Ramve 10 mg

Leaflet accompanying the packaging: information for the user

RAMVE 2.5 mg, hard capsules

RAMVE 5 mg, hard capsules

RAMVE 10 mg, hard capsules

Ramipril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 pack 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 that can increase blood pressure,
• relaxing and dilating blood vessels,
• making it easier for the heart to pump blood throughout the 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 when it is not able to pump enough blood to the whole 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 of the hands, soles of the feet, 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 medicine that combines 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.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine that contains aliskiren.
• If the patient is in the last 6 months of pregnancy (see also the section on "Pregnancy and breastfeeding").

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

Warnings and precautions

Before starting to take Ramve, 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 for bee or wasp stings.
• In case of planned anesthesia. An anesthetic may be used in connection with a surgical procedure or any dental procedure. It may be necessary to stop taking Ramve one day before the procedure. Consult a doctor.
• In case of high potassium levels in the blood (as 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 product containing sacubitril and valsartan. For the combination product 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.
• The patient should inform the doctor about existing (or suspected) pregnancy. Ramve is not recommended during the first 12 weeks of pregnancy and may be harmful to the baby if taken after the 13th week of pregnancy (see also the section on "Pregnancy and breastfeeding").
• If the patient is taking any of the following medicines, as they may not work well with Ramve:

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 adolescents

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

Ramve and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Inform your doctor about taking the following medicines, as they may not work well with Ramve:

• Pain and inflammation medicines (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, or allergies, such as ephedrine, norepinephrine, and epinephrine.

The doctor should check the blood pressure.

Inform your doctor about taking the following medicines, as they may increase the risk of side effects if taken with Ramve:

• A combination product 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").
• Pain and inflammation medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid).
• Cancer medicines (chemotherapy).
• Medicines used to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics (water pills), such as 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).
• Steroidal anti-inflammatory medicines, 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 adjust the dose and/or take other precautions if the patient is taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under the heading "When not to take Ramve" and "Warnings and precautions").

Inform your doctor about taking the following medicines, as Ramve may affect their action:

• Anti-diabetic medicines, 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. The doctor will need to closely monitor lithium levels in the blood.

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

Ramve with food and drink

• Drinking alcohol while taking Ramve may cause dizziness and drowsiness. If in doubt about the amount of alcohol allowed while taking Ramve, 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 breastfeeding 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 be harmful to the baby.

Women who become pregnant while taking Ramve should inform their doctor immediately. 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, consult a doctor or pharmacist.

Driving and using machines

Ramve may cause dizziness. This is more likely to occur when starting to take the medicine or when the dose is increased. If symptoms occur, do not drive 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, 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, consult a doctor or pharmacist before taking the medicine.

3. How to take Ramve

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

Recommended dose:

Adults

Treatment of high blood pressure

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

Reduction of the risk of heart attack or stroke

• The usual starting dose of ramipril is 2.5 mg once daily.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once daily.

Treatment to reduce or delay the worsening of kidney problems

• The usual starting dose is 1.25 mg to 2.5 mg once daily.
• The doctor will adjust the dose.
• The usual dose is 5 mg to 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• The doctor will adjust the dose.
• The maximum dose is 10 mg daily. It is recommended to take the medicine twice daily.

Treatment after a heart attack

• The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.
• The doctor will adjust the dose.
• The maximum dose is 10 mg daily. It is recommended to take the medicine twice daily.

Patient with liver problems

Treatment with ramipril can only be started under close medical supervision, with a maximum dose of Ramve of 2.5 mg daily.

Elderly patients

The doctor will reduce the starting 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 in children have not been established.

Method and route 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, inform a doctor.

Overdose

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

Missed dose

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

Stopping treatment

Do not stop taking Ramve without consulting a doctor first. If treatment is stopped, the patient's condition may worsen.

In case of any further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking Ramve and contact a 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 serious allergic reaction to Ramve.
• Severe skin reactions, including rash, mouth ulcers, worsening of existing skin conditions, redness, rash, and skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).

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.
• Rapid breathing and cough. These may be symptoms of lung problems.
• Easier bruising, bleeding for longer than usual, any signs of bleeding (e.g., bleeding gums), dark red spots, discoloration, or infection more easily than usual, sore throat, or fever, feeling tired, 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, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver problems, such as hepatitis or liver damage.
• Kidney problems, including acute kidney failure. Symptoms may include decreased urine output, loss of appetite, fatigue, swelling of hands and feet, dryness, and itching of the skin, etc.

Other side effects include:

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 tired.
• Dizziness. This is more likely to occur when starting to take Ramve or when the dose is increased.
• 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, indigestion, nausea.
• Rash.
• Chest pain.
• Muscle cramps or pain.
• High 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 stabbing (paresthesia).
• Loss of or altered taste.
• Sleep disorders.
• Feeling depressed, anxious, nervous, or restless.
• 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 when urinating.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Increased or irregular heart rate.
• Swelling of 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 levels 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 trembling or confusion.
• Redness and swelling of the tongue.
• Severe skin peeling, itchy, lumpy rash.
• Nail disorders (e.g., nail loss or separation from the nail bed).
• Rash or bruising.
• Discoloration and cold extremities.
• 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:

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 found in blood tests.
• Low sodium levels found in blood tests.
• Increased levels of anti-nuclear antibodies in the body found in blood tests.
• Change in finger and toe color in cold weather, with 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-colored crust.
• Red, shiny bumps 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-colored), 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, consult a doctor immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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

• Keep the 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.
• Explanations of abbreviations: Expiry date (EXP) Batch number (Lot)
• 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. This will help protect the environment.

6. Contents of the pack 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 (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 contents of the pack:

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