Selexipag stada

Poland
Brand name Selexipag stada
Form tablets, film-coated
Active substance / Dosage
selexipag · 1600 mcg
Prescription type Prescription only – restricted use
ATC code
B01AC27
Registration number 100503064
Manufacturer Synthon B.V. Synthon Hispania S.L. Synfon s.r.o.
Selexipag stada tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

Selexipag STADA, 200 micrograms, film-coated tablets
Selexipag STADA, 400 micrograms, film-coated tablets
Selexipag STADA, 600 micrograms, film-coated tablets
Selexipag STADA, 800 micrograms, film-coated tablets
Selexipag STADA, 1000 micrograms, film-coated tablets
Selexipag STADA, 1200 micrograms, film-coated tablets
Selexipag STADA, 1400 micrograms, film-coated tablets
Selexipag STADA, 1600 micrograms, film-coated tablets
selexipag

Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

  • Keep this leaflet for future reference.
  • If you have any questions, consult your doctor or nurse.
  • This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

  1. What Selexipag is and what it is used for
  2. Important information before taking Selexipag
  3. How to take Selexipag
  4. Possible side effects
  5. How to store Selexipag
  6. Contents of the pack and other information

1. What Selexipag is and what it is used for

Selexipag contains the active substance selexipag. Selexipag affects blood vessels in a similar way to prostacyclin – a substance naturally present in the human body – causing them to relax and dilate.
Selexipag is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients who do not respond adequately to other PAH treatments known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors.
Selexipag may be used as monotherapy in patients who are not eligible for treatment with these other medicines.
PAH refers to high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arteries). In people with PAH, these arteries are narrowed, so the heart must work harder to pump blood through them. This may lead to symptoms such as fatigue, dizziness, shortness of breath, or other symptoms.
By acting similarly to the natural substance prostacyclin, this medicine dilates the pulmonary arteries and reduces their stiffness. This makes it easier for the heart to pump blood through the pulmonary arteries. Selexipag lowers blood pressure in the pulmonary arteries, alleviates PAH symptoms, and slows disease progression.

2. Important information before taking Selexipag

When not to take Selexipag

  • if the patient is allergic to selexipag or any of the other ingredients of this medicine (listed in section 6);
  • if the patient has heart conditions such as:
    • reduced blood flow to the heart muscle (severe coronary artery disease or unstable angina pectoris); symptoms may include chest pain;
    • myocardial infarction (heart attack) within the last six months;
    • weakened heart (decompensated heart failure), if the patient is not under close medical supervision;
    • severe cardiac arrhythmias;
    • heart valve disorders (congenital or acquired) causing abnormal heart function (unrelated to pulmonary hypertension);
  • if the patient has had a stroke within the last 3 months or another event causing reduced cerebral blood flow (e.g. transient ischemic attack);
  • if the patient is taking gemfibrozil (a medicine used to lower blood lipid levels).

Warnings and precautions
Before starting treatment with Selexipag, discuss with the physician managing the patient’s
PAH (pulmonary arterial hypertension) therapy if the patient:

  • is taking medications to lower high blood pressure;
  • has low blood pressure associated with symptoms such as dizziness;
  • has recently lost a significant amount of blood or bodily fluids, e.g. due to severe diarrhea or vomiting;
  • has thyroid function disorders;
  • has severe kidney impairment or is undergoing dialysis;
  • currently or previously had severe liver dysfunction.

If the patient experiences any of the above signs or a change in health status, they should
inform their physician immediately.
Children and adolescents
This medicine must not be given to children under 18 years of age.
Elderly patients
Clinical experience with Selexipag in patients over 75 years of age is limited. Selexipag should be used with caution in this age group.
Selexipag and other medicines
Inform the physician about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform the physician managing the patient’s PAH treatment or the nurse if the patient is taking any of the following medicines:

  • gemfibrozil (a medicine used to lower blood lipid levels),
  • clopidogrel (a medicine used to prevent blood clots in coronary artery disease),
  • deferasirox (a medicine used to remove iron from the bloodstream),
  • teriflunomide (a medicine used to treat relapsing-remitting multiple sclerosis),
  • carbamazepine (a medicine used to treat certain types of epilepsy, neuralgia, or to manage severe affective disorders when other medicines are ineffective),
  • phenytoin (a medicine used to treat epilepsy),
  • valproic acid (a medicine used to treat epilepsy),
  • probenecid (a medicine used to treat gout),
  • fluconazole, rifampicin, or rifapentine (antibiotics used to treat infections).

