AKNENORMIN 20 mg Capsules

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. Aknenormin, 20 mg, soft capsules
   1. WARNING
   2. You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. WHAT IS AKNENORMIN 20 mg AND WHAT IS IT USED FOR
4. IMPORTANT INFORMATION BEFORE TAKING AKNENORMIN 20 mg
   2. Aknenormin 20 mg is absolutely contraindicated in women who are pregnant or may become pregnant during treatment and for one month after treatment.
   3. When not to take Aknenormin 20 mg
   4. Warnings and precautions
   5. Instructions for all patients
   6. Do not donate blood during treatment with this medicine or for one month after stopping treatment.
   7. Never give this medicine to another person.
   8. Special instructions for women Pregnancy Prevention Program
   9. Women who are pregnant must not take Aknenormin 20 mg
   10. Aknenormin 20 mg may be prescribed to women of childbearing age only if they strictly follow the rules listed below.
   11. Women must use effective methods of contraception before, during, and after treatment with Aknenormin 20 mg
   12. Women must agree to have pregnancy tests before, during, and after treatment with Aknenormin 20 mg
   13. Advice for men
   14. Aknenormin 20 mg and other medicines
   15. Taking Aknenormin 20 mg with food and drink
   16. Pregnancy and breastfeeding
   17. Driving and using machines
   18. Important information about some of the ingredients of Aknenormin 20 mg
5. HOW TO TAKE AKNENORMIN 20 mg
   1. If you take more Aknenormin 20 mg than you should
   2. If you forget to take Aknenormin 20 mg
6. POSSIBLE SIDE EFFECTS
   1. Blood disorders
   2. Very common side effects
   3. Common side effects
   4. Very rare side effects
   5. Allergic reactions
   6. Rare side effects
   7. In case of a severe reaction, seek immediate medical attention.
   8. Diabetes
   9. Very rare side effects
   10. Mental disorders
   11. Rare side effects
   12. Very rare side effects
   13. In case of the above-mentioned mental disorders, you must
   14. Nervous system disorders
   15. Common side effects
   16. Very rare side effects
   17. Eye disorders
   18. Very common side effects
   19. Very rare side effects
   20. In case of blurred vision, you must stop taking Aknenormin 20 mg immediately and contact your doctor.
   21. Ear, nose, and throat disorders
   22. Common side effects
   23. Very rare side effects
   24. Gastrointestinal disorders
   25. Very rare side effects
   26. Liver and kidney disorders
   27. Very common side effects
   28. Very rare side effects
   29. Unknown frequency
   30. Skin and hair disorders
   31. Very common side effects
   32. Rare side effects
   33. Very rare side effects
   34. Unknown frequency
   35. Musculoskeletal and connective tissue disorders
   36. Very common side effects
   37. Very rare side effects
   38. Unknown frequency
   39. Other reactions
   40. Very common side effects
   41. Common side effects
   42. Very rare side effects
   43. Unknown frequency
   44. Reporting side effects
7. HOW TO STORE AKNENORMIN 20 mg
   1. Keep out of the sight and reach of children.
8. CONTENTS OF THE PACK AND OTHER INFORMATION
   1. What Aknenormin 20 mg contains
   2. What Aknenormin 20 mg looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names
   5. Date of last revision of the leaflet: 01/2024
   6. Detailed and up-to-date information on this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website: www.almirall.com/en/aknenormin

PATIENT INFORMATION LEAFLET: USER INFORMATION

Aknenormin, 20 mg, soft capsules

Isotretinoin

WARNING

CAN CAUSE SERIOUS HARM TO THE UNBORN CHILD
Women must use effective methods of contraception.
Do not use during pregnancy or suspected pregnancy.

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Aknenormin 20 mg and what is it used for
• 2. Important information before taking Aknenormin 20 mg
• 3. How to take Aknenormin 20 mg
• 4. Possible side effects
• 5. How to store Aknenormin 20 mg
• 6. Contents of the pack and other information

1. WHAT IS AKNENORMIN 20 mg AND WHAT IS IT USED FOR

Aknenormin 20 mg contains the active substance isotretinoin. Isotretinoin reduces
the secretion of fat by the skin glands. It prevents the formation of pimples and reduces
inflammatory nodules and pimples that occur in acne.
Aknenormin 20 mg is used to treat severe forms of acne or acne with a risk of permanent scarring. Aknenormin 20 mg is used when other anti-acne treatments, including antibiotics and topical treatments, have failed.

