Orifarm Generics AB

Capsule, hard 10 mg 
(Brown opaque / white opaque capsule, marked with “U68” in white text on the capsule and filled with a yellow granulate, approximately 14.3 x 5.3 mm)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

WARNINGCAN SERIOUSLY INJURY AN UNBORN CHILDWomen must use effective contraceptionDo not use this medicine if you are pregnant or think you may be pregnant

In this leaflet: 
1. What Acitretin Orifarm is and what it is used for 
2. What you need to know before taking Acitretin Orifarm 
3. How to take Acitretin Orifarm 
4. Possible side effects 
5. How to store Acitretin Orifarm 
6. Contents of the packaging and other information 

What Acitretin Orifarm is and what it is used for

Acitretin Orifarm belongs to a group of medicines called retinoids. Retinoids are derived from vitamin A. The drug is used in the treatment of severe skin problems with thickened skin that may be scaly. 

Acitretin Orifarm has a normalizing effect on the processes that take place during the formation of the outer layer of the skin and dampens the increased formation of skin cells that are seen in, for example, psoriasis. 

Acitretin Orifarm is used for severe forms of psoriasis and other skin diseases that are characterized by disorders in the formation of new skin, such as Darier’s disease in adults.

Acitretin contained in Acitretin Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Acitretin Orifarm

Do not take Acitretin Orifarm:

  • if you are allergic to acitretin, other vitamin A-related substances ( retinoids ), or any of the other ingredients of this medicine (listed in section 6).
  • if you are pregnant or breastfeeding.
  • If there is a possibility that you could become pregnant, you must follow the precautions under “Pregnancy prevention program”, see the section in “Warnings and precautions”.
  • if your liver or kidneys are not working properly
  • if you have very high levels of blood fats or cholesterol in your blood (also called “hyperlipidemia”).
  • If you take other medicines that contain retinoids or a high dose of vitamin A. There is a risk of hypervitaminosis A (high levels of vitamin A in the blood).
  • if you are taking an antibiotic called tetracycline (a medicine used to treat infection )
  • if you are being treated with methotrexate (a medicine used to treat cancer, psoriasis, and rheumatic diseases).

Warnings and cautions

Pregnancy prevention programs


Women who are pregnant should not take Acitretin Orifarm

This medicine can seriously harm an unborn baby (the drug is so-called “teratogenic”) – it can cause severe malformations of the unborn baby’s brain, face, ears, eyes, heart, and certain glands ( thymus and parathyroid gland). It also increases the risk of miscarriage. This can happen even if Acitretin Orifarm is only taken for a short time during pregnancy.

  • You must not take Acitretin Orifarm if you are pregnant or if you think you may be pregnant.
  • You must not take Acitretin Orifarm if you are breast-feeding. Acitretin Orifarm is likely to pass into breast milk and may harm your baby.
  • You must not take Acitretin Orifarm if you may become pregnant at any time during treatment.
  • You must not become pregnant for 3 years after stopping this treatment as a certain amount of medicine may still be present in your body.


Women who may become pregnant are prescribed Acitretin Orifarm under very strict conditions. This is due to the risk of very serious injuries to the unborn baby.

These are the conditions:

  • Your doctor must have explained the risk of birth defects: you must understand why you must not become pregnant and how to prevent pregnancy.
  • You must have discussed the use of effective contraception with your doctor, the doctor should give you information on how to prevent pregnancy. Your doctor can refer you to a specialist for contraceptive advice.
  • Before starting treatment, your doctor will ask you to do a pregnancy test, this must be negative (ie show that you are not pregnant) in order for you to start treatment with Acitretin Orifarm.


