Ramistad 10

Package leaflet: Information for the patient

Ramistad 2.5, 2.5 mg, tablets
Ramistad 5, 5 mg, tablets
Ramistad 10, 10 mg, tablets
( Ramiprilum )
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet contents

1. What Ramistad is and what it is used for
2. What you need to know before taking Ramistad
3. How to take Ramistad
4. Possible side effects
5. How to store Ramistad
6. Contents of the pack and other information

1. What Ramistad is and what it is used for

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

• reducing the production of substances that can raise blood pressure,
• reducing tension and widening blood vessels,
• helping the heart to pump blood through the body.

Ramistad may be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening of kidney function (in patients with or without diabetes),
• to treat heart failure (when the heart does not pump enough blood to meet the body's needs),
• to treat heart conditions following a heart attack complicated by heart failure.

2. Information before using Ramistad

When not to use Ramistad

• If the patient is allergic to ramipril, any other medicine in the ACE inhibitor class, 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 lips, face, throat or tongue.

• If the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on hands,
  feet and throat, swelling of the throat and tongue, swelling around the eyes and mouth, difficulty breathing
  and swallowing.

• If the patient has undergone dialysis or another type of blood filtration. Depending on the type of equipment used, Ramistad may not be suitable.

• If the patient has kidney disease associated with reduced blood flow to the kidneys (renal artery stenosis).

• During the last 6 months of pregnancy (see section "Pregnancy and breastfeeding" below). If blood pressure is very low or unstable. The doctor should assess blood pressure.

• If the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren.

• If the patient has taken or is currently using sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

Do not use Ramistad if any of the above situations apply.
If in doubt about using this medicine, contact your doctor before starting treatment with Ramistad.
Warnings and precautions
Before starting Ramistad, discuss with your doctor or pharmacist if:

• the patient has heart, liver or kidney disease,
• the patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets) or dialysis),
• the patient is to undergo treatment to reduce allergic reactions to bee or wasp venom (desensitisation),
• the patient is to receive medicines used in anaesthesia. These may be used during surgical or dental procedures. It may be necessary to stop treatment with Ramistad one day before the procedure; consult your doctor if in doubt,
• the patient has high potassium levels in the blood (shown in blood test results),
• if the patient is taking medicines or has symptoms that may lower sodium levels in the blood. The doctor may perform regular blood tests, especially to check blood sodium levels, particularly in elderly patients,
• If the patient is taking any of the following medicines, the risk of angioedema (sudden swelling under the skin, e.g. in the throat) may increase:
  • racecadotril, a medicine used to treat diarrhoea;
  • medicines used to prevent organ transplant rejection (e.g. everolimus, sirolimus) or to treat cancer (e.g. temsirolimus);
  • vildagliptin, a medicine used to treat diabetes.
• the patient has been diagnosed with a collagen disease such as scleroderma or systemic lupus erythematosus,
• if the patient is taking any of the following medicines for high blood pressure:
  • an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
  • aliskiren.

The treating 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 use Ramistad".
Inform your doctor if you suspect (or are planning) pregnancy. Use of Ramistad is not recommended during the first 3 months of pregnancy. Use after the third month of pregnancy may seriously harm the unborn child (see section "Pregnancy and breastfeeding" below).
Children and adolescents
Ramistad is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of ramipril have not been established in this age group.
If any of the above situations apply (or if you have any doubts), contact your doctor before starting treatment with Ramistad.
Ramistad with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Ramistad may affect the action of other medicines, and other medicines may affect the action of Ramistad.
Inform your doctor if the patient is taking any of the following medicines. These may weaken the effect of Ramistad:

• Painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [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. Blood pressure monitoring by the doctor will be necessary.

Inform your doctor if the patient is taking any of the following medicines. These may increase the risk of side effects when used together with Ramistad:

• Painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as ibuprofen or indomethacin, and acetylsalicylic acid)
• Medicines used in cancer treatment (chemotherapy)
• Medicines to prevent organ transplant rejection, such as cyclosporine
• Diuretics (water tablets), such as furosemide
• Medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin (a blood-thinning medicine)
• Steroidal anti-inflammatory medicines, such as prednisolone
• Allopurinol (used to reduce uric acid levels in the blood)
• Procainamide (used for heart rhythm disorders)
• mTOR inhibitors (e.g. temsirolimus in cancer treatment, everolimus or sirolimus to prevent organ transplant rejection), see section "Warnings and precautions"
• Vildagliptin (used to treat type 2 diabetes), see section "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 for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots)

Inform your doctor if the patient is taking any of the following medicines. Their effect may be altered when taking Ramistad:

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

The treating doctor may need to adjust the dose and/or take other precautions:

• If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under "When not to use Ramistad" and "Warnings and precautions").

Ramistad with food, drink and alcohol

• Drinking alcohol while taking Ramistad may cause dizziness and a feeling of faintness. Consult your doctor if in doubt about how much alcohol may be consumed during treatment with Ramistad, as blood pressure-lowering medicines and alcohol may enhance each other's effects.
• Ramistad may be taken during or regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy.
Do not use Ramistad during the first 12 weeks of pregnancy and must not be used at all after week 13 of pregnancy, as its use during this period may harm the unborn child.
If pregnancy occurs while taking Ramistad, inform your doctor immediately. Before planning a pregnancy, therapy should be changed to an appropriate alternative treatment.
Breastfeeding
Do not take Ramistad during breastfeeding.
Driving and using machines
Dizziness may occur while taking Ramistad. The risk of dizziness is higher at the beginning of treatment with Ramistad and after an increase in dose. If dizziness occurs, do not drive motor vehicles or operate tools or machinery.
Ramistad contains lactose and sodium
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
Ramistad 2.5, 2.5 mg tablets contain 0.8 mg sodium (less than 1 mmol sodium (23 mg)) per tablet, which means it is considered "sodium-free".
Ramistad 5, 5 mg tablets contain 1.44 mg sodium (less than 1 mmol sodium (23 mg)) per tablet, which means it is considered "sodium-free".
Ramistad 10, 10 mg tablets contain 2.89 mg sodium (less than 1 mmol sodium (23 mg)) per tablet, which means it is considered "sodium-free".

