COAREDAM 10 mg/5 mg Hard Capsules

Зміст інструкції

1. COAREDAM 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/5 mg hard capsules, 20 mg/10 mg hard capsules
   1. What is COAREDAM and what is it used for
   2. What you need to know before taking COAREDAM
   3. How to take COAREDAM
   4. Possible side effects
   5. How to store COAREDAM
   6. Contents of the pack and other information

COAREDAM 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules, 20 mg/5 mg hard capsules, 20 mg/10 mg hard capsules

Rosuvastatin /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. See section 4.

Contents of this leaflet

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

1. What is COAREDAM and what is it used for

COAREDAM contains two active ingredients: rosuvastatin, belonging to a group of medicines
called “statins”, which work by reducing the production of cholesterol by the body itself, and
amlodipine, belonging to a new group of medicines called calcium antagonists, which work
by relaxing blood vessels.
COAREDAM is indicated in replacement therapy for those patients who are adequately controlled
with rosuvastatin and amlodipine administered simultaneously, at the same dosage for the treatment
of hypertension, stable chronic angina pectoris (coronary artery disease that manifests with chest pain) and Prinzmetal's angina (a rare form of angina) in adult patients suffering from one of the following
conditions:

• high levels of cholesterol (a condition called primary hypercholesterolemia) or high levels of cholesterol and triglycerides at the same time (a condition called dyslipidemia)
• high levels of cholesterol of hereditary origin (a condition called homozygous familial hypercholesterolemia)
• the need for prevention of cardiovascular events in adult patients who are estimated to be at high risk for a first cardiovascular event, in addition to the correction of other risk factors.

COAREDAM is indicated in patients who are already taking rosuvastatin and amlodipine at these dosages.
Instead of taking rosuvastatin and amlodipine in separate tablets, you will receive a COAREDAM capsule
containing both substances at the same dosages.
During treatment with COAREDAM, you should continue to follow a standard diet for lowering
cholesterol and continue with physical exercise.

2. What you need to know before taking COAREDAM

Do not take COAREDAM

• if you are allergic to rosuvastatin or amlodipine, or to a group of substances called “calcium channel blockers”, or to medicines similar to rosuvastatin used for reducing fats in the blood, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding. If you become pregnant while taking COAREDAM, stop taking it immediately and inform your doctor. Women must avoid pregnancy during the intake of COAREDAM, using appropriate contraceptive measures;
• if you have a liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle aches or pains (myalgia);
• if you are taking a medicine called cyclosporine (used for example after organ transplantation);
• if you have severe low blood pressure (hypotension);
• if you have a narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide sufficient blood to the body);
• if you suffer from heart failure following a heart attack;
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking COAREDAM or other related medicines .

Warnings and precautions
Talk to your doctor or pharmacist before taking COAREDAM:

• if you have kidney problems;
• if you have liver problems;
• if you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Immediately inform your doctor if you have unexplained muscle aches or pains, especially if accompanied by feeling unwell or fever. Also, inform your doctor or pharmacist if you have a constant muscle weakness;
• if you regularly consume large amounts of alcohol;
• if your thyroid gland is not functioning properly;
• if you are taking other medicines to lower cholesterol called fibrates. Read this carefully
• if you are taking medicines used to treat HIV infections, for example ritonavir with lopinavir and/or atazanavir, see section “Other medicines and COAREDAM”;
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and COAREDAM can lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and COAREDAM”;
• if you are over 70 years old (your doctor needs to choose the appropriate initial dose for you);
• if you have severe respiratory failure;
• if you have had a recent heart attack;
• if you suffer from heart failure;
• if you have a severe increase in blood pressure (hypertensive crisis);
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor needs to choose the appropriate initial dose for you

if you have or have had myasthenia (a disease characterized by generalized muscle weakness
including, in some cases, the muscles used for breathing) or ocular myasthenia (a
disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4).
In a small number of people, statins can have a negative effect on the liver, which can
be identified with a simple test that detects increased levels of liver enzymes in the blood. For
this reason, your doctor will ask you to have this test (liver function test) before and
during treatment with COAREDAM.
During treatment with this medicine, your doctor will carefully check that you do not have diabetes
or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of
sugars and fats in the blood, if you are overweight and have high blood pressure.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with COAREDAM.
Stop using COAREDAM and seek immediate medical attention if you notice any of the symptoms
described in section 4.