Pregnancy and breastfeeding
Selexipag is not recommended during pregnancy and breastfeeding. Women of childbearing potential should use an effective method of contraception during treatment with Selexipag. If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her physician before using this medicine.
Driving and operating machinery
Selexipag may cause adverse effects such as headache and low blood pressure (see section 4), which may impair the ability to drive. The patient’s underlying disease symptoms may also limit their ability to drive or operate machinery.

3. How to take Selexipag

Selexipag should only be prescribed by a physician experienced in the treatment of pulmonary arterial hypertension (PAH). This medicine must always be taken exactly as directed by the physician. If you have any doubts or questions, please consult your doctor.

Inform your doctor if you experience any adverse effects, as they may recommend adjusting the dose of Selexipag.
Inform your doctor if you have impaired liver function or are taking other medications, as your doctor may prescribe a lower dose of Selexipag to be taken twice daily or even once daily.
Patients with visual impairment or blindness should receive assistance from another person when taking Selexipag during the dose-titration period (the process of gradually increasing the dose).

Dose Titration
If your doctor prescribes 200 microgram tablets:
At the beginning of treatment, most patients start with one 200 microgram tablet in the morning and one 200 microgram tablet in the evening, approximately 12 hours apart. It is recommended to start treatment in the evening. Your doctor will instruct you on how to gradually increase the dose. This period is called the dose-titration phase and allows your body to adapt gradually to the new medicine. The goal of dose titration is to find the most appropriate dose for you—the highest dose you can tolerate, up to a maximum of 1600 micrograms in the morning and 1600 micrograms in the evening.

The first pack of tablets you receive will contain light yellow 200 microgram tablets.

Your doctor will instruct you to gradually increase the dose, usually at weekly intervals, although the intervals between dose increases may be longer.

Each time the dose is increased, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose. The first increased dose should preferably be taken in the evening. The diagram below shows the number of tablets to be taken each morning and each evening during the first four titration stages.

Drug dosage schedule divided into four weekly stages, showing an increase in the number of 200-microgram tablets from 400 to 1600 micrograms per day

If your doctor instructs you to continue increasing the dose, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose at each subsequent stage. The first increased dose should preferably be taken in the evening.

If your doctor instructs further dose escalation and you progress to stage 5, this may involve taking one brown 800 microgram tablet and one light yellow 200 microgram tablet in the morning, and one 800 microgram tablet and one 200 microgram tablet in the evening.

The maximum dose of Selexipag is 1600 micrograms in the morning and 1600 micrograms in the evening. However, not all patients will receive this dose, as individual patients require different doses.

The diagram below shows the number of tablets to be taken each morning and evening from stage 5 onwards.

Drug dosage schedule showing stages 5, 6, 7, and 8, divided into morning and evening doses, with numbers of 200- and 800-microgram tablets

If your doctor prescribes 100 microgram tablets:
This medicinal product is not available in 100 microgram tablets. Therefore, if needed, alternative commercially available medicinal products containing selexipag should be used.

Using the Dose-Titration Guide
You will receive a dose-titration pack containing a dose-titration guide and a patient leaflet. The dose-titration guide provides information on the titration process and allows you to record the number of tablets taken each day.

Remember to record the number of tablets taken daily in the dose-titration diary. Each titration stage usually lasts 1 week. If your doctor advises extending any titration stage beyond 1 week, additional pages in the dose-titration diary allow you to record this. Remember to maintain regular contact with your PAH specialist or nurse during the dose-titration period.

Dose Reduction Due to Adverse Effects
During dose titration, you may experience adverse effects such as headache, diarrhea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain, or facial flushing (see section 4). If these adverse effects are difficult to tolerate, discuss with your doctor possible ways to reduce or manage them. There are treatments available to help alleviate these side effects. For example, pain relievers such as paracetamol may help relieve pain and headache.

