Mayesta 10 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

MAYESTA 10 mg soft capsules

Isotretinoin

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it could harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet

1. What Mayesta 10 mg soft capsules is and what it is 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. How to store Mayesta 10 mg soft capsules
6. Contents of the pack and other information

1. What Mayesta 10 mg soft capsules are and what they are used for

Isotretinoin belongs to a group of medicines called systemic anti-acne preparations that work by suppressing the activity of the sebaceous (fat-producing) glands and reducing the size of these glands. In addition, isotretinoin has been reported to have an anti-inflammatory effect on the skin.

Mayesta 10 mg is indicated for the treatment of severe forms of acne (for example, nodular acne or acne conglobata, or acne with risk of permanent scarring) that are resistant to appropriate courses 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 any possibility that you could become pregnant, you must follow the precautions of the “Pregnancy Prevention Programme”; see the section “Warnings and precautions”
• if you have hepatic insufficiency
• 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 to any of the components of this medicine
• if you are taking tetracyclines (a type of antibiotic)
• this medicine contains soya oil. It should not be used if you are allergic to peanuts or soya.
• if you have ever had a severe skin rash, peeling, blistering and/or mouth sores after taking isotretinoin.

Warnings and precautions:

Treatment with isotretinoin must be supervised by a physician specialized in the treatment of severe acne who is fully aware of all the risks associated with isotretinoin therapy, as well as the risk of fetal malformations (teratogenicity).

This medicine may cause severe skin reactions. Stop using Mayesta 10 mg and seek immediate medical attention if you notice any symptoms related to these severe skin reactions, as described in section 4.

Pregnancy Prevention Programme

Pregnant women must not take Mayesta 10 mg

This medicine can seriously harm the unborn baby (the medicine is considered “teratogenic”) – it may cause serious abnormalities in the baby’s brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of spontaneous abortion. This can occur even if Mayesta 10 mg is taken for only a short time during pregnancy.

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

??Do not take Mayesta 10 mg if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.

??Do not take Mayesta 10 mg if you are capable of becoming pregnant during treatment.

??Do not become pregnant during the month following discontinuation of this treatment, as the medicine may still remain in your body.

Women who could become pregnant must be prescribed Mayesta 10 mg under strict rules due to the risk of serious harm to the unborn baby

These rules are:

??Your doctor must explain to you the risk of harm to the unborn baby – you must understand why you must not become pregnant and what you need to do to prevent pregnancy.

??You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.

??Before starting treatment, your doctor will require you to have a pregnancy test. The test must confirm that you are not pregnant when you begin treatment with Mayesta 10 mg.

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

??You must agree to use at least one highly 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 are suitable for you.

??You must use contraception for one month before starting Mayesta 10 mg, during treatment, and for one month after stopping treatment.

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

Women must agree to undergo pregnancy tests before, during, and after taking Mayesta 10 mg

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

??You must agree to undergo regular pregnancy tests, ideally every month during treatment and for one month after stopping treatment with Mayesta 10 mg (unless your doctor decides it is not necessary for your case), because the medicine may still remain in your body.

??You must agree to undergo additional pregnancy tests if requested by your doctor.

??You must not become pregnant during treatment or during the month after stopping treatment, as the medicine may still remain 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 of the risks and that you will follow the above rules.

If you become pregnant while taking Mayesta 10 mg, stop taking the medicine immediately and 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 should consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

Levels of oral retinoids in the semen of men taking Mayesta 10 mg are too low to harm a partner’s unborn baby. However, you must never share your medicine with anyone.

Additional precautions

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

You must not donate blood during treatment with this medicine, or for one month after stopping Mayesta 10 mg, because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting Mayesta 10 mg.

