Norazide

PACKAGE LEAFLET: INFORMATION FOR THE USER

NORAZIDE 2.5 mg + 12.5 mg tablets, 5 mg + 25 mg tablets

ramipril + hydrochlorothiazide
Please read this leaflet carefully before taking this medicine because 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NORAZIDE is and what it is used for
2. What you need to know before taking NORAZIDE
3. How to take NORAZIDE
4. Possible side effects
5. How to store NORAZIDE
6. Contents of the pack and other information

1. WHAT NORAZIDE IS AND WHAT IT IS USED FOR

NORAZIDE 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.
NORAZIDE 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 either component alone is not effective.

2. WHAT YOU NEED TO KNOW BEFORE TAKING NORAZIDE

Do not take NORAZIDE:

• If you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines similar to NORAZIDE (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 ever had a severe allergic reaction called "angioedema". Symptoms 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 or swallowing.
• If you are taking or have recently taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults.
• If you are on dialysis or undergoing any other type of blood filtration. Depending on the equipment used, NORAZIDE 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).
• During the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section below “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 NORAZIDE if any of the above conditions apply to you. If you are unsure,
ask your doctor before taking NORAZIDE.
Warnings and precautions
Talk to your doctor or pharmacist before taking Norazide if:

• You have heart, liver, or kidney problems.
• You have lost significant body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or due to a low-salt diet, or from long-term use of oral diuretics or after dialysis).
• You are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• You are about to receive an anaesthetic that may be used during surgery or dental procedures. You may need to stop taking NORAZIDE the day before – consult your doctor.
• You have high levels of potassium in your blood (shown by a blood test).
• You are taking medicines or have conditions that may reduce sodium levels in your blood. Your doctor may order regular blood tests, especially to monitor blood sodium levels, particularly if you are elderly.
• You are taking medicines that may increase the risk of angioedema, a serious 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 section “Do not take Norazide”.
• You have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• You experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure (glaucoma), which may occur from a few hours to weeks after taking Norazide. If untreated, these may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing this condition.
• You are taking any of the following medicines for 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 levels of electrolytes (e.g. potassium) in your blood at regular intervals (see also section "Do not take Norazide").
• If you are of Black African or Afro-Caribbean origin, the medicine may be less effective in lowering your blood pressure. Your doctor will prescribe an alternative therapy.
• You must inform your doctor if you think you are pregnant (or could become pregnant). NORAZIDE is not recommended during the first trimester of pregnancy and may cause serious harm to the unborn child after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
• 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 Norazide.
• If you have previously experienced respiratory or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If, after taking X, you develop shortness of breath or severe breathing difficulties, consult a doctor immediately.

Children and adolescents
NORAZIDE 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 you are unsure, consult your doctor before
taking NORAZIDE.
Other medicines and NORAZIDE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This is because NORAZIDE may affect how some other medicines work. Likewise,
some medicines may affect how NORAZIDE works.
Inform your doctor if you are taking any of the following medicines. These may interfere with
NORAZIDE and reduce its effectiveness:

• 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 them with
NORAZIDE may increase the risk of side effects:

• Sacubitril/valsartan – used to treat chronic heart failure in adults (see also section "Do not take Norazide").
• 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 medicines for constipation, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to check adrenal gland function).
• Medicines used for cancer treatment (chemotherapy).
• Medicines used for heart problems, including heart rhythm disorders.
• Medicines used 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 thin the blood).
• Steroid medicines used for inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (used for heart rhythm problems).
• Cholestyramine (used to reduce blood fat levels).
• Carbamazepine (used to treat epilepsy).
• Heparin (used to thin the blood).
• Temsirolimus (used for cancer).
• Sirolimus, everolimus (used to prevent transplant rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhoea).

Your doctor may need to adjust your dose and/or take other precautions if you are taking an
angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take Norazide" and "Warnings and precautions").
Inform your doctor if you are taking any of the following medicines. Their effects may be
altered by NORAZIDE:

• Medicines used for diabetes, such as oral hypoglycaemics and insulin. NORAZIDE may lower blood sugar levels. Monitor your blood glucose carefully when taking NORAZIDE.
• Lithium (used for psychiatric conditions). NORAZIDE may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels closely.
• Muscle relaxants.
• Quinine (used to treat malaria).
• Medicines containing iodine, which may be used in hospital before X-rays or scans.
• Penicillin (used to treat infections).
• Oral anticoagulants (medicines that thin the blood), such as warfarin.

If any of the above conditions apply to you (or you are unsure), consult your doctor before
taking NORAZIDE.
Medical tests
Inform your doctor or pharmacist before taking this medicine.
If you are undergoing tests for parathyroid function, NORAZIDE may alter test results.
For athletes
Using this medicine without a medical need constitutes doping and may result in a positive
anti-doping test.
NORAZIDE with food and alcohol

• Drinking alcohol while taking NORAZIDE may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol, if any, is safe to drink while taking NORAZIDE, as alcohol may enhance the blood pressure-lowering effects of the medicine.
• NORAZIDE can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or could become pregnant).
You must not take NORAZIDE during the first 12 weeks of pregnancy and must not take it
at all after week 13, as it may harm the unborn child.
If you become pregnant while taking NORAZIDE, inform your doctor immediately. Before
planning a pregnancy, you should switch to a more suitable medicine.
Breastfeeding
You must not take NORAZIDE while breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Effects on ability to drive and use machines
You may experience dizziness while taking NORAZIDE. This is more likely when you first
start treatment or when you begin taking a higher dose.
If this occurs, do not drive or operate tools or machinery.

