Ramipril/hydrochlorothiazide Krka 2.5 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ramipril/Hydrochlorothiazide Krka 2.5 mg/12.5 mg tablets EFG

ramipril/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Ramipril/Hydrochlorothiazide Krka 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 as follows:

• By reducing the body's production of substances that can increase blood pressure.
• By relaxing and dilating blood vessels.
• By making it easier for the heart to pump blood throughout the body.

Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics" (diuretics are also known as "water tablets"). It works by increasing the amount of water (urine) that is removed from the body. This helps to reduce blood pressure.

Ramipril/Hydrochlorothiazide Krka is used to treat high blood pressure. The two active ingredients it contains work together to lower blood pressure. They are used in combination when treatment with either medicine alone does not provide adequate control of your blood pressure.

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

Do not take 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 other sulfonamide derivatives).
• Symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called “angioedema”. Symptoms may include itching, hives (urticaria), red spots on hands, feet, and throat, swelling of throat and tongue, swelling of eyelids and lips, 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 levels of electrolytes (calcium, potassium, sodium) in your blood.
• If you have kidney problems causing reduced blood flow to your kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section on “Pregnancy and breastfeeding” below).
• If you are breastfeeding (see section on "Pregnancy and breastfeeding" below).
• 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 a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is high.

Do not take Ramipril/Hydrochlorothiazide Krka if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Ramipril/Hydrochlorothiazide Krka.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ramipril/Hydrochlorothiazide Krka:

• If you have heart, liver, or kidney problems.

• If you have lost significant amounts of body salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, prolonged diuretic use, or dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).

• If you are to receive anesthesia, for example, during surgery or a dental procedure. You may need to stop taking Ramipril/Hydrochlorothiazide Krka one day beforehand; consult your doctor.

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

• If you are taking medicines or have conditions that may lower sodium levels in your blood. Your doctor may perform periodic blood tests, especially to monitor blood sodium levels, particularly if you are elderly.

• If you are taking any of the following medicines, your risk of developing angioedema may increase:

• racecadotril, a medicine used to treat diarrhea.

• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

• vildagliptin, a medicine used to treat diabetes.

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

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Ramipril/Hydrochlorothiazide Krka.

• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Ramipril/Hydrochlorothiazide Krka, seek medical attention immediately.

• If you are taking any of the following medicines for blood pressure:

• angiotensin receptor blockers (ARBs) (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems,

• 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 information under the heading "Do not take Ramipril/Hydrochlorothiazide Krka"

• If you experience vision changes or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Ramipril/Hydrochlorothiazide Krka. This may lead to vision loss if untreated. If you previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this condition.

Inform your doctor if you are pregnant (or suspect you might be). Use of Ramipril/Hydrochlorothiazide Krka is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after the third month of pregnancy (see section below on “Pregnancy and breastfeeding”).

Children and adolescents

Ramipril/Hydrochlorothiazide Krka is not recommended for use in children and adolescents under 18 years of age, as it has never been studied in these age groups.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking Ramipril/Hydrochlorothiazide Krka.

Other medicines and Ramipril/Hydrochlorothiazide Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines (including herbal remedies). This is because Ramipril/Hydrochlorothiazide Krka may affect how other medicines work. Some medicines may also affect how Ramipril/Hydrochlorothiazide Krka works.

Inform your doctor if you have taken or are taking any of the following medicines, which could reduce the effectiveness of Ramipril/Hydrochlorothiazide Krka:

• Medicines for pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and aspirin).
• Medicines for 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, which could increase the risk of side effects when taken with Ramipril/Hydrochlorothiazide Krka:

• Medicines for pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and aspirin).
• Medicines that may reduce potassium levels in blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to test adrenal gland function).
• Temsirolimus (for cancer).
• Medicines for heart problems, including heart rhythm disorders.
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin blood and prevent clots).
• Steroid medicines for inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (to lower uric acid in blood).
• Procainamide (to treat heart rhythm problems).
• Cholestyramine (to reduce blood fat levels).
• Carbamazepine (for epilepsy).
• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors) or vildagliptin (for diabetes). See section "Warnings and precautions".

