RAMIPRIL 5 mg/5 mg Hard Capsules

Зміст інструкції

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

Ramipril e Amlodipina Zentiva 5 mg/5 mg hard capsules, 5 mg / 10 mg hard capsules, 10 mg/5 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 Zentiva is and what it is used for
• 2. What you need to know before you take Ramipril e Amlodipina Zentiva
• 3. How to take Ramipril e Amlodipina Zentiva
• 4. Possible side effects
• 5. How to store Ramipril e Amlodipina Zentiva
• 6. Contents of the pack and other information

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

Ramipril and Amlodipine Zentiva contains two active ingredients: ramipril and amlodipine. Ramipril belongs to a
group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Amlodipine belongs to a group of medicines called calcium antagonists.
Ramipril works as follows:

• Decreases the production by your body of substances that can cause an increase in blood pressure.
• Relaxes and dilates your blood vessels.
• Makes it easier for your heart to pump blood around your body.

Amlodipine works as follows:

• Relaxes and dilates blood vessels, so that blood can pass through them more easily.

Ramipril and Amlodipine Zentiva is used to treat hypertension (high blood pressure), in adult patients whose
high blood pressure is adequately controlled with ramipril and amlodipine administered simultaneously in
the form of separate tablets, but having the same dosage present in Ramipril and Amlodipine Zentiva.

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

Do not take Ramipril and Amlodipine Zentiva:

• If you are allergic to ramipril, amlodipine (active ingredients), or to any other ACE inhibitor or calcium channel blocker or to any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include itching, redness of the skin, rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat) (see section “Other medicines and Ramipril and Amlodipine Zentiva”).
• If you have had a serious allergic reaction called “angioedema”. Symptoms include itching, rash (hives), red marks 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 type of machinery used, treatment with Ramipril and Amlodipine Zentiva may not be suitable for you.
• If you have kidney problems where the blood supply to the kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section “Pregnancy, breastfeeding and fertility”).
• If you have diabetes mellitus or kidney damage and are treated with a medicine that lowers blood pressure containing aliskiren.
• If your blood pressure is too low (hypotension) or unstable. Your doctor will need to make an assessment.
• If you have a narrowing of the aortic valve of the heart (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.

Do not take Ramipril and Amlodipine Zentiva if any of the above cases apply to you. If you have any doubts, talk
to your doctor before taking Ramipril and Amlodipine Zentiva.

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

• If you have problems with your heart, liver or kidneys.
• If your body has lost a lot of salts or fluids (due to vomiting, diarrhea, sweating more than usual, following a low-salt diet, if you have been taking diuretics (water tablets) for a long time or if you are undergoing dialysis).
• If you are going to undergo treatment to reduce an allergy, e.g. to bee or wasp stings (desensitization).
• If you are going to receive anesthesia. This may be administered for an operation or for a dental procedure. In such cases, you may need to stop treatment with Ramipril and Amlodipine Zentiva the day before; consult your doctor for advice.
• If you have high levels of potassium in your blood (indicated in blood test results).
• You are taking medicines or suffer from conditions that can reduce sodium levels in your blood. Your doctor may perform regular blood tests, especially to check sodium levels in the blood, particularly if you are elderly.
• If you have a collagen-vascular disease such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you are (or might become) pregnant. Ramipril and Amlodipine Zentiva is not recommended in the first 3 months of pregnancy and can cause serious harm to the baby after 3 months of pregnancy (see the section below on “Pregnancy and breastfeeding”).
• If you are taking any of the following medicines for the treatment of high blood pressure:
• an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren. 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 information in the section “Do not take Ramipril and Amlodipine Zentiva”.
• If you experience a severe increase in blood pressure (hypertensive crisis).
• If you are elderly and your dose needs to be increased.

If you suffer from a sudden swelling of the lips and face, tongue and throat, neck,
possibly also hands and feet, difficulty swallowing or breathing, hives or hoarseness
(“angioedema”). This could be a sign of a serious allergic reaction. Such effects can
occur at any time during treatment. People with black skin may be at a higher risk of suffering from this condition. If you develop these symptoms, you should inform your
doctor immediately.

Children and adolescents
The use of Ramipril and Amlodipine Zentiva is not recommended for children and adolescents under 18 years
of age due to the lack of data in this patient population.