2. IMPORTANT INFORMATION BEFORE TAKING AKNENORMIN 20 mg

Aknenormin 20 mg is absolutely contraindicated in women who are pregnant or may become pregnant during treatment and for one month after treatment.

Isotretinoin can seriously harm the fetus. Due to the risk of birth defects, women of childbearing age can only be prescribed Aknenormin 20 mg if they meet specific requirements listed in the "Special instructions for women" section.

When not to take Aknenormin 20 mg

• if the patient is pregnant or breastfeeding
• if the patient has liver disease
• if the patient has high blood lipid levels
• if the patient has high levels of vitamin A in the blood (hypervitaminosis A)
• if the patient is being treated with tetracyclines (antibiotics)
• if the patient is allergic (hypersensitive) to isotretinoin, cochineal red (E 124), peanuts, or soy, or to any of the other ingredients of Aknenormin 20 mg (listed in section 6).

Warnings and precautions

If there is a risk that the patient may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program

Instructions for all patients

Before starting treatment with Aknenormin 20 mg, you should discuss the following with your doctor:

• If you have ever had mental health problems, including depression, aggression, or mood swings, as well as thoughts of self-harm or suicide. This is because Aknenormin 20 mg may affect your mood. Mental health problems You may not notice some changes in your mood and behavior, so it is very important to tell your friends and family that you are taking this medicine. They may notice such changes and help you identify problems that need to be discussed with your doctor.
• Aknenormin 20 mg may increase blood lipid levels and liver enzyme activity. Your doctor will order a blood test before, during, and after treatment to check their levels.
• You should tell your doctor if you have diabetes, alcoholism, obesity, or other disorders that affect blood lipid levels. More frequent monitoring of lipid and blood sugar levels may be necessary.
• You should discuss with your doctor if you experience persistent back pain or pain in the buttocks during treatment. These symptoms may indicate inflammatory back pain. Your doctor may stop treatment with Aknenormin 20 mg and refer you to a specialist for treatment of back pain. Further evaluation, including imaging tests such as MRI, may be necessary.

Do not donate blood during treatment with this medicine or for one month after stopping treatment.

If the patient's blood is given to a pregnant woman, she may give birth to a child with birth defects.

• You should protect your skin from intense sunlight or ultraviolet radiation (sunlamps or sunbeds).

In case of need, you should use products containing UV filters with a sun protection factor of at least 15.

• To prevent dryness and pain in the lips and skin, you should use a moisturizing cream and lip balm from the start of treatment.
• Cosmetic treatments such as chemical peeling or dermabrasion (removal of the top layers of the skin), laser treatments, and skin piercing should not be performed during treatment and for up to 5-6 months after its completion.
• You should avoid using wax depilatory products (hair removal) for at least 6 months after completing treatment, as there is a risk of skin tearing.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and vision problems, including night vision impairment. There have been cases of dry eyes that did not resolve after treatment. You should inform your doctor if you experience any of these symptoms. Your doctor may recommend using moisturizing eye ointments or tear substitutes. If you experience contact lens intolerance, your doctor may recommend wearing glasses during treatment. If you experience vision problems, your doctor may refer you to a specialist for advice and may recommend stopping isotretinoin.

Never give this medicine to another person.

All unused capsules should be returned to the pharmacist after completing treatment.

Special instructions for women Pregnancy Prevention Program

Women who are pregnant must not take Aknenormin 20 mg

This medicine can seriously harm the unborn child (it has a teratogenic effect).
It can cause serious damage to the brain, face, ear, eye, heart, and some glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage.
These effects can occur even if Aknenormin 20 mg is taken for a short period during pregnancy.

• Do not take Aknenormin 20 mg if you are pregnant or think you may be pregnant.
• Do not take Aknenormin 20 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
• Do not take Aknenormin 20 mg if you may become pregnant during treatment.
• You must not become pregnant for one month after completing treatment because the medicine may still be present in your body.

