MAYESTA 10 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

MAYESTA 10 mg Soft Capsules

Isotretinoin

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

1. What Mayesta 10 mg Soft Capsules are and what they are used for
2. What you need to know before taking Mayesta 10 mg Soft Capsules
3. How to take Mayesta 10 mg Soft Capsules
4. Possible side effects
5. Storage of Mayesta 10 mg Soft Capsules
6. Package Contents and Additional Information

1. What Mayesta 10 mg Soft Capsules are and what they are used for

Isotretinoin belongs to a group of medications called systemic anti-acne preparations that work by suppressing the activity of the sebaceous glands (oil-producing glands) and reducing the size of these glands. Additionally, an anti-inflammatory effect of isotretinoin on the skin has been described.

Mayesta 10 mgis indicated for the treatment of severe forms of acne (e.g., nodular or conglobate acne, or acne with a risk of permanent scarring) that are resistant to adequate cycles of conventional treatment with systemic and topical antibacterial preparations.

2. What you need to know before taking Mayesta 10 mg Soft Capsules

Do not take Mayesta 10 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", consult the "Warnings and Precautions" section
• if you have liver failure
• if you have very high levels of lipids (cholesterol, triglycerides) in the blood
• if you have very high levels of vitamin A in your body (hypervitaminosis A)
• if you are allergic to isotretinoin or any of the components of this medication
• if you are taking tetracyclines (a type of antibiotic)
• this medication contains soybean oil. Do not use if you are allergic to peanuts or soy.

Warnings and Precautions:

Treatment with isotretinoin should be monitored by a doctor specializing in the treatment of severe acne who is aware of all the risks of treatment with isotretinoin, as well as the danger of birth defects (teratogenicity).

Pregnancy Prevention Plan

Pregnant women should not take Mayesta 10 mg

This medication can seriously harm the baby (the medication is considered "teratogenic") - it can cause serious abnormalities to the brain, face, ear, eyes, heart, and certain glands of the baby (thymus and parathyroid). It also increases the likelihood of spontaneous abortion. This can happen even if Mayesta 10 mg is taken only for a short period during pregnancy.

Do not take Mayesta 10 mg if you are pregnant or if you think you may be pregnant.

Do not take Mayesta 10 mg if you are breastfeeding. It is likely that the medication will pass into your milk and may harm your baby.

Do not take Mayesta 10 mg if you may become pregnant during treatment.

Do not become pregnant during the month following the interruption of this treatment because the medication may still be present in your body.

Women who may become pregnant have Mayesta 10 mg prescribed under strict rules. This is due to the risk of serious harm to the baby

These are the rules:

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

You must have discussed contraception (birth control) with your doctor. The doctor will provide you with information on how to avoid becoming pregnant. The doctor may refer you to a specialist for contraception advice.

Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant when you start treatment with Mayesta 10 mg.

Women must use effective contraceptives before, during, and after taking Mayesta 10 mg

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

You must use contraceptives for one month before taking Mayesta 10 mg, during treatment, and for one 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 it is not necessary).

Women must accept to have pregnancy tests before, during, and after taking Mayesta 10 mg

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

You must agree to have regular pregnancy tests, ideally every month during treatment and, because the medication may still be present in your body, one month after finishing treatment with Mayesta 10 mg (unless your doctor decides it is not necessary in your case).

You must agree to have additional pregnancy tests if your doctor requests them.

You must not become pregnant during treatment or during the month following treatment, as it is possible that the medication may still be present 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 10 mg, stop taking the medication immediatelyand consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within one month after stopping Mayesta 10 mg, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for Men

The levels of oral retinoids in the semen of men taking Mayesta 10 mg are too low to harm the baby of their partners. However, you should never share your medication with anyone.

Additional Precautions

Never give this medication to another person. Please return any unused capsules to your pharmacist at the end of treatment.

Do not donate blood during treatment with this medication, nor during one month after stopping Mayesta 10 mg, as a baby may be harmed if a pregnant patient receives your blood.

Consult your doctor before starting to take Mayesta 10 mg.