Other medicines and Ramipril and Amlodipine Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
This is because Ramipril and Amlodipine Zentiva can affect the way some other
medicines work. Also, some medicines can affect the way Ramipril and Amlodipine Zentiva
works.
Tell your doctor if you are taking any of the following medicines. They may reduce
the effect of Ramipril and Amlodipine Zentiva:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin and acetylsalicylic acid).
• Medicines used to treat blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, norepinephrine or adrenaline. Your doctor will need to monitor your blood pressure.
• Rifampicin (antibiotic used to treat tuberculosis).
• Hypericum perforatum (St. John's Wort - remedy for depression).

Tell your doctor if you are taking any of the following medicines. They may increase the
possibility of having unwanted effects when taken with Ramipril and Amlodipine Zentiva:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Ramipril and Amlodipine Zentiva”).
• If you are taking some 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 (e.g. temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used in the treatment of diabetes.
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, acetylsalicylic acid).
• Cancer medicines (chemotherapy).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene and amiloride) and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole) 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 blood clots).
• Diuretics (water tablets) such as furosemide.
• Steroid medicines for inflammation such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Ketoconazole, itraconazole (used to treat fungal infections).
• Ritonavir, indinavir, nelfinavir (called protease inhibitors used to treat patients with HIV).
• Erythromycin, clarithromycin (antibiotics).
• Verapamil, diltiazem (heart medicines).
• Dantrolene (by infusion, for severe abnormalities of body temperature).

Your doctor may need to change the dosage and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information in the sections “Do not take Ramipril and Amlodipine Zentiva” and “Warnings and precautions”).

Tell your doctor if you are taking any of these medicines. The action of the following medicines can
be affected by Ramipril and Amlodipine Zentiva:

• Medicines for diabetes such as oral blood glucose-lowering medicines and insulin. Ramipril and Amlodipine Zentiva can lower blood sugar levels. Carefully monitor your blood sugar (glucose) levels while taking Ramipril and Amlodipine Zentiva.
• Lithium (for mental health problems). Ramipril and Amlodipine Zentiva can increase the amount of lithium in the blood. Your doctor needs to carefully monitor the amount of lithium in your blood.
• Simvastatin (medicine to reduce cholesterol). Ramipril and Amlodipine Zentiva can increase the levels of simvastatin in the blood.

Ramipril and Amlodipine Zentiva can further lower blood pressure if you are already taking
other medicines to treat high blood pressure.
If any of the above situations applies to you (or if you are unsure), consult your
doctor before taking Ramipril and Amlodipine Zentiva.

Ramipril and Amlodipine Zentiva with food, drinks and alcohol
Drinking alcohol during treatment with Ramipril and Amlodipine Zentiva can cause dizziness or a
feeling of mental confusion. If you want to know how much alcohol you can drink during therapy with Ramipril and
Amlodipine Zentiva, talk to your doctor, as the effects of medicines used to
lower blood pressure and the effects of alcohol can add up.

Grapefruit juice and grapefruit should not be consumed by people who are taking
Ramipril and Amlodipine Zentiva. This is because grapefruit or grapefruit juice can lead to an
increase in the levels of the active ingredient amlodipine in the blood, which may cause an
unpredictable increase in the hypotensive (blood pressure lowering) effect of Ramipril and Amlodipine
Zentiva.

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

Pregnancy
You must not take Ramipril and Amlodipine Zentiva during pregnancy.
If you become pregnant during treatment with Ramipril and Amlodipine Zentiva, inform your
doctor immediately. Switching to a suitable alternative treatment should be initiated before planning a
pregnancy.

Breastfeeding
If you are breastfeeding, you must not take Ramipril and Amlodipine Zentiva. Ask your doctor or
pharmacist for advice before taking any medicine.

Fertility
There is insufficient data regarding potential effects on fertility.

Driving and using machines
Ramipril and Amlodipine Zentiva can change your ability to drive or operate machines. If
Ramipril and Amlodipine Zentiva makes you feel unwell, dizzy, tired or gives you a
headache, do not drive or operate machinery and contact your doctor immediately. This is more likely to happen
when you first start taking Ramipril and Amlodipine Zentiva, when you switch from other medicines or when you start taking
a higher dose.

Ramipril and Amlodipine Zentiva contains sodium:
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, that is to say, it is essentially “sodium-free”.

