Prospect: Information for the User

aidessia0.15mg /0.03 mg, film-coated tablets EFG

desogestrel/etinilestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

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

Read this prospect thoroughly before starting to use this medication, because it contains important information for you.

• Keep this prospect, asyou may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you,and you must not give it to other people. It may harm them, even if their symptoms of illness are the same as yours.
• Ifyou experienceadverse effects mentioned in section 4 or if you suffer any adverse effect not mentioned in this prospect, consult your doctor, or pharmacist.

Composition and type of contraceptive medication

This medication isa combined oral contraceptive, also known as the pill.

Each of the 21 white tablets contains a small amount of two different female hormones, desogestrel (a hormone that works similarly to a progestogen)and ethinyl estradiol (a hormone that works similarly to an estrogen).Due to the small amounts of hormones, Aidessia is considered a low-dose contraceptive. Since the amount of each hormone is the same in all tablets of the blister pack, it is called a combined pill.

What it is used for

Take Aidessia to prevent pregnancy.

When taken correctly (without missing tablets) the likelihood of becoming pregnant is very low.

Do not take aidessia:

You should not use aidessia if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (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 the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• Severe diabetes with vascular damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood.
• If you have (or have ever had) jaundice (yellowing of the skin or eyes) or severe liver disease.
• If you have (or have ever had) hormone-dependent cancer, (breast cancer or cancer of the reproductive organs).
• If you have (or have ever had) liver cancer.
• If you have vaginal bleeding that has not been explained by your doctor.
• If you have an abnormal inflammation of the endometrium.
• If you are allergic to ethinylestradiol, to desogestrel, or to any of the other components of this medication (including in section 6). This may manifest as itching, rash, or inflammation.
• If you are allergic to peanuts or soy.
• If you have Hepatitis C and are taking medications that contain ombistavir / paritaprevir / ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see section Taking aidessia with other medications).

If you experience any of these symptoms or have them for the first time while taking aidessia, stop taking it immediately and contact your doctor as soon as possible. In the meantime, use another non-hormonal contraceptive method. Also, see the “General Considerations” at the beginning of section 2.

When to be extra careful with aidessia:

Inform your doctor if any of the following conditions apply to you:

Inform your doctor if any of the following conditions apply to you:

• If you smoke;
• If you have diabetes;
• If you are overweight;
• If you have high blood pressure;
• If you have a problem with your heart valves or a certain heart rhythm disorder;
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If any of your close relatives have ever had a blood clot, heart attack, or stroke.
• If you have ever had migraines.
• If you have epilepsy;
• If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• If you need surgery or cannot stand for a long time (see section 2 “Blood Clots”).
• If you have recently given birth, you have a higher risk of blood clots. Ask your doctor how long after delivery you can start taking aidessia.
• If any of your close relatives have had breast cancer;
• 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 that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• If you have sickle cell anemia (a hereditary disorder of red blood cells).
• If you have any disease that appeared for the first time or worsened during pregnancy or during a previous use of sex hormones (for example, hearing loss, a metabolic disorder called porphyria, a skin disease that causes blisters during pregnancy called herpes gestational, a neurological disorder called Sydenham's chorea that causes involuntary body movements).
• If you have or have ever had melasma (brown or yellowish patches, also called “pregnancy patches”, especially on the face or neck). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Hormonal products can cause or worsen the symptoms of hereditary and acquired angioedema.

Aidessia and blood clots (Thrombosis)

BLOOD CLOTS (TROMBOSIS)

The use of a combined hormonal contraceptive like aidessia increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to aidessia is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

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 in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently 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 may cause deep vein thrombosis (DVT).

If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).

In rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking aidessia, your risk of a blood clot returns to normal in a few weeks.

What is the risk of 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 aidessia is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as aidessia, 9-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

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

Your risk of a blood clot with aidessia is small, but some conditions increase the risk. Your risk is higher:

The risk of a blood clot in a vein increases if you have more of these conditions.

Long flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop taking aidessia.

