RAMIPRIL 2.5 mg/12.5 mg Tabletka powlekana

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1. Ramipril and Hydrochlorothiazide PENSA 2.5 mg/12.5 mg and 5 mg /25 mg tablets
   1. WHAT IS RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg
   2. BEFORE TAKING RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg +
   3. HOW TO TAKE RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 tablets
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg tablets
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Ramipril and Hydrochlorothiazide PENSA 2.5 mg/12.5 mg and 5 mg /25 mg tablets

Ramipril/Hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine.

• 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 personally. Do not pass it on to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg are and what they are used for
• 2. Before you take RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5mg + 25 mg
• 3. How to take RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg
• 4. Possible side effects
• 5. How to store RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg
• 6. Contents of the pack and other information

1. WHAT IS RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg

WHAT IT IS FOR
RAMIPRIL AND HYDROCHLOROTHIAZIDE is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of drugs called “ACE inhibitors” (Angiotensin Converting Enzyme
Inhibitors). It works:

• By decreasing the production, by the body, of substances that can cause an increase in blood pressure.
• By relaxing and widening its blood vessels.
• By making it easier for your heart to pump blood around the body.

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

2. BEFORE TAKING RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg +

25 mg
Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg:

• If you are allergic (hypersensitive) to ramipril, to hydrochlorothiazide or to any of the excipients of RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg (see “Contents of the pack and other information”).
• If you are allergic (hypersensitive) to drugs similar to RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg (other ACE inhibitors or drugs derived from sulfonamide). Signs of an allergic reaction can be skin rashes, 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, hives, 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 taking or are currently taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults.
• If you are on dialysis or undergoing any other type of blood filtration. Depending on the machinery used, RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal levels of salts (calcium, potassium, sodium) in the blood.
• If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
• If you are pregnant for more than three months. It is best to avoid RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg even in the early stages of pregnancy - (see Pregnancy).
• If you are breastfeeding (see “Pregnancy and breastfeeding”).
• If you suffer from diabetes or your kidney function is impaired and are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg if any of the conditions described above occur. If you are not sure, ask your doctor before taking RAMIPRIL
AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Warnings and precautions
Pay particular attention with RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg+12.5 mg and
5mg+25mg
Consult your doctor or pharmacist before taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA:

• If you have problems with your heart, liver or kidneys
• If you have lost a lot of salts or body fluids (due to a state of illness (vomiting), diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis)
• If you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization)
• If you are about to undergo anesthesia. This may be administered for surgery or dental work. It may be necessary to stop treatment with RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg the day before; ask your doctor for advice
• If you have a high amount of potassium in your blood (shown by a blood test)
• If you are taking medicines or are in conditions where sodium levels in the blood may decrease. Your doctor may prescribe blood tests at regular intervals, especially to check sodium levels in the blood, especially if you are elderly
• If you are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see also what is reported under “Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA”.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see Pregnancy).
• if you are taking one of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor blocker" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• “aliskiren”
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA.
• If you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a few hours to weeks after taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported under "Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA".
Children and adolescents
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg is not recommended
for children and adolescents under 18 years of age because this medicine has never been used in this
age group.
If any of the conditions described above occur or you are not sure, ask your doctor before taking
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Other medicines and RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicine.
The doctor may need to adjust the dose and / or take other precautions: if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported under "Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA" and "Warnings and precautions").
This is because RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg
can affect the mechanism of action of some other medicines. Also, some medicines can affect the
mechanism of action of RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25
mg.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere with
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg by altering its action:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine or adrenaline, the doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken with RAMIPRIL AND
HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg, may increase the likelihood
that side effects occur:

• Sacubitril/valsartan - used to treat a long-term (chronic) type of heart failure in adults (see also what is reported under “Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA”).
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin).
• Medicines that can lower the amount of potassium in the blood. These include medicines for constipation, diuretics, amphotericin B (used for fungal infections) and adrenocorticotropic hormone (used to check if your adrenal glands are working properly).
• Cancer medicines (chemotherapy).
• Medicines for heart problems, including heart rhythm problems.
• Medicines to prevent organ rejection after transplantation such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (used to make the blood more fluid).
• Steroid medicines for the treatment of inflammation such as prednisolone.
• Calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Cholestyramine (to reduce the amount of fat in the blood).
• Carbamazepine (for the treatment of epilepsy)
• Heparin: possible increase in serum potassium concentration.
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin: an increased incidence of angioedema has been reported in patients taking ACE inhibitors and vildagliptin.
• Racecadotril (used to treat diarrhea).
• As a result of inhibition of the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalemia and impaired renal function (including acute renal failure) have been reported in sensitive individuals, especially in combination with other drugs that act on this system. Therefore, double blockade of the renin-angiotensin-aldosterone system (e.g. by administering ramipril with other renin-angiotensin-aldosterone system inhibitors) is not recommended. Careful monitoring of renal function is recommended if co-administration is deemed necessary. The use of ramipril in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency (creatinine clearance <60 ml/min).