3. How to take Ramipril and Amlodipina Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
If you feel that the effect of Ramipril and Amlodipina Zentiva is too strong or too weak, consult your doctor or pharmacist.
Take this medicine by mouth at the same time of each day. Ramipril and Amlodipina Zentiva can be taken with or without food.
Swallow the capsule whole with some liquid.
Do not take Ramipril and Amlodipina Zentiva with grapefruit juice.
Ramipril and Amlodipina Zentiva must be administered once a day.
Depending on the effect, your doctor may modify the dose.
The maximum daily dose is 1 capsule of 10 mg/10 mg.

Elderly
Your doctor will reduce the initial dose and adjust the treatment more slowly.

Use in children and adolescents
Ramipril and Amlodipina Zentiva is not recommended for use in children and adolescents under 18 years of age, as data are not available in this population.

If you take more Ramipril and Amlodipina Zentiva than you should
Taking too many capsules can cause a lowering of blood pressure to the point of being even dangerous. You may experience dizziness, lightheadedness, fainting or feeling weak. If the drop in blood pressure is severe enough, shock may occur. The skin may become cold and sweaty and the subject may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath which may develop up to 24-48 hours after taking the medicine.
Consult a doctor immediately or go to the nearest hospital emergency room. Do not drive to the hospital, have someone accompany you or call an ambulance. Bring the package of the medicine with you. This is so that the doctor knows what you have taken.

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

If you stop taking Ramipril and Amlodipina Zentiva
Your doctor will advise you how long you should take the medicine. Your condition may return if you stop taking the medicine before it is recommended.
If you have any further questions on 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 will experience them.

Stop taking Ramipril and Amlodipina Zentiva and contact your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Swelling of the face, eyelids, lips, tongue or throat that makes it difficult to swallow or breathe, as well as itching and rash. This could be a sign of a severe allergic reaction to Ramipril and Amlodipina Zentiva.
• Severe skin reactions, including intense rashes, ulcers in the mouth, hives, redness of the skin all over the body, severe itching, scaling and swelling of the skin, inflammation of the mucous membranes, worsening of a pre-existing skin condition, blisters or detachment of the skin (such as in Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.

Contact your doctor immediately if you experience:

• Fast heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest or more serious problems including heart attack or stroke.
• Shortness of breath or cough. These could be signs of lung problems.
• Increased ease of bruising, bleeding for longer than normal, any sign of bleeding (e.g. bleeding gums), spots on the skin, even purplish in color, or increased susceptibility to infections, sore throat and fever, feeling tired, fainting, dizziness and pale skin. These can be signs of problems with the blood or bone marrow.
• 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 can be signs of liver problems, as well as liver inflammation (hepatitis) or liver damage.

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

• Fluid retention (edema).

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

• Drowsiness (especially at the beginning of treatment)
• Palpitations (feeling your heartbeat), hot flushes
• Swelling of the ankles
• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to occur when you start taking Ramipril and Amlodipina Zentiva or when you start taking a higher dose
• Fainting, hypotension (abnormally low blood pressure), especially when getting up or lying down quickly
• Dry cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath
• Abdominal pain, stomach pain or intestinal pain, changes in bowel habits, diarrhea, constipation, indigestion, feeling sick (nausea)
• Vision disturbances, double vision
• Rash with or without raised areas
• Chest pain
• Muscle cramps or pain
• Blood tests showing more potassium than normal in the blood.

Uncommon (may affect up to 1 in 100 people):

• Mood swings, anxiety, depression, feeling depressed, insomnia
• Tremor, fainting, pain, feeling unwell
• Tinnitus (ringing in the ears)
• Sneezing/runny nose due to inflammation of the lining of the nose (rhinitis)
• Heartburn, dry mouth
• Hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
• Urinary disturbances, increased need to urinate at night, increased number of times you urinate, needing to urinate more frequently than usual during the day
• Inability to have an erection, sexual dysfunction in men, reduced sexual desire in men or women
• Discomfort or enlargement of the breasts in men
• Joint pain, back pain
• Weight gain or loss
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning or feeling that something is crawling on the skin (paresthesia)
• Feeling of numbness or tingling in the limbs, loss of sensation of pain
• Loss or alteration of taste
• Sleep problems
• Feeling more nervous than usual or restlessness
• Blocked nose, difficulty breathing or worsening of asthma
• A swelling of the intestine called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Loss or decrease of appetite (anorexia)
• Increased or irregular heartbeat
• Swelling of the arms and legs. This could be a sign that your body is retaining more fluid than normal
• Blurred vision
• Cough
• Low blood pressure
• Fever
• Blood tests showing an increase in the number of certain white blood cells (eosinophilia)
• Blood tests showing changes in liver, pancreas or kidney function.

