2.5 mg / 12.5 mg, 5 mg / 25 mg tablets
ramipril and hydrochlorothiazide
What Ramipril / Hydrochlorothiazide HEXAL is and what it is used for
Ramipril / Hydrochlorothiazide HEXAL is a combination of two medicines called ramipril and hydrochlorothiazide .
Ramipril belongs to a group of medicines called ‘ACE inhibitors’ ( Angiotensin Converting Enzyme inhibitors) that work by:
- Reduce the body’s production of substances that increase your blood pressure
- Make your blood vessels dilate and relax
- Make it easier for your heart to pump blood around your body
Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or diuretics that work by increasing the amount of water (urine) produced in the body. This lowers your blood pressure.
Ramipril / Hydrochlorothiazide HEXAL is used for high blood pressure . The two active substances work together to lower your blood pressure. They are used together when one or the other has not worked alone.
Ramipril/hydrochlorothiazide contained in Ramipril / Hydrochlorothiazide HEXAL may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Ramipril / Hydrochlorothiazide HEXAL
Do not take Ramipril / Hydrochlorothiazide HEXAL
- if you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to medicines similar to Ramipril / Hydrochlorothiazide HEXAL (other ACE inhibitors or sulfonamides ). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, and swelling of your face, lips, throat, or tongue.
- if you have ever had a severe allergic reaction called “angioedema”. Signs of this include itching, hives ( urticaria ), red marks on the hands, feet, and neck, swelling of the throat and tongue, swelling around the eyes and lips, and difficulty breathing and swallowing.
- if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril / Hydrochlorothiazide HEXAL 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 it means that the blood supply to your kidneys is reduced ( stenosis of the renal artery).
- if you have severe kidney problems and do not undergo dialysis.
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
- if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults, it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).
- during the last 6 months of pregnancy (see section “Pregnancy and breastfeeding” below).
- if you are breastfeeding (see section “Pregnancy and breastfeeding” below).
Do not take Ramipril / Hydrochlorothiazide HEXAL if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril / Hydrochlorothiazide HEXAL.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ramipril / Hydrochlorothiazide HEXAL:
- if you have heart, liver, or kidney problems
- if you have lost a lot of body salts or body fluids (through vomiting, diarrhea, abnormal sweating, strictly low-salt diet, treatment with diuretics for a long time, or have undergone dialysis )
- if you are going to undergo a treatment to reduce your allergy to wasp or bee stings ( hyposensitization )
- if you will be given anesthetics or anesthetics. This can be given to you before an operation or dental treatment. You may need to stop taking Ramipril / Hydrochlorothiazide HEXAL one day before surgery; Ask your doctor for advice
- if you suffer from primary aldosteronism (extra fluid in your body caused by too much of a hormone called aldosterone )
- if you have high levels of potassium in your blood (shown by a blood test)
- if you are taking medicines or have a condition that can reduce the sodium levels (salinity) in your blood. Your doctor may take regular blood tests to check your blood sodium levels, especially if you are older (see section 4).
- the risk of angioedema may increase if you take any of the following medicines:
- racecadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer, called mTOR inhibitors (eg temsirolimus, sirolimus, everolimus)
- vildagliptin, a medicine used to treat diabetes
- if you have a connective tissue disease such as scleroderma or SLE (systemic lupus erythematosus)
- 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 taking Ramipril / Hydrochlorothiazide HEXAL
- 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 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 Ramipril / Hydrochlorothiazide HEXAL”.
- 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 Ramipril / Hydrochlorothiazide HEXAL. Untreated, it can lead to permanent visual impairment. If you have previously had a penicillin and sulfonamide allergy, you may be at a higher risk for this. End treatment and consult a doctor (see section 4).
If you think you may be pregnant (or may become) pregnant during treatment, consult your doctor. Ramipril / Hydrochlorothiazide HEXAL is not recommended during the first 3 months of pregnancy and may cause birth defects if used later in pregnancy (see section “Pregnancy and breast-feeding” below).
Ethnic differences
If you are a black patient of African descent, this medicine may be less effective in lowering your blood pressure or you may have a higher risk of angioedema (rapid swelling under the skin in an area such as the throat).
