Trandolapril Mylan Generics

Package leaflet: Information for the patient

Trandolapril Mylan Generics 0.5 mg, 2 mg hard capsules

trandolapril
Equivalent medicine
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 may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Trandolapril Mylan Generics is and what it is used for

Trandolapril, the active substance in Trandolapril Mylan Generics capsules, belongs to a group of
medicines called angiotensin-converting enzyme inhibitors (sometimes referred to as ACE inhibitors).
ACE inhibitors work by relaxing blood vessels, making it easier for the heart to pump blood around the
body. This helps lower blood pressure.
Trandolapril Mylan Generics is used to treat high blood pressure. It may also be used to help protect
the heart after a heart attack.

2. What you should know before taking Trandolapril Mylan Generics

Do not take Trandolapril Mylan Generics:

• if you are allergic to trandolapril, to other ACE inhibitors (e.g. perindopril or ramipril), or to any of the other ingredients of this medicine (listed in section 6)
• if you have had a condition called angioedema (swelling of the hands, face, lips, tongue, or throat with difficulty swallowing or breathing, possibly accompanied by a skin rash with itching similar to hives) or Quincke's edema (a severe allergic skin condition) after taking an ACE inhibitor
• if you or a member of your family has ever had angioedema
• if you are more than three months pregnant (it is best to avoid trandolapril even in the early stages of pregnancy – see section Pregnancy)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat)

Warnings and precautions
Talk to your doctor or pharmacist before taking Trandolapril Mylan Generics:

• If you have recently started taking or have been on long-term treatment with diuretics (water tablets), are on a low-sodium diet, or have had prolonged or severe episodes of vomiting or diarrhoea, or are dehydrated. In these cases, there is a higher chance that when you start taking the tablets, your blood pressure may drop sharply (hypotension), which could lead to fainting or dizziness.
• If you have narrowing of the blood vessels to one or both kidneys (renal stenosis).
• If you have narrowing of one of the heart valves (aortic stenosis) or of the outflow from the left chamber of the heart. You must not take Trandolapril Mylan Generics. Your doctor will prescribe another medicine more suitable for you.
• If you have a condition known as collagen vascular disease (sometimes called connective tissue disease, e.g. lupus or scleroderma). You may have changes in your blood composition that make infections more likely.
• If you are of Afro-Caribbean origin. Trandolapril Mylan Generics may be less effective in lowering blood pressure or may increase the risk of angioedema.
• If you have diabetes mellitus. Trandolapril Mylan Generics may cause excessive lowering of blood glucose levels.
• If you have heart failure or liver cirrhosis with swelling that may extend to the abdomen. When you start taking the tablets, you may be more likely to experience a sharp drop in blood pressure (hypotension), which may cause weakness or dizziness.
• If you have problems with blood vessels in the brain or have had a stroke, as you will need close medical monitoring at the beginning of treatment and when the dose is changed.
• If you require kidney dialysis, as you may be at risk of severe allergic reactions (some types of dialysis membranes may not be suitable). You may need closer monitoring by your doctor.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is higher:
  • sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs)
  • neprilysin (NEP) inhibitors such as sacubitril (available in fixed-dose combination with valsartan), used in patients with heart failure, and racecadotril, used in patients with acute diarrhoea.
• If you have other liver or kidney problems or if you have had a kidney transplant.
• If you are over 70 years old or have too much acid in your blood (metabolic acidosis). These conditions may increase potassium levels in the blood, which could cause heart problems.
• If you are being treated with a medicine that suppresses the immune response.
• If you are about to undergo a treatment called "LDL-apheresis" (which involves removing cholesterol from your blood using a machine).
• If you are about to undergo desensitisation treatment to reduce the effects of an allergy to insect stings (e.g. bee or wasp).
• 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

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 information under the heading “Do not take Trandolapril Mylan Generics”.
You must inform your doctor if you think you are pregnant (or could become pregnant). Trandolapril is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken during this period (see section Pregnancy).

During treatment with Trandolapril Mylan Generics
If you experience any of the following symptoms, you must inform your doctor immediately:

• Dizziness or fainting after the first dose. Some people may experience dizziness, weakness, fainting, or discomfort after the first dose or after a dose increase.
• Sudden swelling of the lips, tongue, face, throat, or neck, possibly also hands and feet, with difficulty breathing or swallowing. This combination of symptoms is called angioedema and may occur at any time during treatment.
• Stomach pain, sometimes accompanied by nausea or vomiting. This may be a symptom of angioedema in the stomach (intestinal angioedema).
• High temperature, sore throat, or mouth ulcers (these may be symptoms of an infection caused by a decrease in white blood cells).
• Yellowing of the skin and whites of the eyes (jaundice) or blood tests showing increased liver enzymes. These may be signs of liver disease.
• Persistent cough.