If adverse effects cannot be alleviated or do not gradually improve at the current dose, your doctor may instruct you to reduce the dose by decreasing the number of light yellow tablets by one in the morning and one in the evening. The scheme below illustrates the stepwise dose reduction. This should only be done under a doctor’s instruction.

Drug dosing chart with three phases: increasing the dose from 200 to 400 micrograms, reaching the target in stage 6, and potential dose reduction

If the adverse effects become tolerable after dose reduction, your doctor may decide to continue treatment at this reduced dose. Additional information is provided below under “Maintenance Dose.”

Maintenance Dose
The highest dose tolerated during titration becomes the maintenance dose. This is the dose you will take regularly.

Your doctor will prescribe the appropriate tablets corresponding to this dose. This may allow you to take one tablet in the morning and one in the evening instead of multiple tablets each time.

A full description of Selexipag tablets, including their colors and markings, is provided in section 6 of this leaflet.

Over time, your doctor may adjust the maintenance dose as appropriate.

If, at any time during long-term treatment with the same dose, you experience adverse effects that you cannot tolerate or that interfere with your daily activities, contact your doctor, as your dose may need to be adjusted. Your doctor may prescribe a lower dose. Remember to dispose of any unused tablets (see section 5).

Selexipag should be taken in the morning and evening, approximately 12 hours apart.
Take the tablets with food, as this may improve tolerability. The tablet coating provides protection. Swallow the tablets whole with a glass of water. Do not divide or crush the tablets.

Taking more Selexipag than prescribed
If you take more tablets than your doctor has instructed, contact your doctor immediately.

Missing a dose of Selexipag
If you forget to take a dose of Selexipag, take it as soon as possible, then continue taking your tablets at the usual times. However, if it is almost time for your next dose (within 6 hours of the scheduled dose), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Selexipag
Stopping Selexipag abruptly may lead to worsening of your symptoms. Do not stop taking Selexipag without your doctor’s advice. Your doctor may instruct you to gradually reduce the dose before stopping completely.

If, for any reason, you stop taking Selexipag for more than 3 consecutive days (you miss 3 morning and 3 evening doses, or 6 consecutive doses or more), you should contact your doctor immediately, as it may be necessary to reduce the dose upon restarting to avoid adverse effects. Your doctor may decide to restart treatment at a lower dose and gradually increase it back to your previous maintenance dose.

If you have any further questions about the use of this medicine, please consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may occur in patients not only during the dose-titration period, when the dose of the medicine is being increased, but also later, while taking the same dose for a prolonged period of time.
If the patient develops swelling of the face, lips, tongue or throat, which may lead to
difficulty in swallowing or breathing (angioedema), seek immediate medical advice.
If the patient experiences any of the following adverse reactions: headache,
diarrhoea, nausea, vomiting, jaw pain, muscle pain, leg pain, joint pain or facial flushing,
which the patient cannot tolerate or which cannot be relieved with medication,
the patient should consult a doctor, as the dose being taken may be too high and may require reduction.

Very common adverse reactions (may affect more than 1 in 10 people):

  • headache
  • sudden facial flushing
  • nausea and vomiting
  • diarrhoea
  • jaw pain, muscle pain, joint pain, leg pain
  • nasopharyngitis (nasal and throat congestion).

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

  • anaemia (low number of red blood cells)
  • hyperthyroidism
  • decreased appetite
  • weight loss
  • hypotension (low blood pressure)
  • abdominal pain, including dyspepsia
  • pain
  • changes in certain blood test results, including blood cell counts or thyroid function
  • skin rashes, including urticaria, which may cause burning, stinging or skin redness
  • angioedema and its symptoms described at the beginning of this section.

