Dretine 0.03 G/ 3.0 Mg Film-Coated Tablets
REG0083510
REG0083510
What to do if no bleeding occurs during the gap week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.
Other medicines and Dretine
Some medicines can have an influence on the blood levels of Dretine and can make it less effective in preventing pregnancy, or can cause unexpected bleeding. These include:
• medicines used for the treatment of:
• epilepsy (e g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
• tuberculosis (eg. rifampicin)
• HIV and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or other infections (griseofulvin)
• high blood pressure in the blood vessels in the lungs (bosentan)
• the herbal remedy St. John's wort
Dretine may influence the effect of other medicines, e g.
• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this could lead to an increased frequency of
Ask your doctor or pharmacist for advice before taking any medicine.
Dretine with food and drink
Dretine may be taken with or without food, if necessary with a small amount of
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormone contraceptives can affect the results of some tests.
Pregnancy
If you are pregnant, do not take Dretine. If you become pregnant while taking Dretine stop immediately and contact your doctor. If you want to become pregnant, you can stop taking Dretine at any time (see also "If you want to stop taking Dretine").
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Dretine is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Dretine affects driving or use of
Dretine contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or phar Check wth your doctor or pharmacist if you are not sure.
told you.
Take one tablet of Dretine every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example, you start on a Wednesday, take a tablet wth "WED" next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwse called a stop or gap week) bleeding should begin. This so-called “withdrawal bleeding" usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last Dretine tablet (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.
If you use Dretine in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.
• If you have not used a contraceptive with hormones in the previous month
Begin with Dretine on the first day of the cycle (that is, the first day of your period). If you start Dretine on the first day of your period you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from a combination hormonal contraceptive, or combination contraceptive vaginal ring or patch
You can start Dretine preferably on the day after the last active tablet (the last tablet containing the active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combination contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing IUD)
You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage Follow the advice of your doctor.
• After having a baby
You can start Dretine between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of Dretine use.
If, after having a baby you have had sex before starting Dretine (again), be
sure that you are not pregnant or wait until your next period.
Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Dretine. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for
What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible, take it within 12 hours of when you normally take your pill. If that is not possible or 12 hours have passed, you should follow the advice given under "If you forget to take Dretine".
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by going straight to a new strip of Dretine instead of the tablet-free period and finishing it. You may experience light or menstruation-like bleeding while using this second strip. After the usual tablet-free period of 7 days, start the next strip. You might ask your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your period will begin during the tablet-free week. If you have to change this day, reduce the number of tablet-free days (but never increase them - 7 is the maximum!). For example, if your tablet-free days normally begin on a Friday, and you want to change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than usual. If you make the tablet-free interval very short (for example, 3 days or less) you may not have any bleeding during these days. You may then experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you want to stop taking Dretine
You can stop taking Dretine whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Dretine and wait for a period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Dretine, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use
If you experience any of the following, stop taking this medicine immediately and seek urgent medical advice.
Common side effects (may affect up to 1 in 10 people):
• bleeding between periods
• migraine (severe headache)
• vaginal yeast infection (itching, irritation and swelling of the vagina and surrounding area) with thick, whitish vaginal discharge.
Uncommon side effects (may affect up to 1 in 100 people):
• high blood pressure
• infection of the vagina (abnormal, unpleasant smelling vaginal discharge, itching in the vagina and discomfort during sex).
Rare side effects (may affect up to 1 in 1,000 people):
• allergic reactions (hypersensitivity) including swelling of the face, lips, mouth, tongue or throat
• asthma (difficulty in breathing)
• the skin conditions erythema nodosum (characterised by painful reddish skin nodules) or erythema multiforme (characterised by rash with target-shaped reddening or sores).
• harmful blood clots in a vein or artery for example:
• in a leg or foot (i.e. DVT)
• in a lung (i.e. PE)
• heart attack
• mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).
The following is a list of the side effects that have been linked with the use of Dretine:
Common side effects (may affect up to 1 in 10 people):
• menstrual disorders, breast pain, breast tenderness
• headache, depressive mood
• If you are breast-feeding and want to start Dretine (again) after having a baby.
Read the section "Breast-feeding".
Ask your doctor what to do if you are not sure when to start.
If you take more Dretine than you should
There are no reports of serious harmful results of taking too many Dretine tablets.
If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.
If you have taken too many Dretine tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Dretine
• If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules (see the diagram below):
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. In that case, contact your doctor.
• One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.
• One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the tablet-free period start the next strip. Most likely, you will have a period at the end of the second strip or you may also have light or menstruation-like bleeding during the second strip.
2. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on the day you always start, make the tablet-free period less than 7
If you follow one of these two recommendations, you will remain protected
against pregnancy.
• If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.
Version 2.5
Uncommon side effects (may affect up to 1 in 100 people):
• changes in interest in sex
• low blood pressure
• vomiting, diarrhoea
• acne, skin rash, severe itching, hair loss (alopecia)
• breast enlargement
• fluid retention and body weight changes.
Rare side effects (may affect up to 1 in 1,000 people):
• breast secretion
• hearing impairment.
Reporting of side effects
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 wAw.mhra.gcv.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Expiry date
Do no: use this medicine after the expiry date which is stated on the blister and package after "Do not use after" or "EXP"
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 protect the environment.
^6 Contents of the pack and other information
What Dretine contains
The active ingredients are ethinylestradiol and drospirenone.
Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
The other ingredients are:
Tablet core: lactose monohydrate, maize starch, pregelatinised starch (maize), crospovidone, povidone, polysorbate 80, magnesium stearate.
Coating: Polyvinyl alcohol partial hydrolized, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
What Dretine looks like and contents of the pack
Yellow, round film-coated tablets.
Dretine is available in boxes of 1, 2, 3, 6 and 13 blisters, each one containing 21 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Laboratorios Leon Farma, S.A., Pol. Ind. Navatejera., C/ La Vallina s/n,
24008 - Villaquilambre, Leon., Spain
This leaflet was last revised in 12/2015.
PL 00289/1456
nra;/ii 88328-F
Approved
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