Aknenormin 20 mg may be prescribed to women of childbearing age only if they strictly follow the rules listed below.

The following conditions must be met:

• Your doctor must explain the risk of birth defects to you; you must understand why you must not become pregnant and how to prevent it.
• You must discuss contraception (birth control methods) with your doctor. Your doctor will provide you with information on pregnancy prevention methods. Your 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 at the start of treatment with Aknenormin 20 mg.

Women must use effective methods of contraception before, during, and after treatment with Aknenormin 20 mg

• You must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). You should discuss with your doctor which methods are most suitable for you.
• You must use a contraceptive method for one month before taking Aknenormin 20 mg, during treatment, and for one month after completing treatment.
• You must use contraception even if you do not menstruate or are not currently sexually active (unless your doctor decides it is not necessary).

Women must agree to have pregnancy tests before, during, and after treatment with Aknenormin 20 mg

• You must agree to have regular check-ups with your doctor, ideally every month.
• You must agree to have regular pregnancy tests, ideally every month during treatment and one month after completing treatment with Aknenormin 20 mg, because the medicine may still be present in your body (unless your doctor decides it is not necessary for you).
• You must agree to have additional pregnancy tests as recommended by your doctor.
• You must not become pregnant during and for one month after completing treatment, because the medicine may still be present in your body.
• Your doctor will discuss all these matters with you, using a checklist, and ask you (or your parent or legal guardian) to sign it. This form confirms that you have been informed of the risks and agree to follow the rules listed above. If you become pregnant while taking Aknenormin 20 mg, you must stop taking the medicine immediately and contact your doctor.Your doctor may refer you to a specialist for advice. Additionally, if you become pregnant within one month after completing treatment with Aknenormin 20 mg, you should contact your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

The amount of oral retinoids in the sperm of men taking Aknenormin 20 mg is too small to harm the unborn child of their partner. However, you should never share this medicine with anyone, especially women.

Aknenormin 20 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• Due to the risk of vitamin A overdose, you must not take any other products containing vitamin A.
• Do not take antibiotics from the tetracycline group, e.g., oxytetracycline, doxycycline, minocycline. They may cause increased intracranial pressure.
• Do not use other anti-acne medicines used directly on the skin, as this may cause local skin irritation.

Taking Aknenormin 20 mg with food and drink

Take the capsules with food or a drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.
DO NOT take Aknenormin 20 mg during pregnancy. If you become pregnant despite the precautions, you must stop taking the medicine immediately and contact your doctor.
Birth defects associated with Aknenormin 20 mg during pregnancy include abnormalities of the bones, nervous system, heart, and eyes. Additionally, there is a higher risk of miscarriages.
Women who are breastfeeding must not take Aknenormin 20 mg, as there is a high risk of side effects in both the mother and the baby.
For more information on pregnancy and contraception, see section 2 "Pregnancy Prevention Program".

Driving and using machines

Aknenormin 20 mg usually does not affect the ability to drive and use machines.
However, very rare cases of sudden vision impairment have been reported.
If you experience vision disturbances during treatment, you must not drive or operate machines.

Important information about some of the ingredients of Aknenormin 20 mg

This medicine contains 17.0 mg of sorbitol in each capsule.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is "sodium-free".

3. HOW TO TAKE AKNENORMIN 20 mg

Take Aknenormin 20 mg exactly as your doctor has told you.
If you are not sure, ask your doctor.
The dose of the medicine will be calculated based on your body weight. Usually, the initial dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). After a few weeks of treatment, your doctor may adjust the dose of the medicine. For most patients, the dose is 0.5-1.0 mg/kg/day.
If you think the effect of Aknenormin 20 mg is too strong or too weak, talk to your doctor.
Take the capsules once or twice a day. Take the medicine with food. Swallow the capsules whole with a drink.
Your doctor will decide on the duration of treatment based on your response to the medicine.
The treatment cycle usually lasts from 16 to 24 weeks. Most patients only need one treatment cycle. Because further improvement in acne symptoms may occur within 8 weeks after completing treatment, it is usually not considered to repeat the treatment cycle before this time has passed.
If you have severe kidney function disorders, the initial dose is usually lower and then gradually increased to the maximum tolerated dose.
Use in children:
Aknenormin 20 mg is not indicated for the treatment of acne before puberty and in children under 12 years of age.