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

  • increased heart rate.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your anaesthesiologist or another doctor. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Selexipag

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Do not store 200- and 400-microgram tablets at temperatures above 30°C.
The 600-, 800-, 1000-, 1200-, 1400-, and 1600-microgram tablets do not require any special
storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Selexipag STADA contains
The active substance is selexipag.
Selexipag, 200 microgram film-coated tablets contains 200 micrograms of selexipag
Selexipag, 400 microgram film-coated tablets contains 400 micrograms of selexipag
Selexipag, 600 microgram film-coated tablets contains 600 micrograms of selexipag
Selexipag, 800 microgram film-coated tablets contains 800 micrograms of selexipag
Selexipag, 1000 microgram film-coated tablets contains 1000 micrograms of selexipag
Selexipag, 1200 microgram film-coated tablets contains 1200 micrograms of selexipag
Selexipag, 1400 microgram film-coated tablets contains 1400 micrograms of selexipag
Selexipag, 1600 microgram film-coated tablets contains 1600 micrograms of selexipag

The other ingredients are: mannitol, maize starch, hydroxypropylcellulose, methacrylic acid and methyl methacrylate copolymer (1:1), magnesium stearate (tablet core); hypromellose type 2910, propylene glycol, titanium dioxide (E 171), iron oxides (E 172), carnauba wax (tablet coating).

Selexipag, 200 microgram film-coated tablets contains yellow iron oxide (E 172).
Selexipag, 400 microgram film-coated tablets contains black iron oxide (E 172) and red iron oxide (E 172).
Selexipag, 600 microgram film-coated tablets contains red iron oxide (E 172).
Selexipag, 800 microgram film-coated tablets contains black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).
Selexipag, 1000 microgram film-coated tablets contains red iron oxide (E 172).
Selexipag, 1200 microgram film-coated tablets contains black iron oxide (E 172) and red iron oxide (E 172).
Selexipag, 1400 microgram film-coated tablets contains yellow iron oxide (E 172).
Selexipag, 1600 microgram film-coated tablets contains black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).

What Selexipag looks like and contents of the pack
Selexipag, 200 microgram film-coated tablets: round, light yellow film-coated tablets (tablets), embossed with the code "A2" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 400 microgram film-coated tablets: round, violet film-coated tablets (tablets), embossed with the code "A4" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 600 microgram film-coated tablets: round, red film-coated tablets (tablets), embossed with the code "A6" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 800 microgram film-coated tablets: round, brown film-coated tablets (tablets), embossed with the code "A8" on one side and smooth on the other side. The tablets have a diameter of approximately 5.5 mm.
Selexipag, 1000 microgram film-coated tablets: round, red film-coated tablets (tablets), embossed with the code "A10" on one side and smooth on the other side. The tablets have a diameter of approximately 5.6 mm.
Selexipag, 1200 microgram film-coated tablets: round, violet film-coated tablets (tablets), embossed with the code "A12" on one side and smooth on the other side. The tablets have a diameter of approximately 6.5 mm.
Selexipag, 1400 microgram film-coated tablets: round, light yellow film-coated tablets (tablets), embossed with the code "A14" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.
Selexipag, 1600 microgram film-coated tablets: round, brown film-coated tablets (tablets), embossed with the code "A16" on one side and smooth on the other side. The tablets have a diameter of approximately 7 mm.

Selexipag, 200 microgram film-coated tablets are available in blister packs containing 10 or 60 film-coated tablets and 60 or 140 film-coated tablets (dose titration packs), or in unit dose blister packs containing 10x1 or 60x1 film-coated tablets and 60x1 or 140x1 film-coated tablets (dose titration packs).
Selexipag, 400 microgram, 600 microgram, 800 microgram, 1000 microgram, 1200 microgram, 1400 microgram and 1600 microgram film-coated tablets are available in blister packs containing 60 tablets, or in unit dose blister packs containing 60x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
Synthon Hispania S.L.
Calle De Castello 1
08830 Sant Boi De Llobregat
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon s.r.o.
Brnenska 597/32
678 01 Blansko
Czech Republic

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

200 micrograms
Netherlands Selexipag STADA Arzneimittel AG 200 microgram film-coated tablets
Germany Selexipag AL 200 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 200 mcg film-coated tablets
Ireland Selexipag Clonmel 200 microgram film-coated tablets
Iceland Selexipag STADA 200 μg film-coated tablets
Lithuania Selexipag STADA 200 microgram film-coated tablets
Latvia Selexipag STADA 200 microgram film-coated tablets
Malta Selexipag Clonmel 200 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 200 microgram film-coated tablets

