Smilla 125 Micrograms/30 Micrograms Coated Tablets
Package leaflet: Information for the user Smilla 125 micrograms/30 micrograms coated tablets
levonorgestrel/ethinylestradiol/
Important things to know about combined hormonal contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception if used correctly
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)
Read all of 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 doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them.
- 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.
What is in this leaflet
1. What Smilla coated tablet (hereinafter Smilla) is and what it is used for
2. What you need to know before you take Smilla
3. How to take Smilla
4. Possible side effects
5. How to store Smilla
6. Contents of the pack and other information
1. What Smilla is and what it is used for
Smilla is a combined oral contraceptive, also called the pill. It contains two types of female hormones: an estrogen, ethinylestradiol, and a progestogen, levonorgestrel in a low dose.
The combined contraceptive pill protects you against getting pregnant in three ways. These hormones
- stop the ovary from releasing an egg each month (ovulation)
- also thicken the fluid (at the neck of the womb) making it more difficult for the sperm to reach the egg
- alter the lining of the womb to make it less likely to accept a fertilised egg.
2. What you need to know before you take Smilla General notes
Before you start using Smilla you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot - see Section 2 “Blood clots”.
In certain circumstances the effectiveness of the pill may reduce or you should stop taking the pill (see later). In these cases either do not have sex, or use extra non-hormonal contraceptive precautions (such as condoms or another barrier method) during intercourse to ensure effective contraception.
Remember, combined oral contraceptive pills like Smilla will not protect you against sexually-transmitted diseases (such as AIDS). Only condoms can help to do this.
Do not take Smilla
- if you are allergic to ethinylestradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6)
- if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
- if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
- if you need an operation or if you are off your feet for a long time (see section ‘Blood clots)’;
- if you have ever had a heart attack or stroke;
- if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms);
- if you have any of the following disease that may increase your risk of a clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
- if you have (or have ever had) a type of migraine called ‘migraine with aura’;
- if you have or have ever had migraine with neurological disorders of perception, sensation, or movement
- if you have liver tumours or if you have ever had these
- if you have liver disease or if you have ever had this and your liver function is still not normal
- if you have or may have breast cancer or cancer of other female genitals, for example ovarian cancer, cervical cancer, or cancer of the uterus (womb)
- if you have unexplained bleeding from your vagina
- if you have a blood coagulation disorder (e.g. protein C deficiency)
- if you have or have ever had an inflammation of the pancreas, accompanied by a heavy disorder of the lipid metabolism
- if the menstrual bleeding is absent, possibly due to the diet or physical activity Warnings and precautions
Talk to your doctor or pharmacist before using Smilla.
When should you contact your doctor?
Seek urgent medical attention
- if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in
the leg (ie deep vein thrombosis), a blood clot in the lung (ie pulmonary embolism), a heart attack or a stroke (see ‘Blood clot’ (thrombosis) section below.
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Before you can begin taking Smilla, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending upon your personal situation, may also carry out some other tests.
If any of the following diseases/conditions occurs, you must only use Smilla under close medical supervision, as such diseases/conditions may worsen during the use of the pill.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are usingSmilla, you should also tell your doctor.
- if a close relative has or has ever had breast cancer
- if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
- if you have systemic lupus erythematosus (SLE -; a disease affecting your natural defence system);
- if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
- if you have sickle cell anaemia (an inherited disease of the red blood cells);
- if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
- if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’);
- if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Smilla;
- if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
- if you have varicose veins;
- if you have diabetes
- if you have the inherited form of deafness known as otosclerosis
- if you have depressed mood (depression)
- if you have the movement disorder called Sydenham's chorea
- if you have liver and/or gall bladder disease (yellowing of the skin, gallstones)
- if you have the inherited disease called porphyria
- if you have epilepsy (see “Other medicines and Smilla”)
- if you have widespread itching (pruritus) related to metabolism disorder of bile
- if you have the rash known as herpes gestationis
- if you have brown patches on your face and body (chloasma), which you can reduce by staying out of the sun and not using sunbeds or sunlamps.
- if you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing.”
