Ramipril and hydrochlorothiazide Aurobindo

Package leaflet: Information for the user

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

Read all of 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. Never give it to others, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, 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 taking 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 Ramipril and Hydrochlorothiazide Aurobindo is and what it is used for

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

• Reducing the body's production of substances that may cause an increase in blood pressure.
• Helping blood vessels to relax and widen.
• Assisting your heart in pumping blood throughout 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 blood pressure.
Ramipril and Hydrochlorothiazide Aurobindo is used to treat high blood pressure (hypertension). The two active substances work together to reduce blood pressure. They are used in combination when treatment with only one of the two medicines is not effective.

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 sulfonamide-derived medicines).
• Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have previously had a severe allergic reaction called "angioedema". Symptoms may include itching, skin rash (urticaria), red patches 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 diarrhoea;
• 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 equipment used, taking 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 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 a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

If any of these apply to you, do not take Ramipril and Hydrochlorothiazide Aurobindo.
If you are in doubt, 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 large amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, low-sodium diet, prolonged use of oral diuretics, or dialysis).
• If you are undergoing treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are due to receive anaesthesia, for example for surgery or a dental procedure. You may need to stop taking 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 may be pregnant (or if there is a possibility of becoming pregnant).
• Ramipril and Hydrochlorothiazide Aurobindo is not recommended during the first three months of pregnancy and may cause serious harm to the unborn baby if taken after the third month of pregnancy (see Pregnancy and breastfeeding).
• The active ingredient hydrochlorothiazide may cause an unusual adverse reaction leading to reduced vision and eye pain. These could be symptoms of increased eye pressure and may occur within a few hours up to several weeks after taking Ramipril and Hydrochlorothiazide Aurobindo. If untreated, this may lead to permanent vision 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 have kidney problems related to diabetes;
• aliskiren.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, for example in the throat) is higher:
• sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).
• If you have previously had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Ramipril and Hydrochlorothiazide Aurobindo.

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 information under the heading “Do not take Ramipril and Hydrochlorothiazide Aurobindo”.
If any of these situations apply to you (or you are unsure), talk to 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 18 years of age. This 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 might take any other medicines, including those not requiring a prescription (including herbal remedies). Ramipril and Hydrochlorothiazide Aurobindo may affect the action of some medicines. In addition, some medicines may affect the action of Ramipril and Hydrochlorothiazide Aurobindo.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information 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 effectiveness of Ramipril and Hydrochlorothiazide Aurobindo:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, 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.

Tell your doctor if you are taking any of the following medicines, which may increase the likelihood 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 indometacine and aspirin).
• Medicines that may reduce potassium levels in the blood. These include laxatives, diuretics, amphotericin B (used to treat fungal infections), and ACTH (used to test proper adrenal gland function).
• Medicines for cancer (chemotherapy).
• Medicines for heart problems, including heart rhythm disorders.
• Medicines to prevent rejection of transplanted organs, such as ciclosporin.
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene, amiloride), and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs; heparin, a medicine used to thin the blood and prevent clotting).
• Steroid medicines used 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 blood fat levels).
• Carbamazepine (for epilepsy).
• Temsirolimus (for cancer).
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other 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 hypoglycaemics and insulin. Ramipril and Hydrochlorothiazide Aurobindo may reduce blood sugar levels. During treatment with Ramipril and Hydrochlorothiazide Aurobindo, monitor your blood sugar levels carefully.
• Lithium (for mental health conditions). Ramipril and Hydrochlorothiazide Aurobindo may increase lithium levels in the blood. Your doctor will need to monitor lithium levels closely.
• Medicines used to relax muscles.
• Quinine (for treatment of malaria).
• Medicines containing iodine, which may be used during X-ray examinations or scans.
• Penicillin (for infections).
• Oral anticoagulant medicines (blood thinners), such as warfarin.
• Vildagliptin (for type 2 diabetes).

If any of these conditions apply to you (or if you are in doubt), consult your doctor before
taking Ramipril and Hydrochlorothiazide Aurobindo.
Tests
Consult your doctor or pharmacist before taking this medicine:

• If you are undergoing a test to assess parathyroid function. Ramipril and Hydrochlorothiazide Aurobindo may alter test results.
• If you are an athlete and are subject to anti-doping testing. Ramipril and Hydrochlorothiazide Aurobindo may lead to a positive test 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 any doubts about how much alcohol you can consume while taking Ramipril and Hydrochlorothiazide Aurobindo, discuss this with your doctor. Alcohol may enhance 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must inform 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 during the first 12 weeks of pregnancy, and must not take it at all after the 13th week, as use during pregnancy may harm the unborn baby.
Inform your doctor immediately if you become pregnant while being treated with Ramipril and Hydrochlorothiazide Aurobindo. Before planning a pregnancy, you will need to switch to an appropriate alternative treatment.
You must not take Ramipril and Hydrochlorothiazide Aurobindo if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Ramipril and Hydrochlorothiazide Aurobindo may cause dizziness. This is more likely at the start 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 certain sugars, consult him before taking this medicine.

3. How to take Ramipril and Hydrochlorothiazide Aurobindo

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Taking this medicine

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

Recommended dose:
Treatment of high blood pressure
Your doctor will adjust the amount of medicine you need to take until your blood pressure is under control.
Elderly patients
Your doctor will reduce the initial dose and adjust the doses more gradually.
If you take more Ramipril and Hydrochlorothiazide Aurobindo than you should
Contact your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital; instead, ask someone to accompany you or call an ambulance. Take the medicine pack with you. This will allow the doctors to see what you have taken.
If you forget to take Ramipril and Hydrochlorothiazide Aurobindo

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

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

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, itching, and skin rashes. These could be signs of a severe allergic reaction to Ramipril and Hydrochlorothiazide Aurobindo.
• Severe skin reactions, such as rash, mouth ulcers, 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).