If you take more Aknenormin 20 mg than you should

In case of overdose or accidental ingestion of the medicine by another person, contact your doctor or pharmacist immediately.

If you forget to take Aknenormin 20 mg

Wait until the next scheduled dose and take it as usual.
Do not take a double dose to make up for the missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aknenormin 20 mg can cause side effects, although not everybody gets them.
Side effects usually go away after changing the dose or stopping treatment, but some may persist even after treatment is completed.
Side effects are divided into the following categories:

Blood disorders

Very common side effects

• Changes in the number of blood platelets involved in blood clotting (easier bleeding or clotting).
• Anemia (weakness, dizziness, pale skin).

Common side effects

• Decreased number of white blood cells (increased susceptibility to infections).

Very rare side effects

• Lymph node enlargement may occur.

Allergic reactions

Rare side effects

• Allergic reactions causing rashes, itching, swelling, and difficulty breathing and swallowing, anaphylactic reactions.

In case of a severe reaction, seek immediate medical attention.

In case of an allergic reaction, stop taking Aknenormin 20 mg and contact your doctor.

Diabetes

Very rare side effects

• Diabetes: symptoms may include excessive thirst, frequent urination.

Mental disorders

Rare side effects

Depression or related disorders. Symptoms include sadness, mood changes, anxiety, feeling of emotional discomfort.

• Worsening of existing depression.
• Aggression or violence.

Very rare side effects

Some people have had thoughts or ideas about self-harm or suicideor have attempted suicide or committed suicide. These people may not show symptoms of depression.

• Abnormal behavior.
• Psychotic symptoms: loss of contact with reality, e.g., the patient hears voices or sees things that do not exist.

In case of the above-mentioned mental disorders, you must

contact your doctor immediately. Your doctor may recommend stopping Aknenormin 20 mg. Stopping the medicine may not be enough for these effects to resolve; additional help may be necessary, and your doctor can provide it.

Nervous system disorders

Common side effects

• Headache.

Very rare side effects

• Increased intracranial pressure: symptoms include prolonged headache, nausea, vomiting, and vision disturbances, including blurred vision. You must stop taking Aknenormin 20 mg immediately and contact your doctor.
• Seizures, drowsiness, dizziness.

Eye disorders

Very common side effects

• Redness, pain, and dryness of the eyes. You should ask your pharmacist for suitable eye drops. If you wear contact lenses and experience dry eyes, you may need to replace them with glasses.

Very rare side effects

• Night blindness and color blindness.
• Inflammation of the front of the eye (keratitis).
• Increased sensitivity to light may occur, and it may be necessary to wear sunglasses to protect your eyes from too much sunlight.
• Other vision disorders include blurred vision, distorted vision, or "clouding" of the eye surface (corneal clouding, cataract).

In case of blurred vision, you must stop taking Aknenormin 20 mg immediately and contact your doctor.

Aknenormin 20 mg and contact your doctor.If you experience other vision disturbances, you should inform your doctor as soon as possible.

Ear, nose, and throat disorders

Common side effects

• Nosebleeds, inflammation, and dryness of the nose and throat.

Very rare side effects

• Shortness of breath (bronchospasm, especially in patients with asthma), hoarseness.
• Worsening of hearing.

Gastrointestinal disorders

Very rare side effects

• Severe abdominal pain, bloody diarrhea, nausea, and vomiting. These may be symptoms of a serious gastrointestinal disorder (inflammatory bowel disease or pancreatitis). You must stop taking Aknenormin 20 mg immediately and contact your doctor.

Liver and kidney disorders

Very common side effects

• Increased liver enzyme activity observed in blood tests.

Very rare side effects

• Hepatitis, symptoms may include yellowing of the skin or eyes and feeling of fatigue. You must stop taking Aknenormin 20 mg immediately and contact your doctor.
• Kidney inflammation, symptoms may include difficulty urinating, swelling of the eyelids, feeling of excessive fatigue. You must stop taking Aknenormin 20 mg and contact your doctor.

Unknown frequency

• Urinary tract inflammation.

Skin and hair disorders

Very common side effects

• Dry, painful lips, and redness, rash, mild itching, or peeling of the skin.