If you are due to undergo surgery or are to be given an anaesthetic, inform your doctor, dentist, or hospital staff that you are taking Trandolapril Mylan Generics, as taking Trandolapril Mylan Generics at this time may cause a further drop in blood pressure.
At the beginning of treatment and during the dose adjustment period, your doctor may request blood tests to monitor potassium levels and kidney function.

Other medicines and Trandolapril Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, herbal products, or natural remedies.
If you are given another medicine during or immediately after treatment with Trandolapril Mylan Generics, remember to inform your doctor that you are taking/have taken Trandolapril Mylan Generics. Your doctor may consider it necessary to adjust the dose and/or take other precautions.

It is particularly important to inform your doctor if you are using:

• NEP inhibitors such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril: the risk of angioedema (rapid swelling under the skin or mucous membranes, e.g. in the throat) is higher
• If you are taking any of the following medicines, the risk of angioedema may be increased:
  • Racecadotril, a medicine used to treat diarrhoea.
  • Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.
• Other medicines for treating high blood pressure, as they may enhance the effect of trandolapril.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, amiloride, and triamterene), and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting)
• Loop diuretics such as torsemide and furosemide, and thiazide diuretics such as chlorothiazide and bendroflumethiazide, as they may cause a severe drop in blood pressure
• Non-steroidal anti-inflammatory drugs (NSAIDs – e.g. ibuprofen, diclofenac, indomethacin, acetylsalicylic acid, and COX-2 inhibitors), as these may reduce the effect of trandolapril
• Lithium, a medicine used to treat mental disorders, as trandolapril may increase lithium levels in the body
• Tricyclic antidepressants (e.g. amitriptiline, dosulepin), as these may enhance the effects of trandolapril
• Medicines for diabetes (such as insulin, glibenclamide, or gliclazide), as trandolapril may cause excessive lowering of blood glucose levels
• Antacids, to relieve digestive problems; these should not be taken within 2 hours after taking trandolapril. This is because antacids may interfere with the body's effective absorption of trandolapril
• Allopurinol (for gout) or procainamide (for heart rhythm disorders), as these may increase the risk of reducing white blood cell count
• Immunosuppressants (e.g. ciclosporin) that lower the body's immune response, or steroid medicines (e.g. prednisolone, hydrocortisone), or anticancer drugs (cytostatics), as these may increase the risk of reducing white blood cell count
• Medicines containing ephedrine, noradrenaline (norepinephrine), or adrenaline (epinephrine), as they may reduce the effect of trandolapril
• Medicines containing sodium aurothiomalate (gold), as side effects may occur more frequently
• Opioids (strong painkillers), such as methadone, codeine, and morphine, as they may cause a drop in blood pressure
• Antipsychotic medicines such as chlorpromazine, thioridazine, flupentixol, as they may cause a drop in blood pressure
• An angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections “Do not take Trandolapril Mylan Generics” and “Warnings and precautions”)
• Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”

Contact your doctor and inform them if you are taking any of the medicines listed above. Dose adjustments may be necessary.

Trandolapril Mylan Generics and alcohol
Drinking alcohol increases the blood pressure-lowering effect of Trandolapril Mylan Generics.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking trandolapril before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Trandolapril is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to start breastfeeding. Trandolapril is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Trandolapril may cause dizziness, fainting, or tiredness in some people, especially when first starting the capsules. Do not drive, operate machinery, or perform any activity requiring alertness for several hours after the first dose or after any dose increase. Wait until you know how the capsules affect you.

Trandolapril Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Trandolapril Mylan Generics contains the colour sunset yellow (E110)
This medicine may cause allergic reactions.