400 micrograms
Netherlands Selexipag STADA Arzneimittel AG 400 microgram film-coated tablets
Germany Selexipag AL 400 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 400 mcg film-coated tablets
Ireland Selexipag Clonmel 400 microgram film-coated tablets
Iceland Selexipag STADA 400 μg film-coated tablets
Lithuania Selexipag STADA 400 microgram film-coated tablets
Latvia Selexipag STADA 400 microgram film-coated tablets
Malta Selexipag Clonmel 400 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 400 microgram film-coated tablets

600 micrograms
Netherlands Selexipag STADA Arzneimittel AG 600 microgram film-coated tablets
Germany Selexipag AL 600 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 600 mcg film-coated tablets
Ireland Selexipag Clonmel 600 microgram film-coated tablets
Iceland Selexipag STADA 600 μg film-coated tablets
Lithuania Selexipag STADA 600 microgram film-coated tablets
Latvia Selexipag STADA 600 microgram film-coated tablets
Malta Selexipag Clonmel 600 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 600 microgram film-coated tablets

800 micrograms
Netherlands Selexipag STADA Arzneimittel AG 800 microgram film-coated tablets
Germany Selexipag AL 800 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 800 mcg film-coated tablets
Ireland Selexipag Clonmel 800 microgram film-coated tablets
Iceland Selexipag STADA 800 μg film-coated tablets
Lithuania Selexipag STADA 800 microgram film-coated tablets
Latvia Selexipag STADA 800 microgram film-coated tablets
Malta Selexipag Clonmel 800 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 800 microgram film-coated tablets

1000 micrograms
Netherlands Selexipag STADA Arzneimittel AG 1000 microgram film-coated tablets
Germany Selexipag AL 1000 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 1000 mcg film-coated tablets
Ireland Selexipag Clonmel 1000 microgram film-coated tablets
Iceland Selexipag STADA 10 μg film-coated tablets
Lithuania Selexipag STADA 1000 microgram film-coated tablets
Latvia Selexipag STADA 1000 microgram film-coated tablets
Malta Selexipag Clonmel 1000 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 1000 microgram film-coated tablets

1200 micrograms
Netherlands Selexipag STADA Arzneimittel AG 1200 microgram film-coated tablets
Germany Selexipag AL 1200 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 1200 mcg film-coated tablets
Ireland Selexipag Clonmel 1200 microgram film-coated tablets
Iceland Selexipag STADA 1200 μg film-coated tablets
Lithuania Selexipag STADA 1200 microgram film-coated tablets
Latvia Selexipag STADA 1200 microgram film-coated tablets
Malta Selexipag Clonmel 1200 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 1200 microgram film-coated tablets

1400 micrograms
Netherlands Selexipag STADA Arzneimittel AG 1400 microgram film-coated tablets
Germany Selexipag AL 1400 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 1400 mcg film-coated tablets
Ireland Selexipag Clonmel 1400 microgram film-coated tablets
Iceland Selexipag STADA 1400 μg film-coated tablets
Lithuania Selexipag STADA 1400 microgram film-coated tablets
Latvia Selexipag STADA 1400 microgram film-coated tablets
Malta Selexipag Clonmel 1400 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 1400 microgram film-coated tablets

1600 micrograms
Netherlands Selexipag STADA Arzneimittel AG 1600 microgram film-coated tablets
Germany Selexipag AL 1600 microgram film-coated tablets
Denmark Selexipag STADA
Estonia Selexipag STADA
Spain Selexipag STADA 1600 mcg film-coated tablets
Ireland Selexipag Clonmel 1600 microgram film-coated tablets
Iceland Selexipag STADA 1600 μg film-coated tablets
Lithuania Selexipag STADA 1600 microgram film-coated tablets
Latvia Selexipag STADA 1600 microgram film-coated tablets
Malta Selexipag Clonmel 1600 microgram film-coated tablets
Norway Selexipag STADA
Poland Selexipag STADA
Sweden Selexipag STADA 1600 microgram film-coated tablets