Rare side effects

• Hair loss (usually temporary).

Very rare side effects

• During the first few weeks of treatment, acne may worsen, but it should improve over time.
• Persistent worsening of acne without improvement over time and symptoms such as fever, joint pain (fulminant acne).
• Skin inflammation, swelling, and darker skin discoloration, especially on the face.
• Excessive sweating.
• Changes in hair, excessive hair growth on the body or face.
• Increased sensitivity to light.
• Bacterial infections of the nail bed, changes in the nails.
• Bacterial infections of the skin and mucous membranes.
• Swelling, suppuration.
• Thickened scars after injuries or surgical procedures.

Unknown frequency

• Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be life-threatening and require immediate medical attention. The first symptoms include round spots, often with centrally located blisters, usually on the hands and feet or arms and legs. In more severe cases, blisters may occur on the chest and back. Other symptoms may include eye infections (conjunctivitis) or ulcers in the mouth, throat, or nose. Severe skin reactions can progress to widespread skin peeling, which can be life-threatening. Severe skin reactions are often preceded by headache, fever, and flu-like symptoms.

In case of a rash or the above-mentioned skin changes, you must stop taking Aknenormin 20 mg and contact your doctor immediately.

Musculoskeletal and connective tissue disorders

Very common side effects

• Back pain, muscle pain, joint pain (especially in young people).

Very rare side effects

• Arthritis, tendon pain, decreased bone density (diagnosed using special tests).
• Bone disorders (changes in bone growth, especially in young people), calcium deposits in soft tissue, which can cause hard lumps under the skin.
• Increased blood levels of muscle damage products during intense exercise (shown in blood tests), causing muscle pain. To avoid worsening bone and muscle problems, you should limit intense physical activity while taking Aknenormin 20 mg.

Unknown frequency

• Rapid increase in blood levels of muscle breakdown products, which can lead to kidney damage. Intense physical activity, certain medicines (certain antibiotics or cholesterol-lowering medicines), and excessive alcohol consumption can contribute to this reaction and should be avoided. If you experience symptoms such as muscle pain, dark urine, and weakness, you must stop taking Aknenormin 20 mg and contact your doctor immediately.
• Inflammatory back pain, a type of back pain with an inflammatory cause, causing pain in the lower back or buttocks.

Other reactions

Very common side effects

• Changes in blood lipid levels.

Common side effects

• Increased cholesterol levels in the blood.
• Protein or blood in the urine.

Very rare side effects

• General feeling of being unwell.
• Increased uric acid levels in the blood.
• Vasculitis (sometimes with bruising, redness).

Unknown frequency

• Dark or light brown urine.
• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Breast tenderness or swelling, occurring in men.
• Vaginal dryness.

Cochineal red (E124) may cause allergic reactions.
Soybean oil may, very rarely, cause allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AKNENORMIN 20 mg

Store in the original package. Keep the container tightly closed to protect from light.

Keep out of the sight and reach of children.

Do not use Aknenormin 20 mg after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aknenormin 20 mg contains

The active substance is isotretinoin.
One capsule of Aknenormin 20 mg contains 20 mg of isotretinoin.
The other ingredients are:
Core of the capsule: refined soybean oil, all-rac-α-tocopherol, disodium edetate, butylhydroxyanisole, hydrogenated vegetable oil, partially hydrogenated soybean oil, yellow wax.
Cap of the capsule:gelatin, glycerol (98-101%), non-crystallizing liquid sorbitol, purified water, cochineal red (E 124), indigo carmine (E 132), and titanium dioxide (E 171).

What Aknenormin 20 mg looks like and contents of the pack

Aknenormin 20 mg is a chestnut-brown, elongated, soft capsule containing a yellow-orange, non-transparent, viscous liquid.
Aknenormin 20 mg is available in packs of 30, 60, 90, or 100 soft capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
For more information, contact the representative of the marketing authorization holder:
Almirall Sp. z o.o.
Phone: 22 330 02 57

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Date of last revision of the leaflet: 01/2024

Detailed and up-to-date information on this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website: www.almirall.com/en/aknenormin

‘Insert QR code’ +www.almirall.com/en/aknenormin