• Acne may worsen during the first few weeks of treatment, although it should improve later.
• Your skin may become more sensitive to sunlight. Avoid excessive sun exposure and do not use sunlamps or sunbeds. Before sun exposure, apply a sunscreen product with a high protection factor of 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 afterwards, as they may cause skin scarring or irritation.
• Avoid using topical creams or keratolytic or exfoliating preparations not prescribed by your doctor.
• Use a skin moisturizing cream and lip balm during treatment, as Mayesta 10 mg can 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 indicate sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue Mayesta treatment and refer you to a specialist for management of inflammatory back pain. Additional evaluation, including imaging modalities such as magnetic resonance imaging, may be required.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties, including reduced night vision. Cases of persistent dry eyes that do not resolve after discontinuation of treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may recommend using an eye lubricant or tear replacement therapy. If you wear contact lenses and develop intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist if you experience visual difficulties and may ask you to stop taking isotretinoin.
• It is advisable 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 persistent headache, nausea, vomiting, blurred vision, or severe (hemorrhagic: with blood in stool) diarrhea, stop treatment immediately and contact your doctor as soon as possible.
• If you have renal insufficiency, inform your doctor, as you may need to start treatment with a lower dose.
• If you experience allergic reactions (skin redness, itching), inform your doctor, as treatment with Mayesta 10 mg may need to be discontinued.
• Your doctor should regularly monitor your liver function and blood lipid levels. If you are diabetic, obese, drink alcohol frequently, or have any lipid metabolism disorder, your doctor may need to perform more frequent monitoring. Diabetic patients are also advised to monitor blood glucose levels (blood sugar tests) more frequently.
• If you have ever had any mental health problems, including depression, aggressive tendencies, or mood changes, including thoughts of self-harm or suicide. This is because your mood may be affected while taking Mayesta 10 mg.

Mental health problems

You may not notice certain changes in your mood and behavior, so it is very important to inform your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that need to be discussed with your doctor.

Use of Mayesta 10 mg with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Do not take vitamin A supplements or tetracyclines during treatment with Mayesta 10 mg. Taking them together increases the risk of adverse effects.

Pregnancy, breastfeeding, and fertility:

Pregnancy

For more information about pregnancy and contraception, see the "Pregnancy Prevention Plan" in the "Warnings and Precautions" section.

Breast-feeding

Fertility

There are no data indicating that fertility or offspring in men are affected by taking isotretinoin.

Driving and use of machines:

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

Rarely, these disturbances persist after discontinuation of the medication. Therefore, caution should be exercised when driving or operating machinery.

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

3. How to take Mayesta 10 mg soft capsules

Follow exactly the instructions for administering Mayesta 10 mg provided by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will tell you how long to take Mayesta 10 mg. Do not stop treatment earlier.

The capsules should be taken with food, once or twice daily. Swallow the capsules whole without chewing or sucking them.

Adults, including adolescents and elderly patients:

The usual starting dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). After a few weeks, your doctor may adjust this dose depending on your response to treatment. The dose typically ranges between 0.5 and 1.0 mg/kg/day in most cases.

Before starting treatment with Mayesta 10 mg, please read the "Pregnancy Prevention Plan" in the section “Warnings and Precautions”.

Patients with severe renal impairment:

Treatment should be initiated with a lower dose of Mayesta 10 mg, for example, 10 mg/day, and increased later if needed.

Children:

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

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

If you feel that the effect of Mayesta 10 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Mayesta 10 mg than you should:

If you have taken more Mayesta 10 mg than prescribed, contact your doctor or pharmacist immediately.

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

If you forget to take Mayesta 10 mg:

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

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed dose and wait for the next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Mental problems

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

Depression or related disorders. These signs include sad or altered mood, anxiety, and 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 experienced feelings or thoughts about harming themselves or ending their own lives (suicidal thoughts), have attempted suicide, or have died by suicide. These individuals may not appear to be depressed.

Unusual behaviour.

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 any signs of these mental health problems. Your doctor may tell you to stop taking Mayesta 10 mg. This may not be enough to stop the effects: you may need further help, which your doctor can manage.

It is very important to inform your doctor if you have previously had any illness such as depression, suicidal behaviour, or psychosis, and if you are taking any medication to treat these conditions.

Other serious adverse effects

Allergic reactions: Chest tightness or difficulty breathing (especially if you are asthmatic), accompanied by skin rash and itching. If you experience an allergic reaction, treatment must be stopped immediately and you should consult your doctor.

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

Increased intracranial pressure (in the brain): Very rarely, when isotretinoin is administered together with certain antibiotics, increased intracranial pressure, seizures, and drowsiness have been observed. If you experience persistent headache associated with nausea, vomiting, and blurred vision, this may indicate benign intracranial hypertension. Stop taking isotretinoin immediately and consult your doctor.

Gastrointestinal 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 bloody diarrhoea and vomiting, stop taking isotretinoin immediately and consult your doctor.

Liver disorders: Hepatitis. If your skin or eyes turn yellow and you feel tired, stop taking the medication immediately and consult your doctor.

