Herzatec

Italy
Brand name Herzatec
Form tablets
Active substance / Dosage
RAMIPRIL
Prescription type Prescription only
ATC code
C09AA05
Registration number 038214
Manufacturer EPIFARMA S.R.L

Table of Contents

Patient Information Leaflet

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

Ramipril
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
If you experience any side effects, including 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 taking 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 a group of medicines
called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Herzatec works by:
Reducing the body's production of substances that can cause an increase in blood pressure
Relaxing and widening your blood vessels
Helping your heart to pump blood around the body more easily.
Herzatec may be used:
To treat high blood pressure (hypertension)
To reduce the risk of heart attack or stroke
To reduce the risk of, or delay, worsening kidney problems (with or without diabetes)
To treat heart failure (when your heart cannot pump enough blood to the rest of the body)
As a 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 to any of the other
components of this medicine listed in section 6.
Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
If you have previously had a severe allergic reaction called "angioedema". Signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment 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. Your doctor will need to assess this.
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).
Do not take Herzatec if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Herzatec.

Warnings and precautions
Talk to your doctor or pharmacist before taking Herzatec:
If you have heart, liver, or kidney problems.
If you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or due to a low-salt diet, prolonged use of diuretics, or after dialysis).
If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
If you are about to receive an anaesthetic. This may be administered during surgery or dental procedures. You may need to stop taking Herzatec the day before; consult your doctor.
If you have high levels of potassium in your blood (shown by a blood test).
If you are taking medicines or have conditions that may cause low sodium levels in the blood. Your doctor may prescribe regular blood tests, particularly to monitor blood sodium levels, especially 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 rejection of transplanted organs or to treat cancer (such as temsirolimus, everolimus, sirolimus)
  • vildagliptin, a medicine used to treat diabetes
    If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
    You must inform your doctor if you think you may be pregnant (or could become pregnant). Herzatec is not recommended during the first 3 months of pregnancy and may cause serious harm to the unborn 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 antagonist" (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes, or aliskiren.
    Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). 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, as 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 unsure), consult 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 may affect how some other medicines work. Also, some medicines may affect how Herzatec works.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Herzatec and alter its effect:

  • 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. Your doctor should monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these with Herzatec may increase the likelihood of side effects:

  • sacubitril/valsartan – used to treat chronic 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 transplant rejection, such as ciclosporin
  • diuretics such as furosemide
  • potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as spironolactone, triamterene, amiloride, trimethoprim, and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clots)
  • steroid medicines for treating inflammation, such as prednisolone
  • allopurinol (used to lower blood uric acid levels)
  • procainamide (for heart rhythm problems)
  • temsirolimus (for cancer)
  • sirolimus, everolimus (to prevent transplant rejection)
  • vildagliptin (for treatment of type 2 diabetes)
  • racecadotril (used to treat diarrhoea)

Your doctor may consider it necessary to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "Do not take Herzatec" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by Herzatec:

  • Medicines for diabetes, such as oral hypoglycaemics and insulin. Herzatec may lower blood sugar levels. Monitor your blood sugar levels carefully while taking Herzatec.
  • Lithium (for psychiatric conditions). Herzatec may increase blood lithium levels. Your doctor must monitor your blood lithium levels closely.

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking Herzatec.

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

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take Herzatec during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as its use during pregnancy may harm the unborn baby.
If you become pregnant while taking Herzatec, inform your doctor immediately. Before planning a pregnancy, you should switch to a more suitable medicine.

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

Driving and using machines
You may experience dizziness while taking Herzatec. This is more likely when you first start taking Herzatec or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

Herzatec contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Herzatec

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage
High blood pressure treatment

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

To reduce the risk of heart attack or stroke

  • The usual starting dose is 2.5 mg once daily.
  • Your doctor may decide to increase your dose.
  • The usual maintenance dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney problems

  • You may be started on a dose of 1.25 mg or 2.5 mg once daily.
  • Your doctor will adjust your dose accordingly.
  • The usual dose is 5 mg or 10 mg once daily.

Heart failure treatment

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

Elderly population
Your doctor will reduce the starting dose and adjust treatment more gradually.

