Ramipril/hydrochlorothiazide STADA 5 mg/25 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ramipril/Hydrochlorothiazide STADA 5 mg/25 mg Tablets EFG

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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ramipril/Hydrochlorothiazide STADA is and what it is used for.
2. What you need to know before taking Ramipril/Hydrochlorothiazide STADA.
3. How to take Ramipril/Hydrochlorothiazide STADA.
4. Possible side effects.
5. How to store 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 known as ACE inhibitors (angiotensin-converting enzyme inhibitors). It works as follows:

• By reducing the body's production of substances that may increase blood pressure.
• By relaxing and widening 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, thereby lowering 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 in combination when treatment with only one of them does not provide adequate control of your blood pressure.

2. What you need to know before taking 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)
• 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," the symptoms of which 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 taking or have recently taken 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
• 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 levels of certain salts (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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril/Hydrochlorothiazide Stada:

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip 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 large amounts of body salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term 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 one day before; 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 (rapid swelling beneath the skin, such as in the throat) may increase:
  • Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other medicines belonging to the mTOR inhibitor group
  • Vildagliptin, a medicine used to treat diabetes
  • Neprilysin inhibitors (NEP inhibitors) 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
• Inform your doctor if you are pregnant (or suspect you might be). Use of 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 breastfeeding")
• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking ramipril/hydrochlorothiazide. This may lead to permanent vision loss if not treated. Your risk may be higher if you are at risk of developing glaucoma or have previously had an allergy to penicillin or sulfonamides
• If you are taking any of the following medicines for high blood pressure:
  • An angiotensin II receptor antagonist (ARB) (also known as sartans—e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
  • Aliskiren
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking ramipril/hydrochlorothiazide, contact your doctor 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 studied in these age groups.

If you are unsure whether any of the above conditions apply to you, speak with 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 need to take any other medicines. This is because ramipril/hydrochlorothiazide may affect how some other medicines work. Also, some medicines may affect how ramipril/hydrochlorothiazide works.

Inform your doctor if you are taking any of the following medicines. These may reduce the effectiveness of ramipril/hydrochlorothiazide:

• Medicines to relieve 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. These may increase the risk of side effects when 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")
• Medicines to relieve 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)
• Medicines for cancer (chemotherapy)
• 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 cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to 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 organ transplant rejection and for cancer (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). 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 (ARB) or aliskiren (see also information under the headings "Do not take Ramipril/Hydrochlorothiazide Stada" and "Warnings and precautions").

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

• Medicines for diabetes, such as oral glucose-lowering agents and insulin. Ramipril/hydrochlorothiazide may lower blood sugar levels. Monitor your blood sugar carefully while taking ramipril/hydrochlorothiazide
• Lithium (for mental health conditions). Ramipril/hydrochlorothiazide 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 medicines to thin the blood (oral anticoagulants), such as warfarin derivatives

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking ramipril/hydrochlorothiazide.

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are to undergo a parathyroid function test, ramipril/hydrochlorothiazide may affect the results
• If you participate in athletic events subject to doping controls, be aware that ramipril/hydrochlorothiazide may result in a positive test

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 alcohol you can drink while taking ramipril/hydrochlorothiazide, talk to your doctor, as blood pressure-lowering medicines and alcohol may have additive effects
• Ramipril/hydrochlorothiazide 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 inform your doctor if you think you are pregnant (or suspect you might be).

You should not take ramipril/hydrochlorothiazide during the first 12 weeks of pregnancy, and must not take it at any time after week 13, as its use during pregnancy may harm your baby.

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

Breastfeeding

You should not take ramipril/hydrochlorothiazide while breastfeeding. 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 may be a risk in situations where these skills are particularly important (e.g., driving a vehicle or operating machinery).

You may feel dizzy while taking ramipril/hydrochlorothiazide, especially when starting treatment or increasing the dose. If you feel dizzy, do not drive or operate tools or machinery.

Ramipril/Hydrochlorothiazide Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free."

3. How to take Ramipril/Hydrochlorothiazide Stada

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

How much medicine to take

Treatment of high blood pressure

Your doctor will adjust your dose until your blood pressure is controlled.

