RAMIPRIL 2.5 mg/12.5 mg Coated tablet

Зміст інструкції

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

Ramipril e Idroclorotiazide Krka 2.5 mg/12.5 mg tablets, 5 mg/25 mg tablets

ramipril/hydrochlorothiazide
Generic 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet

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

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

Ramipril and Hydrochlorothiazide Krka is a combination of two medicines called ramipril and
hydrochlorothiazide.
Ramipril belongs to the 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 the blood vessels.
• By making it easier for the heart to pump blood around the body. Hydrochlorothiazide belongs to the group of medicines called “thiazide diuretics” or water tablets. It works by increasing the amount of water (urine) produced. This lowers blood pressure. Ramipril and Hydrochlorothiazide Krka is used for the treatment of high blood pressure. The two active substances work together to lower blood pressure. They are used together when treatment with one component alone does not work.

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

Do not take Ramipril and Hydrochlorothiazide Krka

• 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 Krka (other ACE inhibitors or medicines derived from sulfonamides). The signs of an allergic reaction can be 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, hives, 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 in dialysis or undergoing any other type of blood filtration. Depending on the machinery used, Ramipril and Hydrochlorothiazide Krka may not be suitable for you.
• If you have severe liver problems.
• If you have an abnormal amount of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems in which the blood supply to the liver is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).
• If you suffer from diabetes or your kidney function is impaired and 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).

Do not take Ramipril and Hydrochlorothiazide Krka if any of these conditions apply to you. If you are not sure, ask your doctor before taking Ramipril and Hydrochlorothiazide Krka.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril and Hydrochlorothiazide Krka:

• If you have problems with your heart, liver or kidneys.
• If you have lost a lot of salts or fluids (being sick (vomiting), having diarrhoea, sweating more than usual, if you are following a low-salt diet, taking diuretics (water tablets) for a long period or having had dialysis).
• If you are about to undergo treatment to reduce your allergy to bees or wasps (desensitisation).
• If you are about to have an anaesthetic. This may be given for an operation or dental treatment. It may be necessary to stop taking Ramipril and Hydrochlorothiazide Krka 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 are taking medicines or are in conditions in which you need to lower the levels of sodium in your blood. Your doctor may perform regular blood tests, especially to check the levels of sodium in your blood, particularly if you are elderly.
• If you are taking any of the following medicines the risk of angioedema may increase:
• racecadotril (used to treat diarrhoea),
• medicines used to prevent organ rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Ramipril and Hydrochlorothiazide Krka.
• If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have 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 the information in the section “Do not take Ramipril and Hydrochlorothiazide Krka”.
• If you have a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within hours to a week after taking Ramipril and Hydrochlorothiazide Krka. This can lead to

permanent vision loss if not treated. If you have previously had an allergy to
penicillin or sulfonamide you have a higher risk of developing this disorder.
Tell your doctor if you think you are pregnant (or might become pregnant). Ramipril and Hydrochlorothiazide Krka
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 below “Pregnancy and breastfeeding”).

Children and adolescents
The use of Ramipril and Hydrochlorothiazide Krka is not recommended in children and adolescents under
18 years of age. This is because the safety and efficacy of the medicine have never been established in
this age group.
If any of the above conditions occur (or you have any doubts), ask your doctor before taking
Ramipril and Hydrochlorothiazide Krka.

Other medicines and Ramipril and Hydrochlorothiazide Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription (including herbal medicines).
This is because Ramipril and Hydrochlorothiazide Krka can affect the way other medicines work.
Also, some medicines can affect the way Ramipril and Hydrochlorothiazide Krka works.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere
with the effectiveness of Ramipril and Hydrochlorothiazide Krka:

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

Tell your doctor if you are taking any of the following medicines. These medicines, if taken with
Ramipril and Hydrochlorothiazide Krka, 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, indometacin, aspirin).
• Medicines that can lower the amount of potassium in your blood. This includes medicines for constipation, diuretics (water tablets), amphotericin B (used for fungal infections) and ACTH (used to check that the adrenal glands are working properly).
• Temsirolimus for cancer.
• Medicines for heart problems, including problems with the heartbeat.
• Diuretics (water tablets) such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole (for infections caused by bacteria); cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent clots.
• Steroid medicines for treating inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heartbeat problems).
• Cholestyramine (to reduce the amount of fat in the blood).
• Carbamazepine (for epilepsy).
• Medicines that are often used to prevent organ rejection (sirolimus, everolimus and other medicines belonging to the mTOR inhibitors class) or vildagliptin (for diabetes). See section “Warnings and precautions”.

