pregnancy for women of childbearing age. It is an oral hormonal contraceptive (often called “the pill”). Hana works primarily by preventing a woman’s egg cell from ripening (prevents ovulation); it also has effects on cervical mucus which makes it more difficult for sperm to enter the womb.

    Hana contains a small amount of one type of female sex hormone: a progestogen called desogestrel. Unlike the combined pill, Hana does not contain any oestrogen hormone, in addition to the progestogen. For this reason, Hana is called a progestogen-only pill (POP).

    Other methods of contraception are available with a prescription that might suit you better – see section 6.3 “More about contraception and women’s health screening” at the end of this leaflet. Talk to your pharmacist, doctor or family planning nurse if you want more information.

    In contrast to the combined pill, Hana can be used

    If you think you are post-menopausal, talk to your doctor. You may not need to take contraceptives.

    Hormonal contraceptives, including Hana, do not protect you against HIV infection (AIDS) or any other sexually transmitted disease. Only condoms can protect you from sexually transmitted infections.

    This product does not work as an emergency contraceptive. If it’s taken every day it will protect against pregnancy in the future.

    2 What you need to know before you take Hana

    2.1 Do not take Hana

    Talk to your doctor or family planning nurse if any of these apply to you. Your doctor or family planning nurse may advise you to use a different method of birth control.

    2.2 Warnings and precautions

    Talk to your pharmacist, doctor or family planning nurse before taking Hana:

    If any of these apply to you, you may still be able to take Hana but your doctor may want to see you from time to time.

    It is common for women taking Hana to have bleeding patterns that are different from their usual periods. Some women will have bleeding less often, or none at all; some will have bleeding more often. Bleeding patterns may settle with time. A change in your bleeding pattern is not something you should normally be worried about if you are taking your pill as directed – see section 4.2 “Changes to your periods”.

    Breast cancer

    Breast cancer is rare in women under 40 years old. The risk increases as women get older. See your doctor as soon as possible if you feel any lumps or see a change in your breasts. The risk of breast cancer is slightly higher in women taking any contraceptive pill, as compared to women of the same age not on the pill. The risk with progestogen-only pills, such as Hana, is thought to be similar to that in women on the combined pill. It may be lower, though more research is needed to be certain.

    A woman’s risk while on the combined pill is more affected by how old she is, rather than for how long she takes the pill. For example:

    10,000 women take the combined pill for up to 5 years, and stop taking it by the age of 20

    1 extra case of breast cancer found, on top of the 4 cases usually diagnosed in the 10 years afterwards

    10,000 women take the combined pill for up to 5 years, and stop taking it by the age of 30

    5 extra cases of breast cancer found, on top of the 44 cases usually diagnosed in the 10 years afterwards

    10,000 women take the combined pill for up to 5 years, and stop taking it by the age of 40

    20 extra cases of breast cancer found, on top of the 160 cases usually diagnosed in the 10 years afterwards

    Compared to the risk of getting breast cancer ever in life, the increased risk associated with the combined pill is low. It may be that women on the combined pill were examined more often, so that the breast cancer was noticed earlier.

    When women stop taking the pill, their risk of breast cancer gradually reduces so that, within 10 years of stopping, their risk is the same as for those who have never taken it.

    Blood clots

    Blood clots in major arteries and veins are rare but can cause serious health problems. The risk of a blood clot is higher in women on any type of contraceptive pill (but no higher than the risk in pregnant women). The risk with progestogen-only pills, such as Hana, is thought to be lower than in women on the combined pill, but this has yet to be confirmed.

    A clot in the deep veins of the leg (called a deep vein thrombosis, or DVT) can cause the following symptoms, usually in the calf:

    A clot in the leg can travel to the lungs and stop there (a pulmonary embolism), which can be fatal. Signs of a blood clot in the lungs include:

    Contact your doctor immediately if you notice any of the signs above. Do not take Hana if you have a blood clot.

    Being immobile can increase your risk of a blood clot. Consult your doctor at least four weeks before planned surgery to see whether you should stop using Hana during that time.

    Pregnancy outside the womb (ectopic pregnancy)

    Hana consistently inhibits ovulation (see section 1 “What Hana is and what it is used for”) and so reduces the risk of pregnancy outside the womb. However, contact your doctor immediately if you have sudden or severe pain in the lower abdomen or stomach area with or without vaginal bleeding, even if you don’t think you are pregnant.

    Mental health

    Some women using hormonal contraceptives, including Hana, have reported depression or depressed mood. Depression can be serious and sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor as soon as possible.

    High blood pressure (hypertension)

    If you develop high blood pressure during the use of Hana, or if your blood pressure remains high despite treatment you have been given, contact your doctor to decide whether Hana should be stopped.

