Ramipril and hydrochlorothiazide Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ramipril and Hydrochlorothiazide Mylan Generics 2.5 mg / 12.5 mg tablets, 5 mg / 25 mg tablets

Generic medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT RAMIPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS IS AND WHAT IT IS USED FOR

WHAT IT IS USED FOR
Ramipril and Hydrochlorothiazide Mylan Generics 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). It works by:

• Reducing the body's production of substances that can cause an increase in blood pressure
• Relaxing and widening your blood vessels
• Helping your heart pump blood more easily 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) that is produced. This lowers blood pressure.
Ramipril and Hydrochlorothiazide Mylan Generics is used to treat high blood pressure (hypertension). The two active substances work together to lower blood pressure. They are used in combination when treatment with either component alone is not effective.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RAMIPRIL AND

HYDROCHLOROTHIAZIDE MYLAN GENERICS
Do not take Ramipril and Hydrochlorothiazide Mylan Generics:

• If you are allergic (hypersensitive) to ramipril, hydrochlorothiazide, or any of the excipients of Ramipril and Hydrochlorothiazide Mylan Generics (see section 6)
• If you are allergic (hypersensitive) to medicines similar to Ramipril and Hydrochlorothiazide Mylan Generics (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 experienced a severe allergic reaction called “angioedema”. Symptoms 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 or swallowing.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril and Hydrochlorothiazide Mylan Generics may not be suitable for you.
• 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).
• If you are more than 3 months pregnant (avoid taking Ramipril and Hydrochlorothiazide Mylan Generics even in early pregnancy – see section “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section below “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 chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as in the throat).

Do not take Ramipril and Hydrochlorothiazide Mylan Generics if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Ramipril and Hydrochlorothiazide Mylan Generics.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril and Hydrochlorothiazide Mylan Generics:

• 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, diarrhoea, excessive sweating, or due to a low-salt diet, or from long-term use of oral diuretics, or after undergoing dialysis).

• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).

• If you are about to undergo anaesthesia that may be administered during surgery or dental procedures. You may need to stop taking Ramipril and Hydrochlorothiazide Mylan Generics the day before – consult your doctor.

• If you have high levels of potassium in your blood (shown by a blood test).

• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.

• You must inform your doctor if you think you are pregnant (or could become pregnant). Ramipril and Hydrochlorothiazide Mylan Generics is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby (see section “Pregnancy and breastfeeding”).

• If you experience vision loss or eye pain, especially if you are at risk of developing a condition called glaucoma or have an allergy to penicillin or sulfonamide-containing medicines.

• If you are taking any of the following medicines used to treat high blood pressure: or an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes; or aliskiren.

• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, such as in the throat) may be increased: or racecadotril, a medicine used to treat diarrhoea; or medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus); or vildagliptin, a medicine used to treat diabetes.

• If you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Ramipril and Hydrochlorothiazide Mylan Generics.

Your doctor may check 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 Hydrochlorothiazide Mylan Generics”
Children
Ramipril and Hydrochlorothiazide Mylan Generics is not recommended for children and adolescents under 18 years of age, as this medicine has never been studied in this age group.
If any of the above conditions apply to you or if you are unsure, consult your doctor before taking Ramipril and Hydrochlorothiazide Mylan Generics.
Other medicines and Ramipril and Hydrochlorothiazide Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril and Hydrochlorothiazide Mylan Generics may affect the action of certain other medicines. In addition, some medicines may affect the action of Ramipril and Hydrochlorothiazide Mylan Generics.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Ramipril and Hydrochlorothiazide Mylan Generics and alter its effect:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, 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.

Inform your doctor if you are taking any of the following medicines. Taking these medicines together with Ramipril and Hydrochlorothiazide Mylan Generics may increase the likelihood of side effects:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Medicines that may lower potassium levels in the blood. These include laxatives, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to assess whether your adrenal glands are functioning properly)
• Medicines for cancer (chemotherapy)
• Medicines for heart problems, including heart rhythm disorders
• Diuretics such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), angiotensin receptor blockers, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole 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 used to treat inflammation, such as prednisolone
• Calcium supplements
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems)
• Cholestyramine (to reduce blood fat levels)
• Carbamazepine (for treating epilepsy)
• Temsirolimus (used for cancer), see section “Warnings and precautions”
• Sacubitril/valsartan, a medicine used to treat chronic heart failure in adults. See section “Do not take Ramipril and Hydrochlorothiazide Mylan Generics”
• Vildagliptin (a medicine used to treat type 2 diabetes), see section “Warnings and precautions”
• Racecadotril (a medicine used to treat diarrhoea), see section “Warnings and precautions”
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by Ramipril and Hydrochlorothiazide Mylan Generics:

• Medicines for diabetes such as oral hypoglycaemics and insulin. Ramipril and Hydrochlorothiazide Mylan Generics may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Ramipril and Hydrochlorothiazide Mylan Generics.
• Lithium (for psychiatric conditions). Ramipril and Hydrochlorothiazide Mylan Generics may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
• Muscle relaxants
• Quinine (for treating malaria)
• Medicines containing iodine, which may be used in hospital before X-ray or scanning procedures
• Penicillin (for treating infections)
• Oral anticoagulants (medicines that thin the blood), such as warfarin.