Your doctor may need to change the dose and/or take other precautions:

• If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information in the sections “Do not take Ramipril and Hydrochlorothiazide Krka” and “Warnings and precautions”).

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 Hydrochlorothiazide Krka:

• Medicines for diabetes such as oral hypoglycaemic agents and insulin. Ramipril and Hydrochlorothiazide Krka may lower the amount of sugar in your blood. Check your blood sugar levels carefully when taking Ramipril and Hydrochlorothiazide Krka.
• Lithium (for mental health problems). Ramipril and Hydrochlorothiazide Krka may increase the amount of lithium in your blood. Your doctor should check the level of lithium in your blood carefully.
• Medicines to relax muscles.
• Quinine (for malaria).
• Medicines that contain iodine, which may be used when you need to have a scan or X-ray in hospital.
• Penicillins (for infections).
• Medicines to thin the blood taken by mouth (oral anticoagulants) such as warfarin.

If any of the above conditions occur (or you have any doubts), ask your doctor before taking
Ramipril and Hydrochlorothiazide Krka.

Tests
Check with your doctor or pharmacist before taking the medicine:

• If you need to have a test for parathyroid function. Ramipril and Hydrochlorothiazide Krka may affect the test results.
• If you are an athlete who needs to undergo a doping test. Ramipril and Hydrochlorothiazide Krka may give a positive result.

Ramipril and Hydrochlorothiazide Krka with food, drink and alcohol

• Drinking alcoholic beverages with Ramipril and Hydrochlorothiazide Krka may cause dizziness or lightheadedness. If you are concerned about how much you can drink while taking Ramipril and Hydrochlorothiazide Krka, talk to your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• Ramipril and Hydrochlorothiazide Krka can be taken with or without food.

Pregnancy, breastfeeding and fertility
You must tell your doctor if you think you are pregnant (or might become pregnant).

Pregnancy
You must not take Ramipril and Hydrochlorothiazide Krka in the first 12 weeks of pregnancy and you must
absolutely not take it after the 13th week because its use can be harmful to the
baby.
If you become pregnant while taking Ramipril and Hydrochlorothiazide Krka, tell your doctor immediately.
Before planning a pregnancy, you should switch to an alternative medicine suitable.

Breastfeeding
You must not take Ramipril and Hydrochlorothiazide Krka if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
You must not drive vehicles or use machines until you know how Ramipril and
Hydrochlorothiazide Krka affects you. You may feel sleepy and dizzy while taking
Ramipril and Hydrochlorothiazide Krka. This is more likely when you have just started taking
Ramipril and Hydrochlorothiazide Krka or have just increased the dose. If this happens, do not drive or
use machines.

Ramipril and Hydrochlorothiazide Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take Ramipril and Idroclorotiazide Krka

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

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

How much to use

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

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

If you take more Ramipril and Idroclorotiazide Krka than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the
hospital, have someone drive you or call an ambulance. Bring the package of the
medicine with you. This is so the doctor knows what you have taken.

If you forget to take Ramipril and Idroclorotiazide Krka
If you forget a dose, take the normal dose when it is time.
Do not take a double dose to make up for a missed dose.
If you have any doubts 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 everyone gets them.
persone li manifestino.

Stop taking Ramipril and Idroclorotiazide Krka 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 making it difficult to swallow or breathe, as well as itching and rash. This may be a sign of a severe allergic reaction to Ramipril and Idroclorotiazide Krka.
• 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).

Tell your doctor immediately if you experience:

• Fast heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems including heart attack and stroke.
• Shortness of breath or cough for two or three days and feeling tired. These may be signs of lung problems, including inflammation.
• Easier bruising, bleeding that lasts longer than usual, any sign of bleeding (e.g. bleeding gums), purple spots, spots on the skin or increased susceptibility to infections, 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 extend 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 the following conditions becomes severe or lasts for
more than a few days.
Common(may affect up to 1 in 10 people)

• Headache or feeling weak or tired.
• Feeling dizzy. This is more likely when you have just started taking Ramipril and Idroclorotiazide Krka or have just increased the dose.
• Low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly.
• Dry, irritating cough or bronchitis.
• Blood tests showing a higher amount of sugar in the blood than normal. If you have diabetes, this may worsen your diabetes.
• Blood tests showing a higher amount of uric acid in the blood or an increase in fats in the blood than normal.
• Joint pain, redness and swelling.
• Blood tests showing a higher amount of potassium in the blood than normal.

