Patient Information Leaflet

TRIRAMID

5 mg/5 mg/12.5 mg hard capsules
5 mg/5 mg/25 mg hard capsules
10 mg/5 mg/25 mg hard capsules
10 mg/10 mg/25 mg hard capsules
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. Never give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What TRIRAMID is and what it is used for
What you need to know before taking TRIRAMID
How to take TRIRAMID
Possible side effects
How to store TRIRAMID
Contents of the pack and other information

1. What TRIRAMID is and what it is used for

TRIRAMID contains three different active substances called ramipril, amlodipine and hydrochlorothiazide.
Ramipril belongs to a group of medicines known as “ACE inhibitors” (Angiotensin Converting Enzyme inhibitors).
It works by:

Decreasing 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 around the body.

Amlodipine belongs to a group of medicines known as “calcium antagonists”.
It works by:

Relaxing blood vessels, allowing blood to flow through them more easily.

Hydrochlorothiazide is a sulfonamide that belongs to a group of medicines known as “thiazide diuretics” or oral diuretics.
It works by:

Increasing the amount of water (urine) your body produces. This lowers blood pressure.

TRIRAMID may be used to treat high blood pressure (hypertension) in patients who are adequately controlled with the individual active substances administered simultaneously at the same dose levels as TRIRAMID, but in separate tablets.

2. What you should know before taking TRIRAMID

Do not take TRIRAMID if:

you are allergic to ramipril, amlodipine, or hydrochlorothiazide, to any other ACE inhibitor or calcium antagonist, or to any sulfonamide-derived medicine or to any of the other ingredients of this medicine (listed in section 6);
you have severe narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body);
you have previously experienced a severe allergic reaction called "angioedema". 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;
you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, treatment with TRIRAMID may not be suitable for you;
you have severe kidney problems;
you have severe liver problems;
you have abnormal levels of salts (calcium, potassium, sodium) or high levels of uric acid in your blood;
you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis);
during the last 6 months of pregnancy and while breastfeeding (see section "Pregnancy and breastfeeding");
you have abnormally or unstable low blood pressure;
you suffer from heart failure following a heart attack;
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
you have high blood pressure and are pregnant;
you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.

Do not take TRIRAMID if any of these situations apply to you. If you are unsure, consult your doctor before taking TRIRAMID.

Warnings and precautions

Talk to your doctor or pharmacist before taking TRIRAMID.

You must inform your doctor if any of the following conditions apply to you:

you are elderly and your dose needs to be increased;
you have heart, liver, or kidney problems;
you have a severe increase in blood pressure (hypertensive crisis);
you have lost significant amounts of body salts or fluids (due to illness (vomiting), diarrhea, excessive sweating, following a low-salt diet, prolonged use of oral diuretics, or dialysis);
you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization);
you are about to undergo anesthesia that may be administered for surgery or dental procedures. It may be necessary to stop treatment with TRIRAMID 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 are in conditions where sodium levels in your blood may decrease. Your doctor may prescribe regular blood tests, especially to monitor blood sodium levels, particularly if you are elderly;
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;
you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus;
you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur from a few hours to weeks after taking TRIRAMID, especially if you are at risk of developing glaucoma or have an allergy to penicillin- or sulfonamide-containing drugs;
you experience light sensitivity (photosensitivity); in this case, you must stop taking TRIRAMID;
you have diabetes. In this case, you may need to adjust your insulin dose or may require oral hypoglycemic agents;
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), particularly if you have kidney problems related to diabetes, or aliskiren;
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 and lip cancer. Protect your skin from sun and UV exposure while taking TRIRAMID;
you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulty occurs after taking TRIRAMID, consult a doctor immediately.

Your doctor may regularly monitor your kidney function, blood pressure, and levels of electrolytes in your blood (e.g., potassium). See also the information in the section “Do not take TRIRAMID”.

You must inform your doctor if you think you are pregnant (or could become pregnant). TRIRAMID is not recommended during the first three months of pregnancy and may cause serious harm to the baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).

