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AKIZZA 75 MCG /20 MCG TABLETS

Active substance(s): ETHINYLESTRADIOL / GESTODENE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tell your doctor if any of the following conditions apply to you.

Akizza 75 microgram / 20 microgram film-coated tablets
Akizza 75 microgram / 30 microgram film-coated tablets
Gestodene / Ethinylestradiol

If the condition develops, or gets worse while you are using Akizza, you should also tell your doctor.

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 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);

• 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”).
What is in this leaflet
1. What Akizza is and what it is used for
2. What you need to know before you take Akizza
3. How to take Akizza
4. Possible side effects
5. How to store Akizza
6. Contents of the pack and other information
1. What Akizza is and what it is used for
Akizza is a combined oral contraceptive (‘the Pill’). You take it to stop you getting pregnant.
This contraceptive contains two types of female sex hormones called ethinylestradiol and gestodene. Both hormones prevent the
monthly release of an egg from the ovaries, thicken the mucus in the neck of the womb thereby making it more difficult for the
sperm to reach the egg. Akizza also affects the lining of the womb to make it less likely to accept a fertilised egg.
Akizza will not protect you against sexually transmitted infections, such as AIDS. Only condoms can help to do this.
2. What you need to know before you take Akizza
General notes
Before you start using Akizza 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”).
Before you start using Akizza, your doctor is likely to take a full medical history of you and members of your family, check your
blood pressure and make sure you are not pregnant. Your doctor may also give you a comprehensive medical examination.
Once you have started using Akizza, your doctor or prescriber may carry out regular check-ups, usually this will occur when you
request an additional prescription.

The Pill and cancer

thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal

Breast cancer has been observed slightly more often in women using oral contraceptives than in women of the same age who do

contraceptive.

not use them. It is not known whether this difference is caused by oral contraceptives. For example it may be that more tumours
are detected in users of combined oral contraceptives because they tend to be examined more often. The occurrence of breast

• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.

tumours becomes gradually less after stopping the Pill. It is important to regularly check your breasts and you should contact your

• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

doctor if you feel any lump.

When is the risk of developing a blood clot in a vein highest?

The risk of cervical cancer of the uterus is higher inwomen taking oral contraceptives. The most important risk factor for cervical

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

cancer is persistent infection with the human papillomavirus (HPV). These findings may also have something else in common other

time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product)

than the use of oral contraceptives (e.g. differences in sexual behavior). In case of abnormal vaginal bleeding with unknown cause,

after a break of 4 weeks or more.

consult your doctor.

Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• 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

Important things to know about combined hormonal contraceptives (CHCs):

• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous

• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the

leaflet. See section 4.

diseases. Only condoms can help to do this.

What can happen if a blood clot forms in a vein?

• if you have sickle cell anaemia (an inherited disease of the red blood cells);

- If you have any further questions, ask your doctor, pharmacist or nurse.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this

Like all oral contraceptives Akizza does not protect against HIV infection (AIDS) and other sexually transmitted

• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

• if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots ’);

same as yours.

Akizza 75 microgram / 20 microgram
film-coated tablets
Akizza 75 microgram / 30 microgram
film-coated tablets
Gestodene & Ethinylestradiol

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);

BLOOD CLOTS IN A VEIN

can start taking Akizza;
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;if you have diabetes mellitus (diabetes) or susceptibility to its creation;
• if you or your close family have ever had problems with your heart, or circulation such as high blood pressure;
• if you or your close family have ever had problems with blood clotting;

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 Akizza your risk of a blood clot returns to normal within a few weeks.

• if you have the inherited disease called porphyria;

What is the risk of developing a blood clot?

• if you are overweight (obese);

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

• if you have migraines;

The overall risk of a blood clot in the leg or lung (DVT or PE) with Akizza is small.

• if you have any illness that worsened during pregnancy or previous use of the Pill.
Blood Clots

one. In rare cases a blood clot can block vessels and cause serious problems.
Blood clots can develop:

- Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a

• 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.

- 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.

about 9 and 12 women will develop a blood clot in a year.

clot” below).

It is important to remember that the overall risk of having a harmful blood clot due to Akizza is small.

