RAMIPRIL/HYDROCHLOROTHIAZIDE STADA 2.5 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ramipril/Hydrochlorothiazide STADA 2.5 mg/12.5 mg film-coated tablets

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Ramipril/Hydrochlorothiazide Stada is a combination of two medicines called ramipril and hydrochlorothiazide.

Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). It works in the following ways:

• Reducing the production by the body of substances that can increase blood pressure.
• Relaxing and widening the blood vessels.
• Making it easier for the heart to pump blood through 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, which reduces blood pressure.

Ramipril/hydrochlorothiazide is used to treat high blood pressure. The two active substances it contains work together to reduce blood pressure. They are used together when treatment with only one of them does not provide adequate control of your blood pressure.

2. What you need to know before you take Ramipril/Hydrochlorothiazide Stada

Do not take Ramipril/Hydrochlorothiazide Stada

• If you are allergic to the active substances ramipril and/or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergic (hypersensitive) to medicines similar to ramipril/hydrochlorothiazide (other ACE inhibitors or other sulfonamide derivatives)
• The symptoms of an allergic reaction can include rash, problems swallowing or breathing, swelling of the lips, face, throat or tongue
• If you have ever had a severe allergic reaction called “angioedema”, whose symptoms may be: itching, hives (urticaria), red patches on the hands, feet and throat, swelling of the throat and tongue, swelling of the eyelids and lips, difficulty breathing and swallowing.
• 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 under the skin in areas such as the throat) is high.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, ramipril/hydrochlorothiazide 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 where the blood flow to your kidneys is reduced (renal artery stenosis)
• During the last 6 months of pregnancy(see, below, the section on “Pregnancy and Breast-feeding”)
• If you are breast-feeding (see, below, the section on "Pregnancy and Breast-feeding")
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Do not take Ramipril/Hydrochlorothiazide Stada if any of the above conditions apply to you.If you are not sure, talk to your doctor before taking ramipril/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ramipril/Hydrochlorothiazide Stada:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking ramipril/hydrochlorothiazide.
• If you have heart, liver or kidney problems.
• If you have lost a lot of body salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term diuretic use, or dialysis).
• If you are going to undergo desensitization treatment for bee or wasp stings (hyposensitization).
• If you are going to receive an anesthetic, for example, for an operation or dental procedure. You may need to stop your treatment with ramipril/hydrochlorothiazide one day in advance; 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 can lower the levels of sodium in your blood. Your doctor may perform regular blood tests, especially to monitor sodium levels in your blood, particularly if you are elderly.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• • medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other medicines that belong to the mTOR inhibitor group
  • vildagliptin, a medicine used to treat diabetes
  • neprilysin inhibitors (NEP) such as racecadotril, a medicine used to treat diarrhea
  • sacubitril/valsartan. For sacubitril/valsartan, see also “Do not take Ramipril/Hydrochlorothiazide Stada”.
• If you have a collagen vascular disease, such as scleroderma or systemic lupus erythematosus.
• Tell your doctor if you are pregnant (or think you might be). Ramipril/hydrochlorothiazide 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 Breast-feeding”)
• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to weeks after taking ramipril/hydrochlorothiazide. This can lead to permanent loss of vision if not treated. You may be at higher risk of developing this if you are at risk of developing a condition called glaucoma or if you have previously been allergic to penicillin or sulfonamides.
• If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (ARA II) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren

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

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Ramipril/Hydrochlorothiazide Stada”.

Children and adolescents

Ramipril/hydrochlorothiazide is not recommended for use in children and adolescents under 18 years of age, as the medicine has never been used in these age groups.

If you are not sure if any of the above conditions apply to you, talk to your doctor before taking ramipril/hydrochlorothiazide.

Other medicines and Ramipril/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because ramipril/hydrochlorothiazide can affect the way some other medicines work. Also, some medicines can affect the way ramipril/hydrochlorothiazide works.

Tell your doctor if you are taking any of the following medicines. These may make ramipril/hydrochlorothiazide work less well:

• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, 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.

