Suvamod

Package leaflet: Information for the user

SUVAMOD 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What SUVAMOD is and what it is used for

SUVAMOD 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 channel blockers, which work by relaxing blood vessels.
SUVAMOD is indicated as a replacement therapy for patients who are already adequately controlled with rosuvastatin and amlodipine administered simultaneously at the same dosage for the treatment of hypertension, chronic stable angina (coronary artery 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 hypercholesterolemia) or elevated cholesterol and triglyceride levels simultaneously (a condition called dyslipidemia)
• inherited high cholesterol levels (a condition called homozygous familial hypercholesterolemia)
• 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.

SUVAMOD 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 SUVAMOD capsule containing both substances at the same dosages.
1/10
During treatment with SUVAMOD, you must continue to follow a standard cholesterol-lowering diet and maintain physical exercise.

2. What you should know before taking SUVAMOD

Do not take SUVAMOD

• 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 fats, 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 SUVAMOD, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with SUVAMOD by using appropriate contraceptive measures;
• if you have liver disease;
• if you have severe kidney problems;
• if you have repeated or unexplained muscle pains or aches (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 narrowing of the heart's aortic valve (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, skin peeling, blisters, and/or mouth ulcers after taking SUVAMOD or other medicines.

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

• if you have kidney problems;
• if you have liver problems;
• if you have experienced repeated or unexplained muscle pains or aches, 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 discomfort, 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 SUVAMOD”;
• if you are currently taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and SUVAMOD may lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and SUVAMOD”;
• 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);

2/10

• 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, sometimes including 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
SUVAMOD.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or
are at risk of developing diabetes. Risk factors for developing diabetes include high levels of
sugar and fats in the blood, being overweight, and having 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 SUVAMOD. Discontinue use of
SUVAMOD and seek immediate medical attention if you notice any of the symptoms described in section 4.
Children and adolescents
The use of SUVAMOD is not recommended in children and adolescents.
Other medicines and SUVAMOD
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Some medicines may alter the effect of SUVAMOD, or their effect may be altered by
SUVAMOD. Such interactions may make one or both medicines less effective. Conversely,
this could also increase the risk or severity of adverse effects, including a serious but rare
condition of muscle deterioration 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 modify immune system activity 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 channel blockers used for angina or high blood pressure, e.g., diltiazem; medicines to regulate heart rhythm such as digoxin, verapamil;
• medicines used to treat hepatitis C, e.g., telaprevir;
• an oral contraceptive (the pill);
• hormone replacement therapy;
• antiviral medicines used to treat HIV or hepatitis C, alone or in combination (so-called protease inhibitors), such as ritonavir with lopinavir and/or atazanavir, indinavir, darunavir, nelfinavir, tipranavir/ritonavir combination, ombitasvir/paritaprevir, grazoprevir/pibrentasvir, glecaprevir/pibrentasvir, etc.;

3/10

• rifampicin, erythromycin, clarithromycin (antibiotics);
• fluconazole, ketoconazole, itraconazole (antifungals);
• dantrolene (infusion for severe body temperature abnormalities);
• over-the-counter medicines: 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 taking this medicine. Your doctor will advise you when it is safe to restart SUVAMOD.
Taking SUVAMOD with fusidic acid may rarely cause muscle weakness, soreness, or pain (rhabdomyolysis). For more information about rhabdomyolysis,
see section 4 “Possible side effects”.
If you are already taking other medicines for high blood pressure, SUVAMOD may
further reduce your blood pressure.
SUVAMOD with food and drink
You may take SUVAMOD with or without food.
When taking SUVAMOD, you must not consume grapefruit or drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, potentially causing an unpredictable increase in SUVAMOD’s blood pressure-lowering effect.
Pregnancy and breastfeeding
Do not take SUVAMOD if you are pregnant or breastfeeding. If you become pregnant while taking
SUVAMOD, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with SUVAMOD by using appropriate contraceptive measures.
It has been shown that amlodipine passes into breast milk in small amounts.
Driving and using machines
SUVAMOD may affect your ability to drive or operate machinery. Some people may
experience dizziness during treatment with SUVAMOD. If the capsules make you feel unwell, dizzy, or tired, or cause you headaches, do not drive or operate machinery and contact your doctor immediately.

3. How to take SUVAMOD

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended daily dose is one capsule.
This medicine can be taken before or after food and drinks. You must 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 SUVAMOD will be determined by your doctor.
Consult your doctor if you think that the effect of SUVAMOD is too strong or too weak.
Periodic cholesterol checks
It is important to return to your doctor for regular cholesterol checks, to ensure that cholesterol levels have reached and remain at the appropriate levels. Your doctor may decide to increase the dose to the amount of SUVAMOD most suitable for you.
4/10
Use in children and adolescents
The use of SUVAMOD 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, SUVAMOD should be administered with caution, and regular medical follow-up should include frequent monitoring of liver function.
If you take more SUVAMOD than you should
If you have taken too many SUVAMOD capsules, contact your doctor immediately or go to the nearest hospital for assistance. Bring the remaining capsules, the packaging, and the label with you so that 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 up to 24–48 hours after ingestion.
If you forget to take SUVAMOD
Do not worry; 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 SUVAMOD
Do not stop taking SUVAMOD unless your doctor tells you to. If you stop taking SUVAMOD, your cholesterol levels may rise again.
If you have any doubts about how to use 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.
It is important to be aware of which of these side effects may occur. Usually they are mild and disappear quickly.
Stop taking SUVAMOD 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, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome and toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a general feeling of severe illness
• Flat, non-elevated red spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe 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).

In addition, stop taking SUVAMOD and contact your doctor immediately if you experience unusual
muscle pains or aches 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 life-threatening, known as rhabdomyolysis.

Other possible side effects with SUVAMOD:
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
• increased amount of protein in the urine – values usually return to normal on their own without needing to stop taking SUVAMOD
• 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
• increased amount of protein in the urine – these usually return to normal on their own without needing to stop treatment with SUVAMOD (only for SUVAMOD 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 skin itching (with raised wheals). If you suspect an allergic reaction, stop taking SUVAMOD and seek immediate medical help
• muscle damage – as a precaution, stop taking SUVAMOD and contact your doctor immediately if you have unusual muscle pains or aches that last longer than expected (myopathy, rhabdomyolysis, muscle tear)
• lupus-like syndrome (including skin rashes, joint disorders and effects on blood cells)
• inflamed pancreas (pancreatitis) 6/10
• increased 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)
• traces of blood in the urine
• nerve damage in arms and legs (polyneuropathy)
• joint pain
• memory loss
• breast enlargement in men (gynecomastia).

Not known (cannot be estimated from the available data)

• diarrhoea (passing of 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
• constant 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
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Swelling of the ankles
• Muscle cramps
• Tiredness, weakness
• Difficulty breathing (dyspnoea) 7/10
• Visual disturbances including double vision.

Uncommon (may affect up to 1 in 100 people)

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Sensation of numbness and tingling 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 patches on the skin, skin discoloration, skin rash (rash, exanthema and urticaria)
• Urinary disorders, need to urinate at night, frequent need to urinate
• 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
• Swelling of the gums
• Abdominal swelling (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain clinical tests
• Increased muscle tension (hypertonia)
• Inflammation of blood vessels, often with skin 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 .
By reporting side effects, you can help provide more information on the safety of this medicine.
8/10

5. How to store SUVAMOD

Keep this medicine out of the sight and reach of children.
Store below 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 any medicine 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 SUVAMOD contains
The active substances are rosuvastatin (as calcium salt) and amlodipine (as besylate).
SUVAMOD 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.
SUVAMOD 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.
SUVAMOD 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.
SUVAMOD 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:
corn starch, pregelatinized starch, microcrystalline cellulose type 102, crospovidone type A, sodium stearyl fumarate, titanium dioxide (E 171), gelatin.
Description of the appearance of SUVAMOD and pack sizes
SUVAMOD 10 mg/5 mg hard capsules: hard gelatin capsules, size 1, with an opaque white body and cap, filled with powder ranging from off-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.
SUVAMOD 10 mg/10 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and cap, filled with powder ranging from off-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.
SUVAMOD 20 mg/5 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and cap, filled with powder ranging from off-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.
SUVAMOD 20 mg/10 mg hard capsules: hard gelatin capsules, size 00, with an opaque white body and cap, filled with powder ranging from off-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.
9/10
Not all pack sizes may be marketed.
Marketing Authorization Holder
Errekappa Consumer S.r.l
Via Ciro Menotti 1/A
20129 Milano
Manufacturers
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR) - Italy
10/10