Women who are not using a combined hormonal pill/patch/

HOW TO RECOGNISE A BLOOD CLOT

ring and are not pregnant
Women using a combined hormonal contraceptive pill

About 5-7 out of 10,000 women

Are you experiencing any of these signs?
• Swelling of one leg or along a vein in the leg or foot

What are you possibly suffering from?
Deep vein thrombosis

especially when accompanied by:

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

• if you are very overweight (body mass index or BMI over 30kg/m2);

standing or walking;

• 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).

o increased warmth in the affected leg;

In this case you could have a hereditary blood clotting disorder;

o change in colour of the skin on the leg e.g. turning pale,

• 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
Pulmonary embolism

• Sudden cough without an obvious cause, which may bring

a cast. The use of Akizza may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop
Akizza ask your doctor when you can start using it again.
• as you get older (particularly above about 35 years);

up blood;

• if you gave birth less than a few weeks ago.

• Sharp chest pain which may increase with deep breathing;

pregnancy, you are more likely to develop the disorder when taking Akizza. You should therefore be carefully monitored while taking
Very rarely the use of oral contraceptives causes benign liver tumors, which may rupture and cause life-threatening internal
bleeding. The risk of liver cancer is extremely low.
The Pill and eye disorders
While using Akizza, blood clots have been observed in the blood vessels of the eye (ocular vascular thrombosis), which may lead to
or a sudden onset of abnormal vision, you should inform your doctor immediately.
The Pill and migraine / headache
If you feel the onset or worsening of migraine or development of headache with new symptoms that recur, persist or are severe,
contact your doctor immediately. During the use of Akizza, if you have a migraine (particularly migraine with aura), you may be
subject to an increased risk of stroke.
The Pill and diabetes

The risk of a blood clot with Akizza is small but some conditions will increase the risk. Your risk is higher:

o pain or tenderness in the leg which may be felt only when

red or blue.
• Sudden unexplained breathlessness or rapid breathing;

containing levonorgestrel, norethisterone or norgestimate
Women using Akizza

If you have or ever had cholestasis (accumulation of bile in the gallbladder) while using hormonal contraceptives or during

partial or complete loss of vision. If you experience sudden partial or complete loss of vision,

- The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood
Risk of developing a blood clot in a year
About 2 out of 10,000 women

Seek urgent medical attention if you notice any of the following signs or symptoms.

The Pill and diseases of the gallbladder and liver

Akizza.

- Out of 10,000 women who are using a combined hormonal contraceptive that contains gestodene such as Akizza between

• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or VTE);

The increase in blood pressure was observed in women taking oral contraceptives. Tell your doctor if you have or had hypertension
(high blood pressure).

blood clot in a year.

Using a combined hormonal contraceptive such as Akizza increases your risk of developing a blood clot compared with not using

The Pill and blood pressure

Changes in glucose tolerance are observed in women using Akizza. If you have diabetes, your doctor should carefully monitor the
use of Akizza.
If you have high triglycerides (fat) levels, your doctor should carefully monitor the use of Akizza, since there have been rare cases
where a massive increase in triglycerides leads to pancreatitis (inflammation of the pancreas).
The Pill and depression
If you have ever had depression and this depression recurs while you are using Akizza, you should discontinue use and tell your
doctor.
The Pill and its effects on immunity
Use of the product may cause or worsen the symptoms of angioedema (rapid swelling of the tissues which is caused by a problem
with the immune system. In some cases, this causes problems with breathing, swallowing, and rash).
Other medicines and Akizza:

You should not use Akizza if you have any of the conditions listed below. If you do have any of the conditions listed below, you

• Severe light headedness or dizziness;

The risk of developing a blood clot increases the more conditions you have.

must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.

• Rapid or irregular heartbeat;

Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.

• Severe pain in your stomach.

Tell your doctor if you are taking, have recently taken or might use any other medicine.

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

It is also important to tell your doctor or dentist that you are taking Akizza because taking certain other medicines could alter the

Akizza needs to be stopped.

effectiveness of Akizza or the other medicines.

Do not use Akizza:
• 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 a 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 diseases 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 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:

• Painless
blurring of vision which can progress to loss of vision
• Chest pain, discomfort, pressure, heaviness;

• Sudden confusion, trouble speaking or understanding;

• if you are allergic to gestodene, ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6).

• Sudden trouble seeing in one or both eyes;

Warnings and precautions
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 (i.e. deep vein thrombosis),
a blood clot in the lung (i.e. 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”.

method for at least another 7 days after stopping certain other medicines while using Akizza.

What can happen if a blood clot forms in an artery?

Heart attack

Medicines that can make Akizza less effective in preventing pregnancy include:

Factors that increase your risk of a blood clot in an artery

• Medicines for psychological disorders or epilepsy, such as barbiturates, phenytoin, primidone, topiramate, modafinil,

• 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 then about 50). In this case you

Stroke

could also have a higher risk of having a heart attack or stroke;

dexamethasone and Hypericum perforatum (St. John’s wort);
• Medicines for infections such as ritonavir, rifampicin, rifabutin, tetracycline, ampicillin and other penicillins;
• Antifungal medicines (griseofulvin);
• Medicines for pain and anti-inflammatory drugs (e.g. phenylbutazone);
• Drugs used after transplant (cyclosporin);
• Vitamin C or paracetamol;
• Cholesterol-lowering drugs (atorvastatin);
• Medicines such as asthma medications (theophylline).
Medicines containing troleandomycin may increase the risk of cholestasis (accumulation of bile in the gallbladder) when taken

• if you get migraines, especially migraines with aura;

with the pill.

• if you have diabetes.

coordination;

• Medicines for digestive problems (e.g. laxatives);

• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);

• Sudden trouble walking, dizziness, loss of balance or

(such as condoms with spermicide) along with the use of Akizza. It is recommended to use additional non-hormonal contraceptive

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.

stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;

especially on one side of the body;

• if you have ever had liver tumours;

BLOOD CLOTS IN AN ARTERY

• if you smoke. When using a combined hormonal contraceptive like Akizza you are advised to stop smoking. If you are unable to

• Upper body discomfort radiating to the back, jaw, throat,

• Rapid

or irregular heartbeats.
• Sudden weakness or numbness of the face, arm or leg,

During use of Akizza with certain other medicines, it is recommended to use additional non-hormonal methods of contraception

• with increasing age (beyond about 35 years);

• Fullness, indigestion or choking feeling;
arm and stomach;
• Sweating, nausea, vomiting or dizziness;

known reason, or you gain a lot of weight, tell your doctor.

It is important to note that the risk of a heart attack or stroke from using Akizza is very small but can increase:

the breastbone;

• if you have (or have ever had) breast cancer;

Akizza should not be used by children or after menopause.

Heart attack

• Sensation of squeezing or fullness in the chest, arm or below

• Extreme weakness, anxiety, or shortness of breath;

back to normal;

Retinal vein thrombosis (blood clot in the eye)

• Immediate loss of vision or;

• if you have (or have ever had) a type of migraine called ‘migraine with aura’;
• if you have ever had a severe liver disease, and you have been told by your doctor that your liver function test results are not yet

If any of the above conditions change while you are using Akizza, for example a close family member experiences a thrombosis for no

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

If you are taking a medication containing flunarizine at the same time as Akizza, this may cause production of breast milk in
women who have not yet had children.

• Sudden,

severe or prolonged headache with no known cause;

increased even more.

Akizza with food and drink

• Loss of consciousness or fainting with or without seizure.

If any of the above conditions change while you are using Akizza, for example you start smoking, a close family member experiences

Akizza may be taken with or without food, if necessary with a small amount of water.

a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

• Sometimes the symptoms of stroke can be brief with an
almost immediate and full recovery, but you should still seek

What to do if you experience irregular bleeding / spotting

urgent medical attention as you may be at risk of another

During the use of Akizza, if you observe irregular bleeding or spotting, especially during the first three months and if bleeding

stroke.
• Swelling

and slight blue discolouration of an extremity;
• Severe pain in your stomach (acute abdomen).

continues or repeats, stop taking Akizza, use non-hormonal method of contraception and consult your doctor.
Blood clots blocking other blood vessels

What to do if there is no regular bleeding
Some women may not experience regular bleeding during the tablet-free break. If there is failure of two consecutive regular

Some of the conditions listed below can be made worse by taking the Pill or they may mean it is less suitable for you. You may

bleedings, or if the product is not used according to directions before the first regular bleeding that fails, you should discontinue use

still be able to take Akizza but you need to take special care and have check-ups more often.

of Akizza and use any non-hormonal method of contraception to prevent pregnancy.

