Ramistad 5

1. What is Ramistad and what is it used for

Ramistad contains ramipril. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Ramistad works by:

• reducing the production of substances that may increase blood pressure,
• reducing tension and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.

Ramistad 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 kidney function deterioration (in patients with diabetes or without diabetes),
• to treat heart failure when the heart is not pumping enough blood to meet the body's needs,
• to treat heart failure after a heart attack.

2. Important information before taking Ramistad

When not to take Ramistad

• If you are allergic to ramipril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction (hypersensitivity) may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called "angioedema". Its symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and mouth, difficulty breathing and swallowing.

stopach i gardle, obrzęk gardła i języka, obrzęki w okolicy oczu i ust, trudności w oddychaniu
i połykaniu.

• If you have had dialysis or another type of blood filtration. Depending on the type of equipment used, Ramistad may not be a suitable medicine.
• If you have kidney disease related to reduced blood flow to the kidneys (renal artery stenosis).
• In the last 6 months of pregnancy (see "Pregnancy and breastfeeding" below). If your blood pressure is very low or unstable. Your doctor should assess your blood pressure.
• If you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril with valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) may increase.

If any of the above situations apply to you, do not take Ramistad.
In case of doubts about taking the medicine, consult your doctor before starting to take Ramistad.

Warnings and precautions

Before taking Ramistad, discuss it with your doctor or pharmacist if:

• you have heart, liver, or kidney disease,
• you have recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics or dialysis therapy),
• you are to undergo desensitization treatment for bee or wasp stings (allergy shots),
• you are to receive anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Ramistad the day before the procedure, in case of doubts, consult your doctor,
• you have high levels of potassium in your blood (as shown by blood tests),
• you are taking medicines or have symptoms that may lower your sodium levels. Your doctor may perform regular blood tests, especially to check your sodium levels, especially in the elderly,
• If you are taking any of the following medicines, the risk of angioedema (sudden swelling of tissues under the skin, such as the throat) may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection (e.g., everolimus, sirolimus) and to treat cancer (e.g., temsirolimus);
• wildagliptin, a medicine used to treat type 2 diabetes.
• you have collagenosis, such as scleroderma or systemic lupus erythematosus,
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Ramistad".
You should inform your doctor if you suspect (or plan) pregnancy. Ramistad should not be used during the first 3 months of pregnancy. The use of Ramistad above the third month of pregnancy may seriously harm the baby (see "Pregnancy and breastfeeding" below).
Children and adolescents
Ramistad should not be used in children and adolescents under 18 years of age, as the safety and efficacy of ramipril in this age group have not been established.
If any of the above situations apply to you (or there are doubts about it), before taking Ramistad, consult your doctor.

Ramistad and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. Ramistad may affect the way other medicines work, and other medicines may affect the way Ramistad works.
Tell your doctor if you are taking any of the following medicines. They may reduce the effect of Ramistad:

• Pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen or indomethacin and acetylsalicylic acid).
• 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. They may increase the risk of side effects when taken with Ramistad:

• Pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen or indomethacin and acetylsalicylic acid)
• Cancer medicines (chemotherapy)
• Medicines used to prevent organ rejection, such as cyclosporine
• Diuretics, such as furosemide
• Medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (a blood thinner)
• Steroidal anti-inflammatory medicines, such as prednisolone
• Allopurinol (used to reduce uric acid levels in the blood)
• Procainamide (used to treat irregular heart rhythms).
• mTOR inhibitors (e.g., temsirolimus in cancer treatment, everolimus, or sirolimus used to prevent organ rejection), see "Warnings and precautions"
• Wildagliptin (used to treat type 2 diabetes), see "Warnings and precautions"
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole [also known as trimethoprim/sulfamethoxazole], used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots)

Tell your doctor if you are taking any of the following medicines. Their effect may be altered when taken with Ramistad:

• Medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin. Ramistad may lower your blood sugar levels. While taking Ramistad, you should regularly check your blood sugar levels.
• Lithium (used to treat mental illnesses). Ramistad may increase lithium levels in your blood. Your doctor will closely monitor your lithium levels.

