Acitretin Capsules

ACITRETIN PHARMC contains a medicine called acitretin. It belongs to a group of medicines called retinoids.

ACITRETIN PHARMC is used to treat severe skin problems where the skin has become thick and maybe scaly. These skin problems include psoriasis, ichthyosis and keratosis follicularis (Darier’s disease). It works by making your skin grow more normally.

ACITRETIN PHARMC is normally used while under the care of a specialist dermatologist (skin doctor).

Do not take ACITRETIN PHARMC:

• If you are pregnant or breastfeeding your baby. ACITRETIN PHARMC can seriously harm an unborn baby (see below Important information for women under “Warnings and precautions”).
• If you might get pregnant while taking ACITRETIN PHARMC or within 3 years of stopping it (see below: Important information for women under “Warnings and precautions”).
• If you are hypersensitive (allergic) to acitretin or any of the other ingredients of ACITRETIN PHARMC (listed in section 6).
• If you are allergic to other ‘retinoid’ medicines. These include isotretinoin and tazarotene.
• If you have liver or kidney problems.
• If you have very high levels of fat in your blood (also known as hyperlipidaemia).
• If you are taking midcrodosed progesterone preparations or “minipills”.
• If you have hypervitaminosis A, a disorder where there is too much vitamin A in your body.
• If you are younger than 18 years old.
• If you are taking an antibiotic called tetracycline (for an infection) or a medicine called methotrexate (for skin problems, arthritis or cancer).

Do not share medicines prescribed for you with any other person. Always take ACITRETIN PHARMC exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with ACITRETIN PHARMC will last. If you have the impression that the effect of ACITRETIN PHARMC is too strong or too weak, tell your doctor or pharmacist.

Take ACITRETIN PHARMC at a meal time or with a drink of milk.

Swallow each capsule whole. The dose varies from one patient to another. Your doctor will work out the right dose for you.

Adults and elderly people

The usual starting dose for adults and elderly people is 25 mg (1 capsule; 25 mg) or 30 mg (3 capsules; 10 mg) once a day. After 2 to 4 weeks, your doctor may increase or decrease your dose. This will depend on how well it works and how it affects you. The maximum dose is 75 mg a day.

Children

ACITRETIN PHARMC therapy in children under 18 years of age is contraindicated (see Do not take ACITRETIN PHARMC).

If you take more ACITRETIN PHARMC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take the medicine pack with you.

If you forget to take ACITRETIN PHARMC

If you forget to take a dose of ACITRETIN PHARMC, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking ACITRETIN PHARMC

Do not stop taking ACITRETIN PHARMC unless your doctor tells you to.

ACITRETIN PHARMC can have side effects.

Not all side effects reported for ACITRETIN PHARMC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ACITRETIN PHARMC, please consult your health care provider for advice.

If any of the following happens, stop taking / using ACITRETIN PHARMC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, mouth, throat, face, lips or eyes,
• shortness of breath or wheezing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to ACITRETIN PHARMC. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• a severe headache,
• feeling or being sick,
• problems with your eye sight,
• if you feel any aches and pains in your muscles, bones or joints. This may mean you have extra growth on the surface of your bones. This can happen if you take ACITRETIN PHARMC for a long time.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent dry, irritated or swollen eyes, which may lead to intolerance of contact lenses,
• dry, irritated or runny nose, nose bleeding,
• dry mouth, thirst,
• dryness or inflammation of the lips, which may be alleviated by application of a fatty ointment.

Itching, hair loss, peeling of the skin from the palms of hands or the soles of the feet or even rest of the body,

• changes in how the liver is working (shown by blood test),
• increased levels of fats in your blood (shown by blood test),
• headache.

inflammation of the mucous tissue of the mouth, abdominal pain, diarrhoea, feeling sick, being sick,

• fragile skin, sticky feeling on the skin or a rash, skin inflammation, changes to the texture of the hair, brittle nails, skin infection around a nail, redness of the skin,
• joint pain, muscle pain,
• swelling of hands, ankles and feet.

Less frequent

• dizziness,
• blurred vision,
• inflammation of the gums,
• inflammation of the liver,
• fissures cracks or fine linear scars in the skin e.g. around the mouth (rhagades), blisters and inflammation of the skin (dermatitis bullous), skin being more sensitive to the sun (photosensitivity reaction),
• damage to the peripheral nervous system, which may include symptoms like muscle weakness, numbness and tingling in the feet and hands or burning, stabbing or shooting pain,
• increased blood pressure in the skull,
• night blindness, inflammation of the cornea in the eye (ulcerative keratitis),
• yellowing of the skin or the whites of the eyes (jaundice),
• bone pain, changes in bone growth.

Frequency unknown

• infection of the vagina (also known as candida or thrush),
• impaired hearing, ringing in the ear (tinnitus),
• a serious condition which causes the small blood vessels (capillaries) to leak (Capillary Leak Syndrome/Retinoic Acid Syndrome). This can lead to severe hypotension (low blood pressure), oedema (build up of fluid leading to swelling) and shock (collapse),
• flushing, sweating, skin redness on the face,
• changes in the way things taste, bleeding in the rectum,
• a serious skin reaction with symptoms such as rash, blistering or peeling of the skin (Exfoliative dermatitis),
• small, reddish bumps or nodules on the skin that may bleed easily (pyogenic granuloma), scaling or thinning of the skin,
• cracks or scaring at the corners of the mouth,
• loss of eyelashes or eyebrows (madarosis),
• improve or worsen glucose tolerance in diabetic patients,
• general unwell feeling, drowsiness,
• swelling of the face, lips, throat or tongue (angioedema),
• severe itchy skin rash with pale or red irregular raised patches (hives).

An initial worsening of psoriasis symptoms is sometimes seen at the beginning of the treatment period.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Health care providers are asked to report any suspected adverse reactions to

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Protect from moisture.
• Do not use after the expiry date stated on the blister / carton. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).