Ramipril Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

RAMIPRIL ZENTIVA 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Please read 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. Never give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ramipril Zentiva is and what it is used for

Ramipril Zentiva contains a medicine called ramipril which belongs to a group of medicines
called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril Zentiva 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.

Ramipril Zentiva can be used:

To treat high blood pressure (hypertension).
To reduce the risk of heart attack or stroke.
To reduce the risk or delay the worsening of kidney problems (with or without diabetes).
To treat your heart when it is unable to pump an adequate volume of blood to the rest of the body (heart failure).
As a treatment after a heart attack (myocardial infarction) when associated with heart failure.

2. What you need to know before taking Ramipril Zentiva

Do not take Ramipril Zentiva:

If you are allergic to ramipril, to other ACE inhibitor medicines, or to any of the other ingredients 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 and swallowing.
If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
If you are on dialysis or undergoing another type of blood filtration. Depending on the equipment used, Ramipril Zentiva 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 section 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.

Do not take Ramipril Zentiva if any of the above conditions apply to you. If you are unsure,
ask your doctor before taking Ramipril Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril Zentiva:

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 following a low-salt diet, or due to long-term use of oral diuretics, or after undergoing dialysis).
If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
If you are about to undergo anaesthesia. This may be administered for surgery or dental procedures. You may need to stop taking Ramipril Zentiva 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 reduce sodium levels in your blood. Your doctor may prescribe regular blood tests, particularly to monitor blood sodium levels, especially if you are elderly.
If you are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Ramipril Zentiva”.
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). Ramipril Zentiva is not recommended during the first 3 months of pregnancy and may cause serious harm to the unborn child after 3 months of pregnancy (see section 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;
aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also the section "Do not take Ramipril Zentiva"
Children and adolescents
The use of Ramipril Zentiva is not recommended in children and adolescents under 18 years of age
because the safety and efficacy of Ramipril Zentiva in children have not yet been established.
If any of the above conditions apply to you (or you are unsure), ask your doctor before
taking Ramipril Zentiva.
Other medicines and Ramipril Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines. This is because Ramipril Zentiva may affect the way some other medicines work. Also, some medicines may affect the way Ramipril Zentiva works.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere
with Ramipril Zentiva 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 medicines with Ramipril Zentiva may increase the likelihood of side effects:
- Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril Zentiva”).
Medicines used to relieve pain and inflammation [e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, aspirin].
Medicines for cancer treatment (chemotherapy).
Medicines to prevent organ rejection after transplant, such as ciclosporin.
Diuretics such as furosemide.
Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (used to make the blood less likely to clot).
Steroid medicines used to treat inflammation, such as prednisolone.
Allopurinol (used to lower uric acid levels in the blood).
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 the sections "Do not take Ramipril Zentiva" and "Warnings and precautions").
Inform your doctor if you are taking any of the following medicines. The way these
medicines work may be affected by Ramipril Zentiva:

Medicines for diabetes such as oral hypoglycaemics and insulin. Ramipril Zentiva may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Ramipril Zentiva.
Lithium (for psychiatric conditions). Ramipril Zentiva may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels closely. If any of the above conditions apply to you (or you are unsure), ask your doctor before taking Ramipril Zentiva.

Ramipril Zentiva with food and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take Ramipril Zentiva during the first 12 weeks of pregnancy and must not take it at all after week 13, as its use during pregnancy may harm the unborn child. If you become pregnant while taking Ramipril Zentiva, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine more suitable for use during pregnancy.
Breastfeeding
You must not take Ramipril Zentiva if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
You may experience dizziness while taking Ramipril Zentiva. This is more likely when you first start taking Ramipril Zentiva or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

3. How to take Ramipril Zentiva

Take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take

Treatment of high blood pressure

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 (water tablets), your doctor may stop or reduce your diuretic before starting treatment with Ramipril Zentiva.

To reduce the risk of heart attack or stroke

The usual starting dose is 2.5 mg once daily.
Your doctor may later decide to increase your dose.
The usual 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.
The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

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

Taking this medicine

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

If you take more Ramipril Zentiva than you should
Contact your doctor or go to the nearest hospital emergency department immediately. Do not drive to the hospital; have someone drive you or call an ambulance. Take the medicine pack with you. This is important so the doctor knows what you have taken.

If you forget to take Ramipril Zentiva

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ramipril Zentiva and contact your doctor immediately if you experience any serious side effect – you may need urgent medical treatment:

Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Ramipril Zentiva.
Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disorders, 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 longer than normal, any signs 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 appearance. These may be signs of blood or bone marrow problems.
Severe stomach pain that may spread 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 to occur when treatment with Ramipril Zentiva has just started or the dose has just been increased.
Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly.
Dry, persistent 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 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.
Skin spots and cold extremities.
Red, swollen, watery or itchy eyes.
Hearing problems and ringing in the ears.
Feeling weak.
Decreased number of red blood cells, white blood cells, platelets or haemoglobin concentration, 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 persist for more 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 urine (dark in colour), feeling unwell, muscle cramps, confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor promptly.
Fingers of hands and feet changing colour when cold, and tingling or pain upon warming (Raynaud's phenomenon).
Breast enlargement in men.
Slowed or altered reactions.
Burning sensation.
Change in smell perception.
Hair loss.

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 Ramipril Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cartons, blisters, and bottles after 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 Ramipril Zentiva Contains
The active substance is ramipril.
2.5 mg: Each tablet contains ramipril 2.5 mg.
5 mg: Each tablet contains ramipril 5 mg.
10 mg: Each tablet contains ramipril 10 mg.