Uncommon(may affect up to 1 in 100 people)

• Skin rashes with or without red areas.
• Flushing, fainting.
• Problems with balance (vertigo).
• Itching and unusual skin sensations such as numbness, tingling, itching, burning or crawling on the skin (paresthesia).
• Loss or change of taste.
• Difficulty sleeping.
• Depressed mood, anxiety, increased nervousness than usual or restlessness.
• Blocked nose, inflammation of the sinuses (sinusitis), difficulty breathing.
• Inflammation of the gums (gingivitis), swelling of the mouth.
• Redness, itching, swelling or watering of the eyes.
• Ringing in the ears.
• Blurred vision.
• Hair loss.
• Abdominal pain.
• Muscle pain.
• Constipation, stomach or intestinal pain.
• Indigestion or feeling sick.
• Increased amount of water (urine) than usual during the day.
• Increased sweating than usual or feeling thirsty.
• Loss or decrease of appetite (anorexia), feeling of lack of appetite.
• Increased or irregular heartbeat.
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
• Fever.
• Impotence in men, reduced sexual desire in men and women.
• Decreased number of blood cells, white blood cells or platelets or hemoglobin found during blood tests.
• Changes in liver, pancreas or kidney function shown by blood tests.
• Decreased potassium in the blood than usual shown by blood tests.

Rare(may affect up to 1 in 1,000):

• Feeling confused.
• Spots on the skin and cold extremities.

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

• Feeling sick, with diarrhea and stomach pain.
• Red and swollen tongue or dry mouth.

Not known(frequency cannot be estimated from the available data)

• Skin cancer and of the lips (non-melanoma skin cancer)
• Concentrated urine (dark color), feeling sick, muscle cramps, confusion and seizures which can be caused by inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms contact your doctor as soon as possible. Other side effects observed: Tell your doctor if any of the following conditions becomes severe or lasts for more than a few days.
• Difficulty concentrating.
• Fingers of the hands and feet that change color when they get cold and tingle or hurt when they warm up (Raynaud's phenomenon).
• Enlargement of the breasts in men.
• Blood clots.
• Hearing disorders.
• Decreased tearing of the eyes.
• Yellow vision of objects.
• Loss of vision or eye pain due to increased pressure in the eye (possible symptoms of fluid build-up in the vascular layer of the eye (choroidal effusion) or closed-angle glaucoma).
• Dehydration.
• Swelling, pain and redness of the cheeks (inflammation of the salivary glands).
• A swelling in your intestine called "intestinal angioedema" which presents with symptoms such as abdominal pain, vomiting and diarrhea.
• Increased sensitivity to the sun than usual.
• Severe flaking or peeling of the skin, itching, rash with pustules or other skin reactions such as rashes on the face or forehead.
• Rash or bruising.
• Problems with the nails (e.g. loosening or separation of a nail from its bed).
• Stiffness of the musculoskeletal system or inability to move the jaw (tetanus).
• Weakness or cramps in the muscles.
• Blood in the urine. This could be a sign of a kidney problem (interstitial nephritis).
• More sugar than usual in your urine.
• Blood tests showing an increase in some white blood cells (eosinophilia).
• Blood tests showing a decrease in red blood cells in the blood (pancytopenia).
• Blood tests showing a change in the amount of salts such as sodium, calcium, magnesium and chloride in the blood.
• Slowed or impaired reactions.
• Change in the perception of smells.
• Difficulty breathing or worsening of asthma.

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 https://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 Krka

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 EXP. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°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
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What contains Ramipril and Idroclorotiazide Krka

• 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 other ingredients are hypromellose, microcrystalline cellulose, pregelatinized corn starch and sodium stearyl fumarate. See section 2 “Ramipril and Idroclorotiazide Krka contains sodium”.

Description of the appearance of Ramipril and Idroclorotiazide Krka and contents of the pack
2.5 mg/12.5 mg tablets: white to off-white, round tablets, with bevelled edges and engraved C
on one side. Tablet diameter: 5.5 mm.
5 mg/25 mg tablets: white to off-white, round tablets, marked on one side and engraved S
on the other side of the tablet. Tablet diameter: 7.5 mm. The tablet can be divided into
equal parts.
Ramipril and Idroclorotiazide Krka is available in packs of 14, 28, 30, 56, 98 or 100 tablets in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturers responsible for batch release
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: