ACNEMIN 10 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Acnemin 10 mg Soft Capsules EFG

Acnemin 20 mg Soft Capsules EFG

Isotretinoin

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Acnemin and what is it used for
2. What you need to know before you take Acnemin
3. How to take Acnemin
4. Possible side effects
5. Storing Acnemin
6. Contents of the pack and other information

1. What is Acnemin and what is it used for

Acnemin contains isotretinoin,a substance related to vitamin A and belonging to the group of medicines called retinoids(for the treatment of acne).

Acnemin is indicated for the treatment of severe forms of acne(such as nodular acne, conglobate acne, or acne with a risk of permanent scarring) in adults and adolescents.

You will use Acnemin when acne has not improved with anti-acne treatments, including antibiotics and skin treatments. Acnemin should not be used to treat pubertal acne or in children under 12 years of age.

Acnemin treatment should be supervised by a dermatologist(a doctor specializing in skin problem treatments)

2. What you need to know before you start taking Acnemin

Do not take Acnemin:

• If you are pregnant or breastfeeding

• If there is a possibility that you may become pregnant, you must follow the "Pregnancy Prevention Plan" precautions, see the "Warnings and Precautions" section.
• isotretinoin or to any of the other componentsof this medicine (listed in section 6), especially peanuts or soy.
• (severe liver disease).
• (e.g., cholesterol, elevated triglycerides).
• Ain the body (hypervitaminosis A)
• any antibiotic from the tetracyclinefamily (see section "Other medicines and Acnemin")

If any of these apply to you, go back to your doctor before taking Acnemin

Warnings and precautions

Talk to your doctor or pharmacist before starting Acnemin.

• 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 Acnemin.

Pregnancy Prevention Plan

Pregnant women should not take Acnemin

This medicine can seriously harm the baby (the medicine is considered "teratogenic") - it can cause serious brain, face, ear, eye, heart, and certain gland abnormalities (thymus and parathyroid) in the baby. It also increases the likelihood of spontaneous abortion. This can happen even if Acnemin is taken for only a short period during pregnancy.

• Do not take Acnemin if you are pregnant or think you may be pregnant.
• Do not take Acnemin if you are breastfeeding. It is likely that the medicine will pass into your milk and may harm your baby.
• Do not take Acnemin if you may become pregnant during treatment.
• Do not become pregnant during the month following the end of this treatment because the medicine may still be in your body.

Women who could become pregnant are prescribed Acnemin 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 give you 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 Acnemin.

Women must use effective contraceptives before, during, and after taking Acnemin

• 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 a month before taking Acnemin, during treatment, and for a month after finishing treatment.
• You must use contraceptives even if you do not have your period or are not sexually active (unless your doctor decides it is not necessary)

Women must accept to have pregnancy tests before, during, and after taking Acnemin

• 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 medicine may still be in your body, 1 month after finishing treatment with Acnemin (unless your doctor decides it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or for a month after, because the medicine may still be 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 Acnemin, stop taking the medicine immediatelyand talk to your doctor. Your doctor may refer you to a specialist for advice.

Also, if you become pregnant within a month after stopping Acnemin, you should talk to your doctor. Your doctor may refer you to a specialist for advice.

Your doctor has written information about pregnancy prevention for Acnemin users that should be given to you.

A new prescription will be needed for further treatment. Each prescription is only valid for 7 days.

Warning for men

The levels of oral retinoids in the semen of men taking Acnemin are too low to harm the baby of their partners. However, you should 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.

Do not donate blood during treatment with this medicine or for 1 month after stopping Acnemin, because a baby could be harmed if a pregnant patient receives your blood.

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 medicine. They may notice these changes and help you identify any problems you need to talk to your doctor about.

Warnings for all patients

• Tell your doctor if you have ever had any mental illness(including depression, suicidal behavior, or psychosis), or if you are taking medicines for any of these conditions.
• Severe skin reactions(e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN)) have been reported with the use of Acnemin. The skin rash may progress to widespread blistering or peeling of the skin. You should also be aware of the development of ulcers in the mouth, throat, nose, or genitals, as well as conjunctivitis (redness and swelling of the eyes).
• Acnemin can cause serious allergic reactions,some of which may affect the skin in the form of eczema, urticaria (skin rash with bumps), and bruising or red spots on arms and legs. If you experience an allergic reaction, stop taking the medicine, go to your doctor immediately, and tell them you are taking this medicine.
• Reduce physical activity and intense exercise. Acnemin can cause muscle and joint pain, especially in children and adolescents. Acnemin has been associated with inflammatory bowel disease.If you experience severe diarrhea with blood and have no history of gastrointestinal disorders, your doctor will stop treatment with isotretinoin.
• Acnemin can cause dry eyes, intolerance to contact lenses, and visual difficulties such as decreased night vision. There have been reports of dry eyes that do not resolve after treatment is stopped. Contact your doctor if you experience any of these symptoms. Your doctor may recommend the use of an eye lubricant or artificial tears. If you are a contact lens user and develop intolerance, you may be advised to wear glasses during treatment. If you experience visual disturbances, your doctor may refer you to a specialist for advice and may ask you to stop treatment with Acnemin.

• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Acnemin.These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Acnemin and refer you to a specialist for the treatment of inflammatory back pain. Further evaluation may be necessary, including imaging techniques such as magnetic resonance imaging.
• • Benign intracranial hypertension has been reported with the use of Acneminand, in some cases, when Acnemin was used with tetracyclines (a type of antibiotic). Stop taking isotretinoin and talk to your doctor immediately if you experience symptoms such as headache, nausea, vomiting, and vision changes. Your doctor may refer you to a specialist to check for papilledema (inflammation of the optic disc).
  • Acnemin can increase liver enzyme levels. Your doctor will ask you to have a blood test before, during, and after treatment with Acnemin to check these levels. If they remain high, your doctor may reduce the dose or stop treatment with Acnemin.
  • Acnemin often increases blood fat levels, such as cholesterol or triglycerides. Your doctor will ask you to have a blood test before, during, and after treatment with Acnemin. During treatment, it is best not to consume alcoholic beverages or to reduce the amount you usually drink during treatment. Talk to your doctor if you already have high blood fat levels, suffer from diabetes, are overweight, or consume too much alcohol. You may need to have blood tests more often. If your blood fat levels remain high, your doctor may reduce the dose or stop treatment with Acnemin.
  • Talk to your doctor if you have any kidney problems. Your doctor may start treatment with a lower dose of Acnemin and gradually increase it to the maximum tolerated dose.
  • Acnemin can increase blood sugar levels. In rare cases, the person may develop diabetes. Your doctor may perform blood sugar level checks during treatment. This is especially important if you already suffer from diabetes, are overweight, or consume too much alcohol.
  • It is likely that your skin will become dry:use a moisturizing cream and lip balm. To prevent skin irritation, it is best not to use "exfoliating" products or other acne treatments.
  • Avoid exposure to the sun and do not use sunlamps or sunbeds.Your skin may become more sensitive to sunlight. Before exposing yourself to the sun, apply a sunscreen with a high protection factor (SPF 15 or higher).
  • Do not have any cosmetic treatments on your skin.Acnemin can make your skin more fragile. Do not wax or have dermabrasion or laser treatments (to remove thickening of the skin's outer layer or scars) during treatment or for 6 months after treatment. This could cause scarring, skin irritation, or, in rare cases, changes in skin color.

Children and adolescents

Acnemin is not recommended for use in children under 12 years of age. This is because it is not known if it is safe or effective in this age group.

Acnemin should not be used to treat prepubertal acne or in children under 12 years of age.

Other medicines and Acnemin

Talk to your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal products and those without a prescription.

• Do not take supplements containing vitamin A or tetracyclines(a type of antibiotic), or use other acne treatments that dry or peel the skin, while taking Acnemin. You can use moisturizing and emollient products (creams or preparations that prevent water loss and have a soothing effect on the skin).
• Avoid using keratolytic or exfoliating preparationsfor acne by topical route while taking Acnemin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor before taking this medicine.

For more information on contraception, pregnancy, and breastfeeding, see section 2 "Pregnancy Prevention Plan",

Driving and using machines

You may have problems with night vision during treatment. This can occur suddenly. In rare cases, it has continued after treatment is stopped.

In very rare cases, drowsiness and dizziness have been reported. If this happens to you, do not drive or use machinery.

Acnemin contains soybean oil

It should not be used in case of peanut or soy allergy.

Acnemin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; that is, it is essentially "sodium-free".

3. How to take Acnemin

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The usual starting doseis 0.5 mg per kilogram of body weight and per day (0.5 mg/kg/day). Therefore, if you weigh 60 kg, you will normally start with a dose of 30 mg per day.

Take the capsules once or twice a day.

Take them with a full stomach. Swallow them whole with a drink. Do not chew the capsules.

After a few weeks, your doctor may adjust your dose.This will depend on how you feel the medicine is affecting you. For most people, the dose will be between 0.5 and 1 mg/kg/day. If you think Acnemin is too strong or too weak, talk to your doctor or pharmacist.

If you have severe kidney problems,you will normally start with a lower dose (e.g., 10 mg per day) that will be gradually increased to the maximum dose your body can tolerate. If your body cannot tolerate the recommended dose, a lower dose may be prescribed. This means that treatment will be longer and it is more likely that your acne will come back.

