Sarasvati: detailed information

Patient Information Leaflet

SARASVATI

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
Ramipril / amlodipine / hydrochlorothiazide
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 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:

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

1. What SARASVATI is and what it is used for

SARASVATI 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 can 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 channel blockers”.
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 called “thiazide diuretics” or oral diuretics.
It works by increasing the amount of water (urine) produced by the body. This lowers blood pressure.
SARASVATI can 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 in SARASVATI, but in separate tablets.

2. What you should know before taking SARASVATI

Do not take SARASVATI 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 had 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 SARASVATI 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 the blood;
you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis);
during the last 6 months of pregnancy and during 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 suffer from 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 SARASVATI if any of these cases apply to you. If you are unsure, consult your doctor before taking SARASVATI.
Warnings and precautions
Talk to your doctor or pharmacist before taking SARASVATI.
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, or following a low-salt diet, or due to long-term use of oral diuretics or following dialysis);
you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization);
you are about to undergo anesthesia, which may be administered for surgery or dental procedures. It may be necessary to stop treatment with SARASVATI the day before. Consult your doctor;
you have high levels of potassium in the blood (shown by a blood test);
you are taking medicines or are in conditions where sodium levels in the blood may decrease. Your doctor may prescribe regular blood tests, especially to monitor 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 vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to weeks after taking SARASVATI. If untreated, they may lead to permanent vision loss, especially if you are at risk of having an allergy to penicillin- or sulfonamide-containing drugs;
you experience light sensitivity (photosensitivity). In this case, you must stop taking SARASVATI;
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 used to treat high blood pressure: or an angiotensin II receptor antagonist (AIIRA) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially 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 cancers. Protect your skin from sun and UV exposure while taking SARASVATI;
you have had respiratory or lung problems (including inflammation or fluid in the lungs) following previous use of hydrochlorothiazide. If shortness of breath or severe breathing difficulty occurs after taking SARASVATI, consult a doctor immediately.

Your doctor may regularly check your kidney function, blood pressure, and levels of electrolytes in the blood (e.g., potassium). See also the information in the section “Do not take SARASVATI”.
You must inform your doctor if you think you are pregnant (or might become pregnant). SARASVATI 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 SARASVATI is not recommended in children and adolescents under 18 years of age due to lack of safety and efficacy data.
Other medicines and SARASVATI
Inform 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 SARASVATI may affect the mechanism of action of certain other medicines. In addition, some medicines may affect the mechanism of action of SARASVATI.
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 SARASVATI” and “Warnings and precautions”);
barbiturates or narcotics (medicines for sleep).

The following medicines may reduce the effectiveness of SARASVATI:

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, if taken with SARASVATI, 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 SARASVATI”).
Medicines used to relieve pain and inflammation (e.g., Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid).
Medicines for cancer (chemotherapy).
Medicines to prevent organ rejection after transplantation such as cyclosporine.
Medicines that may lower potassium levels in the blood. These include medicines for constipation, 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 less thick).
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 treating 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 SARASVATI:

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

If any of the above conditions occur or if you are unsure, consult your doctor before taking SARASVATI.
Check with your doctor or pharmacist before taking this medicine if:

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

SARASVATI with food, drinks, and alcohol

SARASVATI can be taken with or without food.
While taking SARASVATI, you must not consume grapefruit or grapefruit juice. This is because both grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable hypotensive effect of SARASVATI.
Drinking alcohol with SARASVATI may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking SARASVATI, discuss it 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 might become pregnant). You must not take SARASVATI during the first 12 weeks of pregnancy and must not take it at all after week 13, as its use may be harmful to the baby. If you become pregnant during treatment with SARASVATI, inform your doctor immediately. Before planning a pregnancy, you should switch to an alternative medicine more suitable for pregnancy.
Breastfeeding
You must not take SARASVATI while breastfeeding. Consult your doctor or pharmacist before taking any medicine.
Fertility
Available data on potential effects on fertility are insufficient.
Driving and use of machines
SARASVATI may affect your ability to drive or operate machinery. If the medicine causes 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.
SARASVATI contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

3. How to take SARASVATI

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule of the dosage prescribed by your doctor once daily.
Depending on the effect, your doctor may adjust the dose.
The maximum dose is 1 capsule of the 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 SARASVATI 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 an elderly patient, your doctor may reduce your initial dose and adjust treatment more slowly.
SARASVATI capsules are not recommended for very elderly and frail patients.

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

If you take more SARASVATI 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 attention if you take too many SARASVATI capsules. Do not drive yourself to the hospital; have someone drive you or call an ambulance. Bring the medicine pack with you, as the doctor needs to know what you have taken.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take SARASVATI
If you forget to take a capsule, do not take the missed 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 SARASVATI
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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking SARASVATI 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. These may be signs of a severe allergic reaction to SARASVATI.
Severe skin reactions including rash, mouth ulcers, 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).

Contact your doctor immediately if you experience:

Rapid or 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, including inflammation.
Easy bruising, bleeding that lasts longer than normal, any signs of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat, and fever, feeling tired, weak, faint, dizzy, or pale appearance. These may be signs of circulatory or bone marrow problems.
Severe stomach pain that may spread 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:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.

