Ramve 5 mg

Patient Information Leaflet

RAMVE 2.5 mg, hard capsules
RAMVE 5 mg, hard capsules
RAMVE 10 mg, hard capsules
Ramipril
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Ramve is and what it is 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 Ramve is and what it is used for
Ramve contains the active substance ramipril. Ramipril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors, which act on the heart and blood vessels. The effects of this medicine include:

• reducing the body's production of substances that may increase blood pressure,
• relaxing and widening blood vessels,
• helping the heart pump blood throughout the body more easily.

Ramve may be used to:

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

2. Important information before taking Ramve

When not to take Ramve:

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

Do not take Ramve if any of the above apply.
If in doubt, consult your doctor.
Warnings and precautions
Before starting Ramve, discuss with your doctor or pharmacist if you:

• Have heart, liver, or kidney disorders.
• Have lost a large amount of electrolytes (salts) or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics, or after dialysis).
• Are planning treatment to desensitize against bee or wasp stings (desensitization therapy).
• Are planning to undergo anaesthesia. Anaesthetic may be used during surgery or any dental procedure. You may need to stop taking Ramve one day before the procedure. Consult your doctor for advice.
• Have high potassium levels in the blood (shown in blood tests).
• Are taking medicines that may reduce sodium levels in the blood or have a medical condition that lowers blood sodium levels. Your doctor may perform regular blood tests, especially to check blood sodium levels, particularly in elderly patients.
• Are taking medicines that may increase the risk of angioedema (a serious allergic reaction), such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or a combination medicine containing sacubitril and valsartan. For combination medicine containing sacubitril and valsartan, see also information under the heading "When not to take Ramve".
• Have collagen vascular diseases, such as scleroderma or systemic lupus erythematosus.
• Are pregnant or suspect you may be pregnant. Ramve is not recommended during the first 3 months of pregnancy and may cause severe harm to the unborn child if taken after the third month of pregnancy. See section: "Pregnancy and breastfeeding".
• Are taking any of the following medicines for high blood pressure:
  • an angiotensin II receptor antagonist (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
  • aliskiren.

Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also 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 the efficacy and safety of ramipril in children have not been established.
If any of the above situations apply (or if you are unsure), consult your doctor before starting Ramve.

Ramve with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Inform your doctor if you are taking the following medicines, as they may negatively affect the action of 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, or allergies (e.g. ephedrine, noradrenaline, and adrenaline).

Your doctor should measure your blood pressure.
Inform your doctor if you are taking the following medicines, as they may increase the risk of side effects when taken together with Ramve:

• A combination medicine containing sacubitril and valsartan, used to treat a certain type of chronic heart failure in adults (see also information under the heading "When not to take Ramve").
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and acetylsalicylic acid).
• Medicines used in cancer treatment (chemotherapy).
• Medicines used to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics (water tablets), such as furosemide.
• Medicines that may 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 for heart rhythm disorders).
• Trimethoprim and co-trimoxazole (used to treat bacterial infections).
• Temsirolimus (used to treat malignant tumours).
• Everolimus, sirolimus (used to prevent transplant rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhoea).
• Your doctor may need to adjust the dose and/or take additional precautions if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under the headings "When not to take Ramve" and "Warnings and precautions").

Inform your doctor if you are taking the following medicines, as Ramve may affect their action:

• Antidiabetic medicines, such as oral glucose-lowering agents and insulin. Ramve may lower blood sugar levels. Blood glucose levels should be closely monitored during treatment with Ramve.
• Lithium (used for psychiatric disorders). Ramve may increase lithium levels in the blood. Your doctor must closely monitor blood lithium levels.

If any of the above situations apply (or if you are unsure), consult your doctor before starting Ramve.

Ramve with food and alcohol

• Drinking alcohol while taking Ramve may cause dizziness and a feeling of faintness. If you have any doubts about how much alcohol is safe while taking Ramve, discuss this with your doctor, as alcohol may enhance the blood pressure-lowering effect of the medicine.
• Ramve can be taken with or without food.

Pregnancy and breastfeeding
Women who are pregnant or suspect they may be pregnant should inform their doctor.
Do not take Ramve during the first 12 weeks of pregnancy. Do not take Ramve after the 13th week of pregnancy, as it may harm the unborn child.
Women who become pregnant while taking Ramve should inform their doctor immediately. Before planning a pregnancy, treatment should be switched to an alternative, more suitable therapy.
Do not take Ramve during breastfeeding.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
Ramve may cause dizziness, especially at the beginning of treatment or after a dose increase. If you experience such symptoms, do not drive or operate machinery.

Important information about certain ingredients of Ramve

• Ramve contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions) and, rarely, bronchospasm.
• Capsules of 2.5 mg, 5 mg, and 10 mg also contain the colouring agent carmoisine, which may cause allergic reactions.
• Capsules of 2.5 mg contain the colouring agent sunset yellow, which may cause allergic reactions.
• Capsules of 2.5 mg and 5 mg also contain cochineal red, which may cause allergic reactions.
  Although Ramve contains very small amounts of the above substances, if you know you are allergic to any of them, consult your doctor or pharmacist before taking the medicine.

