Prospecto: information for the patient

MAYESTA 20 mg soft capsules

Isotretinoin

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist. See section 4.

1. What Mayesta 20 mg soft capsules are and for what they are used

2. What you need to know before starting to take Mayesta 20 mg soft capsules

3. How to take Mayesta 20 mg soft capsules

4. Possible adverse effects

5. Storage of Mayesta 20 mg soft capsules

6. Contents of the package and additional information

Isotretinoine belongs to a group of medicines called systemic acne treatments that act by suppressing the activity of sebaceous glands (fat-producing glands) and reducing the size of these glands. Additionally, an anti-inflammatory effect of isotretinoine has been described at the skin level.

Mayesta 20 mgis indicated for treating severe forms of acne (for example, nodular or conglobate acne or acne with a risk of permanent scarring) that is resistant to adequate conventional treatment cycles with systemic and topical antibacterial preparations.

Do not take Mayesta 20 mg:

- if you are pregnant or breastfeeding

- if there is a possibility that you may become pregnant, you must follow the precautions of the “Pregnancy Prevention Plan”, see the section “Warnings and Precautions”

- if you have liver insufficiency

- if you have very high levels of lipids (cholesterol, triglycerides) in your blood

- if you have very high levels of vitamin A in your body (hypervitaminosis A)

- if you are allergic to isotretinoin or to any of the components of this medication

- if you are taking tetracyclines (a type of antibiotic)

- this medication contains soy oil. Do not use it in case of allergy to peanuts or soy.

Warnings and Precautions:

The treatment with isotretinoin must be monitored by a doctor specialized in the treatment of severe acne who knows all the risks of treatment with isotretinoin, as well as the danger of fetal malformations (teratogenicity).

Pregnancy Prevention Plan

Pregnant women should not take Mayesta 20 mg

This medication can severely damage the baby (the medication is considered “teratogenic”) – it can cause severe abnormalities to the brain, face, ear, eyes, heart, and certain glands of the baby (thyroid and parathyroid). It also increases the risk of spontaneous abortion. This can happen even if Mayesta 20 mg is taken only for a short period of time during pregnancy.

??Do not take Mayesta 20 mg if you are pregnant or think you may be pregnant.

??Do not take Mayesta 20 mg if you are breastfeeding. It is likely that the medication will pass to your milk and can harm your baby.

??Do not take Mayesta 20 mgif you may become pregnant during treatment.

??Do not become pregnant during the month following the interruption of this treatment because it is still possible that there may be medication in your body.

Pregnant women who may become pregnant are prescribed Mayesta 20 mg under strict rules. This is due to the risk of severe damage to the baby

These are the rules:

??Your doctor must explain the risk of damage to the baby – you must understand why you should not become pregnant and what you must do to avoid becoming pregnant.

??You must have spoken with your doctor about contraception (birth control). Your doctor will give you information on how to avoid becoming pregnant. Your doctor may send you to a specialist to give you advice on contraception.

??Before starting treatment, your doctor will ask you to undergo a pregnancy test. The test must show that you are not pregnant when you start treatment with Mayesta 20 mg.

Pregnant women must use effective contraceptives before, during, and after taking Mayesta 20 mg

??You must agree to use at least one very reliable method of contraception (for example, an intrauterine device or an implantable contraceptive) or two effective methods that work in different ways (for example, a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you.

??You must use contraceptives during a month before taking Mayesta 20 mg, during treatment, and during a month after finishing treatment.

??You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor decides that it is not necessary).

Pregnant women must accept undergoing pregnancy tests before, during, and after taking Mayesta 20 mg

??You must agree to undergo regular follow-up visits, ideally every month.

??You must agree to undergo regular pregnancy tests, ideally every month during treatment, and, because it is still possible that there may be medication in your body, 1 month after finishing treatment with Mayesta 20 mg (unless your doctor decides that in your case it is not necessary).

??You must agree to undergo additional pregnancy tests if your doctor asks you to.

??You must not become pregnant during treatment or during a month after, because it is possible that there may still be medication in your body.

??Your doctor will discuss all these points with you, using a checklist and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed about the risks and that you will follow the above rules.

If you become pregnant while taking Mayesta 20 mg,stop taking the medication immediatelyand consult your doctor. Your doctor may send you to a specialist for advice.

