HERZATEC 2.5 MG Film-coated tablets

Зміст інструкції

1. Herzatec 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What Herzatec is and what it is used for
   2. What you need to know before taking Herzatec
   3. How to take Herzatec
   4. Possible side effects
   5. How to store Herzatec
   6. Contents of the pack and other information

Herzatec 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Ramipril
Generic medicine

Read this leaflet carefully before taking this medicinebecause 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 pass it on to others,
even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet:

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

1. What Herzatec is and what it is used for

Herzatec contains a medicine called ramipril which belongs to the group of medicines
called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Herzatec works by:
Decreasing the production, by the body, of substances that can cause an
increase in blood pressure
Relaxing and widening its blood vessels
Making it easier for its heart to pump blood around the body.
Herzatec can be used:
To treat high blood pressure (hypertension)
To reduce the risk of a heart attack or stroke
To reduce the risk or delay the worsening of kidney problems (whether or not
diabetes is present)
To treat your heart when it cannot pump a sufficient volume of blood
around the rest of the body (heart failure)
As treatment after a heart attack (myocardial infarction) when associated with
heart failure.

2. What you need to know before taking Herzatec

Do not take Herzatec:
If you are allergic to ramipril, to other ACE inhibitor medicines or any of the other
ingredients of this medicine listed in section 6.
Signs of an allergic reaction can include skin rashes, difficulty
swallowing or breathing, swelling of the lips, face, throat or tongue.
If you have had a severe allergic reaction called “angioedema”. The signs include
itching, skin rash (hives), red patches on the hands, feet and throat,
swelling of the throat and tongue, swelling around the eyes and lips, difficulty
breathing and swallowing.
If you are having dialysis or any other type of blood filtration. Depending on the
machinery that is used, Herzatec may not be suitable for you
If you have kidney problems due to insufficient blood supply to the kidney (renal
artery stenosis).
During the last 6 months of pregnancy (see below “Pregnancy and breastfeeding”)
If your blood pressure is excessively low or unstable. The doctor will need to make
this assessment.
If you suffer from diabetes or your kidney function is impaired and you are being treated with a
medicine that lowers blood pressure, containing aliskiren.
If you have taken or are taking sacubitril/valsartan, a medicine used to treat a
long-term (chronic) type of heart failure in adults, as this
increases the risk of angioedema (rapid swelling under the skin in areas such as the
throat).
Do not take Herzatec if any of the above conditions apply to you. If you are not sure,
ask your doctor before taking Herzatec.

Warnings and precautions
Talk to your doctor or pharmacist before taking Herzatec:
If you have problems with your heart, liver or kidneys
If you have lost a lot of salts or fluids from your body (due to an illness such as vomiting,
diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having dialysis)
If you are about to have treatment to reduce your allergy to bee or
wasp stings (desensitisation)
If you are going to receive an anaesthetic. This may be given for surgery or dental
treatment. You may need to stop taking Herzatec the day before; ask your doctor
If you have a high amount of potassium in your blood (shown by a blood test)
If you are taking medicines or have conditions that may cause the levels of sodium in
your blood to decrease. Your doctor may prescribe blood tests at regular
intervals, especially to check the levels of sodium in your blood, particularly if you are
elderly
If you are taking any of the following medicines, the risk of angioedema may
be increased:

• racecadotril, a medicine used to treat diarrhoea
• medicines used to prevent the rejection of organs after a transplant and to treat cancer (such as temsirolimus, everolimus, sirolimus)
• vildagliptin a medicine used to treat diabetes If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus You must tell your doctor if you think you might be pregnant (or might become pregnant). Herzatec is not recommended in the first 3 months of pregnancy and can cause serious harm to the baby after 3 months of pregnancy (see below “Pregnancy and breastfeeding”) If you are taking any of the following medicines used to treat high blood pressure: an "angiotensin II receptor blocker" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes aliskiren The doctor may check your kidney function, blood pressure, and the amount of electrolytes (for example potassium) in your blood at regular intervals. See also the section "Do not take Herzatec”.