3. How to take Trandolapril Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Swallow the capsules whole without chewing, with a glass
of water. Take the capsules at the same time each day.
The number of capsules you need to take will depend on the condition being treated. If you are already taking
diuretics, your doctor may instruct you to reduce the dose of diuretics or even stop taking them
before starting Trandolapril Mylan Generics.
Adults:
High blood pressure (hypertension):
The recommended starting dose is 0.5 mg once daily. Your doctor will likely increase this
dose to 1–2 mg/day. The maximum dose is 4 mg/day.
Patients with heart failure and hypertension:
Treatment will be initiated in hospital. The recommended starting dose is 0.5 mg once daily.
Treatment after a heart attack:
Treatment is usually started on the third day after a heart attack, usually at the lowest dose of 0.5 mg/day.
Your doctor will likely gradually increase this dose up to a maximum of 4 mg/day.
Dose for adults previously treated with diuretics:
Diuretic therapy should be discontinued at least 72 hours (3 days) before starting treatment with
Trandolapril, and/or treatment may be initiated with a dose of 0.5 mg once daily. Subsequently, the dose will be adjusted based on the therapeutic response observed by your doctor.
Elderly patients:
If renal function is normal, dose reduction is not necessary. Your doctor will monitor your blood pressure and keep renal function under observation.
However, if you are concurrently taking diuretics or have impaired cardiac, hepatic, or renal function, caution is required.
Use in children and adolescents:
Trandolapril must not be administered to children.
Patients with renal problems:
Your doctor will adjust the dose according to laboratory test results (0.5–1 mg/day).
Patients undergoing renal dialysis: 0.5 mg/day.
Patients with hepatic problems:
The initial dose is 0.5 mg/day. Subsequently, your doctor may adjust the dose as necessary.
If you take more Trandolapril Mylan Generics than you should
If you have taken too much medicine, contact your doctor, hospital, or pharmacist immediately.
Symptoms of overdose include severe lowering of blood pressure, shock, slowed thinking (lethargy), slowed heart rate, disturbances in electrolyte balance, and reduced renal function.
If you forget to take Trandolapril Mylan Generics
Do not take a double dose to make up for the missed dose.
If you stop taking Trandolapril Mylan Generics
It is important that you continue taking the capsules until your doctor tells you otherwise. Do not stop treatment just because you feel better. If you stop taking the capsules, your condition may worsen.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop taking Trandolapril immediately if you experience any of the following effects and
seek immediate medical attention at a hospital or contact your doctor:
Rare (may affect up to 1 in 1,000 people):

• increased frequency of infections, such as fever, severe chills, sore throat, or mouth ulcers (this may indicate a reduced number of white blood cells in your body)
• sudden collapse, numbness or weakness in the arms or legs, headache, dizziness and confusion, visual disturbances, difficulty swallowing, slurred or confused speech, or loss of speech (these may be signs of a stroke or transient ischemic attack (mini-stroke) caused by a blood clot or hemorrhage interrupting blood flow to part of the brain)
• sensation of heaviness or tightness in the chest with chest pain and increased shortness of breath on exertion (these may be signs of heart problems such as angina)
• sudden chest pain that may spread to the neck or arm, with shortness of breath and a feeling of sweating (these may be signs of a heart attack or other cardiac problems)
• irregular, slow or fast heartbeat, which if fast may be felt as pounding in the chest (this may result in irregular activity when viewed on an ECG machine)
• reduced heart function, which may cause fatigue, weakness and/or fluid retention, such as swelling of the legs and ankles, breathing difficulties including cough with frothy or watery sputum
• traces of blood in vomit (clots resembling coffee grounds may be visible)
• yellowing of the skin or whites of the eyes, dark urine, pale stools, fatigue, fever, nausea, weakness, drowsiness, and abdominal pain, liver function abnormalities detected in blood tests or elevated bilirubin levels in the blood (these may be signs of liver problems or blockage of the bile duct)
• sudden swelling of the lips, tongue, face, throat or neck that may lead to difficulty swallowing or breathing (these are signs of an allergic reaction)
• absence or low production of urine, cloudy urine or blood in the urine, pain during urination or back pain (these may be signs of serious kidney problems)
• congenital defects, including skin disorders and abnormal blood vessel formation
• fatigue, shortness of breath, feeling cold in hands and feet, pale skin, and wounds that heal poorly (this may indicate a reduced number of red blood cells in your body)

Not known (cannot be estimated from available data):

• raised red itchy skin rashes known as urticaria (signs of an allergic reaction)
• weakness, unexplained or unusual bruising or bleeding, or more frequent infections, potentially severe (these may be signs of a severe reduction in all types of blood cells)
• persistent constipation with bloated stomach and discomfort (these may be signs of intestinal obstruction)
• severe stomach pain, which may radiate to the back (may indicate signs of pancreatic disorders)
• a skin condition with severe blistering and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions starting with painful red areas, followed by large blisters and subsequent shedding of skin layers. These are accompanied by fever and chills, muscle pain and general malaise (toxic epidermal necrolysis)

Other adverse effects include:
Common (may affect up to 1 in 10 people):

• dizziness or headache
• low blood pressure
• general weakness
• cough with or without mucus secretion

Uncommon (may affect up to 1 in 100 people):

• sleep disturbances
• reduced or absent sexual desire
• drowsiness
• a sensation of spinning with loss of balance (also known as vertigo)
• hot flushes
• shortness of breath, sore throat, cold or flu-like symptoms (may indicate infection, congestion or inflammation of the airways)
• may feel unwell or have gastrointestinal problems such as diarrhea, constipation, stomach pain
• itching, skin rashes
• back pain, muscle spasms or pain in hands and feet
• difficulty maintaining an erection
• general feeling or state of malaise
• chest pain
• fluid retention, swelling of hands, feet and ankles
• awareness of heartbeat in the chest

