20 mg / 12.5 mg tablets 
enalapril maleate and hydrochlorothiazide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Enalapril / Hydrochlorothiazide Orion is and what it is used for 
2. What you need to know before you take Enalapril / Hydrochlorothiazide Orion 
3. How to take Enalapril / Hydrochlorothiazide Orion 
4. Possible side effects 
5. How Enalapril / Hydrochlorothiazide Orion should be stored 
6. Contents of the packaging and other information 

What Enalapril / Hydrochlorothiazide Orion is and what it is used for

Enalapril / Hydrochlorothiazide Orion is used to treat high blood pressure. It contains two active substances: enalapril and hydrochlorothiazide.

  • Enalapril belongs to a group of medicines called ACE inhibitors. ACE inhibitors work by dilating the blood vessels, making it easier for blood to flow through them. ACE inhibitors are used to treat high blood pressure.
  • Hydrochlorothiazide belongs to a group of medicines called diuretics ( diuretics ). Diuretics cause the kidneys to produce more urine. They are used to treat high blood pressure.

Enalapril / Hydrochlorothiazide Orion is used in patients whose blood pressure is not sufficiently stabilized by enalapril or hydrochlorothiazide alone. Other medicines that contain only one active substance should therefore be used in the first instance.

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

What you need to know before you take Enalapril / Hydrochlorothiazide Orion

Do not take Enalapril / Hydrochlorothiazide Orion if:

  • you are allergic to:
    • enalapril maleate
    • other ACE inhibitors
    • hydrochlorothiazide
    • other sulfonamides (drugs chemically related to hydrochlorothiazide )
    • or against any of the other ingredients of this medicine (listed in section 6)
  • you have previously experienced swelling of the face, lips, mouth, tongue, or throat which caused difficulty swallowing and/or breathing ( angioedema ) after taking an ACE inhibitor or for some other unknown reason or in hereditary angioedema
  • you have severe renal impairment
  • you have severely impaired liver function
  • your daily amount of urine is very small
  • you have passed the first 3 months of pregnancy (even earlier in pregnancy it is good to avoid the use of Enalapril / Hydrochlorothiazide Orion, see section Pregnancy).
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of chronic ( chronic ) heart failure in adults, as it increases the risk of angioedema(rapid swelling under the skin in an area such as the throat).

The risk of angioedema may increase if you take any of the following medicines:

  • racecadotril, a medicine used to treat diarrhea
  • medicines used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
  • vildagliptin, a medicine used to treat diabetes.

You must tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

  • potassium supplements (including salt substitutes), potassium-sparing diuretic agent (diuretic), and other drugs that may increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against infection s caused by bacteria, cyclosporine, an immunosuppressive drug which prevents the rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots).

Warnings and cautions

Talk to your doctor or pharmacist before taking Enalapril / Hydrochlorothiazide Orion if:

  • you have low blood pressure (you may experience weakness or dizziness, especially when standing up)
  • you have heart problems
  • you have disturbances in the blood circulation in the brain
  • you have a liver disease
  • you have kidney disease (including kidney transplantation). This can lead to elevated levels of potassium in the blood which can be serious. Your doctor may need to adjust your dose or check your blood potassium levels.
  • you get dialysis
  • you have recently had severe vomiting or diarrhea
  • you follow a low-salt diet, are treated with potassium supplements, potassium-sparing drugs, or potassium-containing salt substitutes
  • you have a blood disease such as low number or lack of white blood cells, low platelet count, or decreased red blood cell count ( anemia )
  • you have diabetes because in that case, you should monitor your blood sugar levels closely, especially during the first month of treatment. The levels of potassium in the blood may also increase.
  • you have previously had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing and/or breathing. Black patients are at increased risk for these types of reactions with ACE inhibitors.
  • you have a collagenous vascular disease (eg lupus erythematosus, rheumatoid arthritis, or scleroderma), you are receiving immunosuppressive therapy, treated with allopurinol or procainamide, or a combination of these
  • you receive a treatment to remove cholesterol in the blood (so-called LDL -pheresis)
  • you are going to have a surgical procedure or if you are going to undergo anesthesia (also at the dentist)
  • you receive a hyposensitization treatment, to reduce hypersensitivity to bee or wasp stings.
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an angiotensin II receptor blocker (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
    • aliskiren.
  • if you are taking any of the following medicines, the risk of angioedema (rapidly developing swelling under the skin in areas such as the throat) is higher :
    • sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent rejection of transplanted organs)
    • neprilysin inhibitors, e.g. sacubitril-containing drugs for the treatment of heart failure .- if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while using Enalapril / Hydrochlorothiazide Orion.- if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Enalapril / Hydrochlorothiazide Orion. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

See also the information under the heading “Do not take Enalapril / Hydrochlorothiazide Orion”.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril / Hydrochlorothiazide Orion.