Children and adolescents

The use of TRIRAMID is not recommended in children and adolescents under 18 years of age due to lack of safety and efficacy data.

Other medicines and TRIRAMID

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

This is because TRIRAMID may affect the action of certain other medicines. Also, some medicines may affect the action of TRIRAMID.

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 information in sections “Do not take TRIRAMID” and “Warnings and precautions”);
barbiturates or narcotics (medicines for sleep).

The following medicines may reduce the effectiveness of TRIRAMID:

Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and acetylsalicylic acid).
Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, noradrenaline, and adrenaline. Your doctor will need to monitor your blood pressure.
Rifampicin (an antibiotic used to treat tuberculosis).
Hypericum perforatum (St. John’s wort – herbal treatment for depression).

The following medicines, when taken with TRIRAMID, may increase the likelihood of adverse effects:

Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take TRIRAMID”);
Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid);
Cancer medicines (chemotherapy);
Medicines to prevent organ rejection after transplantation, such as cyclosporine;
Medicines that may lower potassium levels in the blood. These include laxatives, glucocorticoids, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to check if your adrenal glands are functioning properly);
Desmopressin;
Steroid medicines for inflammation such as prednisolone;
Medicines that may increase potassium levels in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for bacterial infections), and heparin (to make blood more fluid);
Medicines for heart problems, including heart rhythm disorders;
Calcium and vitamin D supplements;
Allopurinol (used to lower uric acid levels in the blood);
Procainamide (for heart rhythm problems);
Cholestyramine (to reduce fat levels in the blood);
Carbamazepine, oxcarbazepine (for epilepsy);
Ketoconazole, itraconazole (used to treat fungal infections);
Erythromycin, clarithromycin (antibiotics used to treat certain bacterial infections);
Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV-infected patients);
Verapamil, diltiazem (for treatment of certain heart diseases and high blood pressure);
Dantrolene (infusion for severe abnormalities in body temperature);
Temsirolimus (for cancer);
Sirolimus, everolimus (to prevent transplant rejection);
Vildagliptin (used to treat type 2 diabetes);
Racecadotril (used for diarrhea);
Tacrolimus (used to control the body’s immune response, allowing the body to accept a transplanted organ);
Other medicines that lower blood pressure such as phosphodiesterase 5 inhibitors (used for erectile dysfunction), nitrates, alpha-blockers (for urological use, used to reduce tension in involuntary muscles in the prostate and urethra), tricyclic antidepressants, and neuroleptics;
Medicines that alter gastrointestinal motility such as anticholinergic agents;
Amantadine (for influenza).

The following medicines may be affected by TRIRAMID:

Medicines for diabetes such as oral hypoglycemics and insulin. TRIRAMID may lower blood sugar levels. Monitor your blood sugar levels carefully when taking TRIRAMID;
Lithium (for mental health conditions): TRIRAMID may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels;
Simvastatin (cholesterol medicine): amlodipine increases exposure to simvastatin. Your doctor will need to reduce the simvastatin dose if you are taking TRIRAMID;
Medicines to relax muscles;
Medicines containing iodine, which may be used in hospital before an X-ray or scan;
Medicines that make the blood more fluid taken orally (oral anticoagulants) such as warfarin.

If any of the above conditions occur or if you are unsure, consult your doctor before taking TRIRAMID.

Check with your doctor or pharmacist before taking this medicine if:

you are undergoing a test for parathyroid function. TRIRAMID may alter test results;
you are an athlete required to undergo anti-doping testing. TRIRAMID may give a positive result.

TRIRAMID with food, drinks, and alcohol

TRIRAMID can be taken with or without food.
While taking TRIRAMID, you must not consume grapefruit or grapefruit juice. This is because both grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable hypotensive effect of TRIRAMID.
Drinking alcohol with TRIRAMID may cause dizziness or drowsiness. If you want to know how much alcohol you can drink while taking TRIRAMID, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may enhance each other's sedative effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or could become pregnant). You must not take TRIRAMID during the first 12 weeks of pregnancy and must not take it at all after week 13, as it may harm the unborn baby. If you become pregnant while taking TRIRAMID, inform your doctor immediately. Before planning a pregnancy, you should switch to an alternative medicine more suitable for use during pregnancy.