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

• feeling light-headed or dizzy when standing up from a lying or sitting position (this may be due to a sudden drop in blood pressure)
• discomfort, burning sensation or difficulty urinating, increased frequency of urination (may be a sign of infection in the kidneys, bladder or ureters, the tubes connecting the kidneys to the bladder)
• increased volume of urine
• elevated levels of fats in the blood, such as cholesterol (may increase the risk of blood clots)
• elevated levels of glucose, uric acid or other nitrogenous compounds, low sodium levels or abnormal enzyme levels detected in blood tests
• increased or decreased appetite
• swollen or painful joints, especially in the toes due to crystal accumulation (gout)
• nervousness, restlessness, anxiety, depression, lack of interest or enthusiasm, or seeing, hearing or sensing things that are not real
• fainting, muscle contractions, tingling in hands and feet
• migraine with or without aura, or loss of taste
• eye and vision problems, such as swollen and inflamed eyelids, watery eyes, blurred vision or double vision
• constant ringing in the ears
• high blood pressure
• decreased temperature and color changes in hands and feet or varicose veins
• nosebleeds, sore throat or runny nose
• swelling of the stomach lining
• malaise, indigestion, dry mouth or flatulence
• excessive sweating
• scaly, silvery patches on the skin (psoriasis) or inflamed, swollen, red, itchy, sweaty or dry skin (eczema)
• acne or dry skin
• muscle weakness or muscle, joint and bone pain. Joints may also be stiff and swollen
• fatigue
• injuries
• blockage or damage to blood vessels, which may cause bleeding from the blood vessel or, in more severe cases, damage to surrounding tissue

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

• skin inflammation (dermatitis)

Not known (cannot be estimated from available data):

• increased blood potassium levels
• balance problems
• increased creatinine, urea, alkaline phosphatase, lactate dehydrogenase in the blood
• abnormal blood test results
• hair loss
• fever
• decrease in blood proteins carrying oxygen (hemoglobin) and hematocrit (the percentage of blood volume occupied by red blood cells)

Other adverse effects reported following administration of ACE inhibitors other than trandolapril. You may experience these side effects. The frequency with which they may occur cannot be estimated from available data and include:

• swelling of the intestinal lining
• difficulty recognizing or remembering people, your location, the time, or memory problems
• difficulty breathing through the nose with facial pain (may be signs of sinus problems)
• swelling of the tongue
• increased levels in the blood of certain white blood cells or increased markers in the blood indicating that the immune system may attack your body
• blotchy skin rash similar to measles.

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

5. How to store Trandolapril Mylan Generics

• Keep this medicine out of the sight and reach of children.
• Store in the original packaging.
• Store at a temperature below 25°C.
• Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
• 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 pack and other information

What Trandolapril Mylan Generics contains

• The active substance is trandolapril.
• One capsule contains 0.5 mg or 2 mg of trandolapril.
• The other components are: monohydrate lactose (see section 2 "Trandolapril contains lactose"); pregelatinized maize starch; microcrystalline cellulose; dimethicone; magnesium stearate; anhydrous colloidal silica. The capsule shell contains gelatin; titanium dioxide (E171); and erythrosine (E127).
• Additionally, the following colouring agents are present in these strengths:

0.5 mg: sunset yellow (E110) (see section 2 "Trandolapril contains the colouring agent sunset yellow"), quinoline yellow (E104)
2 mg: sunset yellow (E110) (see section 2 "Trandolapril contains the colouring agent sunset yellow")

Description of the appearance of Trandolapril Mylan Generics and contents of the pack
Each capsule contains a white powder.
0.5 mg: light red-yellow, oblong capsules
2 mg: light red, oblong capsules

Pack sizes:
Trandolapril Mylan Generics 0.5 mg and 2 mg:
14, 20, 28, 30, 50, 56, 84, 90 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer
Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
Pharmathen S.A., 6, Dervenekion str., 153 51 Pallini Attikis, Greece
Viatris Santé, 360 Avenue Henri Schneider, 69330 Meyzieu, France
Mylan Hungary Kft., Mylan utca 1., Komárom, H-2900, Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Denmark: Trandolapril Viatris, harde kapsler 0.5 mg, 1 mg, 2 mg & 4 mg
France: Trandolapril Viatris 0.5 mg, 2 mg & 4 mg gélule
Italy: Trandolapril Mylan Generics
Portugal: Trandolapril Mylan
United Kingdom (Northern Ireland): Trandolapril 0.5 mg, 1 mg, 2 mg & 4 mg Capsules