RAMIPRIL 2.5 mg/12.5 mg Коированная таблетка

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1. Ramipril and Hydrochlorothiazide Aurobindo 2.5 mg/12.5 mg tablets, 5 mg/25 mg tablets
   1. What is Ramipril and Hydrochlorothiazide Aurobindo and what is it used for
   2. What you need to know before taking Ramipril and Hydrochlorothiazide Aurobindo
   3. How to take Ramipril and Idroclorotiazide Aurobindo
   4. Possible side effects
   5. How to store Ramipril and Idroclorotiazide Aurobindo
   6. Package contents and other information

Ramipril and Hydrochlorothiazide Aurobindo 2.5 mg/12.5 mg tablets, 5 mg/25 mg tablets

Generic medicine

Read this 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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ramipril and Hydrochlorothiazide Aurobindo and what is it used for

Ramipril and Hydrochlorothiazide Aurobindo is a combination of two medicines called ramipril and
hydrochlorothiazide.
Ramipril belongs to a group of medicines called "ACE inhibitors" (angiotensin converting enzyme inhibitors). This medicine works:

• By decreasing the production by the body of substances that can cause an increase in blood pressure.
• By relaxing and widening the blood vessels.
• By making it easier for your heart to pump blood around the body.

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or oral diuretics.
It works by increasing the amount of water (urine) produced by the body. This lowers the
blood pressure.
Ramipril and Hydrochlorothiazide Aurobindo is used to treat high blood pressure
(hypertension). The two active ingredients work together to reduce blood pressure. They are
used in combination when treatment with only one of the two medicines does not work.

2. What you need to know before taking Ramipril and Hydrochlorothiazide Aurobindo

Do not take Ramipril and Hydrochlorothiazide Aurobindo

• If you are allergic to ramipril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines similar to Ramipril and Hydrochlorothiazide Aurobindo (other ACE inhibitors or medicines derived from sulfonamide).
• Among the signs of an allergic reaction may be skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you have had a severe allergic reaction called "angioedema" in the past. Signs include itching, skin rash (urticaria), 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 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.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machinery used, the use of Ramipril and Hydrochlorothiazide Aurobindo may not be suitable.
• If you have severe liver problems.
• If you have abnormal levels of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy (see next section "Pregnancy and breastfeeding").
• If you are breastfeeding (see next section "Pregnancy and breastfeeding").
• 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).

If any of these apply to you, do not take Ramipril and Hydrochlorothiazide Aurobindo.
If you are unsure, consult your doctor before taking Ramipril and Hydrochlorothiazide Aurobindo.

Warnings and precautions

• Talk to your doctor or pharmacist before taking Ramipril and Hydrochlorothiazide Aurobindo.
• If you have heart, liver or kidney problems.
• If you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, low-sodium diet, prolonged use of oral diuretics, or dialysis).
• If you are going to undergo treatment to reduce the allergy to bee or wasp stings (desensitization).
• If you are going to receive anesthesia, for example for an operation or dental procedure. You may need to stop treatment with Ramipril and Hydrochlorothiazide Aurobindo the day before; consult your doctor.
• If you have high levels of potassium in your blood (shown by blood tests).
• If you suffer from a collagen vascular disease, such as scleroderma or systemic lupus erythematosus.
• If you think you are pregnant (or if there is a possibility of becoming pregnant).
• Ramipril and Hydrochlorothiazide Aurobindo is not recommended in the first three months of pregnancy and can cause serious harm to the baby if taken after the three months of pregnancy (see Pregnancy and breastfeeding).
• The active ingredient hydrochlorothiazide can cause an unusual adverse reaction, which results in reduced vision and eye pain. These may be symptoms of increased pressure in the eye and can occur within a few hours to several weeks of taking Ramipril and Hydrochlorothiazide Aurobindo. If left untreated, this can lead to permanent visual impairment.
• 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 - 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 (rapid swelling under the skin in areas such as the throat) is greater:
• sirolimus, everolimus and other medicines belonging to the mTOR inhibitor class (used to prevent rejection of transplanted organs).
• If you have had skin cancer in the past or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, can increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Ramipril and Hydrochlorothiazide Aurobindo.