Breastfeeding

You must not take TRIRAMID while breastfeeding. Consult your doctor or pharmacist before taking any medicine.

Fertility

Available data on the potential effect on fertility are insufficient.

Driving and using machines

TRIRAMID may affect your ability to drive or operate machinery. If the medicine causes you discomfort, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Attention for athletes: The medicinal product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.

TRIRAMID contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

3. How to take TRIRAMID

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 capsule of the strength prescribed by your doctor once daily.
Depending on the effect, your doctor may adjust the dose.
The maximum dose is 1 capsule of 10 mg/10 mg/25 mg strength once daily.
You must take the medicine orally at the same time every day, either before or after meals.
Swallow the capsule whole with liquid.
Do not crush or chew the hard capsules.
Do not take TRIRAMID with grapefruit juice.

Liver and kidney disease
If you have liver or kidney disease, your doctor may adjust your dose.

Elderly patients
If you are elderly, your doctor may reduce your initial dose and adjust treatment more gradually.
TRIRAMID capsules are not recommended for very elderly and frail patients.

Use in children and adolescents
The use of TRIRAMID is not recommended in children and adolescents under 18 years of age due to lack of safety and efficacy data.

If you take more TRIRAMID than you should
Taking too many capsules may cause your blood pressure to drop, possibly to dangerously low levels. You may experience dizziness, mental confusion, fainting, or weakness. If the drop in blood pressure is severe, it may lead to shock. Your skin may become cold and clammy, and you may lose consciousness. Seek immediate medical help if you take too many TRIRAMID capsules. Do not drive to the hospital; have someone accompany you or call an ambulance. Bring the medicine pack with you, so the doctor knows what you have taken.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.

If you forget to take TRIRAMID
If you forget to take a capsule, do not take that dose. Take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking TRIRAMID
Your doctor will advise you on how long to take the medicine. If you stop treatment earlier than advised, your medical condition may return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Stop taking TRIRAMID and contact your doctor immediately if you notice any of the following serious side effects, as 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 may be a sign of a severe allergic reaction to TRIRAMID.
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).

Tell your doctor immediately if you experience:

Rapid or irregular, 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, including inflammation.
Easy bruising, bleeding that lasts longer than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, fatigue, weakness, faintness, dizziness or pale appearance. 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 inflammation of the pancreas (pancreatitis).
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 inflammation of the liver (hepatitis) or liver damage.

Other side effects include:
Tell your doctor if any of the following conditions become severe or last for more than a few days.
Very common: may affect more than 1 in 10 people

Swelling (oedema)
Low levels of potassium in the blood (hypokalaemia)
Increased levels of cholesterol and triglycerides (hyperlipidaemia)

Common: may affect up to 1 in 10 people

Headache, dizziness, numbness associated with drowsiness (somnolence; especially at the beginning of treatment), feeling exhausted (fatigue)
Awareness of your heartbeat (palpitations)
Swelling of the ankles
Low blood pressure (hypotension), especially when standing up or sitting quickly (reduced orthostatic blood pressure), weakness (syncope), hot flushes, flushing
Dry, non-productive cough, inflammation of the sinuses (sinusitis), bronchitis, shortness of breath (dyspnoea)
Abdominal pain, diarrhoea, gastrointestinal inflammation, digestive disorders and abdominal discomfort (including dyspepsia), nausea, vomiting, altered bowel habits (including diarrhoea and constipation), loss of appetite (anorexia), spasms
Rash with or without swelling, hives (urticaria)
Chest pain
Muscle cramps or pain (myalgia), muscle spasms
Blood tests showing lower than usual levels of magnesium and sodium in the blood
Feeling of weakness and lack of energy (asthenia)
Blood tests showing higher than usual levels of uric acid or potassium in the blood
Inability to achieve an erection (impotence)
Visual disturbances (including double and blurred vision)
Increased levels of potassium in the blood (hyperkalaemia)