Children and adolescents
The use of COAREDAM is not recommended in children and adolescents.

Other medicines and COAREDAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines can change the effect of COAREDAM, or their effect can be changed by
COAREDAM. This type of interaction can make one or both medicines less effective. Al
contrarily, this could also increase the risk or severity of side effects, including a serious but
rare condition of muscle deterioration known as rhabdomyolysis described in section 4 “Possible
side effects”.
Tell your doctor if you are taking any of the following medicines:

• warfarin, ticagrelor or clopidogrel (or any other medicine used to prevent blood clots);
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol such as ezetimibe, simvastatin, colestipol);
• medicines used to alter the activity of the immune system such as everolimus, tacrolimus, cyclosporine (used for example after organ transplantation);
• antacids (used to neutralize stomach acids);
• temsirolimus or other medicines used for cancer (chemotherapy);
• some calcium antagonists, used for angina or high blood pressure e.g. diltiazem; medicines to regulate the heart rhythm e.g. digoxin, verapamil;
• medicines used in the treatment of hepatitis C e.g. telaprevir
• an oral contraceptive (the pill);
• hormone replacement therapy;
• antiviral medicines used in the treatment of HIV or hepatitis C alone or in combination (so-called protease inhibitors) such as ritonavir with lopinavir and/or atazanavir, indinavir, darunavir, nelfinavir, the combination of tipranavir/ritonavir, ombitasvir /paritaprevir, grazoprevir/pibrentasvir, glecaprevir/pibrentasvir etc;
• rifampicin, erythromycin, clarithromycin (antibiotics);
• fluconazole, ketoconazole, itraconazole (antifungals);
• dantrolene (infusion for severe body temperature abnormalities);
• medicines obtained without a prescription: St. John's Wort (Hypericum perforatum);
• regorafenib (used to treat tumors). If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when to safely restart COAREDAM. Taking COAREDAM with fusidic acid can rarely cause weakness, soreness or muscle pain (rhabdomyolysis). For more information regarding rhabdomyolysis see section 4 “Possible side effects”.

If you are already taking other medicines for the treatment of high blood pressure, COAREDAM
can further reduce your blood pressure.

COAREDAM with food and drink
You can take COAREDAM with or without food.
If you are taking COAREDAM, you should not consume grapefruit or drink grapefruit juice as grapefruit
and its juice can induce an increase in the levels of the active substance amlodipine in the blood and this
can determine an unpredictable increase in the blood pressure lowering effect of
COAREDAM.

Pregnancy and breastfeeding
Do not take COAREDAM if you are pregnant or breastfeeding. If you become pregnant while
taking COAREDAM, you should stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with COAREDAM using appropriate
contraceptive measures.
Amlodipine has been shown to pass into breast milk in small amounts.

Driving and operating machinery
COAREDAM can alter your ability to drive vehicles or operate machinery. Some people may
experience dizziness while taking COAREDAM. If the capsules cause you to feel unwell, dizzy or
tired, or give you a headache, do not drive or operate machinery and immediately contact your
doctor.

3. How to take COAREDAM

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
The recommended daily dose is one capsule.
The medicine can be taken before or after food and beverages. You must take the medicine at the same time of
each day with a sip of water. Do not take the capsule with grapefruit juice.
The duration of treatment with COAREDAM will be established by your doctor.
Consult your doctor if you think the effect of COAREDAM is too strong or too weak.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to ensure that your
cholesterol has reached and maintains the correct levels. Your doctor may decide to increase the
dose up to the amount of COAREDAM most suitable for you.

Use in children and adolescents
The use of COAREDAM is not recommended in patients under 18 years of age.