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 reported under “Do not take Ramipril and Hydrochlorothiazide Aurobindo”.
If any of these apply to you (or you are not sure), consult your doctor before
taking Ramipril and Hydrochlorothiazide Aurobindo.

Children and adolescents
The use of Ramipril and Hydrochlorothiazide Aurobindo is not recommended in children and adolescents under the age of 18 years. In fact, the medicine has not been studied in these age groups.

Other medicines and Ramipril and Hydrochlorothiazide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines, including those without a prescription(including herbal remedies). In fact, Ramipril and Hydrochlorothiazide Aurobindo can affect the
mechanism of action of some medicines. Also, some medicines can affect the
mechanism of action of Ramipril and Hydrochlorothiazide Aurobindo.
Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported under “Do not take Ramipril and Hydrochlorothiazide Aurobindo” and “Warnings and precautions”).

Tell your doctor if you are taking any of the following medicines, which may reduce the
functioning of Ramipril and Hydrochlorothiazide Aurobindo:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs, NSAIDs, such as ibuprofen, indomethacin and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, norepinephrine or epinephrine. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines, which may increase the
possibility of experiencing side effects when taken with Ramipril and Hydrochlorothiazide Aurobindo:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
• Medicines that can reduce the amount of potassium in the blood. These include medicines for constipation, diuretics, amphotericin B (used to treat fungal infections) and ACTH (used to check the proper functioning of the adrenal glands).
• Medicines for the treatment of cancer (chemotherapy).
• Medicines for heart problems, including problems with the heartbeat.
• Medicines to prevent rejection of organs after transplantation, such as cyclosporine.
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene, amiloride) and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; heparin, a medicine used to thin the blood and prevent the formation of clots.
• Steroid medicines to treat inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (used to reduce uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Cholestyramine (to reduce fat levels in the blood).
• Carbamazepine (for epilepsy).
• Temsirolimus (for cancer).
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Tell your doctor if you are taking any of the following medicines, which may be affected
by Ramipril and Hydrochlorothiazide Aurobindo:

• Medicines for diabetes, such as oral hypoglycemic agents and insulin. Ramipril and Hydrochlorothiazide Aurobindo may reduce the amount of sugars in the blood. During treatment with Ramipril and Hydrochlorothiazide Aurobindo, carefully check your blood sugar levels.
• Lithium (for mental health problems). Ramipril and Hydrochlorothiazide Aurobindo may increase the amount of lithium in the blood. Your doctor will need to check the amounts of lithium carefully.
• Medicines to relax muscles.
• Quinine (for the treatment of malaria).
• Medicines that contain iodine, which may be used when undergoing an X-ray or scan.
• Penicillin (for infections).
• Blood-thinning medicines taken by mouth (oral anticoagulants), such as warfarin.
• Vildagliptin (for type 2 diabetes).

If any of these conditions apply to you (or you are unsure), consult your doctor before
taking Ramipril and Hydrochlorothiazide Aurobindo.

Tests
Consult your doctor or pharmacist before taking the medicine:

• If you are undergoing a test to check the function of the parathyroid gland. Ramipril and Hydrochlorothiazide Aurobindo may alter the results of the test.
• If you are an athlete and have to undergo a doping test. Ramipril and Hydrochlorothiazide Aurobindo may give a positive result.

Ramipril and Hydrochlorothiazide Aurobindo with food and alcohol

• Drinking alcohol together with Ramipril and Hydrochlorothiazide Aurobindo may cause dizziness or lightheadedness. If you have doubts about the amount of alcohol you can drink during therapy with Ramipril and Hydrochlorothiazide Aurobindo, talk to your doctor. In fact, alcohol increases the effects of blood pressure medicines.
• Ramipril and Hydrochlorothiazide Aurobindo can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). You should not take Ramipril and Hydrochlorothiazide Aurobindo in the
first 12 weeks of pregnancy, and you should not take it at all after the thirteenth week
because use during pregnancy may be harmful to the baby.
Immediately inform your doctor if you become pregnant while being treated with Ramipril and
Hydrochlorothiazide Aurobindo. Before planning a pregnancy, you should have a transition
to an adequate alternative treatment.
You should not take Ramipril and Hydrochlorothiazide Aurobindo if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery
Ramipril and Hydrochlorothiazide Aurobindo may cause dizziness. This is more likely
at the beginning of treatment with Ramipril and Hydrochlorothiazide Aurobindo or when switching to a higher
dose. If you experience dizziness, do not drive or operate tools or machinery.

