Ramipril Ratiopharm Italia

Italy
Brand name Ramipril Ratiopharm Italia
Form tablets
Active substance / Dosage
RAMIPRIL
Prescription type Prescription only
ATC code
C09AA05
Registration number 037531
Manufacturer TEVA B.V.
Ramipril Ratiopharm Italia tablets

Table of Contents

Patient Information Leaflet

Ramipril ratiopharm Italia 10 mg tablets

Generic medicine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Ramipril ratiopharm Italia is and what it is used for
2. What you need to know before taking Ramipril ratiopharm Italia
3. How to take Ramipril ratiopharm Italia
4. Possible side effects
5. How to store Ramipril ratiopharm Italia
6. Contents of the pack and other information

1. What Ramipril ratiopharm Italia is and what it is used for

Ramipril ratiopharm Italia contains a medicine called ramipril, which belongs to a group of
medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril ratiopharm Italia 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 pump blood more easily around the body.

Ramipril ratiopharm Italia 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 heart failure, when your heart cannot pump enough blood around the body
  • As a treatment after a heart attack (myocardial infarction), when associated with heart failure.

2. What you should know before taking Ramipril ratiopharm Italia

Do not take Ramipril ratiopharm Italia

  • 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". These 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 are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril ratiopharm Italia 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.
  • If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of 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 Ramipril ratiopharm Italia if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Ramipril ratiopharm Italia.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril ratiopharm Italia:

  • If you have heart, liver, or kidney problems.
  • If you have lost significant amounts of salts or body fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or due to a low-salt diet, or from long-term use of oral diuretics, or after dialysis).
  • If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
  • 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), especially if you have kidney problems related to diabetes, or aliskiren. Your doctor should regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "Do not take Ramipril ratiopharm Italia".
  • If you are about to undergo anaesthesia. This may be given during surgery or dental procedures. You may need to stop taking Ramipril ratiopharm Italia the day before. Ask your doctor for advice.
  • 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 of Black origin, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure compared to non-Black patients.
  • If you are taking any of the following medicines, as the risk of angioedema, a severe allergic reaction (rapid swelling under the skin, e.g. in the throat), may be increased: racecadotril, a medicine used to treat diarrhoea; medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus); 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 are pregnant (or could become pregnant). Ramipril ratiopharm Italia is not recommended during the first 3 months of pregnancy and may cause severe harm to the unborn baby after the third month of pregnancy (see section "Pregnancy and breastfeeding").

Children and adolescents

The use of Ramipril ratiopharm Italia is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril ratiopharm Italia in children have not yet been established.

If any of the above conditions apply (or if you are unsure), consult your doctor before taking Ramipril ratiopharm Italia.

Other medicines and Ramipril ratiopharm Italia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril ratiopharm Italia may affect how some other medicines work. Also, some medicines may affect how Ramipril ratiopharm Italia works.

Tell your doctor if you are taking any of the following medicines. These may interfere with Ramipril ratiopharm Italia 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 will need to monitor your blood pressure.

Tell your doctor if you are taking any of the following medicines. Taking these with Ramipril ratiopharm Italia may increase the likelihood of side effects:

  • Sacubitril/valsartan – used to treat a type of chronic heart failure in adults (see section 2 "Do not take Ramipril ratiopharm Italia").
  • Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
  • Cancer medicines (chemotherapy).
  • Diuretics such as furosemide.
  • Potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting).
  • Steroid medicines used to treat inflammation, such as prednisolone.
  • Allopurinol (used to lower uric acid levels in the blood).
  • Procainamide (for heart rhythm problems).
  • Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".
  • Vildagliptin (used to treat 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 sections "Do not take Ramipril ratiopharm Italia" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines. The action of these medicines may be affected by Ramipril ratiopharm Italia:

  • Medicines for diabetes such as oral antidiabetics and insulin. Ramipril ratiopharm Italia may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Ramipril ratiopharm Italia.
  • Lithium (for psychiatric conditions). Ramipril ratiopharm Italia may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.