Additionally, if you become pregnant within a month of stopping Mayesta 20 mg, you must consult your doctor. Your doctor may send you to a specialist for advice.

Advice for men

The levels of oral retinoids in the semen of men taking Mayesta 20 mg are too low to harm the babies of their partners. However, you must never share your medication with anyone.

Additional precautions

You must never give this medication to anyone else. Please take any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medication, nor during 1 month after stopping Mayesta 20 mg because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Mayesta 20 mg.

• It is possible that acne may worsen during the first weeks of treatment, although it should improve later.
• The skin may become more sensitive to sunlight. Avoid excessive sun exposure and do not use sunlamps or take sunbaths. Before going out in the sun, apply a product with a high sun protection factor, of at least 15.
• Mayesta 20 mgmay increase skin fragility. Dermabrasion (removal of keratinized skin or scars) and wax depilation should be avoided during treatment and for at least 6 months after, as they may cause skin scarring or irritation.
• Avoid using topical creams or preparations that have not been prescribed by your doctor.
• Use a moisturizing cream or lotion and a lip balm during treatment because Mayesta 20 mgmay dry out the skin and lips.
• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Mayesta. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Mayesta and refer you to a specialist for back pain treatment. It may be necessary to undergo additional evaluation, including imaging modalities such as MRI.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties, including decreased night vision. Cases of persistent dry eyes that do not resolve after stopping treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may ask you to use an eye lubricant or a tear replacement therapy. If you use contact lenses and develop intolerance to them, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist for advice if you experience visual difficulties and may ask you to stop taking isotretinoin.
• It is recommended to reduce intense physical activity during treatment with Mayesta 20 mg, as muscle and joint pain have been observed during this treatment.
• If you experience constant headaches, nausea, vomiting, or blurred vision, or intense diarrhea (hemorrhagic: with blood in the stool), stop treatment immediately and contact your doctor as soon as possible.
• If you have kidney insufficiency, inform your doctor, as you will need to start treatment with a lower dose.
• If you experience allergic reactions (skin redness, itching), inform your doctor, as they may interrupt treatment with Mayesta 20 mg.
• Your doctor should regularly monitor your liver function and lipid levels in the blood. If you are diabetic, obese, frequently drink alcohol, or have any alteration in lipid metabolism, your doctor may need to perform more frequent checks. Diabetics are also recommended to perform more frequent blood glucose checks (determinations of sugar in the blood).
• If you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. It also includes thoughts of self-harm or suicide. This is because your mood may be affected while taking Mayesta 20 mg.

Mental health problems

You may not notice some changes in your mood and behavior, so it is very important to tell your friends and family that you are taking this medication. They may notice these changes and help you identify any problems you need to discuss with your doctor.

Use of Mayesta 20 mg with other medications:

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications.

Do not take vitamin A supplements or tetracyclines during treatment with Mayesta 20 mg. Taking them together increases the risk of adverse effects.

Pregnancy, breastfeeding, and fertility:

Pregnancy

For more information on pregnancy and contraception, see the “Pregnancy Prevention Plan”, in the section “Warnings and Precautions”.

Breastfeeding

Fertility

There is no evidence that fertility or offspring of men are affected by taking isotretinoin.

Driving and using machines:

Mayesta 20 mgmay cause a decrease in night vision in some cases, which may occur suddenly during treatment.

Rarely, these changes persist after stopping medication. Therefore, you should exercise extreme caution when driving or using machines.

Mayesta 20 mg contains soy oil.Do not use this medication in case of allergy to peanuts or soy.

Follow exactly the administration instructions for Mayesta 20 mg as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Mayesta 20 mg. Do not discontinue treatment before.

The capsules are taken with food, once or twice a day. You must swallow the capsules whole without chewing or sucking them.

Adults, including adolescents and the elderly:

Usually, treatment begins with a dose of 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). Your doctor may adjust this dose after a few weeks based on your response to treatment. The dose varies between 0.5 and 1.0 mg/kg/day in most cases.

Before starting treatment with Mayesta 20 mg, consult the "Pregnancy Prevention Plan," in the "Warnings and Precautions" section.

Patients with severe renal insufficiency:

Treatment should begin with a lower dose of Mayesta 20 mg, for example, 10 mg/day, and then increase it later.

