Rosucard Combi 10 mg/5 mg. 30 capsules

What Rosucard Combi is and what it is used for
Rosucard Combi contains two active substances - rosuvastatin and amlodipine.
Rosucard Combi is indicated in adults for the treatment of high blood pressure and concomitant high cholesterol when dietary changes and increased exercise are not sufficient to correct cholesterol levels and/or prevent cardiovascular events and if you have other factors that increase your risk of heart attack, stroke, or related health problems.

Rosucard Combi is indicated for patients already taking rosuvastatin and amlodipine in the same doses. Instead of taking rosuvastatin and amlodipine as separate tablets, you will receive one capsule of Rosucard Combi, which contains the two active substances in the same concentration.
You should continue your cholesterol-lowering diet and exercise while taking Rosucard Combi.

2. What you need to know before you take Rosucard Combi
Do not take Rosucard Combi;
If you are allergic to rosuvastatin, amlodipine, to some other calcium antagonists, 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 Rosucard Combi, stop taking it immediately and call your doctor. Women should avoid becoming pregnant while taking Rosucard Combi by using appropriate contraception.
If you have liver disease.
If you have severe kidney problems.
If you have had recurring and unexplained muscle pain.
If you are taking the combination medicine sofosbuvir / velpatasvir / voxilaprevir (used for a viral infection of the liver called hepatitis C).
If you are taking a medicine called cyclosporine (used eg after an organ transplant).
You have severely low blood pressure (severe hypotension).
If you have a narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body). You suffer from heart failure after an acute myocardial infarction.
If you have ever had a severe skin rash or skin peeling, blistering and/or mouth sores after taking rosuvastatin or other statins.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rosucard Combi.
If you have kidney problems.
If you have liver problems.
If you have had recurrent and unexplained muscle pain, a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Contact your doctor immediately if you have unexplained muscle pain and especially if you feel unwell or have a fever. Tell your doctor or pharmacist if you experience muscle weakness that is persistent.
If you regularly drink large amounts of alcohol.
If your thyroid gland is not functioning normally.
If you are taking other medicines called fibrates to lower cholesterol. Please read this leaflet carefully, even if you are already taking other medicines for high cholesterol.
If you are taking medicines used to fight HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, please see "Other medicines and Rosucard Combi".
If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine to treat bacterial infections) orally or by injection. Taking Rosucard Combi and fusidic acid can cause serious muscle problems (rhabdomyolysis), please see "Other medicines and Rosucard Combi".
If you have severe respiratory failure.
If you have recently had a heart attack.
If you suffer from heart failure.
If you have severe high blood pressure (hypertensive crisis)
If you are elderly.
If you are of Asian descent - this is Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor must choose the right dose to start treatment with Rosucard Combi that is suitable for you.
In a small number of people, statins can affect the liver. This is determined by a simple test, the purpose of which is to determine whether the levels of liver enzymes in the blood are increased. For this reason, your doctor will do a blood test (liver function test) before and during treatment with Rosucard Combi.

While you are taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are more likely to be at increased risk of developing diabetes if you have high blood sugar and fat levels, 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 in association with rosuvastatin treatment. Stop using Rosucard Combi and seek medical attention immediately if you notice any of the following
Rosucard Kombi with food and drinks
You can take Rosucard Combi with or without food.

Grapefruit juice and grapefruit should not be consumed by people taking Rosucard Combi. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active substance amlodipine, which can lead to an unpredictable increase in the blood pressure-lowering effect of Rosucard Combi.

Pregnancy and breastfeeding
Do not take Rosucard Combi if you are pregnant or breast-feeding. If you become pregnant while taking Rosucard Combi, stop taking it immediately and consult your doctor. Women should avoid becoming pregnant while taking Rosucard Combi by using appropriate contraception.

Driving and using machines
Rosucard Combi may affect your ability to drive or use machines. Some people feel dizzy during treatment with Rosucard Combi. If the capsules make you feel sick, dizzy or tired or give you a headache, you should not drive or use machines and contact your doctor immediately.

Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. practically no sodium.

3. How to take Rosucard Kombi
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one capsule per day.

Your medicine can be used before or after food and drink. You should take your medicine at the same time each day with a glass of water. Capsules should not be chewed. Do not take Rosucard Combi with grapefruit juice.

Use in children and adolescents
Rosucard Kombi should not be used by children and adolescents.

Regular cholesterol checks
It is important to return to your doctor for regular cholesterol checks to ensure that normal cholesterol levels are reached and maintained at all times.

Your doctor may decide to increase your dose so that you take the dose of Rosucard Combi that is best for you.

If you have taken more than the required dose of Rosucard Combi
Contact your doctor or the nearest hospital. Taking too many capsules can cause your blood pressure to drop and become low or even dangerously low. You may feel dizzy, light-headed, tired or weak. If your blood pressure drops too low, you may go into shock. Your skin may become cold and clammy and you may lose consciousness.

If you are admitted to hospital or are being treated for another illness, tell the medical staff that you are taking Rosucard Combi.

An increased amount of fluid may accumulate in the lungs (pulmonary oedema), causing shortness of breath, which may develop up to 24*48 hours after ingestion.