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 sections “Do not take Ramipril and Hydrochlorothiazide Mylan Generics” and “Warnings and precautions”)

If any of the above conditions apply (or if you are unsure), consult your doctor before taking Ramipril and Hydrochlorothiazide Mylan Generics.
Monitoring
Inform your doctor or pharmacist before taking this medicine.

• If you are undergoing tests for parathyroid function. Ramipril and Hydrochlorothiazide Mylan Generics may alter the test results.
• If you are an athlete required to undergo anti-doping testing. Ramipril and Hydrochlorothiazide Mylan Generics may result in a positive test.

Taking Ramipril and Hydrochlorothiazide Mylan Generics with food and alcohol

• Drinking alcoholic beverages together with Ramipril and Hydrochlorothiazide Mylan Generics may cause dizziness or lightheadedness. If you wish to know how much alcohol you can consume while taking Ramipril and Hydrochlorothiazide Mylan Generics, discuss this with your doctor. Alcohol may enhance the effects of blood pressure-lowering medicines.
• Ramipril and Hydrochlorothiazide Mylan Generics can be taken with or without food.

Pregnancy and breastfeeding
Ramipril:
Pregnancy
Inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Ramipril and Hydrochlorothiazide Mylan Generics before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Ramipril and Hydrochlorothiazide Mylan Generics is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn baby if used after the third month of pregnancy.
Hydrochlorothiazide:
Inform your doctor if you are pregnant or think you may be pregnant. Your doctor will usually recommend an alternative medicine, as Ramipril and Hydrochlorothiazide Mylan Generics is not recommended during pregnancy. This is because Ramipril and Hydrochlorothiazide Mylan Generics crosses the placenta and its use after the third month of pregnancy may cause potential harm to the fetus and effects on the newborn.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Ramipril and Hydrochlorothiazide Mylan Generics is contraindicated for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.
Driving and using machines
You may experience dizziness while taking Ramipril and Hydrochlorothiazide Mylan Generics. This is more likely when you first start taking the medicine or after a dose increase. If this occurs, do not drive or operate tools or machinery.
Important information about some excipients of Ramipril and Hydrochlorothiazide Mylan Generics
Ramipril and Hydrochlorothiazide Mylan Generics contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. HOW TO TAKE RAMIPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS

Always take Ramipril and Hydrochlorothiazide Mylan Generics exactly as your doctor has instructed.
If you are unsure, ask your doctor or pharmacist for advice.
Taking this medicine

• Take the medicine orally at the same time each day, usually in the morning.
• Swallow the tablets whole with a liquid.
• Do not break or chew the tablets.

How much to take
Treatment of high blood pressure
Your doctor will adjust your dose until your blood pressure is under control.
Elderly patients
Your doctor will reduce the initial dose and adjust treatment more slowly.
If you take more RAMIPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS than you should
Contact your doctor or go to the nearest hospital emergency department immediately. Do not drive
to the hospital; have someone drive you or call an ambulance. Bring the medicine pack with you,
as the doctor needs to know what you have taken.
If you forget to take RAMIPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Ramipril and Hydrochlorothiazide Mylan Generics may cause adverse reactions, although not everybody gets them.

Stop taking Ramipril and Hydrochlorothiazide Mylan Generics and contact your doctor immediately if you experience any of the following serious adverse reactions – you may need urgent medical treatment:

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Ramipril and Hydrochlorothiazide Mylan Generics.
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blistering, and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid or irregular heartbeat (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Shortness of breath, cough, fever lasting 2 to 3 days, and reduced appetite. These may be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding, signs of bleeding (e.g., bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat, fever, fatigue, weakness, dizziness, or pale appearance. These may indicate 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 pain, malaise, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other adverse reactions include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.