Use in elderly patients
For elderly patients, it is not necessary to modify the dose.

Patients with kidney impairment
In these patients, it is not necessary to modify the dose.

Patients with hepatic impairment
In these patients, COAREDAM must be administered with caution and regular medical follow-up must
include frequent monitoring of liver function.

If you take more COAREDAM than you should
If you have taken too many COAREDAM capsules, contact your doctor immediately or go to the nearest
hospital for assistance. Bring with you the remaining capsules, the box and the label so that the hospital
can easily understand which medicine you have taken.
Taking too many capsules can cause an excessive or even dangerous drop in blood
pressure. You may feel dizzy, lightheaded, faint or weak. If the drop in blood pressure is
severe enough, shock may occur. Your skin may be cold and clammy and you may lose
consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that
can develop up to 24-48 hours after taking it.

If you forget to take COAREDAM
Do not worry, 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 COAREDAM
Do not stop taking COAREDAM unless your doctor tells you to do so. If you stop
taking COAREDAM, your cholesterol levels may increase again.
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.
It is important to be aware of which of these side effects may occur. They are usually mild and disappear in a short time.

Stop taking COAREDAM and seek immediate medical helpif you experience
any of the following rare, serious allergic reactions:

• Sudden onset of shortness of breath, chest pain, wheezing or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which can cause difficulty breathing and/or swallowing
• Severe skin reactions including intense rash, hives, widespread skin redness, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe illness
• Reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug reaction with eosinophilia and systemic symptoms)

Also, stop taking COAREDAM and see your doctor immediately if you have unusual
muscle aches or pains,that last longer than you would expect. As with other statins, a
very small number of people have experienced muscle side effects and rarely these have progressed to a condition leading to muscle damage, potentially life-threatening, known as rhabdomyolysis.
Other possible side effects with COAREDAM:

Side effects related to the use of rosuvastatin
Common (may affect up to 1 in 10 people)

• headache;
• abdominal pain;
• constipation;
• muscle pain;
• feeling of weakness;
• dizziness;
• an increase in the amount of protein in the urine - usually the values return to normal on their own without having to stop taking COAREDAM;
• diabetes. It is more likely if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• nausea

Uncommon (may affect up to 1 in 100 people)

• rash; itching, hives or
• an increase in the amount of protein in the urine - these usually return to normal on their own without the need to stop treatment with COAREDAM (only for COAREDAM 20 mg/5 mg).

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

• serious allergic reactions - the signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe skin itching (with raised hives). If you suspect you are having an allergic reaction, stop taking COAREDAM and seek immediate medical help;
• muscle damage - as a precaution, stop taking COAREDAM and see your doctor immediately if you have unusual muscle aches or pains that persist longer than you would expect (myopathy rhabdomyolysis, muscle tear)
• lupus-like syndrome, (including skin rashes, joint disorders and effects on blood cells)
• inflamed pancreas (pancreatitis);
• increased liver enzymes in the blood.
• reduction of platelets in the blood, which can increase the risk of bleeding or bruising (thrombocytopenia)

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

• jaundice (yellowing of the skin and eyes);
• hepatitis (an inflammation of the liver);
• traces of blood in the urine;
• damage to the nerves of arms and legs (polyneuropathy);
• joint pain;
• memory loss;
• breast enlargement in men (gynecomastia).

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

• diarrhea (loose stools);
• Cough;
• Shortness of breath;
• Edema (swelling);
• Sleep disorders, including insomnia and nightmares;
• Sexual problems;
• Depression;
• Breathing problems, including persistent cough and/or shortness of breath or fever;
• Tendon injury;
• Constant muscle weakness.
• Dysfunction of one or more peripheral nerves (peripheral neuropathy)
• Muscle problems (immune-mediated necrotizing myopathy)
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing)
• Ocular myasthenia (a disease that causes weakness of the eye muscles) See your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Side effects related to the use of amlodipine
Very common (may affect more than 1 in 10 people)