A treatment cycle usually lasts between 16 and 24 weeks.Most people only need one cycle. Your acne may continue to improve for up to 8 weeks after treatment. You will not normally start another cycle until this time has passed.

It is possible that your acne may worsen during the first week of treatment. It usually improves as treatment progresses.

If you take moreAcneminthan you should

If you take too many capsules, or if someone else takes your medicine by accident, contact your doctor or pharmacist immediately, or go to the nearest hospital.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeAcnemin.

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as before. Do not take a double dose (two doses at the same time) to make up for missed doses.

4. Possible Adverse Effects

This medication may produce adverse effects, although not all people will suffer from them. Some of the adverse effects associated with the use of isotretinoin are related to the dose. Adverse effects are generally reversible after changing the dose or suspending treatment; however, some may continue after treatment has been stopped. Some adverse effects may be severe and should be communicated to your doctor immediately.

Side Effects that Require Immediate Medical Attention

Skin Problems

Unknown Frequency(cannot be estimated from available data)

• This medication may cause severe skin rashes (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be potentially fatal and require urgent medical attention. They often begin with hives on the arms, hands, legs, or feet, which may contain blisters. In more severe skin rashes, blisters can form on the chest and back. They may be accompanied by other symptoms, such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. The most severe forms of skin rash can cause the skin to peel off in a generalized manner, which can be fatal. These severe skin rashes are usually preceded by headache, body pain, and fever (flu-like symptoms)

If you experience a severe skin rash or these skin symptoms, stop taking Acnemin and consult your doctor immediately.

Mental Problems

Rare Adverse Effects(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 Adverse Effects(may affect up to 1 in 10,000 people)

• Some people have had thoughts of self-harm or ending their own life (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not appear 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 Acnemin. This may not be enough to stop the effects: you may need more help, and your doctor can manage it.

Allergic Reactions

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

• Severe allergic reactions (anaphylactic shock): difficulty breathing or swallowing caused by a sudden swelling of the throat, face, lips, and mouth. Also, sudden swelling of the hands, feet, and ankles.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Sudden chest tightness, difficulty breathing, and wheezing, especially if you have asthma.

If you have a severe reaction, get emergency medical help immediately.

If you have an allergic reaction, stop taking Acnemin immediately and contact your doctor.

Muscle and Bone Disorders

Unknown Frequency(cannot be estimated from available data)

• Muscle weakness that can be potentially fatal, may be associated with difficulty moving the arms or legs, pain, swelling, bruising on the body, dark-colored urine, reduced or absent urine output, confusion, or dehydration. These are signs of rhabdomyolysis, breakdown of muscle fibers that can lead to kidney failure. This can occur if you engage in intense physical activity while being treated with Acnemin.

Liver and Kidney Disorders

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Yellowing of the skin or eyes, and fatigue. These may be signs of hepatitis. Stop taking Acnemin immediately and consult your doctor.
• Difficulty urinating, swollen and inflamed eyelids, excessive fatigue. These may be signs of kidney inflammation. Stop taking Acnemin immediately and consult your doctor.

Nervous System Disorders

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Persistent headache, along with a feeling of discomfort (nausea), vomiting, and changes in vision, including blurred vision. These may be signs of benign intracranial hypertension, especially if Acnemin is taken with antibiotics called tetracycline. Stop taking Acnemin immediately and consult your doctor.

Gastrointestinal and Stomach Disorders

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Severe abdominal (stomach) pain, with or without severe diarrhea with blood, discomfort (nausea), and vomiting. These may be signs of severe intestinal conditions. Stop taking Acnemin immediately and consult your doctor.

Eye Disorders

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Blurred vision.

If you have blurred vision, stop taking Acnemin immediately and consult your doctor. If your vision is affected in any other way, inform your doctor as soon as possible.

Other Side Effects

Very Common Adverse Effects with Acnemin(may affect more than 1 in 10 people)

• Dry skin, especially on lips and face; red and painful skin, cracked and inflamed lips, skin rash, mild itching, and slight peeling. If you use a moisturizing cream from the beginning of treatment, you can reduce the risk of these disorders.
• The skin may become more fragile and reddened than usual, especially on the face.
• Back pain, muscle and joint pain, especially in children and adolescents. To avoid worsening muscle and bone disorders, reduce intense physical activity while taking Acnemin.
• Eye inflammation (conjunctivitis) and eyelids; dry and irritated eyes. Consult your pharmacist for a suitable eye drop. If you have dry eyes and are a contact lens user, you may need to wear glasses.
• High levels of liver enzymes in blood tests.
• Changes in blood fat levels (such as HDL cholesterol and triglycerides).
• Increased tendency to bruise, bleed, and form blood clots: if the blood cells responsible for coagulation are affected.
• Anemia (weakness, dizziness, pale skin): if red blood cells are affected.