If any of the conditions listed above change while you are using aidessia, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform 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 blood 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 essential to note that the risk of a heart attack or stroke due to aidessia is very small, but it may increase:

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the conditions listed above change while you are using aidessia, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

The pill and cancer

The pill slightly increases the risk of breast cancer compared to women who do not use the pill. There is no difference 10 years after stopping the pill. It is not known if this difference is caused by the pill. It may be that women who use the pill are examined more frequently, so breast cancer is detected earlier.

In rare cases, benign tumors in the liver have been reported in users of contraceptives. Even more rarely, malignant tumors have been reported. Consult your doctor if you experience sudden severe abdominal pain.

The chronic infection with the Human Papillomavirus (HPV) is the most important risk factor for cervical cancer. In women who use the pill for a long time, the probability of contracting cervical cancer may be slightly higher. It is possible that this finding is not caused by the pill itself, but may be related to sexual behavior and other factors (such as better cervical screening).

Mental disorders:

Some women who use hormonal contraceptives like aidessia have reported depression or a depressed mood. Depression can be severe and may sometimes induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Aidessia and use of other medications

Always inform your doctor who prescribed aidessia about the medications or herbal preparations you are taking, have taken recently, or may need to take. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are using aidessia. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

Do not take aidessia if you have Hepatitis C and are taking medications that contain ombistavir / paritaprevir / ritonavir and dasabuvir, glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver enzyme results (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Aidessia can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do not use aidessia”.

Some medications:

• may affect the levels of aidessia in the blood
• may make it less effective in preventing pregnancy
• may cause unexpected bleeding.

This includes medications used in the treatment of:

• Epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate).
• Tuberculosis (e.g., rifampicin, rifabutin).
• HIV (e.g., ritonavir, nelfinavir, nevirapine, efavirenz)
• Hepatitis C (e.g., boceprevir, telaprevir)
• Other infectious diseases (griseofulvin).
• High blood pressure in blood vessels of the lungs (bosentan).
• Mental disorders (the medicinal herb St. John's Wort).

If you are taking medications or herbal preparations that may make aidessia less effective, you should also use a barrier contraceptive method. Since the effect of another medication on aidessia may last for up to 28 days after stopping the medication, you need to use the additional barrier contraceptive method during that time.

Aidessia may affect the effect of other medications, for example:

• Those containing ciclosporin.
• The antiepileptic lamotrigine (this may lead to an increase in seizures).

Laboratory tests

If you are to undergo a laboratory test, inform your doctor or the laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of some tests.

Pregnancy and lactation

Pregnancy

Do not take aidessiaif you are pregnant or think you may be pregnant.If you think you may be pregnant while using aidessia, contact your doctor as soon as possible.

Lactation

It is not recommended to use aidessia during lactation. Contact your doctor if you still want to use aidessia during lactation.

Driving and operating machines

Aidessia has no known effects on your ability to drive or operate machines.

Aidessia contains lactose and soy oil

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

If you are allergic to peanuts or soy, do not use this medication.

Children and adolescents

No clinical data are available on efficacy and safety in adolescents under 18 years.

When to contact your doctor

Regular check-ups

Your doctor may advise you to make regular appointments for a pill check-up. Your personal situation will determine how often you should return for check-ups and what tests will be performed.

Contact your doctor as soon as possible if:

Take this medicine exactly as your doctor or pharmacist has told you to. If you are unsure about how to use it, consult your doctor or pharmacist.

When and how to take the tablets

Each blister contains 21 tablets. In the blister, each tablet is marked with the day of the week when it should be taken. Take your tablet approximately at the same time every day, with a little liquid if necessary.

Follow the arrow direction in the blister until you have taken the 21 tablets. Do not take any tablets for the next 7 days. During these 7 days, you should start your period (bleeding due to deprivation). It usually starts 2-3 days after the last aidessia tablet.

Start taking the next aidessia tablet blister on the 8th day, even if you are still bleeding. This means that you will always start new blisters on the same day of the week, and also means that you will have your period approximately the same days every month.

When can you start with the first blister?

• When no hormonal contraceptive has been used in the previous month.Start taking the tablets on the first day of the cycle, i.e. the first day of your menstrual bleeding. The medicine will work immediately, no additional contraceptive method is needed. You can also start on days 2-5 of the cycle, but in that case, make sure to use an additional contraceptive method, such as a condom, during the first 7 days.

