Ramipril ABC

Package leaflet

Ramipril ABC 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Ramipril
Read carefully this leaflet before taking this medicine.

• 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 personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Ramipril ABC is and what it is used for
2. Before taking Ramipril ABC
3. How to take Ramipril ABC
4. Possible side effects
5. How to store Ramipril ABC
6. Further information

1. WHAT IS RAMIPRIL ABC AND WHAT IS IT USED FOR

Ramipril ABC contains a medicine called ramipril which belongs to a group of medicines
called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
RAMIPRIL ABC 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 pump blood more easily throughout the body.

RAMIPRIL ABC can be used:

• To treat high blood pressure (hypertension)
• To reduce the risk of heart attack or stroke
• To reduce the risk of 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 following a heart attack (myocardial infarction) when associated with heart failure.

2. BEFORE TAKING RAMIPRIL ABC

Do not take RAMIPRIL ABC:

• If you are allergic (hypersensitive) to ramipril, to other ACE inhibitor medicines, or to any of the other excipients of RAMIPRIL ABC listed in section 6. Signs of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have previously had 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 ABC 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 must 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 ABC if any of the above conditions apply to you. If you are unsure,
ask your doctor before taking RAMIPRIL ABC.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking RAMIPRIL ABC:

• 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, a very 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 (desensitisation).
• If you are about to undergo anaesthesia, which may be given during surgery or dental procedures. You may need to stop taking RAMIPRIL ABC 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 have a connective tissue disorder such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you are pregnant (or might become pregnant). RAMIPRIL ABC is not recommended during the first trimester of pregnancy and may cause severe harm to the unborn child after the first three months of pregnancy. See section "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 – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading "Do not take RAMIPRIL ABC".

Children

The use of RAMIPRIL ABC is not recommended in children and adolescents under 18 years of age, as there is no available information for this population.

If any of the above conditions apply (or if you are unsure), ask your doctor before taking RAMIPRIL ABC.

Taking RAMIPRIL ABC with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (including herbal medicines). This is because RAMIPRIL ABC may affect how some other medicines work. Also, some medicines may affect how RAMIPRIL ABC works.

Tell your doctor if you are taking any of the following medicines. These medicines may interfere with RAMIPRIL ABC and alter its effect:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, 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 ABC 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, indomethacin, aspirin).
• Cancer medicines (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, 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 (used for heart rhythm problems).

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

• Medicines for diabetes, such as oral hypoglycaemics and insulin. RAMIPRIL ABC may lower blood sugar levels. Monitor your blood sugar levels carefully when taking RAMIPRIL ABC.
• Lithium (used for psychiatric conditions). RAMIPRIL ABC may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels carefully.

Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: when ACE inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (e.g. selective Cox-2 inhibitors, acetylsalicylic acid at doses ≥ 325 mg/day, and non-selective NSAIDs), the antihypertensive effect may be reduced.
Concomitant use of ACE inhibitors and NSAIDs may increase the risk of worsening renal function, including possible acute kidney injury, and increased serum potassium levels, especially in patients with pre-existing impaired renal function. This combination should be used with caution, particularly in the elderly. Patients should be adequately hydrated, and monitoring of renal function should be considered at the start of concomitant treatment.

Your doctor may consider adjusting your dose and/or taking other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under "Do not take RAMIPRIL ABC" and "Warnings and Precautions").

Taking RAMIPRIL ABC with food and alcohol

• Drinking alcohol while taking RAMIPRIL ABC may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol, if any, is safe to drink while taking RAMIPRIL ABC, as blood pressure-lowering medicines and alcohol may have additive effects.
• RAMIPRIL ABC can be taken with or without food.

Pregnancy and breastfeeding

Inform your doctor if you think you are pregnant (or might become pregnant).
You must not take RAMIPRIL ABC during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as it may harm the unborn child.
If you become pregnant while taking RAMIPRIL ABC, inform your doctor immediately.
Before planning a pregnancy, you should switch to another medicine.
You must not take RAMIPRIL ABC if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel dizzy while taking RAMIPRIL ABC. 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.