3. How to use Ramistad

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, you should contact your doctor or pharmacist.
How to take the medicine
Take this medicine orally, every day at the same time.
The tablets should be swallowed whole with liquid.
Do not crush or chew the tablets.
Recommended dose
Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose until blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water tablets), your doctor may recommend stopping or reducing them before starting Ramistad.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may then recommend increasing the dose.
• The usual maintenance dose is usually 10 mg once daily.

Treatment to reduce or delay worsening of kidney function

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

Treatment of heart failure

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

Treatment after heart attack

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

Elderly patients
Your doctor will recommend a lower starting dose and gradually adjust it.
Taking more Ramistad than prescribed
Contact your doctor immediately or go to the nearest hospital emergency department.
Do not drive yourself—ask someone to take you to the hospital or call an ambulance.
Bring the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Ramistad

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

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Ramistad immediately and contact your doctor without delay – urgent medical attention may be required:

• Swelling of the face, lips or throat, making swallowing or breathing difficult, 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 pre-existing skin disorders, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Seek immediate medical advice if any of the following occur:

• Rapid heartbeat, irregular or forceful heartbeats (palpitations), chest pain, feeling of pressure in the chest, or more serious conditions such as heart attack or stroke.
• Shortness of breath or cough. These may indicate lung-related disorders.
• Easy bruising, prolonged bleeding time, unusual bleeding (e.g. bleeding gums), purplish spots on the skin, or increased frequency of infections, sore throat and fever, fatigue, weakness, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
• Severe upper abdominal pain which may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders such as hepatitis or liver damage.

Other adverse reactions
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.
Common (occur in up to 1 in 10 patients)

• Headache or feeling of fatigue.
• Dizziness. The risk of experiencing dizziness is higher at the beginning of Ramistad treatment and after dose increases.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
• Abdominal pain, diarrhoea, indigestion, nausea or vomiting.
• Rash with raised skin areas or without.
• Chest pain.
• Muscle cramps or muscle pain.
• Increased potassium levels in blood, detected in laboratory tests.

Uncommon (occur in up to 1 in 100 patients)

• Balance disorders (vestibular dizziness).
• Itching and sensory disturbances such as numbness, tingling, pricking, burning or creeping sensations of the skin (paresthesia).
• Loss or disturbances of taste.
• Sleep disturbances.
• Depression, anxiety, nervousness or motor restlessness.
• Nasal congestion, breathing difficulties or worsening of asthma.
• Intestinal swelling known as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dryness of the oral mucosa.
• Increased urine output.
• Excessive sweating.
• Loss of or reduced appetite (anorexia).
• Rapid or irregular heartbeat, swelling of hands and feet. These may be symptoms of fluid retention.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased number of certain white blood cells (eosinophilia), detected in blood tests.
• Liver, pancreas or kidney function disorders, detected in blood tests.

Rare (occur in up to 1 in 1,000 patients)

• Feeling of disorientation, confusion.
• Redness and swelling of the tongue.
• Severe skin peeling, itchy nodular rash.
• Nail disorders (e.g. loosening or separation of the nail from the nail bed).
• Skin rash or development of bruises.
• Skin spots and cold extremities.
• Redness, itching, swelling or watering of the eyes.
• Hearing disturbances and ringing in the ears.
• Weakness.
• Decreased number of red blood cells, white blood cells or platelets, or decreased hemoglobin concentration, detected in blood tests.

Very rare (occur in up to 1 in 10,000 patients)

• Photosensitivity (increased sensitivity to sunlight).

Other reported adverse reactions / frequency unknown (frequency cannot be estimated from available data):
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.

• Difficulty concentrating
• Swelling of the mouth
• Low blood cell count, detected in blood tests
• Decreased sodium concentration, detected in blood tests
• Change in finger color upon cold exposure, accompanied by tingling or pain upon warming (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Smell disturbances
• Hair loss
• Concentrated urine (dark-colored), nausea or vomiting, muscle cramps, confusion and seizures, which may result from abnormal ADH secretion (antidiuretic hormone). If any of these symptoms occur, contact your doctor immediately.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ramistad

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the package and other information

What Ramistad contains:

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

What Ramistad looks like and contents of the pack:

• 2.5 mg tablet: flat, yellow, capsule-shaped tablet with a break line on one side and printed with the code R2.
• 5 mg tablet: flat, pink, capsule-shaped tablet with a break line on one side and printed with the code R3.
• 10 mg tablet: flat, white, capsule-shaped tablet with a break line on one side and printed with the code R4.

Available packs: Aluminium/PVC/Aluminium/OPA blisters in a cardboard box containing 28 tablets.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Belgium Ramipril EG 2.5 mg / 5 mg / 10 mg tabletten
Ireland Ramitace 2.5 mg / 5 mg / 10 mg Tablets
Italy Ramipril EG 2.5 mg / 5 mg / 10 mg compresse
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 tablett
The above leaflet does not contain all information about this medicinal product. For more detailed information, please consult your doctor or pharmacist.