Pregnancy, breast-feeding and fertility
There is no evidence that the use of the Pill in early pregnancy leads to increased neonatal defects. Nevertheless, the Pill should
not be used during pregnancy and the possibility of pregnancy should first be taken into account if you fail to bleed regularly.
The use of oral contraceptives should be stopped until pregnancy is ruled out.
The use of Akizza 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.

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

• One tablet forgotten in week 3

Serious side effects

Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may be due to

advice before taking this medicine.

You have two options:

Tell your doctor straight away if you get any of these symptoms after taking your tablets.

Akizza. Also tell them if any existing conditions get worse while you are taking Akizza.

Rare side effects (between 1 and 10 in every 10,000 users may be affected)

Reporting of side effects

Driving and using machines
There is no information suggesting that the use of Akizza affects driving or use of machines.
Akizza contains lactose
If you have been told by your doctor that you have an intolerance to lactose, contact your doctor before using Akizza
3. How to take Akizza
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take one tablet (Akizza) daily with a little water if necessary. You may take the tablets with or without food, but you should take the
tablets every day around the same time.

1. Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the tablets
at the usual time. Start the next pack as soon as the previous pack is completed, so no break between packs. You may not
have menstrual period until the end of the second pack, but you may have spotting or breakthrough bleeding during the days of
tablet-taking.

- in a leg or foot (i.e. DVT),

2. Stop taking the pills from your current pack, observe an interval of 7 tablet-free days or less (count also the day when you forget

- heart attack,

usual.

- stroke,
- mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA),

In one of these two recommendations, you will remain protected against pregnancy.
• If you forgot one of the tablets in a strip and no bleeding occurs during the tablet-free gap period, you may be pregnant.
Then consult your doctor before starting the next strip.
Several tablets
forgotten in
1 strip

taken.

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
Ask your doctor for advice
Yes

After you have taken all 21 pills in the strip, you have a seven day break when you take no pills. In the course of these 7 pill-free
days, bleeding should begin, so called”withdrawal bleeding”. Usually bleeding starts on the second or third day of the gap week.

in week 1

On the eighth day i.e. after the seven-day gap you should start the next strip of tablets, whether your bleeding has stopped or not.

Had sex in the previous week before
forgetting?

When can you start with the first strip of Akizza
• No hormonal contraceptive has been taken previous cycle:
You can start taking Akizza on the first day of your menstrual cycle and youimmediately get protection against pregnancy. You may

Only 1 tablet
forgotten
(taken more than
12 hours late)

also start taking Akizza on 2nd to 5th day of the menstrual cycle, but in this case, an additional contraceptive method (e.g. condom)
is recommended for the first 7 days.

in week 2

You can start the use of Akizza on the day after the last active tablet (the last tablet containing the active substances) of your
previous pill, but not later than the day following the tablet-free days of your previous pill (or after the last inactive-tablet of your

You may switch any day from the progestogen-only pill (from an implant or an IUS on the day of its removal, from an injectable
when the next injection would be due) but in all of these cases the use of extra protective measures (for example, a condom) for the

Do not use this medicine after the expiry date stated on the blister / carton after EXP. The expiry date refers to the last day of the
month.
This medicinal product does not require any special storage conditions. Keep in the original package.
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.
6. Contents of the pack and other information
What Akizza contains

• any lumps you can see or feel.

Gestodene 75 mcg and Ethinylestradiol 20 mcg or

- Take the forgotten tablet and
- Finish the strip

• unusual vaginal bleeding,

Tablet core:

• pelvic pain,

Lactose monohydrate

• painful sex.

