Ramipril and hydrochlorothiazide Sandoz: detailed information

Patient Information Leaflet

Ramipril Hydrochlorothiazide Sandoz 2.5 mg/12.5 mg tablets, 5 mg/25 mg tablets

Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ is and what it is used for
What you need to know before taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ
How to take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ
Possible side effects
How to store RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ
Contents of the pack and other information

1. What RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ is and what it is used for

RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ 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 by:

Reducing the body's production of substances that can cause an increase in blood pressure
Relaxing and widening your blood vessels
Helping your heart pump blood more easily around the body

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or oral diuretics. It works by
increasing the amount of water (urine) produced. This lowers blood pressure.
RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ is used to treat high blood pressure. The two active ingredients
work together to lower blood pressure. They are used in combination when treatment with either component alone is not effective.

2. What you need to know before taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ

Do not take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ:

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 SANDOZ (other ACE inhibitors or sulfonamide-derived medicines)
signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
if you have had a severe allergic reaction called "angioedema". These signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
if you are on dialysis or undergoing another type of blood filtration. Depending on the equipment used, RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may not be suitable for you
if you have severe liver problems
if you have abnormal levels of salts (calcium, potassium, sodium) in your blood
if you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis)
if you have severe kidney problems and are not on dialysis
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, such as in the throat)
during the last 6 months of pregnancy – (see section below “Pregnancy and breastfeeding”)
if you are breastfeeding (see section “Pregnancy and breastfeeding”)

Do not take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ if any of the above conditions apply to you.
If you are unsure, consult your doctor before taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ.
Warnings and precautions
Talk to your doctor or pharmacist before taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ:

if you have heart, liver, or kidney problems
if you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or from long-term use of oral diuretics or after dialysis)
if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation)
if you are about to undergo anaesthesia that may be administered for surgery or dental procedures. You may need to stop taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ the day before – consult your doctor
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 may reduce sodium levels in your blood. Your doctor may perform regular blood tests, especially to monitor sodium levels, particularly if you are elderly (see section 4).
if you are taking any of the following medicines, the risk of angioedema may be increased:
racecadotril, a medicine used to treat diarrhoea;
medicines used to prevent organ rejection after transplantation and for cancer, called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus)
vildagliptin, a medicine used to treat diabetes.
if you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus
if you have previously had skin cancer or develop unexpected skin lesions 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 exposure to sunlight and UV rays while taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ.
if you are taking any of the following medicines used to treat high blood pressure:
an angiotensin II receptor antagonist (AIIRA) (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 the section “Do not take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ”
if you experience a decrease in vision or eye pain while taking this medicine. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma), which may occur from a few hours to several weeks after taking Lisinopril Hydrochlorothiazide Sandoz. If untreated, this may lead to permanent vision loss. If you previously had an allergy to medicines containing penicillin or sulfonamide, you may be at higher risk of developing glaucoma. You must stop treatment and contact your doctor immediately (see section 4).

You must inform your doctor if you think you are (or might be) pregnant. RAMIPRIL
HYDROCHLOROTHIAZIDE SANDOZ is not recommended during the first 3 months of pregnancy and can cause
serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”).
Children and adolescents
The use of RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ is not recommended for children and adolescents
under 18 years of age, as this medicine has not been studied in this age group.
If any of the above conditions apply to you or if you are unsure, consult your doctor before taking
RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ.
Other medicines and RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. This is because RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may affect the action of certain other medicines. Also, some medicines may affect the action of RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with
RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ and alter its effect:

Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin, and acetylsalicylic acid)
Medicines used to treat 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. Taking these with RAMIPRIL
HYDROCHLOROTHIAZIDE SANDOZ may increase the likelihood of side effects:

Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, acetylsalicylic acid)
Medicines that may lower potassium levels in the blood. These include laxatives, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to check if your adrenal glands are functioning properly)
Medicines for cancer (chemotherapy)
Temsirolimus (for cancer)
Sirolimus, everolimus (to prevent transplant rejection)
Medicines for heart problems, including heart rhythm disorders
Diuretics such as furosemide
Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g. spironolactone, triamterene, amiloride, trimethoprim, and co-trimoxazole for bacterial infections; cyclosporine or tacrolimus, immunosuppressive medicines used to prevent organ transplant rejection; and heparin, used to thin the blood)
Steroid medicines for treating inflammation such as prednisolone
Calcium supplements
Allopurinol (used to lower uric acid levels in the blood)
Procainamide (for heart rhythm problems)
Cholestyramine (to reduce blood fat levels)
Carbamazepine (for treating epilepsy)
Vildagliptin (for treating type 2 diabetes)
Racecadotril (used for diarrhoea)

Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections “Do not take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ” and “Warnings and precautions”).
Inform your doctor if you are taking any of the following medicines. The action of these medicines
may be affected by RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ:

Medicines for diabetes such as oral hypoglycaemics and insulin. RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may lower blood sugar levels. Monitor your blood sugar levels carefully when taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ.
Lithium (for psychiatric conditions). RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
Muscle relaxants
Quinine (for treating malaria)
Medicines containing iodine, which may be used in hospital before an X-ray or scan
Penicillin (for treating infections)
Oral anticoagulants (blood thinners) such as warfarin

If any of the above conditions apply (or if you are unsure), consult your doctor before taking
RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ.
Monitoring
Inform your doctor or pharmacist before taking this medicine.

if you are undergoing tests for parathyroid function. RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may alter test results
if you are an athlete undergoing anti-doping tests. RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may cause a positive result.

RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ and alcohol
Drinking alcoholic beverages with RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking RAMIPRIL
HYDROCHLOROTHIAZIDE SANDOZ, discuss it with your doctor. Alcohol may enhance the effects of blood pressure medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Inform your doctor if you think you are pregnant (or might become pregnant).
You must not take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ during the first 12 weeks of pregnancy, and
you should not take it beyond the 13th completed week, as its use during pregnancy may harm your baby.
If you become pregnant while taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ, inform your doctor immediately. An appropriate alternative treatment should be initiated well in advance of planning a pregnancy.
You must not take RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ if you are breastfeeding.
Inform your doctor or pharmacist before taking any medicine.
Driving and using machines
You may experience dizziness while taking RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ. This is more likely when you first start taking it or after a dose increase. If this occurs, do not drive or operate tools or machinery.
RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take RAMIPRIL IDROCHLOROTHIAZIDE SANDOZ

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Taking this medicine

Take the medicine by mouth at the same time each day, usually in the morning.
This medicine can be taken with or without food.
Swallow the tablets whole with a liquid.
Do not break or chew the tablets.

Recommended dose
Your doctor will adjust the amount you take until your blood pressure is under control.
Elderly patients
Your doctor will reduce the initial dose and adjust treatment more gradually.
RAMIPRIL IDROCHLOROTHIAZIDE SANDOZ 2.5 mg/12.5 mg tablets
The score line is only intended to facilitate tablet breaking for easier swallowing and is not intended for dividing the tablet into equal doses.
RAMIPRIL IDROCHLOROTHIAZIDE SANDOZ 5 mg/25 mg tablets
The tablet may be divided into equal doses.

If you take more RAMIPRIL IDROCHLOROTHIAZIDE SANDOZ than you should
Inform your doctor or go to the nearest hospital emergency department immediately. Do not drive to the hospital; have someone accompany you or call an ambulance. Take the medicine pack with you. This is important so the doctor knows what you have taken.

If you forget to take RAMIPRIL IDROCHLOROTHIAZIDE SANDOZ

If you forget a dose, take your usual dose at the next scheduled time.
Do not take a double dose to make up for the forgotten tablet.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Stop taking RAMIPRIL IDROCLOROTIAZIDE SANDOZ and contact your doctor immediately if you notice any severe side effect – you may need urgent medical treatment:

Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching or skin rash. This could be a sign of a severe allergic reaction to RAMIPRIL IDROCLOROTIAZIDE SANDOZ.
Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disease, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).
Concentrated urine (dark in colour), feeling or being sick, muscle cramps, confusion and seizures which could be due to inadequate secretion of ADH (antidiuretic hormone) (see ‘’Warnings and precautions’’).

The frequency of these side effects is unknown (cannot be estimated from the available data).

Tell your doctor immediately if you experience:

Rapid heartbeat, irregular or strong heartbeats (palpitations), chest pain or a feeling of tightness in the chest (uncommon side effects), or more serious problems including heart attack and stroke (side effects with unknown frequency).
Shortness of breath, cough, persistent fever lasting 2 to 3 days and reduced appetite. These may be signs of lung problems, including inflammation (side effects with unknown frequency).
Easy bruising, prolonged bleeding more than usual, any signs of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale appearance. These may be signs of blood or bone marrow disorders (side effects with unknown frequency).
Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas) (side effect with unknown frequency).
Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) (uncommon side effect) or liver damage (side effect with unknown frequency).
Sudden decrease in vision (myopia) (side effect with unknown frequency). Decreased vision or eye pain, blurred vision or seeing halos around lights, headache, excessive tearing or nausea and vomiting due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma (side effect with unknown frequency)). See “Warnings and precautions”.

Other side effects include:
Tell your doctor if any of the following conditions become severe or persist for more than a few days.

Common (may affect up to 1 in 10 people)

Headache or feeling weak or tired
Dizziness. This is more likely when treatment with RAMIPRIL IDROCLOROTIAZIDE SANDOZ has just started or the dose has recently been increased
Dry, persistent cough or bronchitis
Blood tests show higher than normal blood sugar levels. If you have diabetes, this may worsen
Blood tests show higher than normal levels of uric acid or fats
Painful, red and swollen joints

Uncommon (may affect up to 1 in 100 people)

Rash with or without swelling
Flushing, weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
Balance problems (dizziness)
Itching and unusual skin sensations such as numbness, tingling, pricking or burning (paresthesia)
Loss or change in taste
Sleep disturbances
Depressed mood, anxiety, increased nervousness or irritability
Stuffy nose, inflammation of the sinuses (sinusitis), shortness of breath
Inflammation of the gums (gingivitis), mouth swelling
Red, swollen, watery or itchy eyes
Ringing in the ears
Blurred vision
Hair loss
Chest pain
Muscle pain
Constipation, stomach or intestinal pain
Indigestion or feeling unwell
Increased amount of urine during the day
Increased sweating or thirst
Loss or decrease in appetite (anorexia), reduced feeling of hunger
Fast or irregular heartbeat
Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual
Fever
Impotence in men
Decrease in the number of red blood cells, white blood cells and platelets or in haemoglobin concentration, shown by blood tests
Changes in liver, pancreas or kidney function shown by blood tests
Blood tests show lower than normal potassium levels

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

Feeling unwell, causing diarrhoea or stomach burning
Swollen and red tongue or dry mouth
Blood tests show higher than normal potassium levels

Not known (frequency cannot be estimated from the available data)
Tell your doctor if any of the following conditions become severe or persist for more than a few days.

Difficulty concentrating, feeling restless or confused
Fingers of hands and feet changing colour when cold, and tingling or pain when warmed (this may be Raynaud’s syndrome)
Breast enlargement in men
Blood clots
Hearing disorders
Eyes less moist than normal
Objects appearing yellow
Dehydration
Swelling, pain and paleness of the cheeks (inflammation of a salivary gland)
Intestinal swelling called “intestinal angioedema” presenting with symptoms such as abdominal pain, vomiting and diarrhoea
Increased sensitivity to sunlight
Severe peeling or shedding of the skin, itching, rash or other skin reactions such as redness of the face or forehead
Skin rash or bruising
Skin spots and cold extremities
Nail problems (such as nail loss or separation of the nail from its bed)
Musculoskeletal stiffness or inability to move the jaw (tetanus)
Muscle weakness or cramps
Reduced sexual desire in men and women
Presence of blood in the urine. This could be a sign of a kidney problem (interstitial nephritis)
Higher than normal sugar levels in the urine
Increased number of certain white blood cells in the blood (eosinophilia) detected during blood tests
Too low number of blood cells shown by blood tests (pancytopenia)
Changes in levels of electrolytes such as sodium, calcium, magnesium and chloride in the blood shown by blood tests
Slowed or altered reactions
Changes in the perception of smells
Breathing difficulties or worsening of asthma
Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ

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 blister and outer packaging, after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Blister: store in the original packaging to protect from moisture.
HDPE container: keep the container tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ contains
Active substances: ramipril and hydrochlorothiazide
2.5 mg/12.5 mg:
1 tablet of RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ contains 2.5 mg of ramipril and 12.5 mg of
hydrochlorothiazide
5 mg/25 mg:
1 tablet of RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ contains 5 mg of ramipril and 25 mg of
hydrochlorothiazide
Other components:
sodium bicarbonate, hypromellose, microcrystalline cellulose, maize starch, sodium stearyl fumarate.

Description of the appearance of RAMIPRIL HYDROCHLOROTHIAZIDE SANDOZ and contents of the package
2.5 mg/12.5 mg
White, elongated tablets, with a break line on both sides and engraved with 'R 15' on one side.
5 mg/25 mg
White, elongated tablets, with a break line on both sides and engraved with 'R 30' on one side.
The tablets are packaged in aluminum/aluminum blisters, contained in cardboard boxes or in HDPE bottles. The bottle is equipped with a screw cap made of polypropylene (PP) and includes a desiccant (silica gel, white).
Pack sizes: 14, 20, 28, 30, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA)

Manufacturers
SALUTAS Pharma GmbH - Otto-von-Guericke-Allee, 1 - 39179 Barleben (Germany)
LEK Pharmaceuticals d. d. - Verovškova 57 - 1526 Ljubljana (Slovenia)
LEK S.A. - ul. Podlipie 16, 95-010 Stryków (Poland)
LEK S.A. - ul. Domaniewska 50 C, 02-672 Warszawa (Poland)

This medicinal product has been authorized in the European Economic Area member states under the following names:
Denmark: Tiavase
Belgium: Co-Ramipril Sandoz 5 mg/25 mg tabletten
Greece: PIRAMIL PLUS
Italy: Ramipril Hydrochlorothiazide Sandoz 2.5 mg/12.5 mg tablets (or Ramipril Hydrochlorothiazide Sandoz 5 mg/25 mg tablets)
Netherlands: Ramipril/Hydro-chloorthiazide Sandoz 2.5/12.5 mg, tabletten
Slovenia: Piramil H 2.5 mg/12.5 mg tablete (or Piramil H 5 mg/25 mg tablete)
Sweden: Ramipril/Hydroklortiazid HEXAL 2.5 mg/12.5 mg (or Ramipril/Hydroklortiazid HEXAL 5 mg/25 mg)