Tell your doctor if you are taking any of the following medicines. The mechanism of action of these medicines
may be affected by RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25
mg:

• Diabetes medicines such as oral hypoglycemic agents and insulin. RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg can lower blood sugar levels. Carefully check your blood sugar levels when taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.
• Lithium (for psychiatric problems). RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg can increase the amount of lithium in the blood. The level of lithium in your blood must be carefully monitored by your doctor.
• Muscle relaxant medicines.
• Quinine (for the treatment of malaria).
• Medicines containing iodine, these may be used in hospital before an X-ray or scan.
• Penicillin (for the treatment of infections).
• Blood-thinning medicines taken orally (oral anticoagulants) such as warfarin.

If any of the conditions described above occur (or you are not sure), ask your doctor before taking
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Checks
Tell your doctor or pharmacist before taking this medicine.

• If you are having a check for parathyroid function. RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may alter the results of the check.
• If you are an athlete who needs to undergo doping control. RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may give a positive result.

Taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg with
food and alcohol

• Drinking alcoholic beverages together with RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg, discuss it with your doctor. In fact, alcohol increases the effects of blood pressure medications.
• Taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg can be done with or without food.

Pregnancy and breastfeeding
Ramipril
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking RAMIPRIL AND
HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg before becoming pregnant
or as soon as you find out you are pregnant and will advise you to take another medicine
instead of RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg is not recommended
in early pregnancy, and should not be taken if you are pregnant for more than three months, as
it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or are planning to start breastfeeding.
RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets are not recommended
for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed,
especially if your baby is newborn or was born prematurely.

Hydrochlorothiazide
You must tell your doctor if you are pregnant or if you think you may be pregnant. As a rule, your doctor will advise
you to take another medicine instead of RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5
mg and 5 mg + 25 mg tablets, as RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25
mg tablets are not recommended during pregnancy. This is because RAMIPRIL E IDROCLOROTIAZIDE PENSA
2.5 mg + 12.5 mg and 5 mg + 25 mg tablets cross the placenta and its use after the third month of
pregnancy can cause potential harm to the fetus and effects on the newborn.

Driving and operating machinery
You may feel dizzy while taking RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg
tablets. This is more likely when you have just started taking RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg
tablets or have just increased the dose.
If this happens, do not drive or use tools or machinery.

3. HOW TO TAKE RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 tablets

mg
Always take RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets
exactly as your doctor has instructed. You should ask your doctor or pharmacist if you are not
sure.
Taking this medicine

• Take the medicine by mouth at the same time of day, every day, usually in the morning.
• Swallow the tablets whole with a liquid.
• Do not break or chew the tablets.

How much you should take

Treatment of high blood pressure
Your doctor will adjust the amount you take until your blood pressure is under control.

Elderly
Your doctor will reduce the initial dose and adjust the treatment more slowly.

If you take more RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets than
you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, have
someone drive you or call an ambulance. Bring the medicine packaging with you. This is
because the doctor needs to know what you have taken.

If you forget to take RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25
mg tablets

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a forgotten tablet.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg
can cause side effects, although not everybody gets them.

Stop taking RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg and
seek medical attention immediately if you notice any serious side effect –
you may need urgent medical treatment:

• Swelling of the face, lips or throat which makes it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Fast heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath, cough, fever lasting for 2 to 3 days and decreased feeling of hunger. These can be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or easy onset of infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These can be signs of problems with blood circulation or the bone marrow.
• Severe stomach pain that may extend to your back. This may be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.
• Severe eye pain, blurred vision or seeing halos around lights, headache, widespread tearing or nausea and vomiting which may constitute a condition called glaucoma; reduced vision, difficulty seeing distant objects which may constitute a condition called myopia.

Other side effects include:
Tell your doctor if any of the following conditions becomes severe or lasts for more than a few
days.
Common(affect less than 1 in 10 people in treatment)

• Headache or feeling weak or tired.
• Feeling dizzy. This is more likely to happen when treatment with RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg is first started or the dose has just been increased.
• Dry, irritating cough or bronchitis.
• Blood tests show a higher than normal level of sugar. If you have diabetes, this may worsen.
• Blood tests show a higher than normal level of uric acid or fats.
• Painful, red and swollen joints.