• When changing from another combined hormonal contraceptive, or a vaginal ring or patch.

You can start taking your treatment the day after taking the last tablet of your current blister (i.e. without interruption). If your previous hormonal contraceptive treatment blister contained inactive tablets, you can start your aidessia treatment the day after taking the last active tablet (if you are unsure which one, consult your doctor or pharmacist). You can also start late, but no later than the day after the pause without tablets of your previous contraceptive (or the day after the last inactive tablets of your previous treatment).

If you are using a vaginal ring or patch, you should start taking this medicine on the day of removal. You can also start using this medicine later, but no more than 7 days after removing the ring or the last patch.

If you have taken contraceptive pills, patches, or rings exactly as prescribed and are sure you are not pregnant, you can stop using them or remove the ring or patch on any day of your current cycle and immediately switch to using this medicine.

You do not need to use an additional contraceptive method, such as a condom.

• When changing from a progestin-only method (mini-pill)

You can stop taking the mini-pill on any day and start taking this medicine the next day, at any time. But make sure to use an additional contraceptive method, such as a condom, during the first 7 days of taking tablets.

• When changing from an injectable, implanted, or progestin-releasing intrauterine device (IUD).

Start taking this medicine when it is time for your next injection or the day the implant or IUD is removed. Make sure to use an additional contraceptive method, such as a condom, during the first 7 days you are taking aidessia.

• After having a baby.

If you have just had a baby, your doctor may tell you to wait until after your first normal period before starting to take this medicine. Sometimes it is possible to start earlier. Your doctor will advise you. The same applies if you are breastfeeding and want to take aidessia.

• After a spontaneous or induced abortion

Follow your doctor's advice.

What to do if you take moreaidessiathan you should

No serious harm has been reported in cases where an overdose of this medicine has been taken.

If you take too many tablets, you may feel unwell, vomit, or have vaginal bleeding.

If a child has taken this medicine, consult your doctor.

What to do if:

You forgot to takeyour tablets

• If the missed tablet is takenwithin the12 hours,the contraceptive protection will not be reduced.Take the tablet as soon as you remember and the following tablets at the usual time.
• If you delaymore than 12 hoursin taking a tablet, the reliability of the treatment may be reduced. The more consecutive tablets you have forgotten, the higher the risk of reduced contraceptive efficacy.

There is a particularly high risk of becoming pregnant if you forget to take the tablets at the beginning or end of the blister. Therefore, you must follow the rules below (see diagram):

Forgetting more than one tablet from the blister

Consult your doctor.

Forgetting a tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at the usual time. Useadditional contraceptive precautionsfor the next 7 days.If you have had sex in the week before forgetting the tablet, there is a possibility of becoming pregnant. In that case, consult your doctor immediately.

Forgetting a tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets at the usual time. The reliability of the pill is maintained. No additional contraceptive precautions are needed.

Forgetting a tablet in week 3

You can choose one of the following options, 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. Take the following tablets at the usual time. When you finish the tablet blister, start the next blister the next day without interruption. It is possible that you will not have a withdrawal bleeding until the end of the second blister, but you may have spotting or vaginal bleeding during the second blister.
2. Stop taking the current blister. Leave the usual 7-day break or less (always note the day you forgot to take the tablet). Then continue with the next blister.

By following this method, you can always start your next blister on the same day of the week as you normally do.

• If you have forgotten to take one of the tablets in a blister and do not bleed during the break, it is possible that you are pregnant. In that case, contact your doctor before continuing with the next blister.

What to do if you have gastrointestinal disorders (e.g. vomiting, intense diarrhea)

If you are sick (vomit) or have very intense diarrhea, your body may not get the usual dose of hormones from the pill. If you vomit within 3-4 hours after taking the pill, it is as if you had missed a pill. You should follow the advice given for missed pills. Talk to your doctor if you have intense diarrhea.

What to do if you want to delay your period

You can delay your period, although it is not recommended. You can delay your period in exceptional cases by starting the next aidessia tablet blister the next day without interruption. You can continue with this blister for as long as you want, until the blister is empty. While using the second blister, you may have spotting or vaginal bleeding. Start your next blister after the usual 7-day break without tablets.