Renal disorders: Glomerulonephritis (inflammation of the kidneys). You may feel excessively tired, pass little or no urine, and have swollen, puffy eyelids. If this occurs while taking your medication, stop treatment and consult your doctor.

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

Stop taking isotretinoin and seek immediate medical attention if you notice any of the following symptoms of serious skin reactions:

Skin and hair problems: Severe skin rash (erythema multiforme), initially appearing as circular spots often with a blistered centre, usually on the arms and hands or legs and feet, but may affect any part of the body.

Flat, non-elevated red patches, target-shaped or circular, on the trunk, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome [SJS]/toxic epidermal necrolysis [TEN]).

Generalised reddish rash with skin peeling, lumps under the skin, and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis [AGEP]).

Non-serious adverse effects

The following non-serious 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, especially of the lips and face. You may experience throat or skin inflammation, chapped skin or lips, rash, mild itching, and slight peeling. This dryness can be reduced by regular use of a good moisturiser from the start of treatment.

You may feel your eyes are tired and slightly irritated. Very rarely, contact lens wearers have needed to switch to glasses during treatment due to dry eyes.

These adverse effects are usually reversible once treatment is stopped.

Dermabrasion and waxing should be avoided during treatment and for at least six months afterwards, as they may cause skin scarring or irritation.

Musculoskeletal disorders: Low back pain (lumbago), muscle pain, and joint pain have been frequently reported. These effects are reversible once treatment is discontinued. Intensive physical activity should be minimized during isotretinoin therapy.

The following non-serious adverse effects have been reportedrarely**in patients taking isotretinoin:

Acne may worsen during the first weeks of treatment. However, your acne and other symptoms should improve as treatment continues.

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

You should take measures to protect yourself from sunlight, such as using a high-protection sunscreen (at least SPF 15). Avoid exposure to ultraviolet light. Very rarely, night vision or colour discrimination may be affected, or you may need to wear sunglasses. In some cases, intense eye irritation or eyelid inflammation, corneal opacities, keratitis, and cataracts have occurred. If this happens, inform your doctor immediately so that your vision can be monitored.

Musculoskeletal disorders: Arthritis and occasional tendon pain have been reported very rarely.

Local infections: Infections of the tissue around the base of the nails, pus-discharging swellings, nail changes.

Skin and hair changes: You may notice some changes in your hair (hair loss or, rarely, increased growth). This is usually temporary, and persistent hair thinning is rare. Thickening of surgical scars, increased facial pigmentation, and increased body hair may also occur.

Blood and urine laboratory abnormalities: Very rarely, a decreased white blood cell count has been reported, and you may develop swollen lymph nodes. Blood clotting may be delayed. Occasionally, abnormal levels of urea, blood sugar, or liver enzymes in the blood have been observed. Your doctor may wish to perform blood tests before, during, and after your treatment.

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

Lipid disorders: Since isotretinoin may cause abnormalities in blood levels of fat-like substances (triglycerides and cholesterol) in some patients, alcohol consumption is not recommended. If your doctor finds 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 available data) in patients taking isotretinoin:

Problems achieving or maintaining an erection.

Decreased libido.

Breast swelling with or without tenderness in men.

Vaginal dryness.

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

Urethritis (inflammation of the urethra).

Anal fissure (a small tear in the thin, moist tissue lining the anus).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused or expired medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

Return any unused capsules to your pharmacist. Keep them only if your doctor instructs you to do so.

6. Package contents and other information

Composition of Mayesta 10 mg soft capsules

• The active substance is isotretinoin. Each soft capsule contains 10 mg of isotretinoin.
• The other components are: refined soya oil, yellow beeswax, hydrogenated soya oil, partially hydrogenated vegetable oil, gelatin, glycerol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and purified water.

Appearance of the product and contents of the pack

Mayesta 10 mg are orange-red colored, oval-shaped soft capsules. Each package contains 50 soft capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Manufacturer:

PHARMATHEN S.A.

Dervenakion 6

15351 Pallini ATTIKI. GREECE

PHARMATHEN INTERNATIONAL S.A.

Sapes Industrial Park, Block 5

Rodopi 69300. GREECE

Date of the most recent revision of this leaflet: April 2026

Detailed and up-to-date information on this product is available by scanning the QR code included in the leaflet using a smartphone. The same information is also available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/