Aknenormin 20 mg

Aknenormin 20 mg, soft capsules
Isotretinoinum
WARNING
CAN CAUSE SEVERE DAMAGE TO THE UNBORN CHILD
Women must use effective contraceptive methods.
Do not use during pregnancy or if pregnancy is suspected.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are the same.
• If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Aknenormin 20 mg is and what it is 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 package and other information

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

Aknenormin 20 mg contains the active substance isotretinoin. Isotretinoin reduces
sebum production by the sebaceous glands. It helps prevent the formation of pimples and reduces inflammatory nodules and pustules associated with acne.
Aknenormin 20 mg is used in the treatment of severe forms of acne or acne with a risk of permanent scarring. Aknenormin 20 mg is used when other acne treatments have failed, including antibiotics and topical anti-acne medications.

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINE

AKNENORMIN 20 mg
The use of Aknenormin 20 mg is absolutely contraindicated in women who are pregnant,
or who may become pregnant during treatment and for one month after stopping therapy.
Isotretinoin causes severe fetal harm. Due to the risk of fetal malformations,
Aknenormin 20 mg may be prescribed to women of childbearing potential only if the patient
meets the specific requirements outlined in the section "Special precautions for women".

When not to use Aknenormin 20 mg

• if the patient is pregnant or breastfeeding
• if the patient has liver disease
• if the patient has elevated blood lipid levels
• if the patient has increased blood vitamin A levels (hypervitaminosis A)
• if the patient is being treated concurrently 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 any risk that a female patient could become pregnant, the precautions outlined in the Pregnancy Prevention Programme must be followed.

Advice for all patients
Before starting Aknenormin 20 mg, discuss the following with your doctor:

• If the patient has ever had mental health problems, including depression, aggressive tendencies, mood swings, or thoughts of self-harm or suicide. This is because Aknenormin 20 mg may affect the patient's mood.
  Mental health problems
  The patient may not notice certain changes in mood and behaviour, so it is very important to inform friends and family members about the use of this medicine. These people may notice such changes and help the patient identify problems quickly that need to be discussed with the doctor.

• Aknenormin 20 mg may increase blood lipid levels and liver enzyme activity. Your doctor will order blood tests before, during, and after treatment to monitor these levels.

• Inform your doctor if the patient has diabetes, alcoholism, obesity, or other disorders affecting blood lipid levels. More frequent monitoring of blood lipids and glucose may be necessary.

• Talk to your doctor if the patient experiences persistent lower back or buttock pain during treatment with Aknenormin 20 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue treatment with Aknenormin 20 mg and refer the patient to a specialist for management of inflammatory back pain. Further evaluation, including imaging studies such as magnetic resonance imaging, may be required.

• Do not donate blood while taking this medicine or for one month after stopping
  Aknenormin 20 mg. If a pregnant woman receives the patient's blood, she may give birth
  to a child with congenital malformations.

• Protect the skin from intense sunlight or ultraviolet radiation (tanning lamps or sunbeds).

If necessary, use products containing UV filters with a sun protection factor (SPF) of at least 15.

• To prevent dryness and discomfort of the lips and skin, start using a moisturising cream and lip balm from the beginning of treatment.

• Cosmetic procedures such as chemical peeling or dermabrasion (removal of the outer skin layers), laser treatments, and skin piercing should not be performed during treatment and for 5–6 months after its completion.

• Avoid using wax-based hair removal products for at least 6 months after treatment ends, as there is a risk of tearing the epidermis.

• Isotretinoin may cause dry eyes, intolerance to contact lenses, and vision problems, including night vision impairment. Cases of persistent dry eye that did not resolve after treatment have been reported. Inform your doctor if any of these symptoms occur. The doctor may recommend using moisturising eye ointments or artificial tears. If contact lens intolerance occurs, the doctor may advise wearing glasses during treatment. If vision problems occur, the doctor may refer the patient to a specialist for advice and may consider discontinuing isotretinoin.

• Never give this medicine to anyone else. All unused capsules must be returned to the
  pharmacist after treatment is completed.

Special advice for women
Pregnancy Prevention Programme
Women who are pregnant must not take Aknenormin 20 mg.
This medicine can severely harm the unborn child (the medicine is "teratogenic"). It may cause serious brain, facial, ear, eye, heart, and gland (thymus and parathyroid) abnormalities in the fetus. It also increases the risk of miscarriage. These effects may occur even if Aknenormin 20 mg is taken for only a short time during pregnancy.

