Acnemin 20 mg soft capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acnemin 10 mg soft capsules EFG

Acnemin 20 mg soft capsules EFG

Isotretinoin

Read the entire 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Acnemin is and what it is used for
What you need to know before taking Acnemin
How to take Acnemin
Possible adverse effects
How to store Acnemin
Contents of the pack and other information

1. What Acnemin is and what it is used for

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

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

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

Acnemin treatment must be supervised by a dermatologist (a doctor specialized in treating skin conditions).

2. What you need to know before taking Acnemin

Do not take Acnemin:

If you are pregnant or breastfeeding.
If there is any possibility you could become pregnant, you must follow the precautions outlined in the "Pregnancy Prevention Programme", see the section "Warnings and precautions".
if you are allergic to isotretinoin or to any of the other ingredients of this medicine (listed in section 6), especially peanuts or soya.
if you have hepatic insufficiency (serious liver disease).
if you have high levels of lipids in the blood (e.g. high cholesterol, high triglycerides).
if you have very high levels of vitamin A in your body (hypervitaminosis A).
if you are taking any antibiotic from the tetracycline family (see section “Other medicines and Acnemin”).

If any of these apply to you, please consult your doctor before taking Acnemin.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Acnemin.

If you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. Also included are thoughts of self-harm or ending your life. This is because your mood may be affected while taking Acnemin.

Pregnancy Prevention Programme

Pregnant women must not take Acnemin

This medicine can seriously harm the unborn baby (the medicine is considered "teratogenic") – it may cause severe abnormalities of the baby's brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of miscarriage. This can occur even if Acnemin is taken for only a short time during pregnancy.

You must not take Acnemin if you are pregnant or think you might be pregnant.
You must not take Acnemin if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
You must not take Acnemin if you could become pregnant during treatment.
You must not become pregnant during the month following discontinuation of treatment because medicine may still remain in your body.

Women who could become pregnant are prescribed Acnemin under strict rules due to the risk of serious harm to the unborn baby.

These are the rules:

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 take a pregnancy test. The test must confirm that you are not pregnant when starting treatment with Acnemin.

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

You must agree to use at least one highly reliable method of contraception (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 Acnemin, throughout 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 Acnemin

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 1 month after stopping Acnemin (due to the possibility that medicine may still remain in your body), unless your doctor decides otherwise.
You must agree to undergo additional pregnancy tests if requested by your doctor.
You must not become pregnant during treatment or within one month after stopping it, as 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 Acnemin, 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 Acnemin, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Your doctor will provide you with information about pregnancy prevention for users of Acnemin.

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

Warning for men

Levels of oral retinoids in the semen of men taking Acnemin 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 anyone else. 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 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 behaviour, so it is very important to inform your friends and family that you are taking this medication. They may observe these changes and help you quickly identify any issues that need to be discussed with your doctor.

Warnings for all patients

Tell your doctor if you have ever had a mental illness (including depression, suicidal behaviour, or psychosis), or if you are taking medication for any of these conditions.
Severe skin reactions have been reported (e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN)) with the use of Acnemin. Skin rash may progress to widespread blistering or peeling of the skin. You should also be alert for the development of ulcers in the mouth, throat, nose, or genitals, as well as the onset of conjunctivitis (redness and swelling of the eyes).
In rare cases, Acnemin may cause severe allergic reactions, some of which may affect the skin in the form of eczema, urticaria (skin rash with raised bumps), and bruises or red spots on the arms and legs. If you experience an allergic reaction, stop taking the medicine immediately, seek medical attention, and inform your doctor that you are taking this medication.
Reduce physical activity and intense exercise. Acnemin may cause muscle and joint pain, especially in children and adolescents. Acnemin has been associated with inflammatory bowel disease. If you develop severe bloody diarrhoea and have no history of gastrointestinal disorders, your doctor will discontinue isotretinoin treatment.
Acnemin may cause dry eyes, intolerance to contact lenses, and visual difficulties such as reduced night vision. Cases of persistent dry eyes that do not resolve after stopping treatment have been reported. Contact your doctor if you experience any of these symptoms. Your doctor may recommend using a lubricating eye ointment or artificial tears. If you wear contact lenses 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 evaluation and may ask you to stop treatment with Acnemin.
Talk to your doctor if you experience persistent lower back or buttock pain during treatment with Acnemin. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue Acnemin treatment and refer you to a specialist for management of inflammatory back pain. Additional evaluation, including imaging modalities such as magnetic resonance imaging (MRI), may be required.
- Cases of benign intracranial hypertension have been reported with the use of Acnemin, and in some cases when Acnemin was used together with tetracyclines (a type of antibiotic). Stop taking isotretinoin and contact your doctor immediately if you experience symptoms such as headache, nausea, vomiting, or visual disturbances. Your doctor may refer you to a specialist to check for swelling of the optic disc (papilledema).
- Acnemin may increase liver enzyme levels. Your doctor will request blood tests before, during, and after treatment with Acnemin to monitor these levels. If levels remain elevated, your doctor may reduce your dose or discontinue Acnemin treatment.
- Acnemin often increases blood lipid levels, such as cholesterol and triglycerides. Your doctor will request blood tests before, during, and after treatment with Acnemin. It is best not to consume alcoholic beverages during treatment, or at least reduce your usual intake. Consult your doctor if you already have high blood lipid levels, have diabetes, are overweight, or consume excessive alcohol. You may need more frequent blood tests. If your blood lipid levels remain elevated, your doctor may reduce your dose or discontinue Acnemin treatment.
- Contact 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 may increase blood sugar levels. In rare cases, this may lead to the development of diabetes. Your doctor may monitor your blood sugar levels during treatment. This is especially important if you already have diabetes, are overweight, or consume excessive alcohol.
- You are likely to experience dry skin: use a moisturizing cream and lip balm. To prevent skin irritation, avoid using "exfoliating" products or other acne treatments.
- Avoid sun exposure and do not use sunlamps or tanning beds. Your skin may become more sensitive to sunlight. Apply a high-protection sunscreen (SPF 15 or higher) before sun exposure.
- Do not undergo any cosmetic skin treatments. Acnemin may make your skin more fragile. Do not wax, or undergo dermabrasion or laser treatments (to remove thickened skin or scars) during treatment or within 6 months after stopping treatment. This could lead to scarring, skin irritation, or, in rare cases, changes in skin colour.