Common Adverse Effects(may affect up to 1 in 10 people)

• Headache.
• High cholesterol levels in the blood.
• Protein or blood in the urine.
• Increased susceptibility to infections if white blood cells are affected.
• Dryness and crust formation inside the nasal passages, causing minor bleeding.
• Pain and inflammation of the throat and nose.
• Allergic reactions such as skin rash or itching. If you have an allergic reaction, stop taking Acnemin immediately and contact your doctor.

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

• Hair loss (alopecia), which is usually a temporary effect. Your hair will return to normal after the end of treatment.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Decreased night vision and worsening of color blindness (chromatic vision defects).
• Increased sensitivity to light, you may need to wear sunglasses to protect your eyes.
• Other visual problems, including blurred vision, distorted vision, corneal opacity, and cataracts.
• Excessive thirst, frequent urination, and increased blood sugar levels. These may be symptoms of diabetes.
• Acne may worsen during the first few weeks, but symptoms should improve over time.
• Inflamed, swollen, and darker skin than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis, bone disorders (delayed growth, excessive growth, and changes in bone density). It may affect bone growth.
• Formation of calcium deposits in soft tissues, painful tendons, high levels of muscle breakdown in the blood if intense exercise is performed.
• Increased sensitivity to light.
• Bacterial infection at the base of the nails and changes in the nails.
• Inflammation, suppuration, and pus.
• Thickening of scars after surgery.
• Increased body hair.
• Seizures, drowsiness, and dizziness.
• Lymph nodes may become inflamed.
• Dry throat, hoarseness.
• Hearing problems.
• General discomfort.
• High levels of uric acid in the blood.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising and red spots).

Unknown Frequency(cannot be estimated from available data)

• Dark or brown urine.
• Difficulty achieving or maintaining an erection
• Decreased libido
• Swelling of the breasts with or without sensitivity in men
• Vaginal dryness
• Sacroleitis, a type of inflammatory lower back pain that causes pain in the buttocks or lower back.
• Urethral inflammation

Notification of suspected adverse reactions:

It is important to notify suspected adverse reactions to the medication after its authorization. This allows for continuous monitoring of the benefit/risk relationship of the medication. Healthcare professionals are invited to notify suspected adverse reactions through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

5. Storage of Acnemin

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Keep the blister pack in the original packaging and keep the blister pack in the cardboard box to protect it from light.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy.

6. Package Contents and Additional Information

The active ingredientis isotretinoin.

The other ingredients are:hydrogenated soybean oil, hydrogenated vegetable oil, white beeswax, disodium edetate, butylhydroxyanisole (E320), refined soybean oil, polysorbate 80, gelatin, glycerol (E422), red iron oxide (E172), titanium dioxide (E171), light liquid paraffin.

Appearance of the Product and Package Contents

Acnemin is available in soft capsules containing 10 mg or 20 mg of isotretinoin.

Acnemin 10 mg soft capsules EFG consist of opaque soft gelatin capsules, oval shape, and light pink color, with an approximate length of 9.30±0.5 mm and 6.60±0.5 mm in width, containing an orange-yellow oily suspension.

Acnemin 20 mg soft capsules EFG consist of opaque soft gelatin capsules, oval shape, and orange-red color, with an approximate length of 13.20±0.5 mm and 7.80±0.5 mm in width, containing an orange-yellow oily suspension.

The capsules are packaged in blisters of 20, 30, 50, 60, and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Laboratorios Viñas, S.A.

Provenza, 386

08025 - Barcelona

Spain

Manufacturer:

Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca

400632 Romania

Alkaloida Chemical Company Zrt

Kabay János u.29

Tiszavasvári

H-4440 Hungary

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

This product is authorized in the EEA member states under the following names:

Germany Isotretinoin Basics 10 mg soft capsules

Isotretinoin Basics 20 mg soft capsules

Spain: Acnemin 10 mg soft capsules EFG

Acnemin 20 mg soft capsules EFG

Hungary Sotret Neo 10 mg soft capsules

Sotret Neo 20 mg soft capsules

Italy Isotretinoina SUN 10 mg soft capsules

Isotretinoina SUN 20 mg soft capsules

Netherlands Isotretinoïne SUN 10 mg, soft capsules

Isotretinoïne SUN 20 mg, soft capsules

Poland Sotret 10 mg

Sotret 20 mg

Romania Isotretinoin Terapia 10 mg soft capsules

Isotretinoin Terapia 20 mg soft capsules

United Kingdom Isotretinoin 10 mg soft capsules

Isotretinoin 20 mg soft capsules

This leaflet was revised in: September 2024

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

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