Uncommon: may affect up to 1 in 100 people

Increase in blood cells called eosinophils (eosinophilia)
Swelling of the skin, mucous membranes and surrounding tissues (angioedema/Quincke's oedema: in very rare cases, airway obstruction due to angioedema may be fatal)
Swollen arms and legs (peripheral oedema; may be a sign that your body is retaining more water than usual)
Swelling of the intestine (intestinal angioedema)
Mood changes, depression, anxiety, nervousness, restlessness, sleep disorders (insomnia)
Ringing in the ears (tinnitus)
Sneezing/runny nose (rhinitis), stuffy nose
Difficulty breathing (bronchospasm), including worsening of asthma
Dry mouth, upper abdominal pain including gastritis, constipation
Inflamed pancreas (pancreatitis; fatal outcomes have been reported in very rare cases with ACE inhibitors)
Impaired kidney function, including acute kidney failure and nephritis, urinary disorders, increased urine output during the day, increased need to urinate at night (nocturia)
Worsening of pre-existing proteinuria (more protein than usual in the urine)
Reduced levels of magnesium in the urine (hypomagnesaemia)
Feeling unwell (malaise)
Increase or decrease in weight
Anorexia, decreased appetite
Dizziness, trembling (tremor)
Hair loss (alopecia)
Itching, small spots or areas of bleeding on the skin (purpura), skin colour changes, rash
Unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations on the skin (paraesthesia), reduced skin sensation (hypoesthesia)
Loss of taste (ageusia) or altered taste (dysgeusia)
Sweating more than usual (hyperhidrosis)
Heart attack (myocardial infarction), heart vessel disease (myocardial ischaemia), chest tightness and pain (angina pectoris), increased (tachycardia) or irregular (arrhythmia) heartbeat
Slow heartbeat (bradycardia), specific heart rhythm disorders (atrial fibrillation, ventricular tachycardia)
Joint pain (arthralgia), back pain, general pain
Increased body temperature/fever (pyrexia)
Reduced sexual desire in men and women, breast enlargement in men (gynaecomastia)
Blood tests showing changes in liver function (increased liver enzymes and/or bilirubin conjugates), pancreas (increased pancreatic enzymes) or kidneys (increased urea, increased creatinine)
Cough
Necrotizing arteritis (vasculitis, cutaneous vasculitis)

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

Feeling or being confused, balance disorders
Red and swollen tongue (glossitis)
Inflammation and peeling of the skin (exfoliative dermatitis)
Nail problems, e.g. loss or separation of the nail from its bed (onycholysis)
Redness, itching, swelling or watering of the eyes (conjunctivitis)
Impaired hearing
Yellowing of the skin (cholestatic jaundice), hepatocellular damage and intrahepatic cholestasis
Narrowing of blood vessels (vascular stenosis)
Disturbed blood flow (hypoperfusion)
Inflammation of blood vessels (vasculitis)
Blood tests showing a reduction in the number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leucopenia) or haemoglobin
Blood tests showing a reduction in the number of platelets (thrombocytopenia)
Blood tests showing higher than usual levels of sugar in the blood. If you have diabetes, this may worsen your diabetes
Sensitivity to light or sun (photosensitivity)
Increased levels of calcium in the blood (hypercalcaemia)
Hypersensitivity reactions
Presence of glucose in the urine
Sleep disorder

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

Widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
Inflammation of the liver (hepatitis, mostly with cholestasis)
Allergic reactions
Skin rash, which may blister, resembling small targets (dark central spots surrounded by a lighter area with a dark ring at the edge) (erythema multiforme)
Reaction characterised by erythematous skin and mucosal manifestations (similar to lupus erythematosus), reactivation of lupus erythematosus, inflammation of blood vessel walls (necrotizing vasculitis) and widespread rash with tendency of the skin to detach (toxic epidermal necrolysis)
Enlargement of gum tissue (gingival hyperplasia)
Increased muscle tone (hypertonia)
Peripheral nervous system disorder (peripheral neuropathy)
Bone marrow depression
Severe reduction in the number of blood cells called granulocytes (agranulocytosis)
Blood tests showing too many damaged red blood cells (haemolytic anaemia)
Hypochloraemic alkalosis caused by extreme lack or loss of chloride, which may occur with prolonged vomiting
Respiratory problems (including pneumonia and pulmonary oedema)
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)
Increased levels of glucose in the blood

Not known: frequency cannot be estimated from the available data
Inform your doctor if any of the following side effects become severe or last for more than a few days.