Tell your doctor if you are taking any of the following medicines. These may increase the risk of side effects if taken with ramipril/hydrochlorothiazide:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see also “Do not take Ramipril/Hydrochlorothiazide Stada”).
• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and aspirin)
• Medicines that can lower the levels of potassium in your blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to check if your adrenal glands are working properly)
• Cancer medicines (chemotherapy)
• Heart medicines, including those for heart rhythm problems
• Diuretics such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase the levels of potassium in your blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Corticosteroids for inflammation, such as prednisolone
• Calcium supplements
• Allopurinol (to lower uric acid levels in your blood)
• Procainamide (for heart rhythm problems)
• Colestyramine (to lower cholesterol levels in your blood)
• Carbamazepine (for epilepsy)
• Medicines used more frequently to prevent organ transplant rejection and for cancer (sirolimus, everolimus, temsirolimus, and other medicines of the mTOR inhibitor class). See section “Warnings and precautions”.
• Vildagliptin (used to treat type 2 diabetes)
• Racecadotril (a medicine used to treat diarrhea)

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

If you are taking an angiotensin II receptor antagonist (ARA II) or aliskiren (see also the information under the headings "Do not take Ramipril/Hydrochlorothiazide Stada" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines. These may be affected by ramipril/hydrochlorothiazide:

• Diabetes medicines, such as oral medicines to lower blood sugar and insulin. Ramipril/hydrochlorothiazide may lower your blood sugar levels. Monitor your blood sugar levels carefully while taking ramipril/hydrochlorothiazide.
• Lithium (for mental health problems). Ramipril/hydrochlorothiazide may increase the levels of lithium in your blood. Your doctor will closely monitor your lithium levels in your blood.
• Muscle relaxants
• Quinine (for malaria)
• Medicines that contain iodine (such as those used in hospitals for scans or certain X-rays)
• Penicillin (for infections)
• Oral blood thinners (anticoagulants), such as warfarin derivatives

If any of the above conditions apply to you (or you are not sure), consult your doctor before taking ramipril/hydrochlorothiazide.

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are going to have a parathyroid function test, ramipril/hydrochlorothiazide may affect the results.
• If you are participating in doping-controlled athletic competitions, be aware that ramipril/hydrochlorothiazide may give a positive result.

Taking Ramipril/Hydrochlorothiazide Stada with food and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you think you are pregnant (or might be).

You must not take ramipril/hydrochlorothiazide during the first 12 weeks of pregnancy, and you must not take it at all after the 13th week, as its use during pregnancy may be harmful to your baby.

If you become pregnant while taking ramipril/hydrochlorothiazide, inform your doctor immediately. Alternative treatment should be carried out if you plan to become pregnant.

Breast-feeding

You must not take ramipril/hydrochlorothiazide if you are breast-feeding. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some side effects (e.g., symptoms of low blood pressure such as dizziness) may affect your ability to concentrate and react. This can be a risk in situations where these abilities are of particular importance (e.g., driving a vehicle or operating machines).

You may feel dizzy while taking ramipril/hydrochlorothiazide, which is more likely to happen when you start taking ramipril/hydrochlorothiazide or start taking a higher dose. If you feel dizzy, do not drive or operate tools or machines.

Ramipril/Hydrochlorothiazide Stada contains sodium

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

3. How to take Ramipril/Hydrochlorothiazide Stada

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

How much to take

Treatment of high blood pressure

Your doctor will adjust the amount you need to take to control your blood pressure.

Elderly patients

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

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.
• The score line is not intended to break the tablet.

If you take more Ramipril/Hydrochlorothiazide Stada than you should

Consult your doctor immediately or go to the emergency department of your nearest hospital. Do not drive to the hospital: ask someone to drive you or call an ambulance. Take the medicine package with you, so your doctor knows what you have taken.

You can also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ramipril/Hydrochlorothiazide Stada

• If you forget to take a dose, take your normal dose when it is time for your next dose.
• Do not take a double dose to make up for forgotten tablets.

If you have any further questions on 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 all people suffer from them.

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

• Swelling of the face, lips, or throat, which can make swallowing or breathing difficult, as well as itching and rash, which can be a sign of a significant allergic reaction to ramipril/hydrochlorothiazide.
• Severe skin reactions, such as rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

• Faster heart rate, 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 2 to 3 days, and loss of appetite. These could be symptoms of lung problems, including inflammation.
• Easy bruising, bleeding for longer than usual, any sign of bleeding (e.g., from the gums), purple spots on the skin, skin spots, or getting infections more easily than usual, sore throat, and fever, feeling tired, dizzy, or pale skin, which could be signs of blood or bone marrow problems.
• Severe stomach pain, which can radiate to the back, which could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (vomiting), yellowing of the skin or eyes (jaundice), which could be symptoms of liver problems, such as hepatitis (inflammation of the liver) or liver damage.
• Severe eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which can be a condition called glaucoma;
• Rapid onset of reduced distance vision (acute myopia), decreased vision, or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other adverse effects may be:

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

Frequent(may affect up to 1 in 10 people)

• Headache or feeling of weakness or fatigue.
• Feeling of dizziness, which is more likely to occur when starting to take ramipril/hydrochlorothiazide or when starting to take a higher dose.
• Dry, irritating cough or bronchitis.
• Blood test showing higher than normal sugar levels. If you have diabetes, this may worsen.
• Blood test showing higher than normal uric acid or fat levels.
• Pain, redness, or inflammation of the joints.