The other components of the tablets are:
2.5 mg tablets
hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate, yellow iron oxide (E172).
5 mg tablets
hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide (E172).
10 mg tablets
hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate.

Description of the Appearance of Ramipril Zentiva and Contents of the Package
2.5 mg tablets
Oblong, yellow to yellowish tablets, 8 x 4 mm, with a score line, marked on the upper side with "2.5" and company logo, and on the lower side with "HMR" and "2.5". The tablet can be divided into equal doses.

5 mg tablets
Oblong, light red tablets, 8 x 4 mm, with a score line, marked on the upper side with "5" and company logo, and on the lower side with "HMP" and "5". The tablet can be divided into equal doses.

10 mg tablets
Oblong, white to almost white tablets, 7 x 4.5 mm, with a score line, marked on the upper side with "HMO/HMO". The tablet can be divided into equal doses.

Ramipril Zentiva 2.5 mg tablets are available in packs of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 60, 90, 98, 99, 100, 300, 500 tablets in PVC/aluminum blisters, and in bottles of 500 tablets made of dark glass with a closure cap.

Ramipril Zentiva 5 mg tablets are available in packs of 10, 14, 15, 18, 20, 21, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 500 tablets in PVC/aluminum blisters, and in bottles of 500 tablets made of dark glass with a closure cap.

Ramipril Zentiva 10 mg tablets are available in packs of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 500 tablets in PVC/aluminum blisters, and in bottles of 28, 56, and 500 tablets made of dark glass with a closure cap.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale L. Bodio, 37/B - 20158 Milan, Italy

Manufacturer
Sanofi S.p.A.
Strada Statale 17, Km 22, 67019 Scoppito, L’Aquila (Italy)
Delpharm Dijon
6, Boulevard de l’Europe, 21800 Quetigny (France)
S.C. ZENTIVA S.A.
B-dul Theodor Pallady nr. 50, Sector 3, Bucharest, 032266 (Romania)

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Austria:
Tritace 1.25 mg Tabletten, Tritace 2.5 mg Tabletten, Tritace 5 mg Tabletten, Tritace 10 mg Tabletten.

Belgium:
Tritace 2.5 mg tabletten/comprimés/Tabletten,
Tritace 5 mg tabletten/comprimés/Tabletten, Tritace 10 mg tabletten/comprimés/Tabletten.

Bulgaria:
Tritace 2.5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки.

Cyprus:
Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία.

Czech Republic:
Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety.

Denmark:
Triatec 5 mg tabletter.

Estonia:
Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid.

Finland:
Cardace 2.5 mg tabletit, Cardace 5 mg tabletit, Cardace 10 mg tabletit.

France:
Triatec 1.25 mg comprimés, Triatec 2.5 mg comprimés sécable, Triatec 5 mg comprimés sécable, Triatec 10 mg comprimés sécable.
Ramipril Zentiva 2.5 mg comprimés sécable, Ramipril Zentiva 5 mg comprimés sécable, Ramipril Zentiva 10 mg comprimés sécable.

Germany:
Delix 2.5 mg Tabletten, Delix 5 mg Tabletten, Delix Protect 10 mg Tabletten.
Delix Protect Startset.
Ramilich 2.5 mg Tabletten, Ramilich 5 mg Tabletten, Ramilich 10 mg Tabletten.
Delix 1.25 mg Tabletten.
Delix 1.25 mg Kapseln, Delix P 2.5 mg Kapseln, Delix P 5 mg Kapseln, Delix P 10 mg Kapseln.

Greece:
Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία.

Hungary:
Tritace Mite 1.25 mg tabletta.
Tritace 2.5 mg tabletta, Tritace 5 mg tabletta, Tritace 10 mg tabletta.
Ramipril – Zentiva 5 mg tabletta.
Ramipril – Zentiva 10 mg tabletta.

Ireland:
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets.

Italy:
Triatec 1.25 mg compresse, Triatec 2.5 mg compresse, Triatec 5 mg compresse, Triatec 10 mg compresse.
Ramipril Zentiva 2.5 mg compresse, Ramipril Zentiva 5 mg compresse, Ramipril Zentiva 10 mg compresse.

Latvia:
Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets.

Lithuania:
Cardace 5 mg tabletės, Cardace 10 mg tabletės.

Luxembourg:
Tritace 2.5 mg tabletten/comprimés/Tabletten,
Tritace 5 mg tabletten/comprimés/Tabletten, Tritace 10 mg tabletten/comprimés/Tabletten.

Norway:
Triatec 1.25 mg tabletter, Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter.

Poland:
Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki.

Portugal:
Triatec 2.5 mg comprimidos, Triatec 5 mg comprimidos, Triatec 10 mg comprimidos.
Triatec 1.25 mg cápsulas, Triatec 2.5 mg cápsulas, Triatec 5 mg cápsulas, Triatec 10 mg cápsulas.

Romania:
Tritace 2.5 mg comprimate, Tritace 5 mg comprimate, Tritace 10 mg comprimate.
Zenra 2.5 mg comprimate, Zenra 5 mg comprimate, Zenra 10 mg comprimate.

Slovakia:
Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety.

Slovenia:
Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete.

Spain:
Acovil 1.25 mg comprimidos, Acovil 2.5 mg comprimidos, Acovil 5 mg comprimidos, Acovil 10 mg comprimidos.

Sweden:
Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter.

United Kingdom:
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets.
Tritace Titration Pack tablets.