Children and adolescents
The use of Herzatec is not recommended in children and adolescents under 18 years of age
because the safety and efficacy of Herzatec in children have not yet been established.
If any of the above conditions apply to you (or you are not sure), ask your doctor before
taking Herzatec.

Other medicines and Herzatec
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This is because Herzatec can affect the way some other medicines work. Also some medicines can affect the
way Herzatec works.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with Herzatec by altering its action:
medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin)
medicines used to treat low blood pressure, shock,
heart failure, asthma or allergies such as ephedrine, noradrenaline or
adrenaline. The doctor will need to check your blood pressure.
Tell your doctor if you are taking any of the following medicines. These medicines, if taken
with Herzatec, may increase the likelihood of side effects:
sacubitril/valsartan - used to treat a long-term (chronic) type of heart failure
in adults (see section 2 “Do not take Herzatec”)
medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin)
cancer medicines (chemotherapy)
medicines to prevent organ rejection after a transplant such as ciclosporin
diuretics such as furosemide
potassium supplements (including salt substitutes), potassium-sparing diuretics and
other medicines that may increase the amount of potassium in your blood
(such as spironolactone, triamterene, amiloride, trimethoprim and co-trimoxazole for treating
infections caused by bacteria; ciclosporin, an immunosuppressant medicine used
to prevent organ rejection; and heparin, a medicine used to
thin the blood and prevent blood clots).
steroid medicines for treating inflammation such as prednisolone
allopurinol (used to lower uric acid levels in the blood)
procainamide (for heart rhythm problems)
temsirolimus (for cancer)
sirolimus, everolimus (for preventing transplant rejection)
vildagliptin (for treating type 2 diabetes)
racecadotril (used to treat diarrhoea)
The doctor may need to adjust the dose and/or take other precautions
if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see
also the sections "Do not take Herzatec” and “Warnings and precautions”).
Tell your doctor if you are taking any of the following medicines. The mechanism of action of
these medicines may be affected by Herzatec:
medicines for diabetes such as oral hypoglycaemics and insulin. Herzatec can
lower your blood sugar levels. Check your blood sugar levels carefully when taking Herzatec.
lithium (for mental health problems). Herzatec can increase the amount of lithium in
your blood. Your doctor should carefully check the level of lithium in your blood.
If any of the above conditions apply to you (or you are not sure), ask your doctor before
taking Herzatec.

Herzatec with food, drinks and alcohol
Drinking alcohol together with Herzatec may cause dizziness or
lightheadedness. If you want to know how much alcohol you can drink when taking Herzatec discuss
this with your doctor, as medicines used to lower blood pressure and alcohol can
have additive effects.
Herzatec can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you might be pregnant (or might become pregnant).
You should not take Herzatec in the first 12 weeks of pregnancy and must not
take it after the 13th week because its use during pregnancy can be harmful
to the baby.
If you become pregnant while taking Herzatec, tell your doctor immediately. Before
planning a pregnancy you should switch to another medicine that is more
suitable.

Breastfeeding
You should not take Herzatec if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
You may feel dizzy while taking Herzatec. This is more likely
when you first start taking Herzatec or have just increased the dose. If this
happens, do not drive or use tools or machines.

Herzatec contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. How to take Herzatec

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

How much to take

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the amount you take until your blood pressure is under control.
• The maximum daily dose is 10 mg.
• If you are already taking diuretics, your doctor may stop them or reduce the amount before starting you on Herzatec.

To reduce the risk of a heart attack or stroke

• The usual starting dose is 2.5 mg once a day
• The doctor may decide to increase the dosage you take
• The usual dose is 10 mg once a day.

Treatment to reduce or delay the worsening of kidney problems

• You may be given to start a dose of 1.25 mg or 2.5 mg once a day
• The doctor will adjust the amount you are taking
• The usual dose is 5 mg or 10 mg once a day

Treatment of heart failure

• The usual starting dose is 1.25 mg once a day
• The doctor will adjust the amount you take
• The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations

Treatment after a heart attack

• The usual starting dose is from 1.25 mg once a day to 2.5 mg twice a day
• The doctor will adjust the amount you take
• The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Elderly population
The doctor will reduce the initial dose and adjust the treatment more slowly.