Ramipril and Hydrochlorothiazide Aurobindo contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult him before
taking this medicine.

3. How to take Ramipril and Idroclorotiazide Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth every day at the same time, generally in the morning.
• Swallow the tablets whole with some liquid.
• The tablets must not be broken or chewed.

The recommended dose is:

Treatment of high blood pressure
The doctor will adjust the amount of medicine you need to take until your blood
pressure is under control.

Elderly
The doctor will reduce the initial dose and adjust the doses more gradually.

If you take more Ramipril and Idroclorotiazide Aurobindo than you should
Inform your doctor immediately or go to the nearest hospital emergency room. Do not drive to
the hospital, but ask someone to accompany you or call an ambulance. Bring the
package of medicine with you. This will allow doctors to know what you have taken.

If you forget to take Ramipril and Idroclorotiazide Aurobindo

• If you forget a dose, take the next dose as usual at the scheduled time.
• Do not take a double dose to make up for the missed tablet.

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 gets them.

If you notice any of the following serious side effects, stop taking Ramipril and Idroclorotiazide Aurobindo and consult a doctor immediately: you may need urgent medical treatment.

• Swelling of the face, lips or throat that makes it difficult to swallow or breathe, itching and skin rashes. These may be signs of a severe allergic reaction to Ramipril and Idroclorotiazide Aurobindo.
• Severe skin reactions, such as 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).

Tell your doctor immediately if you experience any of the following conditions:

• 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, cough, fever that persists for 2 or 3 days and loss of appetite. These may be signs of lung problems, including inflammation.
• Increased ease of bruising, prolonged bleeding more than usual (e.g. bleeding gums), purple spots on the skin or infections that occur more easily than usual, sore throat and fever, feeling tired, weak, dizzy or pale skin. These may be signs of problems with blood circulation or the bone marrow.
• Severe stomach pain that may spread to your back. This may 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.

Other side effects include:
Tell your doctor if any of these effects gets worse or lasts more than a few days.
Common(may affect up to 1 in 10 people)

• Headache, weakness or fatigue.
• Feeling dizzy. This is more likely to happen at the beginning of therapy with Ramipril and Idroclorotiazide Aurobindo or when you switch to a higher dose.
• Dry, irritating cough or bronchitis.
• Blood test results showing a higher than normal amount of sugar in your blood. If you have diabetes, this may worsen.
• Blood test results showing a higher than normal amount of uric acid or fats in your blood.
• Painful, red and swollen joints.

Uncommon(may affect up to 1 in 100 people)

• Skin reactions with or without swelling.
• Hot flushes, weakness, low blood pressure (excessively low blood pressure), especially when standing up or getting up quickly.
• Problems with balance (dizziness).
• Itching and abnormal skin sensations such as numbness, tingling, prickling, burning or altered sensitivity (paresthesia).
• Loss or alteration of the taste of food.
• Sleep problems.
• Depression, anxiety, increased nervousness or irritability than usual.
• Blocked nose, inflammation of the sinuses (sinusitis), shortness of breath.
• Inflammation of the gums (gingivitis), swelling of the mouth.
• Red, itchy, swollen or watery eyes.
• Tinnitus in the ears.
• Blurred vision.
• Hair loss.
• Chest pain.
• Muscle pain.
• Constipation, stomach or intestinal pain.
• Indigestion or feeling unwell.
• Producing an abnormal amount of urine during the day.
• Sweating more than usual or feeling thirsty.
• Loss or decrease of appetite (anorexia); reduced feeling of hunger.
• Fast or irregular heartbeat.
• Swelling of arms and legs. This may be a sign that the body is retaining more water than usual.
• Fever.
• Impotence in men.
• Blood test results showing a decrease in the number of red blood cells, white blood cells or platelets or the amount of hemoglobin.
• Blood test results showing an alteration in the functioning of the liver, pancreas or kidneys.
• Blood test results showing a lower than normal amount of potassium in your blood.