Children and young people
Ramipril / Hydrochlorothiazide HEXAL is not recommended for use in children and adolescents below 18 years. This is because the drug has never been used in this age group.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril / Hydrochlorothiazide HEXAL.
Other medicines and Ramipril / Hydrochlorothiazide HEXAL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril / Hydrochlorothiazide HEXAL may affect the way some other medicines work. Some medicines may also affect the way Ramipril / Hydrochlorothiazide HEXAL works.
Tell your doctor if you are taking any of the following medicines. They can make Ramipril / Hydrochlorothiazide HEXAL work worse:
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and acetylsalicylic acid )
- Medicines are used to treat low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, norepinephrine, or adrenaline. Your doctor will check your blood pressure.
Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects if you take them with Ramipril / Hydrochlorothiazide HEXAL:
- Drugs used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and acetylsalicylic acid )
- Drugs that can reduce the amount of potassium in your blood. These include medicines for constipation, diuretics (diuretics), amphotericin B (used to treat fungal infections), and ACTH (used to examine the function of your adrenal glands)
- Anti-cancer drugs ( chemotherapy )
- Temsirolimus (for cancer)
- Sirolimus, everolimus (for graft rejection prevention )
- Medicines for heart problems including problems with heart rhythm
- Diuretics (diuretics) such as furosemide
- Potassium supplements (including salt substitutes), potassium-sparing diuretics (diuretics), and other medicines that may increase the amount of potassium in your blood (eg spironolactone, triamterene, amiloride, trimethoprim, and cotrimoxazole against bacterial infections; cyclosporine or tacrolimus, an immunosuppressive drug that prevents rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots).
- Steroids used in inflammation such as prednisolone
- Calcium supplementation
- Allopurinol (used to reduce the amount of uric acid in your blood)
- Procainamide (used for heart rhythm disorders)
- Cholestyramine (used to reduce blood fats)
- Carbamazepine (used to treat epilepsy )
- Vildagliptin (used to treat type 2 diabetes )
- NEP inhibitors (eg racecadotril used for diarrhea).
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 the headings “Do not take Ramipril / Hydrochlorothiazide HEXAL” and “Warnings and precautions”).
Tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril / Hydrochlorothiazide HEXAL:
- Antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril / Hydrochlorothiazide HEXAL may lower your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril / Hydrochlorothiazide HEXAL.
- Lithium (used in mental illness). Ramipril / Hydrochlorothiazide HEXAL may increase the amount of lithium in your blood. Your lithium levels will need to be monitored closely by your doctor.
- Muscle relaxants
- Quinine (used against malaria )
- Drugs that contain iodine, can be used in X-ray examinations in hospitals
- Penicillin (used to treat infections )
- Oral blood thinners (oral anticoagulants ) such as warfarin.
If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril / Hydrochlorothiazide HEXAL.
Surveys
Check with your doctor or pharmacist before taking your medicine:
- Whether the function of your parathyroid gland should be examined. Ramipril / Hydrochlorothiazide HEXAL may affect the results of the study.
Ramipril / Hydrochlorothiazide HEXAL with alcohol
- If you drink alcohol while taking Ramipril / Hydrochlorothiazide HEXAL you may feel dizzy. If you are concerned about how much you can drink while taking Ramipril / Hydrochlorothiazide HEXAL, talk to your doctor as alcohol may increase the effect of antihypertensive drugs.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must tell your doctor if you think you are (or might become) pregnant.
You should not take Ramipril / Hydrochlorothiazide HEXAL during the first 12 weeks of pregnancy and you should not take them at all after the 13th week of pregnancy as use during pregnancy may be harmful to your baby.
If you become pregnant while taking Ramipril / Hydrochlorothiazide HEXAL, tell your doctor immediately. A change to an alternative treatment that is better suited for pregnancy should be done in advance if you plan to become pregnant.