Tell your doctor if you think you may be pregnant or if you may become pregnant. The use of Enalapril / Hydrochlorothiazide Orion is not recommended in early pregnancy and should not be used after the first three months of pregnancy as it may cause serious harm to the baby (see section Pregnancy).

The drug usually does not lower blood pressure as effectively in black patients.

Children

Efficacy and safety of use in children have not been established.

Other medicines and Enalapril / Hydrochlorothiazide Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies to prescription drugs as well as over-the-counter drugs, (traditional) herbal medicines, and herbal medicines.

If Enalapril / Hydrochlorothiazide Orion is taken with certain other medicines, the effect of these may change or you may experience side effects. These medicines include:

  • other antihypertensive drugs
  • diuretics ( diuretics )
  • potassium supplements or salt substitutes containing potassium, diuretics ( diuretics, especially so-called potassium-sparing diuretics ), other medicines that can increase potassium levels in the body (eg heparin and the combination trimethoprim/sulfamethoxazole)
  • drugs for diabetes (both medicines taken by mouth and insulin )
  • lithium (a medicine used to treat certain types of depression)
  • medicines for depression called tricyclic antidepressants drugs
  • -drugs for mental disorders, so-called antipsychotics
  • certain medicines for coughs and colds and for weight loss which contain something called sympathomimetic
  • painkillers, including acetylsalicylic acid when used as painkillers
  • gold preparations
  • some muscle relaxants
  • drugs and strong painkillers (eg opiates)
  • digoxin (used for heart failure )
  • certain drugs for the treatment of irregular heartbeat ( procainamide, amiodarone, sotalol)
  • adrenaline and other catecholamines s
  • chemotherapy (anti-cancer drugs)
  • cholestyramine and colestipol (for lowering blood cholesterol ), as these reduce the absorption of hydrochlorothiazide from the gastrointestinal tract. Take Enalapril / Hydrochlorothiazide Orion one hour before or 4-6 hours after these medicines.
  • drugs most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other drugs belonging to the mTOR inhibitor group). See section “Warnings and Precautions”.

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

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under

headings “Do not take Enalapril / Hydrochlorothiazide Orion” and “Warnings and Precautions”).

Enalapril / Hydrochlorothiazide Orion with food, drink, and alcohol

Alcohol

Avoid the use of alcohol, as alcohol may increase the blood pressure-lowering effect of Enalapril / Hydrochlorothiazide Orion too much.

Pregnancy and breastfeeding

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

Pregnancy

Tell your doctor if you think you may be pregnant or may become pregnant. Usually, your doctor will suggest that you stop taking Enalapril / Hydrochlorothiazide Orion before pregnancy or as soon as you know you are pregnant and recommend another medicine for you instead. Enalapril / Hydrochlorothiazide Orion is not recommended in early pregnancy and should not be used after the third month of pregnancy, as it may cause serious harm to the baby.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Enalapril / Hydrochlorothiazide Orion is not recommended for breastfeeding mothers.

Driving and using machines

This medicine may cause dizziness or drowsiness and may impair the ability to drive and use machines. Driving and using machines should be avoided at the beginning of drug treatment until you know how this medicine affects you.

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

Enalapril / Hydrochlorothiazide Orion contains lactose

This medicine contains 123.6 mg of lactose per tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Enalapril / Hydrochlorothiazide Orion

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

Taking the medicine

The tablets can be taken with or without food. Drink a glass of water or other beverage while taking the tablet.

Dosage of the drug

Adults

The usual dose is one tablet once a day. Dose one can be increased to two tablets once daily if needed.

If you are taking any other diuretic ( diuretics ), your doctor will tell you to stop taking it 2-3 days before you start taking Enalapril / Hydrochlorothiazide Orion.

Kidney disease

If you have kidney disease, your doctor will closely monitor your dosage.

Older

Your doctor will prescribe an appropriate dose based on your kidney function.

Use for children

Efficacy and safety of use in children have not been established.

If you take more Enalapril / Hydrochlorothiazide Orion then you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack with you if you see a doctor or hospital.

Symptoms of overdose are a feeling of fainting or dizziness, which is due to a sudden or sharp drop in blood pressure.

If you forget to take Enalapril / Hydrochlorothiazide Orion

If you forget to take a tablet, skip the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Enalapril / Hydrochlorothiazide Orion

Do not change the dosage or stop the drug treatment without first talking to your doctor.

