Ramipril and amlodipine Doc Generici: detailed information

Package leaflet: Information for the user

RAMIPRIL AND AMLODIPINE DOC Generics 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 entire leaflet carefully before taking this medicine because 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Contents of this leaflet

What RAMIPRIL AND AMLODIPINE DOC Generics is and what it is used for
What you need to know before taking RAMIPRIL AND AMLODIPINE DOC Generics
How to take RAMIPRIL AND AMLODIPINE DOC Generics
Possible side effects
How to store RAMIPRIL AND AMLODIPINE DOC Generics
Contents of the pack and other information

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

RAMIPRIL E AMLODIPINA DOC Generici contains two active substances: amlodipine and ramipril. Amlodipine
belongs to a group of medicines called calcium channel blockers. 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;
relaxing and widening blood vessels;
helping the heart pump blood around the body more easily.

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

2. What you should know before taking RAMIPRIL AND AMLODIPINE DOC Generics

Do not take RAMIPRIL AND AMLODIPINE DOC Generics:

if you are allergic to the active substances, any other calcium antagonist, or any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6). The reaction may include itching, skin redness, or difficulty breathing;
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 ever had a severe allergic reaction called "angioedema." 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 undergoing dialysis or any other type of blood filtration. Depending on the machine used,
RAMIPRIL AND AMLODIPINE DOC Generics 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 have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling beneath the skin, such as in the throat).

Do not take RAMIPRIL AND AMLODIPINE DOC Generics if any of the above conditions apply to you. If you are
unsure, consult your doctor or pharmacist before taking RAMIPRIL AND AMLODIPINE DOC Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL AND AMLODIPINE DOC Generics.
Inform your doctor if any of the following conditions apply to you:

if you have increased blood pressure (hypertensive crisis);
if you are elderly and your dosage needs to be increased;
if you have heart, liver, or kidney problems;
if you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhea, excessive sweating, following a low-salt diet, or from long-term use of oral diuretics, or after dialysis);
if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization);
if you are about to receive anesthesia. This may be administered during surgery or dental procedures. You must stop treatment with RAMIPRIL AND AMLODIPINE DOC Generics one day before; for further information, consult your doctor;
if you have high levels of potassium in your blood (shown by a blood test);
if you have a vascular collagen 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 antagonist" (AIIRA) (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if you have 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 monitor 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 DOC Generics."
Children and adolescents
The use of RAMIPRIL AND AMLODIPINE DOC Generics is not recommended in children and adolescents
under 18 years of age, as there is insufficient information available for this patient population.
Other medicines and RAMIPRIL AND AMLODIPINE DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose and/or take other precautions:

if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take RAMIPRIL AND AMLODIPINE DOC Generics" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines, as they may reduce the effectiveness of
RAMIPRIL AND AMLODIPINE DOC Generics:

medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and aspirin);
medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure;
rifampicin (an antibiotic used to treat tuberculosis); erythromycin, clarithromycin (antibiotics);
Hypericum perforatum (St. John's wort, used to treat depression). Inform your doctor if you are taking any of the following medicines, as they may increase the likelihood of side effects when taken with RAMIPRIL AND AMLODIPINE DOC Generics:
medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacine, 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 potassium levels in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
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 virus);
erythromycin, clarithromycin (medicines to treat bacterial infections);
verapamil, diltiazem (medicines to treat heart conditions or high blood pressure);
vildagliptin (an oral medicine that lowers glucose levels);
dantrolene (an intravenous medicine for severe body temperature disorders);
racecadotril (used to treat diarrhea);
everolimus, sirolimus (to prevent graft rejection);
tacrolimus (used to control immune response, allowing the body to accept a transplanted organ).

