Ramipril and amlodipine EG: detailed information

Patient Information Leaflet

Ramipril and Amlodipine 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
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Ramipril and Amlodipine EG is and what it is used for
What you need to know before taking Ramipril and Amlodipine EG
How to take Ramipril and Amlodipine EG
Possible side effects
How to store Ramipril and Amlodipine EG
Contents of the pack and other information

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

Ramipril and Amlodipine EG contains two active substances: 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 to treat hypertension (high blood pressure) in patients whose
blood pressure is adequately controlled with amlodipine and ramipril taken together at the same dose as in Ramipril and Amlodipine EG, but as separate medicines.

2. What you should know before taking Ramipril and Amlodipine EG

DO NOT take Ramipril and Amlodipine EG:

if you are allergic to ramipril, amlodipine (active substances), other ACE inhibitors, or any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include itching, skin redness, or difficulty breathing;
if you have ever had a severe allergic reaction known as “angioedema”. Signs include itching, hives, red spots on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
if you are on dialysis or undergoing any other type of blood filtration. Depending on the machine 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 containing aliskiren to lower blood pressure;
if your blood pressure is unusually low or unstable. Your doctor will need to assess this;
if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
if you have heart failure following a heart attack;
if you have taken or are currently 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, such as in the throat).

Do not take Ramipril and Amlodipine EG if any of the above apply to you. If you are unsure, consult 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. Inform your doctor if any of the conditions listed below apply to you. If:

you have heart, liver, or kidney problems;
you have lost significant amounts of salts or body fluids due to illness (such as vomiting), diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretic tablets (diuretics), or dialysis;
you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation);
you are about to receive an anaesthetic. This may be administered during surgery or dental procedures. You may need to stop taking Ramipril and Amlodipine EG one day beforehand; consult your doctor for further information;
you have high levels of potassium in your blood (shown by a blood test);
you are taking medicines or have conditions that may reduce sodium levels in your blood. Your doctor may prescribe regular blood tests primarily to monitor your blood sodium levels, especially if you are elderly;
you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin, such as in the throat) may be increased:
o medicines used to prevent rejection of transplanted organs and to treat cancer (medicines belonging 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;
you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus;
you are taking any of the following medicines used to treat high blood pressure:
o an angiotensin II receptor blocker (also known as a sartan – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
o aliskiren;
your blood pressure is severely elevated (hypertensive crisis);
you are elderly and your dosage needs to be increased;
you develop a persistent dry cough; or your blood pressure has not decreased sufficiently. Medicines of this type appear to be less effective in people of Black origin.

Your doctor may check your kidney function, blood pressure, and levels 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, and possibly hands and feet swell suddenly, and you experience difficulty swallowing or breathing, hives, or hoarseness ("angioedema"): these could be signs of a severe allergic reaction. These may occur at any time during treatment. People with Black skin may be at higher risk of developing this condition. If you develop any of these symptoms, contact your doctor immediately.
Children and adolescents
Ramipril and Amlodipine EG is not recommended for use in children and adolescents under 18 years of age, as there is insufficient information available for this population.
Other medicines and Ramipril and Amlodipine EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines. They may make Ramipril and Amlodipine EG less effective:

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 monitor your blood pressure;
rifampicin (an antibiotic used to treat tuberculosis);
St John's wort (Hypericum perforatum – used to treat depression).

Inform your doctor if you are taking any of the following medicines. They may increase the likelihood of experiencing side effects when taken 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 belonging 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;
diuretic tablets (diuretics) such as furosemide;
potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride, and other medicines that may increase potassium levels in the blood such as trimethoprim and cotrimoxazole (also known as trimethoprim/sulfamethoxazole) used to treat bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting;
steroids used to treat 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 used to treat heart conditions or high blood pressure);
dantrolene (infusion for severe body temperature disturbances);
vildagliptin (for the treatment of diabetes);
racecadotril (for the treatment of diarrhoea).

Your doctor may consider it necessary to adjust your dosage and/or take other precautions:

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

Inform your doctor if you are taking any of the following medicines. Their effects may be altered by Ramipril and Amlodipine EG:

medicines for diabetes, such as oral glucose-lowering medicines and insulin. Ramipril and Amlodipine EG may lower blood sugar levels. Monitor your blood sugar levels closely while taking Ramipril and Amlodipine EG;
lithium (for mental health conditions). Ramipril and Amlodipine EG may increase lithium levels in the blood. Your doctor will need to closely monitor your blood lithium levels;
simvastatin (a medicine to lower cholesterol). Ramipril and Amlodipine EG may increase simvastatin levels in the blood.

If any of the above apply to you (or if you are unsure), discuss this with 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 a light-headed feeling. If you are concerned about how much alcohol you can drink while taking Ramipril and Amlodipine EG, talk to your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
People taking Ramipril and Amlodipine EG must not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of Ramipril and Amlodipine EG.
Pregnancy, breastfeeding and fertility
Pregnancy
Ramipril and Amlodipine EG must 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, inform your doctor immediately. You should switch to an alternative treatment before planning a pregnancy.
Breastfeeding
If you are breastfeeding, you must not take Ramipril and Amlodipine EG.
Amlodipine, one of the two active ingredients in Ramipril and Amlodipine EG, passes into breast milk in small amounts. Before taking Ramipril and Amlodipine EG, inform your doctor if you are breastfeeding or intend to breastfeed your baby.
Fertility
There are insufficient data on potential effects on fertility.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ramipril and Amlodipine EG may impair your ability to drive vehicles or operate machinery. If Ramipril and Amlodipine EG causes you discomfort, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately. This is particularly likely at the beginning of treatment or when switching from another therapy.

3. How to take Ramipril and Amlodipine EG

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you feel that the effect of Ramipril and Amlodipine EG is too strong or too weak, consult your doctor or pharmacist.
Method of administration
Take the medicine orally at the same time each day, with or without food.
Swallow the capsule whole with liquid.
Do not take Ramipril and Amlodipine EG with grapefruit juice.
Dosage
Your doctor will determine the most appropriate dosage for you.
The maximum daily dose is 1 capsule of Ramipril and Amlodipine EG 10 mg/10 mg (containing the combination of 10 mg ramipril and 10 mg amlodipine).
Ramipril and Amlodipine EG should be taken once daily.
Use in children and adolescents
Ramipril and Amlodipine EG is not recommended for use in children and adolescents under 18 years of age, as there is no available information in this population.
If you take more Ramipril and Amlodipine EG than you should
Taking too many capsules may cause a lowering or dangerously low drop in blood pressure. You may experience dizziness, lightheadedness, fainting, or feel weak. If the drop in blood pressure is particularly severe, shock may occur. Your skin may become cold and clammy, and you may lose consciousness. Contact your doctor immediately or go immediately to the nearest hospital. Do not drive to the hospital; have someone drive you or call an ambulance. Take the medicine package with you so the doctor knows what you have taken.
If you forget to take Ramipril and Amlodipine EG
If you forget to take a capsule, skip that dose completely. Take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Ramipril and Amlodipine EG
Your doctor will inform you how long you should take this medicine. If you stop treatment before being instructed to do so, your condition may return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following serious side effects, stop treatment with Ramipril and Amlodipine EG and consult your doctor immediately – you may need urgent medical treatment:

swelling of the face, lips or throat which may cause difficulty swallowing or breathing, together with itching and skin rashes. These could be signs of a severe allergic reaction to Ramipril and Amlodipine EG;
severe skin reactions, including rashes, mouth ulcers, worsening of pre-existing skin disease, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), or other allergic reactions. These side effects are classified as frequency not known (frequency cannot be determined from the available data).

Contact your doctor immediately if you experience:

rapid, irregular or strong heartbeat (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke. The frequency of these side effects is common (palpitations), uncommon (chest pain, chest tightness, rapid heartbeat, heart attack) or not known (stroke);
shortness of breath or cough. These effects are common and may indicate lung problems;
increased tendency to bruise, bleeding that lasts longer than usual, any sign of bleeding (e.g. bleeding gums), purple spots, skin patches, or increased susceptibility to infections, sore throat and fever, feeling tired, weakness, dizziness or paleness. These are rare side effects and may indicate blood or bone marrow problems;
severe stomach pain that may radiate to the back. This could 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 side effects have a frequency not known.

Other side effects
Inform your doctor if any of the following side effects become severe or persist for more than a few days.
Very common (may affect more than 1 in 10 people)

swollen ankles (oedema).

Common (may affect up to 1 in 10 people)

drowsiness (especially at the beginning of treatment);
palpitations (awareness of a fast or strong heartbeat), hot flushes;
headache or feeling tired;
dizziness – this may occur especially at the start of treatment with Ramipril and Amlodipine EG or when the dose is increased;
fainting, hypotension (abnormally low blood pressure), particularly when standing up or sitting down quickly;
dry, persistent cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath;
abdominal pain, stomach ache or discomfort, diarrhoea, indigestion, feeling unwell or malaise, changes in bowel habits (including diarrhoea or constipation), heartburn;
skin rash with or without swelling;
chest pain;
weakness;
muscle cramps or muscle pain;
blood tests showing abnormally high levels of potassium in the blood.

Uncommon (may affect up to 1 in 100 people)

mood changes, insomnia;
tremors, pain, feeling unwell;
visual disturbances, double vision, blurred vision;
ringing in the ears;
cold or runny nose due to inflammation of the nasal mucosa (rhinitis);
dry mouth;
hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration;
problems with urination, increased need to urinate, especially at night, increased frequency of urination;
inability to achieve erection, sexual dysfunction in men, reduced sexual desire in men or women;
discomfort or enlargement of the breasts in men;
joint or muscle pain, back pain;
weight gain or weight loss;
balance problems (dizziness);
itching and unusual skin sensations such as numbness, tingling, prickling, burning or chills (paraesthesia), loss of sensitivity to pain;
loss or change in taste sensation;
sleep problems;
feeling depressed, anxious, more nervous than usual or restless;
stuffy nose, difficulty breathing or worsening of asthma;
intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea;
loss or decrease in appetite (anorexia);
increased or irregular heartbeat;
swollen arms and legs – this could indicate your body is retaining more fluid than normal;
fever;
increase in a certain type of white blood cells (eosinophilia), detected during a blood test;
blood tests showing changes in liver, pancreas or kidney function.

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

sensation of trembling or confusion;
red or swollen tongue;
severe peeling or flaking of the skin, itching, skin rash with swelling;
nail problems (e.g. loss or separation of a nail from the nail bed);
skin rash or bruising;
inflammation of blood vessels, often associated with skin rash;
urticaria (hives);
skin patches and coldness in the extremities;
red, itchy, swollen or watery eyes;
hearing problems;
blood tests showing a reduction in the number of red blood cells, white blood cells, platelets or haemoglobin levels.

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

increased sensitivity to sunlight;
abnormally high blood sugar levels (hyperglycaemia);
swollen gums;
abdominal swelling (gastritis);
liver function abnormalities, liver inflammation (hepatitis), yellowing of the skin (jaundice);
increased muscle tension;
light sensitivity;
movement disorders combining rigidity, tremors and/or movement disturbances.

Not known (frequency cannot be determined from the available data)

concentrated urine (dark in colour), feeling unwell or malaise, muscle cramps, confusion and seizures 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 shuffling, unbalanced gait.

Other reported side effects
Inform your doctor if any of the following side effects become severe or persist for more than a few days:

difficulty concentrating;
blood tests showing abnormally low levels of blood cells;
blood tests showing abnormally low levels of sodium in the blood;
fingers of the hands and feet changing colour when cold, followed by tingling or painful sensations when warming up (Raynaud's phenomenon);
slowed or altered reactions;
changes in the perception of smells;
psoriasis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Amlodipine EG

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

6. Package contents and other information

What Ramipril and Amlodipine EG contains

The active substances are: Each capsule contains 5 mg of ramipril and amlodipine besylate equivalent to 5 mg of amlodipine. Each capsule contains 5 mg of ramipril and amlodipine besylate equivalent to 10 mg of amlodipine. Each capsule contains 10 mg of ramipril and amlodipine besylate equivalent to 5 mg of amlodipine. Each capsule contains 10 mg of ramipril and amlodipine besylate equivalent to 10 mg of amlodipine.
Other components are: microcrystalline cellulose, hypromellose, crospovidone type B, glycerol dibehenate
Capsule cap/body: gelatin, titanium dioxide (E171), indigo carmine (E132)

Description of the appearance of Ramipril and Amlodipine EG and contents of the pack
Hard gelatin capsules, light blue in colour. The contents consist of a white or almost white powder or slightly compacted agglomerates; capsule size is approximately 15.9 mm x 5.8 mm (no. 3).
Hard gelatin capsules, with white body and blue cap. The contents consist of a white or almost white powder or slightly compacted agglomerates; capsule size is approximately 19.4 mm x 6.9 mm (no. 1).
Hard gelatin capsules, with white body and white cap. The contents consist of a white or almost white powder or slightly compacted agglomerates; capsule size is approximately 19.4 mm x 6.9 mm (no. 1).
Hard gelatin capsules, blue in colour. The contents consist of a white or almost white powder or slightly compacted agglomerates; capsule size 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, Italy

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 Wien (Austria)

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Ramipril/Amlodipin STADA 5 mg/5 mg Hartkapseln
Ramipril/Amlodipin STADA 5 mg/10 mg Hartkapseln
Ramipril/Amlodipin STADA 10 mg/5 mg Hartkapseln
Ramipril/Amlodipin STADA 10 mg/10 mg Hartkapseln
Belgium: Ramipril/ Amlodipine EG 5mg/5mg harde capsules
Ramipril/ Amlodipine EG 5mg/10mg harde capsules
Ramipril/ Amlodipine EG 10 mg/5 mg harde capsules
Ramipril/ Amlodipine EG 10 mg/10 mg harde capsules
Germany: Ramipril/Amlodipin AL 5 mg/5 mg Hartkapseln
Ramipril/Amlodipin AL 5 mg/10 mg Hartkapseln
Ramipril/Amlodipin AL 10 mg/5 mg Hartkapseln
Ramipril/Amlodipin AL 10 mg/10 mg Hartkapseln
Italy: Ramipril e Amlodipina EG
Luxembourg: Ramipril/ Amlodipine EG 5mg/5mg gélules
Ramipril/ Amlodipine EG 5mg/10mg gélules
Ramipril/ Amlodipine EG 10 mg/5 mg gélules
Ramipril/ Amlodipine EG 10 mg/10 mg gélules
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