RAMIPRIL 2.5 mg/12.5 mg Tabletka powlekana

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1. RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 2.5 /12.5 mg tablets
   1. What is RAMIPRIL and IDROCLOROTIAZIDE DOC Generici and what is it used for
   2. What you need to know before taking RAMIPRIL and IDROCLOROTIAZIDE DOC Generici
   3. How to take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici
   4. Possible side effects
   5. How to store RAMIPRIL and IDROCLOROTIAZIDE DOC Generici
   6. Package contents and other information

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 2.5 /12.5 mg tablets

RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 5 /25 mg tablets
Generic Equivalent Medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, 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:

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

1. What is RAMIPRIL and IDROCLOROTIAZIDE DOC Generici and what is it used for

RAMIPRIL and IDROCLOROTIAZIDE DOC Generici is a combination of two medicines called
ramipril and idroclorothiazide.
Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors). It works:

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

Idroclorothiazide 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 IDROCLOROTIAZIDE DOC Generici is used to treat high blood pressure
(hypertension). The two active ingredients work together to lower blood pressure. They are
used in combination when treatment with a single component does not work.

2. What you need to know before taking RAMIPRIL and IDROCLOROTIAZIDE DOC Generici

Do not take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici

• 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 drugs similar to RAMIPRIL and IDROCLOROTIAZIDE DOC Generici (other ACE inhibitors or sulfonamide-derived medicines). Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• If you have had a serious allergic reaction called “angioedema”. These signs include itching, skin rash (hives), red patches on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you are on dialysis or undergoing any other type of blood filtration. Depending on the machinery used, RAMIPRIL and IDROCLOROTIAZIDE DOC Generici 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici if any of the above conditions apply to you.
If you are not sure, ask your doctor before taking RAMIPRIL and IDROCLOROTIAZIDE
DOC Generici.

Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL and IDROCLOROTIAZIDE DOC
Generici

• 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, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis)
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization)
• If you are about to have anesthesia that may be given for surgery or dental treatment. It may be necessary to stop treatment with RAMIPRIL and IDROCLOROTIAZIDE DOC Generici the day before, ask your doctor for advice
• If you have a high amount of potassium in your blood (shown by a blood test)
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must tell your doctor if you think you may be pregnant (or might become pregnant). RAMIPRIL and IDROCLOROTIAZIDE DOC Generici is not recommended during the first trimester of pregnancy and can cause serious harm to the baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you experience decreased vision or eye pain. These may be symptoms of increased pressure in the eye and may occur within hours or weeks of taking ramipril/hydrochlorothiazide. This can lead to permanent vision impairment 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), especially if you suffer from kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported in the section “Do not take RAMIPRIL and IDROCLOROTIAZIDE DOC
Generici”.

Children and adolescents
RAMIPRIL and IDROCLOROTIAZIDE DOC Generici is not recommended for use in children and
adolescents under 18 years of age because the safety and efficacy of RAMIPRIL and
IDROCLOROTIAZIDE DOC Generici in children have not yet been established.
If any of the above conditions occur or you are not sure, ask your doctor before taking
RAMIPRIL and IDROCLOROTIAZIDE DOC Generici.

Other medicines and RAMIPRIL and IDROCLOROTIAZIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because RAMIPRIL and IDROCLOROTIAZIDE DOC Generici can
influence the mechanism of action of some other medicines. Also, some medicines can
influence the mechanism of action of RAMIPRIL and IDROCLOROTIAZIDE DOC Generici.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere with
RAMIPRIL and IDROCLOROTIAZIDE DOC Generici by altering its action:

• 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, norepinephrine or epinephrine. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, when taken with
RAMIPRIL and IDROCLOROTIAZIDE DOC Generici, may increase the likelihood of adverse effects:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Medicines that can lower the amount of potassium in your blood. These include medicines for constipation, diuretics, amphotericin B (used for fungal infections) and adrenocorticotropic hormone (used to check if your adrenal glands are working properly)
• Cancer medicines (chemotherapy)
• Medicines for heart problems, including heart rhythm problems
• Medicines to prevent organ rejection after transplantation such as cyclosporine
• Diuretics such as furosemide
• Medicines that can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to make the blood more fluid)
• Steroid medicines for treating inflammation such as prednisolone
• Calcium supplements
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems)
• Cholestyramine (to reduce the amount of fat in the blood)
• Carbamazepine (for the treatment of epilepsy)
• Vildagliptin (for diabetes).
• Trimethoprim and cotrimoxazole (for bacterial infections)
• Temozolomide (for cancer)
• Everolimus (to prevent graft rejection).

