Ramipril and hydrochlorothiazide Pensà

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Ramipril/Hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before 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. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

WHAT IT IS USED FOR
RAMIPRIL AND HYDROCHLOROTHIAZIDE 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 may cause an increase in blood pressure.
• Relaxing and widening your blood vessels.
• Helping your heart pump blood more easily throughout 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 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 alone is not effective.

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, hydrochlorothiazide, or 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 medicines similar to RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg (other ACE inhibitors or sulfonamide-derived medicines). Signs of an allergic reaction may include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have previously experienced a severe allergic reaction called “angioedema”. Symptoms 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 or swallowing.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are on dialysis or undergoing any other type of blood filtration. Depending on the equipment 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 your blood.
• If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
• If you are more than three months pregnant. 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 have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 above conditions apply to you. If you are unsure, consult your doctor before taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Warnings and precautions

Take special care with RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg

Consult your doctor or pharmacist before taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA:

• If you have heart, liver, or kidney problems
• If you have lost significant body salts or fluids (due to illness (vomiting), diarrhoea, excessive sweating, a low-salt diet, 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 due to receive anaesthesia, which may be administered during surgery or dental procedures. You may need to stop taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg 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 conditions that may lower sodium levels in your blood. Your doctor may order regular blood tests, particularly to monitor sodium levels, 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 inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see also “Do not take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA”.
• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus
• You must inform your doctor if you think you may be 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 must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken during this period (see Pregnancy).
• 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”
• If you have previously had skin cancer or are developing 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 cancer and lip cancer. Protect your skin from sun and UV exposure while taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA.
• If you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur from a few hours to weeks after taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section “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, as this medicine has never 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 AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Other medicines and RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may consider it necessary to adjust your dose and/or take additional precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “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 may affect the mechanism of action of certain other medicines. Conversely, some medicines may affect the action of RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Inform your doctor if you are taking any of the following medicines. These may interfere with RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg, altering its effect:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, aspirin)
• 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 AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may increase the likelihood of side effects:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see also “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, indometacin, aspirin).
• Medicines that may lower potassium levels in the blood. These include laxatives, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to assess adrenal gland function).
• Medicines for cancer (chemotherapy).
• Medicines for heart problems, including heart rhythm disorders.
• Medicines to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (used to make blood less viscous).
• Steroid medicines for treating inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm disorders).
• Cholestyramine (to reduce blood lipid levels).
• Carbamazepine (for 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 observed in patients taking ACE inhibitors and vildagliptin.
• Racecadotril (used to treat diarrhoea).
• As a consequence of inhibition of the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalemia, and renal function impairment (including acute renal failure) have been reported in susceptible individuals, especially when combined with other medicines acting on this system. Therefore, dual blockade of the renin-angiotensin-aldosterone system (e.g. administering ramipril with other inhibitors of this system) is not recommended. Careful monitoring of renal function is advisable if co-administration is considered necessary. The use of ramipril in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (creatinine clearance <60 ml/min).

Inform 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:

• Medicines for diabetes such as oral hypoglycaemics and insulin. RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may lower blood sugar levels. Monitor your blood glucose levels carefully when taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.
• Lithium (for psychiatric conditions). RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
• Muscle relaxants.
• Quinine (for the treatment of malaria).
• Medicines containing iodine, which may be used in hospital before X-rays or scans.
• Penicillin (for treating infections).
• Oral anticoagulant medicines (e.g. warfarin).

If any of the above conditions apply (or if you are unsure), consult your doctor before taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg.

Tests

Inform your doctor or pharmacist before taking this medicine:

• If you are undergoing tests for parathyroid function. RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may alter test results.
• If you are an athlete undergoing anti-doping testing. RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg may result in a positive test.

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

• Drinking alcohol 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 you can drink while taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg, discuss it with your doctor. Alcohol increases the effects of blood pressure medicines.
• RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg can be taken with or without food.

Pregnancy and breastfeeding

Ramipril

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally 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 pregnancy is confirmed, and will recommend an alternative medicine.
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken beyond the third month of gestation.

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

Hydrochlorothiazide
You must inform your doctor if you are pregnant or think you may be pregnant. Your doctor will normally advise you to take another medicine instead of RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg, as it is not recommended during pregnancy. This is because RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg crosses the placenta and its use after the third month of pregnancy may cause potential harm to the fetus and adverse effects in the newborn.

Driving and using machines
You may experience dizziness while taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg + 25 mg. This is more likely when you first start taking the medicine or when your dose has just been increased.
If this occurs, do not drive or operate tools or machinery.

3. HOW TO TAKE RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg AND 5 mg + 25 mg TABLETS

mg
Always take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg AND 5 mg + 25 mg TABLETS
exactly as prescribed by your doctor. Ask your doctor or pharmacist for advice if you are
unsure.
When taking this medicine:

• Take the tablet by mouth at the same time each 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 your dose until your blood pressure is under control.
Elderly patients
Your doctor will reduce the initial dose and adjust treatment more gradually.
If you take more RAMIPRIL AND HYDROCHLOROTHIAZIDE 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 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 that the doctor knows what you have taken.
If you forget to take RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg AND 5 mg + 25 mg
TABLETS

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

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets
may cause adverse reactions, although not everyone experiences them.
Stop taking RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets and
contact your doctor immediately if you experience any serious adverse reaction –
you may require urgent medical treatment:

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a severe allergic reaction to RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets.
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin conditions, redness, blistering, and skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid or irregular heartbeat (palpitations), chest pain, chest tightness, or more serious problems such as heart attack or stroke.
• Shortness of breath, cough, persistent fever lasting 2 to 3 days, and reduced appetite. These may be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat, fever, fatigue, dizziness, weakness, or pale appearance. These may indicate blood or bone marrow problems.
• Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, malaise, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.
• Severe eye pain, blurred vision or halos around lights, headache, excessive tearing, nausea, or vomiting, which may indicate a condition called glaucoma; reduced vision or difficulty seeing at a distance, which may indicate a condition called myopia.

