Ramipril / Hydrochlorothiazide Krka - Ramipril / Hydrochlorothiazide uses, dose and side effects

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or diuretics that work by increasing the amount of water (urine) produced in the body. This lowers your blood pressure.

Ramipril / Hydrochlorothiazide Krka is used for high blood pressure . The two active substances work together to lower your blood pressure. They are used together when one or the other has not worked alone.

Ramipril and hydrochlorothiazide contained in Ramipril / Hydrochlorothiazide Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Ramipril / Hydrochlorothiazide Krka

Do not use Ramipril / 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 / Hydrochlorothiazide Krka (other ACE inhibitors or sulphonamides ). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, and swelling of your lips, face, throat, or tongue.
if you have ever had a severe allergic reaction called “angioedema”. Signs of this include itching, hives ( urticaria ), red marks on the hands, feet, and neck, swelling of the throat and tongue, swelling around the eyes and lips, and difficulty breathing and swallowing.
if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril / Hydrochlorothiazide Krka may not be suitable for you
if you have severe liver problems
if you have abnormal amounts of salts (calcium, potassium, sodium ) in your blood
if you have kidney problems which means that the blood supply to your kidneys is reduced ( stenosis of the renal artery)
during the last 6 months of pregnancy (see section “Pregnancy and breast-feeding” below)
if you are breast-feeding (see section “Pregnancy and breast-feeding” below)
if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine 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, it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).

Do not take Ramipril / Hydrochlorothiazide Krka if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril / Hydrochlorothiazide Krka.

Warnings and cautions

Talk to your doctor or pharmacist before taking Ramipril / Hydrochlorothiazide Krka.

if you have heart, liver, or kidney problems
if you have lost a lot of body salts or body fluids (through vomiting, diarrhea, abnormal sweating, strictly low-salt diet, treatment with diuretics ( diuretics ) for a long time, or have undergone dialysis)
if you are going to undergo a treatment to reduce your allergy to wasp or bee stings ( hyposensitization )
if you will be given anesthetics. This can be given to you before an operation or dental treatment. You may need to stop taking Ramipril / Hydrochlorothiazide Krka one day before surgery; Ask your doctor for advice
if you have high levels of potassium in your blood (shown by a blood test)
if you are taking medicines or have a condition that can lower the sodium levels in your blood.
Your doctor may take regular blood tests, especially to check your blood sodium levels, especially if you are older
if you are taking any of the following medicines, the risk of angioedema may increase:
- racecadotril is a medicine used to treat diarrhea.
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus).
- vildagliptin is a medicine used to treat diabetes.
if you have connective tissue diseases such as scleroderma or SLE (systemic lupus erythematosus)
if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Ramipril / Hydrochlorothiazide Krka
if you have previously had breathing or lung problems (including inflammation or fluid in your lungs) after taking hydrochlorothiazide. If you get severe shortness of breath or severe breathing problems after taking Ramipril / Hydrochlorothiazide Krka, you should seek medical attention immediately.
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 diabetes-related kidney problems.
- aliskiren

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals. See also the information under the heading “Do not take Ramipril / Hydrochlorothiazide Krka”.

if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Ramipril / Hydrochlorothiazide Krka. Without treatment, this can lead to permanent vision loss. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.

If you think you are or will become pregnant during treatment, consult your doctor.

Ramipril / Hydrochlorothiazide Krka is not recommended during the first 3 months of pregnancy and may cause birth defects if used after more than 3 months of pregnancy (See section “Pregnancy and breast-feeding” below).

Children and young people

Ramipril / Hydrochlorothiazide Krka is not recommended for use in children and adolescents below 18 years. This is because the drug has never been used in this age group.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril / Hydrochlorothiazide Krka.

Other medicines and Ramipril / Hydrochlorothiazide Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (including herbal medicines). This is because Ramipril / Hydrochlorothiazide Krka may affect the effectiveness of certain medicines, and some medicines may affect the effect of Ramipril / Hydrochlorothiazide Krka.

Tell your doctor if you are taking any of the following medicines. They can make Ramipril / Hydrochlorothiazide Krka work worse:

medicines used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen or indomethacin and acetylsalicylic acid )
medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, norepinephrine, or adrenaline. Your doctor will check your blood pressure.

Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects if you take them with Ramipril / Hydrochlorothiazide Krka:

drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and acetylsalicylic acid )
drugs that can reduce the amount of potassium in your blood. These include medicines for constipation, diuretics (diuretics), amphotericin B (used to treat fungal infections), and ACTH (used to examine the function of your adrenal glands)
temsirolimus (for cancer)
drugs for heart problems including problems with heart rhythm
diuretics (diuretics) such as furosemide
potassium supplements (including salt substitutes), potassium-sparing diuretics (diuretics), and other medicines that may increase the amount of potassium in your blood (eg trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against bacterial infections; cyclosporine, an immunosuppressive drug rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots).
steroids used in inflammation such as prednisolone
calcium supplementation
allopurinol (used to reduce the amount of uric acid in your blood)
procainamide (used for heart rhythm disorders)
cholestyramine (used to reduce blood fats)
carbamazepine (used to treat epilepsy)
medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors). See section “Warnings and Precautions”.

