RAMIPRIL 5 mg/5 mg Hard Capsule

Зміст інструкції

1. Ramipril e Amlodipina EG 5 mg/5 mg hard capsules, 5 mg/10 mg hard capsules, 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules
   1. What is Ramipril and Amlodipine EG and what it is used for
   2. What you need to know before taking Ramipril and Amlodipine EG
   3. How to take Ramipril and Amlodipine EG
   4. Possible side effects
   5. How to store Ramipril and Amlodipina EG
   6. Package contents and other information

Ramipril e Amlodipina EG 5 mg/5 mg hard capsules, 5 mg/10 mg hard capsules, 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Ramipril and Amlodipine EG and what it is used for

Ramipril and Amlodipine EG contains two active ingredients: ramipril and amlodipine. Ramipril belongs to a
group of medicines known as ACE inhibitors (angiotensin converting enzyme inhibitors).
Amlodipine belongs to a group of medicines called calcium antagonists.
Ramipril works by:

• reducing the body's production of substances that can raise blood pressure;
• relaxing and widening blood vessels;
• making it easier for the heart to pump blood around the body.

Amlodipine works by:

• relaxing and widening blood vessels so that blood can flow more easily.

Ramipril and Amlodipine EG is used for the treatment of hypertension (high blood pressure), in patients whose
blood pressure is adequately controlled with amlodipine and ramipril taken simultaneously
at the same dose as in Ramipril and Amlodipine EG, but as separate medicines.

2. What you need to know before taking Ramipril and Amlodipine EG

DO NOT take Ramipril and Amlodipine EG:

• if you are allergic to ramipril, amlodipine (active ingredients), other ACE inhibitors or any other calcium channel blocker, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction can include itching, skin redness or difficulty breathing;
• if you have ever had a serious allergic reaction called “angioedema”. The signs include itching, hives, red patches on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine being used, Ramipril and Amlodipine EG may not be suitable for you;
• if you have kidney problems caused by reduced blood flow to the kidneys (renal artery stenosis);
• during the last 6 months of pregnancy (see the section below "Pregnancy and breastfeeding");
• if you have diabetes or kidney problems and are taking medicines that contain aliskiren to lower your blood pressure;
• if your blood pressure is unusually low or unstable. Your doctor will need to make this assessment;
• if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body);
• if you suffer from heart failure following a heart attack;
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Do not take Ramipril and Amlodipine EG if any of the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Ramipril and Amlodipine EG.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril and Amlodipine EG. Tell your doctor if any of the following applies to you:

• if you have problems with your heart, liver or kidneys;
• if you have lost a lot of salts or fluids from your body due to an illness (such as vomiting), diarrhoea, excessive sweating, or following a low-salt diet, or if you have been taking water tablets (diuretics) for a long time or have undergone dialysis;
• if you are about to undergo treatment to reduce your allergy to bee or wasp stings (desensitisation);
• if you are going to receive an anaesthetic. This may be given for surgery or dental work. You may need to stop taking Ramipril and Amlodipine EG one day before; for more information, ask your doctor;
• if you have a high level of potassium in your blood (shown by a blood test);
• if you are taking medicines or have conditions that can reduce the levels of sodium in your blood. Your doctor may prescribe regular blood tests mainly to monitor the levels of sodium in your blood, especially if you are elderly;
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased: o medicines used to prevent organ rejection and to treat cancer (medicines that belong to the class of mTOR inhibitors, such as temsirolimus, sirolimus, everolimus), o vildagliptin, a medicine used to treat diabetes, o racecadotril, a medicine used to treat diarrhoea;
• if you have a connective tissue disease such as scleroderma or systemic lupus erythematosus;
• if you are taking any of the following medicines used to treat high blood pressure: o an angiotensin II receptor blocker (also known as a sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, o aliskiren;
• if your blood pressure is severely increased (hypertensive crisis);
• if you are elderly and your dosage needs to be increased;
• if you experience a dry cough that persists for a long time; or if your blood pressure has not lowered sufficiently. Medicines of this type seem to be less effective in people of colour.

Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “DO NOT take Ramipril and Amlodipine EG”.
If your lips and face, tongue and throat, neck, possibly also hands and feet suddenly swell, you experience difficulty swallowing or breathing, hives or hoarseness ('angioedema'): these could be signs of a serious allergic reaction. These can occur at any time during treatment. People of black skin may be more at risk of developing this condition. If you develop any of these symptoms, seek immediate medical attention.
Children and adolescents
Ramipril and Amlodipine EG is not recommended for use in children and adolescents under the age of 18 years, as there is no data available in this population.

Other medicines and Ramipril and Amlodipine EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines. They may make Ramipril and Amlodipine EG work less well:

• medicines used to relieve pain and inflammation, e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin or 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 check your blood pressure;
• rifampicin (an antibiotic for the treatment of tuberculosis);
• St John's wort (Hypericum perforatum- used to treat depression).

