RAMIPRIL 2.5 mg/5 mg Hard capsules

Зміст інструкції

1. RAMIPRIL E AMLODIPINA DOC Generici 2.5 mg + 5 mg hard capsules, 5 mg + 5 mg hard capsules, 10 mg + 5 mg hard capsules, 5 mg + 10 mg hard capsules, 10 mg + 10 mg hard capsules
   1. What is RAMIPRIL E AMLODIPINA DOC Generici and what is it used for
   2. What you need to know before taking RAMIPRIL E AMLODIPINA DOC Generici
   3. How to take RAMIPRIL E AMLODIPINA DOC Generici
   4. Possible side effects
   5. How to store RAMIPRIL E AMLODIPINA DOC Generici
   6. Package Contents and Other Information
2. RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 5 mg hard capsules: hard gelatin capsules,
3. RAMIPRIL E AMLODIPINA DOC Generici 5 mg + 10 mg hard capsules: hard gelatin capsules,
4. RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 10 mg hard capsules: hard gelatin capsules,

RAMIPRIL E AMLODIPINA DOC Generici 2.5 mg + 5 mg hard capsules, 5 mg + 5 mg hard capsules, 10 mg + 5 mg hard capsules, 5 mg + 10 mg hard capsules, 10 mg + 10 mg hard capsules

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 their symptoms are the same as yours, as it could 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 DOC Generici is and what it is used for
• 2. What you need to know before you take RAMIPRIL E AMLODIPINA DOC Generici
• 3. How to take RAMIPRIL E AMLODIPINA DOC Generici
• 4. Possible side effects
• 5. How to store RAMIPRIL E AMLODIPINA DOC Generici
• 6. Contents of the pack and other information

1. What is RAMIPRIL E AMLODIPINA DOC Generici and what is it used for

RAMIPRIL E AMLODIPINA DOC Generici contains two active ingredients: amlodipine and ramipril.
Amlodipine belongs to a group of medicines called calcium antagonists. Ramipril belongs
to a group of medicines called ACE inhibitors (angiotensin converting enzyme
inhibitors).
Amlodipine works:

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

Ramipril works:

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

RAMIPRIL E AMLODIPINA DOC Generici 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 E AMLODIPINA DOC
Generici, but as separate medicines.

2. What you need to know before taking RAMIPRIL E AMLODIPINA DOC Generici

Do not take RAMIPRIL E AMLODIPINA DOC Generici:

• if you are allergic to the active ingredients, any other calcium antagonist or any other ACE inhibitor, or to any of the other components of this medicine (listed in section 6). The reaction may be itching, skin redness or difficulty breathing;
• 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 ever had a serious allergic reaction called “angioedema”. The signs 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 on dialysis or undergoing any other type of blood filtration. Depending on the machine used, RAMIPRIL E AMLODIPINA DOC Generici 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 section "Pregnancy, breastfeeding and fertility");
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• 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 E AMLODIPINA DOC Generici if any of the above cases apply to you. If
you are not sure, ask your doctor or pharmacist before taking RAMIPRIL E AMLODIPINA DOC
Generici.

Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL E AMLODIPINA DOC Generici.
Tell your doctor if any of the following cases apply to you:

• if you have a sudden increase in blood pressure (hypertensive crisis);
• if you are elderly and your dosage needs to be increased;
• if you have problems with your heart, liver or kidneys;
• if you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis);
• if you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization);
• if you are about to receive anesthesia. This may be administered for surgery or dental work. You must stop treatment with RAMIPRIL E AMLODIPINA DOC Generici one day before; for more information, consult your doctor;
• if you have a high amount of potassium in your blood (shown by a blood test);
• 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:
• an “angiotensin II receptor blocker” (AIIRA) (also known as sartans, for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes;
• aliskiren.

If you are taking any of the following medicines, the risk of angioedema may be
increased.

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

During treatment with this medicine, 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 what is stated in the section “Do not take RAMIPRIL E AMLODIPINA DOC Generici”.