• It is possible that acne may worsen during the first few weeks of treatment, although it should improve later.
• The skin may become more sensitive to the sun's effects. Avoid excessive sun exposure and do not use sunlamps or take sunbaths. Before taking the sun, apply a product with a high protection factor, at least 15.
• Mayesta 10 mg may increase skin fragility. Energetic 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 scarring or skin irritation.
• Avoid using creams or preparations that are keratolytic or exfoliative in nature, unless prescribed by your doctor.
• Use a skin moisturizer and lip balm during treatment, as Mayesta 10 mg may dry 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 the treatment of inflammatory back pain. Further evaluation, including imaging modalities such as magnetic resonance imaging, may be necessary.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties, including decreased night vision. Cases of dry eyes that do not resolve after treatment have been reported. Inform your doctor if you have any of these symptoms. Your doctor may ask you to use an eye lubricant or tear replacement therapy. If you wear contact lenses and have developed intolerance, 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 it is possible that you may be asked to stop taking isotretinoin.
• It is recommended to reduce intense physical activity during treatment with Mayesta 10 mg, as muscle and joint pain have been observed during this treatment.
• If you experience constant headache, nausea, vomiting, or blurred vision, or severe diarrhea (hemorrhagic: with blood in the stool), stop treatment immediately and contact your doctor as soon as possible.
• If you have kidney failure, inform your doctor, as you should start treatment with a lower dose of Mayesta 10 mg.
• If you experience allergic reactions (skin redness, itching), inform your doctor, as they may interrupt treatment with Mayesta 10 mg.
• Your doctor should regularly monitor liver function and blood lipid levels. If you are diabetic, obese, frequently drink alcohol, or have any lipid metabolism disorders, your doctor may need to perform more frequent checks. Diabetics are also advised to perform blood glucose tests more frequently.
• 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 ending your life. This is because your mood may be affected while taking Mayesta 10 mg.

Mental Health Problems

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

Using Mayesta 10 mg with other medications:

Inform your doctor or pharmacist if you are taking or have recently taken any other medications, including those purchased without a prescription.

Do not take vitamin A supplements or tetracyclines during treatment with Mayesta 10 mg. Their concurrent use increases the risk of adverse effects.

Pregnancy, Breastfeeding, and Fertility:

Pregnancy

To obtain more information about pregnancy and contraception, consult the "Pregnancy Prevention Plan" in the "Warnings and Precautions" section.

Breastfeeding

Fertility

There are no data to indicate that fertility or offspring of men are affected by taking isotretinoin.

Driving and Using Machines:

Mayesta 10 mg can cause a decrease in night vision in some cases, which may occur suddenly during treatment.

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

Mayesta 10 mg contains soybean oil.Do not use this medication if you are allergic to peanuts or soy.

3. How to take Mayesta 10 mg Soft Capsules

Follow your doctor's instructions for taking Mayesta 10 mg exactly.

Consult your doctor or pharmacist if you have any questions.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Mayesta 10 mg. Do not stop 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 starts with a dose of 0.5 mg per kilogram of body weight and 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 10 mg, consult the "Pregnancy Prevention Plan" in the "Warnings and Precautions" section.

Patients with severe kidney failure:

Treatment should start with a lower dose of Mayesta 10 mg, for example, 10 mg/day, and increased later.

Children:

Mayesta 10 mg is not indicated for the treatment of acne that appears before puberty or in children under 12 years of age.

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

If you think the action of Mayesta 10 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Mayesta 10 mg than you should:

If you have taken more Mayesta 10 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 or call the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Mayesta 10 mg:

Do not take a double dose to make up for forgotten doses.

In case of forgetting a dose, you should take the medication as soon as possible, continuing treatment as prescribed. However, when the next administration is near, it is better not to take the forgotten dose and wait for the next administration.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Severe Adverse Effects

Mental Problems

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

Depression or related disorders. These signs include a sad or altered mood, anxiety, feelings of 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 own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not seem to be depressed.

Unusual behavior.

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

Contact your doctor immediately if you experience signs of any of these mental problems.Your doctor may advise you to stop taking Mayesta 10 mg. This may not be enough to stop the effects: you may need more help, and your doctor can manage it.

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

Other Severe Adverse 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 discontinued immediately and you should consult your doctor.