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

4. Possible side effects

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

Stop taking the tablets and contact a doctor immediately, if you experience:

  • swelling of the face, lips, tongue, or throat, which may cause breathing and/or swallowing difficulties
  • swelling of hands, feet, or ankles
  • if you develop raised red skin rashes ( hives ).

Black patients are at increased risk for these types of reactions.

Contact your doctor if necessary:

At the beginning of the treatment, you may experience a feeling of fainting or dizziness, which is caused by a drop in blood pressure. If this happens, it helps to lie down. It usually improves if you continue to take the medicine. If you are worried, talk to a doctor.

Decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ).

A very common side effect is ( can occur in more than 1 in 10 ):

  • dizziness, weakness, or malaise
  • nausea
  • dimsyn
  • cough.

Common side effects are ( may affect up to 1 in 10 ):

  • low blood pressure, fainting, changes in heart rate, palpitations, angina or chest pain
  • headache
  • taste changes
  • respiratory distress
  • diarrhea or abdominal pain
  • rash
  • fatigue
  • Depression
  • allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing and/or breathing
  • increased or decreased level of potassium in the blood, increased level of cholesterol, triglycerides, uric acid, or creatinine in the blood (detected by a blood test)
  • muscle cramps.

Less common side effects are ( may affect up to 1 in 100 ):

  • a sudden drop in blood pressure
  • fast or uneven heartbeat (palpitations)
  • myocardial infarction or stroke (possibly due to low blood pressure in some high-risk patients including patients with blood flow disorders in the heart or brain)
  • anemia
  • confusion, insomnia or drowsiness, nervousness, hallucinations, dizziness
  • ringing in the ears ( tinnitus )
  • runny nose, sore throat, hoarseness, asthma
  • inflammation of the pancreas
  • nausea (vomiting), indigestion, constipation, gas, loss of appetite
  • irritated stomach (irritation of the stomach), dry mouth, stomach ulcers
  • renal impairment, renal failure
  • joint pain ( arthralgia )
  • increased sweating, itching or hives, hair loss
  • redness
  • general malaise
  • fever
  • impotence
  • high level of protein in the urine (detected in urine test)
  • gout
  • decreased libido
  • -low blood sugar or low level of sodium or magnesium in the blood, high level of urea in the blood (detected by a blood test).

Rare side effects are ( may affect up to 1 in 1000 ):

  • Raynaud’s phenomenon where hands and feet can become very cold and white due to low blood flow
  • changes in blood counts such as low white and red blood cell counts, low hemoglobin levels, low platelet count
  • decreased bone marrow function
  • autoimmune diseases
  • strange dreams or difficulty sleeping
  • pulmonary infiltrates, inflammation of the nose, pneumonia, difficulty breathing (including pneumonitis and pulmonary edema )
  • inflammation of the cheeks, gums, tongue, lips, throat
  • sores in the mouth
  • reduced urine output
  • erythema multiforme or Stevens-Johnson syndrome, ie a serious skin condition with redness and scaling of the skin, blisters or sores, or skin loosening
  • liver problems such as hepatic impairment, inflammation of the liver, jaundice (yellowing of the skin and eyes), higher levels of liver enzymes, and bilirubin(detected in blood tests)
  • inflammation of the kidney that is not caused by bacteria (interstitial kidney inflammation)
  • enlargement of the mammary glands in men
  • high blood sugar.

Very rare side effects are ( may affect up to 1 in 10 000 users ):

  • swelling of the intestine (intestinal angioedema )
  • high level of calcium in the blood.

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

  • overproduction of the antidiuretic hormone, which causes fluid retention and leads to weakness, fatigue, or confusion
  • a symptom complex has been reported which may include some or all of the following: fever, inflammation of the blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin changes may occur.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Enalapril / Hydrochlorothiazide Orion

Do not store above 25 ° C.

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

Do not use this medicine after the expiry date which is stated on the carton (after EXP). The expiration date is the last day of the specified month.

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

6. Contents of the packaging and other information

Content declaration

  • The active substances are enalapril maleate, 20 mg per tablet and hydrochlorothiazide , 12.5 mg per tablet.
  • The other ingredients are maleic acid, lactose monohydrate, pregelatinized starch, yellow iron oxide (E172), corn starch, and sodium stearyl fumarate.

What the medicine looks like and the contents of the pack

Light yellow, round, biconvex, uncoated tablet with one side-notched and the other side with a smooth surface. The switch is not for dividing the tablet into equal doses, but only to facilitate swallowing.

Pack sizes: 30 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sale

Orion Corporation

Orionintie 1

02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

02200 Espoo

Finland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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