Premilatic

• Adults with active psoriatic arthritis
• Adults with plaque psoriasis who are candidates for phototherapy or systemic therapy
• Adults with oral ulcers associated with Behçet’s disease
• Pediatrics ≥ 6 years of age and ≥ 20 kg with moderate to severe plaque psoriasis

• Premilatic is for oral use.
• Swallow the tablets whole, preferably with water.
• You can take the tablets either with or without food.
• Take Premilatic at about the same time each day, one tablet in the morning and one tablet in the evening.

Warnings & Precautions

Talk to your doctor or pharmacist before taking Premilatic If:

• You have Severe kidney problems: Your dosing will be different.
• You are losing weight without a known reason.
• You have digestive issues. Inform your doctor if severe diarrhea, nausea, or vomiting occurs.
• You experience any changes in behavior, mood, or feelings of depression, notify your doctor immediately.
• You have been told by your doctor that you have an intolerance to some sugars. Premilatic contains lactose (a type of sugar).

Driving and using machines

• Premilatic has no effect on the ability to drive and use machines.

Pregnancy & Breastfeeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including the following:

• Rifampicin – an antibiotic used for tuberculosis
• Phenytoin, phenobarbital and carbamazepine – medicines used in the treatment of seizures or epilepsy
• St John’s Wort – a herbal medicine for mild anxiety and depression.

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

Very common side effects

• Diarrhea
• Dausea
• Headache
• Upper respiratory tract infections such as cold, runny nose, sinus infection

If you take more Premilatic than you should
If you take more Premilatic than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you.

If you forget to take Premilatic
If you miss a dose of Premilatic, take it as soon as you remember. If it is close to the time for your next dose, just skip the missed dose. Take the next dose at your regular time.
Do not take a double dose to make up for a forgotten dose.

If you are allergic to Apremilast or any of the other ingredients of this medicine.

• 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 blister or on the wallet or on the carton after EXP. The expiry date refers to the last day of that month.
• Store below 30°C.
• Do not use this medicine if you notice any damage or signs of tampering to the medicine packaging.

• The treatment initiation pack is a folding wallet containing 8 film-coated tablets:
  4 ×10 mg tablets and 4 × 20 mg tablets.
• The standard pack contains 60 × 20 mg film-coated tablets.
• The other standard pack contains 60 × 30 mg film-coated tablets.