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

if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Ramipril / Hydrochlorothiazide Krka” and “Warnings and precautions”).

Tell your doctor if you are taking any of the following medicines. They can be affected by Ramipril / Hydrochlorothiazide Krka:

Antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril / Hydrochlorothiazide Krka may lower your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril / Hydrochlorothiazide Krka.
Lithium (used in mental illness). Ramipril / Hydrochlorothiazide Krka may increase the amount of lithium in your blood. Your lithium levels will need to be monitored closely by your doctor.
Muscle relaxants
Quinine (used against malaria)
Drugs that contain iodine, can be used in X-ray examinations in hospitals
Penicillin (used to treat infections)
Oral blood thinners (oral anticoagulants ) such as warfarin.

If any of the above applies to you (or you are not sure), talk to your doctor before taking Ramipril / Hydrochlorothiazide Krka.

Surveys

Check with your doctor or pharmacist before taking your medicine:

If you are going to examine the function of your parathyroid gland. Ramipril / Hydrochlorothiazide Krka may affect the results of the study
If you play sports and are about to undergo a doping test. Ramipril / Hydrochlorothiazide Krka may have a positive effect

Ramipril / Hydrochlorothiazide Krka with food, drink, and alcohol

If you drink alcohol while taking Ramipril / Hydrochlorothiazide Krka, you may feel dizzy. If you are concerned about how much you can drink while taking Ramipril / Hydrochlorothiazide Krka, talk to your doctor as alcohol may increase the effect of antihypertensive drugs.
Ramipril / Hydrochlorothiazide Krka can be taken with or without food

Pregnancy and breastfeeding

If you think you are or will become pregnant during treatment, consult your doctor.

Pregnancy

You should not take Ramipril / Hydrochlorothiazide Krka during the first 12 weeks of pregnancy and do not take them at all after the 13th week as use may be harmful to the baby.

If you become pregnant while taking Ramipril / Hydrochlorothiazide Krka, contact your doctor immediately. A change to a suitable alternative should be carried out well in advance of a planned pregnancy.

Breast-feeding

You should not take Ramipril / Hydrochlorothiazide Krka if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy when taking Ramipril / Hydrochlorothiazide Krka. This is more likely to happen when you start taking Ramipril / Hydrochlorothiazide Krka or if you start taking a higher dose. If this happens, do not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ramipril / Hydrochlorothiazide Krka contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Ramipril / Hydrochlorothiazide Krka

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

the drug should be swallowed and taken at the same time each day, usually in the morning
swallow the tablets with liquid
do not crush or chew the tablets

What dose should you take?

Treatment of high blood pressure

Your doctor will adjust the dose until your blood pressure is under control.

Older

Your doctor will reduce the starting dose and adjust your treatment at a slower pace.

If you use more Ramipril / Hydrochlorothiazide Krka than you should

Contact a doctor or see the emergency department at the nearest hospital as soon as possible. Do not drive to the hospital, ask someone else to drive you or call an ambulance. Bring your medicine pack. This is so that the doctor knows what you have taken.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.

If you forget to use Ramipril / Hydrochlorothiazide Krka

If you forget to take a dose, take your normal dose at the next dose.

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril / Hydrochlorothiazide Krka and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:

swelling of the face, lips, or throat which makes it difficult to swallow or breathe, but also itching and rash. This may be a sign of a severe allergic reaction to Ramipril / Hydrochlorothiazide Krka.
severe skin reactions including rash, cold sores, worsening of skin conditions, redness, blistering, or skin rash (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
acute respiratory distress syndrome (signs of severe shortness of breath, fever, weakness, and confusion) (very rare (may affect up to 1 in 10,000 people)).

Tell your doctor immediately if you experience:

increased heart rate, irregular or severe heartbeat ( palpitation ), chest pain, chest tightness, or more serious problems including heart attack and stroke
shortness of breath, cough, and fever for 2-3 days, and decreased appetite. This can be a sign of lung problems including pneumonia
bruising that occurs more easily than usual, prolonged bleeding time, signs of bleeding (eg bleeding in the gums), purple spots on the skin, spots on the skin or increased susceptibility to infection, sore throat and fever, fatigue, weakness, dizziness or pale skin. This could be a sign of blood or bone marrow problems
or severe abdominal pain that can be felt in the back. This may be a sign of inflammation of the pancreas ( pancreatitis ).
fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). This can be a sign of liver problems such as inflammation of the liver ( hepatitis ) or other liver damage.