Very common: may affect more than 1 in 10 people

Swelling (edema)
Low levels of potassium in the blood (hypokalemia)
Increased levels of cholesterol and triglycerides (hyperlipidemia)

Common: may affect up to 1 in 10 people

Headache, dizziness, drowsiness associated with a feeling of sleepiness (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 down quickly (reduced orthostatic blood pressure), weakness (syncope), hot flushes, flushing
Dry, non-productive cough, inflammation of the sinuses (sinusitis), bronchitis, shortness of breath (dyspnea)
Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders and abdominal discomfort (including dyspepsia), nausea, vomiting, altered bowel habits (including diarrhea and constipation), loss of appetite (anorexia), spasms
Skin rash with or without swellings, 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 or blurred vision)
Increased levels of potassium in the blood (hyperkalemia)

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 edema; in very rare cases, airway obstruction due to angioedema can be fatal)
Swollen arms and legs (peripheral edema; may indicate that your body is retaining more water than usual)
Swelling of the intestine (angioedema of the small intestine)
Mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
Ringing in the ears (tinnitus)
Sneezing/runny nose (rhinitis), nasal congestion
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)
Kidney impairment, including acute kidney failure and nephritis, urinary problems, increased urination 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 (hypomagnesemia)
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), changes in skin color, rash
Unusual skin sensations such as numbness, tingling, pricking, burning, or creeping sensations on the skin (paresthesia), 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 ischemia), chest stiffness 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 (gynecomastia)
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 vasculitis (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 tearing of the eyes (conjunctivitis)
Hearing impairment
Yellowing of the skin (cholestatic jaundice), hepatocellular damage, and intrahepatic cholestasis
Narrowing of blood vessels (vascular stenosis)
Impaired 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, leukopenia), or hemoglobin levels
Blood tests showing a reduction in the number of platelets (thrombocytopenia)
Blood tests showing higher than usual blood sugar levels. If you have diabetes, this may worsen your diabetes
Sensitivity to light or sun (photosensitivity)
Increased levels of calcium in the blood (hypercalcemia)
Hypersensitivity reactions
Presence of glucose in the urine
Sleep disorder

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

Widespread rash with blisters and peeling of the skin, particularly 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 around the edge) (erythema multiforme)
Reaction characterized by erythematous skin and mucosal manifestations (lupus-like), reactivation of systemic lupus erythematosus, inflammation of blood vessel walls (necrotizing vasculitis), and extensive skin rash with tendency for 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 (hemolytic anemia)
Hypochloremic alkalosis caused by a severe lack or loss of chloride, which may occur with prolonged vomiting
Respiratory problems (including pneumonia and pulmonary edema)
Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)
Increased blood glucose levels

Not known: frequency cannot be estimated from the available data
Inform your doctor if any of the following side effects become severe or last longer 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 anemia)
Fingers of hands and feet changing color when exposed to cold, followed by tingling or pain when warming up (Raynaud's phenomenon)
Cerebral ischemia including ischemic stroke and transient ischemic attack (TIA)
Impaired psychomotor skills
Burning sensation
Altered sense of smell (parosmia)
Acute liver failure, cholestatic and cytolytic hepatitis (fatal outcomes have been reported in very rare cases)
Skin inflammation (psoriasiform dermatitis), acute rash (pemphigoid or lichenoid exanthem), worsening of skin flaking or peeling (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), decreased vision or eye pain due to increased 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
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 SARASVATI

Keep this medicine below 30 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What SARASVATI contains
SARASVATI 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.

SARASVATI 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.
SARASVATI 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.

SARASVATI 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): Red iron oxide (E172), Yellow iron oxide (E172), Titanium dioxide (E171), Gelatin
Capsule shell (10 mg/5 mg/25 mg): Red iron oxide (E172), Yellow iron oxide (E172), Titanium dioxide (E171), Gelatin
Capsule shell (10 mg/10 mg/25 mg): Red iron oxide (E172), Yellow iron oxide (E172), Black iron oxide (E172), Titanium dioxide (E171), Gelatin
Capsule shell (5 mg/5 mg/12.5 mg): Red iron oxide (E172), Black iron oxide (E172), Titanium dioxide (E171), Gelatin

Description of the appearance of SARASVATI and pack sizes
SARASVATI 5 mg/5 mg/12.5 mg hard capsules:
Type 3 capsules with opaque pink cap and opaque light grey body.
SARASVATI 5 mg/5 mg/25 mg hard capsules:
Type 1 capsules with opaque pink cap and opaque ivory body.
SARASVATI 10 mg/5 mg/25 mg hard capsules:
Type 1 capsules with opaque dark pink cap and opaque yellow body.
SARASVATI 10 mg/10 mg/25 mg hard capsules:
Type 1 capsules with opaque brown cap and opaque caramel body.
Packaged in blister packs of PA-AL-PVC (laminated) with aluminium foil, containing 28 hard capsules, boxed in cardboard cartons.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano, Italy

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