Coaredam

Package leaflet: Information for the user

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
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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to 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 taking 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 COAREDAM is and what it is used for

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

• elevated cholesterol levels (a condition called primary hypercholesterolaemia) or elevated cholesterol and triglyceride levels simultaneously (a condition called dyslipidaemia)
• inherited high cholesterol levels (a condition called homozygous familial hypercholesterolaemia)
• need for prevention of cardiovascular events in adult patients estimated to be at high risk of a first cardiovascular event, in addition to correction of other risk factors.

COAREDAM is indicated for patients who are already taking rosuvastatin and amlodipine at these dosages.
Instead of taking rosuvastatin and amlodipine as separate tablets, you will receive one COAREDAM capsule containing both substances at the same dosages.
While being treated with COAREDAM, you must continue to follow a standard cholesterol-lowering diet and maintain physical exercise.

2. What you should 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 to reduce blood lipids, 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 while taking COAREDAM by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle cramps or pain (myalgia);
• if you are taking a combination of medicines sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection known as hepatitis C);
• 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 narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
• if you have heart failure following a heart attack;
• if you have ever developed a severe skin rash or skin peeling, 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 experienced repeated or unexplained muscle cramps or pain, have a personal or family history of muscle disorders, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness;
• if you regularly consume large amounts of alcohol;
• if your thyroid gland is not functioning properly;
• if you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
• if you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir; see section “Other medicines and COAREDAM”;
• if you are currently taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (a medicine for bacterial infections). The combination of fusidic acid and COAREDAM may lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and COAREDAM”;
• if you are over 70 years of age (your doctor needs to choose the appropriate starting dose for you);
• if you have severe respiratory insufficiency;
• if you have recently had a heart attack;
• if you have heart failure;
• if you have a severe increase in blood pressure (hypertensive crisis);
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the appropriate starting 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 causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

In a small number of people, statins may have a negative effect on the liver, which can be detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will request this test (liver function test) before and during treatment with COAREDAM.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may alter the effect of COAREDAM, or their effect may be altered by COAREDAM. This type of interaction may make one or both medicines less effective. Conversely, it could also increase the risk or severity of adverse effects, including a serious but rare condition of muscle breakdown known as rhabdomyolysis, described in section 4 “Possible side effects”.
Inform 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);
• certain calcium antagonists used for angina or high blood pressure, e.g. diltiazem; medicines to regulate 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 abnormalities in body temperature);
• over-the-counter medicines: St. John’s wort (Hypericum perforatum);
• regorafenib (used for the treatment of tumors);
• one of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see section “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, simeprevir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• capmatinib (used for the treatment of tumors);
• febuxostat (used for the treatment and prevention of high levels of uric acid in the blood);
• fostamatinib (used for the treatment of low platelet count);
• teriflunomide (used for the treatment of multiple sclerosis).

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart COAREDAM. Taking COAREDAM with fusidic acid may rarely cause muscle weakness, soreness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4 “Possible side effects”.
If you are already taking other medicines for high blood pressure, COAREDAM may further lower your blood pressure.

COAREDAM with food and drink
You may take COAREDAM with or without food.
If you are taking COAREDAM, you must not consume grapefruit or drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, which could lead to 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 must stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with COAREDAM by using appropriate contraceptive measures.
It has been shown that amlodipine passes into breast milk in small amounts.

Driving and using machines
COAREDAM may affect your ability to drive or use machines. Some people may experience dizziness during treatment with COAREDAM. If the capsules make you feel unwell, dizzy, or tired, or cause you to have headaches, do not drive or use machines and contact your doctor immediately.

3. How to take COAREDAM

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended daily dose is one capsule.
This medicine can be taken before or after food and drinks. Take the medicine at the same time each day, with a glass of water. Do not take the capsule with grapefruit juice.
The duration of treatment with COAREDAM will be determined by your doctor.
Consult your doctor if you think that the effect of COAREDAM is too strong or too weak.
Periodic cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and remains at the appropriate levels. Your doctor may decide to increase the dose 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
No dose adjustment is necessary for elderly patients.
Patients with renal impairment
No dose adjustment is required in these patients.
Patients with hepatic impairment
In these patients, COAREDAM should be administered with caution, and regular medical follow-up should 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 medical assistance. Bring any remaining capsules, the pack, and the label with you so the hospital can easily identify the medicine you have taken.
Taking too many capsules may cause an excessive or even dangerous drop in blood pressure.
You may experience dizziness, vertigo, fainting, or weakness. If the drop in blood pressure is severe enough, shock may occur. Your skin may become cold and clammy, and you may lose consciousness.
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 COAREDAM
Do not worry; take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking COAREDAM
Do not stop taking COAREDAM unless your doctor tells you to. If you stop taking COAREDAM, your cholesterol levels may rise again.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important to be aware of which of these side effects may occur. Usually they are mild and disappear quickly.
Stop taking COAREDAM and seek immediate medical help if you experience any of the following rare, serious allergic reactions:

• Sudden onset of shortness of breath, chest pain, breathlessness or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which may cause difficulty breathing and/or swallowing
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, intense itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a general feeling of severe illness
• Reddish, non-elevated, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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 hypersensitivity syndrome)

Also, stop taking COAREDAM and contact your doctor immediately if you have unusual
muscle pains or cramps lasting longer than expected. As with other statins, a very small number of people have experienced muscle-related side effects, and rarely these have progressed to a condition causing muscle damage, potentially fatal, 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 – values usually return to normal on their own without needing to stop taking COAREDAM;
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, 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 needing to stop treatment with COAREDAM (only for COAREDAM 20 mg/5 mg).

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

• severe allergic reactions – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised welts).

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 contact your doctor immediately if you have unusual muscle cramps or pain lasting longer than expected (rhabdomyolysis, muscle tear)
• lupus-like syndrome (including skin rashes, joint disorders and effects on blood cells)
• inflamed pancreas (pancreatitis);
• increase in liver enzymes in the blood.
• reduction in platelets in the blood, which may increase the risk of bleeding or bruising (thrombocytopenia)

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

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

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

• diarrhoea (passing liquid stools);
• cough;
• shortness of breath;
• oedema (swelling);
• sleep disorders, including insomnia and nightmares;
• sexual problems;
• depression;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• tendon injury;
• persistent muscle weakness.
• dysfunction of one or more peripheral nerves (peripheral neuropathy)
• muscle problems (immune-mediated necrotizing myopathy)
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles). Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or laboured breathing.

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

• oedema

Common (may affect up to 1 in 10 people)

• headache, dizziness, drowsiness (especially at the beginning of treatment)
• palpitations (awareness of your heartbeat), flushing
• hot flushes
• abdominal pain, nausea
• altered bowel habits, diarrhoea, constipation, indigestion
• swollen ankles
• muscle cramps
• fatigue, weakness
• difficulty breathing (dyspnoea)
• visual disturbances including double vision

Uncommon (may affect up to 1 in 100 people)

• mood changes, anxiety, depression, insomnia
• tremor, altered taste, fainting
• tingling and numbness in limbs, loss of sensitivity to pain
• ringing in the ears
• changes in 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, skin itching, red skin patches, skin discoloration, skin rash (rash, exanthema and urticaria)
• urinary disorders, need to urinate at night, need to urinate frequently
• inability to achieve an erection, discomfort or breast enlargement in men
• chest pain, pain, discomfort
• joint or muscle pain, back pain
• weight gain or weight loss

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

• confusion

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

• low levels of white blood cells and platelets in the blood
• allergic reactions
• high blood sugar levels (hyperglycaemia)
• myocardial infarction
• a nerve disorder which may cause weakness, tingling or numbness (peripheral neuropathy)
• pancreatitis
• swollen gums
• abdominal swelling (gastritis)
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
• increase in liver enzymes which may lead to changes in certain clinical tests
• increased muscle tension (hypertonia)
• inflammation of blood vessels, often with rash
• light sensitivity
• disorders related to stiffness, tremor and/or movement disorders
• angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke’s oedema

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects 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 pack and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What COAREDAM contains
The active substances are rosuvastatin (as calcium salt) and amlodipine (as besylate).
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 besylate 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 besylate 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 besylate 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 besylate equivalent to 10 mg of amlodipine.
The other components are:
Maize 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 package contents
COAREDAM 10 mg/5 mg hard capsules: hard gelatin capsules, size 1, with an opaque white body and cap, filled with powder ranging from dark white to yellowish. The capsules are printed in red ink with “Aml 5 mg” on the body and in green ink with “Rsv 10 mg” on the cap.
COAREDAM 10 mg/10 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and cap, filled with powder ranging from dark white to yellowish. The capsules are printed in red ink with “Aml 10 mg and line” on the body and in green ink with “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 from dark white to yellowish. The capsules are printed in red ink with “Aml 5 mg” on the body and in green ink with “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 cap, filled with powder ranging from dark white to yellowish. The capsules are printed in red ink with “Aml 10 mg” on the body and in green ink with “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 Authorization Holder
Scharper S.p.A.
Viale Ortles, 12 – 20139 Milano, Italy

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