Children and adolescents
The use of RAMIPRIL E AMLODIPINA DOC Generici is not recommended in children and
adolescents under the age of 18 years, because information is not available for this patient
population.

Other medicines and RAMIPRIL E AMLODIPINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the section “Do not take RAMIPRIL E AMLODIPINA DOC Generici” and “Warnings and precautions”);

Tell your doctor if you are taking any of the following medicines, because they may make
RAMIPRIL E AMLODIPINA DOC Generici work less well:

• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin);
• medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine or adrenaline. Your doctor will need to check your blood pressure;
• rifampicin (an antibiotic used to treat tuberculosis); erythromycin, clarithromycin (antibiotics)
• hypericum perforatum(St. John's wort used to treat depression). Tell your doctor if you are taking any of the following medicines, because they may increase the likelihood of experiencing side effects if you take them with RAMIPRIL E AMLODIPINA DOC Generici:
• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin);
• cancer medicines (chemotherapy) such as temsirolimus;
• diuretics such as furosemide;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene and amiloride) and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating

infections caused by bacteria; cyclosporine, an immunosuppressant used to
prevent rejection of transplanted organs; and heparin, a medicine used to thin the
blood and prevent the formation of clots);

• steroid medicines for 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 (so-called protease inhibitors, used to treat HIV);
• erythromycin, clarithromycin (medicines for treating bacterial infections);
• verapamil, diltiazem (medicines for treating heart problems or high blood pressure);
• vildagliptin (oral medicine that lowers glucose levels);
• dantrolene (infusion medicine for severe temperature alterations);
• everolimus (to prevent organ rejection);
• tacrolimus (used to control the immune response, to allow the body to accept the transplanted organ).

Tell your doctor if you are taking any of the following medicines, because their action
may be altered by RAMIPRIL E AMLODIPINA DOC Generici:

• medicines for diabetes, such as oral medicines to lower blood sugar levels and insulin. RAMIPRIL E AMLODIPINA DOC Generici may lower your blood sugar level. Monitor your blood sugar level while taking RAMIPRIL E AMLODIPINA DOC Generici;
• lithium (for mental health problems). RAMIPRIL E AMLODIPINA DOC Generici may raise the level of lithium in your blood. Your doctor will need to monitor your lithium levels closely;
• simvastatin (a medicine to lower cholesterol). RAMIPRIL E AMLODIPINA DOC Generici may raise the level of simvastatin in your blood.

If any of the above cases apply to you (or if you are not sure), tell your doctor before taking
RAMIPRIL E AMLODIPINA DOC Generici.

RAMIPRIL E AMLODIPINA DOC Generici with food, drinks and alcohol
RAMIPRIL E AMLODIPINA DOC Generici can be taken with or without food.
People taking RAMIPRIL E AMLODIPINA DOC Generici should not consume
grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can
lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an
unpredictable increase in blood pressure, reducing the effect of RAMIPRIL E AMLODIPINA
DOC Generici.
Drinking alcohol with RAMIPRIL E AMLODIPINA DOC Generici can cause dizziness or confusion. If you
are concerned about how much you can drink while taking RAMIPRIL E AMLODIPINA DOC Generici,
talk to your doctor, as medicines used to lower blood pressure and alcohol
can have additive effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take RAMIPRIL E AMLODIPINA DOC Generici during pregnancy.
If you think you are pregnant while taking RAMIPRIL E AMLODIPINA DOC Generici, tell
your doctor immediately. Before planning a pregnancy, you should switch to an alternative
therapy that is suitable.

Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. Do not take
RAMIPRIL E AMLODIPINA DOC Generici if you are breastfeeding. Ask your doctor or pharmacist
before taking any medicine.

Fertility
There is insufficient data regarding potential effects on fertility.

Driving and operating machinery
RAMIPRIL E AMLODIPINA DOC Generici may affect your ability to drive or operate
machinery. If RAMIPRIL E AMLODIPINA DOC Generici causes you to feel unwell, dizzy or tired,
headache, do not drive or use machinery and contact your doctor immediately. This
may happen especially at the beginning of therapy or when switching from other medicines.

