Tensiram

Italy
Brand name Tensiram
Form tablets
Active substance / Dosage
RAMIPRIL
Prescription type Prescription only
ATC code
C09AA05
Registration number 038355
Manufacturer I.B.N. SAVIO S.R.L

Table of Contents

Patient Information Leaflet

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

Equivalent medicine
Ramipril
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 others, even if they have the same symptoms as yours, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 substance ramipril, which belongs to a group of medicines called ACE
inhibitors (Angiotensin Converting Enzyme inhibitors).
TENSIRAM works by:

  • Reducing the body's production of substances that can cause an increase in blood pressure
  • Relaxing and widening your blood vessels
  • Helping your heart to pump blood around the body more easily.

TENSIRAM may be used:

  • To treat high blood pressure (hypertension)
  • To reduce the risk of heart attack or stroke
  • To reduce the risk of or delay the worsening of kidney problems (with or without diabetes)
  • To treat heart failure (when your heart cannot pump enough blood to the rest of the body)
  • As treatment after a heart attack (myocardial infarction), when associated with heart failure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TENSIRAM

Do not take TENSIRAM

  • If you are allergic to ramipril, to other ACE inhibitor medicines, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
  • If you have previously had a severe allergic reaction called "angioedema". These signs 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 and 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 undergoing dialysis or any other type of blood filtration. Depending on the equipment 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 assess this.
  • If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take TENSIRAM if any of the above conditions apply to you. If you are unsure,
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.
  • You have lost significant amounts of salts or body fluids (due to illness such as vomiting, diarrhoea, excessive sweating, following a low-salt diet, or after prolonged 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 undergo anaesthesia, which may be administered during surgery or dental procedures. Consult your doctor, as you may need to stop taking TENSIRAM the day before the procedure.
  • You have high levels of potassium in your blood (shown by a blood test).
  • You are taking medicines or have conditions that may cause low sodium levels in your blood. Your doctor may prescribe regular blood tests, particularly to monitor sodium levels, especially if you are elderly.
  • 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 section 2 “Do not take TENSIRAM”.
  • You have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
  • You think you may be pregnant (or could become pregnant). Inform your doctor, as TENSIRAM 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”).
  • 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), particularly if you have kidney problems related to diabetes.
    • aliskiren

Your doctor may check 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 TENSIRAM”.
Children and adolescents
The use of TENSIRAM is not recommended in children and adolescents under 18 years of age
because there is insufficient information available on safety and efficacy in this population.
If any of the above conditions apply to you (or if you are unsure), consult your doctor before
taking TENSIRAM.
Other medicines and TENSIRAM
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (including herbal medicines).
This is because TENSIRAM may affect how some other medicines work.
Also, some medicines may affect how TENSIRAM works.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with TENSIRAM and alter 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 them with
TENSIRAM may 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);
  • Sacubitril/valsartan used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take TENSIRAM”);
  • Medicines for cancer (chemotherapy);
  • 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 the blood less likely to clot);
  • Steroid medicines used to treat 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 treatment of type 2 diabetes);
  • Racecadotril (used to treat diarrhoea);
  • Your doctor may consider it necessary to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take TENSIRAM” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medicines. The action of
these medicines may be affected by TENSIRAM:

  • Medicines for diabetes such as oral hypoglycaemics and insulin. TENSIRAM may lower blood sugar levels. Monitor your blood sugar levels carefully during treatment with TENSIRAM.
  • Lithium (for psychiatric conditions). TENSIRAM may increase lithium levels in the blood. Your doctor must monitor lithium levels in your blood carefully.

If any of the above conditions apply to you (or if you are unsure), consult your doctor before
taking TENSIRAM.
TENSIRAM with food and alcohol