Uncommon(may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Redness, feeling of dizziness, hypotension (low blood pressure), especially when standing up or getting up quickly.
• Balance problems (vertigo).
• Itching and abnormal sensations on the skin, such as numbness, tingling, pinching, burning, or prickling sensation on the skin (paresthesias).
• Loss or change in taste.
• Sleep problems.
• Depression, anxiety, more nervousness or restlessness than usual.
• Stuffy nose, inflammation of the facial sinuses (sinusitis), difficulty breathing.
• Gingivitis (gum inflammation), 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 pain, or abdominal pain.
• Stomach upset after eating or nausea.
• Urinating more than usual during the day.
• Sweating more than usual or feeling thirsty.
• Loss or decrease in appetite (anorexia), feeling less hungry.
• Faster or irregular heartbeats.
• Swelling of arms and legs, which can be a sign that your body is retaining more fluid than usual.
• Fever.
• Impotence in men.
• Blood test showing a decrease in the number of red blood cells, white blood cells, or platelets, or the amount of hemoglobin.
• Blood test showing changes in how your liver, pancreas, or kidney is functioning.
• Blood test showing lower than normal potassium levels.

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

• Vomiting, diarrhea, or stomach burning.
• Inflamed and reddened tongue or dry mouth.
• Blood test showing higher than normal potassium levels.

• Acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion).

Frequency Not Known(cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).

Other Adverse Effects Observed:

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

• Difficulty concentrating, feeling restless or confused.
• Fingers on hands and feet changing color with cold and then tingling or pain when warming up, which could be a Raynaud's phenomenon.
• Breast growth in males.
• Blood clot formation.
• Hearing problems.
• Less tear formation than usual.
• Seeing objects in a yellow color.
• 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.
• Significant skin peeling or shedding, rash with itching and lumps, or other skin reactions, such as a red rash on the face or forehead.
• Rash or bruising on the skin.
• Spots on the skin and cold extremities.
• Nail problems (e.g., nail detachment or separation from the nail bed).
• Musculoskeletal stiffness or inability to move the jaw (tetany).
• Muscle weakness or cramps.
• Decreased sexual appetite in men or women.
• Blood in the urine, which could be a sign of kidney problems (interstitial nephritis).
• Higher than normal sugar levels in the urine.
• Blood test showing an increase in the number of a certain type of white blood cell (eosinophilia).
• Blood test showing very few blood cells (pancytopenia).
• Blood test showing a change in the amount of salts, such as sodium, calcium, magnesium, and chloride, in the blood.
• Concentrated urine (dark color), feeling or being sick, having muscle cramps, confusion, and seizures, which may be due to inadequate ADH (antidiuretic hormone) secretion. If you have these symptoms, consult your doctor as soon as possible.
• Slowness or difficulty reacting.
• Change in the smell of things.
• Difficulty breathing or worsening of asthma.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ramipril/Hydrochlorothiazide Stada

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

Do not use this medicine after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect the product from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ramipril/Hydrochlorothiazide Stada

• The active ingredients are ramipril and hydrochlorothiazide.

• Each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: hypromellose, microcrystalline cellulose, pregelatinized corn starch, and sodium stearyl fumarate.

Appearance of the Product and Package Contents

Ramipril/Hydrochlorothiazide Stada 2.5 mg/12.5 mg: White or almost white, oblong tablets, engraved with the letter "R" and the number "21" on either side of the score line on one face and also with a score line on the other face.

The score lineshould notbe used to splitthe tablet.

Ramipril/Hydrochlorothiazide Stada is available in packages of 14, 20, 28, 50, and 100 tablets in cold-forming blisters with desiccant (OPA/Al/PE/HDPE) or triple-layer blister packaging (PVC/PE/PVdC/Al).

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp,

Netherlands

Date of the Last Revision of the Leaflet: January 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es