Package leaflet: Information for the user

Auretica 60 mg film-coated tablets

ticagrelor
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Auretica is and what it is used for
What you need to know before taking Auretica
How to take Auretica
Possible side effects
How to store Auretica
Contents of the pack and other information

1. What Auretica is and what it is used for

What Auretica is
Auretica contains an active substance called ticagrelor, which belongs to a group of medicines known as antiplatelet agents.

What Auretica is used for
Auretica, in combination with acetylsalicylic acid (another antiplatelet agent), should only be used in adult patients. You have been prescribed this medicine because you have:

had a heart attack more than one year ago. This medicine reduces the likelihood that you will suffer another heart attack or stroke, or that you may die from heart or blood vessel-related disease.

However, platelets can also form clots inside diseased blood vessels of the heart and brain. This can be very dangerous because:

the clot may completely block blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
the clot may partially block blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (known as 'unstable angina').

Auretica helps prevent platelets from sticking together. This reduces the likelihood of forming a blood clot that could restrict blood flow.

2. What you need to know before taking this medicine

Do not take Auretica if:

You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
You are currently experiencing active bleeding.
You have had a stroke caused by bleeding in the brain.
You suffer from severe liver disease.
You are taking any of the following medicines:
- ketoconazole (used to treat fungal infections)
- clarithromycin (used to treat bacterial infections)
- nefazodone (an antidepressant)
- ritonavir and atazanavir (used to treat HIV infection and AIDS)

Do not take Auretica if any of the situations listed above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Auretica if:

You have an increased risk of bleeding due to:
- a recent severe injury
- recent surgery (including dental procedures; please consult your dentist)
- a disease affecting blood clotting
- recent bleeding from the stomach or intestines (e.g., due to gastric ulcer or colon "polyps")
You are scheduled for surgery (including dental procedures) at any time while taking Auretica. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
Your heart rate is unusually slow (generally less than 60 beats per minute) and you do not already have a heart rhythm-regulating device implanted (pacemaker).
You suffer from asthma or any other lung disease or breathing difficulties.
You develop irregular breathing patterns such as rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
You have previously had liver problems or any liver-related condition.
You have previously had blood tests showing higher than normal levels of uric acid. If any of the situations listed above apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both Auretica and heparin:

Your doctor may request a blood sample for diagnostic testing if they suspect a rare platelet disorder caused by heparin. It is important to inform your doctor that you are taking both Auretica and heparin, as Auretica may affect the diagnostic test.

Children and adolescents
Auretica is not recommended for children and adolescents under 18 years of age.
Other medicines and Auretica
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Auretica can affect how some medicines work, and some medicines can affect Auretica.
Inform your doctor or pharmacist if you are taking any of the following medicines:

rosuvastatin (a medicine used to treat high cholesterol)
more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
rifampicin (an antibiotic)
phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
digoxin (used to treat heart failure)
cyclosporine (used to suppress the immune system)
quinidine and diltiazem (used to treat abnormal heart rhythms)
beta-blockers and verapamil (used to treat high blood pressure)
morphine and other opioids (used to treat severe pain)

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, which increase the risk of bleeding:

'oral anticoagulants', often referred to as 'blood thinners', including warfarin.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
Selective Serotonin Reuptake Inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram.
other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), or ergot alkaloids (used to treat migraine and headache).

Additionally, inform your doctor that, since you are taking Auretica, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'thrombolytics', such as streptokinase or alteplase.
Pregnancy and breastfeeding
The use of Auretica is not recommended during pregnancy or if you suspect you may be pregnant. Women should use appropriate contraceptive methods to avoid pregnancy while taking this medicine.
Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of treatment with Auretica during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Auretica will affect your ability to drive or operate machinery.
However, if you experience dizziness or confusion while taking Auretica, exercise caution when driving or operating machinery.

3. How to take Auretica

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Auretica to take

The usual dose is one 60 mg tablet twice daily. Continue taking Auretica for the entire duration indicated by your doctor.
Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you take Auretica with other blood-thinning medicines
Your doctor will generally also instruct you to take acetylsalicylic acid. This is a substance
found in many medicines used to prevent blood clotting. Your doctor will tell you
how much to take (usually between 75 and 150 mg per day).
How to take Auretica

You may take the tablet during or apart from meals.
You can check when you took your last dose of Auretica by looking at the blister pack. There is a sun symbol (for the morning) and a moon symbol (for the evening). These will help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

Crush the tablet into a fine powder.
Pour the powder into half a glass of water.
Mix and drink immediately.
To ensure you do not leave any medicine behind, rinse the empty glass with another half glass of water and drink it. If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered through a tube inserted through the nose (nasogastric tube).