Tell your doctor if you are taking any of the following medicines. They may increase the likelihood of experiencing side effects if you take them with Ramipril and Amlodipine EG:

• erythromycin, clarithromycin (antibiotics - used to treat bacterial infections);
• medicines mostly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines that belong to the class of mTOR inhibitors). See section “Warnings and precautions”;
• medicines used to relieve pain and inflammation, e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin or acetylsalicylic acid;
• water tablets (diuretics) such as furosemide;
• potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride and other medicines that may increase the amount of potassium in your blood such as trimethoprim and co-trimoxazole (also known as trimethoprim/sulfamethoxazole) for treating bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots;
• steroids for treating inflammation such as prednisolone;
• allopurinol (used to lower uric acid levels in the blood);
• procainamide (for heart rhythm problems);
• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors, used to treat HIV);
• verapamil, diltiazem (medicines for treating heart disorders or high blood pressure);
• dantrolene (infusion for severe temperature alterations);
• vildagliptin (for the treatment of diabetes);
• racecadotril (for the treatment of diarrhoea).

Your doctor may consider it appropriate to adjust the dosage and/or take other precautions:

• if you are taking an angiotensin II receptor blocker or aliskiren (see also the sections “DO NOT take Ramipril and Amlodipine EG” and “Warnings and precautions”).

Tell your doctor if you are taking any of the following drugs. Their action may be modified by Ramipril and Amlodipine EG:

• medicines for diabetes, such as oral medicines to lower blood glucose levels and insulin. Ramipril and Amlodipine EG may lower your blood sugar level. Carefully monitor your blood sugar level while taking Ramipril and Amlodipine EG;
• lithium (for mental health problems). Ramipril and Amlodipine EG may raise the level of lithium in your blood. Your doctor will need to check your lithium levels closely;
• simvastatin (a medicine to lower cholesterol). Ramipril and Amlodipine EG may raise the level of simvastatin in your blood.

If any of the above applies to you (or if you are not sure), talk to your doctor or pharmacist before taking Ramipril and Amlodipine EG.

Ramipril and Amlodipine EG with food, drinks and alcohol
Ramipril and Amlodipine EG can be taken with or without food.
Drinking alcohol with Ramipril and Amlodipine EG may cause dizziness or lightheadedness. If you are concerned about how much you can drink while taking Ramipril and Amlodipine EG, talk to your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
People taking Ramipril and Amlodipine EG should not consume grapefruit or grapefruit juice, as grapefruit and its juice can increase the levels of the active ingredient amlodipine in the blood, which may lead to an unpredictable increase in the hypotensive effect of Ramipril and Amlodipine EG.

Pregnancy, breastfeeding and fertility
Pregnancy
Ramipril and Amlodipine EG should not be taken during the second and third trimesters of pregnancy. The medicine is not recommended during the first trimester of pregnancy.
If you become pregnant while taking Ramipril and Amlodipine EG, tell your doctor immediately. You should switch to an alternative treatment before planning a pregnancy.
Breastfeeding
If you are breastfeeding, you should not take Ramipril and Amlodipine EG.
Amlodipine, one of the two active ingredients of Ramipril and Amlodipine EG, passes into breast milk in small amounts. Before taking Ramipril and Amlodipine EG, tell your doctor if you are breastfeeding or intend to breastfeed your baby.
Fertility
There is insufficient data regarding potential effects on fertility.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Ramipril and Amlodipine EG may impair your ability to drive or operate machinery. If Ramipril and Amlodipine EG makes you feel unwell, dizzy or tired or gives you a headache, do not drive or operate machinery and contact your doctor immediately. This is especially likely at the beginning of treatment or when switching from another therapy.

3. How to take Ramipril and Amlodipine EG

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
If you feel that the effect of Ramipril and Amlodipine EG is too strong or too weak, ask your
doctor or pharmacist.

Method of administration
Take the medicine by mouth always at the same time of day, before or after meals.
Swallow the capsule whole with liquids.
Do not take Ramipril and Amlodipine EG with grapefruit juice.

Dosage
The doctor will establish the best dosage for you.
The maximum daily dose is equal to 1 capsule of Ramipril and Amlodipine EG 10 mg/10 mg (which contains
the association of 10 mg of ramipril and 10 mg of amlodipine).
Ramipril and Amlodipine EG must be taken once a day.

Use in children and adolescents
Ramipril and Amlodipine EG is not recommended for use in children and adolescents under the age of
18 years, as there is no information available on this population.

