Ramve 2,5 mg

Leaflet attached to the packaging: information for the user

RAMVE 2.5 mg, hard capsules

RAMVE 5 mg, hard capsules

RAMVE 10 mg, hard capsules

Ramipril

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ramve and what is it used for
• 2. Important information before taking Ramve
• 3. How to take Ramve
• 4. Possible side effects
• 5. How to store Ramve
• 6. Contents of the packaging and other information

1. What is Ramve and what is it used for

Ramve contains the active substance ramipril. Ramipril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors), which act on the heart and blood vessels. The action of the medicine is based on:

• reducing the production of substances by the body that can increase blood pressure,
• relaxing and dilating blood vessels,
• making it easier for the heart to pump blood to the entire body.

Ramve can be used to:

• treat high blood pressure (hypertension),
• reduce the risk of heart attack or stroke,
• reduce the risk of or delay the worsening of kidney disease (regardless of whether the patient has diabetes or not),
• treat the heart if it is not able to pump enough blood to the entire body (heart failure),
• treat post-heart attack heart failure.

2. Important information before taking Ramve

When not to take Ramve:

• If the patient is allergic to ramipril or any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has ever had a severe allergic reaction known as "angioedema". Symptoms include itching, hives, red spots on the palms, soles, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient has taken or is taking a combination medicine containing sacubitril and valsartan, used to treat a certain type of chronic heart failure in adults.
• If the patient is undergoing dialysis or another type of blood filtration. Depending on the equipment/membrane used, Ramve may not be a suitable medicine.
• If the patient has kidney problems where blood flow to the kidneys is reduced (renal artery stenosis).
• If the patient's blood pressure is exceptionally low or unstable, the doctor will need to assess it properly.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient is in the last 6 months of pregnancy(see also the section "Pregnancy and breastfeeding").

If any of the above points apply, do not take Ramve. In case of doubts, consult a doctor.

Warnings and precautions

Before starting to take Ramve, you should discuss it with your doctor or pharmacist:

• In case of heart, liver, or kidney problems.
• In case of loss of a large amount of electrolytes (salts) or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term use of diuretics, or after dialysis).
• In case of planned desensitization treatment.
• In case of planned anesthesia. An anesthetic may be used in connection with surgery or any dental procedure. It may be necessary to stop taking Ramve one day before the procedure. You should consult your doctor.
• In case of high potassium levels in the blood (shown in blood tests).
• In case of taking medicines that can lower sodium levels in the blood or being in a state of health that can lower sodium levels in the blood. The doctor may regularly perform blood tests, especially to check sodium levels in the blood, especially in elderly people.
• If the patient is taking medicines that can increase the risk of angioedema, a serious allergic reaction, such as mTOR kinase inhibitors (e.g., temsirolimus, everolimus, sirolimus) or vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or a combination medicine containing sacubitril and valsartan. For a combination medicine containing sacubitril and valsartan, see also the information under the heading "When not to take Ramve".
• In case of collagen vascular diseases, such as scleroderma, systemic lupus erythematosus.
• You should inform your doctor if you are pregnant or think you may be pregnant. Ramve is not recommended during the first 3 months of pregnancy and may cause serious harm to the baby if taken after the third month of pregnancy, see the section "Pregnancy and breastfeeding".
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Ramve". Children and adolescentsRamve is not recommended for use in children and adolescents under 18 years of age, as the efficacy and safety of ramipril in children have not yet been established. If any of the above situations apply (or in case of uncertainty), before taking Ramve, you should consult a doctor.

Ramve and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. You should inform your doctor about taking the following medicines, as they may not work well with Ramve:

• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin),
• medicines used to treat low blood pressure, shock, heart failure, asthma, allergy, such as ephedrine, noradrenaline, and adrenaline.

The doctor should measure blood pressure. You should inform your doctor about taking the following medicines, as they may increase the risk of side effects if taken with Ramve:

• a combination medicine containing sacubitril and valsartan, used to treat a certain type of chronic heart failure in adults (see also the information under the heading "When not to take Ramve").
• medicines used to reduce pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid).
• medicines used to treat cancer (chemotherapy).
• medicines used to prevent organ rejection after transplantation, such as cyclosporine.
• diuretics (e.g., furosemide).
• medicines that can increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim, or trimethoprim in combination with sulfamethoxazole (used to treat infections) and heparin (used to thin the blood).
• corticosteroids, such as prednisolone.
• allopurinol (used to reduce uric acid levels in the blood).
• procainamide (used to treat heart rhythm disorders).
• trimethoprim and co-trimoxazole (used to treat bacterial infections).
• temsirolimus (used to treat malignant tumors).
• everolimus, sirolimus (used to prevent transplant rejection).
• vildagliptin (used to treat type 2 diabetes).
• racecadotril (used to treat diarrhea).
• The doctor may need to change the dose and/or take other precautions if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Ramve" and "Warnings and precautions").