Metabolic disorders: Excessive thirst, frequent need to urinate, representative of an increase in your blood sugar levels, which could mean the presence of diabetes. Your doctor may monitor your blood sugar levels more frequently during your treatment.

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

Digestive system disorders: Pancreatitis (inflammation of the pancreas), 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 disorders: Hepatitis. If your skin or eyes turn yellow and you feel tired, stop taking your medication as soon as possible and consult your doctor.

Kidney disorders: Glomerulonephritis (inflammation of the kidneys). You may feel excessively tired, stop urinating, and have swollen and bulging eyelids. If this happens while you are taking your medication, discontinue therapy and consult your doctor.

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

Skin and hair problems: Serious skin rash (erythema multiforme) that initially appears as circular spots 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 taking Mayesta 10 mg and contact your doctor.

Severe skin rash (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that can be life-threatening and require immediate medical attention. They initially appear as circular spots, often with a central blister, usually on the 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 ulcers in the mouth, throat, or nose may occur. More severe forms of rash can lead to generalized peeling of the skin, which can be life-threatening. These types of skin rash can often be preceded by headache, fever, body aches (flu-like symptoms).

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

Mild Adverse Effects

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

Skin and eye disorders: You should expect dry skin to appear, especially on the lips and face. You may have throat or skin inflammation, your skin or lips may crack, you may have a rash, some mild itching, and mild peeling. This dryness can be reduced with the regular use of a good moisturizer from the start of treatment.

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

Normally, these adverse effects are reversible once treatment is stopped.

Dermabrasion and wax depilation should be avoided during treatment and for at least six months after treatment, as they can cause scarring or skin irritation.

Muscle and bone disorders: Frequent lumbar pain (back pain), muscle pain, and joint pain have been reported. These effects are reversible once treatment is stopped. You should try to reduce intense physical activity during isotretinoin therapy.

The following mild adverse effects have been reportedrarelyin 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 with treatment.

Other adverse effects observed rarely are: excessive sweating and pruritus (itching), photosensitivity.

You should take measures to protect yourself from the sun, such as using a sunscreen product with a high protection factor (at least SPF 15). Avoid exposure to ultraviolet light. Very rarely, you may experience night vision problems or difficulty distinguishing colors, or you may need to wear sunglasses. On other occasions, severe eye irritation or eyelid inflammation, corneal opacities, keratitis, and cataracts have occurred. If this happens, inform your doctor immediately, so they can monitor your vision.

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

Local infections: Infections of the tissue around the base of the nails, swellings that discharge pus, changes in the nails.

Changes in skin and hair: You may notice some changes in your hair (loss or, rarely, an increase). This is usually only temporary, and persistent hair thinning is rare. Also, thickening of scar tissue after surgical interventions, increased facial pigmentation, and body hair levels may occur.

Blood and urine analytical changes: In very rare cases, a decrease in white blood cell count and lymph node inflammation have been reported. The coagulation process may be delayed. Abnormal levels in blood urea, sugar, or liver enzymes have also 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 anomalies in blood levels of fat-like substances (triglycerides and cholesterol) in some patients, it is recommended that you do not drink alcoholic beverages. If your doctor checks that you have high triglyceride levels, it may be necessary to reduce the dose of isotretinoin and follow a low-fat diet.

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

Difficulty getting or maintaining an erection.

Decreased libido.

Breast inflammation with or without sensitivity in men.

Vaginal dryness.

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

Urethral inflammation.

Reporting Adverse Effects:

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

5. Storage of Mayesta 10 mg Soft Capsules

Do not store above 25°C.

Keep the blister pack in the outer packaging to protect it from light and moisture.

Keep out of sight and reach of children.

Do not use Mayesta 10 mg after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

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

6. Package Contents and Additional Information

Composition of Angileptol Mint Flavor

Each tablet contains:

• Active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• Other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Product Appearance and Package Contents

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one side.

They come in packages containing 15 and 30 sucking tablets.

Other Presentations

Angileptol Mint-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing Authorization Holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

ManufacturerPharmaloop, S.L

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), SPAIN

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), ITALY

Date of the Last Revision of this Prospectus:September 2021

Other Sources of Information

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