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

• Feeling of trembling or confusion
• Red and swollen tongue
• Severe scaling or cracking of the skin, itching, raised rash
• Problems with the nails (e.g. detachment or separation of the nail from its bed)
• Rash or bruising
• Spots on the skin and cold extremities
• Red, itchy, swollen or moist eyes
• Hearing disorders
• Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets, or the amount of hemoglobin.

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

• Decrease in platelets in the blood which can cause unusual bruising or easy bleeding
• Increased sensitivity to sunlight than usual
• Excess sugar (glucose) in the blood (hyperglycemia)
• A nerve disorder that can cause muscle weakness, tingling or numbness
• Swelling of the gums, bleeding gums
• Swollen stomach (gastritis)
• Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can affect some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with a rash
• Sensitivity to light
• Disorders related to stiffness, tremor, and/or movement disorders.

Frequency not known (the frequency cannot be estimated from the 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 (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly.
• Tremor, rigid posture, mask-like face, slow movements and a shuffling, dragging gait.

Other side effects reported:
Inform your doctor if any of the following side effects worsen or last for more than a few
days.

• Difficulty concentrating
• Swollen mouth
• Blood tests showing a decrease in sodium levels in the blood compared to normal values
• Fingers of the hands and feet that change color when you have cold and then tingling or a sensation of pain when they warm up (Raynaud's phenomenon)
• Slowed or impaired reactions
• Burning sensation
• Change in the perception of smells Reporting of side effectsIf you get any side effects, talk to 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 and Amlodipina Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after EXP. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Store in the original package to protect the medicine from light.
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 Amlodipina Zentiva contains

• The active ingredients are: 5 mg/5 mg hard capsules: each capsule contains 5 mg of ramipril and amlodipine besilate equivalent to 5 mg of amlodipine. 5 mg/10 mg hard capsules: each capsule contains 5 mg of ramipril and amlodipine besilate equivalent to 10 mg of amlodipine. 10 mg/5 mg hard capsules: each capsule contains 10 mg of ramipril and amlodipine besilate equivalent to 5 mg of amlodipine. 10 mg/10 mg hard capsules: each capsule contains 10 mg of ramipril and amlodipine besilate equivalent to 10 mg of amlodipine.
• The other ingredients are: microcrystalline cellulose, anhydrous dibasic calcium phosphate, pregelatinized corn starch, sodium starch glycolate (type A), sodium stearyl fumarate, red iron oxide (E 172), titanium dioxide (E 171), gelatin, yellow iron oxide (E 172) (10 mg/10 mg), black iron oxide (E 172) (10 mg/10 mg).

Description of the appearance of Ramipril and Amlodipina Zentiva and package contents
Ramipril and Amlodipina Zentiva 5 mg/5 mg hard capsules: hard gelatin capsules; approximately 19.1 –
19.7 mm long, cap: opaque, pink in color; body: opaque, white in color. Capsule content: white or almost white powder.
Ramipril and Amlodipina Zentiva 5 mg/10 mg hard capsules: hard gelatin capsules; approximately 19.1 –
19.7 mm long, cap: opaque, red-brown in color, body: opaque, white in color. Capsule content: white or almost white powder.
Ramipril and Amlodipina Zentiva 10 mg/5 mg hard capsules: hard gelatin capsules; approximately 19.1 –
19.7 mm long, cap: opaque, dark pink in color; body: opaque, white in color. Capsule content: white or almost white powder
Ramipril and Amlodipina Zentiva 10 mg/10 mg hard capsules: hard gelatin capsules; cap: opaque, brown in color; body: opaque, white in color. Capsule content: white or almost white powder
Ramipril and Amlodipina Zentiva is available in packs containing 28, 30, 32, 50, 56, 60, 90, 91, 96, 98 or 100 capsules contained in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: