ROZAMLAD 10 mg/5 mg Hard Capsule

Зміст інструкції

1. Rozamlad 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 Rozamlad and what is it used for
   2. What you need to know before taking Rozamlad
   3. How to take Rozamlad
   4. Possible side effects
   5. How to store Rozamlad
   6. Package contents and other information

Rozamlad 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 their symptoms are the same as yours, as it could 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 Rozamlad is and what it is used for
• 2. What you need to know before you take Rozamlad
• 3. How to take Rozamlad
• 4. Possible side effects
• 5. How to store Rozamlad
• 6. Contents of the pack and other information

1. What is Rozamlad and what is it used for

Rozamlad contains two active substances – rosuvastatin and amlodipine.
Rozamlad is indicated in adults for the treatment of high blood pressure and concomitant high cholesterol levels when changes to diet and increased exercise have not been sufficient to correct cholesterol levels and/or to prevent cardiovascular events if there are other factors that increase the risk of heart attack, stroke or related health problems.
Rozamlad 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 Rozamlad capsule containing both substances at the same dosages.
You should continue with a diet to reduce cholesterol levels and exercise during treatment with Rozamlad.

2. What you need to know before taking Rozamlad

Do not take Rozamlad:

• If you are allergic to rosuvastatin, amlodipine, to any calcium channel blockers 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 Rozamlad, stop taking it immediately and contact your doctor. Women must avoid pregnancy during treatment with Rozamlad, 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;
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines (used for a liver viral infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• if you suffer from severe low blood pressure (severe 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 supply enough blood to the body);
• if you have heart failure following an acute heart attack:
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking Rozamlad or other related medicines.

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

• 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 if you have had a previous history of muscle problems during treatment with other medicines that lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if accompanied by feeling unwell or fever. Also, tell your doctor or pharmacist if you have constant muscle weakness;
• If you regularly consume significant amounts of alcohol;
• If your thyroid gland is not functioning properly;
• If you are taking other medicines called fibrates to lower cholesterol. Read carefully

cholesterol;

• If you are taking medicines used to fight HIV infection, for example ritonavir with lopinavir and/or atazanavir, see section “Other medicines and Rozamlad”;
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rozamlad can lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and Rozamlad”;
• If you have severe respiratory failure;
• If you have recently had a heart attack;
• If you suffer from heart failure;
• If you have a severe increase in blood pressure (hypertensive crisis);
• If you are elderly;
• If you are of Asian origin (i.e. Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor must choose the correct starting dose of Rozamlad suitable for you.

Statins can alter liver function in a small number of people. This is
detected with a simple test that allows monitoring of increased levels of liver enzymes in
the blood. For this reason, your doctor will usually request this blood test (liver function test) before and during treatment with Rozamlad.
During treatment with this medicine, your doctor will carefully monitor if you 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 if you 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 Rozamlad.
Stop using Rozamlad and seek immediate medical attention if you notice any of the symptoms
described in section 4.

Children and adolescents
Rozamlad should not be used in children and adolescents.

Other medicines and Rozamlad
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Rozamlad can have effects on other medicines or other medicines can have effect on Rozamlad,
such as:

• blood anticoagulants e.g. warfarin, acenocoumarol or fluindione (their blood-thinning effect and risk of bleeding may increase if taken together with this medicine), ticagrelor or clopidogrel; fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• remedies for indigestion (used to neutralize stomach acid);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• ritonavir with lopinavir and/or atazanavir, indinavir, nelfinavir (used to treat HIV infection, see section “Warnings and precautions”);
• ketoconazole, itraconazole (antifungal medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• Hypericum perforatum (St John's wort);
• verapamil, diltiazem (medicines for the treatment of certain heart diseases);
• dantrolene (in infusion for severe alterations of body temperature);
• Temsirolimus or other cancer medicines (chemotherapy);
• Everolimus, tacrolimus, cyclosporine or other medicines (used to control the immune response, to allow the body to accept the transplanted organ);
• simvastatin (used to reduce cholesterol levels);
• regorafenib (used to treat tumors);
• darolutamide (used to treat 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, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir. If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking Rozamlad again. Taking Rozamlad with fusidic acid can rarely cause weakness, tenderness or pain in the muscles (rhabdomyolysis). For more information on rhabdomyolysis see section 4. Rozamlad can further lower blood pressure if you are already taking other medicines to treat high blood pressure.

Rozamlad with food and drink
Rozamlad can be taken with or without food.
People taking Rozamlad should not consume grapefruit juice and
grapefruit. This is because grapefruit and grapefruit juice can lead to an increase in
the levels of the active ingredient amlodipine in the blood, which may determine an unpredictable
effect of the hypotensive (blood pressure lowering) effect of Rozamlad.

Pregnancy and breastfeeding
Do not take Rozamlad if you are pregnant or breastfeeding. If you become pregnant during treatment
with Rozamlad, stop taking it immediately and inform your doctor. Women must
avoid pregnancy during treatment with Rozamlad using suitable contraception.