Elderly patients

Your doctor will reduce your starting dose and adjust your treatment more gradually.

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 tablet may be divided into equal doses.

If you take more Ramipril/Hydrochlorothiazide 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

• If you forget to take a dose, take your next dose at the usual 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 will experience them.

Stop taking Ramipril/Hydrochlorothiazide Stada and consult your doctor immediately if you notice any of the following serious adverse effects; 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 severe allergic reaction to ramipril/hydrochlorothiazide.
• Severe 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).

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 or 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 longer than normal, any sign of bleeding (e.g., from 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 indicate pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (feeling like vomiting), yellowing of the skin or eyes (jaundice), which could be symptoms of liver problems such as hepatitis (liver inflammation) or liver damage.
• Severe eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which may indicate a condition called glaucoma.
• Rapid onset of reduced distance vision (acute myopia), decreased vision, or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other possible adverse effects may include:

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

Common (may affect up to 1 in 10 people)

• Headache or feeling weak or tired.
• Dizziness, which is more likely when starting ramipril/hydrochlorothiazide or when increasing the dose.
• Dry, irritating cough or bronchitis.
• Blood tests showing higher than normal blood sugar levels. If you have diabetes, it may worsen.
• Blood tests showing higher than normal levels of uric acid or fats.
• Pain, redness, or swelling in the joints.

Uncommon (may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Flushing, dizziness, low blood pressure (hypotension), especially when standing up or getting up quickly.
• Balance problems (vertigo).
• Itching and abnormal skin sensations such as numbness, tingling, pricking, burning, or skin "pins and needles" (paresthesias).
• Loss or changes in taste.
• Sleep problems.
• Depression, anxiety, increased nervousness or restlessness.
• Stuffy nose, facial sinus inflammation (sinusitis), difficulty breathing.
• Inflammation of the gums (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.
• Blood tests showing reduced numbers of red blood cells, white blood cells, or platelets, or reduced hemoglobin levels.
• Blood tests showing changes in liver, pancreas, or kidney function.
• Blood tests showing lower than normal potassium levels.

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

• Vomiting, diarrhea, or stomach burning.
• Swollen and red tongue or dry mouth.
• Blood tests showing higher than normal potassium levels.
• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

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

Other observed adverse effects:

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

• Difficulty concentrating, feeling restless or confused.
• Fingers and toes changing color in cold conditions, followed by tingling or pain upon warming, which could indicate Raynaud's phenomenon.
• Breast enlargement in men.
• Formation of blood clots.
• Hearing problems.
• Reduced tear production.
• Seeing objects in yellow.
• 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 a reddish rash on the face or forehead.
• Rash or bruising on the skin.
• Skin spots and cold extremities.
• Nail problems (e.g., nail 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 indicate kidney problems (interstitial nephritis).
• Higher than normal sugar in the urine.
• Increased number of a certain type of white blood cells (eosinophilia) in a blood test.
• Blood tests showing very low numbers of blood cells (pancytopenia).
• Blood tests showing changes in levels of electrolytes such as sodium, calcium, magnesium, and chloride.
• Concentrated urine (dark color), feeling unwell or being sick, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, consult your doctor as soon as possible.
• Slowness or difficulty reacting.
• Change in the smell of things.
• Breathing problems or worsening of asthma.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 Stada

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 is the last day of the month indicated.

Do not store above 25°C.

Store in the original container to protect the product 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 dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril/Hydrochlorothiazide Stada

• The active substances are ramipril and hydrochlorothiazide.

Each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.

• The other components are hypromellose, microcrystalline cellulose, pregelatinized corn starch and sodium stearyl fumarate.

Appearance of the product and contents of the pack

Ramipril/Hydrochlorothiazide Stada 5 mg/25 mg: White or almost white, oblong tablets, marked with the letter “R” and the number “22” on either side of the score on one side, and also scored on the other side.

The tablet can be divided into equal doses.

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

Only certain pack 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

[email protected]

Manufacturer

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp,

The Netherlands

Date of latest revision of the leaflet: January 2022

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