Women must use effective contraception before, during, and after treatment with Acitretin Orifarm

  • You must agree to use at least one effective contraceptive (eg IUD or contraceptive implant) or two effective means that work differently (eg a hormonal contraceptive pill and a condom). Discuss with your doctor which methods are best for you.
  • You must use contraception for 1 month before taking Acitretin Orifarm, during treatment, and for 3 years after treatment.
  • You must use contraception even if you are not menstruating or not sexually active (unless your doctor deems it necessary)


Women must agree to take pregnancy tests before, during, and after treatment with Acitretin Orifarm

  • You must agree to go on follow-up visits, preferably every month.
  • You must agree to take regular pregnancy tests, preferably every month during treatment and, as a certain amount of medicines may still remain in your body, every three months for 3 years after stopping treatment with Acitretin Orifarm (unless your doctor tells you to) determines that it is not necessary in your case).
  • You must agree to extra pregnancy tests if your doctor asks you to.
  • You must not become pregnant during the treatment period or within 3 years after the end of treatment as a certain amount of medicine may still remain in your body.
  • The doctor will discuss these points with you using a checklist and will ask you (or your parent/guardian) to sign it. You hereby confirm that you have been informed of the risks and that you will comply with the above conditions.


If you become pregnant during treatment with Acitretin Orifarm, stop taking the medicine immediately, and contact your doctor. Your doctor may refer you to a specialist for advice.


If you become pregnant within 3 years after stopping treatment, consult your doctor. Your doctor may refer you to a specialist for advice.


Advice for men

The levels of retinoids in the semen of men using Acitretin Orifarm are too low to cause harm to their partner’s unborn children. However, you must remember to never give your medicine to anyone else.


Additional precautions

You should never give this medicine to anyone else. Return any unused capsules to the pharmacy when the treatment is completed.


You should not donate blood during treatment with this medicine or within 3 years after stopping treatment with Acitretin Orifarm as unborn babies can be harmed if pregnant women get your blood.


Talk to your doctor, pharmacist, or nurse before taking Acitretin Orifarm.

  • if you are a blood donor. You should not donate blood while you are taking Acitretin Orifarm and 3 years after you stop taking it.
  • whether you get a blood transfusion is. You should not receive a blood transfusion from patients treated with acitretin if you are a woman of childbearing potential.
  • If you are a woman of childbearing potential, you must avoid alcohol (in beverages, foods, or medicines) during treatment with Acitretin Orifarm and 2 months after stopping treatment.
  • if you have high blood sugar ( diabetes ). You need to check your blood sugar levels more often when you start taking this medicine.
  • if you have vision problems, especially in the dark.
  • if you wear contact lenses. Acitretin Orifarm causes dryness in the eyes and therefore you should wear glasses throughout the treatment.
  • If Acitretin Orifarm is to be used in children, growth and bone development must be monitored regularly. In the long-term treatment of children, the doctor must carefully weigh the risk of serious side effects against the benefits of treatment with this drug.
  • If Acitretin Orifarm is used for a long time in adults, especially the elderly, regular check-ups must be performed for possible bone malformations.
  • if you stay in strong sun or if you use a solarium, you must use a sunscreen with at least a sun protection factor of 15.
  • if you get severe headaches, nausea, vomiting, and visual disturbances. This may be a sign of increased pressure in the head. Contact your doctor.
  • if you have ever had problems with your mental health, including depression, aggressive tendencies, or mood swings. Acitretin Orifarm can affect your mood.


Acitretin usually increases blood fats, such as cholesterol or triglycerides, which have been associated with pancreatitis. Tell your doctor if you experience severe pain in your abdomen and back (these may be signs of inflammation of the pancreas).


It should be noted that not all effects of long-term treatment with acitretin may be known yet.


Examinations before and during treatment:

  • Your doctor should test your blood counts before starting treatment and during treatment to check your liver function and blood fat levels.
  • If you have high blood sugar ( diabetes ) or if you have high blood fat levels, such as triglycerides or cholesterol, if you are overweight or if you drink a lot of alcohol and are treated for a long time, your blood fat and cholesterol levels must be checked.
  • In the treatment of children, and in the long-term treatment of Acitretin Orifarm, certain parts of the skeleton will be checked regularly by a doctor as this medicine may cause bone changes.