    Effect on bone mineral density

    Because Hana prevents ovulation, it reduces the overall level of estrogen hormone in the bloodstream. It is not known whether this reduction has any effect on bone density and risk of fracture in later life.

    2.3 Children and adolescents

    No clinical data on efficacy and safety are available in adolescents below 18 years.

    2.4 Taking other medicines

    Tell your pharmacist, doctor or family planning nurse if you are taking any other medicines, have recently taken any, or might in the future. This includes medicines that you buy without a prescription, and herbal remedies.

    If any pharmacist, doctor or family planning nurse prescribes you another medicine, tell them that you take Hana. They can tell you if the other medicine is OK to take at the same time, and whether you need to use extra contraception (for example, condoms).

    If you are using these medicines or herbal remedies listed below either chronically or for long-term treatment, you should consult your doctor as an alternative method of contraception may be more appropriate for you.

    Substances which may lead to unexpected bleeding and/or contraceptive failure in women using Hana

    These include treatments for:

    All these medicines or herbal remedies can stop Hana working properly.

    If you are using any of these medicines or herbal remedies for short-term treatment, you can continue taking Hana, but you must also use extra contraception (for example, condoms) every time you have sex during treatment and until 28 days after stopping the last dose of the other medicine or herbal remedy.

    If you are using any of these medicines or herbal remedies either chronically or for a long-term treatment, you should consult your doctor for further advice.

    Substances increasing the blood levels of Hana

    These include medicines used for the treatments of:

    The leaflet for these medicines needs to be consulted to identify potential interactions and any recommendations. Ask your pharmacist for advice.

    Substances with variable effects on the blood levels of Hana

    These include treatments for:

    The leaflet for these medicines needs to be consulted to identify potential interactions and any recommendations. Ask your pharmacist for advice. In case of doubt, you must use extra contraception (for example, condoms) during treatment with these medicines.

    Hana may also interfere with how other medicines work, causing them to either have an increased effect (e.g. medicines containing ciclosporin) or a decreased effect (e.g. lamotrigine).

    For more advice, ask your pharmacist.


    Taking emergency contraceptive containing ulispristal acetate

    Using Hana and emergency contraception containing ulipristal acetate together can alter the effect of both these medicines, resulting in reduced contraceptive effect and increased risk of pregnancy.

    If you have used emergency contraception containing ulipristal acetate during your cycle, you must wait 5 days after taking ulipristal acetate before taking Hana. You must also use additional contraception (for example, condoms) every time you have sex during the 5 days while you wait to start or resume taking Hana and for the first 7 days of taking Hana (ie. for a total of 12 days).

    For more advice, ask your pharmacist, doctor or family planning nurse.

    2.5 Pregnancy and breast-feeding

    If you are pregnant or think you may be pregnant

    Do not use Hana if you are pregnant, or think you may be pregnant. Take a pregnancy test or talk to your pharmacist, doctor or family planning nurse if your period is late after missing any pills in the last month, or if you think you may be pregnant. If you become pregnant, stop taking Hana and see your doctor.

    Signs that you may be pregnant include: a missed period, tender breasts, feeling sick, tiredness, and mood swings.


    If you are breast-feeding

    Hana may be used while you are breast-feeding. Desogestrel, the active substance of Hana, does not appear to influence the production or the quality of breast-milk. However, there have been infrequent reports of a decrease in breast milk production while using desogestrel. A small amount of desogestrel passes into the milk.

    Researchers have followed children who were breast-fed for 7 months while their mothers were using desogestrel. The children’s health was studied up until they were 2½ years old. No effects on their growth or development were seen.

    If you want to get pregnant

    If you decide you want to become pregnant, simply stop taking Hana. Hana will not delay your ability to get pregnant.

    2.6 Driving and using machines

    Hana has no known effect on your ability to drive or use machines.

    2.7 Hana contains lactose

    Hana contains lactose (milk sugar). Contact your doctor before taking Hana if you have been told by a doctor that you are intolerant to some sugars.

    2.8 Regular screening

    It is important that you continue to have regular smear tests (cervical screening) while taking Hana.

    If you are worried you may have got a Sexually Transmitted Infection (STI) including HIV (AIDS), go for a check-up at a sexual health clinic as soon as you can. Many STIs, like HIV, have no symptoms at all. The only way to know for sure that you do not have an STI is to get tested. Only barrier methods (such as condoms) can protect you from sexually transmitted infections.

    2.9 Contact your doctor

    Immediately

    As soon as possible

    3 How to take Hana

    3.1 When and how to take the tablets

    Hana will not prevent pregnancy unless taken exactly as directed.

    Take one tablet at the same time every day, without a break between packs.