Inform your doctor if you are taking any of the following medicines, as their effects may be altered by
RAMIPRIL AND AMLODIPINE DOC Generics:

medicines for diabetes, such as oral glucose-lowering medicines and insulin. RAMIPRIL AND AMLODIPINE DOC Generics may lower blood sugar levels. Monitor your blood sugar levels while taking RAMIPRIL AND AMLODIPINE DOC Generics;
lithium (for mental health conditions). RAMIPRIL AND AMLODIPINE DOC Generics 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 DOC Generics may increase simvastatin levels in the blood.

If any of the above conditions apply to you (or if you are unsure), inform your doctor before taking RAMIPRIL
AND AMLODIPINE DOC Generics.
RAMIPRIL AND AMLODIPINE DOC Generics with food, drinks, and alcohol
RAMIPRIL AND AMLODIPINE DOC Generics can be taken with or without food.
People taking RAMIPRIL AND AMLODIPINE DOC Generics must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable drop in blood pressure, thereby enhancing the effect of RAMIPRIL AND AMLODIPINE DOC Generics.
Drinking alcohol with RAMIPRIL AND AMLODIPINE DOC Generics may cause dizziness or confusion. If you are concerned about how much alcohol you can drink while taking RAMIPRIL AND AMLODIPINE DOC Generics, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take RAMIPRIL AND AMLODIPINE DOC Generics during pregnancy.
If you become pregnant while taking RAMIPRIL AND AMLODIPINE DOC Generics, inform your doctor immediately. Before planning a pregnancy, you should switch to an appropriate alternative therapy.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. Do not take RAMIPRIL AND
AMLODIPINE DOC Generics if you are breastfeeding. Inform your doctor or pharmacist before taking any medicine.
Fertility
There are insufficient data on potential effects on fertility.
Driving and using machines
RAMIPRIL AND AMLODIPINE DOC Generics may affect your ability to drive or operate machinery. If RAMIPRIL AND AMLODIPINE DOC Generics causes you discomfort, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately. This may especially occur at the beginning of treatment or when switching from other medicines.
RAMIPRIL AND AMLODIPINE DOC Generics 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 AND AMLODIPINE DOC Generics

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
If you feel that the effect of RAMIPRIL AND AMLODIPINE DOC Generics is too strong or too
weak, inform your doctor or pharmacist.
Take the medicine orally at the same time each day, with or without food.
Swallow the capsule whole with liquid.
Do not break or chew the capsules.
Do not take RAMIPRIL AND AMLODIPINE DOC Generics with grapefruit juice.
RAMIPRIL AND AMLODIPINE DOC Generics should be taken once daily.
Your doctor may adjust the dose depending on how it affects you. The maximum daily dose is one
capsule of 10 mg/10 mg.
Elderly patients
Your doctor will reduce the initial dose and adjust treatment more gradually.
The administration of RAMIPRIL AND AMLODIPINE DOC Generics capsules is not recommended
in very elderly and frail patients.
Use in children and adolescents
The use of RAMIPRIL AND AMLODIPINE DOC Generics is not recommended in children and adolescents
under 18 years of age, as information for this patient population is not available.
If you take more RAMIPRIL AND AMLODIPINE DOC Generics than you should
Taking too many capsules may cause a drop or a dangerous drop in blood pressure.
You may experience dizziness, lightheadedness, fainting, or weakness. If the drop in blood pressure is severe,
shock may occur. The 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 yourself to the hospital; have someone
drive you or call an ambulance. Take the medicine pack with you so the doctor knows what you have taken.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may
develop up to 24–48 hours after ingestion.
If you forget to take RAMIPRIL AND AMLODIPINE DOC Generics
If you forget to take a capsule, skip that dose completely and take the next dose at your usual time. Do not
take a double dose to make up for the missed capsule.
If you stop taking RAMIPRIL AND AMLODIPINE DOC Generics
Your doctor will inform you how long you should take this medicine. If you stop treatment before being told
to do so, your condition may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop treatment with RAMIPRIL AND AMLODIPINE DOC Generics and consult your doctor immediately, as you may require urgent medical treatment:

swelling of the face, lips or throat, which may cause difficulty swallowing or breathing, together with itching and skin rash. This could be a sign of a severe allergic reaction to RAMIPRIL AND AMLODIPINE DOC Generics;
severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blisters or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), or other allergic reactions.