What to do if you want to change the day of your period

If you take the tablets as instructed, you will have your period approximately the same day. If you want to change this, simply shorten (never lengthen) the break without tablets between two blisters. For example, if your period usually starts on a Friday and in the future you want it to start on a Tuesday (3 days earlier), you should start your next blister 3 days earlier than usual. If you make your break without tablets very short (e.g. 3 days or less), it is possible that you will not bleed during the break. You may have spotting or vaginal bleeding during the use of the next blister of the medicine.

What to do if you have unexpected bleeding

With the use of any contraceptive pill, during the first months, you may have irregular vaginal bleeding (spotting or intermenstrual bleeding) between periods. You may need to use sanitary products, but continue taking your tablets as usual. Irregular vaginal bleeding usually stops once your body has adapted to the treatment (usually after 3 blisters). Contact your doctor if the bleeding continues, increases, or starts again.

What to do if your period does not appear

If you have taken all the tablets at the right time, and have not vomited, or had intense diarrhea, or taken other medicines, it is very unlikely that you are pregnant. Start your next blister as usual.

If you have two consecutive missed periods, it is possible that you are pregnant. Contact your doctor immediately. Do not start the next blister of this medicineuntil your doctor has confirmed that you are not pregnant.

What to do if you want to stop the treatment with aidessia

You can stop taking this medicineat any time you want. If you do not want to become pregnant, consult your doctor for advice on the use of other reliable contraceptive methods. If you stop because you want to become pregnant, it is usually recommended that you wait until you have had a normal period before trying to conceive. This helps you know when the baby will be born.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due toaidessia, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to useaidessia”.

Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

Like with all pills, during the first few months, your menstrual pattern may change. This difference may manifest in the frequency of bleeding (if it does not appear, less frequently, more frequently, or continuously), the amount of bleeding, or the duration of bleeding.

Frequent(mayaffect up to 1 in 10 women):

• Depression or mood changes.
• Headaches.
• Nausea.
• Abdominal pain.
• Breast tenderness or pain.
• Weight gain.

Infrequent(mayaffect up to 1 in 100 women):

• Fluid retention.
• Decreased libido.
• Migraine.
• Vomiting.
• Diarrhea.
• Skin rash or urticaria.
• Breast enlargement.

Rare(mayaffect up to 1 in 1,000 women):

• Deleterious 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.
  • Mild stroke or temporary symptoms similar to a stroke, known as a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having 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 the symptoms of a blood clot).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30°C. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging, after ‘CAD’.The expiration date is the last day of the month indicated.

Do not useaidessiaif you observe a change in color, broken tablets, or any visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at your local SIGRE drop-off point.At your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of aidessia

• The active principles are: desogestrel and etinilestradiol. Each tablet contains 0.150 milligrams of desogestrel and 0.030 milligrams of etinilestradiol.
• The other components are: lactose monohydrate, cornstarch, povidone K-30 (E1201), alpha-tocopherol (E307), soybean oil, hydrated colloidal silica (E551), anhydrous colloidal silica (E551), stearic acid (E570), hypromellose 2910 (E464), triacetin (E1518), polisorbate, titanium dioxide (E171).

Appearance of aidessiaand contents of the packaging

Coated tablets, white in color, round, and marked with “C” on one face and “7” on the other.

Available in boxes of 1, 3, 6, and 13 blisters, each containing 21 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10 – Areta Industrial Estate

31620 Huarte (Navarra)

Spain

Responsible manufacturer

León Farma Laboratories, S.A.

Navatejera Industrial Estate; La Vallina s/n,

24008 - Villaquilambre, León.

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Ethinylestradiol/Desogestrel 0.03 mg/0.15 mg Focus, fimomhulde tabletten

Belgium:Desolina 150/30 microgram, coated tablet

LuxembourgDesolina 30 0.150 mg/0.030 mg, coated tablets

Spain:aidessia0.15mg/0.03 mg, coated tablets EFG

Last review date of this leaflet:March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77783/P_77783.html

QR code to:https://cima.aemps.es/cima/dochtml/p/77783/P_77783.html