Blood tests showing too few red blood cells, white blood cells and platelets (pancytopenia)
Anaphylactic or anaphylactoid reactions
Lumpy skin (pemphigus)
Increased antinuclear antibodies
Difficulty concentrating (attention disorder)
Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
Reduced production of blood cells (aplastic anaemia)
Fingers of hands and feet changing colour when exposed to cold, followed by tingling or painful sensation when warming up (Raynaud's phenomenon)
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack (TIA)
Impaired psychomotor performance
Burning sensation
Altered sense of smell (parosmia)
Acute liver failure, cholestatic and cytolytic hepatitis (fatal outcome has been reported in very rare cases)
Skin inflammation (psoriasiform dermatitis), acute rash (pemphigoid or lichenoid eruption), worsening of skin peeling or desquamation (aggravated psoriasis), mucosal rash (enantema)
Feeling unwell or malaise. Muscle cramps, confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
Tremor, rigid posture, mask-like face, slow movements and shuffling, unbalanced gait.
Rapid-onset reduction in distance vision (acute myopia), reduced 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)
Skin and lip cancer (non-melanoma skin cancer)
Bone marrow failure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
http://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 TRIRAMID

Keep this medicine below 30 °C.
Keep this medicine out of sight and reach of children.
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 TRIRAMID contains
TRIRAMID 5 mg/5 mg/12.5 mg hard capsules:

The active substances are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.

TRIRAMID 5 mg/5 mg/25 mg hard capsules:

The active substances are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

TRIRAMID 10 mg/5 mg/25 mg hard capsules:

The active substances are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 10 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

TRIRAMID 10 mg/10 mg/25 mg hard capsules:

The active substances are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 10 mg of ramipril, 10 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.
Other components are: Capsule contents: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized starch, Sodium glycolate starch (type A), Sodium stearil fumarate

Capsule shell (5 mg/5 mg/25 mg): Iron oxide red (E172), Iron oxide yellow (E172), Titanium dioxide (E171), Gelatin
Capsule shell (10 mg/5 mg/25 mg): Iron oxide red (E172), Iron oxide yellow (E172), Titanium dioxide (E171), Gelatin
Capsule shell (10 mg/10 mg/25 mg): Iron oxide red (E172), Iron oxide yellow (E172), Iron oxide black (E172), Titanium dioxide (E171), Gelatin
Capsule shell (5 mg/5 mg/12.5 mg): Iron oxide red (E172), Iron oxide black (E172), Titanium dioxide (E171), Gelatin

Description of the appearance of TRIRAMID and pack contents
TRIRAMID 5 mg/5 mg/12.5 mg hard capsules:
Type 3 capsules with an opaque pink cap and a light grey opaque body.
TRIRAMID 5 mg/5 mg/25 mg hard capsules:
Type 1 capsules with an opaque pink cap and an ivory opaque body.
TRIRAMID 10 mg/5 mg/25 mg hard capsules:
Type 1 capsules with an opaque dark pink cap and an opaque yellow body.
TRIRAMID 10 mg/10 mg/25 mg hard capsules:
Type 1 capsules with an opaque brown cap and a caramel-coloured opaque body.
Pack size: 28 hard capsules in PA-AL-PVC (laminate) blister packs with aluminum foil, packed in cardboard cartons.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl - Via Turati 40 - 20121 Milano - Italy

Manufacturer
Adamed Pharma S.A. - ul. Marszałka Józefa Piłsudskiego 5 - 95-200 Pabianice - Poland

Triramide