APREMILAST 10 mg/20 mg /30 Mg Фильм-Coated Таблетки

Содержание инструкции

1. Apremilast Teva 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets
   1. What is Apremilast Teva and what is it used for
   2. What you need to know before you take Apremilast Teva
   3. How to take Apremilast Teva
   4. Possible side effects
   5. How to store Apremilast Teva
   6. Contents of the pack and other information

Apremilast Teva 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets

apremilast

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Apremilast Teva is and what it is used for
• 2. What you need to know before you take Apremilast Teva
• 3. How to take Apremilast Teva
• 4. Possible side effects
• 5. How to store Apremilast Teva
• 6. Contents of the pack and other information

1. What is Apremilast Teva and what is it used for

Apremilast Teva contains the active ingredient “apremilast”. This ingredient belongs to a group of
medicines called “phosphodiesterase 4 inhibitors”, which help to reduce inflammation.
Apremilast Teva is used for the treatment of adults with the following clinical conditions:

• Active psoriatic arthritis- if another type of medicines called “disease-modifying antirheumatic drugs” (DMARDs) cannot be used, or if treatment with one of these medicines has been attempted without being effective.
• Moderate to severe chronic plaque psoriasis- if one of the following treatments cannot be used, or if one of these treatments has been attempted without being effective:
• phototherapy - a treatment in which certain areas of the skin are exposed to ultraviolet light;
• systemic therapy - a treatment that affects the whole body rather than just a localized area, such as “cyclosporine”, “methotrexate” or “psoralen”.
• Behçet's disease (BD)- for the treatment of mouth ulcers, a common problem for people with this disease.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis, an inflammatory skin disease.

What is plaque psoriasis
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick, itchy and painful patches on the skin and can also affect the scalp and nails.

What is Behçet's disease
Behçet's disease is a rare type of inflammatory disease that affects many parts of the body. The
most common problem is mouth ulcers.

How does Apremilast Teva work
Psoriatic arthritis, psoriasis and Behçet's disease are diseases that usually last a lifetime and
for which there is currently no cure. Apremilast Teva works by reducing the activity of an enzyme
present in the body, called “phosphodiesterase 4”, which is involved in the inflammatory process.
By reducing the activity of this enzyme, Apremilast Teva can help to control the inflammation
associated with psoriatic arthritis, psoriasis and Behçet's disease and thus alleviate the signs and symptoms
of these clinical conditions.
In psoriatic arthritis, treatment with Apremilast Teva produces an improvement in swelling and
joint pain and can improve overall physical function.
In psoriasis, treatment with Apremilast Teva produces a reduction in psoriatic plaques
on the skin and other signs and symptoms of the disease.
In Behçet's disease, treatment with Apremilast Teva reduces the number of mouth ulcers and
can completely stop their development. It can also alleviate the associated pain.
Apremilast Teva has also been shown to improve the quality of life of patients with psoriasis,
psoriatic arthritis or Behçet's disease. This means that the impact of the clinical condition on daily activities, relationships and other factors should be less than before.

2. What you need to know before you take Apremilast Teva

Do not take Apremilast Teva:

• if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast Teva.

Depression and suicidal thoughts
Tell your doctor before starting treatment with Apremilast Teva if you suffer from depression that is
worsening with suicidal thoughts.
You or the person who cares for you should also immediately inform your doctor of
any changes in behaviour or mood, feelings of depression and suicidal thoughts
that you may experience after taking Apremilast Teva.

Severe kidney problems
If you have severe kidney problems, your dose will be different; see section 3.

If you are underweight
Talk to your doctor if you lose weight unintentionally during treatment with Apremilast Teva.

Intestinal problems
If you develop severe diarrhoea, nausea or vomiting, talk to your doctor.

Children and adolescents
Apremilast Teva has not been studied in children and adolescents; therefore, use is not
recommended in children and adolescents aged 17 years or younger.

Other medicines and Apremilast Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal medicines.
Apremilast Teva can in fact affect the action of some other medicines and some other medicines
can affect the action of Apremilast Teva.
In particular, tell your doctor or pharmacist before taking Apremilast Teva if you are taking
any of the following medicines:

• rifampicin - an antibiotic used for tuberculosis;
• phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures of epilepsy;
• St John's wort - a herbal medicine used for mild forms of anxiety and depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the effects of Apremilast Teva during pregnancy. Do not become pregnant
while taking this medicine and use effective contraception during treatment with
Apremilast Teva.
It is not known whether this medicine passes into breast milk. Do not use Apremilast Teva during
breastfeeding.

Driving and using machines
Apremilast Teva does not impair the ability to drive and operate machines.

Apremilast Teva contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

Apremilast Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Apremilast Teva

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.