• Edema

Common (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness, (especially at the beginning of treatment)
• Palpitations (feeling your heartbeat), flushing
• Hot flashes
• Abdominal pain, nausea
• Altered bowel habits, diarrhea, constipation, indigestion
• Swelling of the ankles
• Muscle cramps
• Fatigue, weakness
• Difficulty breathing (dyspnea)
• Visual disturbances including double vision

Uncommon (may affect up to 1 in 100 people)

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting
• Feeling of numbness and tingling in the limbs, loss of pain sensation
• Ringing in the ears
• Abnormal heart rhythm (bradycardia, ventricular tachycardia and atrial fibrillation)
• Low blood pressure
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration, rash (rash, exanthema and urticaria)
• Urinary disorders, need to urinate at night, frequent urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Chest pain, pain, discomfort
• Joint or muscle pain, back pain
• Weight gain or loss

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

• Confusion

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

• Low levels of white blood cells and platelets in the blood
• Allergic reactions
• High blood sugar levels (hyperglycemia)
• Heart attack
• A nervous disorder that can cause weakness, tingling or numbness (peripheral neuropathy)
• Pancreatitis
• Swelling of the gums
• Swollen abdomen (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice),
• Increased liver enzymes which can lead to changes in some clinical tests
• Increased muscle tension (Hypertonia)
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders
• Angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke's edema

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 COAREDAM

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C in the original packaging to protect the medicine from
light.
Do not use this medicine after the expiry date stated on the packaging and on the 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 COAREDAM contains
The active ingredients are rosuvastatin (as calcium salt) and amlodipine (as besilate).

COAREDAM 10 mg/5 mg hard capsules
Each capsule contains 10.40 mg of rosuvastatin calcium salt equivalent to 10 mg of rosuvastatin and 6.94
mg of amlodipine besilate equivalent to 5 mg of amlodipine.

COAREDAM 10 mg/10 mg hard capsules
Each capsule contains 10.40 mg of rosuvastatin calcium salt equivalent to 10 mg of rosuvastatin and 13.88
mg of amlodipine besilate equivalent to 10 mg of amlodipine.

COAREDAM 20 mg/5 mg hard capsules
Each capsule contains 20.80 mg of rosuvastatin calcium salt equivalent to 20 mg of rosuvastatin and 6.94
mg of amlodipine besilate equivalent to 5 mg of amlodipine.

COAREDAM 20 mg/10 mg hard capsules
Each capsule contains 20.80 mg of rosuvastatin calcium salt equivalent to 20 mg of rosuvastatin and 13.88
mg of amlodipine besilate equivalent to 10 mg of amlodipine.
The other ingredients are:
Corn starch, pregelatinized starch, microcrystalline cellulose type 102, crospovidone type A, sodium
stearyl fumarate, titanium dioxide (E 171), gelatin.

Description of the appearance of COAREDAM and contents of the pack
COAREDAM 10 mg/5 mg hard capsules: hard gelatin capsules, size 1, with an opaque white body and cap
filled with powder ranging in colour from off-white to pale yellow. The capsules are imprinted with
red ink “Aml 5 mg” on the body and with green ink “Rsv 10 mg” on the cap.
COAREDAM 10 mg/10 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and a
cap, filled with powder ranging in colour from off-white to pale yellow. The capsules are
imprinted with red ink “Aml 10 mg and line” on the body and with green ink “Rsv 10 mg” on the
cap.
COAREDAM 20 mg/5 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and cap
filled with powder ranging in colour from off-white to pale yellow. The capsules are imprinted with
red ink “Aml 5 mg” on the body and with green ink “Rsv 20 mg and line” on the cap.
COAREDAM 20 mg/10 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and a
cap, filled with powder ranging in colour from off-white to pale yellow. The capsules are
imprinted with red ink “Aml 10 mg” on the body and with green ink “Rsv 20 mg and line” on the
cap.
The capsules are available in PA/AL/PVC-AL blisters in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Scharper S.p.A.
Viale Ortles, 12 – 20139 Milan

Manufacturers
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR) Italy
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice, Poland