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

• If you are taking angiotensin receptor blockers (ARBs) or aliskiren (see also information under the headings “Do not take Ramipril/Hydrochlorothiazide Krka” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medicines, as they may be affected by Ramipril/Hydrochlorothiazide Krka:

• Medicines for diabetes, such as oral glucose-lowering medicines and insulin. Ramipril/Hydrochlorothiazide Krka may lower blood sugar levels. Monitor your blood sugar carefully while taking Ramipril/Hydrochlorothiazide Krka.
• Lithium (for mental health conditions). Ramipril/Hydrochlorothiazide Krka may increase lithium levels in blood. Your doctor will closely monitor your blood lithium levels.
• Medicines to relax muscles.
• Quinine (for malaria).
• Medicines containing iodine (such as those sometimes used in hospitals for scans or certain X-rays).
• Penicillin (for infections).
• Oral anticoagulant medicines (blood thinners) such as warfarin.

If any of the above apply to you (or you are unsure), consult your doctor before taking Ramipril/Hydrochlorothiazide Krka.

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are to have a parathyroid function test, Ramipril/Hydrochlorothiazide Krka may affect the results.
• If you participate in athletic events subject to doping controls, be aware that Ramipril/Hydrochlorothiazide Krka may lead to a positive test result.

Taking Ramipril/Hydrochlorothiazide Krka with food, drinks, and alcohol

• Drinking alcohol with Ramipril/Hydrochlorothiazide Krka may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking Ramipril/Hydrochlorothiazide Krka, speak with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril/Hydrochlorothiazide Krka can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must not take Ramipril/Hydrochlorothiazide Krka during the first 12 weeks of pregnancy, and you must not take it at any time after week 13, as its use during pregnancy may be harmful to the baby.

If you become pregnant while taking Ramipril/Hydrochlorothiazide Krka, inform your doctor immediately. An appropriate alternative treatment should be initiated if you plan to become pregnant.

Breastfeeding

You must not use Ramipril/Hydrochlorothiazide Krka if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

You are advised not to drive or operate machinery until you know how Ramipril/Hydrochlorothiazide Krka affects you. You may feel dizzy while taking Ramipril/Hydrochlorothiazide Krka, especially when starting treatment or when increasing the dose. If you feel dizzy, do not drive or operate tools or machinery.

Ramipril/Hydrochlorothiazide Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Ramipril/Hydrochlorothiazide Krka

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking this medicine

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

How much medicine to take

Treatment of high blood pressure

Your doctor will adjust the dose you need to take until your blood pressure is controlled.

Elderly patients

Your doctor will reduce your initial dose and adjust your treatment more slowly.

If you take more Ramipril/Hydrochlorothiazide Krka than you should

Contact your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital: ask someone to take you or call an ambulance. Take the medicine packaging with you so your doctor will know what you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ramipril/Hydrochlorothiazide Krka

If you forget to take a dose, take your usual dose at the next scheduled time.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Ramipril/Hydrochlorothiazide Krka and contact your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• Swelling of the face, lips or throat, which may make swallowing or breathing difficult, as well as itching and rash, which could be signs of a serious allergic reaction to Ramipril/Hydrochlorothiazide Krka.
• Serious skin reactions, such as rash, mouth sores, worsening of a pre-existing skin condition, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion) (Very rare (affects fewer than 1 in 10,000 people)).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness or more serious problems such as heart attack and stroke.
• Difficulty breathing, cough and fever lasting two to three days, and loss of appetite, which could be symptoms of lung problems including inflammation.
• Easy bruising, bleeding lasting longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin, skin rashes or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy or pale skin, which could be signs of blood or bone marrow problems.
• Severe stomach pain, possibly radiating to the back, which could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (feeling sick), yellowing of the skin or eyes (jaundice), which could be symptoms of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other adverse effects may include:

Inform your doctor if any of the following adverse effects worsen or last more than a few days.

