RAMLOID 5 mg/5 mg /12.5 Mg Hard Capsule

Зміст інструкції

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

Ramloid hard capsules 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

Ramipril/amlodipine/hydrochlorothiazide

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. See section 4.

Contents of this leaflet

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

1. What is Ramloid and what is it used for

Ramloid contains three active ingredients called ramipril, amlodipine and hydrochlorothiazide.
Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). This medicine works:

• By decreasing the production of substances in the body that can potentially increase blood pressure
• By relaxing and widening blood vessels
• By making it easier for the heart to pump blood throughout the body Amlodipine belongs to a group of medicines called calcium antagonists. This medicine works:
• By relaxing blood vessels, so that blood can flow more easily

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or “water pills”.
This medicine works:

• By increasing the production of water (urine). This helps to lower blood pressure. Ramloid can be used to treat high blood pressure (hypertension) in adult patients who are adequately controlled with the individual products administered simultaneously at the same dosages as the combination, but in separate tablets.

2. What you need to know before taking Ramloid

Do not take Ramloid

• If you are allergic to ramipril ,amlodipine or hydrochlorothiazide (active ingredients), to any other calcium channel blocker or ACE inhibitor or to sulfonamide-derived medicines or to any of the other components of this medicine (listed in section 6).
• If you have a severe narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide a sufficient amount of blood to the body).
• If you have had a severe allergic reaction called “angioedema” in the past. The signs include itching, hives, red patches 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 undergoing dialysis or any other type of blood filtration. Depending on the device used, treatment with Ramloid may not be suitable for you.
• If you have severe kidney problems.
• If you suffer from liver failure.
• If you have abnormal levels of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems where the blood supply to the kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see the section “Pregnancy and breastfeeding” below).
• If you have excessively low or unstable blood pressure.
• If you suffer from heart failure after having a heart attack.
• If you have diabetes or kidney dysfunction and are being treated with a medicine to lower blood pressure containing aliskiren.

Do not take Ramloid if you fall into any of the conditions described above. If you have any doubts, ask your doctor before taking Ramloid.

Warnings and precautions

• If you are elderly and your dose needs to be increased;
• If you have problems with your heart, liver or kidneys;
• If you suffer from severe increases in blood pressure (hypertensive crisis);
• If you have lost a lot of salts or body fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, prolonged use of diuretics [water tablets] or dialysis);
• If you are breastfeeding;
• If you are to undergo treatment to reduce an allergy to bee or wasp stings (desensitization therapy);
• If you are about to receive an anesthetic that may be administered for surgery or dental treatment. In this case, you may need to stop treatment with Ramloid one day before the procedure; ask your doctor for advice;
• If you have a high amount of potassium in your blood (as shown by blood tests);
• If you are taking medicines or suffer from conditions that may decrease the amount of sodium in your blood. Your doctor may prescribe blood tests regularly, especially to check sodium levels in the blood, particularly if you are elderly;
• If you are taking medicines called mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin or racecadotril, as they may increase the risk of angioedema, a severe allergic reaction;
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus;
• If you have decreased vision or eye pain, especially if you are at risk of developing a condition called glaucoma or suffer from an allergy to penicillin- or sulfonamide-containing medicines;
• If you experience photosensitivity reactions, you should stop treatment with Ramloid;
• If you have diabetes, the dosage of insulin may need to be adjusted or you may need to use hypoglycemic drugs;
• If you are taking any of the following medicines used to treat hypertension: an angiotensin II receptor blocker (ARB), also known as a sartan (e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes; or Aliskiren;

If you fall into any of the conditions described above (or if you have doubts), consult your doctor before taking Ramloid.
Verify with your doctor or pharmacist before taking this medicine:

• If you are undergoing a parathyroid function test. The ramipril/hydrochlorothiazide combination may alter the results of this test.
• If you are an athlete and need to undergo doping control. The ramipril/hydrochlorothiazide combination may cause you to test positive for doping control.

Ramloid with food, drinks and alcohol

• Ramloid can be taken before and after meals.
• People taking Ramloid should not eat grapefruit or drink grapefruit juice. Grapefruit and grapefruit juice can cause an increase in the levels of the active ingredient amlodipine in the blood, with a consequent and unexpected increase in the blood pressure lowering effects of Ramloid.
• Drinking alcohol during treatment with Ramloid may cause dizziness or lightheadedness. If you have any doubts about the amount of alcohol allowed during treatment with Ramloid, talk to your doctor, as medicines used to lower blood pressure and alcohol can intensify each other's sedative effects.

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

Pregnancy
Tell your doctor if you think you are (or might become) pregnant. Ramloid should not be taken during the first 12 weeks of pregnancy and none of its components should be taken after the 13th week, because the use of these medicines during pregnancy may be harmful to the baby. If you become pregnant while taking Ramloid, tell your doctor immediately.
If you are planning to become pregnant, it is advisable to choose an appropriate alternative treatment.

Breastfeeding
Do not take Ramloid if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Fertility
There is insufficient data regarding the potential effect on fertility.

Driving and operating machinery
Ramloid may impair your ability to drive vehicles or operate machinery. If this medicine causes you to feel nauseous, dizzy, tired or headache, avoid driving vehicles or operating machinery and contact your doctor immediately.

