TENSIRAM 2.5 mg Tablet

Зміст інструкції

1. TENSIRAM 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. WHAT TENSIRAM IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING TENSIRAM
   3. HOW TO TAKE TENSIRAM
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE TENSIRAM
   6. PACKAGE CONTENTS AND OTHER INFORMATION

TENSIRAM 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Ramipril

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 TENSIRAM is and what it is used for.
• 2. What you need to know before you take TENSIRAM
• 3. How to take TENSIRAM
• 4. Possible side effects
• 5. How to store TENSIRAM
• 6. Contents of the pack and other information

1. WHAT TENSIRAM IS AND WHAT IT IS USED FOR

TENSIRAM contains the active ingredient ramipril which belongs to the group of medicines called ACE
inhibitors (Angiotensin Converting Enzyme Inhibitors).
TENSIRAM 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 its heart to pump blood around the body.

TENSIRAM can be used:

• To treat high blood pressure (hypertension)
• To reduce the risk of a heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)
• To treat your heart when it cannot pump enough blood around the rest of the body (heart failure)
• As treatment after a heart attack (myocardial infarction) if associated with heart failure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TENSIRAM

Do not take TENSIRAM

• If you are allergic to ramipril, to other ACE inhibitor drugs or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue. 1 of 8
• If you have had a serious allergic reaction called “angioedema”. These signs include itching, skin rash (urticaria), red patches 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 undergoing dialysis or are undergoing any other type of blood filtration. Depending on the machinery used, TENSIRAM may not be suitable for you.
• 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 “Pregnancy and breastfeeding”).
• If your blood pressure is excessively low or unstable. Your doctor will need to make this assessment.
• 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 TENSIRAM if any of the above conditions apply to you. If you are not sure, ask your
doctor before taking TENSIRAM.

Warnings and precautions
Talk to your doctor or pharmacist before taking TENSIRAM.

• 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 diuretics for a long time or having undergone dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are about to undergo anesthesia. This may be administered for surgery or dental work. Ask your doctor for advice, as it may be necessary to stop treatment with TENSIRAM the day before the procedure.
• 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, particularly if you are elderly.
• If you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin or racecadotril, as they may increase the risk of angioedema, a serious allergic reaction.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
• If you think you are pregnant (or intend to become pregnant). Tell your doctor, as TENSIRAM 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 are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example 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 stated under "Do not take TENSIRAM".

Children and adolescents
The use of TENSIRAM is not recommended in children and adolescents under the age of 18 because
there is no information available for this population.
If any of the above conditions apply (or you are not sure), ask your doctor before taking
TENSIRAM.
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Other medicines and TENSIRAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription (including herbal medicines).
This is because TENSIRAM can affect the mechanism of action of some other medicines. Also
some medicines can affect the mechanism of action of TENSIRAM.
Medicines that can interfere with TENSIRAM, altering its action:

• 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. Medicines that can increase the likelihood of side effects:
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, aspirin);
• Cancer medicines (chemotherapy);
• 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:
• Allopurinol (used to lower uric acid levels in the blood);
• Procainamide (for heart rhythm problems);
• Temsirolimus (for cancer)
• Sirolimus, everolimus (to prevent transplant rejection)
• Vildagliptin (for the treatment of 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 stated under "Do not take TENSIRAM" and "Warnings and precautions") TENSIRAM can affect the mechanism of action of the following medicines:
• Medicines for diabetes such as oral hypoglycemic agents and insulin. TENSIRAM can lower blood sugar levels. Carefully check your blood sugar levels during treatment with this medicine.
• Lithium (for psychiatric problems). TENSIRAM can increase the amount of lithium in the blood. Lithium levels in the blood must be carefully monitored by your doctor. If any of the above conditions apply (or you are not sure), ask your doctor before taking TENSIRAM.

TENSIRAM with food and alcohol

• Drinking alcoholic beverages with TENSIRAM can cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking TENSIRAM, discuss this with your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• TENSIRAM can be taken with or without food

Pregnancy and breastfeeding
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Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, you must inform your doctor.
Avoid taking TENSIRAM in the first 12 weeks of pregnancy and do not take the
medicine after the 13th week because its use may be harmful to the baby.
If you become pregnant while taking TENSIRAM, tell your doctor immediately. Before
planning a pregnancy, you should switch to another more suitable medicine.
Breastfeeding
Do not take TENSIRAM if you are breastfeeding. Ask your doctor or pharmacist before taking
any medicine.