If you take more Ramipril and Amlodipine EG than you should
Taking too many capsules can cause a lowering or a dangerous lowering of blood
pressure. You may experience dizziness, lightheadedness, fainting or feel weak. If the drop in blood pressure is particularly
severe, shock may occur. The skin may become cold and clammy and you may lose
consciousness. Inform your doctor immediately or go immediately to the nearest hospital. Do not drive
to go to the hospital, but have someone accompany you or call an ambulance. Bring the package of the
medicine with you so that the doctor knows what you have taken.

If you forget to take Ramipril and Amlodipine EG
If you forget to take a capsule, completely skip that dose. Take the next dose at the usual
time. Do not take a double dose to make up for the missed dose.

If you stop taking Ramipril and Amlodipine EG
The doctor will inform you how long you should take this medicine. If you stop treatment
before being told to do so, your condition may recur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

If you notice any of the following serious side effects, stop taking Ramipril and
Amlodipina EG and consult your doctor immediately - you may need urgent medical
treatment:

• swelling of the face, lips or throat that can cause difficulty swallowing or breathing, as well as itching and skin rashes. These could be signs of a severe allergic reaction to Ramipril and Amlodipina EG;
• severe skin reactions, including rashes, ulcers in the mouth, worsening of a pre-existing skin condition, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions. The above side effects are classified as having an unknown frequency (frequency cannot be estimated based on available data).

Consult your doctor immediately if you experience:

• a fast, irregular or strong heartbeat (palpitations), chest pain, a feeling of tightness in the chest, or more serious problems including heart attack and stroke. The frequency of these side effects is common (palpitations), uncommon (chest pain, feeling of tightness in the chest, fast heart rate, heart attack) or unknown (stroke);
• shortness of breath or cough. These effects are common and may be indicative of lung problems;
• an increased tendency to bruise, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots, blotches on the skin or an increased tendency to infections, sore throat and fever, feeling tired, weak, dizzy or pale. These are rare side effects and may be signs of problems with the blood or bone marrow;
• severe stomach pain that may radiate to the back. This may be a sign of pancreatitis (inflammation of the pancreas). This is an uncommon side effect;
• fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (liver inflammation) or liver damage. These are side effects with an unknown frequency.

Other side effects
Tell your doctor if any of the following side effects becomes serious or lasts more than a few days.

Very common(may affect more than 1 in 10 people)

• swollen ankles (edema).

Common(may affect up to 1 in 10 people)

• drowsiness (especially at the beginning of treatment);
• palpitations (feeling of a strong heartbeat), hot flushes;
• headache or feeling tired;
• feeling dizzy. This may happen especially at the beginning of therapy with Ramipril and Amlodipina EG or when the dose is increased;
• fainting, low blood pressure (abnormally low blood pressure), especially when getting up or sitting up quickly;
• dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
• abdominal pain, stomach pain or discomfort, diarrhea, indigestion, feeling unwell or sick, changes in bowel habits (including diarrhea or constipation), heartburn;
• skin rash with or without swelling;
• chest pain;
• weakness;
• muscle cramps or pain;
• blood tests showing too much potassium in the blood than normal.

Uncommon(may affect up to 1 in 100 people)

• mood changes, insomnia;
• tremors, pain, feeling unwell;
• vision disturbances, double vision, blurred vision;
• ringing in the ears;
• runny nose/nasal congestion caused by inflammation of the nasal mucosa (rhinitis);
• dry mouth;
• hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration;
• urination problems, increased need to urinate, especially at night, increased number of times you urinate;
• inability to achieve an erection, sexual dysfunction in men, decreased sexual desire in men or women;
• discomfort or enlargement of the breasts in men;
• joint or muscle pain, back pain;
• weight gain or loss;
• balance problems (dizziness);
• itching and unusual skin sensations such as numbness, tingling, prickling, burning or chills (paresthesia), loss of sensation to pain;
• loss or alteration of the sense of taste;
• difficulty sleeping;
• feeling depressed, anxious, more nervous than usual or restless;
• blocked nose, difficulty breathing or worsening of asthma;
• an intestinal swelling called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhea;
• loss or decrease of appetite (anorexia);
• increased or irregular heartbeat;
• swollen arms and legs. This may indicate that your body is retaining more water than normal;
• fever;
• increased number of a certain type of white blood cells (eosinophilia), detected during a blood test;
• blood tests showing changes in the function of the liver, pancreas or kidneys.

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

• feeling shaky or confused;
• red or swollen tongue;
• severe exfoliation or flaking of the skin, itching, rash with swelling;
• problems with nails (e.g. loss or separation of a nail from the nail bed);
• rash or bruising;
• inflammation of blood vessels, often associated with rash;
• hives;
• spots on the skin and coldness to the extremities;
• red, itchy, swollen or watery eyes;
• hearing impairment;
• blood tests showing a decrease in the number of red blood cells, white blood cells, platelets or hemoglobin.