Children:

Mayesta 20 mg is not indicated for treating acne that appears before puberty or in children under 12 years old.

The usual treatment cycle lasts 16 to 24 weeks. Acne may continue to improve up to 8 weeks after completing treatment. Most patients only need one treatment cycle.

If you estimate that the effect of Mayesta 20 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Mayesta 20 mg than you should:

If you have taken more Mayesta 20 mg than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the nearest hospital immediately or call the Toxicology Information Service at 91 562 04 20.

If you forgot to take Mayesta 20 mg:

Do not take a double dose to compensate for the missed dose.

If you forget a dose, take the medication as soon as possible and continue treatment as prescribed. However, when the next administration is near, it is better not to take the missed dose and wait for the next administration.

Like all medications,this medicationmay cause side effects, although not everyone will experience them.

Severe side effects

Mental problems

Rare (may affect up to 1 in 1,000 people)

Depression or related disorders. These symptoms include a sad or altered mood, anxiety, emotional distress.

Worsening of existing depression.

Becoming violent or aggressive.

Very rare (may affect up to 1 in 10,000 people)

Some people have had feelings or thoughts about self-harm or ending their lives (suicidal thoughts), have attempted to end their lives (suicide attempt), or have ended their lives (suicide). These people may not seem depressed.

Unusual behavior.

Symptoms of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Immediately contact your doctor if you experience symptoms of any of these mental problems.Your doctor may prescribe you to stop taking Mayesta 20 mg. That may not be enough to stop the effects: you may need more help, and your doctor can manage it.

It is very important to inform your doctor if you have had any disease such as depression, suicidal behavior, or psychosis and if you are receiving any medication for the treatment of these diseases.

Other severe side effects

Allergic reactions: chest tightness or difficulty breathing (especially if you are asthmatic) with skin rashes and itching. If you experience an allergic reaction, therapy should be interrupted immediately and you should consult your doctor.

Metabolic changes: excessive thirst, frequent need to urinate, indicative of high blood sugar levels, which may indicate the presence of diabetes. Your doctor may monitor your blood sugar levels more frequently during treatment.

Increased intracranial pressure (brain): In very rare cases, when isotretinoin is administered with some antibiotics, increased intracranial pressure, seizures, and drowsiness have been observed. If you are affected by persistent headaches with nausea, vomiting, and blurred vision, this may indicate that you are suffering from benign intracranial hypertension. Stop taking isotretinoin as soon as possible and consult your doctor.

Gastrointestinal changes: pancreatitis (pancreas inflammation), gastrointestinal bleeding, colitis, ileitis (intestinal inflammation), and inflammatory bowel disease. If you experience severe abdominal pain with or without severe diarrhea with blood, and vomiting, stop taking isotretinoin as soon as possible and consult your doctor.

Liver changes: hepatitis. If your skin or eyes turn yellow and you feel tired, stop taking your medication as soon as possible and consult your doctor.

Renal changes: glomerulonephritis (kidney inflammation). You may feel excessively tired, stop urinating, and have inflamed and swollen eyelids. If this happens while taking your medication, stop therapy and consult your doctor.

The following severe side effects have been reported withunknown frequency(cannot be estimated from available data) in patients taking isotretinoin:

Skin and hair problems: severe skin rash (erythema multiforme) that initially appears as circular patches often with a central blister, usually on the arms and hands or legs and feet, but can affect any part of the body. If this rash appears, stop takingMayesta 20 mgand contact your doctor.

Severe skin rash (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that can potentially be life-threatening and requires immediate medical attention. Initially appear as circular patches, often with a central blister, usually on arms and hands or legs and feet; more severe rashes can also include blisters on the chest and back. Additionally, symptoms such as eye infection (conjunctivitis) or mouth, throat, or nasal ulcers may occur. More severe forms of skin rash can lead to generalized skin peeling that can be life-threatening. These types of skin rash may often be preceded by headache, fever, and body aches (symptoms similar to the flu).

In the event that you present this type of skin symptoms, stop taking this medication and contact your doctor immediately.