Other adverse reactions include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.
Common (affects less than 1 in 10 patients)

• Headache or feelings of weakness or fatigue.
• Dizziness. This is more likely to occur when treatment with RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets 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 (affects less than 1 in 100 patients)

• Skin rash with or without swelling.
• Flushing, weakness, hypotension (unusually low blood pressure), especially when standing up or rising quickly.
• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, prickling, or burning (paresthesia).
• Loss or change in taste.
• Sleep disturbances.
• Depressed mood, anxiety, increased nervousness, or irritability.
• Nasal congestion, sinus inflammation (sinusitis), shortness of breath.
• Gum inflammation (gingivitis), mouth swelling.
• Red, swollen, watery, or itchy eyes.
• Ringing in the ears (tinnitus).
• Blurred vision.
• Hair loss.
• Chest pain.
• Muscle pain.
• Constipation, stomach or intestinal pain.
• Indigestion or feeling unwell.
• Increased urine output during the day.
• Excessive sweating or thirst.
• Loss or reduced appetite (anorexia), reduced sense of hunger.
• Rapid or irregular heartbeat.
• Swollen arms and legs. This may indicate fluid retention.
• Fever.
• Male impotence.
• Decreased number of red blood cells, white blood cells, platelets, or hemoglobin concentration, as shown in blood tests.
• Changes in liver, pancreas, or kidney function as shown in blood tests.
• Blood tests show lower than normal potassium levels.

Very rare (affects less than 1 in 10,000 patients)

• Feeling unwell, leading to diarrhea or stomach burning.
• Swollen and red tongue or dry mouth.
• Blood tests show higher than normal potassium levels.

Other adverse reactions reported:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days.

• Difficulty concentrating, restlessness, or confusion.
• Fingers of hands and feet changing color when cold, with tingling and pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Blood clots.
• Hearing disturbances.
• Dry eyes.
• 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 diarrhea.
• Increased sensitivity to sunlight.
• Severe skin peeling or shedding, itching, rash, or other skin reactions such as facial or forehead redness.
• Skin rash or bruising.
• Skin spots and cold extremities.
• Nail problems (such as nail loss or separation from the nail bed).
• Musculoskeletal stiffness or inability to move the jaw (tetanus-like symptoms).
• Muscle weakness or cramps.
• Reduced sexual desire in men and women.
• Presence of blood in urine. This could be a sign of kidney problems (interstitial nephritis).
• Increased sugar in urine.
• Increased number of certain white blood cells (eosinophilia) detected in blood tests.
• Abnormally low blood cell count (pancytopenia) detected in blood tests.
• Changes in blood levels of electrolytes such as sodium, calcium, magnesium, and chloride, detected in blood tests.
• Concentrated urine (dark-colored), malaise, muscle cramps, confusion, or seizures, which may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Slowed or altered reactions.
• Changes in smell perception.
• Breathing difficulties or worsening of asthma.
• Acute myopia and closed-angle 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 closed-angle glaucoma).
• Skin and lip cancer (non-melanoma skin cancer).

Hydrochlorothiazide, a sulfonamide, may cause an idiosyncratic reaction leading to transient myopia and closed-angle glaucoma. Symptoms include decreased visual acuity or eye pain and usually occur within hours to one week after starting treatment. Untreated acute closed-angle glaucoma may lead to permanent vision loss. The first step is to discontinue hydrochlorothiazide treatment as quickly as possible. If intraocular pressure remains uncontrolled, medical or surgical treatments should be considered. Risk factors for developing closed-angle glaucoma may include previous allergy to sulfonamides or penicillin.

If you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

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

5. HOW TO STORE RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA tablets 2.5 mg + 12.5 mg and 5 mg +

25 mg
Keep out of the reach and sight of children.
Do not store ramipril and hydrochlorothiazide above 30°C.
Do not use ramipril and hydrochlorothiazide after the expiry date stated on the blister and on the plastic container. The expiry date refers to the last day of the month.
Medicines must 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. PACK CONTENTS AND OTHER INFORMATION

What RAMIPRIL HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets contain

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

Description of the appearance of RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg and 5 mg + 25 mg tablets and pack 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 score on one side and the number "12.5" in relief on the other side, size 4 x 8 mm.
The tablet is not intended to be divided.
Ramipril and Hydrochlorothiazide 5 mg/25 mg:
Capsule-shaped, flat, white to off-white, uncoated tablet, with a score on one side and the number "25" in relief on the other side, size 5 x 10 mm.
The tablet can be divided into two equal halves.
Pack sizes:
Blister packs and plastic containers:
14, 28 tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturers and responsible persons for batch release:
Actavis hf.
Reykjavikurvegur 76-78, 220 Hafnarfjörður
Iceland
Actavis Ltd.
B16, Bulebel Industrial Estate, Zejtun ZTN 08
Malta

This medicinal product is authorized in the EEA Member States under the following names:
Italy RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 2.5 mg + 12.5 mg tablets
RAMIPRIL AND HYDROCHLOROTHIAZIDE PENSA 5 mg + 25 mg tablets

This leaflet was last approved on
This patient information leaflet does not contain all the information about this medicine. If you have any further questions or are unsure about anything, please consult your doctor or pharmacist.