You should not take Ramipril / Hydrochlorothiazide HEXAL if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy when taking Ramipril / Hydrochlorothiazide HEXAL. This is more likely to happen when you start taking Ramipril / Hydrochlorothiazide HEXAL or if you start taking a higher dose. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Ramipril / Hydrochloride HEXAL contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Ramipril / Hydrochlorothiazide HEXAL
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
- To be swallowed. Taken at the same time each day, usually in the morning
- This medicine can be taken with or without food
- Swallow the tablets with liquid
- Do not crush or chew the tablets.
Recommended dose
Your doctor will adjust dose one until your blood pressure is under control.
Older
Your doctor will reduce the starting dose and adjust your treatment at a slower pace.
Ramipril / Hydrochlorothiazide HEXAL 2.5 mg / 12.5 mg:
The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing.
Ramipril / Hydrochlorothiazide HEXAL 5 mg / 25 mg:
The tablet can be divided into two equal doses .
If you take more Ramipril / Hydrochlorothiazide HEXAL than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Tell your doctor or see the emergency department at the nearest hospital as soon as possible. Do not drive to the hospital, ask someone else to drive you or call an ambulance. Bring your medicine pack. This is so that the doctor knows what you have taken.
If you forget to take Ramipril / Hydrochlorothiazide HEXAL
- If you forget to take a dose, take your normal dose at the next dose
- Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ramipril / Hydrochlorothiazide HEXAL and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical attention:
- Swelling of the face, lips, or throat, which makes it difficult to swallow or breathe, as well as itching and rash. This may be a sign of a severe allergic reaction to Ramipril / Hydrochlorothiazide HEXAL.
- Severe skin reactions include rash, cold sores, worsening of skin conditions, redness, blisters, or skin detachment (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
- Concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion, and seizures may be caused by incorrect secretion of ADH ( antidiuretic hormone ) (see “Warnings and Precautions”).
These side effects have been reported (occurring in an unknown number of users).
Tell your doctor immediately if you experience:
- Increased heart rate, irregular or severe heartbeat ( palpitations ), chest pain, pressure over the chest (less common side effects ), or more serious problems including heart attack and stroke ( side effects that occur in an unknown number of users).
- Shortness of breath, cough, and fever for 2-3 days, and decreased appetite. This may be a sign of lung problems including pneumonia ( side effects that occur in an unknown number of users).
- Bruising that occurs more easily than usual, prolonged bleeding time, signs of bleeding (eg bleeding in the gums), purple spots on the skin or increased susceptibility to infection, sore throat and fever, fatigue, weakness, dizziness, or pale skin. This may be a sign of blood or bone marrow problems ( side effects that occur in an unknown number of users).
- Severe abdominal pain can be felt in the back. This may be a sign of pancreatitis ( inflammation of the pancreas) ( a side effect that occurs in an unknown number of users).
- Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). This can be a sign of liver problems such as hepatitis ( inflammation of the liver) (less common side effect ) or other liver damage (a side effect that occurs in an unknown number of users).
- Sudden myopia (side effect with unknown frequency).
- Impaired vision or pain in the eyes, blurred vision or vision of halos around light sources, headache, watery eyes or nausea and vomiting due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ) (side effect with unknown frequency). See “Warnings and Cautions”.
Other side effects include:
Tell your doctor if any of the following become serious or persist for more than a few days.
Common (may affect up to 1 in 10 people)
- Headache, fatigue, or feeling of weakness
- Dizziness. This is more likely to happen when you start taking Ramipril / Hydrochlorothiazide HEXAL or if you start taking a higher dose.
- Dry cough or bronchitis
- Blood tests show higher blood sugar than normal. If you have diabetes, this can make your diabetes worse.
- Blood tests that show more uric acid or more fatty acids than normal
- Sore, red, and swollen joints.
Uncommon (may affect up to 1 in 100 people)
- Skin rash with or without swelling
- Hemorrhoids, fainting, abnormally low blood pressure ( hypotension ), especially when standing or sitting up quickly
- Balance problem (fraud)
- Itching and abnormal sensations in the skin such as numbness, tingling, tingling, burning sensation, or ant crawling ( paresthesia )
- Changed or lost taste experience
- Sleep disorders
- Depression, anxiety, increased nervousness or shaking
- Nasal congestion, sinusitis, shortness of breath
- Inflammation of the gums ( gingivitis ), swelling of the mouth
- Red, itchy, swollen, or watery eyes
- Earrings
- Dimsyn
- Hair loss
- Chest pain
- Muscle pain
- Constipation, stomach or intestinal pain
- Poor digestion or nausea
- Increased urination
- Increased sweating or thirst
- Lost or decreased appetite ( anorexia ), feeling of decreased hunger
- Increased or irregular heartbeat
- Swollen arms and legs. This may be a sign that your body is storing more water than usual.
- Fever
- Sexual inability in men
- Blood tests that show changes in the number of red blood cells, white blood cells, or platelets or a decrease in the level of hemoglobin
- Blood tests that show changes in your liver function, pancreas, or kidney function
- Blood tests show less potassium in your blood.
Very rare (may affect up to 1 in 10,000 people)
- Vomiting, diarrhea, or heartburn
- Red and swollen tongue or dry mouth
- Blood tests that show an increased amount of potassium than normal in your blood.
Has been reported (occurs in an unknown number of users):
Tell your doctor if any of the following become serious or persist for more than a few days
- Difficulty concentrating, restlessness, or confusion
- Color change of fingers and toes when cold and then pain and tingling when warmed up (Raynaud’s phenomenon)
- Enlarged breasts in men
- Blood clots
- Hearing changes
- Reduced tear flow
- The visual disturbance which means that things look yellow
- Dehydration
- Swelling, pain, and redness of the cheek ( inflammation of the salivary gland)
- Swelling in the intestine is called “intestinal angioedema” which causes symptoms such as abdominal pain, vomiting, and diarrhea
- Increased sun sensitivity
- Severe skin flaking, itchy lumpy rash, or other skin reactions such as red rash on the face or forehead
- Skin rash or bruising
- Stains on the skin and cold limbs
- Nail problems (eg loose nails or loosening of the nail from its attachment)
- Muscle stiffness or inability to move the jaw ( tetany )
- Feeling weak or have muscle cramps
- Decreased sexual desire in men or women
- Blood in the urine. This may be a sign of a kidney problem (interstitial nephritis).
- More sugar than normal in the urine
- Increased number of certain white blood cells ( eosinophilia ) detected by blood tests
- Blood tests that show too few blood cells in your blood (pancytopenia)
- Blood tests that show a change in the number of salts such as sodium, calcium , magnesium, and chloride in your blood
- Slow or worsening reactions
- Change of the sense of smell
- Difficulty breathing or worsening asthma.
- Skin and lip cancer (Non- melanoma skin cancer)
How to store Ramipril / Hydrochlorothiazide HEXAL
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 and carton after EXP. The expiration date is the last day of the specified month.
Store below 30 o C.
Blister: Store in the original package. Moisture sensitive.
HDPE jar: Close the jar tightly. Moisture sensitive.
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.
Contents of the package and other information
Content declaration
The active substances are ramipril and hydrochlorothiazide.
2.5 mg / 12.5 mg tablets:
Each tablet contains ramipril 2.5 mg and hydrochlorothiazide 12.5 mg.
5 mg / 25 mg tablets:
Each tablet contains ramipril 5 mg and hydrochlorothiazide 25 mg.
The other ingredients are: sodium bicarbonate, hypromellose, microcrystalline cellulose, corn starch, sodium stearyl fumarate
What the medicine looks like and the contents of the pack
Ramipril / Hydrochlorothiazide HEXAL 2.5 mg / 12.5 mg tablets:
The tablets are white, oblong with a scoreline on both sides and marked “R 15” on one side.
Ramipril / Hydrochlorothiazide HEXAL 5 mg / 25 mg tablets:
The tablets are white, oblong with a scoreline on both sides and marked “R 30” on one side.
The tablets are packaged in aluminum/aluminum blisters in a carton or a tablet jar of HDPE. The jar has a screw cap made of PP with desiccant (white silica gel).
HDPE can: 14, 20, 28, 30, 50, 98, 100 tablets.
Blister: 14, 20, 28, 30, 50, 98, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland