IMPORTANT NOTES & COMMON QUESTIONS

Before you start to take Zematane, tell your doctor if you are pregnant or intend to become pregnant.

This medicine can seriously harm an unborn baby (the medicine is said to be “teratogenic”). It can cause serious abnormalities of the unborn baby’s brain, face, ear, eye, heart and certain glands. It also makes a miscarriage more likely. This may happen even if alitretinoin is taken only for a short time during pregnancy. You must not get pregnant for one month after stopping this treatment because some medicine may still be left in your body.

Women who could get pregnant are prescribed Zematane under strict rules. This is because of the risk of serious harm to the unborn baby.

These may include:

• Your doctor has explained the risk of harm to the unborn baby – you must understand why you must not get pregnant and what you need to do to prevent getting pregnant.
• You have talked about contraception (birth control) with your doctor. The doctor will give you information how not to get pregnant.
• Before you start treatment, your doctor may ask you to take a pregnancy test. The test must show that you are not pregnant when starting treatment with Zematane.
• You must agree to use at least one very reliable method of contraception (for example an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., a hormonal contraceptive pill and a condom).
• You must use contraception for a month before taking Zematane, during treatment and for a month afterwards.
• You must use contraception even if you do not have periods or you are not sexually active (unless your doctor decides this is not necessary).

PROTECT YOUR SKIN WHEN YOU ARE IN THE SUN

Zematane may cause your skin to be more sensitive to sunlight. So, if you are outdoors, it is important to wear protective clothing and use a SPF 30+ or higher sunscreen.

TELL YOUR DOCTOR IF:

• You are breastfeeding or planning to breastfeed. The medicine is likely to pass into your milk and may harm your baby.
• You have ever had any kind of mental health problems. This includes depression, aggressive tendencies, or mood changes. It also includes thoughts about hurting yourself or ending your life. This is because your mood may be affected while taking Zematane.
• You have kidney disease. Zematane is not recommended for people with moderate kidney disease. If you have kidney disease – check with your doctor that Zematane is suitable for you.
• You have high blood fats. You may need blood tests more often. Zematane commonly increases blood fats, such as cholesterol or triglycerides. If your blood fats stay high, your doctor may lower your dose, or take you off Zematane.
• You have high blood sugar (diabetes). Your blood sugar levels may need to be checked more often.
• You have been suffering from thyroid disease. Zematane may lower your thyroid hormone levels.
• You have allergies to: • Any other medicines. Any other substances, such as foods, preservatives or dyes.

TELL YOUR DOCTOR OR PHARMACIST IF YOU NOTICE ANY OF THE FOLLOWING AND THEY WORRY YOU:

• Headache
• Raised blood fats such as triglycerides and cholesterol
• Thyroid problems
• Eye problems such as dry and irritated eyes
• Persistent noise in the ears (tinnitus)
• Dizziness
• Flushing, high blood pressure
• Feeling sick (nausea), being sick (vomiting), dry mouth
• Muscle pain, joint pain, lack of energy (fatigue)
• Dryness of the skin, especially of the face, dry and inflamed lips, redness of the skin, itchy skin rash, inflamed skin, hair loss.

TELL YOUR DOCTOR AS SOON AS POSSIBLE IF YOU NOTICE ANY OF THE FOLLOWING SYMPTOMS:

• Altered mood, anxiety, feelings of emotional discomfort Depression
• Existing depression worsening
• Unusual behaviour e.g., becoming aggressive
• Having thoughts or feelings about harming yourself
• A loss of contact with reality, such as hearing voices or seeing things that are not there.

IF ANY OF THE FOLLOWING HAPPEN, STOP TAKING ZEMATANE AND TELL YOUR DOCTOR IMMEDIATELY, OR GO TO ACCIDENT AND EMERGENCY AT YOUR NEAREST HOSPITAL:

Swelling of the face, lips, mouth or throat which may cause difficulty

in swallowing or breathing; hives; fainting. These are very serious side effects. If you have them, you may have had a serious allergic reaction to Zematane. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Severe stomach (abdominal) pain, with or without bloody diarrhoea, feeling sick (nausea) and being sick (vomiting). Stop taking Zematane immediately and contact your doctor. These can be signs of serious gut conditions.

These may be serious side effects of Zematane. You may need urgent medical attention. Serious side effects are uncommon. Tell your doctor if you notice any other effects. Other adverse effects not listed above may also occur in some patients.