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

If you have stopped taking Rosucard Kombi
Your doctor will advise you on how long to take your medicine. Your cholesterol levels may rise again if you stop taking Rosucard Combi. Your illness may return if you stop using your medicine before being advised to do so.

If you have any further questions related to 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 everybody gets them.

Stop taking Rosucard Combi and seek medical help immediately if you have any of the following:
Sudden wheezing, chest pain, shortness of breath or difficulty breathing.
Swelling of the eyelids, face or lips
Swelling of the tongue and throat that causes great difficulty in breathing and/or swallowing.
Severe skin reactions, including intense skin rash, hives, reddening of the skin all over the body, severe itching, blistering of the skin, peeling and swelling of the skin, inflammation of the mucous membranes (Steven-Johnson syndrome) or other allergic reactions Reddish unraised, similar to targets or circular spots on the body, often with central blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Steven-Johnson syndrome)
Extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
Heart attack, abnormal heart rhythm.
Inflammation of the pancreas, which can cause severe abdominal pain and back pain, accompanied by a feeling of being very unwell.
Lupus-like syndrome (including rash, joint disorders and effects on blood cells).
Muscle tearing.
Also stop taking Rosucard Combi and contact a doctor
Rare: may affect up to 1 in 1,000 people
Severe allergic reaction - signs are swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with a rash). If you think you are having an allergic reaction, stop taking Rosucard Combi and seek medical help immediately.
Muscle damage in adults - as a precaution, stop taking Rosucard Combi and see your doctor straight away if you have any unusual muscle aches or pains that last longer than expected. Severe stomach pain (inflammation of the pancreas)
Elevation of liver enzymes in the blood
Reduction of platelets in the blood, which may increase the risk of bleeding or bruising (thrombocytopenia)
Lupus-like syndrome (including rash, joint disorders and effects on blood cells).
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 (numbness)
Pain in the joints
Memory loss
Gynecomastia (male breast enlargement)
Not known: cannot be predicted from the available data
Diarrhea (poor stools)
A cough
Lack of air
Edema (swelling)
Sleep disturbances, including insomnia and nightmares
Sexual dysfunction
Depression
Respiratory problems including persistent cough and/or shortness of breath or fever
Tendon injury
A nerve disorder that can cause weakness, numbness, or stiffness
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 (you feel your heart beating), flushing of the face
Abdominal pain, feeling sick (nausea)
Ankle swelling (edema), fatigue
Diarrhea or constipation
Indigestion
Muscle cramps
Weakness
Visual impairment, double vision
Other side effects that have been reported are listed below. If any of these become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people
Mood swings, anxiety, depression, insomnia
Trembling, taste abnormalities, seizures, weakness
Numbness or numbness in the extremities, loss of pain sensation
Noise in the ears
Low blood pressure
Sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)
Dry mouth, vomiting (feeling sick)
Hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
Urination disorder, increased need to urinate at night, more frequent urination Inability to get an erection, discomfort or breast enlargement in men
Abnormal heart rhythm
Lack of air
A cough
Rash, itching, urticaria
Pain, chest pain, feeling unwell
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 users
A decrease in the number of white blood cells, a decrease in platelets in the blood, which can lead to unusual bruising of the skin or easy bleeding
High blood sugar (hyperglycaemia)
Nerve disease that can cause weakness, numbness, or stiffness
Swelling of the gums
Bloating (gastritis)
Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which may affect some medical tests
Increase in muscle tension
Inflammation of the blood vessels, often with a skin rash
Sensitivity to light
Disease combining rigidity, tremor, and/or movement disorders
Heart attack
Alergic reaction
Severe stomach pain (inflammation of the pancreas)
Severe skin reactions, including severe skin rash, hives, reddening of the skin all over your body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions.
If any of the side effects become serious, or you notice others not described in this leaflet, please tell your doctor or pharmacist.
5. How to store Rosucard Kombi
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP/EXP. The expiration date corresponds to the last day of the specified month.
Store below 30°C. Store in the original package to protect from light.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Rosucard Combi contains
The active substances 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 shell: gelatin, titanium dioxide (E 171)

Red ink\shellac (E904), propylene glycol (£1520), strong ammonia solution (E527), red iron oxide (E172), potassium hydroxide (E525)
Green ink: shellac (E904), titanium dioxide (E171), indigotin (E132), yellow iron oxide (E172), strong ammonia solution (E527), propylene glycol (E1520)

What Rosucard Combi looks like and what it contains
10 mg/5 mg: size 1 hard gelatin capsules and white opaque body with red

designation “Aml 5 mg” and a white opaque cap with a green designation “Rsv 10 mg”.

10 mg/10 mg: 00 size hard gelatin capsules and white opaque body with red marking “Aml 10 mg and line” and white opaque cap with green marking “Rsv 10 mg”
20 mg/5 mg: size 00 hard gelatin capsules and white opaque body with red marking “Aml 5 mg” and white opaque cap with green marking “Rsv 20 mg and line”
20 mg/10 mg: size 00 hard gelatin capsules with a white opaque body with a red imprint “Aml 10 mg and line” and a white opaque cap with a green imprint “Rsv 20 mg and line”.
Rosucard Combi is available in blisters containing 10, 14, 28, 30, 56, 60, 90, 98 and 100 hard capsules.

Not all types of packaging can be put on sale

 

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