Other side effects include:

Tell your doctor if any of the following become serious or persist for more than a few days.

Common (may affect up to 1 in 10 people):

headache, fatigue, or feeling of weakness
dizziness. This is more likely to happen when you start taking Ramipril / Hydrochlorothiazide Krka or if you take a higher dose
abnormally low blood pressure ( hypotension ), especially when standing or sitting up
dry cough or bronchitis
blood tests that show higher blood sugar than normal. If you have diabetes, this can make your diabetes worse
blood tests that show more uric acid or more fatty acids than normal
sore, red, and swollen joints
blood tests that show more potassium than normal in your blood

Uncommon (may affect up to 1 in 100 people):

skin rash with or without swelling
hot flashes, fainting
balance problem (fraud)
itching and abnormal sensations in the skin such as numbness, tingling, burning sensation, or an ant crawling ( paresthesia )
altered or lost taste experience
sleep disorders
depression, anxiety, increased nervousness or restlessness
stuffy nose, sinusitis, shortness of breath
inflammation of the gums ( gingivitis ), swelling of the mouth
red, itchy, swollen, or watery eyes
earrings
dimsyn
hair loss
chest pain
muscle pain
constipation, abdominal pain
indigestion or nausea
increased urination
increased sweating or thirst
lost or decreased appetite ( anorexia ), feeling of decreased hunger
increased or irregular heartbeat
swollen arms and legs. This may be a sign that your body is storing more water than usual
fever
sexual inability in men decreased sexual desire in men or women
blood tests showing changes in the number of red blood cells, white blood cells, or platelets or a decrease in the level of hemoglobin
blood tests that show changes in your liver function, pancreas, or kidney function
blood tests that show less potassium in your blood

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

confusion
blemishes on the skin and cold limbs (hands and feet)

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

vomiting, diarrhea, or heartburn
red and swollen tongue or dry mouth

Has been reported (occurs in an unknown number of users):

skin and lip cancer (Non- melanoma skin cancer)
concentrated urine (dark-colored), nausea or vomiting, muscle cramps, confusion, and seizures, which may be due to incorrect secretion of antidiuretic hormone ( ADH ). If you experience these symptoms, contact your doctor as soon as possible.

Other reported side effects:

Tell your doctor if any of the following become serious or persist for more than a few days:

concentration difficulties
color change of fingers and toes in cold and then pain and creeps when warmed up (Raynaud’s phenomenon)
enlarged breasts in men
blood clots
hearing changes
reduced tear flow
the visual disturbance which means that things look yellow
impaired vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma )
dehydration
swelling, pain, and redness of the cheek ( inflammation of the salivary gland)
swelling in the stomach called “intestinal angioedema” which causes symptoms such as abdominal pain, vomiting, and diarrhea
increased sun sensitivity
severe skin flaking, itchy lumpy rash, or other skin reactions such as red rash on the face or forehead
skin rash or bruising
nail problems (eg loose nails or the nail coming loose from its bracket)
muscle stiffness or inability to move the jaw ( tetany )
the feeling of weakness or cramps in the muscles
blood in the urine. This may be a sign of a kidney problem (interstitial nephritis)
more sugar than normal in the urine
increased number of certain blood cells ( eosinophilia ) detected by blood tests
blood tests that show too few blood cells in your blood (pancytopenia)
blood tests that show changes in the number of salts such as sodium, calcium, magnesium, and chloride in the blood
slow or worsening reactions
change of sense of smell
difficulty breathing or worsening asthma

How to store Ramipril / Hydrochlorothiazide 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 carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

The active substances are ramipril and hydrochlorothiazide .2.5 mg / 12.5 mg tablets: Each tablet contains 2.5 mg ramipril and 12.5 mg hydrochlorothiazide .5 mg / 25 mg tablets: Each tablet contains 5 mg ramipril and 25 mg hydrochlorothiazide .
The other ingredients are hypromellose, microcrystalline cellulose, pregelatinized maize starch, and sodium stearyl fumarate. See section 2 “Ramipril / Hydrochlorothiazide Krka contains sodium”.

What the medicine looks like and the contents of the pack

2.5 mg / 12.5 mg tablets: white to off-white, round tablets, with beveled edges and marked C on one side. Tablet diameter: 5.5 mm.

5 mg / 25 mg tablets: white to off-white, round tablets, with beveled edges, scored on one side and marked with S on the other side of the tablet. Tablet diameter: 7.5 mm. The tablet can be divided into two equal doses.

Ramipril / Hydrochlorothiazide Krka is available in cartons of 14, 28, 30, 56, 98, and 100 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Krka, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer