Enalapril/hydrochlorothiazide Teva-Ratiopharm 20 mg/12.5 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Enalapril/Hydrochlorothiazide Teva-ratiopharm 20 mg/12.5 mg Tablets EFG

Enalapril maleate and hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it could 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 Enalapril/Hydrochlorothiazide Teva-ratiopharm is and what it is used for
2. What you need to know before taking Enalapril/Hydrochlorothiazide Teva-ratiopharm
3. How to take Enalapril/Hydrochlorothiazide Teva-ratiopharm
4. Possible adverse effects
5. How to store Enalapril/Hydrochlorothiazide Teva-ratiopharm
6. Contents of the pack and other information

1. What Enalapril/Hydrochlorothiazide ratiopharm is and what it is used for

Enalapril/Hydrochlorothiazide Teva-ratiopharm belongs to a combination of medicines used to treat high blood pressure (hypertension). It contains two active substances, enalapril (an ACE inhibitor) and hydrochlorothiazide (a diuretic). Enalapril prevents the formation of certain substances in the body that cause an increase in blood pressure, and hydrochlorothiazide increases the elimination of water and salts from the body, which also lowers blood pressure.

Enalapril/Hydrochlorothiazide Teva-ratiopharm is used in patients whose blood pressure is satisfactorily controlled by taking the same doses of each active substance in the same proportions separately.

2. What you need to know before taking Enalapril/Hydrochlorothiazide Teva-ratiopharm

Do not take Enalapril/Hydrochlorothiazide Teva-ratiopharm

• if you are allergic to enalapril maleate, other ACE inhibitors, thiazides (medicines that increase urine elimination), or sulfonamide derivatives (some antibiotics and diabetes medicines), or to any of the other ingredients of this medicine (listed in section 6),
• if you or a close family member have ever experienced swelling of the limbs, face, lips, throat, mouth, or tongue (angioedema) under any circumstances,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in the throat area) is high,
• if you are more than 3 months pregnant. (It is also advisable to avoid using Enalapril/Hydrochlorothiazide Teva-ratiopharm during the first months of pregnancy—see Pregnancy section),
• if you have severe kidney or liver disease,
• if you are not passing urine,
• if you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting Enalapril/Hydrochlorothiazide Teva-ratiopharm.

Your doctor should know if:

• you are taking diuretics,
• you are on a low-salt diet or have had or currently have severe diarrhoea or vomiting,
• you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance),
• you have heart failure,
• you have arterial narrowing (atherosclerosis) or a cerebrovascular disorder (such as stroke),
• you have heart muscle disease (hypertrophic cardiomyopathy), narrowing of the main artery carrying blood from the heart (aortic stenosis), or another type of heart problem called outflow tract obstruction,
• you are undergoing LDL apheresis (removal of cholesterol from the blood using a machine),
• you have kidney problems, narrowing of the renal arteries (renal artery stenosis), a single functioning kidney, or are on dialysis,
• you have recently had a kidney transplant,
• you have diabetes,
• you have a collagen vascular disease such as systemic lupus erythematosus (SLE) or scleroderma, or have been treated with immunosuppressants, allopurinol, procainamide, or a combination of these,
• your liver is not functioning properly,
• you are receiving desensitization treatment with insect venom,
• you have allergic disorders or asthma,
• you are scheduled for surgery during treatment, as certain anaesthetics used during surgery may cause excessive drop in blood pressure when combined with enalapril/hydrochlorothiazide,
• you have high levels of potassium in your blood,
• you are taking any of the following medicines for high blood pressure (hypertension):
• angiotensin II receptor antagonists (ARA) (also known as “sartans”—e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren.

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

See also information under the heading “Do not take Enalapril/Hydrochlorothiazide Teva-ratiopharm”.

• if you are taking any of the following medicines, your risk of angioedema (rapid swelling under the skin, e.g., in the throat) may increase:
• sirolimus, everolimus, temsirolimus, and other mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment),
• racecadotril, a medicine used to treat diarrhoea,
• vildagliptin, a medicine used to treat diabetes.
• 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 sun and UV exposure while taking Enalapril/Hydrochlorothiazide Teva-ratiopharm.
• if you experience vision changes or eye pain. These may 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 Enalapril/Hydrochlorothiazide Teva-ratiopharm. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.
• if you have previously had respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Enalapril/Hydrochlorothiazide Teva-ratiopharm, contact your doctor immediately.

Inform your doctor if you are pregnant (or suspect you may be). Enalapril/Hydrochlorothiazide Teva-ratiopharm is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that point onward (see Pregnancy section).

At any time during treatment, sudden swelling of the tongue, lips, face, neck, possibly also hands and feet, or wheezing or hoarseness may occur. This condition is called angioedema. If this happens, stop taking Enalapril/Hydrochlorothiazide Teva-ratiopharm and consult your doctor immediately. ACE inhibitors cause a higher rate of angioedema in Black patients compared to non-Black patients.

If you develop a dry cough during treatment, consult your doctor, who will decide whether treatment should continue.

Children and adolescents

Do not give Enalapril/Hydrochlorothiazide Teva-ratiopharm to children under 18 years of age. Safety and efficacy data for Enalapril/Hydrochlorothiazide Teva-ratiopharm in children are limited.

Kidney

If you have kidney disease (renal failure), it is important not to take potassium supplements or potassium-sparing diuretics during treatment with Enalapril/Hydrochlorothiazide Teva-ratiopharm, as they may excessively increase potassium levels in your body.

This medicine contains hydrochlorothiazide, which may cause a positive result in doping control tests.

Enalapril/Hydrochlorothiazide Teva-ratiopharm with other medicines

Taking Enalapril/Hydrochlorothiazide Teva-ratiopharm with other medicines may affect its effectiveness and safety. Conversely, Enalapril/Hydrochlorothiazide Teva-ratiopharm may affect the effectiveness and safety of other medicines. 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, herbal products, or natural remedies. When being prescribed another medicine, remember to inform your doctor that you are taking or have recently stopped taking Enalapril/Hydrochlorothiazide Teva-ratiopharm.

It is especially important to inform your doctor if you are taking any of the following medicines:

• potassium-sparing diuretics such as spironolactone, triamterene, or amiloride; potassium or calcium supplements; potassium- or calcium-containing salt substitutes; or dietary supplements containing potassium or calcium. This combination may lead to dangerously high levels of potassium or calcium in your blood,
• other antihypertensive medicines or high-dose diuretics. The combination may cause a dangerous drop in blood pressure,
• angiotensin II receptor blockers (ARBs) or aliskiren (antihypertensive agents): your doctor may need to adjust your dose and/or take other precautions if you are taking an ARB or aliskiren (see also information under “Do not take Enalapril/Hydrochlorothiazide Teva-ratiopharm” and “Warnings and precautions”),
• allopurinol (a medicine for gout), procainamide (a medicine for heart rhythm disorders), cytostatic agents (cancer medicines), or medicines affecting the body's immune system (such as cyclosporine),
• lithium (a medicine used to treat mental disorders). The combination may cause lithium to accumulate in your body, increasing the risk of adverse effects,
• antipsychotics, certain antidepressants (tricyclic antidepressants), or medicines that stimulate the central nervous system,
• certain anaesthetics, barbiturates, or strong analgesics. The combination may cause dizziness when standing up,
• other medicines that may increase potassium levels (such as heparin, a medicine used to prevent blood clots; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; trimethoprim, an antibiotic for urinary tract infections; and cotrimoxazole, also known as trimethoprim/sulfamethoxazole),
• non-steroidal anti-inflammatory drugs (NSAIDs),
• carbenoxolone (used to treat ulcers), corticosteroids, corticotropin (ACTH, used to treat epilepsy), or stimulant laxatives. The combination may lead to abnormal fluid and electrolyte levels in your body, particularly potassium deficiency,
• cardiac glycosides (such as digitoxin) or tubocurarine (a muscle relaxant). The effect of these medicines may be enhanced,
• insulin or oral antidiabetic medicines,
• cholestyramine or colestipol (cholesterol-binding medicines),
• medicines commonly used to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section “Warnings and precautions”,
• racecadotril (a medicine used to treat diarrhoea).

Enalapril/Hydrochlorothiazide Teva-ratiopharm with food and drinks

Enalapril/Hydrochlorothiazide Teva-ratiopharm should be taken with liquid, with or without food.

Be aware that alcohol consumption may enhance the effect of this medicine.

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

Your doctor will usually advise you to stop taking Enalapril/Hydrochlorothiazide Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril/Hydrochlorothiazide Teva-ratiopharm is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby from that point.

Breastfeeding

Enalapril/Hydrochlorothiazide Teva-ratiopharm is not recommended for women who are breastfeeding.

Driving and using machines

Enalapril/Hydrochlorothiazide Teva-ratiopharm may make you feel tired or dizzy, which could affect your ability to drive or operate machinery requiring special attention.

Enalapril/Hydrochlorothiazide Teva-ratiopharm contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Enalapril/Hydrochlorothiazide Teva-ratiopharm

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist.

The recommended dose is 1 tablet daily.

Use in children and adolescents

This medicine must not be used in children, as its effects have not been studied in this population.

Elderly patients

Your doctor will decide the appropriate dose for you. The dose will depend on how well your kidneys are functioning.

Dosing in patients with kidney problems

The dose will depend on how well your kidneys are functioning. Follow your doctor's instructions.

Before treatment with diuretics

Treatment with other hydrochlorothiazide-containing diuretic medicines should be discontinued 2 to 3 days before starting treatment with Enalapril/Hydrochlorothiazide Teva-ratiopharm. Follow your doctor's instructions.

Do not change the dose or stop taking this medicine without first consulting your doctor.

If you take more Enalapril/Hydrochlorothiazide Teva-ratiopharm than you should

If you have taken a higher dose than you should (overdose), contact your doctor or the nearest hospital immediately. An overdose may cause low blood pressure, a heartbeat that is too fast or too slow, palpitations (awareness of a fast or irregular heartbeat), shock, rapid breathing, cough, feeling sick and unwell, muscle cramps, dizziness, drowsiness, confusion or anxiety, excessive urination, or inability to urinate.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Enalapril/Hydrochlorothiazide Teva-ratiopharm

Take the next dose at your usual scheduled time.

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

If you stop taking Enalapril/Hydrochlorothiazide Teva-ratiopharm

Treatment for high blood pressure is long-term, and stopping treatment should be discussed with your doctor. Interrupting or stopping treatment may cause your blood pressure to rise.

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 this medicine and contact your doctor or go to the nearest hospital immediately if you

• notice swelling of the hands, feet, ankles, face, lips, or throat that may cause difficulty swallowing or breathing, together with skin itching and hives. This is a common and serious adverse effect called angioedema (may affect up to 1 in 10 people).
• notice red, swollen, or "burned" skin with blisters on the lips, eyes, mouth, nose, and/or genitals. You may also have high fever, swollen glands, or joint pain. This could be a rare condition called Stevens-Johnson syndrome (may affect up to 1 in 1,000 people).

Any of these symptoms could indicate that you are having an allergic reaction to Enalapril/Hydrochlorothiazide Teva-ratiopharm.

Contact your doctor immediately if you notice any of the following adverse effects.

Uncommon or rare (may affect up to 1 in 100 people)

• Feeling of bloating and painful cramps in the stomach (abdomen), feeling dizzy (nausea), indigestion, heartburn, stomach pain, constipation, loss of appetite, dry mouth. These symptoms may be caused by an obstruction or blockage of the intestine (ileus).
• Severe stomach pain that may radiate to your back. This may be a sign of pancreatitis.
• Blood disorders including bone marrow problems and anemia. Symptoms include a tendency to bruise easily, prolonged bleeding after injuries, bleeding gums or from other sites, purple spots on the skin (caused by damage to small blood vessels), increased risk of infection.
• Lung problems including inflammation of the lungs. You may feel unwell or lose your appetite, develop a fever for 2 or 3 days, have difficulty breathing, shortness of breath, or cough.
• Fever, tiredness, loss of appetite, stomach pain, dizziness, yellowing of the skin and eyes (jaundice). These are symptoms of hepatitis (liver inflammation), which may progress to liver failure.
• A disorder that may include one or more of the following: high temperature, inflammation of veins, painful inflammation of muscles and joints, blood abnormalities detected by blood test, skin rash, sensitivity to sunlight, other skin effects.

