AKNENORMIN 10 mg Capsules

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. Aknenormin, 10 mg, soft capsules
   1. WARNING
   2. You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. WHAT IS AKNENORMIN 10 mg AND WHAT IS IT USED FOR
4. IMPORTANT INFORMATION BEFORE USING AKNENORMIN 10 mg
   2. Aknenormin 10 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 use Aknenormin 10 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. All unused capsules should be returned to the pharmacist after treatment.
   8. Special instructions for women Pregnancy Prevention Program
   9. Women who are pregnant must not take Aknenormin 10 mg
   10. Aknenormin 10 mg may be prescribed to female patients of childbearing age only if they strictly follow the rules listed below, due to the risk of serious birth defects.
   11. Female patients must use effective contraception methods before, during, and after treatment with Aknenormin 10 mg
   12. Female patients must agree to have pregnancy tests before, during, and after treatment with Aknenormin 10 mg
   13. Advice for men
   14. Aknenormin 10 mg and other medicines
   15. Using Aknenormin 10 mg with food and drink
   16. Pregnancy and breastfeeding
   17. Driving and using machines
   18. Important information about some of the ingredients of Aknenormin 10 mg
5. HOW TO USE AKNENORMIN 10 mg
   1. Taking more than the recommended dose of Aknenormin 10 mg:
   2. Missing a dose of Aknenormin 10 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, you should seek immediate medical attention.
   8. Diabetes
   9. Very rare side effects
   10. Psychiatric disorders
   11. Rare side effects
   12. Very rare side effects
   13. In case of the above-mentioned psychiatric disorders, you should
   14. Nervous system disorders
   15. Common side effects
   16. Very rare side effects
   17. You should stop taking Aknenormin 10 mg immediately and contact your doctor.
   18. Eye disorders
   19. Very common side effects
   20. Very rare side effects
   21. In case of blurred vision, you should
   22. Ear, nose, and throat disorders
   23. Common side effects
   24. Very rare side effects
   25. Gastrointestinal disorders
   26. Very rare side effects
   27. Liver and kidney disorders
   28. Very common side effects
   29. Very rare side effects
   30. Unknown frequency
   31. Skin and hair disorders
   32. Very common side effects
   33. Rare side effects
   34. Very rare side effects
   35. Unknown frequency
   36. Musculoskeletal and connective tissue disorders
   37. Very common side effects
   38. Very rare side effects
   39. Unknown frequency
   40. Other reactions
   41. Very common side effects
   42. Common side effects
   43. Very rare side effects
   44. Unknown frequency
   45. Reporting side effects
7. HOW TO STORE AKNENORMIN 10 mg
   1. Store in a place out of sight and reach of children.
8. CONTENTS OF THE PACK AND OTHER INFORMATION
   1. What Aknenormin 10 mg contains
   2. What Aknenormin 10 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, 10 mg, soft capsules

Isotretinoin

WARNING

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

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Aknenormin 10 mg and what is it used for
• 2. Important information before using Aknenormin 10 mg
• 3. How to use Aknenormin 10 mg
• 4. Possible side effects
• 5. How to store Aknenormin 10 mg
• 6. Contents of the pack and other information

1. WHAT IS AKNENORMIN 10 mg AND WHAT IS IT USED FOR

Aknenormin 10 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 10 mg is used to treat severe forms of acne or acne with a risk of permanent scarring. Aknenormin 10 mg is used when other anti-acne therapies, including antibiotics and topical treatments, have failed.

2. IMPORTANT INFORMATION BEFORE USING AKNENORMIN 10 mg

Aknenormin 10 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, Aknenormin 10 mg can only be prescribed to women of childbearing age if the patient meets specific requirements listed in the "Special instructions for women" section.

When not to use Aknenormin 10 mg

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 10 mg, you should discuss the following with your doctor:

• Aknenormin 10 mg may increase blood lipid levels and liver enzyme activity. Your doctor will order blood tests before, during, and after treatment to check their levels.
• You should tell your doctor if you have diabetes, alcoholism, obesity, or other conditions that affect blood lipid levels. More frequent monitoring of blood lipid and 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 10 mg and refer you to a specialist for back pain treatment. 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 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 (tanning lamps or tanning beds).

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 mouth and skin, you should use a moisturizing cream and lip balm from the start of treatment.
• Cosmetic treatments such as chemical skin peeling or dermabrasion (removal of the top layers of the skin), laser treatments, and skin piercing should not be performed during treatment and for 5-6 months after its completion.
• You should avoid using wax hair removal products for at least 6 months after treatment, as there is a risk of skin tearing.
• Isotretinoin may cause dry eyes, contact lens intolerance, 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 treatment.

Special instructions for women Pregnancy Prevention Program

Women who are pregnant must not take Aknenormin 10 mg

This medicine can seriously harm an 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 10 mg is taken for a short period during pregnancy.

• Do not take Aknenormin 10 mg if you are pregnant or think you may be pregnant.
• Do not take Aknenormin 10 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
• Do not take Aknenormin 10 mg if you may become pregnant during treatment.
• You must not become pregnant for one month after stopping treatment because the medicine may still be present in your body.