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

• increased sensitivity to the sun than usual;
• excessive sugar in the blood (hyperglycemia);
• swelling of the gums;
• swelling of the stomach (gastritis);
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice);
• increased muscle tension;
• sensitivity to light;
• disorders combining rigidity, tremors and/or movement disorders.

Not known(frequency cannot be estimated based on available data)

• concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experience these symptoms, contact your doctor as soon as possible;
• tremors, rigid posture, expressionless face, slow movements and unsteady gait.

Other side effects reported
Tell your doctor if any of the following side effects becomes serious or lasts more than a few days

• difficulty concentrating;
• blood tests showing too few cells in the blood;
• blood tests showing a low amount of sodium in the blood than usual;
• fingers and toes changing color when cold and then tingling or pain when warmed up (Raynaud's phenomenon);
• slowed or altered reactions;
• alteration in the perception of smells;
• psoriasis.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Ramipril and Amlodipina EG

Store at a temperature below 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging or on the blister after the
wording “EXP.” The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ramipril and Amlodipine EG contains

• The active ingredients are: Each capsule contains 5 mg of ramipril and amlodipine besilate equivalent to 5 mg of amlodipine. Each capsule contains 5 mg of ramipril and amlodipine besilate equivalent to 10 mg of amlodipine. Each capsule contains 10 mg of ramipril and amlodipine besilate equivalent to 5 mg of amlodipine. Each capsule contains 10 mg of ramipril and amlodipine besilate equivalent to 10 mg of amlodipine.
• The other ingredients are: microcrystalline cellulose, hypromellose, crospovidone type B, dibeenate glycerol
• Capsule shell/body: gelatin, titanium dioxide (E171), indigo carmine (E132)

Description of the appearance of Ramipril and Amlodipine EG and package contents
Hard gelatin capsules, light blue in color. The contents consist of a white or almost white powder or in
slightly compacted agglomerates; the size of the capsules is approximately 15.9 mm x 5.8 mm (No. 3).
Hard gelatin capsules, with a white body and a blue cap. The contents consist of a white or
almost white powder or in slightly compacted agglomerates; the size of the capsules is approximately 19.4 mm x 6.9
mm (No. 1).
Hard gelatin capsules, with a white body and a white cap. The contents consist of a powder
white or almost white or in slightly compacted agglomerates; the size of the capsules is approximately 19.4
mm x 6.9 mm (No. 1).
Hard gelatin capsules, blue in color. The contents consist of a white or almost white powder or in
slightly compacted agglomerates; the size of the capsules is approximately 19.4 mm x 6.9 mm (No. 1).
Ramipril and Amlodipine EG is available in blisters containing 28, 30, 50, 56, 60, 98, 100, 200, 300 capsules.
For 5/5 mg: 28, 30, 50, 56, 60, 98, 100, 200, 300
For 5/10 mg: 28, 30, 50, 56, 60, 98, 100, 200, 300
For 10/5 mg: 28, 30, 50, 56, 60, 98, 100, 200, 300
For 10/10 mg: 28, 30, 50, 56, 60, 98, 100, 200, 300
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan

Manufacturer
Zakłady Farmaceutyczne POLPHARMA SA (Pharmaceutical Works POLPHARMA SA), 19 Pelplińska
Street, 83-200 Starogard Gdański (Poland)
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna (Austria)

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria: Ramipril/Amlodipin STADA 5 mg/5 mg hard capsules
Ramipril/Amlodipin STADA 5 mg/10 mg hard capsules
Ramipril/Amlodipin STADA 10 mg/5 mg hard capsules
Ramipril/Amlodipin STADA 10 mg/10 mg hard capsules
Belgium: Ramipril/ Amlodipine EG 5mg/5mg hard capsules
Ramipril/ Amlodipine EG 5mg/10mg hard capsules
Ramipril/ Amlodipine EG 10 mg/5 mg hard capsules
Ramipril/ Amlodipine EG 10 mg/10 mg hard capsules
Germany: Ramipril/Amlodipin AL 5 mg/5 mg hard capsules
Ramipril/Amlodipin AL 5 mg/10 mg hard capsules
Ramipril/Amlodipin AL 10 mg/5 mg hard capsules
Ramipril/Amlodipin AL 10 mg/10 mg hard capsules
Italy: Ramipril e Amlodipina EG
Luxembourg: Ramipril/ Amlodipine EG 5mg/5mg capsules
Ramipril/ Amlodipine EG 5mg/10mg capsules
Ramipril/ Amlodipine EG 10 mg/5 mg capsules
Ramipril/ Amlodipine EG 10 mg/10 mg capsules
United Kingdom: Ramipril/Amlodipine 5 mg/5 mg capsule, hard
Ramipril/Amlodipine 5 mg/10 mg capsule, hard
Ramipril/Amlodipine 10 mg/5 mg capsule, hard
Ramipril/Amlodipine 10 mg/10 mg capsule, hard