The above mentioned diseases may worsen while taking the pill, this is why you have to undergo regular check-ups, as long as you are taking the pill.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Smilla increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
- in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
- in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Smilla is small. HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
|
Are you experiencing any of these signs? |
What are you possibly suffering from? |
|
- swelling of one leg or along a vein in the leg or foot especially when accompanied by: - pain or tenderness in the leg which may be felt only when standing or walking - increased warmth in the affected leg - change in colour of the skin on the leg e.g. turning pale, red or blue |
Deep vein thrombosis |
|
- sudden unexplained breathlessness or rapid breathing; - sudden cough without an obvious cause, which may bring |
Pulmonary embolism |
|
up blood; - sharp chest pain which may increase with deep breathing; - severe light headedness or dizziness; - rapid or irregular heartbeat - severe pain in your stomach; | |
|
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’). | |
|
Symptoms most commonly occur in one eye: - immediate loss of vision or - painless blurring of vision which can progress to loss of vision |
Retinal vein thrombosis (blood clot in the eye) |
|
- chest pain, discomfort, pressure, heaviness - sensation of squeezing or fullness in the chest, arm or below the breastbone; - fullness, indigestion or choking feeling; - upper body discomfort radiating to the back, jaw, throat, arm and stomach; - sweating, nausea, vomiting or dizziness; - extreme weakness, anxiety, or shortness of breath; - rapid or irregular heartbeats |
Heart attack |
|
- sudden weakness or numbness of the face, arm or leg, especially on one side of the body; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure. |
Stroke |
|
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke. | |
|
- swelling and slight blue discolouration of an extremity; - severe pain in your stomach (acute abdomen) |
Blood clots blocking other blood vessels |
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
- The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).
- If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
- Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop Smilla your risk of a blood clot returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Smilla is small.
- Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
- Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.
- The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below).
|
Risk of developing a blood clot in a year | |
|
Women who are not using a combined hormonal pill/patch/ring and are not pregnant |
About 2 out of 10,000 women |
|
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate |
About 5-7 out of 10,000 women |
|
Women using Smilla |
About 5-7 out of 10,000 women |
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Smilla is small but some conditions will increase the risk. Your risk is higher:
- if you are very overweight (body mass index or BMI over 30 kg/m2);
- if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder;
- if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Smilla may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Smilla ask your doctor when you can start using it again.
- as you get older (particularly above about 35 years);
- if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Smilla needs to be stopped.
If any of the above conditions change while you are using Smilla, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Smilla is very small but can increase:
- with increasing age (beyond about 35 years);
- if you smoke. When using a combined hormonal contraceptive like Smilla you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;
- if you are overweight;
- if you have high blood pressure;
- if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke;
- if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
- if you get migraines, especially migraines with aura;
- if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
- if you have diabetes.
If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Smilla, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Smilla and cancer
Breast cancer has been found slightly more often in women who take the pill than in women of the same age who do not take the pill. If women stop taking the pill this reduces the risk so that 10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier.
In women using the pill malignant and benign liver tumours have been reported. Liver tumours may lead to life-threatening intra-abdominal haemorrhage (bleeding in the stomach). So, if you have pain in your upper stomach that does not soon clear up, tell your doctor.
An increased risk of cervical cancer in long-term users of the pill has been reported in some studies. It is uncertain whether this increased risk is caused by the pill. Development of the disease depends on many different factors such as the sexual behaviour (e.g. for the frequent change of partners increases the risk of sexually transmitted virus infection).
Regular check-ups
Once you have started taking Smilla, your doctor will see you again for regular check-ups yearly, or if you have any problem you can see your doctor at any time.
Bleeding between periods
During the first few months that you are taking Smilla, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must investigate the cause.
What you must do if no bleeding occurs in 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 blister until you are sure that you are not pregnant.
Other medicines and Smilla
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Also tell any other doctor or dentist who prescribes another medicine that you use Smilla. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or whether the use of another medicine you need must be changed.
Some medicines
- can have an influence on the blood levels of Smilla.
- can make it less effective in preventing pregnancy.
- can cause unexpected bleeding.
These include:
medicines used for the treatment of
- epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate, felbamate);
- tuberculosis (e.g. rifampicin);
- HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapin, efavirenz);
- fungal infections (e.g. griseofulvin, itraconalzole, voriconalzole, fluconazole);
- bacterial infectons (macrolide antibiotics such as clarithromycin, erythromycin);
- certain heart diseases and high blood pressure (calcium chanel blockers, e.g. verapamil, diltiazem);
- arthritis, arthrosis (etoricoxib);
- high blood pressure in the blood vessels in the lungs (bosentan);
- a certain type of stomach problem (metoclopramid); the herbal remedy St. Johns wort,
grape fruit juice.
Troleandomycin (an antibiotic) may increase the risk of intrahepatic cholestasis (impairment of bile flow) during co-administration with combined oral contraceptives.
Smilla may influence the efficacy of other medicines, e.g.
- ciclosporin (medicine used to treat a suppression of tissue rejection following transplant surgery),
- theophylline (medicine used to treat breathing problems),
- lamotrigine (this could lead to an increased frequency of seizures),
- midazolam, melatonin (medicines used to treat a sleep disorders),
- tizanidine (medicine used to treat a muscle pain and/or muscle cramps).
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must not use Smilla when you are pregnant. If you become pregnant or you think you might be pregnant, stop taking Smilla and talk to your doctor immediately.
Smilla should not be taken during breast-feeding. If you are breast-feeding and want to take the pill, you should discuss this with your doctor.
Driving and using machines
Smilla has no or only negligible effect on your ability to drive or use machines.
Laboratory tests
If you need a blood or urine test, tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.
Smilla contains lactose and sucrose
Each coated tablet contains 31.35 mg lactose (milk sugar) and 22.01 mg sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Smilla
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Each blister 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 Tuesday, take a tablet with “Tue.” next to it. Follow the direction of the arrow on the blister.
One tablet should be taken once a day, if necessary with a small amount of water. The tablets may be taken with or without food, but preferably always at the same time, starting on the first day of the monthly period for 21 days. This is followed by a tablet-free period of 7 days, during which a menstruation-like bleeding occurs.
Starting the first pack of Smilla
If no oral contraception has been used during the preceding cycle
Start taking Smilla on the first day of the cycle (that is, on the first day of your period). If you start Smilla on the first day of your period, you will be protected from pregnancy immediately. You may also start on days 2-5 of the cycle, but must use additional methods of contraception (for example a condom) for the first 7 days.
Changing from another combined hormonal contraceptive, combined contraceptive vaginal ring or patch
You can start Smilla on the day after the interval week of your previous contraceptive (or after taking the last inactive tablet). When you change from a combined contraceptive vaginal ring or patch, follow your doctor’s recommendations.
Changing from a progestogen-only method (mini-pill, injection, implant or a progestogen-releasing intrauterine system (IUS))
You can change from the mini-pill on any day (for an implant or IUS, on the same day it is removed; for an injectable method, when the next injection is due), but in all cases, it is recommended that you use additional methods of contraception (for example, a condom) for the first 7 days of pill-taking.
After having a baby or after a miscarriage or abortion
After a birth, abortion or miscarriage, your doctor should advise you about taking the pill.
If you have had a miscarriage or an abortion during the first three months of pregnancy, you can start taking Smilla straight away. In this case you do not need extra contraceptive precautions.
If you have had a delivery or miscarriage during the 4th to 6th month of pregnancy, you can start Smilla between 21 and 28 days after having a baby. If you start later than day 28, you should use a so-called barrier method (for example, a condom) during the first seven days of Smilla use. If, after having a baby, you have had sex before starting Smilla (again), you should be sure that you are not pregnant or wait until your next period before you start Smilla”.
If you are breastfeeding and want to start taking Smilla (again) after having had a child See section “Pregnancy and breast-feeding”.
If you take more Smilla than you should
If you take more Smilla than you should, it is not likely that it will do you any harm, but you may have nausea, vomiting or vaginal bleeding. If you have taken too many Smilla tablets, or you discover that a child has taken some, you should talk to your doctor who can tell you what, if anything, you need to do.
If you forget to take Smilla
If you forget to take a pill please follow these instructions.
• If you are less than 12 hours late in taking a tablet, the effect of Smilla will not be reduced. Take the tablet as soon as you remember and take the rest of the tablets at the usual time.
• If you are more than 12 hours late in taking a tablet, the effect of Smilla may be reduced. The more tablets are forgotten, the higher the risk of this effect being reduced.
The risk of incomplete protection against pregnancy is greatest if you forget to take a tablet from the beginning of the pack or at the end of the third week. The following recommendations should be followed in this situation:
Forgetting more than one tablet of the pack
Ask your doctor for advice.
Forgetting one tablet in week 1
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the rest of the tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week preceding the forgotten tablet, there is a risk of pregnancy. In this case, ask your doctor for advice.
Forgetting one tablet in week 2
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the rest of the tablets at the usual time. Contraceptive efficacy will not be reduced and you will not need to take additional precautions.
Forgetting one tablet in week 3
The risk of pregnancy is high because of the forthcoming tablet-free interval. The reduced contraceptive protection may, however, be prevented by adjusting the tablet intake. Therefore, by following one of the following two alternatives, it is not necessary to take further contraceptive measures, provided that all tablets have been taken correctly during the 7 days before the first missed tablet. If you have not taken Smilla correctly during the 7 days before the first missed tablet, you should follow the first of the two alternatives. Additionally a barrier method (such as a condom) should be used for the next 7 days.