    Swallow the tablet whole.

    Choose a convenient time of day. It is best to link this to something you already do at the same time every day. For example, when you wake up, or when you brush your teeth.

    Never skip your daily tablet. Take it every day, even when you bleed or have spotting (see Section 4, “Possible side effects”).

    The Hana pack contains 28 tablets. The days of the week are printed on the pack, and arrows show the order to take the tablets. Every time you start a new pack of Hana, take a tablet labelled with the correct day. For example, if you start on a Wednesday, you must take a tablet marked with Wed. Don’t start with just any tablet.

    Continue to take one tablet a day until the pack is empty, following the direction shown by the arrows.

    When a pack is empty, you must start with a new pack of Hana on the next day, without a break, and without waiting for a bleed.

    3.2 Starting your first pack of Hana

    Not currently using hormonal contraception:

    If you are not using hormonal contraception now or in the past month (for example, pill, vaginal ring, skin patch, injection, implant, hormone-containing coil (IUS)), wait for your period to begin.

    Changing from a combined pill:

    Changing from a vaginal ring or skin patch:

    Changing from another progestogen-only pill:

    Switch on any day from another progestogen-only pill. You must start the day after you stop your other pill. You do not need extra contraception.

    Changing from an injection, implant or hormone-containing coil (IUS):

    When changing from an injection, start using Hana on the same day the injection is due. You do not need extra contraception.

    When changing from an implant or hormone-containing coil (IUS), start Hana the same day the IUS or implant is removed. Your doctor will advise you when the IUS should be removed and whether you need any extra contraception.

    Starting or resuming Hana following emergency contraception:

    Ask your pharmacist for advice on how to start taking or resume taking Hana following emergency contraception. If you have taken emergency contraception, it is advisable to wait until day 1 of your next menstrual period before taking Hana.

    Emergency contraception containing levonorgestrel can be used with Hana. If you have used emergency contraception containing levonorgestrel during your cycle, you can start or continue taking Hana the same day, but you must use additional contraception (for example, condoms) every time you have sex for the next 7 days.

    Using Hana and emergency contraception containing ulipristal acetate together can alter the effect of both these medicines, resulting in reduced contraceptive effect and increased risk of pregnancy. If you have used emergency contraception containing ulipristal acetate during your cycle, you must wait 5 days after taking ulipristal acetate before taking Hana and you must also use additional contraception (for example, condoms) every time you have sex during the 5 days while you wait to start or resume taking Hana and for the first 7 days of taking Hana (ie. for a total of 12 days).

    If you have had a baby:

    You can start Hana any day between day 1 and day 21 after the birth of your baby.

    If you start later than 21 days afterwards, make sure that you use extra contraception (for example, condoms) for the first 7 days of taking Hana. If you have already had unprotected sex, take a pregnancy test or talk to your doctor before starting Hana. Information for breast-feeding women can be found in section 2.5, “Pregnancy and breast-feeding”.

    Your pharmacist, doctor or family planning nurse can also advise you.

    If you have had a miscarriage or an abortion:

    You can start Hana immediately or within 5 days of a miscarriage or an abortion. You do not need extra contraception. If in doubt, your doctor or family planning nurse will advise you.

    3.3 If you forget to take Hana

    When were you due to
    take the missed pill?

    Less than
    12 hours ago

    • Take the delayed pill straight away.
    • Take your further pills as usual. This may mean taking two pills in one day.
    • Don’t worry, your contraceptive protection should not be reduced.

    More than
    12 hours ago

    • Take the most recently missed pill straight away. Leave any earlier missed pills in the strip.
    • Take your further pills as usual. This may mean taking two pills in one day.
    • Use extra contraception (e.g. condoms) for the next 7 days.
    • If you have missed one or more tablets in the very first week of taking Hana and had sex in the week before missing the tablets, the risk of getting pregnant is higher than at any other time in your cycle. Ask your pharmacist for advice and if you need to use emergency contraception.

    If your period is late after missing any pills in the last month, or if you think you may be pregnant, take a pregnancy test.

    Stop taking Hana and see your doctor if you become pregnant (see section 2.5 "Pregnancy and breast-feeding").

    3.4 If you vomit or have severe diarrhoea

    If you vomit within 3-4 hours of taking Hana, the pill should be considered ‘missed’ and the advice under section 3.3 “If you forget to take Hana” followed. If you have severe or persistent vomiting or diarrhoea, Hana may not have been completely absorbed and contraceptive effect may be reduced. You should use additional contraception (for example, condoms) for the duration of the illness and for the first 7 days of normal pill taking.

    If you are not sure what to do, ask your pharmacist for advice.