3. How to take Ramloid

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule per day of the concentration prescribed by your doctor.
Based on the effect of the medicine, your doctor may modify the dose.
The maximum dose is 1 capsule once a day of the concentration of 10 mg/10 mg/25 mg.
Take this medicine by mouth at the same time each day, before or after meals.
Swallow the hard capsule whole with some liquid.
Avoid crushing or chewing the hard capsules.
Do not take Ramloid with grapefruit juice.

Liver and kidney diseases
The doses may be modified in the presence of liver and kidney diseases.

Elderly
The doctor will reduce the initial dose and adjust the treatment more slowly.
The administration of Ramloid capsules is not recommended in case of very elderly and
frail patients.

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

If you take more Ramloid than you should
Too many capsules may cause a drop in blood pressure, lowering it to dangerous levels. You may experience dizziness, lightheadedness, a feeling of fainting or weakness. If the drop
in blood pressure is severe enough, shock may occur. The skin may become
cold and sweaty, and you may lose consciousness. If you take an excessive amount of Ramloid
seek immediate medical assistance. Do not drive yourself to the hospital, but have someone drive you or call an ambulance. Bring the package of the medicine with you;
this way the doctor will know what you have taken.

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

If you stop taking Ramloid
Your doctor will tell you how long you should take this medicine. If you stop treatment
with this medicine prematurely, your problem 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 will experience them.

Stop taking Ramloid and consult your doctor immediately if you notice any of the following serious side effects (in which case you may need urgent medical treatment):

• Swelling of the face, lips or throat that makes it difficult to swallow or breathe, accompanied by itching and rash. These may be signs of a severe allergic reaction to Ramloid.
• Severe skin reactions including rash, ulcers in the mouth, 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).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems such as heart attack and stroke
• Shortness of breath or cough. These may be signs of lung problems, such as inflammation.
• Increased tendency to bruise, bleeding that lasts longer than usual, any sign of bleeding (e.g., bleeding gums), appearance of purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, feeling faint, dizziness or paleness. These can be signs of problems with the blood or bone marrow.
• Severe stomach pain that may radiate to the back. This could be a sign of inflammation of the pancreas (pancreatitis).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These can be signs of liver problems such as inflammation (hepatitis) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions worsen or persist for more than a few
days.

Very common: may affect more than 1 in 10 people

• Swelling (edema)
• Hypokalemia
• Hyperlipidemia

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness associated with sleepiness (drowsiness especially at the beginning of treatment), feeling tired (fatigue)
• Awareness of heartbeat (palpitations)
• Swelling of the ankles
• Low blood pressure (hypotension), especially when getting up or sitting quickly (orthostatic hypotension), fainting (syncope), hot flushes
• Dry, irritating cough, sinus inflammation (sinusitis), bronchitis, shortness of breath (dyspnea)
• Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders and discomfort (including dyspepsia), nausea, vomiting, changes in bowel habits (including diarrhea and constipation), loss of appetite (anorexia), spasms
• Rash with or without blisters, hives
• Chest pain
• Muscle cramps or pain (myalgia)
• Blood tests showing lower than normal levels of magnesium and sodium
• Feeling weak and powerless (asthenia)
• Blood tests showing a decreased number of platelets (thrombocytopenia)
• Blood tests showing a higher amount of uric acid or potassium than normal
• Inability to have an erection (impotence)
• Vision disturbances (including blurred vision and double vision)

Uncommon: may affect up to 1 in 100 people

• Swelling of the skin, mucous membranes and surrounding tissues (angioedema/Quincke's edema; in extremely rare cases, airway obstruction resulting from angioedema can be fatal)
• Swelling of the arms and legs (peripheral edema; this may be a sign of fluid retention)
• Swelling of the intestine (angioedema of the small intestine)
• Mood swings, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
• Ringing in the ears (tinnitus)
• Sneezing/Runny nose (rhinitis), stuffy nose
• Difficulty breathing (bronchospasm), including worsening of asthma
• Dry mouth, pain in the upper abdomen, including gastritis
• Inflammation of the pancreas (pancreatitis; fatal cases have been reported in very rare cases with ACE inhibitors)
• Kidney impairment including kidney failure, urination disorders, needing to urinate more often during the day, increased need to urinate at night (nocturia)
• Worsening of pre-existing proteinuria (amount of protein in the urine higher than normal)
• Feeling unwell
• Weight gain or loss
• Vertigo, tremor
• Hair loss (alopecia)
• Itching, presence of small bleeding spots or areas of bleeding on the skin (purpura), changes in skin color, rash
• Strange sensations felt on the skin such as numbness, tingling, prickling, burning or formication (paresthesia), reduced skin sensitivity (hypoesthesia)
• Loss (ageusia) or alteration (dysgeusia) of taste
• Excessive sweating (hyperhidrosis)
• Heart attack (myocardial infarction), heart disease (myocardial ischemia), chest tightness and pain (angina pectoris), increased (tachycardia) or irregular (arrhythmia) heartbeat
• Slowing of the heartbeat (bradycardia), specific heart rhythm disorders (atrial fibrillation, ventricular tachycardia)
• Joint pain (arthralgia), back pain, widespread pain
• Increased body temperature/fever (pyrexia)
• Decreased sexual desire in men or women, breast enlargement in men (gynecomastia)
• Increased number of certain white blood cells (eosinophilia) found during a blood test
• Blood tests showing changes in liver function (increased liver enzymes and/or conjugated bilirubin), pancreas (increased pancreatic enzymes) or kidneys (increased creatinine)
• Cough
• Necrotizing angiitis (vasculitis, cutaneous vasculitis)

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

• Feeling or state of confusion, balance disorders
• Redness and swelling of the tongue (glossitis)
• Inflammation and peeling of the skin (exfoliative dermatitis)
• Problems with the nails, e.g. loss or separation of a nail from its bed (onycholysis)
• Redness, itching, swelling or tearing of the eyes (conjunctivitis)
• Hearing impairment
• Yellowing of the skin (cholestatic jaundice), hepatocellular damage
• Narrowing of blood vessels (vascular stenosis)
• Circulatory disorders (hypoperfusion)
• Inflammation of blood vessels (vasculitis)
• Blood tests showing a decrease in the number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leucopenia) or the amount of hemoglobin
• Blood tests showing a higher amount of sugar than normal. If you have diabetes, this situation may worsen your illness
• Sensitivity to sunlight or other sources of light (photosensitivity)
• Hypercalcemia
• Hypersensitivity reaction

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

• Widespread rash, with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• Inflammation of the liver (hepatitis, in most cases with cholestasis)
• Rash that may form blisters and appears as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• Type of lupus erythematosus reaction, reactivation of lupus erythematosus, necrotizing vasculitis and toxic epidermal necrolysis
• Enlargement of the gum tissue (gingival hyperplasia)
• Increased muscle tone (hypertonia)
• Peripheral nervous system disease (peripheral neuropathy)
• Bone marrow failure
• Blood tests showing an excessive amount of damaged red blood cells (hemolytic anemia)
• Allergic reactions
• Hypochloremic alkalosis
• Respiratory distress (including pneumonia and pulmonary edema)

Not known: (frequency cannot be estimated on the basis of available data)
Inform your doctor if any of the following conditions worsen or persist for more than a few
days.

• Blood tests showing an excessively reduced amount of red blood cells, white blood cells and platelets (pancytopenia)
• Anaphylactic or anaphylactoid reactions
• Blistering on the skin (pemphigus)
• Increased antinuclear antibodies
• Attention disorders
• Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
• Aplastic anemia
• Alteration of the color of the fingers of the hands and feet when it is cold and then tingling or a burning sensation when it warms up (Raynaud's phenomenon).
• Cerebral ischemia, including ischemic stroke and transient ischemic attack
• Impairment of psychomotor skills
• Burning sensation
• Alteration of smell (parosmia)
• Acute liver failure, cytolytic and cholestatic hepatitis (with fatal outcomes in very rare cases)
• Inflammation of the skin (psoriasiform dermatitis), severe rashes (pemphigoid or lichenoid rash), worsening of scaling or cracking of the skin (worsening of psoriasis), redness of the mucous membranes (enanthem)
• Concentrated urine (dark in color), feeling unwell, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Tremor, rigid posture, expressionless face, slow movements and shuffling gait with balance problems
• Acute angle-closure glaucoma
• Skin and lip tumors (non-melanoma skin cancers)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
or or . You can also report side effects
directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store Ramloid

Store at a temperature below 30 °C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack 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 Ramloid contains
Ramloid hard capsules 5 mg/5 mg/12.5 mg:
one capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate), 12.5 mg of
hydrochlorothiazide.
Ramloid hard capsules 5 mg/5 mg/25 mg:
one capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate), 25 mg of
hydrochlorothiazide.
Ramloid hard capsules 10 mg/5 mg/25 mg:
one capsule contains 10 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate), 25 mg of
hydrochlorothiazide.
Ramloid hard capsules 10 mg/10 mg/25 mg:
one capsule contains 10 mg of ramipril, 10 mg of amlodipine (as amlodipine besilate), 25 mg of
hydrochlorothiazide.
The other ingredients are:

Capsule content: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized
starch, sodium starch glycolate (type A), sodium stearyl fumarate

Capsule shell (5 mg/5 mg/12.5 mg):red iron oxide (E172), black iron oxide
(E172), titanium dioxide (E171), gelatin

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
Ramloid hard capsules 5 mg/5 mg/12.5 mg:
capsule with opaque pink cap and opaque light grey body
Ramloid hard capsules 5 mg/5 mg/25 mg:
capsule with opaque pink cap and opaque ivory body
Ramloid hard capsules 10 mg/5 mg/25 mg:
capsule with opaque dark pink cap and opaque yellow body
Ramloid hard capsules 10 mg/10 mg/25 mg:
capsule with opaque brown cap and opaque caramel body
Packs of 10, 28, 30, 60, or 100 hard capsules in blisters inside a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed S.r.l.,
Via G. Mazzini 20
20123 Milan
Italy

Manufacturers:

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