• Do not take Aknenormin 20 mg if the patient is pregnant or suspects she 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 the patient could become pregnant during treatment.
• The patient must not become pregnant for one month after stopping treatment, as the medicine may still be present in her body.

Aknenormin 20 mg may be prescribed to women capable of becoming pregnant only if they
strictly comply with specific requirements. This is due to the risk of severe birth defects.

The following conditions must be met:

• The doctor must explain to the patient the risk of fetal harm (birth defects); the patient must understand why she must not become pregnant and how to prevent it.
• The patient must discuss contraception (birth control methods) with her doctor. The doctor will provide information on contraceptive methods. The doctor may refer the patient to a specialist for contraceptive advice.
• Before starting treatment, the doctor will ask the patient to take a pregnancy test. The test must confirm that the patient is not pregnant at the start of treatment with Aknenormin 20 mg.
• Patients must use effective contraceptive methods before, during, and after treatment with Aknenormin 20 mg.
• The patient must agree to use at least one highly reliable contraceptive method (e.g. intrauterine device or contraceptive implant), or two effective methods with different mechanisms (e.g. oral hormonal contraceptives and condoms). Discuss with the doctor which methods are most suitable.
• The patient must use contraception for one month before starting Aknenormin 20 mg, throughout treatment, and for one month after stopping the medicine.
• The patient must use contraception even if she is not menstruating or is not currently sexually active (unless the doctor determines it is not necessary).
• Patients must agree to undergo pregnancy tests before, during, and after treatment with Aknenormin 20 mg.
• The patient must agree to regular follow-up visits with her doctor, ideally every month.
• The patient must agree to undergo regular pregnancy tests, ideally monthly during treatment and one month after stopping Aknenormin 20 mg, as the medicine may still be present in her body (unless the doctor determines it is not necessary for a particular patient).
• The patient must agree to undergo additional pregnancy tests as recommended by her doctor.
• The patient must not become pregnant during or for one month after treatment, as the medicine may still be present in her body.
• The treating doctor will discuss all issues with the patient using a checklist and ask the patient (or her parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the rules outlined above.

If a patient becomes pregnant while taking Aknenormin 20 mg, she must immediately stop taking the medicine and contact her doctor. The doctor may refer her to a specialist for advice. Additionally, a patient who becomes pregnant within one month after stopping Aknenormin 20 mg should contact her doctor. The doctor may refer her to a specialist for advice.

Advice for men
The amount of oral retinoids in the semen of men taking Aknenormin 20 mg is too low to harm the unborn child of their partner. However, this medicine must never be shared with anyone else, especially women.

Aknenormin 20 mg and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.

• Due to the risk of vitamin A overdose, do not take any other products containing vitamin A.
• Do not use tetracycline antibiotics such as oxytetracycline, doxycycline, or minocycline, as they may increase intracranial pressure.
• Do not use other acne medicines applied directly to the skin, as they 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

DO NOT use Aknenormin 20 mg during pregnancy. If, despite taking precautions, the patient becomes pregnant during treatment or within one month after stopping treatment, she must contact her doctor immediately.
Congenital abnormalities associated with the use of Aknenormin 20 mg during pregnancy include malformations of, among others, bones, the nervous system, heart, and eyes. There is also an increased risk of spontaneous miscarriage.
Women who are breastfeeding must not use Aknenormin 20 mg, as there is a high risk of adverse effects in both mother and child.
More information on pregnancy and contraception can be found in section 2, "Pregnancy Prevention Programme".

Driving and using machines
Generally, Aknenormin 20 mg does not affect the ability to drive or operate machinery.
However, very rare cases of sudden worsening of night vision have been reported.
If vision disturbances occur during treatment, the patient must not drive or operate any machinery.

Important information about some 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, meaning it is considered "sodium-free".