Children and adolescents

The use of Acnemin is not recommended in children under 12 years of age, as it is not known whether 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

Consult your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal products and over-the-counter medications.

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

Pregnancy and breastfeeding

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

For more information on contraception, pregnancy, and breastfeeding, see section 2 “Pregnancy Prevention Programme”.

Driving and use of machines

You may experience problems with night vision during treatment. This may occur suddenly. In rare cases, it has persisted after treatment has been stopped.

Very rarely, drowsiness and dizziness have been reported. If this occurs, you should not drive or operate machinery.

Acnemin contains soya oil

Do not use if you are allergic to peanuts or soya.

Acnemin contains sodium

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

3. How to take Acnemin

Follow exactly the instructions for using this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

Take the capsules once or twice a day.

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

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

If you have severe kidney problems, you will usually start with a lower dose (e.g., 10 mg daily), which will be gradually increased until reaching 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 return.

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 ends. Typically, another cycle will not be started before this period has passed.

In some people, acne may worsen during the first week of treatment. Usually, it improves as treatment progresses.

If you take more Acnemin than you should

If you take too many capsules, or if someone else accidentally takes your medicine, 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 immediately or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Acnemin

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 with your regular schedule. Do not take a double dose (two doses at the same time) to make up for a missed dose.

Opening the blister pack

To ensure proper removal of the capsules without damaging them, follow the procedure described below:

The blister has an unscored area at the back, which can be peeled off (image 1).
Carefully remove the lid foil as shown in the image (image 2 and 3).
Carefully remove the capsule from its compartment.

Three sequential diagrams show how to handle a blister pack by pressing and lifting the back part with one hand to remove the pills

4. Possible adverse effects

This medicine may cause adverse effects, although not everyone experiences them. Some of the adverse effects associated with the use of isotretinoin are dose-related. Adverse effects are usually reversible after adjusting the dose or stopping treatment; however, some may persist even after treatment has been discontinued. Some adverse effects may be serious and require immediate medical attention.

Side effects requiring immediate medical attention

Skin problems

Frequency not known (cannot be estimated from available data)

This medicine may cause severe skin rashes (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be potentially life-threatening and will require urgent medical help. These rashes often start as red spots on the arms, hands, legs, or feet, which may contain blisters. In more severe rashes, blisters may 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 may cause widespread skin peeling, which can be fatal. These serious skin rashes are often preceded by headache, body aches, and fever (flu-like symptoms).

If you experience a severe skin rash or these skin symptoms, stop taking Acnemin immediately and consult your doctor without delay.

Mental health problems

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

Depression or related disorders. These signs include sad or changed 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), attempted suicide, or died by suicide. These individuals may not appear 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 any of these mental health symptoms. Your doctor may instruct you to stop taking Acnemin. This may not be sufficient to stop the effects; you may need further help, which your doctor can manage.

Allergic reactions

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

Severe allergic reactions (anaphylactic shock): difficulty breathing or swallowing due to 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 tightness in the chest, difficulty breathing, and wheezing, especially if you have asthma.