Driving and using machines
Rozamlad can alter the ability to drive vehicles or use machines. Some people
may experience dizziness during treatment with Rozamlad. If the capsules cause you to feel unwell,
dizzy or tired, or give you a headache, do not drive or use machines and contact
your doctor immediately.

Sodium content
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
‘sodium-free’.

3. How to take Rozamlad

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is one capsule per day.
The medicine can be taken before or after food and drinks. You must take the medicine at the same
time each day with some water. The capsules must not be chewed. Do not take Rozamlad
with grapefruit juice.

Use in children and adolescents
Rozamlad must not be used in children and adolescents.

Regular checks of cholesterol levels
It is important to return to your doctor to regularly check your cholesterol levels and ensure
that they have been reached and maintained within normal values. The dose of Rozamlad may be
increased by your doctor until the amount you need is reached.

If you take more Rozamlad than you should
Contact your doctor or the nearest hospital. Taking too many capsules can cause a lowering
of blood pressure to the point of being dangerous. You may experience dizziness, lightheadedness, weakness
or fainting. If the drop in blood pressure is severe enough, shock may occur. The skin
may become cold and sweaty and the subject may lose consciousness. If you go to hospital or
are being treated for another condition, inform the medical staff that you are taking Rozamlad.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath
which can develop up to 24-48 hours after taking it.

If you forget to take Rozamlad
Do not worry. If you forget to take a capsule, completely skip that
dose. Take the next dose at the right time. Do not take a double dose to
make up for the missed dose.

If you stop taking Rozamlad
Your doctor will advise you how long you should take the medicine. Your cholesterol levels may increase again if you stop taking Rozamlad. Your condition may
reappear if you stop treatment with the medicine before being advised to do so.
If you have any further questions about the use of the 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 takingRozamlad and seek immediate medical attentionif you experience any of the following side effects:

• 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 great difficulty in breathing and/or swallowing;
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions;
• 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• Heart attack, abnormal heartbeat;
• Inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe discomfort;
• Lupus-like illness syndrome (including rash, joint disorders and effects on blood cells);
• Muscle breakdown.

Also, stop taking Rozamlad and see your doctor immediately if you have unusual muscle aches and tenderness,which persist longer than expected.As with other statins, a very small number of people have experienced unpleasant muscle effects that have rarely progressed to a potentially life-threatening muscle damage known as rhabdomyolysis. The following common side effectshave been reported. If any of these side effects occur or persist for more than a week, see your doctor.
ROSUVASTATIN

Common: may affect up to 1 in 10 people

• Headache;
• Stomach pain;
• Constipation;
• Feeling unwell;
• Muscle pain;
• Feeling of weakness;
• Dizziness;
• Slight increase in the amount of protein in the urine - values usually return to normal spontaneously without having to stop taking Rozamlad capsules;
• Diabetes. This is more likely if you already have high blood sugar and fat levels, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon: may affect up to 1 in 100 people

• Skin rash, itching, hives or other skin reactions;
• Increased amount of protein in the urine - values usually return to normal spontaneously without having to stop taking Rozamlad capsules (only 5-20 mg dosages).

Rare:may affect up to 1 in 1,000

• Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps). If you think you are having an allergic reaction, stop takingRozamladand seek medical help immediately.
• Muscle damage in adults - as a precaution, stop taking Rozamlad and see your doctor immediately if you have unusual muscle aches or tendernessthat persist longer than expected;
• Severe stomach pain (inflammation of the pancreas),
• Increased liver enzymes in the blood;
• Reduction in platelets in the blood, which increases the risk of bleeding or bruising (thrombocytopenia).
• Lupus-like illness syndrome (including rash, joint disorders and effects on blood cells).

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

• Jaundice (yellowing of the skin and eyes);
• Hepatitis (inflamed liver);
• Traces of blood in the urine;
• Damage to the nerves of the legs and arms (such as numbness);
• Joint pain;
• Memory loss;
• Gynecomastia (breast enlargement in men). Not known: frequency cannot be estimated based on available data
• Diarrhea (loose stools);
• Cough;
• Shortness of breath;
• Edema (swelling);
• Sleep disorders, including insomnia and nightmares;
• Sexual dysfunction;
• Depression;
• Breathing problems, including persistent cough and/or wheezing or fever
• Tendon injury;
• A nerve disorder that can cause weakness, tingling or numbness. AMLODIPINE

Very common:may affect more than 1 in 10 people

• Edema (swelling). Common: may affect up to 1 in 10 people
• Headache, dizziness, drowsiness (especially at the beginning of treatment);
• Palpitations (awareness of your heartbeat), flushing;
• Abdominal pain, feeling unwell (nausea);
• Swelling of the ankles (edema), fatigue;
• Diarrhea or constipation;
• Impaired digestion;
• Muscle cramps;
• Feeling of weakness;
• Visual disturbances, double vision.