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

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

Other possible adverse effects:

Very common (may affect more than 1 in 10 people)

• Dizziness
• Blurred vision
• Nausea
• Cough
• Weakness

Common (may affect up to 1 in 10 people)

• Headache
• Tiredness
• Chest pain
• Fainting
• Irregular and/or altered heartbeat
• Low blood pressure, including postural hypotension with associated symptoms (dizziness, weakness, blurred vision)
• Diarrhea
• Distortion or decreased sense of taste
• Abdominal pain
• Rash (exanthema)
• Muscle cramps
• Changes in blood potassium levels
• Increased levels of creatinine and blood lipids
• Excess acid levels in urine and blood
• Depression
• Difficulty breathing

Uncommon (may affect up to 1 in 100 people)

• Vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence
• Kidney problems, protein in urine
• Impotence
• Reduction in the number of red blood cells leading to pale skin, weakness, or shortness of breath (anemia)
• Palpitations (awareness of rapid or particularly strong or irregular heartbeat)
• Heart attack or stroke ("mini-stroke") (mainly in patients with low blood pressure)
• Confusion, drowsiness, insomnia, nervousness, tingling sensation, itching, and numbness (paresthesia)
• Dizziness
• Joint pain, discomfort, fever
• Facial flushing, ringing in the ears (tinnitus)
• Itching, blisters, hair loss
• Nasal discharge, sore throat, hoarseness, wheezing
• Excessive sweating
• Gout
• Low levels of sodium and/or magnesium in the blood, decreased blood glucose levels
• Inflammation of the gallbladder, especially in patients with gallstones

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

• Changes in blood count, lymph node disease, autoimmune disease (where the body attacks itself)
• Stomatitis, glossitis
• Skin allergic reactions (e.g., erythema multiforme, redness, peeling, or blisters on the skin, epidermal necrolysis [a serious condition with shedding of the outer layer of skin], purpura), skin disease with scaly red patches on the nose and cheeks (lupus erythematosus)
• Inflammation of the nasal mucosa causing nasal discharge (rhinitis)
• Reduced urine production
• Inflammation of the kidneys (interstitial nephritis)
• Breast enlargement, including in men
• Sleep disturbances, sleep disorders
• Worsening of muscle movements (due to low blood potassium levels)
• Raynaud's syndrome (symptoms include color changes in fingers when exposed to cold or pressure, pain in fingers or toes when cold, tingling or pain when warmed)
• Increased levels of liver enzymes and waste products from liver metabolism

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

• A condition called "intestinal angioedema." Symptoms include stomach pain with or without nausea
• Increased levels of calcium in the blood

Frequency not known (cannot be estimated from available data)

• Inflammation of the salivary gland
• Increased blood and urine glucose levels
• Restlessness
• Headache
• Visual disturbances
• Loss of 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))
• Inflammation of blood vessels
• Anaphylactic reactions (rapidly developing allergic hypersensitivity with generalized symptoms)
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (symptoms include headache, nausea, vomiting, agitation, or confusion, and may progress to seizures and coma if untreated)
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Enalapril/Hydrochlorothiazide Teva-ratiopharm

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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE disposal point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Hydrochlorothiazide Teva-ratiopharm

The active substances are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

The other components are monohydrate lactose (lactose), corn starch, sodium hydrogen carbonate, pregelatinized corn starch (corn starch), talc and magnesium stearate.

Appearance of the product and contents of the pack

Enalapril/Hydrochlorothiazide Teva-ratiopharm tablets are white, round, with a bevelled surface and edges, a score line on one side, and a diameter of 8 mm.

The tablets may be divided into equal halves.

Available in packs with blisters of 14, 20, 28, 1 x 28, 1 x 30, 56, 60, 98, 1 x 98, 100, 1 x 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

This medicine is authorized in the European Economic Area member states under the following names:

Austria: Enalapril-HCT ratiopharm 20 mg/12.5 mg Tabletten

Spain: Enalapril/Hydrochlorothiazide Teva-ratiopharm 20/12.5 mg tablets EFG

Finland: Enalapril comp ratiopharm tabletti

Portugal: Enalapril e Hidroclorotiazida-ratiopharm 20 mg e 12.5 mg, comprimidos

Sweden: Enalapril comp ratiopharm tabletter

Date of the most recent review of this leaflet: June 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64054/P_64054.html

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