How to take this medicine

  • Take this medicine orally at the same time each 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 immediately to the nearest hospital emergency department. Do not drive to the hospital; have someone drive you or call an ambulance. Bring the medicine pack with you, so the doctor knows what you have taken.

If you forget to take Herzatec

  • If you miss a dose, take your usual dose at the next scheduled time.
  • Do not take a double dose to make up for the forgotten tablet.

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 everybody gets them.
Stop taking Herzatec and contact your doctor immediately if you notice any of the following
serious side effects – you may need urgent medical treatment:

  • Swelling of the face, lips or throat causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Herzatec
  • Serious skin reactions including rash, mouth ulcers, worsening of pre-existing skin conditions, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact your doctor immediately if you experience:

  • Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, 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
  • Easy 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, weakness, dizziness or pale appearance. These may be signs of blood or bone marrow problems
  • Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas)
  • Fever, chills, tiredness, 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 become severe or last longer than a few days:
Common (may affect up to 1 in 10 people)

  • Headache or feeling tired
  • Dizziness. This is more likely when treatment with Herzatec has just started or the dose has just been increased
  • Weakness, low blood pressure (hypotension), especially when standing up or getting up quickly
  • Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
  • Stomach or intestinal pain, diarrhoea, indigestion, nausea or feeling unwell
  • Rash with or without swelling
  • Chest pain
  • Muscle cramps or muscle pain
  • Blood tests show higher than normal potassium levels

Uncommon (may affect up to 1 in 100 people)

  • Balance problems (dizziness)
  • Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling sensations (paresthesia)
  • Loss or change in taste
  • Sleep problems
  • Depressed mood, anxiety, increased nervousness or irritability
  • Stuffy nose, breathing difficulties or worsening of asthma
  • Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea
  • Heartburn, constipation or dry mouth
  • Increased amount of urine during the day
  • Increased sweating
  • Loss of appetite or reduced appetite (anorexia)
  • Fast or irregular heartbeat
  • Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual
  • Hot flushes
  • Blurred vision
  • Joint pain
  • Fever
  • Impotence in men, reduced sex drive in men and women
  • Increase in the number of white blood cells (eosinophilia) detected in blood tests
  • Changes in liver, pancreas or kidney function shown by blood tests

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

  • Feeling faint or confused
  • Swollen and red tongue
  • Severe peeling or shedding of the skin, itching, rash with pustules
  • Nail problems (such as nail loss or separation of the nail from its bed)
  • Skin rash or bruising
  • Spots on the skin and cold extremities
  • Red, swollen, watery or itchy eyes
  • Hearing disturbances and ringing in the ears
  • Feeling weak
  • Decrease in the number of red blood cells, white blood cells and platelets, and in haemoglobin concentration, as shown by blood tests

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

  • Increased sensitivity to sunlight

Other side effects observed:
Inform your doctor if any of the following conditions become severe or last longer than a few days.

  • Difficulty concentrating
  • Mouth swelling
  • Blood tests showing too few blood cells
  • Blood tests showing low sodium levels in the blood
  • Concentrated (dark-coloured) urine, feeling unwell, muscle cramps, confusion and seizures which may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience these symptoms, contact your doctor promptly
  • Fingers of hands and feet changing colour when cold, and tingling or painful when warmed (Raynaud's phenomenon)
  • Breast enlargement in men
  • Slowed or altered reactions
  • Burning sensation
  • Change in sense of smell
  • Hair loss

Reporting of side effects
If you get any side effects, including ones 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 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 below 25 °C.
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 Herzatec contains
The active substance is Ramipril.
Herzatec 2.5 mg tablets:
Each scored tablet contains 2.5 mg of Ramipril.
The other components are: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, yellow iron oxide E172.
Herzatec 5 mg tablets:
Each scored tablet contains 5 mg of Ramipril.
The other components are: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide E172.
Herzatec 10 mg tablets:
Each scored tablet contains 10 mg of Ramipril.
The other components are: hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate.

Description of the appearance of Herzatec and package contents
Herzatec 2.5 mg tablets
Scored tablets. Box containing 28 tablets.
Herzatec 5 mg tablets
Scored tablets. Box containing 14 tablets.
Herzatec 10 mg tablets
Scored tablets. Box containing 28 tablets.
The tablets can be divided into two equal doses.

Marketing Authorization 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)