Common (affects less than 1 in 10 people)

• Headache or feeling weak or tired.
• Dizziness. This is more likely when starting Ramipril/Hydrochlorothiazide Krka or when starting a higher dose.
• Hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Irritative dry cough or bronchitis.
• Blood tests showing higher than normal blood sugar levels. If you have diabetes, this may worsen.
• Blood tests showing higher than normal levels of uric acid or fats.
• Pain, redness or swelling in the joints.
• Blood tests showing higher than normal potassium levels in the blood.

Uncommon (affects less than 1 in 100 people)

• Skin rash, with or without raised areas.
• Redness, feeling faint.
• Balance problems (dizziness).
• Itching and abnormal skin sensations, such as numbness, tingling, prickling, burning or "pins and needles" sensations (paresthesias).
• Loss or changes in taste.
• Sleep problems.
• Depression, anxiety, increased nervousness or restlessness.
• Stuffy nose, facial sinus inflammation (sinusitis), difficulty breathing.
• Gum inflammation (gingivitis), mouth inflammation.
• Redness, itching or swelling of the eyes or excessive tearing.
• Ringing in the ears.
• Blurred vision.
• Hair loss.
• Chest pain.
• Muscle pain.
• Constipation, stomach or abdominal pain.
• Stomach discomfort after meals or nausea.
• Urinating more than normal during the day.
• Sweating more than normal or feeling thirsty.
• Loss or decrease in appetite (anorexia), reduced hunger.
• Faster or irregular heartbeats.
• Swelling of arms and legs, which may indicate your body is retaining more fluid than normal.
• Fever.
• Sexual impotence in men, reduced sexual desire in men or women.
• Blood tests showing reduced numbers of red blood cells, white blood cells or platelets, or reduced hemoglobin levels.
• Blood tests showing changes in how your liver, pancreas or kidneys are functioning.
• Blood tests showing lower than normal potassium levels.

Rare (affects less than 1 in 1,000 people)

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

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

• Feeling unwell, having diarrhea or stomach burning.
• Swollen and red tongue or dry mouth.

Frequency not known (cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).
• Concentrated urine (dark-colored), feeling or being unwell, muscle cramps, confusion and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you have these symptoms, consult your doctor as soon as possible.

Other observed adverse effects:

Inform your doctor if any of the following adverse effects worsen or last more than a few days.

• Difficulty concentrating.
• Fingers and toes changing color in the cold, followed by tingling or pain when warming up, which could be Raynaud's phenomenon.
• Breast enlargement in males.
• Blood clot formation.
• Hearing problems.
• Reduced tear production.
• Seeing objects in yellow color.
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the eye's vascular layer (choroidal effusion) or acute angle-closure glaucoma).
• Dehydration.
• Swelling, pain and redness in one cheek (inflammation of a salivary gland).
• Intestinal inflammation called "intestinal angioedema," with symptoms such as abdominal pain, vomiting and diarrhea.
• Increased sensitivity to sunlight.
• Severe skin peeling or flaking, itchy rash with lumps or other skin reactions, such as reddish rash on the face or forehead.
• Rash or bruising on the skin.
• Nail problems (detachment or separation of a nail from its bed).
• Musculoskeletal stiffness or inability to move the jaw (tetany).
• Muscle weakness or cramps.
• Blood in the urine, which could be a sign of kidney problems (interstitial nephritis).
• Higher than normal sugar levels in urine.
• Increased number of a certain type of white blood cells (eosinophilia) in a blood test.
• Blood tests showing very low blood cell counts (pancytopenia).
• Blood tests showing changes in the levels of salts such as sodium, calcium, magnesium and chloride in the blood.
• Slowness or difficulty reacting.
• Change in the smell of things.
• Breathing problems or worsening of asthma.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ramipril/Hydrochlorothiazide Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ramipril/Hydrochlorothiazide Krka

• The active substances are ramipril and hydrochlorothiazide.

Each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.

• The other components (excipients) are hypromellose, microcrystalline cellulose, pregelatinized maize starch, and sodium stearyl fumarate. See section 2 “Ramipril/Hydrochlorothiazide Krka contains sodium”.

Appearance of the product and contents of the container

White or almost white, round, bevel-edged tablets marked with a "C" on one side. Tablet diameter: 5.5 mm.

The tablets are packaged in blister packs containing 14, 28, 30, 56, 98 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of the summary: April 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es