PARVATI 2.5 mg/5 mg Hard capsules

Зміст інструкції

1. Parvati 2.5 mg + 5 mg hard capsules, 5 mg + 5 mg hard capsules, 10 mg + 5 mg hard capsules
   1. What is Parvati and what is it used for
   2. What you need to know before taking Parvati
   3. How to take Parvati
   4. Possible side effects
   5. How to store Parvati
   6. Contents of the pack and other information

Parvati 2.5 mg + 5 mg hard capsules, 5 mg + 5 mg hard capsules, 10 mg + 5 mg hard capsules

Parvati 5 mg + 10 mg hard capsules
Parvati 10 mg + 10 mg hard capsules
Ramipril/amlodipine
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

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

1. What is Parvati and what is it used for

Parvati contains two active ingredients: amlodipine and ramipril. Amlodipine belongs to a
group of medicines called calcium antagonists. Ramipril belongs to a group of medicines
called ACE inhibitors (angiotensin converting enzyme inhibitors).
Amlodipine works by:

• relaxing and widening blood vessels so that blood can flow more easily. Ramipril works by:
• reducing the body's production of substances that can raise blood pressure;
• relaxing and widening blood vessels;
• making it easier for the heart to pump blood around the body. Parvati is used for the treatment of hypertension (high blood pressure), in patients whose blood pressure is adequately controlled with amlodipine and ramipril taken simultaneously at the same dose as in Parvati, but as separate medicines.

2. What you need to know before taking Parvati

Do not take Parvati:

• if you are allergic to amlodipine, ramipril (active ingredients), any other calcium antagonist or any other ACE inhibitor, or to any of the other components of this medicine (listed in section 6). The reaction may be itching, skin redness or difficulty breathing;
• if your blood pressure is unusually low or unstable. Your doctor will need to make this assessment;
• if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body);
• if you suffer from heart failure following a heart attack;
• if you have ever had a severe allergic reaction called “angioedema”. The signs include: itching, hives, 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 are on dialysis or undergoing any other type of blood filtration. Depending on the machine used, Parvati may not be suitable for you;
• if you have kidney problems caused by reduced blood flow to the kidneys (renal artery stenosis);
• during the last 6 months of pregnancy (see section "Pregnancy and breastfeeding");
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).
• 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.

Do not take Parvati if any of the above cases apply to you. If you are not sure, ask your doctor or pharmacist before taking Parvati.

Warnings and precautions
Talk to your doctor or pharmacist before taking Parvati. Tell your doctor if any of the cases listed below apply to you:

• if you have a sudden increase in blood pressure (hypertensive crisis);
• if you are elderly and your dosage needs to be increased;
• if you have problems with your heart, liver or kidneys;
• if you have lost a lot of salts or fluids from your body (due to an illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis);
• if you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization);
• if you are about to be treated with an anesthetic. This may be given for surgery or dental treatment. You will need to stop taking Parvati one day before; for more information, consult your doctor;
• if you have a high amount of potassium in your blood (shown by a blood test);
• if you have a connective tissue disease such as scleroderma or systemic lupus erythematosus;
• if you are taking one of the following medicines used to treat high blood pressure: an “angiotensin II receptor blocker” (AIIRA) (also known as sartans, for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes aliskiren your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under “Do not take Parvati”.

Children and adolescents
The use of Parvati is not recommended in children and adolescents under the age of 18 years, because information is not available for this patient population.

Other medicines and Parvati
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in your blood (such as trimethoprim and co-trimoxazole for treating bacterial infections;
• cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs;
• heparin, a medicine used to thin the blood and prevent blood clots)

Tell your doctor if you are taking any of the following medicines, because they may make Parvati less effective:

• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and 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 check your blood pressure;
• rifampicin (an antibiotic used to treat tuberculosis);
• hypericum perforatum (St John's wort used to treat depression).

Tell your doctor if you are taking any of the following medicines, because they may increase the likelihood of side effects if taken with Parvati:

• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)
• cancer medicines (chemotherapy)
• medicines to stop rejection of organs after a transplant, such as cyclosporine
• diuretics such as furosemide
• medicines that can increase the amount of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin (to thin the blood)
• steroid medicines for inflammation, such as prednisolone
• allopurinol (used to lower uric acid levels in the blood)
• procainamide (for heart rhythm problems)
• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV)
• erythromycin, clarithromycin (antibiotics, for infections caused by bacteria)
• verapamil, diltiazem (medicines to treat heart problems or high blood pressure)
• vildagliptin (oral medicine that lowers blood glucose levels)
• dantrolene (infusion medicine for severe temperature alterations)
• trimethoprim and co-trimoxazole (for bacterial infections)
• temsirolimus (for cancer)
• everolimus (to prevent rejection of grafts)
• tacrolimus (used to control the immune response, to allow the body to accept the transplanted organ)

Tell your doctor if you are taking any of the following medicines, because their action may be altered by Parvati:

• medicines for diabetes, such as oral medicines to lower blood sugar levels and insulin. Parvati can lower blood sugar levels. Monitor your blood sugar levels while taking Parvati;
• lithium (for mental health problems). Parvati can raise lithium levels in the blood. Your doctor will need to closely monitor your lithium levels in the blood;
• -simvastatin (a medicine to lower cholesterol). Parvati can raise simvastatin levels in the blood.

Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also “Do not take Parvati” and “Warnings and precautions”).

If any of the above applies to you (or if you are not sure), tell your doctor before taking Parvati.

Parvati with food, drink and alcohol
Parvati can be taken with or without food.
People taking Parvati should not consume grapefruit or grapefruit juice. This is because grapefruit and its juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can enhance the effect of Parvati causing an unpredictable lowering of blood pressure.
Drinking alcohol with Parvati can cause dizziness or confusion. If you are concerned about how much you can drink while taking Parvati, talk to your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Parvati during pregnancy.
If you find you are pregnant during treatment with Parvati, inform your doctor immediately. Before planning a pregnancy, you should switch to an alternative therapy that is suitable.

Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts.
Do not take Parvati if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Parvati may affect your ability to drive or operate machinery. If Parvati makes you feel unwell, dizzy or tired, or gives you a headache, do not drive or operate machinery and contact your doctor immediately. This may happen especially at the beginning of treatment, or when switching from other medicines.

Parvati contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say, it is essentially ‘sodium-free’.

3. How to take Parvati

Take this medicine following the instructions of your doctor or pharmacist exactly as given. If you have doubts, consult your doctor or pharmacist.
If you feel that the effect of Parvati is too strong or too weak, inform your doctor or pharmacist.
Take the medicine by mouth always at the same time of day, before or after meals.
Swallow the capsule whole with some liquid.
Do not break or chew the capsules.
Do not take Parvati with grapefruit juice.
Parvati must be taken once a day.
The doctor may modify the dose depending on the effect it has on you. The maximum daily dose is one 10 mg + 10 mg capsule.

Elderly
The doctor will reduce the initial dose and adjust the treatment more slowly.

Use in children and adolescents
The use of Parvati is not recommended in children and adolescents under the age of 18, because information is not available for this patient population.

If you take more Parvati than you should
Taking too many capsules can cause a decrease or a dangerously low blood pressure. You may experience dizziness, lightheadedness, fainting or weakness. If the drop in blood pressure is so severe, shock may occur. The skin may become cold and clammy and you may lose consciousness. Inform your doctor immediately or go immediately to the nearest hospital. Do not drive to the hospital, but have someone accompany you or call an ambulance. Bring the packaging of the medicine with you, so that the doctor knows what you have taken.

If you forget to take Parvati
If you forget to take a capsule, skip that dose altogether and take the next dose at the usual time. Do not take a double dose to make up for a missed capsule.

If you stop taking Parvati
The doctor will inform you how long you will need to take this medicine. If you stop treatment before being told to do so, your condition may recur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following serious side effects, stop taking Parvati and consult your doctor immediately as you may need urgent medical treatment:

• swelling of the face, lips or throat that can cause difficulty swallowing or breathing, as well as itching and skin rashes. This could be a sign of a severe allergic reaction to Parvati;
• severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.

Tell your doctor immediately if any of the following occur:

• a fast, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems including heart attack and stroke;
• shortness of breath or cough. This could be a sign of lung problems;
• a greater tendency to bruise, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple patches, spots on the skin or a greater tendency to infections, sore throat and fever, feeling tired, weak, dizzy or pale. These can be signs of blood or bone marrow problems;
• severe stomach pain that may radiate to your back. This may be a sign of pancreatitis (inflammation of the pancreas);
• fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These can be signs of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Tell your doctor if any of the following side effects becomes serious or lasts more than a few days.
Common (may affect up to 1 in 10 people):

• drowsiness (especially at the beginning of treatment);
• palpitations (feeling of a strong heartbeat), hot flushes;
• swelling of the ankles (edema);
• headache or feeling tired;
• feeling dizzy. This is more likely to happen at the start of therapy with Parvati or when you start taking a higher dose;
• fainting, low blood pressure (blood pressure too low), especially when getting up or sitting up too quickly;
• dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
• abdominal pain, stomach pain or discomfort, diarrhea, indigestion, feeling or being sick;
• skin rash with or without swelling;
• chest pain;
• muscle cramps or pain;
• blood tests showing too much potassium in the blood than normal.

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

• changes in mood, insomnia;
• tremor, weakness, pain, feeling unwell;
• vision disturbances, double vision, blurred vision, ringing in the ears;
• cold/runny nose caused by inflammation of the nasal mucosa (rhinitis);
• changes in bowel habits (including diarrhea or constipation), heartburn, dry mouth;
• hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration;
• problems with urination, increased need to urinate, especially at night, increased number of times you urinate;
• inability to achieve an erection, sexual dysfunction in men, reduced sexual desire in men or women;
• discomfort or enlargement of the breasts in men;
• joint or muscle pain, muscle cramps, back pain;
• weight gain or loss;
• balance problems (dizziness);
• itching and unusual skin sensations such as numbness, tingling, prickling, burning or chills (paresthesia), loss of sensation to pain;
• loss or change in the sense of taste;
• problems with sleeping;
• feeling depressed, anxious, more nervous than usual or restless;
• blocked nose, difficulty breathing or worsening of asthma;
• an intestinal swelling called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhea;
• loss or decrease in appetite (anorexia);
• increase or irregularity in heartbeat;
• swollen arms and legs. This could be a sign that your body is retaining more water than normal;
• fever;
• an increase in the number of a certain type of white blood cells (eosinophilia), detected during a blood test;
• blood tests showing changes in the function of the liver, pancreas or kidneys.

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

• feeling shaky or confused;
• red or swollen tongue;
• severe peeling or flaking of the skin, itching, rash with swelling;
• nail problems (e.g. loss or separation of a nail from the nail bed);
• skin rash or bruising;
• hives;
• spots on the skin and hands, cold extremities;
• red, itchy, swollen or watery eyes;
• hearing disorders;
• blood tests showing a reduction in the number of red blood cells, white blood cells, platelets or in the amount of hemoglobin.

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

• increased sensitivity to sunlight than usual;
• excessive amount of sugar in the blood (hyperglycemia);
• swelling of the gums;
• abdominal swelling (gastritis);
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice);
• increased muscle tension;
• inflammation of blood vessels, often with skin rash;
• sensitivity to light;
• disorders combining rigidity, tremors and/or movement disorders;
• psoriasis.

Not known (frequency cannot be estimated from the available data):

• concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experience these symptoms, contact your doctor promptly;
• tremor, rigid posture, mask-like face, slow movements and a shuffling, dragging gait.

Other side effects reported:
Tell your doctor if any of the following side effects becomes serious or lasts more than a few days:

• difficulty concentrating;
• blood tests showing too few blood cells;
• blood tests showing too little sodium in the blood than normal;
• fingers of the hands and feet that change color in the cold and then tingle or feel pain when warmed (Raynaud's phenomenon);
• slowed or altered reactions;
• change in the perception of smells.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly through the national

reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side

effects, you can help provide more information on the safety of this medicine.

5. How to store Parvati

Keep this medicine out of the sight and reach of children. Store below
30°C.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the box and blister
after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Parvati contains
The active ingredients are:

Parvati 2.5 mg + 5 mg hard capsules
each capsule contains: 2.5 mg of ramipril and 6.934 mg of amlodipine besilate (corresponding to
5 mg of amlodipine)

Parvati 5 mg + 5 mg hard capsules
each capsule contains: 5 mg of ramipril and 6.934 mg of amlodipine besilate (corresponding to 5
mg of amlodipine)

Parvati 10 mg + 5 mg hard capsules
each capsule contains: 10 mg of ramipril and 6.934 mg of amlodipine besilate (corresponding to
5 mg of amlodipine)

Parvati 5 mg + 10 mg hard capsules
each capsule contains: 5 mg of ramipril and 13.868 mg of amlodipine besilate (corresponding to
10 mg of amlodipine)

Parvati 10 mg + 10 mg hard capsules
each capsule contains: 10 mg of ramipril and 13.868 mg of amlodipine besilate (corresponding to
10 mg of amlodipine)
The other ingredients are: Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized
starch, low moisture pregelatinized starch, sodium starch glycolate
(type A), sodium stearyl fumarate, red iron oxide (E172), titanium dioxide (E171), gelatin.
In Parvati 10 mg + 10 mg also present are: yellow iron oxide (E172), black iron oxide
(E172).

Description of the appearance of Parvati and contents of the pack
Parvati 2.5 mg + 5 mg hard capsules: hard gelatin capsules, light pink
opaque cap, opaque white body. Capsule contents: white or almost white powder.
Parvati 5 mg + 5 mg hard capsules: hard gelatin capsules, opaque pink cap,
opaque white body. Capsule contents: white or almost white powder.
Parvati 10 mg + 5 mg hard capsules: hard gelatin capsules, dark pink
opaque cap, opaque white body. Capsule contents: white or almost white powder.
Parvati 5 mg + 10 mg hard capsules: hard gelatin capsules, reddish-
brown opaque cap, opaque white body. Capsule contents: white or almost
white powder.
Parvati 10 mg + 10 mg hard capsules: hard gelatin capsules, brown
opaque cap, opaque white body. Capsule contents: white or almost white powder.
Parvati is available in blisters containing 28 capsules.

Marketing Authorisation Holder
Neopharmed Gentili S.p.A. – Via San Giuseppe Cottolengo, 15 – 20143 Milan

Manufacturers

• Adamed Pharma S.A. - Ul. Szkolna 33 - 95-054 Ksawerów-Poland
• Adamed Pharma S.A. - Ul. Marszałka Józefa Piłsudskiego 5 - 95-200 Pabianice-Poland