Uncommon(affect less than 1 in 100 people in treatment)

• Rash with or without swelling.
• Flushing, weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly.
• Problems with balance (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, prickling or burning (paresthesia).
• Loss or change of taste.
• Problems sleeping.
• Depressed mood, anxiety, increased nervousness than usual or irritability.
• Blocked nose, inflammation of the sinuses (sinusitis), shortness of breath.
• Inflammation of the gums (gingivitis), swelling of the mouth.
• 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 feeling thirsty than usual.
• Loss or decrease of appetite (anorexia), decreased feeling of hunger.
• Fast or irregular heartbeat.
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
• Fever.
• Impotence in men.
• Decreased number of red blood cells, white blood cells and platelets in the blood or hemoglobin concentration, highlighted by blood tests.
• Changes in liver, pancreas or kidney function highlighted by blood tests.
• Blood tests show a lower than normal level of potassium.

Very rare(affect less than 1 in 10,000 people in treatment)

• Feeling unwell, which causes diarrhea or heartburn.
• Swollen and red tongue or dry mouth.
• Blood tests show a higher than normal level of potassium.

Other side effects reported:
Tell your doctor if any of the following conditions becomes severe or lasts for more than a few
days.

• Difficulty concentrating, feeling restless or confused.
• Fingers of the hands and feet that change color when cooled and tingle and hurt when warmed (Raynaud's phenomenon).
• Increase in breast volume in men.
• Blood clots.
• Hearing disorders.
• Eyes less moist than normal.
• Objects appear yellow.
• Dehydration.
• Swelling, pain and paleness of the cheeks (inflammation of a salivary gland).
• Swelling of the intestine called "intestinal angioedema" which presents with symptoms such as abdominal pain, vomiting and diarrhea.
• Increased sensitivity to the sun.
• Severe flaking or peeling of the skin, itching, rash or other skin reactions such as redness of the face or forehead.
• Rash or bruising.
• Spots on the skin and cold extremities.
• Problems with nails (such as loss or separation of the nail from its bed).
• Musculoskeletal stiffness or inability to move the jaw (tetanus).
• Weakness or muscle cramps.
• Decreased sexual desire in men and women.
• Blood in the urine. This may be a sign of a kidney problem (interstitial nephritis).
• Greater amount of sugar in the urine than normal.
• Increase in the number of some white blood cells (eosinophilia) detected during blood tests.
• Too low number of blood cells detected by blood tests (pancytopenia).
• Change in the level of salts such as sodium, calcium, magnesium and chlorine in the blood highlighted by blood tests.
• Concentrated urine (dark in color), feeling unwell or ill, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms contact your doctor as soon as possible.
• Slowed or altered reactions.
• Change in the perception of smells.
• Difficulty breathing or worsening of asthma.
• Acute myopia and angle-closure glaucoma
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Skin and lip cancer (non-melanoma skin cancer)

Hydrochlorothiazide, sulfonamides, can cause an idiosyncratic reaction, resulting in transient myopia
and angle-closure glaucoma. Symptoms include decreased visual acuity or eye pain
and usually occur within a few hours to a week of starting treatment. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The first
thing to do is to stop treatment with hydrochlorothiazide as quickly as possible. If intraocular pressure remains uncontrolled, medical or surgical treatments should be considered.
Risk factors for the development of angle-closure glaucoma may include previous history of allergy to sulfonamides or penicillin.
If you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: https://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 E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg tablets

25 mg
Keep out of the reach and sight of children.
Do not store Ramipril and Hydrochlorothiazide at a temperature above 30° C.
Do not use Ramipril and Hydrochlorothiazide after the expiry date which is stated on the blister and on the container.
The expiry date refers to the last day of the month.
Medicines should not be disposed of 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 PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets contain

• The active ingredients in the combined preparation ramipril hydrochlorothiazide are ramipril and hydrochlorothiazide 2.5mg/12.5 mg and 5mg/25 mg
• The excipients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized corn starch, sodium stearyl fumarate.

Description of the appearance of RAMIPRIL E IDROCLOROTIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg +
25 mg tablets and package contents
Appearance of the tablets:
Ramipril and Hydrochlorothiazide 2.5 mg/12.5 mg:
Capsule-shaped, flat, white to off-white, uncoated tablet, with a notch on one side,
on the other side, embossed “12,5” , size 4 x 8 mm.
The tablet is not made to be divided.
Ramipril and Hydrochlorothiazide 5 mg/25 mg:
Capsule-shaped, flat, white to off-white, uncoated tablet, with a notch on one side,
on the other side, embossed “25” , size 5 x 10 mm.
The tablet can be divided into two equal halves.
Packages:
Blisters and plastic container:
14, 28 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy
Manufacturers and batch release responsible:
Actavis hf.
Reykjavikurvegur 76-78, 220 Hafnarfjörður
Iceland
Actavis Ltd.
B16, Bulebel Industrial Estate Zejtun ZTN 08
Malta

This medicinal product is authorised in the Member States of the EEA with the following denominations:
Italy RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 2.5 mg + 12.5 mg
RAMIPRIL E IDROCLOROTIAZIDE PENSA tablets 5 mg + 25 mg

This leaflet was last approved on
if you are unsure, ask your doctor or pharmacist.