Taking this medicine

• Take this medicine by mouth at the same time of day, every day
• Swallow the tablets whole with liquid.
• Do not break or chew the tablets.

If you take more Herzatec than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, have someone accompany you or call an ambulance. Bring the
medicine box with you. This is because the doctor needs to know what you have taken.

If you forget to take Herzatec

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for the missed tablet.

If you have any further questions on 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 everyone will experience them.

Stop taking Herzatec and contact your doctor immediately if you notice the onset of any serious side effect – you may need urgent medical treatment:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to Herzatec
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke
• Shortness of breath or cough. These may be signs of lung problems.
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These may be signs of circulatory or bone marrow problems
• Severe abdominal pain that may extend to the back. This may be a sign of pancreatitis (inflammation of the pancreas)
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions becomes severe or persists for more than a few days:

Common(may affect up to 1 in 10 people)

• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when therapy with Herzatec is just started or you have just increased the dose
• Weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, indigestion, feeling unwell or malaise
• Rash with or without swelling
• Chest pain
• Cramps or muscle pain
• Blood tests show a higher than normal level of potassium

Uncommon(may affect up to 1 in 100 people)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the intestine called “intestinal angioedema” and which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating than usual
• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual
• Hot flashes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increased number of white blood cells (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function as highlighted by blood tests.

Rare(may affect up to 1 in 1,000 people)

• Feeling faint or confused
• Swollen and red tongue
• Severe flaking or peeling of the skin, itching, rash characterized by pustules
• Nail problems (such as loss or separation of the nail from its bed)
• Rash or bruising
• Spotted skin and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing disorders and ringing in the ears
• Feeling weak
• Decrease in the number of red blood cells, white blood cells and platelets in the blood, or hemoglobin concentration, as highlighted by blood tests

Very rare(may affect up to 1 in 10,000 people)

• Increased sensitivity to the sun

Other side effects reported:
Inform your doctor if any of the following conditions becomes severe or persists for more than a few days.

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing a too low number of blood cells
• Blood tests showing a low level of sodium in the blood
• Concentrated urine (dark in color), feeling unwell or malaise, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly
• Fingers of the hands and feet that change color when cooled and tingle or hurt when warmed (Raynaud's phenomenon)
• Increased breast volume in men
• Slowed or altered reactions
• Burning sensation
• Change in the perception of smells
• Hair loss

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 Herzatec

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 packaging after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 25 °C
Do not dispose of any medicine in waste water 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 Herzatec contains
The active ingredient is Ramipril

Herzatec 2.5 mg tablets:
Each divisible tablet contains 2.5 mg of Ramipril
The other ingredients are: hypromellose, pregelatinized corn starch, microcrystalline
cellulose, sodium stearylfumarate, yellow iron oxide E172.

Herzatec 5 mg tablets:
Each divisible tablet contains 5 mg of Ramipril
The other ingredients are: hypromellose, pregelatinized corn starch, microcrystalline
cellulose, sodium stearylfumarate, red iron oxide E 172.

Herzatec 10 mg tablets:
Each divisible tablet contains 10 mg of Ramipril
The other ingredients are: hypromellose, pregelatinized corn starch, microcrystalline
cellulose, sodium stearylfumarate.

Description of the appearance of Herzatec and contents of the pack
Herzatec 2.5 mg tablets
Divisible tablets. Pack of 28 tablets

Herzatec 5 mg tablets
Divisible tablets. Pack of 14 tablets

Herzatec 10 mg tablets
Divisible tablets. Pack of 28 tablets
The tablets can be divided into two equal doses

Marketing Authorisation Holder
Epifarma S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – Quinto De’ Stampi - 20089 Rozzano (MI)
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)