3. How to use Ramve

This medicine should always be taken exactly as your doctor or pharmacist has advised.
If in doubt, consult 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.
• Your doctor will adjust the dose until adequate blood pressure control is achieved.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water tablets), your doctor may stop or reduce the dose of the diuretic before starting treatment with Ramve.

Reducing the risk of heart attack or stroke

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

Treatment to reduce or delay worsening of kidney problems

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

Treatment of heart failure

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

Treatment after heart attack

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

Patients with liver problems
In patients with liver problems, treatment with ramipril should only be initiated under strict medical supervision, with a maximum daily dose of Ramve of 2.5 mg.
Elderly patients
Your 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 have not been established in this population.
Route and method of administration
The medicine should be taken orally every day at the same time. Ramve capsules should be swallowed with liquid. Do not chew or crush the capsules. If you have difficulty swallowing the capsule, inform your doctor.
Taking more Ramve than recommended
If you take more capsules than recommended or take the wrong strength of Ramve, contact your doctor immediately or go to the nearest hospital emergency department.
If you miss a dose of Ramve
If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Ramve treatment
Do not stop taking Ramve without first consulting your doctor. If treatment is stopped, your condition may worsen.
If you have any 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.
You must stop taking Ramve and contact your doctor immediately if any of the following serious side effects occur –
immediate medical intervention may be required:

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

You must immediately inform your doctor if you experience:

• Rapid, irregular or forceful heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious events including heart attack and stroke.
• Rapid breathing and cough. These may be symptoms of lung disorders.
• Bruising more easily, bleeding for longer than usual, any sign of bleeding (e.g. bleeding gums), dark red spots, discolouration, or becoming infected more easily than usual, sore throat or fever, feeling tired, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
• Severe stomach pain that may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, fatigue, 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 function disorders, including acute kidney failure. Symptoms may include reduced urine output, loss of appetite, fatigue, swelling of hands and feet, dry and itchy 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 tired.
• Dizziness. This symptom occurs more frequently when starting treatment with Ramve or after increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down suddenly.
• Dry, tickly cough, sinusitis or bronchitis, rapid breathing.
• Stomach or intestinal pain, diarrhoea, indigestion, nausea.
• Skin rash with or without raised areas.
• Chest pain.
• Muscle cramps or pain.
• Increased potassium levels shown in blood tests.

Uncommon (may affect up to 1 in 100 people)

• Balance disorders, dizziness.
• Itching or abnormal skin sensations such as numbness, tingling, pricking, burning or crawling sensations (paresthesia).
• Loss or disturbance of taste sensation.
• Sleep disturbances.
• Feeling of depression, anxiety, nervousness or restlessness.
• Feeling of nasal congestion, difficulty breathing, worsening of asthma.
• Intestinal swelling called "intestinal angioedema", characterised by symptoms such as abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation, dry mouth.
• Passing more water than usual during the day (in urine).
• Excessive sweating.
• Loss of or reduced appetite (anorexia).
• Increased frequency or irregular heartbeat.
• Swelling of hands and feet. This may be a sign of greater than usual fluid retention in the body.
• 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 disorders.

Rare (may affect up to 1 in 1000 people)

• Feeling of trembling or confusion.
• Redness and swelling of the tongue.
• Acute skin peeling, itchy nodular rash.
• Nail disorders (e.g. loss or separation of the nail from the nail bed).
• Skin rash or bruising.
• Skin discolouration and cold extremities.
• Redness, itching, swelling or watering of the eyes.
• Hearing disorders or ringing in the ears.
• Feeling of weakness.
• Blood test results showing decreased number of red blood cells, white blood cells, or platelets, or decreased haemoglobin concentration.

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 concentration shown in blood tests.
• Increased concentration of antinuclear antibodies in the body shown in blood tests.
• Change in colour of fingers and toes in cold conditions, followed by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reaction.
• Burning sensation.
• Blisters on the skin and mucous membranes.
• Increased occurrence of red, scaly, crusted areas of skin covered with silvery scales.
• Red, shiny skin nodules.
• Small spots on mucous membranes.
• Dark red, sharply demarcated, scaly patches on the skin.
• Smell disorders.
• Hair loss.
• Concentrated urine (dark-coloured), nausea or vomiting, muscle cramps, confusion and seizures, which may result from abnormal ADH (antidiuretic hormone - vasopressin) secretion. If any of these symptoms occur, you should contact your doctor immediately.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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: [email protected].
Reporting side effects helps provide more information on the safety of this medicine.
Side effects can also be reported to the responsible entity.

5. How to store Ramve 2,5 mg

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box and blister pack following "EXP". The expiry date refers to the last day of the stated 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. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Ramve contains

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

Additionally, the capsule shells contain:
Ramve 2.5 mg contains colourants: sunset yellow (E 110), cochineal red (E 124), and carmoisine (E 122).
Ramve 5 mg contains colourants: cochineal red (E 124), brilliant blue (E 133), and carmoisine (E 122).
Ramve 10 mg contains colourants: 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 – brownish-red and white capsules.
Ramve 10 mg – blue and white capsules.
Ramve is available in packs containing 28 capsules.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Recordati Polska sp. z o.o.
ul. Królewska 16
00-103 Warsaw
Poland

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 authorised in 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