If any of the above conditions apply (or if you are unsure), consult your doctor before taking Ramipril ratiopharm Italia.

Ramipril ratiopharm Italia with food and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).

You must not take Ramipril ratiopharm Italia 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 baby. If you become pregnant while taking Ramipril ratiopharm Italia, 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 ratiopharm Italia while breastfeeding.

Driving and using machines

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

Ramipril ratiopharm Italia contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Ramipril ratiopharm Italia contains sodium

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

3. How to take Ramipril ratiopharm Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
How much you should take
High blood pressure treatment

  • The recommended 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.

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  • If you are already taking diuretics, your doctor may stop or reduce them before starting your treatment with Ramipril ratiopharm Italia.

To reduce the risk of heart attack or stroke

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

Treatment to reduce or prevent 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 recommended starting dose is 1.25 mg once daily.
  • Your doctor will adjust your dose.
  • The maximum daily dose is 10 mg. It is preferable to divide the dose into two daily administrations.

Treatment after a heart attack

  • The recommended 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 daily. It is preferable to divide the dose into two daily administrations.

Elderly patients
Your doctor will reduce the starting dose and adjust treatment more slowly.
Taking this medicine

  • Take the medicine orally at the same time each day.
  • Swallow the tablets with liquid.
  • Do not break or chew the tablets.
  • The tablet may be divided into equal doses.

If you take more Ramipril ratiopharm Italia than you should
Inform your doctor or go to the nearest hospital emergency department. Do not drive to the
hospital; have someone accompany you or call an ambulance. Bring the medicine pack with you.
This is because the doctor needs to know what you have taken.
If you forget to take Ramipril ratiopharm Italia

  • 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 missed 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 Ramipril ratiopharm Italia and contact your doctor immediately if you notice
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 ratiopharm Italia.
  • Severe skin reactions including rash, mouth ulcers, 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).

Contact your doctor immediately if you experience:

  • Rapid heartbeat, irregular or forceful 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.
  • 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, weak, dizzy 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 (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions become severe or persist for 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 ratiopharm Italia has just started or the dose has just been increased
  • Fainting, 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, feeling unwell or malaise
  • 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 (paraesthesia)

  • 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 volume of urine during the day

  • Kidney impairment, acute kidney failure

  • 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

  • Erectile dysfunction in men, reduced sexual desire in men and women

  • Increased number of white blood cells (eosinophilia) found 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 problems and ringing in the ears
  • Feeling weak
  • Decreased number of red blood cells, white blood cells and platelets, or decreased haemoglobin concentration, shown by blood tests.

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

  • Increased sensitivity to sunlight.

Not known: frequency cannot be estimated from the available data

  • Concentrated urine (dark in colour), feeling unwell, muscle cramps, confusion and seizures which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
  • Difficulty concentrating
  • Mouth ulcers
  • Blood tests showing increased levels of antibodies
  • Blood tests showing too few blood cells
  • Blood tests showing low sodium levels in the blood
  • Fingers of hands and feet changing colour when exposed to cold and tingling or painful when warmed (Raynaud's phenomenon)
  • Breast enlargement in men
  • Slowed or altered reactions
  • Burning sensation
  • Change in perception of smells
  • 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store Ramipril ratiopharm Italia

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.
Do not store above 25 °C.
Store in the original packaging to protect the medicine from moisture.
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 ratiopharm Italia contains
The active substance is ramipril.
Each tablet contains 10 mg of ramipril.
The other components are: sodium hydrogen carbonate, monohydrate lactose, sodium
croscarmellose, pregelatinized starch, sodium stearil fumarate.
Description of the appearance of Ramipril ratiopharm Italia and package contents
White to off-white, capsule-shaped, uncoated, flat tablets, 11.0 x 5.5 mm, marked on one side and on the lateral edges with "R/4".
Pack sizes of 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets in blisters or in PP containers with desiccants and PE caps.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Italy: Ramipril ratiopharm Italia 10 mg tablets
This patient information leaflet does not contain all the information about this medicinal product. If you have any questions or are unsure about anything, please consult your doctor or pharmacist.
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