RAMIPRIL E AMLODIPINA DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet,
i.e. essentially ‘sodium-free’.

3. How to take RAMIPRIL E AMLODIPINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
If you feel that the effect of RAMIPRIL E AMLODIPINA DOC Generici is too strong or
too weak, inform your doctor or pharmacist.
Take the medicine by mouth always at the same time of day, before or after meals.
Swallow the capsule whole with liquids.
Do not break or chew the capsules.
Do not take RAMIPRIL E AMLODIPINA DOC Generici with grapefruit juice.
RAMIPRIL E AMLODIPINA DOC Generici must be taken once a day.
The doctor may modify the dose depending on the effect it has on you. The maximum
daily dose is one capsule of 10 mg + 10 mg.

Elderly
The doctor will reduce the initial dose and adjust the treatment more slowly.
In very elderly and debilitated patients, the administration of RAMIPRIL and AMLODIPINA
DOC Generici capsules should be avoided.

Use in children and adolescents
The use of RAMIPRIL E AMLODIPINA DOC Generici is not recommended in children and
adolescents under the age of 18 because information is not available for this patient population.

If you take more RAMIPRIL E AMLODIPINA DOC Generici 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 weakness. If the drop in blood pressure
is so 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 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 E AMLODIPINA DOC Generici
If you forget to take a capsule, skip that dose altogether and take the next dose at the usual time.
Do not take a double dose to make up for the forgotten capsule.

If you stop taking RAMIPRIL E AMLODIPINA DOC Generici
The doctor will inform you how long you should take this medicine. If you stop the
treatment before being told to do so, your illness may recur.
If you have any further questions 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.
If you notice any of the following serious side effects, stop taking RAMIPRIL E AMLODIPINA DOC Generici and consult your doctor immediately as 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 RAMIPRIL E AMLODIPINA DOC Generici;

• severe skin reactions including rash, mouth sores, 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.

Tell 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;
• shortness of breath or cough. This could be a sign of lung problems;
• an increased tendency to bruise, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple patches, spots on the skin or an increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale. These may be signs of blood or bone marrow problems;
• very severe stomach pain that may radiate to your back. This could be a sign of pancreatitis (inflammation of the pancreas);
• 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 (inflammation of the liver) or liver damage;
• tremor, stiff posture, mask-like face, slow movements and an unbalanced, shuffling walk (extrapyramidal disorders).

Other side effects include:
Tell your doctor if any of the following side effects becomes serious or lasts for more than
a few days.
Common (may affect up to 1 in 10 people):

• drowsiness (especially at the beginning of treatment);
• palpitations (feeling of a fast-beating heart), hot flushes;
• swelling of the ankles (edema);
• headache or feeling tired;
• feeling dizzy. This is more likely to happen at the beginning of therapy with RAMIPRIL E AMLODIPINA DOC Generici or when you start taking a higher dose;
• fainting, low blood pressure (blood pressure too low), especially when getting up or sitting up too quickly;
• dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
• abdominal pain, stomach pain or discomfort, diarrhea, indigestion, feeling sick or unwell;
• skin rash with or without swelling;
• chest pain;
• muscle cramps or pain;
• blood tests showing too much potassium in your blood than normal.

Not common (may affect up to 1 in 100 people):

• mood changes, insomnia;
• tremors, weakness, pain, feeling unwell;
• vision disturbances, double vision, blurred vision, ringing in the ears;
• cold/runny nose caused by inflammation of the nasal mucosa (rhinitis);
• changes in bowel habits (including diarrhea or constipation), heartburn, dry mouth;
• hair loss, increased sweating, itchy skin, red spots on the skin, discoloration of the skin;
• difficulty urinating, increased need to urinate, especially at night, increased number of times you urinate;
• inability to get an erection, sexual dysfunction in men, reduced sexual drive in men or women;
• discomfort or enlargement of the breasts in men;
• joint or muscle pain, muscle cramps, 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 sensitivity to pain;
• loss or change in the sense of taste;
• problems sleeping;
• feeling depressed, anxious, more nervous than usual or restless;
• nasal congestion, 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 could be a sign that your body is retaining more water than normal;
• fever;
• an increase in the 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 peeling 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;
• hives;
• spots on the skin and cold hands and feet;
• red, itchy, swollen or watery eyes;
• hearing disorders;
• blood tests showing a reduction 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;
• stomach swelling (gastritis);
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice);
• increased muscle tension;
• inflammation of blood vessels, often with skin rash;
• sensitivity to light;
• disorders combining rigidity, tremors and/or movement disorders;