3. HOW TO USE THE MEDICINAL PRODUCT AKNENORMIN 20 mg

AKNENORMIN 20 mg must always be taken as directed by the physician.
In case of doubt, consult your doctor.
The dose will be calculated based on the patient's body weight. Usually,
the initial dose is 0.5 mg per kg of body weight per day (0.5 mg/kg/day). After several
weeks of treatment, the doctor may adjust the dose. For most
patients, the dose ranges from 0.5 to 1.0 mg/kg/day.
If you feel that the effect of AKNENORMIN 20 mg is too strong or too weak,
consult your doctor.
Capsules should be taken once or twice daily. The medicinal product should be taken with a full stomach.
The capsules must be swallowed whole with liquid.
The physician will determine the duration of therapy depending on the patient's response to treatment.
A treatment cycle usually lasts from 16 to 24 weeks. Most patients require only
one treatment cycle. Since further improvement of acne symptoms may occur within 8 weeks after completion of therapy, a repeat treatment cycle should generally not be considered before this period has elapsed.
In patients with severe renal function impairment, the initial dose is usually lower and is then gradually increased to the highest dose tolerated by the patient.

Use in children:
AKNENORMIN 20 mg is not indicated for the treatment of acne in prepubertal children or in children under 12 years of age.

Overdose of AKNENORMIN 20 mg:
In case of overdose or accidental ingestion by another person, contact a physician or pharmacist immediately.

Missed dose of AKNENORMIN 20 mg:
Wait until the next scheduled dose according to the prescribed dosing regimen and take it as usual.
Do not take a double dose to make up for a missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Aknenormin 20 mg may cause adverse reactions, although
not everyone will experience them.
Adverse reactions usually subside after dose adjustment or discontinuation of treatment,
but some may persist even after therapy has ended.
Adverse reactions have been categorized as follows:

Blood disorders
Very common adverse reactions

• Changes in the number of blood platelets involved in clotting (increased tendency to bleeding or clotting).
• Anaemia (weakness, dizziness, pale skin). Common adverse reactions
• Decreased number of white blood cells (increased susceptibility to infections). Very rare adverse reactions
• Enlargement of lymph nodes may occur.

Hypersensitivity reactions
Rare adverse reactions

• Hypersensitivity reactions causing rashes, itching, swelling, and difficulty breathing or swallowing, anaphylactic reactions. In case of a severe reaction, immediate medical assistance must be obtained. If a hypersensitivity reaction occurs, the use of Aknenormin 20 mg should be discontinued and a doctor should be contacted.

Diabetes
Very rare adverse reactions

• Diabetes: symptoms may include excessive thirst and frequent need to urinate.

Psychiatric disorders
Rare adverse reactions
Depression or related disorders. Symptoms include sadness, mood changes, anxiety,
and emotional discomfort.

• Worsening of existing depression.
• Tendency towards violence or aggression. Very rare adverse reactions Some individuals have experienced thoughts or images of self-harm or of taking their own life (suicidal thoughts), attempted suicide, or committed suicide. These individuals may not necessarily show symptoms of depression.
• Unusual behaviour.
• Psychotic symptoms: loss of contact with reality, e.g. the patient hears voices or sees things that do not exist in reality. If symptoms described above related to psychiatric disorders occur, contact a doctor immediately. The doctor may recommend discontinuation of Aknenormin 20 mg. Discontinuation of the drug may not be sufficient for these effects to resolve; additional help may be required, which the doctor can provide.

Nervous system disorders
Common adverse reactions

• Headache. Very rare adverse reactions
• Increased intracranial pressure: symptoms include prolonged headache, nausea, vomiting, and visual disturbances, including blurred vision. The use of Aknenormin 20 mg must be discontinued immediately and a doctor contacted.
• Seizures, drowsiness, dizziness.

Eye disorders
Very common adverse reactions

• Redness, pain, and dryness of the eyes. Ask a pharmacist for suitable eye drops. If dry eyes occur in patients using contact lenses, it may be necessary to replace the lenses with glasses. Very rare adverse reactions
• Night blindness and colour blindness.
• Inflammation of the front part of the eye (keratitis).
• Light sensitivity may increase; wearing sunglasses may be necessary to protect the eyes from excessively bright sunlight.
• Other visual disturbances include blurred vision, distorted vision, "clouding" of the eye surface (corneal opacity, cataract). In case of blurred vision, discontinue Aknenormin 20 mg immediately and contact a doctor. If other visual disturbances occur, inform the doctor as soon as possible.

Ear, nose and throat disorders
Common adverse reactions

• Nosebleeds, inflammation, and dryness of the nose and throat. Very rare adverse reactions
• Shortness of breath (bronchospasm, especially in patients with asthma), hoarseness.
• Hearing loss.