    3.5 If you take more Hana than you should

    There have been no reports of serious harmful effects from taking too many Hana tablets at one time. Symptoms can include nausea and vomiting and, in young girls, slight vaginal bleeding. For more information, ask your pharmacist, doctor or family planning nurse.

    3.6 If you stop taking Hana

    You can stop taking Hana whenever you like. From the day you stop, you are no longer protected against pregnancy.

    If you have any further questions on the use of this medicine, ask your pharmacist, doctor or family planning nurse.

    4 Possible side effects

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

    Tell your pharmacist, doctor or family planning nurse if you notice any unwanted effect, especially if severe or persistent.

    4.1 Serious side effects are rare

    Severe allergic reactions

    You may experience signs of a severe allergic reaction (hypersensitivity) including:

    Get medical advice immediately if you get any of these.

    Pregnancy outside the womb (ectopic pregnancy)

    Rarely, women taking Hana have had an ectopic pregnancy, where the baby develops outside the womb. Symptoms might include:

    Contact your doctor immediately if you get these.

    Risk of blood clots

    Women taking hormonal contraceptive pills are at increased risk of blood clots – see ‘Blood clots’ in section 2.2 ‘Warnings and precautions’. Symptoms might include:

    Contact your doctor immediately if you notice these.

    4.2 Changes to your periods

    You are likely to experience changes in your periods while using Hana. You do not need to take any action, just continue taking Hana exactly as directed, even if you start to have these changes:

    Contact your doctor or family planning nurse if you start to have these changes:

    Meanwhile, you must continue to take Hana every day.

    4.3 Common side effects

    These may affect up to 1 in 10 women

    4.4 Uncommon side effects

    These may affect up to 1 in 100 women

    4.5 Rare side effects

    These may affect up to 1 in 1,000 women

    As well as these side effects, you may notice breast secretion or leakage.

    4.6 Reporting of side effects

    If you get any side effects talk to your doctor, pharmacist or family planning nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

    5 How to store Hana

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

    Do not use Hana after the expiry date which is stated on the carton label and blister foil. The expiry date is the last day of that month.

    Do not store above 30°C. Use within 3 months of first opening of the sachet.

    The active substance could cause an environmental risk to fish. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

    6 Contents of the pack and other information

    6.1 What Hana contains

    The active substance is desogestrel.

    Each film-coated tablet contains 75 microgram desogestrel.

    The other ingredients are alpha-tocopherol; maize starch; povidone; stearic acid; hypromellose; macrogol 400; titanium dioxide (E 171); lactose monohydrate (see also “Hana contains lactose” in section 2).

    6.2 What Hana looks like and contents of the pack

    Each blister pack of Hana contains 28 biconvex, round, white film-coated tablets without a score line.

    Hana contains 1 or 3 blister packs. Each blister is packed in a foil sachet.

    Marketing Authorisation Holder : Laboratoire HRA Pharma, 200 avenue de Paris, 92320 Chatillon, France

    Manufacturer: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany

    This leaflet was last revised in July 2021.

    Latest approved information on this product is available on the following URL: www.hra-pharma.com/PIL/UK/DSG.

    Is this leaflet hard to see or read? Phone 0800 917 9548 for help.

    6.3 More about contraception and women’s health screening

    Regular contraception

    There are many different types of contraception available, and you should be able to find the right method for you. The different contraception options are listed below from the most effective to the least effective. You can ask your doctor or family planning nurse for advice.

    Male and female sterilisation

    Permanent method

    Progestogen-only implant

    Long-lasting method

    (3 years)

    Hormone-containing coil (IUS)

    Long-lasting method

    (5 years)

    Copper-coil (IUD)

    Long-lasting method

    (5 to 10 years)

    Progestogen-only injectable

    Long-lasting method

    (8 to 13 weeks)

    Combined oral contraception (COC) pill, progestogen-only pill (POP)

    Transdermal patch (patch), vaginal ring

    Daily method (pill)


    Weekly or monthly method

    Male and female condoms

    With every episode of sex

    Female diaphragm

    With every episode of sex

    Natural family planning

    Avoid sex during fertile time

    Emergency contraception

    Consider taking emergency contraception after unprotected sex, or if your contraceptive method has failed (for example, a condom has split or you have missed a pill). Ask any pharmacist for advice.

    Women’s health screening

    Smear tests (cervical screening) are offered by the NHS to women aged 25 to 64 to check the health of cells in the cervix. Breast screening is also offered to women aged 50 to 71 to detect early signs of breast cancer. For cervical screening and breast screening, contact your doctor. You can also contact your local breast screening unit.

    Other sources of information

    For further information on all methods of contraception, emergency contraception or screening, go to https://www.nhs.uk .