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

• dark colored urine (concentrated), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of oADH (anti- diuretic hormone [antidiuretic hormone]). If you experience these symptoms, contact your doctor promptly.
• inflammation of the oral mucosa with small ulcers;
• psoriasis.

Other side effects reported:

• difficulty concentrating
• blood tests showing too few red and white blood cells;
• blood tests showing too little sodium in the blood than normal;
• fingers and toes that change color are cold and then tingle or feel pain when warmed (Raynaud's phenomenon);
• slowed or altered reactions;
• change in the perception of smells.

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 https://www.aifa.gov.it/content/-segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store RAMIPRIL E AMLODIPINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the box and blister after
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 eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What RAMIPRIL E AMLODIPINA DOC Generici contains
The active ingredients are:

RAMIPRIL E AMLODIPINA DOC Generici 2.5 mg + 5 mg hard capsules
each capsule contains: 2.5 mg of ramipril and 6.934 mg of amlodipine besylate (corresponding to 5 mg
of amlodipine)

RAMIPRIL E AMLODIPINA DOC Generici 5 mg + 5 mg hard capsules
each capsule contains: 5 mg of ramipril and 6.934 mg of amlodipine besylate (corresponding to 5 mg of
amlodipine)

RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 5 mg hard capsules
each capsule contains: 10 mg of ramipril and 6.934 mg of amlodipine besylate (corresponding to 5 mg
of amlodipine)

RAMIPRIL E AMLODIPINA DOC Generici 5 mg + 10 mg hard capsules
each capsule contains: 5 mg of ramipril and 13.868 mg of amlodipine besylate (corresponding to 10 mg
of amlodipine)

RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 10 mg hard capsules
each capsule contains: 10 mg of ramipril and 13.868 mg of amlodipine besylate (corresponding to 10
mg of amlodipine)
The other ingredients are: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch
glycolate (type A), sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171),
gelatin.
In RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 10 mg also present are: yellow iron oxide
(E172), black iron oxide (E172)

Description of the appearance of RAMIPRIL E AMLODIPINA DOC Generici and package contents
RAMIPRIL E AMLODIPINA DOC Generici 2.5 mg + 5 mg hard capsules: hard gelatin capsules,
cap of pale pink opaque color, body of opaque white color. Capsule content:
white or almost white powder.
RAMIPRIL E AMLODIPINA DOC Generici 5 mg + 5 mg hard capsules: hard gelatin capsules,
cap of opaque pink color, body of opaque white color. Capsule content: powder
white or almost white.

RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 5 mg hard capsules: hard gelatin capsules,

dark opaque pink cap, opaque white body. Capsule contents: white or almost white powder
white or almost white.

RAMIPRIL E AMLODIPINA DOC Generici 5 mg + 10 mg hard capsules: hard gelatin capsules,

opaque reddish-brown cap, opaque white body. Capsule contents:
white or almost white powder.

RAMIPRIL E AMLODIPINA DOC Generici 10 mg + 10 mg hard capsules: hard gelatin capsules,

opaque brown cap, opaque white body. Capsule contents: white or almost white powder
white or almost white.
RAMIPRIL E AMLODIPINA DOC Generici is available in blisters containing 28, 30 capsules.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano (MI)

Manufacturers

• Adamed Pharma S.A. - Ul. Szkolna 33 - 95-054 Ksawerów - Poland
• Adamed Pharma S.A. - Ul. Marszałka Józefa Piłsudskiego 5 - 95-200 Pabianice - Poland