Planum

Package leaflet: Information for the user

PLANUM 0.15 mg + 0.03 mg tablets

desogestrel/ethinylestradiol
Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly.
• They slightly increase the risk of blood clots forming in the veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PLANUM is and what it is used for
2. What you need to know before taking PLANUM
3. How to take PLANUM
4. Possible side effects
5. How to store PLANUM
6. Contents of the pack and other information

1. What PLANUM is and what it is used for

Composition and type of pill
PLANUM is a combined oral contraceptive pill. Each tablet contains a small amount of two different female hormones: desogestrel (a progestogen) and ethinylestradiol (an oestrogen).
Due to its low hormone content, PLANUM is considered a low-dose oral contraceptive. Since all tablets in the pack contain the same hormones in the same dosage, PLANUM is classified as a monophasic combined oral contraceptive.
Why use PLANUM
PLANUM is used to prevent pregnancy.
When taken correctly (without missing any tablets), the chance of pregnancy is very low.

2. What you should know before taking PLANUM

General information
Before starting to take PLANUM, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Do not take PLANUM
Do not take PLANUM if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other contraceptive methods that might be more suitable for your case.

• if you are allergic to the active substances or to 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 in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in another organ;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or if you will be confined to bed for a prolonged period (see “Blood clots”);
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer or have suffered in the past from pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood;
• if you suffer from jaundice (yellowing of the skin) or from severe liver disease;
• if you have or have ever had a cancer that can grow under the influence of sex hormones (e.g. of the breast or genital organs);
• if you have or have ever had a liver tumour;
• if you have any vaginal bleeding of unknown origin;
• if you have endometrial hyperplasia (abnormal growth of the inner lining of the uterus);
• if you are pregnant or suspect you may be pregnant;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section 2 “Other medicines and Planum”).

If any of these conditions occurs for the first time while you are taking the pill, stop taking it immediately and inform your doctor. In the meantime, use non-hormonal contraceptive methods. See also section “General information”.
Warnings and precautions
Talk to your doctor or pharmacist before taking PLANUM.
General information
This patient information leaflet describes certain situations in which you must stop taking the pill or in which the pill’s effectiveness may be reduced. In these situations, you must either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use rhythm or basal body temperature methods. These methods may not be reliable because the pill alters the normal changes in body temperature and cervical mucus that occur during the menstrual cycle.
Regular check-ups
While using the pill, your doctor will ask you to attend regular check-up visits. You should generally have a check-up at least once a year.
Contact your doctor as soon as possible if:

• you notice signs suggestive of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see “Blood clots (thrombosis)”). For a description of the symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.
• you notice any change in your health status, particularly related to what is reported in this leaflet (see also sections “Do not take PLANUM” and “What you should know before taking PLANUM”). Do not forget changes in the health status of your close relatives);
• you detect a lump in your breast;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with breathing difficulties;
• you need to take other medicines (see also section “Other medicines and PLANUM”);
• you need to be immobilized or are scheduled for surgery (inform your doctor at least 4 weeks in advance);
• you experience heavy and unusual vaginal bleeding;
• during the first week you forgot to take the tablets from the pack and had sexual intercourse in the previous seven days;
• you suffer from severe diarrhoea;
• you have missed two consecutive menstrual periods or suspect you are pregnant (do not start a new pack without first consulting your doctor).

Stop taking the tablets and see your doctor immediately if you notice possible signs of thrombosis such as:

• unusual cough;
• severe chest pain that may spread to the left arm;
• shortness of breath;
• unusual, severe or prolonged headache or a migraine attack;
• partial or complete loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of the body;
• severe abdominal pain;
• severe pain or swelling in one leg.