Mental health problems

You may not notice any changes in your mood and behavior yourself, so it is very important that you tell your friends and family that this medicine may affect your mood and behavior. They can notice these changes and help you identify any problems that you need to talk to your doctor about.

Other medicines and Acitretin Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.


The effect of phenytoin (a medicine used to treat epilepsy ) may be increased by Acitretin Orifarm. Phenytoin dose may need to be adjusted.


Do not take Acitretin Orifarm with:

  • tetracycline (medicines for infections ) as increased pressure in the brain may occur.
  • methotrexate (medicines used to treat cancer, psoriasis, and rheumatic diseases), as the combination may cause hepatitis.
  • so-called mini-pills (a contraceptive pill with only low levels of progesterone ). Acitretin may reduce the effect of the contraceptive and you should therefore not use mini- pills as a method of contraception when taking Acitretin Orifarm.
  • medicines or vitamin A supplements that contain high levels of vitamin A.
  • other retinoid drugs, such as isotretinoin

Acitretin Orifarm with food, drink, and alcohol

Acitretin Orifarm should be taken with food or a glass of milk.

You should not drink alcohol during treatment with Acitretin Orifarm as the risk of side effects is increasing.

Women of childbearing potential must completely avoid alcohol (in beverages, foods, or medicines) during treatment with Acitretin Orifarm and 2 months after stopping it.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must NOT take Acitretin Orifarm if you are pregnant, think you may be pregnant or are planning to have a baby.
Acitretin Orifarm may cause birth defects. Therefore, you must rule out being pregnant before starting treatment with Acitretin Orifarm.You must use the effective method of contraception (preferably two complementary methods) without interruption for 
four weeks before, during, and for 3 years after stopping treatment with acitretin.For more information on pregnancy and contraception, see section 2 “Pregnancy prevention programs”.


Breast-feeding

Do not take Acitretin Orifarm if you are breast-feeding as acitretin passes into breast milk and may harm your baby.

Driving and using machines

Your night vision may deteriorate during treatment. This can happen suddenly. In rare cases, the deterioration has persisted after the end of treatment. Be careful if you drive a motor vehicle or use machines in the evening or in a tunnel. 

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Acitretin Orifarm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one of Acitretin Orifarm is determined by the prescribing specialist who adapts it individually.


Take Acitretin Orifarm with a meal and preferably with milk.

Swallow the capsule whole.


The recommended dose is:

Adults and the elderly

  • The usual starting dose for adults and the elderly is 10 mg, 25 mg, or 30 mg once daily.
  • After 2 to 4 weeks, your doctor may increase or decrease your dose depending on how well it works and how it affects you.
  • The maximum dose is usually 30 mg per day (75 mg per day in some cases).
  • Most people take Acitretin Orifarm for up to 3 months. However, your doctor may decide that you need to take it for a long time.


You can use complementary treatments locally on the skin, including skincare products, after consulting your doctor.

Use for children and adolescents

Acitretin Orifarm is given to children only in special circumstances. If a child is being treated, the doctor will determine the correct dose based on the child’s weight. Long-term treatment of children is not recommended.

If you take more Acitretin Orifarm than you should you may experience headaches, dizziness, nausea and/or vomiting, drowsiness, irritability, and itching. Stop taking Acitretin Orifarm and contact your doctor immediately.

If you forget to take Acitretin Orifarm

Do not take a double dose to make up for a forgotten capsule. If you forget to take a dose, take it as soon as you notice and then continue with your usual dosing schedule. However, if it is almost time for your next dose, skip the missed dose.

If you stop taking Acitretin Orifarm

Your doctor can best decide if and how you should stop taking Acitretin Orifarm. Always consult your doctor before stopping your medicine.