Contact your doctor immediately if you experience:

a fast, irregular or strong heartbeat (palpitations), chest pain, 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;
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 may be signs of blood or bone marrow disorders;
severe stomach pain that may radiate to the 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 (liver inflammation) or liver damage;
tremors, rigid posture, mask-like facial expression, slow movements and unbalanced, shuffling gait (extrapyramidal disorders).

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

Common (may affect up to 1 in 10 people):

drowsiness (particularly at the beginning of treatment);
palpitations (awareness of a fast or forceful heartbeat), hot flushes;
swelling of the ankles (oedema);
headache or feeling tired;
dizziness. This is more likely at the beginning of treatment with RAMIPRIL AND AMLODIPINE DOC Generics or when starting a higher dose;
fainting, hypotension (low blood pressure), particularly when standing up or sitting up too quickly;
dry, persistent cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
abdominal pain, stomach ache or discomfort, diarrhoea, indigestion, feeling sick or vomiting;
skin rash with or without swelling;
chest pain;
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, weakness, 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);
changes in bowel habits (including diarrhoea or constipation), heartburn, dry mouth;
hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration;
problems with urination, increased need to urinate, particularly at night, increased frequency of urination;
inability to achieve an erection, sexual dysfunction in men, reduced sexual desire in men or women;
breast discomfort or enlargement in men;
joint or muscle pain, muscle cramps, back pain;
weight gain or weight loss;
balance problems (dizziness);
itching and unusual skin sensations such as numbness, tingling, pricking, burning or chills (paraesthesia), loss of sensitivity to pain;
loss or change in the sense of taste;
sleep problems;
feeling depressed, anxiety, increased nervousness or restlessness;
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 be a sign that your body is retaining more fluid than normal;
fever;
an 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 shedding 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;
hives (urticaria);
skin patches and cold hands and feet;
red, itchy, swollen or watery eyes;
hearing disturbances;
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;
excessive blood sugar levels (hyperglycaemia);
swollen gums;
abdominal swelling (gastritis);
liver function abnormalities, liver inflammation (hepatitis), yellowing of the skin (jaund游戏副本

5. How to store RAMIPRIL E AMLODIPINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 E AMLODIPINA DOC Generici contains
The active substances 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 (equivalent 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 (equivalent 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 (equivalent 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 (equivalent 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 (equivalent to 10 mg of
amlodipine).

The other components 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, the following are also present: yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of RAMIPRIL E AMLODIPINA DOC Generici and contents of the pack
RAMIPRIL E AMLODIPINA DOC Generici 2.5 mg/5 mg hard capsules: hard gelatin capsules, cap pale pink opaque, body white opaque. Capsule contents: white or almost white powder.
RAMIPRIL E AMLODIPINA DOC Generici 5 mg/5 mg hard capsules: hard gelatin capsules, cap pink opaque, body white opaque. Capsule contents: white or almost white powder.
RAMIPRIL E AMLODIPINA DOC Generici 10 mg/5 mg hard capsules: hard gelatin capsules, cap dark pink opaque, body white opaque. Capsule contents: white or almost white powder.
RAMIPRIL E AMLODIPINA DOC Generici 5 mg/10 mg hard capsules: hard gelatin capsules, cap reddish-brown opaque, body white opaque. Capsule contents: white or almost white powder.
RAMIPRIL E AMLODIPINA DOC Generici 10 mg/10 mg hard capsules: hard gelatin capsules, cap brown opaque, body white opaque. Capsule contents: white or almost white powder.

RAMIPRIL E AMLODIPINA DOC Generici is available in blisters containing 28 or 30 capsules.

Marketing Authorization 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