Maize Starch

Take the forgotten tablet and
Finish the strip
Instead of the gap week
Go straight on to the next strip
or

Signs of cancer of the cervix include:
• vaginal discharge that smells and/or contains blood,

Signs of severe liver problems include:
• severe pain in your upper abdomen,
• yellow skin or eyes (jaundice),

Gestodene 75 mcg and Ethinylestradiol 30 mcg
The other ingredients are

Polyvinyl Pyrrolidone
Magnesium stearate
Tablet film-coating:

• inflammation of the liver (hepatitis),

Composition of Opadry white 03F58750

• your whole body starts itching.

HPMC 2910/Hypromellose (E464)

If you think you may have any of these, see a doctor straight away. You may need to stop taking Akizza.

Titanium dioxide (E171)
Macrogol 6000

Akizza may cause some other side effects and these are shown below:-

Talc (E553b)

What to do in case of vomiting or severe diarrhoea

Common side effects (between 100 and 1000 in every 10,000 users may be affected)

What Akizza looks like and contents of the pack

If you vomit within 3-4 hours of taking a tablet or you have severe diarrhea, there is a risk that the active substances in the pill will

• feeling sick,

For Akizza 75 microgram / 30 microgram film-coated tablets

not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhea, 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 ‘what to do if you forget to take Akizza’

not pregnant or wait until your next period.

Postponing your period:

• If you are breast-feeding.

Although it is not recommended, you can postpone your period by directly consuming Akizza without taking a break from the next

Read the section “Pregnancy, breast-feeding and fertility”.

If you take more Akizza than you should

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

- Take the forgotten tablet
- Use a barrier method (condom) for the
following 7 days
- And finish strip

first 7 days of taking Akizza is recommended.

There is no data available for use in adolescents below 18 years.

5. How to store Akizza

Each tablet contains either

- Stop the strip immediately
- Begin the gap week (not longer than
7 days, including the forgotten tablet)
- Then go on to the next strip

• 
Changing from a progestogen-only pill (also called “mini-pill”) or injection or implant or a progestogen-releasing IUS:

Use in children and adolescents

breathing,
• a red bumpy rash (hives) and itching.

By reporting side effects you can help provide more information on the safety of this medicine.

• changes in the nipple,

in week 3

previous pill). If you switch from a combined contraceptive vaginal ring or patch, follow the advice of given by your doctor.

Ask your doctor what to do if you are not sure when to start Akizza.

• swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongue/throat may lead to difficulty swallowing and

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

The active substances are gestodene and ethinylestradiol.

-

• 
Changing from a combined hormonal contraceptive, combined vaginal ring or patch:

is recommended for first seven days. After childbirth, if you have had sex before starting Akizza, you must first be sure that you are

Signs of a severe allergic reaction or worsening of hereditary angioedema:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

• dimpling of the skin,

No

Correct use of your tablets will ensure protection against pregnancy whilst you take the tablets and also during the 7 days break.

You can start taking Akizza after 21 to 28 days of childbirth. If you start taking tablet after 28 days, an additional contraceptive method

Signs of a blood clot (see section 2 “Blood clots”)

Signs of breast cancer include:

This means that each strip begins on the same day of the week and withdrawal bleeding every month coincides.

• After childbirth:

- blood clots in the liver, stomach/intestine, kidneys or eye.

information on the conditions that increase risk for blood clots and the symptoms of a blood clot).

Wednesday, take a tablet where “Wednesday” is stated. Follow the direction of the arrow on the strip until all 21 tablets have been

Follow the advice given by your doctor.

- in a lung (i.e. PE),

a tablet) and continue with the next pack. With this method you can always start your next pack on the same day of the week as

Each strip contains 21 tablets. At each tablet, the day of the week is printed on the back of the blister. For example, if you start on a

• After a miscarriage or abortion:

• harmful blood clots in a vein or artery for example:

• stomach ache,

Round, white to off white, biconvex, Film-Coated tablet debossed ‘B’ on one side and other side plain.