If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Side effects of acitretin are dose-dependent. Most side effects occur at the beginning of treatment when the dose still needs to be adjusted. Most side effects disappear when the dose is changed or when the treatment is stopped. The symptoms in your skin may worsen at the beginning of the treatment. Because acitretin is derived from vitamin A, most side effects are similar to the symptoms that occur in someone who has taken too much vitamin A.


Stop taking Acitretin Orifarm and see a doctor if you get any of the following:


Uncommon (may affect up to 1 in 100 people):

  • liver infection (yellowish skin and eye color, dark urine, light stools, abdominal pain, loss of appetite, and fatigue)


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

  • increased pressure in the brain (headache, pain behind the eyes, visual disturbances)
  • skeletal changes (stiffness and skeletal pain)

Has been reported (occurs in an unknown number of users):

  • swelling around the eyes, mouth, and lips ( angioedema )


Other side effects:


Very common (may affect more than 1 user in 10):

  • dry nose, nosebleeds, runny nose
  • dry mouth, thirst, dry lips, cracks in the lips, dry skin, itching, hair loss, peeling of the skin especially on the palms and soles of the feet
  • increased levels of blood fats ( triglycerides, cholesterol ): increased risk of atherosclerosis
  • transient changes in liver function values ​​(blood tests).


Common (may affect up to 1 in 10 people):

  • headache
  • dry and infected mucous membranes of the eyes (may prevent you from wearing contact lenses)
  • inflammation of the mouth and lips
  • stomach problems (eg stomach pain, diarrhea, nausea, vomiting)
  • sensitive skin, oily skin, skin inflammation with blisters, hair changes, brittle nails, nail inflammation, reddening of the skin
  • joint pain, muscle pain
  • swollen hands, feet, and ankles


Uncommon (may affect up to 1 in 100 people):

  • dizziness
  • Tamsyn
  • gingivitis
  • cracks in the skin, skin infection with blisters, increased sensitivity of the skin to sunlight

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

  • weakness, tingling, numbness or paralysis, pain in hands and feet


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

  • corneal ulcer with pain and blurred vision
  • impaired night vision
  • taste changes
  • bleeding rectum
  • skeletal pain, fatigue
  • jaundice


Has been reported (occurs in an unknown number of users):

  • cardiovascular fluid leakage, which can cause low blood pressure and blood changes ( systemic capillary leakage / retinoic acid syndrome )
  • infection in the vagina (cod)
  • hypersensitivity reaction
  • hearing loss, ringing in the ears
  • redness
  • small, red, bleeding lumps in the skin
  • dropped eyelash s
  • hives
  • thinned skin
  • scaly or flaky skin
  • changes in how the voice sounds ( dysphonia )


Treatment with high doses of drugs such as acitretin can cause mood swings with irritability, aggression, and depression.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Acitretin Orifarm

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


Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month. 

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is acitretin. One capsule contains 10 mg or 25 mg of acitretin.
  • Other ingredients are Capsule contents: Maltodextrin, microcrystalline cellulose, sodium ascorbate, disodium edetate, poloxamer. Capsule shell: Gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).Labeling inks: Shellac, titanium dioxide (E171), propylene glycol.

What the medicine looks like and the contents of the pack

10 mg: Brown opaque/white opaque capsule, marked “U68” in white and filled with a yellow granulate. The size of the capsule is approximately 14.3 x 5.3 mm.


25 mg: Brown opaque/yellow opaque capsule, marked “U69” in white and filled with a yellow granulate. The size of the capsule is approximately 19.4 x 6.9 mm.


Blister packs:

10 mg: 50 and 100 hard capsules

25 mg: 30, 50, and 100 hard capsules.


Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energizer 15

5260 Odense S

Denmark


Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com


This medicinal product is authorized under the European Economic Area under the names:

Denmark, Sweden, Norway, Finland: Acitretin Orifarm

Muhammad Nadeem

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