For further information, see the section “The pill and thrombosis” in this patient information leaflet.
PLANUM, like all combined oral contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.
PLANUM should not normally be used to delay a menstrual period. However, if in exceptional cases it is necessary to delay a period, contact your doctor.
Inform your doctor if any of the following conditions apply to you.
If this condition develops or worsens while you are using PLANUM, inform your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have a heart valve disorder or certain heart rhythm disorders;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if close relatives have had a history of thrombosis, heart attack, or stroke;
• if you suffer from migraine;
• if you suffer from depression;
• if you suffer from epilepsy;
• if you have liver or gallbladder disease;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE; a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or if you will be confined to bed for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking PLANUM;
• if any of your close relatives have had breast cancer;
• if disorders that first appeared or worsened during pregnancy or during previous treatment with sex hormones (e.g. hearing loss, a disease called porphyria, a skin condition called herpes gestationis, a disease called Sydenham’s chorea);
• if you have or have ever had chloasma (brownish-yellow patches on the skin, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet radiation;
• if you develop symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly accompanied by breathing difficulties, contact your doctor immediately. Products containing oestrogens may induce or worsen symptoms of hereditary or acquired angioedema.

If any of the above conditions appears for the first time, or reappears or worsens during use of the pill, consult your doctor.
The pill and thrombosis
BLOOD CLOTS
Taking a combined hormonal contraceptive such as PLANUM increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with PLANUM is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg that may be felt

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form 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 in which you
start 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 or a different drug) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking PLANUM, the risk of developing a blood clot returns
to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and on the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with PLANUM is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as PLANUM, about 9–12 will develop a blood clot over one year.
• The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with PLANUM is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking PLANUM several weeks before surgery or during periods of reduced mobility. If you need to stop taking PLANUM, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting > 4 hours) may temporarily increase the risk of blood clot formation, especially if you have any of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of PLANUM.
If any of the above conditions change while you are using PLANUM—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of PLANUM is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as PLANUM, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using PLANUM—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.
Very rarely, thrombosis can cause serious permanent disability or be fatal.

Pill and cancer
Breast cancer is diagnosed slightly more frequently in women using the pill compared to those who do not. This slight increase in risk gradually disappears over the 10 years following discontinuation of the pill. It is not known whether the pill is the cause of this difference. It could be due to the fact that women are examined more frequently, making it more likely that breast cancer is diagnosed earlier.
Benign liver tumors have been observed rarely, and malignant liver tumors even more rarely, in women using the pill. These tumors can cause internal bleeding. Contact your doctor immediately if you experience any severe abdominal pain.
Cervical cancer is caused by human papillomavirus (HPV) infection. It is more common in women who use the pill for a long time. It is not known whether this is due to hormonal contraceptive use, sexual behavior, or other factors (such as improved cervical screening).

Psychiatric disorders
Some women using hormonal contraceptives, including PLANUM, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, consult your doctor as soon as possible for further medical advice.

Children and adolescents
There are no clinical data available on the efficacy and safety of PLANUM in adolescents under 18 years of age.

Other medicines and PLANUM
Always inform your doctor about any medicines or herbal products you are currently using. Also inform any other doctors, dentists (or pharmacist) who prescribe other medicines that you are taking PLANUM, so they can advise whether you need to use additional contraceptive precautions (for example, a condom) and, if so, for how long, or whether the use of another medicine you need should be modified.
Do not use Planum if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood tests (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Planum can be resumed approximately 2 weeks after completion of this treatment. See section “Do not take Planum”.

Some medicines:

• may affect blood levels of PLANUM;
• may reduce contraceptive effectiveness;
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• hepatitis C virus infection (e.g., boceprevir, telaprevir);
• other infectious diseases (e.g., griseofulvin);
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension) (bosentan);
• depression (herbal remedy St. John's Wort).

If you are taking medicines or herbal products that may reduce the effectiveness of PLANUM, you must also use a barrier contraceptive method. Because the effect of other medicines on PLANUM may last up to 28 days after discontinuation, you must use an additional barrier contraceptive method throughout this period.
PLANUM may affect the effect of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

Laboratory tests
If you require a blood test, inform your doctor or laboratory that you are taking the pill, as oral contraceptives may affect the results of certain blood tests.

Pregnancy and breastfeeding
If you suspect or are planning a pregnancy, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
PLANUM is contraindicated in pregnant women or in women who suspect they are pregnant. If you suspect you are pregnant while taking PLANUM, you must stop treatment immediately and contact your doctor as soon as possible.

Breastfeeding
The use of PLANUM is not recommended during breastfeeding. If you wish to take the pill while breastfeeding, consult your doctor.

Driving and use of machines
PLANUM does not affect the ability to drive or operate machinery.