In addition, the following side effects have been reported. If any of these side effects worsen or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100

• Mood changes, anxiety, depression, insomnia (difficulty sleeping);
• Tremor, altered taste, fainting, weakness;
• Feeling of numbness or tingling in the limbs; loss of sensitivity to pain;
• Tinnitus (ringing in the ears);
• Low blood pressure;
• Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis);
• Dry mouth, vomiting;
• Hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration;
• Urinary disorders, increased need to urinate at night, increased need to urinate frequently;
• Inability to achieve an erection; discomfort or enlargement of the breasts in men;
• Abnormal heartbeat;
• Shortness of breath;
• Cough;
• Rash, itching, hives;
• Pain, chest 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

• Decreased number of white blood cells, decreased platelets in the blood which can cause unusual bruising or a tendency to bleed;
• Excess sugar in the blood (hyperglycemia);
• A nerve disorder that can cause weakness, tingling or numbness;
• Swelling of the gums;
• Swelling of the abdomen (gastritis);
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzyme that can affect some clinical tests;
• Increased muscle tension;
• Inflammation of blood vessels, often with a rash;
• Sensitivity to light;
• Disorders combining rigidity, tremor and/or movement disorders;
• Heart attack (myocardial infarction);
• Allergic reaction;
• Severe stomach pain (inflamed pancreas);
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions. If any of these side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

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 Rozamlad

Keep this medicine out of the 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.
Store at a temperature below 30°C. Store in the original package to protect the
medicine from light.
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. Package contents and other information

What Rozamlad contains
The active ingredients are rosuvastatin (as rosuvastatin calcium) and amlodipine (as amlodipine
besylate):
10 mg/5 mg: Each hard capsule contains 10 mg rosuvastatin (as rosuvastatin calcium) and 5 mg
amlodipine (as amlodipine besylate).
10 mg/10 mg: Each hard capsule contains 10 mg rosuvastatin (as rosuvastatin calcium) and 10
mg amlodipine (as amlodipine besylate).
20 mg/5 mg: Each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 5 mg
amlodipine (as amlodipine besylate).
20 mg/10 mg: Each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 10 mg
amlodipine (as amlodipine besylate).
The other ingredients are:

Capsule content:corn starch, pregelatinized starch, microcrystalline cellulose, crospovidone
type A, sodium stearyl fumarate.

Capsule coating: gelatin, titanium dioxide (E 171).

Red ink: shellac (E9404), propylene glycol (E1520), strong ammonia solution
(E527), red iron oxide (E172), potassium hydroxide (E525).

Green ink:shellac (E9404), titanium dioxide (E171), indigo carmine, aluminum lake
(E132), yellow iron oxide (E172), strong ammonia solution (E527), propylene glycol
(E1520).

Description of the appearance of Rozamlad and contents of the pack
10 mg/5 mg: hard gelatin capsules size 1 and opaque white body with red print
"Aml 5 mg" and opaque white cap with green imprint "Rsv 10 mg".
10 mg/10 mg: hard gelatin capsules size 00 and opaque white body with red print
"Aml 10 mg and line" and opaque white cap with green imprint "Rsv 10 mg".
20 mg/5 mg: hard gelatin capsules size 00 and opaque white body with red print
"Aml 5 mg" and opaque white cap with green imprint "Rsv 20 mg and line".
20 mg/10 mg: hard gelatin capsules size 00 and opaque white body with red print
"Aml 10 mg and line" and opaque white cap with green imprint "Rsv 20 mg and
line".

Rozamladis available in blisters containing 10, 14, 28, 30, 56, 60, 90, 98, 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
Adamed s.r.l.
Via G. Mazzini, 20
20123 Milan
Italy

Manufacturer
Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, Czosnów 05-152, Poland
BELUPO lijekovi i kozmetika, d.d., Ulica Danica 5, 48000 Koprivnica, Croatia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Poland Zahron Combi
Germany Rosuvastatin/Amlodipin-ratiopharm 10 mg/5 mg hard capsules
Rosuvastatin/Amlodipin-ratiopharm 10 mg/10 mg hard capsules
Rosuvastatin/Amlodipin-ratiopharm 20 mg/5 mg hard capsules
Rosuvastatin/Amlodipin-ratiopharm 20 mg/10 mg hard capsules
Bulgaria Росукард Комби 10 mg/5 mg твърди капсули
Росукард Комби 10 mg/10 mg твърди капсули
Росукард Комби 20 mg/5 mg твърди капсули
Росукард Комби 20 mg/10 mg твърди капсули
Croatia Rosix-Am
Czech Republic Zahron Combi
Greece Zahron Combi
Italy Rozamlad
Slovakia ZAHRON COMBI 10 mg /5 mg
ZAHRON COMBI 10 mg /10 mg
ZAHRON COMBI 20 mg /5 mg
ZAHRON COMBI 20 mg /10 mg
Portugal ASUTAM 10 mg + 5 mg, capsules, hard
ASUTAM 10 mg + 10 mg, capsules, hard
ASUTAM 20 mg + 5 mg, capsules, hard
ASUTAM 20 mg + 10 mg, capsules, hard