3. HOW TO TAKE NORAZIDE

Always take NORAZIDE exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Taking this medicine

• Take this medicine by mouth at the same time each day, usually in the morning.
• Swallow the tablets with liquid.
• Do not crush the tablets or chew them.

How much you should take
Treatment of high blood pressure
Your doctor will adjust your dose until your blood pressure is under control.
Elderly population
Your doctor will reduce the initial dose and adjust treatment more slowly.
If you take more NORAZIDE than you should
Inform your doctor or go to the nearest hospital emergency department. Do not drive to the hospital; have someone drive you or call an ambulance. Bring the medicine pack with you. This is because the doctor needs to know what you have taken.
If you forget to take NORAZIDE

• 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, NORAZIDE may cause adverse reactions, although not everyone experiences them.
Stop taking NORAZIDE and contact your doctor immediately if you notice any of the following serious side effects – 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. These could be signs of a severe allergic reaction to NORAZIDE.
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin conditions, redness, blistering, and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath or cough, fever lasting 2 to 3 days, and reduced appetite. These may be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding longer than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy, or pale appearance. These may be signs of blood or bone marrow problems.
• Severe stomach pain that may radiate to the back. This could 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 may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other adverse reactions include:
Inform your doctor if any of the following conditions become severe or persist for longer than a few days:
Common (may affect up to 1 in 10 people)

• Headache or feeling weak or tired
• Dizziness. This is more likely to occur when treatment with NORAZIDE has just started or the dose has recently been increased
• Dry, irritating cough or bronchitis
• Blood tests show higher than normal sugar levels. If you have diabetes, this may worsen it
• 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 rising quickly
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling, or crawling sensations (paresthesia)
• Loss or change in taste
• Sleep disturbances
• Depressed mood, anxiety, increased nervousness, or irritability
• Stuffy nose, sinus inflammation (sinusitis), shortness of breath
• Gum inflammation (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
• Rapid or irregular heartbeat
• Swollen arms and legs. This may indicate your body is retaining more fluid than usual
• Fever
• Erectile dysfunction in males
• Decreased number of red blood cells, white blood cells, platelets, or hemoglobin concentration, as shown by blood tests
• Changes in liver, pancreas, or kidney function as 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 diarrhea or stomach burning
• Swollen and red tongue or dry mouth
• Blood tests show higher than normal potassium levels
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

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, feeling restless or confused
• Fingers of hands and feet changing color when cold, and tingling or pain when warmed (Raynaud's phenomenon)
• Breast enlargement in males
• Blood clots
• Hearing disorders
• Eyes less moist than normal
• Yellow vision (xanthopsia)
• Increased intraocular pressure, sudden-onset nearsightedness (acute myopia), 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
• 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 exfoliation, 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 of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetany)
• Muscle weakness or cramps
• Reduced sexual desire in men and women
• Presence of blood in the urine. This may be a sign of a kidney problem (interstitial nephritis)
• Higher than normal amount of sugar in the urine
• Increased number of white blood cells in the blood (eosinophilia) detected during blood tests
• Abnormally low number of blood cells as shown by blood tests (pancytopenia)
• Changes in blood levels of salts such as sodium, calcium, magnesium, and chloride as shown by blood tests
• Concentrated urine (dark-colored), feeling unwell, muscle cramps, confusion, and seizures that may be due to inappropriate ADH (antidiuretic hormone) 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
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
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 NORAZIDE

Do not use NORAZIDE after the expiry date stated on the cartons and blister packs after Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. OTHER INFORMATION

What NORAZIDE contains
NORAZIDE 2.5 mg + 12.5 mg tablets
One divisible tablet contains:
Active substances: ramipril 2.5 mg + hydrochlorothiazide 12.5 mg;
Excipients: hypromellose, pregelatinized starch, microcrystalline cellulose and sodium stearyl fumarate.
NORAZIDE 5 mg + 25 mg tablets
One divisible tablet contains:
Active substances: ramipril 5 mg + hydrochlorothiazide 25 mg;
Excipients: hypromellose, pregelatinized starch, microcrystalline cellulose and sodium stearyl fumarate.

Description of the appearance of NORAZIDE and contents of the pack
Tablets.
NORAZIDE 2.5 mg + 12.5 mg tablets: pack of 14 divisible tablets in blister.
NORAZIDE 5 mg + 25 mg tablets: pack of 14 divisible tablets in blister.

MARKETING AUTHORISATION HOLDER
S.F. GROUP S.R.L.
Via Tiburtina, 1143 - 00156 Rome
MANUFACTURER AND FINAL CONTROLLER
DOPPEL FARMACEUTICI S.r.l.
Via Volturno, 48
Quinto de Stampi – 20089 Rozzano (MI)
Pack of 5 mg + 25 mg tablets:
LACHIFARMA S.r.l. – Laboratorio Farmaceutico Salentino
S.S. 16 Adriatica – Zona Industriale
73010 Zollino (LE)

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