If you take more Auretica than you should
If you have taken more Auretica than you should have, contact your doctor or go to hospital
immediately. Take the medicine packaging with you. You may be at increased risk of
bleeding.
If you forget to take Auretica

If you forget to take a dose, take the next dose as scheduled.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you stop taking Auretica
Do not stop taking Auretica without first talking to your doctor. Take this medicine
regularly for as long as your doctor prescribes it. If you stop taking Auretica, this
may increase your risk of having another heart attack or stroke, or of dying from
a condition related to heart or blood vessel disease.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The following side effects may occur with this medicine:
Auretica affects blood clotting; therefore, most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleedings are common (such as bruising and nosebleeds). Severe bleeding is uncommon in frequency but may be life-threatening.
Seek immediate medical attention if you notice any of the following symptoms – you may need urgent medical treatment:

Bleeding in the brain or within the skull is an uncommon side effect and may cause signs of stroke, such as:
- sudden numbness or weakness of arms, legs, or face, especially on one side of the body
- sudden confusion, difficulty speaking or understanding others
sudden difficulty walking or loss of balance or coordination
sudden dizziness or sudden and severe headache without known cause
- Signs of bleeding such as:
severe bleeding or bleeding that cannot be controlled
unexpected bleeding or bleeding that lasts a long time
pink, red, or brown urine
vomit that is red or looks like coffee grounds
red or black stools (resembling tar)
coughing up or vomiting blood clots
- Fainting (syncope)
temporary loss of consciousness due to a sudden reduction in blood flow to the brain (common)
- Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion

Contact your doctor if you notice any of the following symptoms:

Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it could represent a side effect of Auretica. Dyspnea (shortness of breath) due to Auretica is usually mild and characterized by a sudden and unexpected need for air, which generally occurs at rest and may appear during the first weeks of therapy; in many cases, it may resolve spontaneously. If your shortness of breath worsens or persists over time, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

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

High levels of uric acid in the blood (shown by laboratory tests)
Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

Bruising
Headache
Dizziness or sensation of spinning
Diarrhea or indigestion
Feeling unwell (nausea)
Constipation
Rash
Itching
Severe joint pain and swelling – these are signs of gout
Dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
Nosebleeds
Bleeding after surgery or cuts (e.g., during shaving) and wounds, more than usual
Bleeding from the stomach lining (ulcer)
Bleeding gums

Uncommon (may affect up to 1 in 100 people)

Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
Confusion
Visual disturbances caused by bleeding in the eyes
Heavier vaginal bleeding or bleeding occurring at different times than normal menstrual bleeding
Bleeding into joints and muscles, which may cause painful swelling
Blood in the ears
Internal bleeding, which may cause dizziness or mental confusion

Not known (frequency cannot be estimated from available data)

Abnormally slow heart rate (usually less than 60 beats per minute)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 Auretica

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after the abbreviation "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Auretica contains

The active substance is ticagrelor. Each film-coated tablet contains 60 mg of ticagrelor.
The other components are: Tablet core: mannitol powder (E421), calcium hydrogen phosphate (E341), crospovidone (E1202), hypromellose (E464), vegetable magnesium stearate (E470b) and purified water.

Film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521),
talc, red iron oxide (E172), yellow iron oxide (E172) and purified water.
Description of the appearance of Auretica and pack contents
Auretica tablets are pink, round, film-coated, 7.6–8.4 mm in size,
with '60' engraved on one side and smooth on the other.
Auretica is available in:

Blister packs (with sun/moon symbols) in cartons containing 56 film-coated tablets.

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aurora Licensing Srl
Via del Milliario, 32
40133 - Bologna
Italy
Manufacturer:
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate, Limassol, 3056
Cyprus

Package leaflet: information for the user

Auretica 90 mg film-coated tablets

ticagrelor
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Auretica is and what it is used for
What you need to know before taking Auretica
How to take Auretica
Possible side effects
How to store Auretica
Contents of the pack and other information

1. What is Auretica and what is it used for

What is Auretica
Auretica contains an active substance called ticagrelor, which belongs to a group of medicines known as antiplatelet agents.
What Auretica is used for
Auretica, in combination with acetylsalicylic acid (another antiplatelet agent), is intended for use only in adult patients. You have been prescribed this medicine because you have had:

a heart attack, or
unstable angina (angina or chest pain that is not well controlled).

This medicine reduces the likelihood that you will suffer another heart attack or stroke, or that you may die from heart or blood vessel disease.

How Auretica works
Auretica acts on blood cells called 'platelets' (also known as thrombocytes). These are very small blood cells that help stop bleeding by clumping together to seal tiny holes in cut or damaged blood vessels.
However, platelets can also form clots inside diseased blood vessels of the heart and brain. This can be very dangerous because:

the clot may completely block blood flow; this can cause a heart attack (myocardial infarction) or a stroke, or
the clot may partially block blood vessels supplying the heart; this reduces blood flow to the heart and may cause chest pain that comes and goes (called 'unstable angina').

Auretica helps prevent platelets from clumping together. This reduces the possibility of forming a blood clot that could reduce blood flow.

2. What you need to know before taking Auretica

Do not take Auretica if:

You are allergic to ticagrelor or to any of the other ingredients of this medicine (listed in section 6).
You are currently experiencing active bleeding.
You have had a stroke caused by bleeding in the brain.
You suffer from severe liver disease.
You are taking any of the following medicines:
- ketoconazole (used to treat fungal infections)
- clarithromycin (used to treat bacterial infections)
- nefazodone (an antidepressant)
- ritonavir and atazanavir (used to treat HIV and AIDS infection)

Do not take Auretica if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Auretica if:

You have an increased risk of bleeding due to:
- a recent serious injury
- a recent surgical procedure (including dental surgery; consult your dentist)
- a blood clotting disorder
- recent gastrointestinal bleeding (e.g., due to gastric ulcer or colon "polyps")
You are scheduled to undergo surgery (including dental surgery) at any time while taking Auretica. This is because there is an increased risk of bleeding. Your doctor may instruct you to stop taking this medicine 5 days before surgery.
Your heart rate is unusually low (generally less than 60 beats per minute) and you do not already have a device implanted to regulate your heart rhythm (pacemaker).
You suffer from asthma or another lung condition or have breathing difficulties.
You develop irregular breathing patterns such as periods of rapid breathing, slow breathing, or brief pauses in breathing. Your doctor will decide whether further evaluation is needed.
You have previously had liver problems or any liver-related illness.
You have previously had blood tests showing elevated levels of uric acid. If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

If you are taking both Auretica and heparin:

Your doctor may request a blood sample for diagnostic testing if heparin-induced thrombocytopenia (a rare platelet disorder) is suspected. It is important to inform your doctor that you are taking both Auretica and heparine, as Auretica may interfere with the diagnostic test.

Children and adolescents
Auretica is not recommended for children and adolescents under 18 years of age.

Other medicines and Auretica
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Auretica may affect how some medicines work, and some medicines may affect Auretica.
Inform your doctor or pharmacist if you are taking any of the following medicines:

rosuvastatin (a medicine used to treat high cholesterol)
more than 40 mg daily of simvastatin or lovastatin (medicines used to treat high cholesterol)
rifampicin (an antibiotic)
phenytoin, carbamazepine, and phenobarbital (used to control epileptic seizures)
digoxin (used to treat heart failure)
ciclosporin (used to suppress the immune system)
quinidine and diltiazem (used to treat abnormal heart rhythm)
beta-blockers and verapamil (used to treat high blood pressure)
morphine and other opioids (used to treat severe pain)

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, which increase the risk of bleeding:

'Oral anticoagulants', often referred to as 'blood thinners', including warfarin.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used as painkillers, such as ibuprofen and naproxen.
Selective Serotonin Reuptake Inhibitors (SSRIs), taken as antidepressants, such as paroxetine, sertraline, and citalopram.
other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone (an antidepressant), ritonavir and atazanavir (used to treat HIV and AIDS infection), cisapride (used to treat heartburn), or ergot alkaloids used to treat migraine and headache.

Additionally, inform your doctor that, because you are taking Auretica, you may have an increased risk of bleeding if your doctor prescribes fibrinolytic agents, often called 'thrombolytics', such as streptokinase or alteplase.

Pregnancy and breastfeeding
The use of Auretica is not recommended if you are pregnant or suspect you may be pregnant. Women must use appropriate contraceptive methods to prevent pregnancy while taking this medicine.
Consult your doctor before taking this medicine if you are breastfeeding. Your doctor will discuss with you the benefits and risks of treatment with Auretica during this period.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Auretica will affect your ability to drive or operate machinery. However, if you experience dizziness or confusion while taking Auretica, exercise caution when driving or operating machinery.

3. How to take Auretica

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Auretica to take

The initial dose is two tablets at once (a loading dose of 180 mg). This dose is normally administered in hospital.
After this initial dose, the usual dose is one 90 mg tablet twice daily for up to 12 months, unless your doctor tells you otherwise.
Take this medicine at approximately the same time each day (for example, one tablet in the morning and one in the evening).

If you take Auretica with other blood-thinning medicines
Your doctor will usually also instruct you to take acetylsalicylic acid. This is a substance
found in many medicines used to prevent blood clotting. Your doctor will tell you
how much to take (usually between 75 and 150 mg per day).
How to take Auretica

You may take the tablet during or apart from meals.
You can check when you took your last dose of Auretica by looking at the blister pack. There is a sun symbol (for morning) and a moon symbol (for evening). These will help you remember whether you have taken your dose.