Common (affects less than 1 in 10 patients treated)

• Headache or feeling weak or tired
• Dizziness. This is more likely when treatment with Ramipril and Hydrochlorothiazide Mylan Generics has just started or the dose has recently been increased
• Dry, persistent cough or bronchitis
• Blood tests show higher than normal blood sugar levels. If you have diabetes, this may worsen
• Blood tests show higher than normal levels of uric acid or fats
• Painful, red, and swollen joints

Uncommon (affects less than 1 in 100 patients treated)

• Rash with or without swelling
• Flushing, weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling, or burning (paresthesia)
• Loss or change in taste
• Sleep disturbances
• Depressed mood, anxiety, increased nervousness, or irritability
• Stuffy nose, sinus inflammation (sinusitis), shortness of breath
• Gum inflammation (gingivitis), mouth swelling
• Red, swollen, watery, or itchy eyes
• Ringing in the ears
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach or intestinal pain
• Indigestion or feeling unwell
• Increased amount of urine during the day
• Increased sweating or thirst
• Loss or decrease in appetite (anorexia), reduced sense of hunger
• Rapid or irregular heartbeat
• Swollen arms and legs. This may indicate that your body is retaining more fluid than usual
• Fever
• Impotence in males
• Decreased number of red blood cells, white blood cells, platelets, or hemoglobin concentration, as shown by blood tests
• Changes in liver, pancreas, or kidney function as indicated by blood tests
• Blood tests show lower than normal potassium levels

Very rare (affects less than 1 in 10,000 patients treated)

• Feeling unwell, causing diarrhea or stomach burning
• Swollen and red tongue or dry mouth
• Blood tests show higher than normal potassium levels

Not known

• Concentrated (dark-colored) urine, malaise, muscle cramps, confusion, and seizures that may be due to inappropriate production of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly. Skin and lip cancer (non-melanoma skin cancer)

Other adverse reactions reported:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.

• Difficulty concentrating, restlessness, or confusion
• Fingers of hands and feet changing color when cold, and tingling or pain when warmed (Raynaud's phenomenon)
• Breast enlargement in males
• Blood clots
• Hearing disturbances
• Eyes less moist than usual
• Objects appearing yellow
• Dehydration
• Swelling, pain, and paleness 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 flaking of the skin, itching, rash, or other skin reactions such as redness of the face or forehead
• Skin rash or bruising
• Spots on the skin and cold extremities
• Nail problems (such as nail loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetanus-like symptoms)
• Muscle weakness or cramps
• Reduced sexual desire in men and women
• Presence of blood in the urine. This could be a sign of kidney problems (interstitial nephritis)
• Increased amount of sugar in the urine
• Increased number of certain white blood cells (eosinophilia) found in blood tests
• Too low number of blood cells as shown by blood tests (pancytopenia)
• Changes in blood levels of electrolytes such as sodium, calcium, magnesium, and chloride as shown by blood tests
• Slowed or altered reactions
• Changes in the sense of smell
• Breathing difficulties or worsening of asthma

If you experience any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE RAMIPRIL AND HYDROCHLOROTHIAZIDE MYLAN GENERICS

Keep Ramipril and Hydrochlorothiazide Mylan Generics out of the sight and reach of children.
Do not store Ramipril and Hydrochlorothiazide Mylan Generics above 30°C.
Do not use Ramipril and Hydrochlorothiazide Mylan Generics after the expiry date stated on the
blister and plastic container. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Ramipril and Hydrochlorothiazide Mylan Generics contains

• The active substances in the combination preparation ramipril and hydrochlorothiazide are ramipril and hydrochlorothiazide 2.5 mg/12.5 mg and 5 mg/25 mg.
• The excipients are: sodium bicarbonate, monohydrate lactose, sodium croscarmellose, pregelatinized corn starch, sodium stearil fumarate.

Description of the appearance of Ramipril and Hydrochlorothiazide Mylan Generics and contents of the pack
Appearance of the tablets:
Ramipril and Hydrochlorothiazide Mylan Generics 2.5 mg/12.5 mg:
Capsule-shaped, flat, uncoated tablet, white to off-white, with a score on one side and the number "12.5" in relief on the other side, size 4 x 8 mm.
The tablet is not intended to be divided into two equal parts.
Ramipril and Hydrochlorothiazide Mylan Generics 5 mg/25 mg:
Capsule-shaped, flat, uncoated tablet, white to off-white, with a score on one side and the number "25" in relief on the other side, size 5 x 10 mm.
The tablet can be divided into two equal parts.
Packs:
Blister packs and plastic containers: 10, 14, 20, 28, 30, 42, 50, 98, 100 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani, 20 – 20124 Milano, Italy
Manufacturers responsible for batch release
Actavis Ltd.
B16, Bulebel Industrial Estate, Zejtun ZTN 08, Malta
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