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

• Diabetes medicines such as oral hypoglycemic agents and insulin. RAMIPRIL and IDROCLOROTIAZIDE DOC Generici can lower blood sugar levels. Carefully check your blood sugar levels when taking RAMIPRIL and IDROCLOROTIAZIDE DOC Generici.
• Lithium (for psychiatric problems). RAMIPRIL and IDROCLOROTIAZIDE DOC Generici can increase the amount of lithium in your blood. Your lithium levels in your blood must be carefully monitored by your doctor.
• Muscle relaxants
• Quinine (for the treatment of malaria)
• Medicines containing iodine, these may be used in hospital before an X-ray or scan
• Penicillin (for the treatment of infections)
• Oral blood thinners (oral anticoagulants) such as warfarin.

If any of the above conditions occur (or you are not sure), ask your doctor before taking
RAMIPRIL and IDROCLOROTIAZIDE DOC Generici.
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
“Do not take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici” and
“Warnings and precautions”).

Checks
Talk to your doctor or pharmacist before taking RAMIPRIL and IDROCLOROTIAZIDE DOC
Generici:

• If you are having a check for parathyroid function. RAMIPRIL and IDROCLOROTIAZIDE DOC Generici may alter the results of the check
• If you are an athlete who needs to undergo doping control. RAMIPRIL and IDROCLOROTIAZIDE DOC Generici may give a positive result.

RAMIPRIL and IDROCLOROTIAZIDE DOC Generici with food and alcohol

• Drinking alcoholic beverages with RAMIPRIL and IDROCLOROTIAZIDE DOC Generici may cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking RAMIPRIL and IDROCLOROTIAZIDE DOC Generici, discuss it with your doctor. In fact, alcohol increases the effects of blood pressure medications.
• Taking RAMIPRIL and IDROCLOROTIAZIDE DOC Generici can be done with or without food.

Pregnancy and breastfeeding
You must tell your doctor if you think you may be pregnant (or might become pregnant).
You must not take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici in the first 12 weeks of
pregnancy and must absolutely not take it after the thirteenth week because its use could be
harmful to the baby.
If you become pregnant while taking RAMIPRIL and IDROCLOROTIAZIDE DOC Generici, inform
your doctor immediately.
Before planning a pregnancy, a switch to another medicine must be made.
You must not take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici if you are breastfeeding.

Driving and using machines
You may feel dizzy while taking RAMIPRIL and IDROCLOROTIAZIDE DOC
Generici. This is more likely when you first start taking RAMIPRIL and
IDROCLOROTIAZIDE DOC Generici or have just increased the dose. If this happens, do not drive
or use tools or machinery.

RAMIPRIL and IDROCLOROTIAZIDE DOC Generici contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici

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

Taking this medicine

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

How much you should take

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

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

If you take more RAMIPRIL and IDROCLOROTIAZIDE DOC Generici than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, have
someone accompany you or call an ambulance. Bring the medicine package with you. This
is because the doctor needs to know what you have taken.

If you forget to take RAMIPRIL and IDROCLOROTIAZIDE DOC Generici

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a 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 will experience them.
Like all medicines, RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici can cause side effects, although not everyone will experience them.