Aknenormin 10 mg may be prescribed to female patients of childbearing age only if they strictly follow the rules listed below, due to the risk of serious birth defects.

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 birth control methods. Your doctor may refer you to a specialist for birth control 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 10 mg.

Female patients must use effective contraception methods before, during, and after treatment with Aknenormin 10 mg

• You must agree to use at least one highly effective contraception method (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 10 mg, during treatment, and for one month after stopping the medicine.
• You must use contraception, even if you do not menstruate or are not currently sexually active (unless your doctor decides it is not necessary).

Female patients must agree to have pregnancy tests before, during, and after treatment with Aknenormin 10 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 stopping Aknenormin 10 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 stopping treatment because the medicine may still be present in your body.
• Your doctor will discuss all these issues 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 10 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 stopping treatment with Aknenormin 10 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 semen of men taking Aknenormin 10 mg is too small to harm an unborn child. However, you should never share this medicine with anyone, especially women.

Aknenormin 10 mg and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to 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 use tetracycline antibiotics, e.g., oxytetracycline, doxycycline, minocycline, as 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.

Using Aknenormin 10 mg with food and drink

Capsules should be taken 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, you should consult your doctor before using this medicine.
DO NOT use Aknenormin 10 mg during pregnancy. If you become pregnant despite taking precautions, you should stop taking the medicine immediately and contact your doctor.
Birth defects associated with the use of Aknenormin 10 mg during pregnancy include abnormalities of the bones, nervous system, heart, and eyes. Additionally, there is a higher risk of miscarriages.
Aknenormin 10 mg must not be used by breastfeeding women, as there is a high risk of adverse 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 10 mg usually does not affect the ability to drive or use machines.
However, rare cases of sudden night vision impairment have been reported.
If you experience vision disturbances during treatment, you should not drive or operate machines.

Important information about some of the ingredients of Aknenormin 10 mg

This medicine contains 5.3 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 USE AKNENORMIN 10 mg

Aknenormin 10 mg should always be taken as directed by your doctor.
If you are unsure, you should consult 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 feel that the effect of Aknenormin 10 mg is too strong or too weak, you should consult your doctor.
Capsules should be taken once or twice a day. The medicine should be taken on a "full stomach". Capsules should be swallowed 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 stopping treatment, it is usually not considered necessary to start another treatment cycle until 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 10 mg is not indicated for the treatment of acne before puberty and in children under 12 years of age.

Taking more than the recommended dose of Aknenormin 10 mg:

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

Missing a dose of Aknenormin 10 mg:

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aknenormin 10 mg can cause side effects, although not everybody gets them.
Side effects usually resolve after dose adjustment or treatment discontinuation, but some may persist even after treatment completion.
Side effects are divided into the following categories:

Blood disorders

Very common side effects

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

Common side effects

• Decreased white blood cell count (increased susceptibility to infections).

Very rare side effects

• Enlargement of lymph nodes 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, you should seek immediate medical attention.

In case of an allergic reaction, you should stop taking Aknenormin 10 mg and contact your doctor.

Diabetes

Very rare side effects

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

Psychiatric 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 fantasies about self-harmor suicide (suicidal thoughts), attempted suicide (suicide attempts), 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 actually exist.

In case of the above-mentioned psychiatric disorders, you should

immediately contact your doctor. Your doctor may recommend stopping Aknenormin 10 mg. Stopping the medicine may not be enough to resolve these effects; 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 should stop taking Aknenormin 10 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 your lenses with glasses.

Very rare side effects

• Night blindness and color blindness.
• Inflammation of the front part 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 should

stop taking Aknenormin 10 mg immediately 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 severe intestinal disorder (inflammatory bowel disease or pancreatitis). You should stop taking Aknenormin 10 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 should stop taking Aknenormin 10 mg immediately and contact your doctor.
• Kidney inflammation, symptoms may include difficulty urinating, swelling of the eyelids, feeling of excessive fatigue. You should stop taking Aknenormin 10 mg immediately 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, 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 color, especially on the face.
• Excessive sweating.
• Changes in hair growth, 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, pus.
• 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 should stop taking Aknenormin 10 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 physical exercise (shown in blood tests), causing muscle pain. To avoid worsening bone and muscle problems, you should limit intense physical activity while taking Aknenormin 10 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 should stop taking Aknenormin 10 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 color.
• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Breast tenderness or swelling, occurring in men.
• Vaginal dryness.

Carmine (E 120) 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, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, 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 10 mg

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

Store in a place out of sight and reach of children.

Do not use Aknenormin 10 mg after the expiration date stated on the blister and carton. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aknenormin 10 mg contains

The active substance of the medicine is isotretinoin.
One capsule of Aknenormin 10 mg contains 10 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, carmine (E 120), iron oxide black (E 172), and titanium dioxide (E 171).

What Aknenormin 10 mg looks like and contents of the pack

Aknenormin 10 mg is a light purple, elongated, soft capsule containing a yellow-orange, opaque, viscous liquid.
Aknenormin 10 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
To obtain more detailed information, you should 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