Ramipril / Hydrochlorothiazide Actavis | Ramipril / Hydrochlorothiazide uses, dose and side effects

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 Actavis is used for high blood pressure in adults. 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 contained in Ramipril / Hydrochlorothiazide Actavis 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 Actavis

Do not take Ramipril / Hydrochlorothiazide Actavis

if you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
if you are allergic (hypersensitive) to medicines similar to Ramipril / Hydrochlorothiazide Actavis (other ACE inhibitors or sulphonamides ). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, and swelling of your lips, face, 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 Actavis 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 which 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
during the last 6 months of pregnancy (see the section on pregnancy and breastfeeding).
if you are breast-feeding (see section “Pregnancy and breast-feeding” below)
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).

Do not take Ramipril / Hydrochlorothiazide Actavis if any of the above applies to you. If you are not sure, talk to your doctor before taking Ramipril / Hydrochlorothiazide Actavis.

Warnings and cautions

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

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. This can be given to you before an operation or dental treatment. You may need to stop taking Ramipril / Hydrochlorothiazide Actavis one day before surgery; Ask your doctor for advice.
if you have high levels of potassium in your blood (shown by blood tests).
if you have a connective tissue disease such as scleroderma or SLE (systemic lupus erythematosus), as the symptoms of the disease may be activated or worsen.
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 Actavis.
The drug may have less effect on blood pressure and cause more side effects in black patients.
if you have very high blood pressure.
You must tell your doctor if you think you are (or might become) pregnant. Ramipril / Hydrochlorothiazide Actavis is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby if used after more than 3 months of pregnancy (see pregnancy section).
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 hours to weeks after taking Ramipril / Hydrochlorothiazide Actavis. This can lead to permanent vision loss without treatment. If you have previously had an allergic reaction to penicillin or sulfonamides, you may be at a higher risk of developing this
Ramipril / Hydrochlorothiazide Actavis may cause angioedema . Symptoms may include swelling of the hands, face, mouth, tongue, and throat with difficulty swallowing and breathing.
If you get a dry cough for a long time, consult a doctor or pharmacist.
if you have previously had breathing or lung problems (including inflammation or fluid in your lungs) after taking hydrochlorothiazide. If you get severe shortness of breath or severe breathing problems after taking Ramipril / Hydrochlorothiazide Actavis, seek medical attention immediately.
Ramipril / Hydrochlorothiazide Actavis may cause hypersensitivity reactions .
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 (rapid swelling under the skin in areas such as the throat) may be increased:
- racecadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- vildagliptin is a medicine used to treat diabetes.

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 Actavis”.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril / Hydrochlorothiazide Actavis.

Children and young people

Ramipril / Hydrochlorothiazide Actavis 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.

Other medicines and Ramipril / Hydrochlorothiazide Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril / Hydrochlorothiazide Actavis may affect the way other medicines work. Some medicines may also affect the way Ramipril / Hydrochlorothiazide Actavis works.

Tell your doctor if you are taking any of the following medicines. They can make Ramipril / Hydrochlorothiazide Actavis 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 Actavis:

Medicines 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 )
Medicines for heart problems including problems with heart rhythm
Diuretics (diuretics) such as furosemide
Potassium supplements (including salt replacement), potassium-sparing diuretics (diuretics), and other medicines that can increase the amount of potassium in your blood (eg trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against bacterial infections; ciclosporin, an immunosuppressant which prevents the 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 )
Temsirolimus (for cancer)
Medicines are most commonly used to prevent the rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors). See section “Warnings and Precautions”

Tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril / Hydrochlorothiazide Actavis:

Antidiabetic drugs such as oral glucose-lowering drugs and insulin. Ramipril / Hydrochlorothiazide Actavis may lower your blood sugar levels. Check your blood sugar levels carefully while you are taking Ramipril / Hydrochlorothiazide Actavis.
Lithium (used in mental illness). Ramipril / Hydrochlorothiazide Actavis 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.
Vildagliptin (used for type 2 diabetes )

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

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 Actavis” and “Warnings and precautions”)

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril / Hydrochlorothiazide Actavis.

Surveys

Check with your doctor or pharmacist before taking your medicine:

If you are going to examine the function of your parathyroid gland. Ramipril / Hydrochlorothiazide Actavis may affect the results of the study

Ramipril / Hydrochlorothiazide Actavis with food and alcohol

If you drink alcohol while taking Ramipril / Hydrochlorothiazide Actavis, you may feel dizzy. If you are concerned about how much you can drink while taking Ramipril / Hydrochlorothiazide Actavis, talk to your doctor as alcohol may increase the effect of blood pressure-lowering medicines.

Ramipril / Hydrochlorothiazide Actavis can be taken with or without food.

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 before taking this medicine.

Ramipril

You must tell your doctor if you think you are (or might become) pregnant.

You should not take Ramipril / Hydrochlorothiazide Actavis during the first 12 weeks of pregnancy and do not take them at all after the 13th week as use may be harmful to your baby.

If you become pregnant while taking Ramipril / Hydrochlorothiazide Actavis, contact your doctor immediately. A change to a suitable alternative should be carried out well in advance of a planned pregnancy.

You should not take Ramipril / Hydrochlorothiazide Actavis if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Hydrochlorothiazide

You must tell your doctor if you are pregnant or think you may be. Your doctor will usually advise you to use another medicine instead of Ramipril / Hydrochlorothiazide Actavis, as Ramipril / Hydrochlorothiazide Actavis is not recommended during pregnancy. This is because Ramipril / Hydrochlorothiazide Actavis crosses the placenta and its use after the first three months can have potentially harmful fetal and neonatal effects.

Driving and using machines

You may feel dizzy when taking Ramipril / Hydrochlorothiazide Actavis. This is more likely to happen when you start taking Ramipril / Hydrochlorothiazide Actavis 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 / Hydrochlorothiazide Actavis contains lactose and sodium

Ramipril / Hydrochlorothiazide Actavis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ramipril / Hydrochlorothiazide Actavis contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Ramipril / Hydrochlorothiazide Actavis

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

The recommended dose is one

Treatment of high blood pressure

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.

Dosage

To be swallowed. Taken at the same time each day, usually in the morning
Swallow the tablets with liquid.
The tablet can be divided into two equal doses.

If you take more Ramipril / Hydrochlorothiazide Actavis than you should

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 will know what you have taken.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.

If you forget to take Ramipril / Hydrochlorothiazide Actavis

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 Actavis and see a doctor straight away 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, but also itching and rash. This may be a sign of a severe allergic reaction to Ramipril / Hydrochlorothiazide Actavis.
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).
Acute shortness of breath syndrome (signs of this are severe shortness of breath, fever, weakness, and confusion) (frequency: very rare).

Tell your doctor immediately if you experience:

Increased heart rate, irregular or severe heartbeat ( palpitation ), chest pain, chest tightness, or more serious problems including heart attack and stroke
Shortness of breath, cough, and fever for 2-3 days, and decreased appetite. This can be a sign of lung problems including pneumonia
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 could be a sign of blood or bone marrow problems
Severe abdominal pain can be felt in the back. This may be a sign of pancreatitis ( inflammation of the pancreas).
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) or other liver damage.

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 Actavis or if you take 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, burning sensation, or ant crawling ( paresthesia )
Involuntary shaking
Psoriasis (a recurring skin disease that involves dandruff and dry skin rash)
Changed or lost taste experience
Sleep disorders
Depression, lack of interest in everyday life, anxiety, increased nervousness or restlessness
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, abdominal pain
Poor digestion or nausea
Digestive disorders
Increased urination
Kidney problems and kidney failure (symptoms can be a pain in the lower back and less 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
Inflammation of the gallbladder (which can cause abdominal pain, nausea, and vomiting)
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 that show less potassium in your blood

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

Vomiting, diarrhea, or heartburn
Cold sores
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):

Skin and lip cancer (Non- melanoma skin cancer)
Concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion, and seizures may be caused by inadequate ADH ( antidiuretic hormone ) secretion. If you get these symptoms, contact your doctor as soon as possible
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
Impaired vision or pain in your eyes due to increased pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma )
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 stomach 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
Exacerbated psoriasis if you have the disease
A condition called systemic lupus erythematosus ( SLE ) causes joint pain, rash, and fever
Stains on the skin and cold limbs
Nail problems (eg loose nails or the nail coming loose from its bracket)
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 blood cells ( eosinophilia ) that are detected via blood tests
Blood tests that show too few blood cells in your blood (pancytopenia)
Blood tests show a lower content of sodium, chloride, and magnesium than usual in the blood.
Blood tests show a lower content of calcium than usual in the blood.
Slow or worsening reactions
Change of the sense of smell
Difficulty breathing or worsening asthma

How to store Ramipril / Hydrochlorothiazide Actavis

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.

Blister pack

Store in the original package.

Can

Close the package tightly.

Do not store above 25 ° C.

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.
The other ingredients are sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch, and sodium stearyl fumarate.

What the medicine looks like and the contents of the pack

Tablets

Ramipril / Hydrochlorothiazide Actavis 5 mg / 25 mg are white, creamy white capsule-shaped flat tablets without a coating, with a notch on one side and a beveled edge. Embossed with “25”.

Pack sizes

10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC EHF.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Actavis (Balkanpharma) Dupnitsa AD

3 Samokovsko Shose Str.

Dupnitsa 2600

Bulgaria

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