Ramipril and hydrochlorothiazide Doc Generici: detailed information

Package leaflet: Information for the user

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics 2.5 /12.5 mg tablets, 5 /25 mg tablets

Generic Medicine
Please read all of this leaflet carefully before you start 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 yours, as 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:

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

1. What RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics is and what it is used for
RAMIPRIL and HYDROCHLOROTHIAZIDE DOC 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 may cause an increase in blood pressure
Relaxing and widening your blood vessels
Helping your heart to pump blood around the body more easily

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 kidneys. This lowers blood pressure.

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC 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 DOC Generics

Do not take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics

If you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
If you are allergic (hypersensitive) to medicines similar to RAMIPRIL and HYDROCHLOROTHIAZIDE DOC 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 had 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 DOC 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).
During the last 6 months of pregnancy (see section below "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.

Do not take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics if any of the above conditions apply to you. If you are unsure, consult your doctor before taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics.

Warnings and precautions

Talk to your doctor or pharmacist before taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC 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, diarrhea, excessive sweating, following a low-salt diet, long-term use of oral diuretics, or after dialysis).
If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
If you are about to undergo anesthesia that may be administered during surgery or dental procedures. You may need to stop taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics the day before; consult your doctor.
If you have high levels of potassium in your blood (detected by a blood test).
If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
You must inform your doctor if you think you may be pregnant (or could become pregnant). RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended during the first trimester of pregnancy and may cause serious harm to the fetus after the first three months of pregnancy (see section "Pregnancy and breastfeeding").
If you experience a decrease in vision or eye pain. These may be symptoms of increased intraocular pressure and may occur within hours or weeks after starting ramipril/hydrochlorothiazide. This may lead to permanent vision loss if not treated.
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), particularly if you have kidney problems related to diabetes.
- aliskiren.

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 DOC Generics".

Children and adolescents
RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics in children have not yet been established.

If any of the above conditions apply to you or if you are unsure, consult your doctor before taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics.

Other medicines and RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may affect the action of certain other medicines. Likewise, some medicines may affect the action of RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics.

Tell your doctor if you are taking any of the following medicines. These may interfere with RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics, altering 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.

Tell your doctor if you are taking any of the following medicines. When taken together with RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics, these 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 check if your adrenal glands are functioning properly).
Medicines for cancer (chemotherapy).
Medicines for heart problems, including heart rhythm disorders.
Medicines to prevent organ rejection after transplantation, such as cyclosporine.
Diuretics such as furosemide.
Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (used to make the blood less likely to clot).
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 fat levels in the blood).
Carbamazepine (for epilepsy).
Vildagliptin (for diabetes).
Trimethoprim and cotrimoxazole (for bacterial infections).
Temsirolimus (for cancer).
Everolimus (to prevent graft rejection).

Tell your doctor if you are taking any of the following medicines. The action of these medicines may be affected by RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics:

Medicines for diabetes, such as oral hypoglycemics and insulin. RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may lower blood sugar levels. Monitor your blood sugar levels carefully when taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics.
Lithium (for psychiatric conditions). RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels closely.
Muscle relaxants.
Quinine (for the treatment of malaria).
Medicines containing iodine, which may be used in hospital before X-ray or scanning procedures.
Penicillin (for treating infections).
Oral anticoagulants (blood thinners) such as warfarin.

If any of the above conditions apply to you (or if you are unsure), consult your doctor before taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics.

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics" and "Warnings and precautions").

Monitoring

Talk to your doctor or pharmacist before taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics:

If you are undergoing testing for parathyroid function. RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may alter test results.
If you are an athlete undergoing anti-doping testing. RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may produce a positive test result.

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics with food and alcohol

Drinking alcoholic beverages together with RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics, discuss this with your doctor. Alcohol may enhance the effects of blood pressure-lowering medicines.
RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics can be taken with or without food.

Pregnancy and breastfeeding

You must inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as it may harm the unborn child.
If you become pregnant while taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine.
You must not take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics if you are breastfeeding.

Driving and using machines

You may experience dizziness while taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics. This is more likely when you first start taking the medicine or have just increased the dose. If this occurs, do not drive or operate tools or machinery.

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics contains lactose monohydrate

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Taking this medicine

Take the medicine by mouth 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 population
Your doctor will reduce the initial dose and adjust treatment more slowly.

If you take more RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici than you should
Inform 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, so the doctor knows what you have taken.

If you forget to take RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici

If you forget 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Like all medicines, RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics may cause side effects, although not everyone experiences them.
Stop taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics and contact your doctor immediately if you notice any of the following serious side effects – 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 severe allergic reaction to RAMIPRIL and HYDROCHLOROTHIAZIDE DOC 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, tightness in the chest, or more serious problems such as heart attack or 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, any signs of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy, weak, or pale appearance. These may be signs of blood or bone marrow disorders.
Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.
Common (may affect up to 1 in 10 people)

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, swollen joints.
Headache or feeling weak or tired.
Dizziness. This is more likely when treatment with RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generics has just started or the dose has recently been increased.
Dry, persistent cough or bronchitis.

Uncommon (may affect up to 1 in 100 people)

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

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

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

Not known (frequency cannot be estimated from the available data)
Concentrated (dark-colored) urine, feeling unwell, muscle cramps, confusion and seizures which may be due to inappropriate secretion of ADH (anti-diuretic hormone [antidiuretic hormone]). If you experience these symptoms, contact your doctor promptly.
Other reported side effects:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.

Increase in certain white blood cells (eosinophilia) detected in blood tests.
Too low number of blood cells shown by blood tests (pancytopenia).
Changes in levels of electrolytes such as sodium, calcium, magnesium and chloride in the blood, shown by blood tests.
Higher than normal sugar levels in urine.
Dehydration.
Difficulty concentrating, feeling restless or confused.
Slowed or altered reactions.
Changes in sense of smell.
Objects appearing yellow.
Eyes less moist than normal.
Severe eye pain with redness and sudden blurred vision (possible signs of acute angle-closure glaucoma). If you suddenly develop a red, painful eye, contact your doctor immediately; treatment may be needed to prevent permanent vision loss.
Hearing disturbances.
Blood clots.
Fingers of hands and feet changing color when cold, with tingling and pain upon warming (Raynaud's phenomenon).
Breathing difficulties or worsening of asthma.
Intestinal swelling called "intestinal angioedema", presenting with symptoms such as abdominal pain, vomiting and diarrhea.
Swelling, pain and paleness of the cheeks (inflammation of a salivary gland).
Skin spots and cold extremities.
Skin rash or bruising.
Severe peeling or shedding of the skin, itching, rash or other skin reactions such as facial redness or redness of the forehead.
Increased sensitivity to sunlight.
Nail problems (such as nail loss or separation of the nail from its bed).
Muscle weakness or cramps.
Musculoskeletal stiffness or inability to move the jaw (tetanus).
Presence of blood in the urine. This may be a sign of kidney problems (interstitial nephritis).
Reduced sexual desire in men and women.
Breast enlargement in men.

Reporting of side effects
If you experience any side effect, 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 http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici contains

The active substances are ramipril and hydrochlorothiazide. One tablet contains either 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide, or 5 mg of ramipril and 25 mg of hydrochlorothiazide.
The other components are monohydrate lactose, hypromellose ( E464 ), crospovidone ( E1202 ), microcrystalline cellulose and sodium stearil fumarate.

Description of the appearance of RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici and contents of the
pack

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 2.5/12.5 mg tablets:
White, capsule-shaped tablet. Scored with a break line on both sides; on one side the numbers “2.5” and “12.5” appear on both sides of the break line. The tablet can be divided into equal parts.

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 5/25 mg tablets:
White, capsule-shaped tablet. Scored with a break line on both sides; on one side the numbers “5” and “25” appear on both sides of the break line. The tablet can be divided into equal parts.

The tablets are packaged in blisters containing 7, 10, 14, 20, 28, 50, 98, 100, 2x14, 300 (10x30) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
allphamed Pharbil Arzneimittel GmbH
Hildebrandstr. 12
37081 Göttingen
Germany

Lamp San Prospero S.p.A.
Via della Pace 25/A
41030 San Prospero (MO)
Italy

This medicinal product is authorized in the European Economic Area countries under the following
names:
Netherlands: RAMIPRIL HCT DOC Generici 2.5/12.5, tabletten and RAMIPRIL HCT DOC Generici 5/25, tabletten
Italy: RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 2.5/12.5 mg tablets and RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 5/25 mg tablets