RAMIPRIL 2.5 mg Tablet

Зміст інструкції

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

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

Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it could 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 Ramipril Zentiva is and what it is used for
• 2. What you need to know before you take Ramipril Zentiva
• 3. How to take Ramipril Zentiva
• 4. Possible side effects
• 5. How to store Ramipril Zentiva
• 6. 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 the group of drugs
called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril Zentiva 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.

Ramipril Zentiva 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 you have diabetes).
• To treat your heart when it cannot pump enough blood to the rest of the body (heart failure).
• As treatment after a heart attack (myocardial infarction) if 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 can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you have had a serious allergic reaction called “angioedema”. The signs include itching, rash (hives), red patches on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty in 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 having dialysis or any other type of blood filtration. Depending on the machinery 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 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.

Do not take Ramipril Zentiva if any of the above conditions apply to you. If you are not sure,
ask your doctor before taking Ramipril Zentiva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril Zentiva:

• 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 after having dialysis).
• If you are about to undergo treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are about to have an anaesthetic. This may be given for surgery or dental treatment. You may need to stop taking Ramipril Zentiva the day before; ask your doctor for advice.
• If you have a high amount of potassium in your blood (shown by a blood test).
• If you are taking medicines or are in conditions that can lower the levels of sodium in your blood. Your doctor may prescribe blood tests at regular intervals, particularly to check the levels of sodium in your blood, especially if you are elderly.
• If you are taking medicines that can increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. See section 2 “Do not take Ramipril Zentiva” for sacubitril/valsartan.
• 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). Ramipril Zentiva is not recommended in the first 3 months of pregnancy and can cause serious harm to the baby 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 check your kidney function, blood pressure, and the amount 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 not sure), 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 can affect the mechanism of action of
some other medicines. Also some medicines can affect the mechanism of action of
Ramipril Zentiva.
Tell your doctor if you are taking any of the following medicines. These medicines can interfere
with Ramipril Zentiva 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. Your 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 Ramipril Zentiva, can 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].
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after transplantation such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (used to make the blood more fluid).
• Steroid medicines for the treatment of inflammation such as prednisolone.
• Allopurinol (used to lower the amount of uric acid in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin (for type 2 diabetes treatment).
• Racecadotril (used to treat diarrhea).
• Your doctor may need to adjust the 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"
Tell your doctor if you are taking any of the following medicines. The mechanism of action of these
medicines can be affected by Ramipril Zentiva:

• Diabetes medicines such as oral hypoglycaemics and insulin. Ramipril Zentiva can lower the amount of sugar in your blood. Check your blood sugar levels carefully when taking Ramipril Zentiva.
• Lithium (for psychiatric problems). Ramipril Zentiva can increase the amount of lithium in your blood. The level of lithium in your blood must be carefully monitored by your doctor. If any of the above conditions apply to you (or you are not sure), ask your doctor before taking Ramipril Zentiva.

Ramipril Zentivawith food and alcohol

• Drinking alcoholic beverages together with Ramipril Zentiva can cause dizziness or lightheadedness. Discuss with your doctor how much alcohol you can drink when taking Ramipril Zentiva, as medicines used to lower blood pressure and alcohol can have additive effects.
• Ramipril Zentiva 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 must not take Ramipril Zentiva during the first 12 weeks of pregnancy and must not take it at all after the 13th week because its use during pregnancy can be harmful to the
baby. If you become pregnant while taking Ramipril Zentiva, inform your doctor immediately.
Before planning a pregnancy, you must switch to another medicine
more suitable.

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 feel dizzy while taking Ramipril Zentiva. This is more likely
when you first start taking Ramipril Zentiva or have just increased the dose. If this
happens, do not drive or use tools or machines.

3. How to take Ramipril Zentiva

Take this medicine following the instructions of your doctor exactly. Ask 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 a day.
• Your 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 (water tablets), your doctor may stop or reduce the amount of diuretic before starting you on Ramipril Zentiva. To reduce the risk of a heart attack or stroke
• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the dose you take later.
• 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 with a dose of 1.25 mg or 2.5 mg once a day
• Your 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.
• Your 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.
• Your 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
Your doctor will reduce the starting dose and adjust the treatment more gradually.

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 Ramipril Zentiva than you should
Tell 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 packaging with you.
This is because the doctor needs to know what you have taken.

If you forget to take Ramipril Zentiva

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

If you have any further questions about 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 everybody gets them.

Stop taking Ramipril Zentivaand 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 which makes it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to Ramipril Zentiva.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Fast heartbeat, irregular or strong 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 can 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 easy development of infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These can be signs of problems with the blood circulation or bone marrow.
• Severe stomach pain that may extend to your back. This can 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 can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Tell your doctor if any of the following becomes severe or lasts 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 you first start taking Ramipril Zentiva or 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, diarrhoea, indigestion, feeling sick or unwell.
• Rash with or without swelling.
• Chest pain.
• Muscle cramps or pain.
• Blood tests may show a higher than normal level of potassium.

Uncommon(may affect up to 1 in 100 people)

• Problems with balance (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or creeping (paresthesia).
• Loss or change of taste.
• Difficulty sleeping.
• 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 diarrhoea.
• 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 can be a sign that your body is retaining more water than usual.
• Flushing.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, reduced sexual drive in men and women.
• Increase in the number of white blood cells (eosinophilia) found during blood tests.
• Changes in liver, pancreas or kidney function 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 characterised by pustules.
• Problems with nails (such as loss or separation of the nail from its bed).
• Rash or bruising.
• Spots on the skin and cold extremities.
• Red, swollen, watery or itchy eyes.
• Hearing problems and ringing in the ears.
• Feeling weak.
• Decrease in the number of red blood cells, white blood cells and platelets in the blood or in the concentration of haemoglobin, highlighted by blood tests.

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

• Increased sensitivity to the sun.

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests showing too few blood cells.
• Blood tests showing a low level of sodium in the blood.
• Concentrated urine (dark in colour), feeling unwell or sick, 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 and toes that change colour when cold and tingle or hurt when warmed (Raynaud’s phenomenon).
• Increase in 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Ramipril Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated 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 in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Ramipril Zentiva contains
The active ingredient 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 corn starch, microcrystalline cellulose, sodium stearylfumarate, iron
oxide yellow (E172).

5 mg tablets
hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate, iron
oxide red (E172).

10 mg tablets
hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate.

Description of the appearance of Ramipril Zentivaand content of the pack
2.5 mg tablets
Oblong tablets, from yellow to yellowish, of 8 x 4 mm with a fracture 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 tablets, light red, of 8 x 4 mm with a fracture 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 tablets, from white to almost white, of 7 x 4.5 mm with a fracture line, marked
on the upper side with HMO/HMO. The tablet can be divided into equal doses.

Ramipril Zentiva2.5 mg tabletsare 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 packs of 500 tablets
in dark glass bottles with a closing cap.

Ramipril Zentiva5 mg tabletsare 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 packs of 500 tablets
in dark glass bottles with a closing cap.

Ramipril Zentiva10 mg tabletsare 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 packs of 28, 56, 500
tablets in dark glass bottles with a closing cap.
Not all pack sizes may be marketed.

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

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 is authorised in the Member States of the European Economic Area with
the following denominations:
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 secable, Ramipril Zentiva 5 mg comprimés secable, Ramipril
Zentiva 10 mg comprimés secable.
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 tabletes, Cardace 10 mg tabletes.
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.