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

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

Muscle and bone disorders

Frequency not known (cannot be estimated from available data)

Muscle weakness that may be potentially life-threatening, possibly associated with difficulty moving arms or legs, pain, swelling, bruising, dark or brown urine, reduced or absent urine output, confusion, or dehydration. These are signs of rhabdomyolysis, the breakdown of muscle fibers that can lead to kidney failure. This may occur if you engage in intense physical activity while taking 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 tiredness. 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, accompanied by malaise (nausea), vomiting, and vision disturbances including blurred vision. These may be signs of benign intracranial hypertension, especially if Acnemin is taken with antibiotics called tetracyclines. Stop taking Acnemin immediately and consult your doctor.

Intestinal and stomach disorders

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

Severe abdominal (stomach) pain, with or without severe bloody diarrhea, malaise (nausea), and vomiting. These may be signs of serious 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 experience 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 the lips and face; red and sore skin, cracked and inflamed lips, skin rash, mild itching, and slight peeling. Using a moisturizing cream from the start of treatment may reduce the risk of these disorders.
The skin may become more fragile and redder than usual, especially on the face.
Back, muscle, and joint pain, especially in children and adolescents. To prevent worsening of muscle and bone disorders, reduce intense physical activity while taking Acnemin.
Inflammation of the eyes (conjunctivitis) and eyelids; dry and irritated eyes. Consult your pharmacist for advice on a suitable eye drop. If you have dry eyes and wear contact lenses, you may need to switch to glasses.
Elevated liver enzyme levels in blood tests.
Changes in blood fat levels (such as HDL cholesterol and triglycerides).
Increased tendency to bruise, bleed, or form clots: if blood cells responsible for clotting 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.
Elevated blood cholesterol levels.
Protein or blood in the urine.
Increased susceptibility to infections if white blood cells are affected.
Dryness and crusting inside the nostrils leading to minor nosebleeds.
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 temporary. Your hair should return to normal after treatment ends.

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, 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-than-usual skin, especially on the face.
Excessive sweating or itching.
Arthritis, bone disorders (delayed growth, extra growth, changes in bone density). May affect bone growth.
Formation of calcium deposits in soft tissues, painful tendons, high levels of muscle breakdown products in the blood if intense exercise is performed.
Increased light sensitivity.
Bacterial infection at the base of the nails and nail changes.
Inflammation, discharge, and pus.
Thickening of surgical scars.
Increased body hair.
Seizures, drowsiness, and dizziness.
Lymph nodes may become swollen.
Dry throat, hoarseness.
Hearing problems.
General malaise.
Elevated blood uric acid levels.
Bacterial infections.
Inflammation of blood vessels (sometimes with bruising and red spots).

Frequency not known (cannot be estimated from available data)

Dark or brown urine.
Difficulty 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).

Reporting suspected adverse reactions:

It is important to report suspected adverse reactions to the medicine after it has been authorized. This allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are encouraged to report suspected adverse reactions via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

5. Storage of Acnemin

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Store the blister in the original packaging and keep the blister inside the cardboard box to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

The active substance is isotretinoin.

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

Nature of the product and contents of the pack

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

Acnemin 10 mg soft capsules EFG are opaque, oval-shaped, light pink soft gelatin capsules, approximately 9.30±0.5 mm in length and 6.60±0.5 mm in width, containing an orange-yellow oily suspension.

Acnemin 20 mg soft capsules EFG are opaque, oval-shaped, reddish-orange soft gelatin capsules, approximately 13.20±0.5 mm in length and 7.80±0.5 mm in width, containing an orange-yellow oily suspension.

The capsules are packed 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
The Netherlands

This product is authorised in the EEA Member States under the following names:

Germany: Isotretinoin Basics 10 mg Weichkapseln
Isotretinoin Basics 20 mg Weichkapseln

Spain: Acnemin 10 mg soft capsules EFG
Acnemin 20 mg soft capsules EFG

Hungary: Sotret Neo 10 mg lágy kapszula
Sotret Neo 20 mg lágy kapszula

Italy: Isotretinoina SUN 10 mg capsule molli
Isotretinoina SUN 20 mg capsule molli

Netherlands: Isotretinoïne SUN 10 mg, zachte capsules
Isotretinoïne SUN 20 mg, zachte capsules

Poland: Sotret 10 mg
Sotret 20 mg

Romania: Isotretinoin Terapia 10 mg capsule moi
Isotretinoin Terapia 20 mg capsule moi

United Kingdom: Isotretinoin 10 mg soft capsules
Isotretinoin 20 mg soft capsules

This leaflet was last reviewed in: September 2024

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

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