  • Drinking alcohol while taking TENSIRAM may cause dizziness or drowsiness. Discuss with your doctor how much alcohol you may consume during treatment with TENSIRAM, as blood pressure-lowering medicines and alcohol may have additive effects.
  • TENSIRAM can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, inform your
doctor. You must not take TENSIRAM during the first 12 weeks of pregnancy and must not take
the medicine at all after week 13, as it may harm the unborn child.
If you become pregnant while taking TENSIRAM, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine more suitable for use during pregnancy.
Breast-feeding
Do not take TENSIRAM if you are breast-feeding. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
During treatment with TENSIRAM, you may experience dizziness. This is more likely when you have just started taking TENSIRAM or have recently increased your dose.
If this occurs, do not drive or operate tools or machinery.
TENSIRAM contains sodium
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 exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended doses are:
➢ Treatment of high blood pressure
The usual starting dose is 1.25 mg or 2.5 mg once daily. Your doctor will adjust your dose until your blood pressure is under control. The maximum daily dose is 10 mg.
If you are already taking diuretics, your doctor may stop or reduce them before starting your treatment with TENSIRAM.
➢ To reduce the risk of heart attack or stroke
The initial dose is 2.5 mg once daily. Your doctor may decide to increase your dosage. The usual dose is 10 mg once daily.
➢ Treatment to reduce or delay worsening of kidney problems
The initial dose is 1.25 mg or 2.5 mg once daily. Your doctor will adjust your dose accordingly. The usual dose is 5 mg or 10 mg once daily.
➢ Treatment of heart failure
The usual starting dose is 1.25 mg once daily. Your doctor will adjust your dose. The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.
➢ Treatment after a heart attack
The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily. Your doctor will adjust your dose accordingly. 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 initial dose and adjust treatment more slowly.
Taking this medicine
Take the medicine orally at the same time each day.
Swallow the tablets whole with liquid.
Do not break or chew the tablets.
If you take more TENSIRAM than you should
Inform your doctor or go to the nearest hospital emergency department. Do not drive to the hospital; have someone accompany you or call an ambulance. Bring the medicine pack with you.
This is so the doctor knows what you have taken.
If you forget to take TENSIRAM
If you miss a dose, take your usual dose at the next scheduled time.
Do not take a double dose to make up for a forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop taking TENSIRAM and contact your doctor immediately if you notice any serious adverse reaction – you may need 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 TENSIRAM.
  • 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 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. These may be signs of lung problems.
  • Easy 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, fever, fatigue, weakness, dizziness, or pale appearance. These may be signs of circulatory 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, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

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 patients)

  • Headache or feeling tired
  • Dizziness. This is more likely to occur at the beginning of treatment or after a dose increase.
  • Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
  • Dry, persistent 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
  • Muscle cramps or muscle pain
  • Blood tests show higher than normal potassium levels

Uncommon (may affect up to 1 in 100 patients)

  • 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, breathing difficulties, or worsening of asthma
  • Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting, and diarrhea
  • Heartburn, constipation, or dry mouth
  • Increased amount of urine during the day
  • Increased sweating
  • Loss or decrease in appetite (anorexia)
  • Rapid or irregular heartbeat
  • Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual.
  • Hot flushes
  • Blurred vision
  • Joint pain
  • Fever
  • Erectile dysfunction in men, reduced sexual desire in men and women
  • Increased number of white blood cells (eosinophilia) detected in blood tests
  • Changes in liver, pancreas, or kidney function indicated by blood tests

Rare (may affect up to 1 in 1,000 patients)

  • Feeling faint or confused
  • Swollen and red tongue
  • Severe skin peeling or shedding, itching, rash with pustules
  • Nail problems (such as nail loss or separation of the nail from its bed)
  • Skin rash or bruising
  • Skin spots and cold extremities
  • Red, swollen, watery, or itchy eyes
  • Hearing disturbances and ringing in the ears (tinnitus)
  • Feeling weak
  • Decreased number of red blood cells, white blood cells, platelets, or hemoglobin concentration, as shown by blood tests

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

  • Increased sensitivity to sunlight

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
  • Mouth swelling
  • Blood tests showing abnormally low blood cell counts
  • Blood tests showing low sodium levels in the blood
  • 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 promptly
  • Fingers of hands and feet changing color when cold, and tingling or hurting when warmed (Raynaud's phenomenon)
  • Breast enlargement in men
  • Slowed or altered reactions
  • Burning sensation
  • Change in sense of smell
  • Hair loss
  • Increased levels of antinuclear antibodies
  • Acute liver failure, cholestatic or cytolytic hepatitis

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
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 TENSIRAM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blisters. The
expiry date refers to the last day of that month.
Do not store above 25°C.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What TENSIRAM contains

  • The active substance 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 stearyl fumarate.

Description of the appearance of TENSIRAM and contents of the pack
TENSIRAM is available as divisible tablets.
TENSIRAM 2.5 mg tablets blister pack: 28 divisible tablets.
TENSIRAM 5 mg tablets blister pack: 14 divisible tablets.
TENSIRAM 10 mg tablets blister pack: 28 divisible tablets.
Marketing Authorization 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)