Mild side effects

The following mild side effects have been reportedfrequently(may affect up to 1 in 10 patients) in patients taking isotretinoin:

Skin and eye changes: You should expect to develop dry skin, especially on the lips and face. You may experience throat or skin inflammation, cracked skin, mild itching, and light peeling. This dryness can be reduced with regular use of a good moisturizing cream from the start of treatment.

You may feel your eyes are tired and slightly irritated. Very rarely, people who wear contact lenses have needed to use glasses during treatment due to eye dryness.

These side effects are usually reversible once treatment is stopped.

Avoid dermabrasion and waxing during treatment and for at least six months after, as they can cause skin scarring or irritation.

Muscle and bone changes: Lumbalgia (back pain), muscle pain, and joint pain have been reported frequently. These side effects are reversible once treatment is stopped. Try to reduce intense physical activity during isotretinoin therapy.

The following mild side effects have been reportedinfrequentlyin patients taking isotretinoin:

It is possible that acne may worsen during the first weeks of treatment. However, your acne and other symptoms should improve as you continue treatment.

Other side effects observed infrequently are: excessive sweating and pruritus (itching), photosensitivity.

Take measures to protect yourself from the sun, such as using a high-protection sunscreen product (at least SPF 15). Avoid exposure to ultraviolet light. Very rarely, you may experience impaired night vision or color perception, or need to wear sunglasses. In other cases, you may experience intense eye irritation or eyelid inflammation, corneal opacities, keratitis, and cataracts. If this happens, inform your doctor immediately, so they can monitor your vision.

Muscle and bone changes: Arthritis and occasional tendon pain have been reported in very rare cases.

Local infections: Infections around the base of the nails, swelling that drains pus, changes in the nails.

Skin and hair changes: You may notice some changes in your hair (loss or, rarely, an increase). This is usually temporary, and persistent hair thinning is rare. You may also experience skin thickening after surgical interventions, increased facial pigmentation, and increased body hair.

Blood and urine analytical changes: In very rare cases, it has been reported that you may experience a decrease in white blood cell count and may develop lymph node inflammation. You may experience delayed coagulation. Abnormal blood levels of urea, sugar, or liver enzymes have been observed sporadically. Your doctor may want to perform some blood tests before, during, and at the end of your treatment.

In rare cases, isotretinoin may cause disorders in certain substances, such as proteins and blood cells excreted in the urine. If you notice any change in the appearance of your urine, consult your doctor.

Lipid changes: Since isotretinoin can produce abnormalities in blood levels of substances similar to fats (triglycerides and cholesterol) in some patients, it is recommended that you do not consume alcoholic beverages. If your doctor checks that you have high triglyceride levels, you may need to reduce the dose of isotretinoin and follow a low-fat diet.

The following side effects have been reported withunknown frequency(cannot be estimated from available data) in patients taking isotretinoin:

Problems with achieving or maintaining an erection.

Decreased libido.

Inflammation of the breasts with or without sensitivity in men.

Vaginal dryness.

Sacroiliitis, a type of low back inflammatory pain that causes pain in the buttocks or lower back.

Inflammation of the urethra.

Reporting side effects:

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

Do not store at a temperature above 25°C.

Store the blister in the outer packaging to protect it from light and humidity.

Keep out of sight and reach of children.

Do not useMayesta 20 mgafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. In this way, you will help protect the environment.

Return unused capsules to your pharmacist. Store them only if your doctor asks you to.

Composition of Mayesta 20 mg soft capsules

- The active ingredient is isotretinoin. Each soft capsule contains 20 mg of isotretinoin.

- The other components are: Refined soybean oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated vegetable oil, gelatin, glycerol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and purified water.

Appearance of the product and contents of the packaging

Mayesta 20 mgare soft capsules of orange-red color and oval shape. Each package contains 50 soft capsules.

Holder of the marketing authorization and responsible manufacturer

Holder:

Alfasigma España, S.L.

Avda. Diagonal, 490, 4th 2nd

08006 Barcelona. SPAIN

Responsible manufacturer:

PHARMATHEN S.A.

Dervenakion 6

15351 Pallini ATTICA. GREECE

PHARMATHEN INTERNATIONAL S.A.

Sapes Industrial Park, Block 5

Rodopi 69300. GREECE

Revision date of this leaflet: April 2024

The detailed andupdatedinformation about this product is available by scanning the QR code included in the leaflet through a smartphone. The same information is also available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/