3. HOW TO TAKE RAMIPRIL ABC

Always take Ramipril ABC exactly as directed by your doctor. If you are unsure, you should 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 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, your doctor may stop or reduce them before starting your treatment with Ramipril ABC.

To reduce the risk of heart attack or stroke

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

Treatment to reduce or prevent worsening of kidney problems

• You may start with 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.

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 daily dose into two administrations.

Treatment after a heart attack

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

Elderly patients
Your doctor will reduce the initial dose and adjust treatment more slowly.
If you take more Ramipril ABC 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 so the doctor knows what you have taken.
If you forget to take Ramipril ABC

• 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 further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Ramipril ABC can cause adverse reactions, although not everyone experiences them.
Stop taking Ramipril ABC and contact your doctor immediately if you notice any of the following serious adverse reactions – you may require urgent medical treatment:

• Swelling of the face, lips, or throat causing difficulty in swallowing or breathing, as well as itching or skin rash. These could be signs of a severe allergic reaction to Ramipril ABC.
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disease, 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 signs of bleeding (e.g. bleeding gums), purple spots on the skin, increased susceptibility to infections, sore throat, fever, feeling tired, weakness, dizziness, or pale appearance. These may be signs of blood or bone marrow problems.
• Severe stomach pain radiating to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, malaise, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other adverse reactions include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days:
Common (affects less than 1 in 10 patients on therapy)

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

Uncommon (affects less than 1 in 100 patients on therapy)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling, or crawling sensations (paresthesia)
• Loss or change in taste
• Sleep disturbances
• Depressed mood, anxiety, increased nervousness, or irritability
• Nasal congestion, breathing difficulties, or worsening of asthma
• Intestinal swelling called "intestinal angioedema," presenting with symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Increased frequency of urination during the day
• Increased sweating
• Loss of appetite or reduced appetite (anorexia)
• Fast or irregular heartbeat
• Swollen arms and legs. This may indicate 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) detected in blood tests
• Changes in liver, pancreas, or kidney function as shown by blood tests.

Rare (affects less than 1 in 1,000 patients on therapy)

• 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 disturbances and ringing in the ears (tinnitus)
• Feeling weak
• Decreased number of red blood cells, white blood cells, platelets, or hemoglobin concentration, as shown by blood tests

Very rare (affects less than 1 in 10,000 patients on therapy)

• Increased sensitivity to sunlight

Other adverse reactions reported:
Inform your doctor if any of the following conditions become severe or persist for longer 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 color when cold, and tingling or hurting when warmed (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or altered reactions
• Burning sensation
• Changes in the perception of smells
• Hair loss

If you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE RAMIPRIL ABC

Do not use RAMIPRIL ABC after the expiry date stated on the label. The expiry date refers to the last day of the month.
Store below 25 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

6. OTHER INFORMATION

What Ramipril ABC contains
Ramipril ABC 2.5 mg tablets:
One divisible tablet contains
Active substance: 2.5 mg Ramipril
Excipients: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate, yellow iron oxide E172.

Ramipril ABC 5 mg tablets:
One divisible tablet contains
Active substance: 5 mg Ramipril
Excipients: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide E172.

Ramipril ABC 10 mg tablets:
One divisible tablet contains
Active substance: 10 mg Ramipril
Excipients: hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate.

Pharmaceutical form and contents
RAMIPRIL ABC 2.5 mg tablets
Divisible tablets. Box of 28 tablets

RAMIPRIL ABC 5 mg tablets
Divisible tablets. Box of 14 tablets

RAMIPRIL ABC 10 mg tablets
Divisible tablets. Box of 28 tablets

The tablets can be divided into two equal parts.

Marketing Authorization Holder: ABC FARMACEUTICI S.P.A., Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer: DOPPEL FARMACEUTICI SRL – Via Volturno, 48 – Quinto De Stampi 20084 Rozzano (MI)