If you have difficulty swallowing the tablet
If you have difficulty swallowing the tablet, you may crush it and mix it with water as follows:

Crush the tablet into a fine powder.
Pour the powder into half a glass of water.
Mix and drink immediately.
To ensure no medicine is left behind, rinse the empty glass with another half glass of water and drink it.
If you are in hospital, the tablet may be given to you mixed with a small amount of water and administered via a tube through the nose (nasogastric tube).

If you take more Auretica than you should
If you have taken more Auretica than you should have, contact your doctor or go to hospital
immediately. Take the medicine pack with you. You may be at increased risk of
bleeding.
If you forget to take Auretica

If you forget to take a dose, take the next dose at your usual time.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Auretica
Do not stop taking Auretica without first talking to your doctor. Take this medicine
regularly and for as long as your doctor prescribes it. If you stop taking Auretica, this
may increase the risk of having another heart attack or stroke, or of dying from a condition related to heart or blood vessel disease.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine:
Auretica affects blood clotting; therefore, most side effects are related to bleeding. Bleeding can occur anywhere in the body. Some bleedings are common (such as bruising and nosebleeds). Severe bleeding is uncommon in frequency but may be life-threatening.
Seek immediate medical attention if you notice any of the following symptoms – you may need urgent medical treatment:

Bleeding in the brain or within the skull is an uncommon adverse effect and may cause signs of stroke, such as:
- sudden numbness or weakness of arms, legs, or face, especially on one side of the body
- sudden confusion, difficulty speaking or understanding others
sudden difficulty walking or loss of balance or coordination
sudden dizziness or sudden, severe headache without known cause
- Signs of bleeding such as:
severe bleeding or bleeding that cannot be controlled
unexpected bleeding or bleeding that lasts a long time
pink, red, or brown urine
vomit that is red or looks like coffee grounds
red or black stools (resembling tar)
coughing up or vomiting blood clots
- Fainting (syncope)
a temporary loss of consciousness due to a sudden drop in blood flow to the brain (common)
- Signs of a blood clotting disorder called Thrombotic Thrombocytopenic Purpura (TTP) such as:
fever and purple spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme fatigue or confusion

Contact your doctor if you notice any of the following symptoms:

Shortness of breath – this event is very common. It may be due to your heart condition or another cause, or it could represent a side effect of Auretica. Dyspnea (shortness of breath) due to Auretica is generally mild and characterized by a sudden and unexpected need for air, which usually occurs at rest and may appear during the first weeks of therapy; for many people, it may resolve over time. If your shortness of breath worsens or persists, inform your doctor. Your doctor will decide whether treatment is needed or further investigations are required.

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

High levels of uric acid in the blood (as shown by laboratory tests)
Bleeding caused by blood disorders

Common (may affect up to 1 in 10 people)

Bruising
Headache
Dizziness or sensation of spinning
Diarrhea or indigestion
Malaise (nausea)
Constipation
Rash
Itching
Severe pain and swelling of joints – these are signs of gout
Dizziness or mental confusion, or blurred vision – these are signs of low blood pressure
Nosebleeds
Bleeding after surgery or cuts (e.g., during shaving) and wounds, more than normal
Bleeding from the stomach lining (ulcer)
Bleeding gums

Uncommon (may affect up to 1 in 100 people)

Allergic reaction – rash, itching, or swelling of the face or lips/tongue may be signs of an allergic reaction
Confusion
Vision problems caused by bleeding in the eyes
Heavier vaginal bleeding or bleeding occurring at different times than normal menstrual bleeding
Bleeding into joints and muscles, which may cause painful swelling
Blood in the ears
Internal bleeding, which may cause dizziness or mental confusion

Not known (frequency cannot be estimated from available data)

Abnormally slow heart rate (usually less than 60 beats per minute)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://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 Auretica

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton after the abbreviation "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Auretica contains

The active substance is ticagrelor. Each film-coated tablet contains 90 mg of ticagrelor.
The other components are: Tablet core: mannitol powder (E421), calcium hydrogen phosphate (E341), crospovidone (E1202), hypromellose (E464), vegetable magnesium stearate (E470b), and purified water.

Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol (E1521),
talc, yellow iron oxide (E172), and purified water.
Description of the appearance of Auretica and pack contents
Auretica tablets are yellow, round, film-coated, 8.6–9.5 mm in size,
with the number ‘90’ engraved on one side and smooth on the other.
Auretica is available in:

Blister packs (with sun/moon symbols) in boxes containing 56 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurora Licensing Srl
Via del Milliario, 32
40133 - Bologna
Italy
Manufacturer
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate, Limassol, 3056
Cyprus