PLANUM contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PLANUM

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
When and how to take the tablets
The PLANUM pack contains 21 tablets, each marked with the day of the week on which it should be taken.
Take one tablet every day at approximately the same time, with a little water if necessary. Follow the direction of the arrows until all 21 tablets are used.
Do not take any tablets during the following 7 days.
Your period should occur during these 7 days (withdrawal bleeding). It usually starts 2–3 days after taking the last tablet of PLANUM.
Start the new pack on the eighth day, even if your period has not yet finished. By doing so, you will always start the new pack on the same day of the week, and withdrawal bleeding will generally occur around the same days each month.

Use in children and adolescents
There are no clinical data available on efficacy and safety in adolescents under 18 years of age.

How to start the first pack of PLANUM

• If you have not used any hormonal contraceptive pill in the previous month: Start taking PLANUM on the first day of your cycle, i.e., the first day of your menstrual bleeding, taking the tablet marked with that day of the week. Then continue in the order indicated by the arrows. PLANUM is effective immediately. Therefore, you do not need additional contraceptive methods. Alternatively, you may start between the second and fifth day of the cycle, but in this case you must use an additional contraceptive method (barrier method) for the first 7 days of tablet intake in the first cycle.

• Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch): You may start taking PLANUM the day after the last active pill of the previous contraceptive (i.e., without any pill-free interval). If the previous contraceptive pack contains inactive tablets, you may start PLANUM the day after taking the last active tablet (in case of doubt, consult your doctor or pharmacist). You may also start later, but not later than the day after the pill-free interval (or the day after the last inactive tablet) of the previous contraceptive. If you are using a vaginal ring or transdermal patch, it is preferable to start taking PLANUM on the same day the ring or patch is removed. At the latest, you may start on the day the next application of the ring or patch would normally occur.
  If you have used the pill, patch, or ring correctly and are sure you are not pregnant, you may stop taking the previous method or remove the ring or patch on any day and start using PLANUM immediately.
  If you follow these instructions, you do not need to use additional contraceptive methods.

• Switching from a progestogen-only pill (minipill): You may stop taking the minipill on any day and start taking PLANUM the following day at the same time. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) during the first 7 days of taking PLANUM.

• Switching from a progestogen-only injectable contraceptive, a progestogen-only implant, or a progestogen-releasing intrauterine system (IUS): You may start taking PLANUM on the day the next injection is due, or on the day of removal of the implant or IUS. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) during the first 7 days of taking PLANUM.

• After childbirth: After giving birth, your doctor may advise you to wait until your first normal menstrual cycle before starting PLANUM. Sometimes it may be possible to start earlier. Your doctor will give you specific instructions. If you are breastfeeding and wish to use PLANUM, discuss this with your doctor first.

• After miscarriage or induced abortion: Your doctor will give you instructions.

If you take more PLANUM than you should
No serious harmful effects have been reported after taking multiple PLANUM tablets at once. If you have taken several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding.
If you discover that a child has taken PLANUM, contact a doctor for advice.

If you forget to take PLANUM
WHAT TO DO IF…
…you forget to take tablets
If less than 12 hours have passed since your usual intake time, contraceptive reliability is maintained. Take the missed tablet as soon as you remember, then take the following tablets at your usual time.
If more than 12 hours have passed since your usual intake time, contraceptive reliability may be reduced. The greater the number of consecutive missed tablets, the higher the risk that contraceptive protection is reduced.
The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the pack. Therefore, follow the instructions below (see also the scheme that follows).
If you have missed more than one tablet in a pack
Contact your doctor for advice.
If you missed 1 tablet during the first week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Use additional contraceptive methods (barrier methods) for the next 7 days.
If you had sexual intercourse during the week before the missed tablet, there is a possibility of pregnancy. Contact your doctor immediately.
If you missed 1 tablet during the second week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Contraceptive protection remains effective. No additional contraceptive measures are necessary.
If you missed 1 tablet during the third week
You may choose one of the following alternatives, without needing additional contraceptive precautions:

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Start the new pack immediately after finishing the current one, without any interval between packs. Withdrawal bleeding may not occur until the end of the second pack, but you may experience intermenstrual bleeding (spotting) or breakthrough bleeding during the second pack. or
2. Stop taking tablets from the current pack, observe a pill-free interval of 7 days or less ( including the day of the missed tablet ), and then start a new pack. If you choose this option, you can always start the new pack on the same day of the week as usual.