Driving and operating machinery
During treatment with this medicine you may feel dizzy. This is more
likely when you have just started taking TENSIRAM or have just increased the dose. If this
happens, do not drive vehicles or use tools or machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE TENSIRAM

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Recommended doses are:

• Treatment of high blood pressureThe usual starting dose is 1.25 mg or 2.5 mg once a day. Your doctor will adjust the amount you take until your blood pressure is under control. The maximum daily dose is 10 mg. If you are already taking diuretics, your doctor may stop them or reduce the amount before starting you on TENSIRAM.
• To reduce the risk of a heart attack or strokeThe starting dose is 2.5 mg once a day. Your doctor may decide to increase the dosage you take. The usual dose is 10 mg once a day.
• Treatment to reduce or delay the worsening of kidney problemsThe starting dose is 1.25 mg or 2.5 mg once a day. Your doctor will adjust the amount you are taking. The usual dose is 5 mg or 10 mg once a day.
• Treatment of heart failureThe usual starting dose is 1.25 mg once a day. Your doctor will adjust the amount you take. The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.
• Treatment after a heart attackThe usual starting dose is from 1.25 mg once a day to 2.5 mg twice a day. Your doctor will adjust the amount you take. The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Elderly population
Your doctor will reduce the starting dose and adjust the treatment more slowly.
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Taking this medicine
Take the medicine by mouth at the same time of day, every day.
Swallow the tablets whole with some liquid.
Do not break or chew the tablets.

If you take more TENSIRAM than you should
Inform your doctor or go to the emergency room of the nearest hospital. Do not drive to the hospital, get
someone to accompany you or call an ambulance. Bring the medicine package with you.
This is because the doctor needs to know what you have taken.

If you forget to take TENSIRAM
If you forget a dose, take your usual dose when it is time.
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Stop taking TENSIRAM and contact your doctor immediately if you notice 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 rash. This could be a sign of a severe allergic reaction to TENSIRAM.
• 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. These can be signs of lung problems.
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These can be signs of circulatory or bone marrow problems.
• Severe stomach pain that can 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 can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

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 tired
• Feeling dizzy. This is more likely to happen at the beginning of therapy or after increasing the dose. 5 of 8
• Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, tickly cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, nausea, vomiting, indigestion, feeling unwell or malaise
• Rash with or without swelling
• Chest pain
• Cramps or muscle pain
• Blood tests show a higher than normal potassium level

Uncommon(may affect up to 1 in 100 people)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the intestine called “intestinal angioedema” and which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating than usual
• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat.
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
• Hot flashes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increased number of white blood cells (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function highlighted by blood tests
• Kidney damage including acute renal failure

Rare(may affect up to 1 in 1000 people)

• Feeling faint or confused
• Swollen and red tongue
• Severe flaking or peeling of the skin, itching, rash characterized by pustules
• Nail problems (such as loss or separation of the nail from its bed)
• Rash or bruising
• Spots on the skin and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing disorders and tinnitus (ringing in the ears)
• Feeling of weakness
• Decrease in the number of red blood cells, white blood cells and platelets or hemoglobin concentration, highlighted by blood tests
• Cholestatic jaundice, hepatocellular damage

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

• Increased sensitivity to the sun

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

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing a low number of cells in the blood
• Blood tests showing a low level of sodium in the blood
• Concentrated urine (dark in color), feeling unwell or malaise, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly
• Fingers of the hands and feet that change color when cooled and that tingle or hurt when warmed (Raynaud's phenomenon)
• Increased breast volume in men
• Slowed or altered reactions
• Burning sensation
• Change in the perception of smells
• Hair loss
• Increased antinuclear antibodies
• Acute hepatic failure, cholestatic or cytolytic hepatitis

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 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 TENSIRAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister packs. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 TENSIRAM contains

• The active ingredient is ramipril. TENSIRAM 2.5 mg tablets: each tablet contains 2.5 mg of ramipril. TENSIRAM 5 mg tablets: each tablet contains 5 mg of ramipril. TENSIRAM 10 mg tablets: each tablet contains 10 mg of ramipril.
• The other ingredients are: hypromellose, pregelatinized starch, microcrystalline cellulose, sodium stearylfumarate.

Description of the appearance of TENSIRAM and package contents
TENSIRAM is available in the form of divisible tablets.
Blisters of TENSIRAM 2.5 mg tablets: 28 divisible tablets.
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Blisters of TENSIRAM 5 mg tablets: 14 divisible tablets.
Blisters of TENSIRAM 10 mg tablets: 28 divisible tablets.

Marketing Authorisation Holder:
I.B.N. SAVIO S.r.l. - Via del Mare n. 36 – Pomezia (RM)

Manufacturer:
Special Product’s Line Spa – Via Fratta Rotonda Vado Largo, 1 – Anagni (FR)
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