Ramipril Ratiopharm: detailed information

Patient Information Leaflet

RAMIPRIL RATIOPHARM 2.5 mg tablets, 5 mg tablets

Equivalent medicine
Please read all of 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 give it to other people, 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, tell your doctor or pharmacist. See section 4.

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

1. What Ramipril ratiopharm is and what it is used for
Ramipril ratiopharm contains a medicine called ramipril, which belongs to a group of medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril ratiopharm works by:

Reducing the body's production of substances that may cause an increase in blood pressure
Relaxing and widening your blood vessels
Helping your heart to pump blood around the body more easily.

Ramipril ratiopharm may 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 the heart is unable to pump sufficient blood around the body)
As treatment after a heart attack (myocardial infarction), when associated with heart failure.

2. What you need to know before taking Ramipril ratiopharm

Do not take Ramipril ratiopharm

If you are allergic to ramipril, to other ACE inhibitors, 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 experienced a severe allergic reaction called "angioedema". Symptoms 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, Ramipril ratiopharm 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 "Pregnancy and breastfeeding").
If your blood pressure is excessively low or unstable. Your doctor must 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 beneath the skin, e.g., in the throat).

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

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, diarrhea, excessive sweating, a low-salt diet, long-term use of oral diuretics, or after dialysis).
If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
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,
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 Ramipril ratiopharm".
If you are about to undergo anesthesia, which may be administered during surgery or dental procedures. You may need to stop taking Ramipril ratiopharm the day before; consult your doctor.
If you have high levels of potassium in your blood (as shown by a blood test).
If you are taking any of the following medicines, as the risk of angioedema (a severe allergic reaction causing rapid swelling under the skin, e.g., in the throat) may be increased:
racecadotril, a medicine used to treat diarrhea;
medicines used to prevent rejection of transplanted organs or 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 may be pregnant (or could become pregnant). Ramipril ratiopharm is not recommended during the first three months of pregnancy and may cause serious harm to the unborn child after the third month of pregnancy (see section "Pregnancy and breastfeeding").

Children and adolescents
The use of Ramipril ratiopharm is not recommended in children and adolescents under 18 years of age, as its safety and efficacy 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.
Other medicines and Ramipril ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril ratiopharm may affect the action of certain other medicines, and some medicines may affect the action of Ramipril ratiopharm.
Inform your doctor if you are taking any of the following medicines. These may interfere with Ramipril ratiopharm 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.

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

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 blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; 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 blood uric acid levels)
Procainamide (used for heart rhythm problems)
Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions"
Vildagliptin (used to treat type 2 diabetes)

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" 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 Ramipril ratiopharm:

Medicines for diabetes, such as oral antidiabetics and insulin. Ramipril ratiopharm may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Ramipril ratiopharm.
Lithium (for psychiatric conditions). Ramipril ratiopharm 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.
Ramipril ratiopharm with food and alcohol

Drinking alcohol while taking Ramipril ratiopharm may cause dizziness or lightheadedness. If you wish to know how much alcohol you can consume while taking Ramipril ratiopharm, discuss this with your doctor. Blood pressure-lowering medicines and alcohol may enhance each other's effects, potentially leading to excessive lowering of blood pressure.
Ramipril ratiopharm can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take Ramipril ratiopharm 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 child. If you become pregnant while taking Ramipril ratiopharm, inform your doctor immediately. Before planning a pregnancy, you should switch to a more suitable medicine.
Breastfeeding
You must not take Ramipril ratiopharm while breastfeeding.
Driving and using machines
You may experience dizziness while taking Ramipril ratiopharm. This is more likely when you first start taking it or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.
Ramipril ratiopharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Ramipril ratiopharm 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

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

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

How much you should 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, your doctor may stop or reduce them before starting your treatment with Ramipril ratiopharm.

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 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 as needed.
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 daily. 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 daily. It is preferable to divide the dose into two daily administrations.

Elderly patients
Your doctor will reduce the initial dose and adjust treatment more slowly.
If you take more Ramipril ratiopharm than you should
Inform your doctor or go to the nearest hospital emergency department immediately. Do not drive to the hospital; have someone accompany 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 ratiopharm

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 further questions about the use of 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 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 swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Ramipril ratiopharm
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, 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 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 becomes severe or persists for more 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 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, 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 (paresthesia)
Loss or change in taste
Sleep problems
Depressed mood, anxiety, increased nervousness or irritability
Stuffy nose, breathing difficulties or worsening of asthma
Swelling in the intestine 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 or decrease in 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 sexual desire 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 problems and ringing in the ears (tinnitus)
Feeling weak
Decrease in the number of red blood cells, white blood cells and platelets or in 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 or ill, 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.

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
Mouth swelling
Blood tests showing too low a number of blood cells
Blood tests showing low sodium levels in the blood
Fingers of the 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
Changes in the perception of smells
Hair loss.

Reporting of side effects
If you get 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 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 ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep 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 contains

The active substance is ramipril.

Ramipril ratiopharm 2.5 mg tablets
Each tablet contains 2.5 mg of ramipril.
Ramipril ratiopharm 5 mg tablets
Each tablet contains 5 mg of ramipril.

The other ingredients (excipients) are:
Ramipril ratiopharm 2.5 mg tablets
Monohydrate lactose, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized starch, sodium stearil fumarate, yellow iron oxide.

Ramipril ratiopharm 5 mg tablets
Monohydrate lactose, sodium hydrogen carbonate, sodium croscarmellose, pregelatinized starch, sodium stearil fumarate, yellow iron oxide, red iron oxide.

Description of the appearance of Ramipril ratiopharm and contents of the pack

Ramipril ratiopharm 2.5 mg tablets
The tablets are flat, uncoated, capsule-shaped and yellow in colour. The tablets have a break line on one side and the imprint "R2" on the opposite side.

Ramipril ratiopharm 5 mg tablets
The tablets are flat, uncoated, capsule-shaped and pink in colour. The tablets have a break line on one side and the imprint "R3" on the opposite side.
The tablet can be divided into two equal doses.

Blister packs (Al/Al)
Pack sizes: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH, Graf-Arco Strasse 3 – 89079 Ulm (Germany)

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren (Germany)

Ramipril ratiopharm 2.5 mg tablets
This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark: Mertabyl
Finland: Ramipril ratiopharm 2.5 mg tabletti
Italy: Ramipril ratiopharm 2.5 mg compresse

Ramipril ratiopharm 5 mg tablets
This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark: Mertabyl
Finland: Ramipril ratiopharm 5 mg tabletti
Italy: Ramipril ratiopharm 5 mg compresse

This patient information leaflet does not contain all the information available on this medicine. If you have further questions or are unsure, please consult your doctor or pharmacist.