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

• Rapid, irregular, or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath, cough, fever lasting for 2 or 3 days, and reduced appetite. These could be signs of lung problems, including inflammation.
• Increased tendency to bruise easily, prolonged bleeding more than usual (e.g. bleeding gums), purple spots on the skin, or infections occurring more frequently than usual, sore throat and fever, feeling tired, weakness, dizziness, or pale skin. These may be signs of blood or bone marrow disorders.
• Severe stomach pain that may spread to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach discomfort, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Tell your doctor if any of the following side effects worsen or last longer than a few days.
Common (may affect up to 1 in 10 people)

• Headache, weakness, or fatigue.
• Dizziness. This is more likely to occur at the beginning of treatment with Ramipril and Hydrochlorothiazide Aurobindo or when increasing to a higher dose.
• Dry, persistent cough or bronchitis.
• Blood test results showing higher than normal levels of sugar in the blood. If you have diabetes, this may worsen.
• Blood test results showing higher than normal levels of uric acid or fats in the blood.
• Painful, red, and swollen joints.

Uncommon (may affect up to 1 in 100 people)

• Skin reactions with or without swelling.
• Hot flushes, weakness, hypotension (excessively low blood pressure), especially when standing up or getting up quickly.
• Balance problems (dizziness).
• Itching and abnormal skin sensations such as numbness, tingling, pricking, burning, or altered sensitivity (paresthesia).
• Loss or change in taste.
• Sleep problems.
• Depression, anxiety, increased nervousness, or irritability.
• Stuffy nose, inflammation of the sinuses (sinusitis), shortness of breath.
• Inflammation of the gums (gingivitis), swelling of the mouth.
• Red, itchy, swollen, or watery eyes.
• Ringing in the ears (tinnitus).
• Blurred vision.
• Hair loss.
• Chest pain.
• Muscle pain.
• Constipation, stomach or intestinal pain.
• Indigestion or feeling unwell.
• Production of an abnormal amount of urine during the day.
• Excessive sweating or feeling thirsty.
• Loss or reduction of appetite (anorexia); reduced sense of hunger.
• Rapid or irregular heartbeat.
• Swelling of arms and legs. This may be a sign that your body is retaining more fluid than usual.
• Fever.
• Sexual dysfunction in men.
• Blood test results showing a reduced number of red blood cells, white blood cells, or platelets, or reduced hemoglobin levels.
• Blood test results indicating impaired liver, pancreas, or kidney function.
• Blood test results showing lower than normal potassium levels in the blood.

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

• Nausea, diarrhea, or gastric burning.
• Red and swollen tongue or dry mouth.
• Blood test results showing higher than normal potassium levels in the blood.

Not known (frequency cannot be estimated from available data)

• Concentrated urine (dark in color), nausea or vomiting, muscle cramps, confusion, and seizures, 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.
• Changes in the colour of fingers and toes when exposed to cold, followed by tingling or pain upon warming. This may be Raynaud's phenomenon.
• Breast enlargement in men.
• Blood clots.
• Hearing disorders.
• Reduced tear production.
• Reduced vision and eye pain (possible signs of acute angle-closure glaucoma).
• Objects appearing yellow.
• Dehydration.
• Swelling, pain, and redness of the cheeks (inflammation of a salivary gland).
• Intestinal swelling called "intestinal angioedema," presenting with symptoms such as abdominal pain, vomiting, and diarrhea.
• Increased sensitivity to sunlight.
• Severe peeling or shedding of the skin, itchy rashes or hives, or other skin reactions such as a red rash on the face or forehead.
• Skin rash or bruising.
• Spots on the skin and cold extremities.
• Nail problems (e.g. weakening or separation of the nail from its bed).
• Musculoskeletal stiffness or inability to move the jaw (tetany).
• Muscle weakness or cramps.
• Reduced sexual desire in men or women.
• Presence of blood in the urine. This could be a sign of a kidney problem (interstitial nephritis).
• Higher than normal levels of sugar in the urine.
• Increased number of certain white blood cells (eosinophilia) detected during blood tests.
• Blood test results showing lower than normal levels of blood cells (pancytopenia).
• Blood test results showing changes in levels of electrolytes such as sodium, calcium, magnesium, and chloride in the blood.
• Slowed or impaired reflexes.
• Loss or change in the sense of smell.
• Difficulty breathing or worsening of asthma.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Ramipril and Hydrochlorothiazide 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, container for tablets or blister after "Exp". The expiry date refers to the last day of the month.
Store below 25°C.
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. Contents of the pack and other information

What Ramipril and Hydrochlorothiazide Aurobindo contains

• The active substances 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 stearyl fumarate, sodium bicarbonate, lactose monohydrate, sodium croscarmellose.

Description of the appearance of Ramipril and Hydrochlorothiazide Aurobindo and contents of the pack
Ramipril and Hydrochlorothiazide Aurobindo 2.5 mg/12.5 mg: flat, uncoated, capsule-shaped tablets, white to cream in colour, 4 x 8 mm, with a score line on one side and engraved "12.5" on the other.
The score line is provided only to facilitate breaking the tablet and swallowing, and not to divide the tablet into equal doses.
Ramipril and Hydrochlorothiazide Aurobindo 5 mg/25 mg: flat, uncoated, capsule-shaped tablets, white to cream in colour, 5 x 10 mm, with a score line on one side and on both edges, and engraved "25" on the other side.
The tablet can be divided into two equal doses.
Ramipril and Hydrochlorothiazide Aurobindo is packed in blisters (aluminium/aluminium) or plastic containers for tablets, with desiccant and plastic closure.
Pack sizes:
Blister packs: 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 Authorization 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