NORAZIDE 2.5 mg/12.5 mg Tablets

Зміст інструкції

1. NORAZIDE 2.5 mg + 12.5 mg tablets, 5 mg + 25 mg tablets
   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. OTHER INFORMATION

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

ramipril + hydrochlorothiazide

Read this leaflet carefully before you start 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 pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 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
• Relaxing and widening its blood vessels
• Making it easier for your heart to pump blood 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) that is 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 one component alone does not work.

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 drugs similar to NORAZIDE (other ACE inhibitors or medicines derived from sulfonamide). Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you have ever had a serious allergic reaction called “angioedema”. The signs include itching, skin rash (urticaria), red spots on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you are taking or 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 machinery 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 the 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 the section below “Pregnancy and breastfeeding”)
• If you are breastfeeding (see section below “Pregnancy and breastfeeding”).
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take NORAZIDE if any of the above conditions apply to you. If you are not sure,
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
• If you have lost a lot of salts or body fluids (due to an illness such as 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 receive an anesthetic that may be given for surgery or dental treatment. It may be necessary to stop treatment with NORAZIDE 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 that may lower sodium levels in the blood. Your doctor may prescribe blood tests at intervals

regularly, 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 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 what is reported under “Do not take Norazide”
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• If you have decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and can occur within a period ranging from a few hours to weeks after taking Norazide. If left untreated, they can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamide in the past, you may be at greater risk of developing this disorder.
• 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 suffer from kidney problems related to diabetes
• aliskiren. Your 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 Norazide”)
• If you are a black patient, the medicine may not be suitable for you, in lowering blood pressure. Your doctor will give you alternative therapy
• You must tell your doctor if you think you may be pregnant (or may become pregnant). NORAZIDE is not recommended during the first trimester of pregnancy and can cause serious harm to the baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with 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 Norazide.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking X, consult a doctor immediately.

Children and adolescents
NORAZIDE 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 above conditions occur or you are not sure, ask your doctor before
taking NORAZIDE.

Other medicines and NORAZIDE
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This is because NORAZIDE can affect the mechanism of action of some other
medicines. Also, some medicines can affect the mechanism of action of
NORAZIDE.
Tell your doctor if you are taking any of the following medicines. These medicines may
interfere with NORAZIDE by reducing 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, norepinephrine or adrenaline. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, when taken
with NORAZIDE, may increase the likelihood of side effects:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see also what is reported under "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 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)
• Medicines used to treat cancer (chemotherapy)
• Medicines used for heart problems, including heart rhythm problems
• Medicines used 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 (used for heart rhythm problems)
• Cholestyramine (used to reduce the amount of fat in the blood)
• 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 diarrhea)

Your doctor may need to adjust the dose and/or take other precautions: if you are
taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also
what is reported under "Do not take Norazide" and "Warnings and precautions”).
Tell your doctor if you are taking any of the following medicines. The mechanism of action of
these medicines may be affected by NORAZIDE:

• Medicines used for diabetes such as oral hypoglycemic agents and insulin. NORAZIDE may lower the amount of sugar in the blood. Carefully check your blood sugar levels when taking NORAZIDE.
• Lithium (used for psychiatric problems). NORAZIDE may increase the amount of lithium in the blood. Your doctor must carefully monitor your lithium levels in your blood.
• Muscle relaxants
• 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)
• Oral anticoagulants (oral blood thinners) such as warfarin.

If any of the above conditions occur (or you are not sure), ask your doctor before
taking NORAZIDE.

Tests
Tell your doctor or pharmacist before taking this medicine.
If you are having a test for parathyroid function. NORAZIDE may
alter the results of the test

For those who play sports
The use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests.
NORAZIDE with food and alcohol

• Drinking alcoholic beverages with NORAZIDE may cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking NORAZIDE, discuss it with your doctor. In fact, alcohol increases the effects of blood pressure medications.
• Taking NORAZIDE can be done with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or may become pregnant).
You must not take NORAZIDE in the first 12 weeks of pregnancy and must not
absolutely take it after the 13th week because its use can be harmful to
the baby.
If you become pregnant while taking NORAZIDE, tell your doctor immediately.
Before planning a pregnancy, a switch to another
more suitable drug must be made.
Breastfeeding
You must not take NORAZIDE if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Effects on the ability to drive and operate machinery
You may feel dizzy while taking NORAZIDE. This is more likely
when you have just started taking NORAZIDE or have started taking a higher dose.
If this happens, do not drive or use tools or machinery.

3. HOW TO TAKE NORAZIDE

Always take NORAZIDE exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.

Taking this medicine

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

How much to take

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

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

If you take more NORAZIDE 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 NORAZIDE

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

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, NORAZIDE can cause side effects, although not everybody gets them.

Stop taking NORAZIDE and contact your doctor immediately if you notice the
appearance of any serious side effect – you may need urgent medical treatment:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or skin rash. This could be a sign of a severe allergic reaction to NORAZIDE.
• 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:

• Increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of 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 decreased feeling of hunger. These may be signs of lung problems, including inflammation
• Easier 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 may be signs of circulatory or bone marrow problems
• Severe stomach pain that may extend to the 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 may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.
• 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).

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

Common(may affect up to 1 in 10 people)

• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to happen when you first start taking NORAZIDE or have just increased the dose
• Dry, irritating cough or bronchitis
• Blood tests show a higher than normal sugar level. If you have diabetes, this may worsen it
• Blood tests show a higher than normal uric acid or fat level
• Painful, red and swollen joints

Not common(may affect up to 1 in 100 people)

• Skin rash with or without swelling
• Hot flushes, weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Balance problems (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling (paresthesia)
• Loss or change of taste
• Sleep problems
• 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 concentration of hemoglobin, as shown by blood tests
• Changes in liver, pancreas or kidney function as shown by blood tests
• Blood tests show a lower than normal potassium level.

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

• Feeling unwell, which causes diarrhea or heartburn
• Swollen and red tongue or dry mouth
• Blood tests show a higher than normal potassium level
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

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

• Difficulty concentrating, feeling restless or confused
• Fingers and toes that change color when cooled and tingle or hurt when warmed (Raynaud's phenomenon)
• Increased breast volume in men
• Blood clots
• Hearing disorders
• Eyes less moist than usual
• Yellow vision (xanthopsia)
• Increased pressure inside the eye, rapid onset of distant vision impairment (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)
• Swelling of the intestine called “intestinal angioedema” and which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Increased sensitivity to the sun
• Severe peeling or flaking 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
• Nail problems (such as loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw/mandible (tetany)
• Muscle weakness or 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
• Increased number of white blood cells in the blood (eosinophilia) found during blood tests
• Too low number of blood cells as shown by blood tests (pancytopenia)
• Change in the level of salts such as sodium, calcium, magnesium and chlorine in the blood as shown by blood tests
• Concentrated urine (dark in color), feeling unwell or sick, 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
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. 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 NORAZIDE

Do not use NORAZIDE after the expiry date which is reported
on the cartons and blisters after Exp. The expiry date refers to the last day of that
month.
Store at a temperature not exceeding 25°C
Keep this medicine out of the sight and reach of children.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
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 blisters.

NORAZIDE 5 mg + 25 mg tablets:pack of 14 divisible tablets in blisters

MARKETING AUTHORISATION HOLDER
S.F. GROUP S.R.L.Via Tiburtina, 1143- 00156 Rome

MANUFACTURER AND FINAL CONTROL
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)
if you have any questions or are not sure about something, ask your doctor or pharmacist.