If you have missed one or more tablets from a pack and do not have a withdrawal bleed during the first pill-free interval, pregnancy may have occurred. In this case, consult your doctor before starting the next pack.

……if you experience gastrointestinal disturbances (such as vomiting or severe diarrhoea)
If you vomit or have severe diarrhoea, the active ingredients in the PLANUM tablet may not be fully absorbed. If you vomit within 3–4 hours of taking a tablet, this situation is similar to missing a tablet. Follow the instructions for missed tablets. In case of severe diarrhoea, contact your doctor.
……if you wish to delay the onset of your period
You can delay the start of your period by starting the next pack of PLANUM immediately after finishing the current one. You may continue taking tablets from the new pack for as long as desired, up to the end of the second pack. To allow your period to start, stop taking tablets. During use of the second pack, you may experience breakthrough bleeding or spotting while taking the tablets. Start the following pack after the usual 7-day pill-free interval.
……if you wish to change the day your period starts
If you take the tablets correctly, your period will occur approximately on the same day every 4 weeks. To change this day, you should shorten (but never extend) the next pill-free interval. For example, if your period usually starts on Friday and you wish it to start on Tuesday (3 days earlier), begin the next pack 3 days earlier than usual. If you shorten the pill-free interval significantly (e.g., 3 days or less), you may not have bleeding during that interval. You may experience breakthrough bleeding or spotting during use of the next pack.
……if you have unexpected bleeding
With all oral contraceptives, during the first few months of use, you may experience irregular vaginal bleeding (spotting or breakthrough bleeding) between periods. You may need to use sanitary protection, but continue taking the tablets as usual. Irregular bleeding usually stops once your body has adjusted to the pill (usually after about 3 months). Consult your doctor if bleeding persists, becomes heavy, or recurs frequently.
……if your period does not occur
If you have taken all tablets correctly, have not vomited, and have not taken other medicines, it is very unlikely that you are pregnant. Continue taking PLANUM as usual.
If your period does not occur twice in succession, pregnancy may have occurred. Contact your doctor immediately. Do not start a new pack of PLANUM until your doctor has ruled out pregnancy.

If you stop taking PLANUM
If you have any questions about using this medicine, consult your doctor or pharmacist.
You may stop taking PLANUM at any time. If you still wish to avoid pregnancy, consult your doctor for advice on alternative methods of birth control.
If you wish to stop taking PLANUM in order to become pregnant, wait for a natural menstrual period before trying to conceive. This will help you determine the expected date of delivery.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to PLANUM, inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking PLANUM”.

Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly accompanied by breathing difficulties (see also section “Warnings and precautions”).
Serious reactions associated with the use of the pill and their related symptoms are described in the sections “The pill and thrombosis” and “The pill and cancer”.

Common (may affect up to 1 in 10 people):

• depressed mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• increase in body weight

Uncommon (may affect up to 1 in 100 people):

• fluid retention
• decreased sexual desire
• migraine
• vomiting, diarrhoea
• skin reactions, hives
• breast enlargement

Rare (may affect more than 1 in 1,000 people):

• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• hypersensitivity reactions
• increased sexual desire
• intolerance to contact lenses
• nodular erythema, erythema multiforme (skin disorders)
• breast discharge, vaginal discharge
• decrease in body weight

Following the instructions provided in the leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PLANUM

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not freeze.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the carton after “Exp”.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any colour changes in the tablets, crumbling of the tablets, or any other visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PLANUM contains

• The active substances are: desogestrel (0.150 mg) and ethinylestradiol (0.030 mg).
• The other components are: anhydrous colloidal silica, monohydrate lactose, potato starch, povidone, stearic acid, alpha-tocopherol.

Description of the appearance of PLANUM and package contents
PLANUM is available in packages containing 1 and 3 blisters of 21 tablets, packed in a box.
The tablets are biconvex, round, 6 mm in diameter, marked with "TR5" on one side and
"Organon*" on the other side.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 – Florence
Under licence from Organon
Manufacturer:
N.V. Organon, Kloostersstraat 6, Oss (The Netherlands)
A. Menarini Manufacturing Logistics and Services s.r.l., Via Sette Santi 3 - Florence