Dosage to be taken

• When you start taking Apremilast Teva, you will receive a “treatment start pack” containing all the doses listed in the following table.
• The “treatment start pack” has clear labelling to ensure you take the right tablet at the right time.
• Treatment will begin with a lower dose, which will be gradually increased over the first 6 days of treatment.
• The “treatment start pack” will also contain enough tablets for another 8 days of treatment at the recommended dose (days 7 to 14).
• The recommended dose of Apremilast Teva is 30 mg twice a day, once the dose escalation phase is completed: one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food.
• This corresponds to a total daily dose of 60 mg. By the end of day 6, you will have reached this recommended dose.
• Once the recommended dose is reached, you will only take the 30 mg tablet in the prescribed packs. You will only need to follow this dose escalation phase once, even if you restart treatment after an interruption.

People with severe kidney problems
If you have severe kidney problems, the recommended dose of Apremilast Teva is 30 mg once a day
(morning dose). The doctor will explain how to increase the dose when you start treatment with
Apremilast Teva.

How and when to take Apremilast Teva

• Apremilast Teva is for oral use.
• Swallow the tablets whole, preferably with water.
• You can take the tablets with or without food.
• Take Apremilast Teva at approximately the same time each day, one tablet in the morning and one tablet in the evening.
• To remove the tablets from the blister, fold the blister and tear along the perforated line to detach a single unit. Then gently remove the aluminium foil from the single unit starting from the arrow. Do not push the tablet through the foil.

If your condition has not improved after six months of treatment, consult your doctor.

If you take more Apremilast Teva than you should
If you take more Apremilast Teva than you should, consult your doctor or go to hospital

If you forget to take Apremilast Teva

• If you forget to take a dose of Apremilast Teva, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Apremilast Teva

• Continue to take Apremilast Teva until your doctor tells you to stop treatment.
• Do not stop taking Apremilast Teva without first talking to your doctor.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects – depression and suicidal thoughts
Tell your doctor immediately about any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (uncommon).

Very common side effects(may affect more than 1 in 10 people)

• Diarrhoea
• Nausea
• Headache
• Upper respiratory tract infections such as common cold, runny nose, sinus infection

Common side effects(may affect up to 1 in 10 people)

• Cough
• Back pain
• Vomiting
• Feeling tired
• Stomach pain
• Loss of appetite
• Frequent bowel movements
• Difficulty sleeping (insomnia)
• Indigestion or heartburn
• Inflammation and swelling of the airways (bronchitis)
• Common cold (nasopharyngitis)
• Depression
• Migraine
• Tension headache

Uncommon side effects(may affect up to 1 in 100 people)

• Skin rash
• Hives
• Weight loss
• Allergic reaction
• Bleeding in the intestine or stomach
• Suicidal ideation or behaviour

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Severe allergic reaction (may include swelling of the face, lips, mouth, tongue or throat, which can cause difficulty breathing or swallowing)

If you are 65 years of age or older, you may be more at risk of complications from severe diarrhoea, nausea and vomiting. If your bowel problems become severe, see your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Apremilast Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not use this medicine if you notice damage or signs of tampering with the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Apremilast Teva contains

• The active ingredient is apremilast.
• Apremilast Teva 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
• Apremilast Teva 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
• Apremilast Teva 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

The other components of the tablet core are: lactose monohydrate, microcrystalline cellulose,
sodium croscarmellose and magnesium stearate.
The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol and iron oxide
red (E172).
Apremilast Teva 20 mg film-coated tablets also contain iron oxide yellow (E172).

Description of the appearance of Apremilast Teva and contents of the pack
Apremilast Teva 10 mg film-coated tablets are oval, light pink film-coated tablets,
with “TV” imprinted on one side and “Y2” on the other side. The dimensions of the
tablets are approximately 9 mm x 5 mm.
Apremilast Teva 20 mg film-coated tablets are oval, beige film-coated tablets,
with “TV” imprinted on one side and “Y3” on the other side. The dimensions of the tablets
are approximately 11 mm x 6 mm.
Apremilast Teva 30 mg film-coated tablets are oval, pink film-coated tablets,
with “TV” imprinted on one side and “Y4” on the other side. The dimensions of the tablets
are approximately 12 mm x 7 mm.
Apremilast Teva 10 mg, 20 mg, 30 mg film-coated tablets (starter pack)
The starter pack contains 27 film-coated tablets (4 tablets of 10
mg, 4 tablets of 20 mg and 19 tablets of 30 mg) in perforated PVC/aluminum blisters.
Packs: 27 tablets (in a common blister)
27x1 tablets (in a blister divisible for single doses)
Apremilast Teva 30 mg film-coated tablets
Perforated PVC/aluminum blister
Packs: 30x1 (in a blister divisible for single doses), 56, 56x1 (in a blister divisible for single doses), 60, 168x1 (in a blister divisible for single doses)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
31-546, Krakow
Poland