• putting on weight,

For Akizza 75 microgram / 20 microgram film-coated tablets

• headaches,
• depressive moods or mood swings,

Round, white to off white, biconvex, Film-Coated tablet debossed ‘A’ on one side and other side plain.

• sore or painful breasts.

Each carton contains 1, 3, or 6 blister strips of 21 tablets each.

blister and continue this till the end. During the administration of the second blister you can experience minor or menstrual-like

Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)

Each carton contains blister packed in a sealed tri-laminated pouch.

bleeding. Begin by following the regular 7-day rest as usual with your next blister.

• being sick and stomach upsets,

Not all pack sizes may be marketed.

You should ask your doctor for advice before you decide to postpone your menstrual period.

• fluid retention,

Change in first day of bleeding:

• loss of interest in sex,

Morningside Healthcare Ltd

• breast enlargement,

115 Narborough Road

• skin rash, which may be itchy.

Leicester

If you take the tablets as directed, your period / withdrawal bleeding start during the week off between taking tablets. If you need
to change that day, you can do shorter (but never stretching!) rest interval between taking tablets. For example, if your rest interval

• migraine,

Marketing Authorisation Holder

LE3 0PA

It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding.

between taking tablets starts on Friday, and you want to change to Tuesday (3 days earlier), you should start a new pack 3 days

Other symptoms may include tender breasts, dizziness , stomach pain, drowsiness and feeling tired.

earlier than usual. If you make the rest interval between taking tablets very short (for example, 3 days or less) bleeding may not

Talk to your doctor if you have any of these symptoms. If you have taken too many tablets, or you discover that a child has taken

occur during this period. You can then experience spotting (drops or flecks of blood) or breakthrough bleeding.

• poor tolerance of contact lenses,

If you are unsure how to do this, ask your doctor for advice.

• increase of interest in sex,

Morningside Pharmaceuticals Ltd

• vaginal or breast discharge.

5 Pavilion Way

some, ask your doctor or pharmacist for advice.
If you forget to take Akizza
• 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 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 must follow the following rules:

If you stop using Akizza:
You can stop taking Akizza 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 using Akizza and wait until you have a menstrual period,
before trying to get pregnant. You can then easily calculate the expected date of birth.
If you have any questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects

Rare side effects (between 1 and 10 in every 10,000 users may be affected)

• losing weight,

Other side effects reported
• Bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body
has adjusted to Akizza. If it continues, becomes heavy or starts again, contact your doctor (see section 4.3).
• Chloasma (yellow brown patches on the skin). This may happen even if you have been using Akizza for a number of months.

Manufacturer

Loughborough
LE11 5GW
UK
This leaflet was last revised in April 2015

Chloasma may be reduced by avoiding too much sunlight and/or UV lamps.
Conditions that may worsen during pregnancy or previous use of the Pill:
- yellowing of the skin (jaundice),

• More than one tablet forgotten in this strip

Like all medicines, Akizza can cause side effects, although not everybody gets them. If you get any side effect, particularly if

Please contact your doctor.

severe and persistent, or have any change to your health that you think may be due to Akizza, please talk to your doctor.

• One tablet forgotten in week 1

An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial

- gall stones,

Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the

thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on

- certain rare medical conditions such as systemic lupus erythematosus,

tablets again at the usual time and for the next seven days use an additional contraceptive method such as a condom.

the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use

- occurrence or deterioration of the movement disorder chorea,

Akizza”.

- blister-like rash (herpes gestationis) whilst pregnant,

If you had sex in the week prior to the missed tablet, you may be pregnant. In these cases please contact your doctor.

UK

- persistent itching (pruritus),
- kidney or liver problems,

- an inherited form of deafness (otosclerosis),

• One tablet forgotten in week 2

- Crohn’s disease,

Take the forgotten tablet as soon as you remember, even if that means that you have two tablets at the same time. Take the

- ulcerative colitis,

tablets again at the usual time. Contraceptive protection is not reduced and you need not take extra contraceptive precautions.

- a personal or family history of a form of sickle cell disease,
- swelling of body parts (hereditary angioedema),
- an inherited disease called porphyria,
- cancer of the cervix.
M0252-LA-M-UK-NA-001

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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