Stop taking RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici and contact your doctor immediately if you notice any serious side effect – you may need urgent medical treatment:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or rash. This may be a sign of a severe allergic reaction to RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke
• Shortness of breath, cough, fever lasting 2 to 3 days, and decreased feeling of hunger. These may be signs of lung problems, including inflammation
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or easy onset of infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These may be signs of circulatory or bone marrow problems.
• Severe stomach pain that may extend to the 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:
Inform your doctor if any of the following conditions becomes severe or persists for more than a few days.
Common(may affect up to 1 in 10 people)

• Blood tests show a higher than normal sugar level. If you have diabetes, this may worsen
• Blood tests show a higher than normal uric acid or fat level
• Painful, red and swollen joints
• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to happen when therapy with RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici is just started or you have just increased the dose
• Dry, irritating cough or bronchitis

Uncommon(may affect up to 1 in 100 people)

• Decrease in the number of red blood cells, white blood cells and platelets in the blood, or concentration of hemoglobin, as revealed by blood tests
• Loss or decrease of appetite (anorexia), decreased feeling of hunger
• Blood tests show a lower than normal potassium level.
• Increased sweating or feeling thirsty than usual
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Sleep problems
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling or chafing (paresthesia)
• Loss or change of taste
• Blurred vision
• Red, swollen or watery, itchy eyes
• Tinnitus (ringing in the ears)
• Fast or irregular heartbeat
• Flushing, weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Blocked nose, inflammation of the sinuses (sinusitis), shortness of breath
• Constipation, stomach or intestinal pain
• Indigestion or feeling unwell
• Inflammation of the gums (gingivitis), swelling of the mouth
• Changes in liver, pancreas or kidney function as revealed by blood tests
• Swollen arms and legs. This may be a sign that your body is retaining more water 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 a higher than normal potassium level
• Feeling unwell, causing diarrhea or heartburn
• Swollen and red tongue or dry mouth

Not known(frequency cannot be estimated from available data)
Concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (anti-diuretic hormone [antidiuretic hormone]). If you experience these symptoms, contact your doctor promptly

Other side effects reported:
Inform your doctor if any of the following conditions becomes severe or persists for more than a few days.

• Increased number of certain white blood cells in the blood (eosinophilia) found during blood tests
• Too low number of blood cells as revealed by blood tests (pancytopenia)
• Change in the level of salts such as sodium, calcium, magnesium and chlorine in the blood as revealed by blood tests
• Increased amount of sugar in the urine than normal
• Dehydration
• Difficulty concentrating, feeling agitated or confused
• Slowed or altered reactions
• Change in the perception of smells
• Objects appear yellow
• Eyes less moist than normal
• Severe eye pain with redness and sudden blurred vision (possible signs of acute angle-closure glaucoma). If your eye suddenly becomes red and painful, contact your doctor immediately; treatment may be needed to avoid permanent vision loss
• Hearing problems
• Blood clots
• Fingers of the hands and feet that change color when cooled and tingle and hurt when warmed (Raynaud's phenomenon)
• Difficulty breathing or worsening of asthma
• Swelling in the intestine called "intestinal angioedema" which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Swelling, pain and pallor of the cheeks (inflammation of a salivary gland)
• Spots on the skin and cold extremities
• Rash or bruising
• Severe flaking or peeling of the skin, itching, rash or other skin reactions such as redness of the face or forehead
• Increased sensitivity to the sun
• Problems with nails (such as 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 a kidney problem (interstitial nephritis)
• Decreased sexual desire in men and women
• Increased breast volume in men

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 IDROCLOROTIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that 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 ingredients are ramipril and hydrochlorothiazide. One tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide or 5 mg of ramipril and 25 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, hypromellose ( E464), crospovidone ( E1202), microcrystalline cellulose and sodium stearyl fumarate.

Description of the appearance of RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici and package contents
RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 2.5/12.5 mg tablets:
White capsule-shaped tablet. Scored on both sides, with the inscription “2.5” and “12.5” on either side of the score line on one side.
The tablet can be divided into equal parts.
RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 5/25 mg tablets:
White capsule-shaped tablet. Scored on both sides, with the inscription “5” and “25” on either side of the score line on one side.
The tablet can be divided into equal parts.
The tablets are packaged in blisters of 7, 10, 14, 20, 28, 50, 98, 100, 2x14, 300 (10x30) tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer

allphamedPharbil 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 authorised in the Member States of the European Economic Area under the following
names:
Netherlands: RAMIPRIL HCT DOC Generici 2.5/12.5, tablets and RAMIPRIL HCT DOC Generici
5/25, tablets
Italy: RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 2.5/12.5 mg tablets and
RAMIPRIL and HYDROCHLOROTHIAZIDE DOC Generici 5/25 mg tablets