Gastrointestinal disorders
Very rare adverse reactions

• Severe abdominal pain, bloody diarrhoea, nausea, and vomiting. These may be symptoms of a serious intestinal disorder (inflammation of the intestine or pancreas). The use of Aknenormin 20 mg must be discontinued immediately and a doctor contacted.

Liver and kidney disorders
Very common adverse reactions

• Increased liver enzyme activity observed in blood tests. Very rare adverse reactions
• Hepatitis, symptoms may include yellowing of the skin or eyes and feeling tired. The use of Aknenormin 20 mg must be discontinued immediately and a doctor contacted.
• Nephritis, symptoms may include difficulty urinating, eyelid swelling, and feeling excessively tired. The use of Aknenormin 20 mg must be discontinued immediately and a doctor contacted. Frequency not known
• Urethritis.

Skin and hair disorders
Very common adverse reactions

• Dry, painful lips, and redness, rash, mild itching, or peeling of the skin. Rare adverse reactions
• Hair loss (usually temporary). Very rare adverse reactions
• Acne may worsen during the first few weeks, but symptoms should gradually 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 than usual skin discoloration, especially on the face.
• Excessive sweating.
• Changes in hair, excessive body or facial hair growth.
• Increased sensitivity to light.
• Bacterial infections of the nail fold, nail changes.
• Bacterial infections of the skin and mucous membranes.
• Swelling, pus formation.
• Thickened scars after injuries or surgical procedures.

Frequency not known

• Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which may be life-threatening and require immediate medical attention. Early symptoms include round spots, often with centrally located blisters, usually appearing on hands and palms or feet and soles. In more severe cases, blisters may appear on the chest and back. Other symptoms may also occur, such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. Severe forms of skin lesions may progress to extensive skin peeling, which may be life-threatening. Severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

If a rash or the above skin changes occur, discontinue the use of Aknenormin 20 mg and contact a doctor immediately.
Bone and muscle disorders
Very common adverse reactions

• Back pain, muscle pain, joint pain (especially in adolescents). Very rare adverse reactions
• 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 may cause hard lumps under the skin.
• Increased blood levels of muscle damage products during intense exercise (detected in blood tests), causing muscle pain. To avoid worsening bone and muscle problems, intense physical activity should be limited during treatment with Aknenormin 20 mg. Frequency not known
• Rapid increase in blood levels of muscle breakdown products, which may lead to kidney damage. Intense physical exertion, certain medications (some antibiotics or cholesterol-lowering drugs), and alcohol abuse may contribute to such a reaction and should be avoided. If symptoms such as muscle pain, dark urine, and weakness occur, discontinue Aknenormin 20 mg immediately and contact a doctor without delay.
• Sacroiliitis, a type of inflammatory back pain causing pain in the lower back or buttocks area.

Other types of reactions
Very common adverse reactions

• Changes in blood lipid levels. Common adverse reactions
• Increased blood cholesterol levels.
• Protein or blood in urine. Very rare adverse reactions
• General malaise.
• Increased blood uric acid levels.
• Vasculitis (sometimes with bruising, redness). Frequency not known
• Dark or light brown urine colour.
• Difficulty achieving or maintaining erection.
• Reduced libido.
• Breast swelling with or without tenderness in men.
• Vaginal dryness.

Carmoisine (E124) may cause allergic reactions.
Soybean oil may, very rarely, cause allergic reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.

5. HOW TO STORE AKNENORMIN 20 mg

Keep in the original packaging. Store 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Please consult your pharmacist for guidance on how to dispose of medicines no longer required. Such measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Aknenormin 20 mg contains
The active substance is isotretinoin.
Each capsule of Aknenormin 20 mg contains 20 mg of isotretinoin.
The other ingredients are:
Capsule core: refined soybean oil, all-rac-α-tocopherol, disodium edetate,
butylhydroxyanisole, hydrogenated vegetable oil, partially hydrogenated soybean oil,
yellow wax.
Capsule shell: gelatin, glycerol (98–101%), non-crystallizing liquid sorbitol, purified water,
carmoisine (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 chestnut-brown, elongated soft capsules containing a yellow-orange,
opaque, sticky liquid.
Aknenormin 20 mg is available in packs of 30, 60, 90 or 100 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
For further information, contact the local representative of the Marketing Authorisation Holder:
Almirall Sp. z o.o.
Tel.: 22 330 02 57

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

Detailed and up-to-date information about this medicine is available by scanning the QR code on the Package 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