1. Make up for the intake of the forgotten tablet as soon possible, even if that means that you have to take two tablets at the same time. Thereafter, you should continue taking the next pill at the usual time of the day. You should then start the next pack immediately, i.e. without a tablet-free interval between the packs. Withdrawal bleeding is unlikely until the end of the second pack, but there may be some spotting or breakthrough bleeding, on the days you are taking the pill.
2. You may also stop taking tablets from the current pack. In that case, you should keep a period without tablets of up to 7 days, including those days when you forgot to take your tablets, and thereafter continue with the next pack.
If you have missed tablets and then do not get withdrawal bleeding in the first normal tablet-free interval, the possibility of pregnancy must be considered.
If you stop taking Smilla
You can stop taking Smilla at any time. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you stop taking Smilla to have a baby, use another method of contraception until you have had a true period. In this case it will be easier for your doctor to tell you when your baby will be born.
What to do if you have a stomach upset
If you have been sick within 3-4 hours after taking the pill or you have severe diarrhoea, the active substances in the pill may not be fully absorbed into your body. In this case the advice concerning missed pills, described above should be followed. In case of vomiting or diarrhoea, use extra contraceptive precautions, such as a condom, for any intercourse during the stomach upset and for the next seven days.
What to do if you want to delay or to shift your period
If you want to delay or to shift your period, you should contact your doctor for advice.
If you want to delay your period
If you want to delay your period, you should continue the next pack of Smilla after taking the last tablet in the current pack, without a pill-free interval. You can take as many pills from this next pack as you want, until the end of the second blister pack. When you use the second pack, you may have breakthrough bleeding or spotting. Regular intake of Smilla is resumed after the usual 7 days tablet-free interval.
If you want to shift your period to another day of the week
If you take Smilla correctly, you will always have your monthly period on the same day of the month. If you want to shift your period to another day of the week, rather than the one you are used to with the present pill intake, you may shorten (but never lengthen) the forthcoming pill-free break by as many days as you like. For example, if your monthly period usually starts on Friday and you want it to start on Tuesday (i.e. 3 days earlier), you should start the next pack of Smilla three days earlier. The shorter the pill-free interval, the greater the possibility that you will not have a withdrawal bleeding, and that you may have breakthrough bleeding or spotting during the second pack.
4. 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 Smilla, 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 Smilla.
The use of “pills” containing the same active substances as Smilla is most commonly associated with the side effects headaches, irregular bleeding and spotting.
Further side effects that can occur during the use of these “pills” are:
Common side effects (may affect up to 1 in 10 people):
- fluctuating mood
- depression
- headaches
- nausea
- abdominal pain
- breast tenderness
- breast pain
- weight gain
Uncommon side effects (may affect up to 1 in 100 people):
- fluid retention
- decrease of sexual desire (decrease of libido)
- migraine
- vomiting
- diarrhoea
- skin rash
- hives (itching)
- breast enlargement
Rare side effects (may affect up to 1 in 1,000 people):
- hypersensitivity
- increase of sexual desire (increase of libido)
- eye irritation when wearing contact lenses
- erythema, blotches on or nodules under the skin
- vaginal secretion
- breast secretion
- weight loss
- 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
- stroke
- 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).
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Smilla
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package 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 protect the environment.
6. Contents of the pack and other information What Smilla contains
- The active substances are ethinylestradiol and levonorgestrel.
Each coated tablet contains 30 microgram ethinylestradiol and 125 microgram levonorgestrel.
- The other ingredients are
Tablet core: lactose monohydrate, maize starch, talc (E553b), magnesium stearate (E470b), colloidal anhydrous silica (E551)
Coating: sucrose, talc (E553b), calcium carbonate, titanium dioxide (E171), copovidone K-28, yellow iron oxide (E172), macrogol 6000, colloidal anhydrous silica (E551), povidone K-30, carmellose sodium.
What Smilla looks like and contents of the pack
Smilla tablets are light brownish yellow, biconvex, round, coated tablets.
One box contains 1 x 21, 3 x 21, 6 x 21 or 13 x 21 coated tablets in transparent, hard PVC/PVDC//Aluminium blister(s) with package leaflet and etui storage bag.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
1103 Budapest,
Gyomroi ut 19-21.
Hungary
This leaflet was last revised in
September 2016
12