Your doctor may need to change the dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Ramistad" and "Warnings and precautions").

Ramistad with food, drink, and alcohol

• Drinking alcohol while taking Ramistad may cause dizziness and drowsiness. Consult your doctor if you are unsure how much alcohol you can drink while taking Ramistad, as blood pressure medicines and alcohol can enhance each other's effects.
• Ramistad can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you suspect (or plan) pregnancy.
Ramistad should not be used during the first 12 weeks of pregnancy and should not be used at all after the 13th week of pregnancy, as its use during this period may harm the baby.
If you become pregnant while taking Ramistad, tell your doctor immediately. Before planned pregnancy, you should switch to a suitable alternative treatment.
Breastfeeding
Ramistad should not be taken during breastfeeding.

Driving and using machines

While taking Ramistad, you may experience dizziness. The risk of dizziness is greater at the start of treatment with Ramistad and when the dose is increased. If you experience dizziness, do not drive or operate machinery.

Ramistad contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Ramistad.
Ramistad 2.5 mg, 2.5 mg tablets contain 0.8 mg of sodium (less than 1 mmol of sodium [23 mg]) per tablet, which means it is considered "sodium-free".
Ramistad 5 mg, 5 mg tablets contain 1.44 mg of sodium (less than 1 mmol of sodium [23 mg]) per tablet, which means it is considered "sodium-free".
Ramistad 10 mg, 10 mg tablets contain 2.89 mg of sodium (less than 1 mmol of sodium [23 mg]) per tablet, which means it is considered "sodium-free".

3. How to take Ramistad

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

How to take the medicine

Take the medicine orally, once a day, at the same time every day.
Swallow the tablets whole with a drink of water.
Do not crush or chew the tablets.

Recommended dose

Treating high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the dose until your blood pressure is controlled.
• The maximum dose is 10 mg once a day.
• If you are taking diuretics, your doctor may advise you to stop taking them or reduce the dose before starting Ramistad.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Your doctor may then increase the dose.
• The usual maintenance dose is 10 mg once a day.

Treating to reduce the risk of or delay kidney function deterioration

• Treatment starts with a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will then adjust the dose.
• The usual maintenance dose is 5 mg or 10 mg once a day.

Treating heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will then adjust the dose.
• The maximum dose is 10 mg per day. It is recommended to divide the daily dose into two divided doses.

Treating after a heart attack

• The usual starting dose is 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will then adjust the dose.
• The usual maintenance dose is 10 mg per day. It is recommended to divide the daily dose into two divided doses.

Elderly patients
Your doctor will prescribe a lower starting dose and will gradually adjust it.

Taking a higher dose of Ramistad than recommended

Contact your doctor or go to the emergency department of your nearest hospital immediately. Do not drive yourself, ask someone to drive you to the hospital or call an ambulance. Bring the packaging of the medicine with you, so that the doctor knows what medicine was taken.

Missing a dose of Ramistad

• If you miss a dose, take the next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you have any doubts about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ramistad can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Ramistad and contact your doctor immediately – you may need urgent medical attention:

• Swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ramistad.
• Severe skin reactions, including rash, mouth ulcers, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Seek immediate medical attention if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious conditions, including heart attack or stroke.
• Shortness of breath or cough. They may indicate lung problems.
• Easy bruising, prolonged bleeding time, unusual bleeding (e.g., bleeding from the gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders.
• Severe abdominal pain that may radiate to the back. It may be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver problems, such as inflammation or liver damage.

Other side effects

Tell your doctor if any of the following symptoms get worse or last more than a few days.
Common(may affect up to 1 in 10 people)

• Headache or feeling tired.
• Dizziness. The risk of dizziness is greater at the start of treatment with Ramistad and when the dose is increased.
• Fainting, low blood pressure (abnormally low blood pressure) occurring especially when standing up quickly or sitting down.
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
• Abdominal pain, diarrhea, nausea, or vomiting.
• Rash with raised areas of skin or without.
• Chest pain.
• Muscle cramps or pain.
• High levels of potassium in the blood, as shown by laboratory tests.

Uncommon(may affect up to 1 in 100 people)

• Balance disorders (dizziness of vestibular origin).
• Itching and sensory disturbances, such as numbness, tingling, prickling, burning, or "pins and needles" (paresthesia).
• Loss or disturbance of taste.
• Sleep disturbances.
• Depression, anxiety, nervousness, or restlessness.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal angioedema, which may cause abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urine production.
• Excessive sweating.
• Loss or decreased appetite (anorexia).
• Rapid or irregular heartbeat, swelling of the hands and feet. These may be symptoms of fluid accumulation in the body.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased levels of certain white blood cells (eosinophilia), as shown by blood tests.
• Liver, pancreas, or kidney function disorders, as shown by blood tests.

Rare(may affect up to 1 in 1,000 people)

• Feeling disoriented, confused.
• Redness and swelling of the tongue.
• Severe skin peeling, itchy, lumpy rash.
• Nail disorders (e.g., loosening or separation of the nail from the nail bed).
• Skin rash or bruising.
• Spots on the skin and discoloration of the extremities.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing or ringing in the ears.
• Weakness.
• Decreased red blood cell, white blood cell, or platelet count, or hemoglobin level, as shown by blood tests.

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

• Sensitivity to sunlight.

Other reported side effects / frequency not known(frequency cannot be estimated from the available data):
Tell your doctor if any of the following symptoms get worse or last more than a few days.

• Difficulty concentrating
• Mouth swelling
• Low blood cell count, as shown by blood tests
• Low sodium levels, as shown by blood tests
• Color change of the fingers upon cold exposure and tingling or pain upon warming (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Smell disorders
• Hair loss.
• Concentrated urine (dark-colored), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience any of these symptoms, seek medical attention immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramistad

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 carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ramistad contains:

• The active substance is ramipril, 2.5 mg, 5 mg, or 10 mg.
• The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, croscarmellose sodium, cornstarch, and sodium stearyl fumarate.
• The 2.5 mg tablets also contain the colorant Blend PB 22960 Yellow: lactose monohydrate and yellow iron oxide (E 172); and the 5 mg tablets also contain the colorant Blend PB 24877 Pink: lactose monohydrate, yellow iron oxide (E 172), and red iron oxide (E 172).

What Ramistad looks like and contents of the pack:

• 2.5 mg tablet: yellow, capsule-shaped tablet with a score line on one side, with the imprint R2.
• 5 mg tablet: pink, capsule-shaped tablet with a score line on one side, with the imprint R3.
• 10 mg tablet: white, capsule-shaped tablet with a score line on one side, with the imprint R4.

Available packs: Aluminum/PVC/Aluminum/OPA blister pack in a cardboard box containing 28 tablets.

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

Actavis Ltd. BLB 016 Bulebel Industrial Estate Zejtun ZTN 3000, Malta
Sanico N.V., Industriezone IV, Veejijk 59, 2300 Turnhout, Belgium
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary, Ireland

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

Belgium
Ramipril EG 2.5 mg / 5 mg / 10 mg tablets
Ireland
Ramitace 2.5 mg / 5 mg / 10 mg Tablets
Italy
Ramipril EG 2.5 mg / 5 mg / 10 mg tablets
Luxembourg
Ramipril EG 2.5 mg, 5 mg, 10 mg tablet
Poland
RAMISTAD 2.5 / 5 / 10
Sweden
Ramipril STADA 2.5 mg, /5 mg / 10 mg tablet
Date of last revision of the leaflet:24.06.2021
The above leaflet does not contain all the information about this medicinal product. For more detailed information, consult your doctor or pharmacist.