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

• Nausea, diarrhea or heartburn.
• Red and swollen tongue or dry mouth.
• Blood test results showing a higher than normal amount of potassium in your blood.

Not known(frequency cannot be estimated from available data)

• Concentrated urine (dark in color), nausea or vomiting, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Difficulty concentrating, restlessness or confusion.
• Change in the color of the fingers and toes when it is cold, followed by tingling or pain when warming up. This may be Raynaud's phenomenon.
• Increase in breast volume in men.
• Blood clots.
• Hearing disorders.
• Decreased tearing.
• Reduced vision and eye pain (possible signs of acute angle-closure glaucoma).
• Objects appear yellow.
• Dehydration.
• Swelling, pain and redness of the cheeks (inflammation of a salivary gland).
• A swelling of the intestine called "intestinal angioedema", which manifests with symptoms such as abdominal pain, vomiting and diarrhea.
• Increased sensitivity to the sun than usual.
• Severe peeling or detachment of the skin, itchy rashes or blisters, or other skin reactions, such as a reddish rash on the face or forehead.
• Rash or bruising.
• Spots on the skin and cold extremities.
• Problems with nails (e.g. weakening or separation of the nail from its bed).
• Musculoskeletal stiffness or inability to move the jaw (tetany).
• Weakness or muscle cramps.
• Decreased sexual desire in men or women.
• Blood in the urine. This may be a sign of a kidney problem (interstitial nephritis).
• Higher than normal amount of sugar in the urine.
• Increased number of some white blood cells (eosinophilia) detected during blood tests.
• Blood test results showing a decrease in the number of cells in the blood (pancytopenia).
• Blood test results showing a change in the amount of salts, such as sodium, calcium, magnesium and chloride in the blood.
• Slowed or impaired reflexes.
• Loss or alteration of the perception of smells.
• Difficulty breathing or worsening of asthma.
• Skin and lip cancer (non-melanoma skin cancer).

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 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 Idroclorotiazide Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, on the tablet container or on the blister after “Exp”. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
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 Hydrochlorothiazide Aurobindo contains

• The active ingredients are ramipril and hydrochlorothiazide. Each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide. Each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.
• The excipients are: pregelatinized starch, sodium stearylfumarate, sodium bicarbonate, lactose monohydrate, sodium croscarmellose.

Description of the appearance of Ramipril and Hydrochlorothiazide Aurobindo and package contents
Ramipril and Hydrochlorothiazide Aurobindo 2.5 mg/12.5 mg: flat, uncoated, capsule-shaped tablets, from white to cream-colored, 4 x 8 mm, with a dividing line on one side and the inscription
"12.5" on the other.
The dividing line is provided only to facilitate breaking and ease swallowing and not for
dividing the tablet into equal doses.
Ramipril and Hydrochlorothiazide Aurobindo 5 mg/25 mg: flat, uncoated, capsule-shaped tablets, from white to cream-colored, 5 x 10 mm, with a dividing line on one side and on both
edges and with the inscription “25” on the other side.
The tablet can be divided into two equal doses.
Ramipril and Hydrochlorothiazide Aurobindo is packaged in blisters (aluminum/aluminum) or plastic
tablet containers, with a desiccant and plastic closure.

Pack sizes:
Blisters: 10, 14, 20, 28, 30, 42, 50, 56, 60, 98 and 100 tablets.
Tablet containers: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
Coripharma ehf – Reykjavíkurvegur 78, IS-220 Hafnarfjördur – Iceland
Actavis Ltd – BLB16 Bulebel Industrial Estate – Zejtun ZTN 3000 – Malta
Actavis (Balkanpharma) Dupnitsa AD – 3 Samokovsko Schosse Str. – Dupnitsa 2600 – Bulgaria