You should inform your doctor about taking the following medicines, as Ramve may affect their action:

• oral hypoglycemic agents, such as oral glucose-lowering medicines and insulin. Ramve may lower blood sugar levels. Blood sugar levels should be closely monitored while taking Ramve.
• lithium (used to treat mental disorders). Ramve may increase lithium levels in the blood. Close monitoring of lithium levels in the blood by the doctor will be necessary.

If any of the above situations apply (or in case of uncertainty), before taking Ramve, you should consult a doctor.

Ramve with food and alcohol

• Consuming alcohol while taking Ramve may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Ramve, you should consult a doctor, as alcohol may enhance the effects of blood pressure-lowering medicines.
• Ramve can be taken with or without food.

Pregnancy and breastfeeding

Pregnant or potentially pregnant women should inform their doctor. Ramve should not be taken during the first 12 weeks of pregnancy. Ramve should not be taken after the 13th week of pregnancy, as it may harm the baby. Women who become pregnant while taking Ramve should immediately inform their doctor. Before planned pregnancy, the treatment should be switched to a more suitable alternative treatment. Ramve should not be taken during breastfeeding. Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Ramve may cause dizziness. This occurs more frequently at the beginning of treatment or after increasing the dose. If symptoms occur, you should not drive vehicles or operate machinery.

Important information about some of the ingredients of Ramve

• Ramve contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions) and occasionally bronchospasm.
• The 2.5 mg, 5 mg, and 10 mg capsules also contain the dye carmoisine, which may cause allergic reactions.
• The 2.5 mg capsules contain the dye orange yellow S, which may cause allergic reactions.
• The 2.5 mg and 5 mg capsules also contain the dye erythrosine, which may cause allergic reactions.

Although Ramve contains very small amounts of these substances, if you know you are allergic to them, you should consult a doctor or pharmacist before taking the medicine.

3. How to take Ramve

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubts, you should consult a doctor or pharmacist.

Recommended dose:

Adults

Treatment of high blood pressure

• The usual initial dose of ramipril is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the dose taken until full control of blood pressure is achieved.
• The maximum dose is 10 mg once a day.
• If the patient is taking diuretics, the doctor may stop or reduce the dose of the diuretic before starting Ramve.

Reducing the risk of heart attack or stroke

• The usual initial dose of ramipril is 2.5 mg once a day.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once a day.

Treatment to reduce or delay the worsening of kidney problems

• The usual initial dose is 1.25 mg to 2.5 mg once a day.
• The doctor will adjust the dose taken.
• The usual dose is 5 mg to 10 mg once a day.

Treatment of heart failure

• The usual initial dose is 1.25 mg once a day.
• The doctor will adjust the dose taken.
• The maximum dose is 10 mg per day. It is recommended to take the medicine twice a day.

Treatment after a heart attack

• The usual initial dose is 1.25 mg once a day to a dose of 2.5 mg twice a day.
• The doctor will adjust the dose taken.
• The maximum dose is 10 mg per day. It is recommended to take the medicine twice a day.

Patient with liver problemsIn case of liver problems, treatment with ramipril can be started only under close medical supervision, with a maximum dose of Ramve of 2.5 mg per day. Elderly patientsThe doctor will reduce the initial dose and adjust it more slowly.

Use in children and adolescents

Ramve is not recommended for use in children and adolescents under 18 years of age, as its safety and efficacy have not been established in children.

Route and method of administration

The medicine should be taken orally every day at the same time. Ramve should be swallowed with a drink of water. Do not chew or crush the medicine. If swallowing the capsule is difficult, you should inform your doctor.

Taking a higher dose of Ramve than recommended

In case of taking a larger number of capsules than recommended or taking Ramve at an inappropriate strength, you should immediately inform your doctor or go to the emergency room of the nearest hospital.

Missing a dose of Ramve

If you forget to take a dose, you should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ramve

You should not stop taking Ramve without consulting your doctor first. If you stop taking the medicine, your condition may worsen. In case of any further doubts about taking the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

You should stop taking Ramve and contact your doctor immediately if you experience any of the following serious side effects - you may need urgent medical attention:

• Swelling of the face, lips, or throat, causing difficulty swallowing or breathing, as well as hives and rash. This may be a sign of a severe allergic reaction to Ramve.
• Severe skin reactions, including rash, mouth ulcers, exacerbation of existing skin conditions, redness, rash, and skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).

You should inform your doctor immediately if you experience:

• Increased heart rate, irregular or rapid heartbeat, chest pain, feeling of pressure in the chest, or more serious disorders, including heart attack and stroke.
• Increased breathing rate and cough. These may be symptoms of lung disorders.
• Easier bruising, bleeding for longer than usual, any signs of bleeding (e.g., bleeding from the gums), dark spots, discoloration, or development of infections more easily than usual, sore throat, or fever, feeling of tiredness, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders.
• Severe stomach pain that may radiate to the back. This may be a sign of pancreatitis.
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.
• Kidney problems, including acute kidney failure. Symptoms may include decreased urine output, loss of appetite, tiredness, swelling of the hands and feet, dryness, and itching of the skin, etc.

Other side effects include:

You should inform your doctor if any of the following symptoms worsen or persist for more than a few days. Common(may affect up to 1 in 10 people)

• Headache or feeling of tiredness.
• Dizziness. This occurs more frequently at the beginning of treatment or after increasing the dose.
• Fainting, low blood pressure, especially when standing up or sitting down quickly.
• Dry, tickly cough, sinusitis, or bronchitis, rapid breathing.
• Stomach or intestinal pain, diarrhea, nausea, or vomiting.
• Rash with elevated areas or without.
• Chest pain.
• Muscle cramps or pain.
• Increased potassium levels in the blood.

Uncommon(may affect up to 1 in 100 people)

• Balance disorders, dizziness.
• Itching or abnormal skin sensations, such as numbness, tingling, prickling, burning, or stinging (paresthesia).
• Loss of or altered taste.
• Sleep disorders.
• Feeling of depression, anxiety, nervousness, or restlessness.
• Feeling of nasal congestion, difficulty breathing, worsening of asthma.
• Intestinal angioedema, characterized by symptoms such as abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, dry mouth.
• Passing more water than usual with the urine during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Increased or irregular heart rate.
• Swelling of the hands and feet. This may be a sign of more water being retained in the body than usual.
• Sudden flushing of the face.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, decreased libido in men and women.
• Increased number of certain white blood cells (eosinophilia) found in blood tests.
• Blood test results showing liver, pancreas, or kidney problems.

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

• Feeling of shakiness or confusion.
• Redness and swelling of the tongue.
• Acute exfoliative dermatitis, itching, lumpy rash.
• Nail disorders (e.g., loss or separation of the nail from the nail bed).
• Rash or bruising.
• Discoloration and cold limbs.
• Redness, itching, swelling, or tearing of the eyes.
• Hearing or ringing in the ears.
• Feeling of weakness.
• Blood test results showing decreased red blood cell count, white blood cell count, or platelet count, or decreased hemoglobin levels.

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

• Increased sensitivity to sunlight.

Other reported side effects:

You should inform your doctor if any of the following symptoms worsen or persist for more than a few days.

• Difficulty concentrating.
• Swelling of the lips.
• Low blood cell count shown in blood tests.
• Low sodium levels in the blood shown in blood tests.
• Increased levels of antinuclear antibodies in the body found in blood tests.
• Change in finger color in cold temperatures, with subsequent tingling or pain when warming up (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reaction.
• Feeling of burning.
• Blisters on the skin and mucous membranes.
• Worsening of existing red, scaly skin areas with a silver scale.
• Red, shiny nodules on the skin.
• Small spots on the mucous membranes.
• Dark red, sharply defined, scaly patches on the skin.
• Disorders of smell.
• Hair loss.
• Concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures, which may be due to abnormal secretion of ADH (antidiuretic hormone). If these symptoms occur, you should immediately consult your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Ramve

• The medicine should be stored 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.
• Explanation of abbreviations: Expiry date (EXP) Batch number (Lot)
• Do not store above 25°C. Store in the original packaging.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ramve contains

• The active substance of Ramve is ramipril.
• Ramve also contains cornstarch.
• The capsule shell for all strengths of Ramve contains gelatin, titanium dioxide (E 171), sodium lauryl sulfate, methyl parahydroxybenzoate, and propyl parahydroxybenzoate.

In addition, the capsule shells contain: Ramve 2.5 mg contains the dyes orange yellow S (E 110), erythrosine (E 124), and carmoisine (E 122). Ramve 5 mg contains the dyes erythrosine (E 124), brilliant blue (E 133), and carmoisine (E 122). Ramve 10 mg contains the dyes brilliant blue (E 133), erythrosine (E 127), and carmoisine (E 122).

What Ramve looks like and what the pack contains:

Ramve 2.5 mg - orange and white capsules. Ramve 5 mg - brown-red and white capsules. Ramve 10 mg - blue and white capsules. Ramve is available in packs of 28 capsules.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Recordati Polska sp. z o.o. ul. Królewska 16 00-103 Warsaw

Manufacturer:

Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, United Kingdom Bristol Laboratories Limited, Unit 5, Traynor Way, Whitehouse Business Park, Peterlee, SR8 2RU, United Kingdom Bristol Laboratories Limited, Laporte Way, Luton, LU4 8WL, United Kingdom

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

United Kingdom: Ramipril 1.25mg 2.5mg, 5mg, 10mg, capsules Netherlands: Ramipril Bristol 1.25mg 2.5mg, 5mg, 10mg, capsules, hard Poland: Ramve 2.5 mg; Ramve 5 mg; Ramve 10 mg

Date of last revision of the leaflet: 04/2019