Hana Mini-Pill Tablets

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.

The recommended dose:

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

Hana will not prevent pregnancy unless taken exactly as directed.

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.

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. Do not 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.

How you first start taking Hana will depend on whether you have previously used other contraception or if you have recently been pregnant. You may also need to use additional contraception for the first 7 days. Read the following information carefully to see which applies to you.

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.

• it is preferable to take your first tablet on day 1 of your period. When doing so, you do not need to use extra contraception
• if you take your first tablet on days 2–5 of your period, use extra contraception (for example, condoms) for the first 7 days of taking the tablets

Changing from a combined pill:

• If you have had your usual break from a combined pill, take the first Hana tablet on the day after your break, or when you have taken all the inactive tablets of your other contraceptive. If you follow these instructions, make sure you use extra contraception (for example, condoms) for the first 7 days of taking Hana
• If you haven’t had your usual break from a combined pill, start taking Hana on the day after you take the last tablet from your present pill pack. Even if your other pill pack contains inactive tablets, you can start Hana on the day after taking the last active tablet. If you are not sure which this is, ask your pharmacist. If you follow these instructions, you do not need extra contraception

Changing from a vaginal ring or skin patch:

• If there has been a break between removal of the vaginal ring or skin patch (ie. you are not starting Hana on the day of removal of the ring or patch), make sure you use extra contraception (for example condoms) for the first 7 days of taking Hana.
• If you start taking Hana on the day of removal of the vaginal ring or skin patch, you do not need extra contraception

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.

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 wihin 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.

If you forget to take Hana (missed pill)

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.

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 above to 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.

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.

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Side Effects

Common

• Altered mood, depressed mood
• Decreased sexual drive (libido)
• Headache
• Bausea
• Acne
• Breast pain
• Irregular or no periods
• Increased body weight

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:

• Irregular periods: your periods may be less or more frequent, shorter or longer, lighter or heavier than before you started Hana.
• Spotting or bleeding when you are not having your period. This may be just slight staining which may not even require a pad, or heavier bleeding like a light period. You may need to use tampons or sanitary towels.
• Stop having periods while taking Hana

Uncommon

• Infection of the vagina
• Difficulties in wearing contact lenses
• Vomiting
• Hair loss
• Painful periods
• Ovarian cysts
• Tiredness

Rare

• Rash
• Hives
• Painful blue-red skin lumps (erythema nodosum)
• Breast secretion or leakage.

Serious Side Effects

Severe allergic reactions

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

• Swollen face, lips, tongue and/or throat
• Difficulty swallowing or breathing

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:

• A sudden or severe pain in the lower abdomen or stomach area with or without vaginal bleeding

Contact a doctor immediately if you get these.

Risk of blood clots

Women taking hormonal contraceptive pills are at increased risk of blood clots. Symptoms might include:

• Swelling, redness or pain in the leg
• Chest pain, breathlessness or coughing up blood

Contact your doctor immediately if you notice these.

Contact your prescriber or doctor if you start to have these changes:

Your menstrual period differs from that which would be expected with Hana

• Your menstrual period is more frequent than you find acceptable
• Your menstrual period is unusually heavy
• You repeatedly have bleeding that is brought on by sex

Meanwhile, you must continue to take Hana every day.

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 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.

Warning & Precautions

Please refer to the ‘Information and Advice’ tab to access the Patient Information Leaflet for more detailed guidance.

Do not take Hana

• if you have cancer that is affected by sex-steroid hormones, such as certain types of breast cancer, ovarian cancer, endometrial (uterine) cancer
• if you have a blood clot in the legs (deep vein thrombosis) or lungs (pulmonary embolism
• if you have, or have had, jaundice (yellowing of the skin or whites of the eyes) or severe liver diseases and blood tests show your liver has not returned to normal
• if you have any unexplained vaginal bleeding between your periods, or if you repeatedly have bleeding after sex
• if you are allergic to desogestrel, or any of the other ingredients of Hana
• if you are pregnant or think you may be pregnant.

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.

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

• if you have had cancer that is affected by progestogen hormones, such as certain types of breast cancer, ovarian cancer, endometrial (uterine) cancer
• if you have had a blood clot in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• if you have liver cancer or other liver problems
• if you have high blood pressure
• if you have diabetes
• if you have epilepsy
• if you have tuberculosis
• if you have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face)

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.

Breast cancer

Breast cancer is uncommon in women under 40, but the risk increases with age. See your doctor as soon as possible if you notice any lumps or changes in your breasts.

Women taking any contraceptive pill may have a slightly higher risk of breast cancer compared to women who are not on the pill. The risk with progestogen-only pills, such as Hana, is thought to be similar to that of the combined pill, and may possibly be lower, although more research is needed.

For the combined pill, a woman’s risk is influenced more by her age than by how long she has been taking 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:

• swelling of the leg
• redness and warm skin
• severe pain in the leg

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:

• chest pain
• breathlessness
• coughing up blood

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 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.

Age Restrictions

For childbearing age women, 18 years and above

Other Medicines and Conditions

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:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate, phenobarbital)
• tuberculosis (e.g. rifampicin, rifabutin)
• HIV infections (e.g. efavirenz)
• pulmonary arterial hypertension: high blood pressure in the blood vessels of the lungs (bosentan)
• depression (the herbal remedy St. John’s Wort)
• fungal infections (e.g. griseofulvin)

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.

Medication increasing the blood levels of Hana. These include medicines used for the treatments of:

• fungal infections (e.g. ketoconazole, itraconazole, fluconazole)
• certain bacterial infections (e.g. clarithromycin, erythromycin)
• high blood pressure, angina or certain abnormal heart rhythm (e.g. diltiazem)

Medication with variable effects on the blood levels of Hana. These include treatments for:

• HIV infections (e.g. ritonavir, nelfinavir, nevirapine)
• hepatitis C virus infection (e.g. boceprevir, telaprevir)

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 contraception 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).

Pregnancy and Breastfeeding

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 breastfeeding

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.

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.

Patient Information Leaflet

https://hanapharmacist.co.uk/static/media/PIL.91aafd6a.pdf

Ingredients

• Active Ingredients: Desogestrel
• Other Ingredients: maize starch, povidone, stearic acid, hypromellose, macrogol 400, titanium dioxide (E 171), lactose monohydrate

Product Information

• Brand Name: Hana
• Route of Administration: Oral
• Legal Classification: P-med
• Strength: 75mcg
• Dosage From: Tablet

Storage

• Keep this medicine out of the sight and reach of children.
• Do not use after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of the month.
• Store in the original packaging in order to protect from light.
• 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.

Advice & Helpful Links

https://www.nhs.uk/contraception/

https://www.letstalkaboutit.nhs.uk/contraception

Regular contraception

There are many different types of contraception available, and you should be able to find the right method for you.

You can speak to your prescriber, doctor or family planning nurse for advice.

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 your pharmacist for advice.

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.