Amlator

Leaflet accompanying the packaging: patient information

Amlator, 10 mg + 5 mg, film-coated tablets

Amlator, 10 mg + 10 mg, film-coated tablets

Amlator, 20 mg + 10 mg, film-coated tablets

Atorvastatin + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Amlator and what is it used for

Amlator is a combination product that contains two active substances: atorvastatin and amlodipine.
Atorvastatin belongs to a group of medicines called statins, which are lipid-regulating medicines.
Amlodipine belongs to a group of medicines called calcium channel blockers, which have a vasodilating effect on blood vessels.
Amlator is indicated as a substitute for patients whose condition is adequately controlled with amlodipine and atorvastatin administered concomitantly at the same dose as in the combination product. Amlator is used to treat high blood pressure in adult patients (with chronic stable angina pectoris (or without it) and (or) Prinzmetal's angina), who have one of the following conditions:

• high cholesterol levels (primary hypercholesterolemia) or high cholesterol and triglyceride levels (combined or mixed hyperlipidemia),
• hereditary high cholesterol levels (homozygous familial hypercholesterolemia),
• prevention of cardiovascular events in adult patients at high risk of a first cardiovascular event, in addition to measures aimed at reducing other risk factors.

Amlator is not intended for initial therapy. During treatment with Amlator, the use of its individual components (medicines containing amlodipine and atorvastatin) should be discontinued.
During treatment, a standard low-cholesterol diet should be followed.
The doctor may decide to use Amlator if they determine that both active substances are suitable for the patient, or if the patient has already taken medicines containing these active substances.

2. Important information before taking Amlator

When not to take Amlator

• if the patient is allergic to amlodipine, atorvastatin, or if the patient is allergic to calcium channel blockers or to any other medicines similar to atorvastatin used to lower lipid levels in the blood, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe low blood pressure (hypotension),
• if the patient has aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart does not supply enough blood to the body),
• if the patient has heart failure after a heart attack,
• if the patient has liver disease,
• if the patient has abnormal liver function test results of unknown cause,
• in women of childbearing potential who are not using effective contraception methods,
• in pregnant or breastfeeding women,
• if the patient is taking fusidic acid orally or by injection in the last 7 days. Taking fusidic acid with Amlator may lead to severe muscle damage (rhabdomyolysis).

Warnings and precautions

Before starting treatment with Amlator, the patient should discuss it with their doctor or pharmacist

• if the patient has heart failure,
• if the patient has recently had a heart attack,
• if the patient has acute increase in blood pressure (hypertensive crisis),
• if the patient has had a stroke with bleeding into the brain or if the patient has small fluid-filled spaces in the brain, which are a consequence of a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4),
• in case of muscle problems in the past when taking other lipid-lowering medicines (e.g., other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of liver disease in the past,
• in patients over 70 years of age,
• if the patient is taking or has taken fusidic acid orally or by injection in the last 7 days. Taking fusidic acid with Amlator may lead to severe muscle damage (rhabdomyolysis).

Consult a doctor or pharmacist before taking Amlator

• if the patient has severe respiratory failure.

In patients who are in any of the above situations, the doctor will order a blood test before starting treatment with Amlator and probably during treatment to monitor the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, increases when taking certain medicines (see section 2 "Amlator and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at risk of developing diabetes.

Children and adolescents

Amlator is not recommended for children and adolescents due to lack of data on safety and efficacy.

Amlator and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Some medicines may affect the way Amlator works, and Amlator may affect the way other medicines work. Such interactions can lead to reduced efficacy of one or both medicines.
This may increase the risk of side effects, including a serious muscle disease called rhabdomyolysis, described in section 4.

• Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.
• Other lipid-regulating medicines, e.g., gemfibrozil, other fibrates, colestyramine, simvastatin.
• Certain calcium channel blockers used for angina pectoris or high blood pressure, e.g., diltiazem; heart rhythm regulators, e.g., digoxin, verapamil, amiodarone.
• Immunosuppressants, e.g., cyclosporine.
• Letermowir, a medicine used to prevent cytomegalovirus disease,
• Medicines used to treat HIV infection, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, nelfinavir, combination therapy with tipranavir/ritonavir, etc.
• Certain medicines used to treat hepatitis C, e.g., telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir.
• Other medicines known to interact with Amlator, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium).
• Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).
• Dantrolene (an injection used to treat severe body temperature disorders).
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the immune system).
• Over-the-counter medicines: St. John's Wort (Hypericum perforatum) preparations.
• If the patient must take fusidic acid orally for the treatment of bacterial infections, they should temporarily stop taking Amlator. The doctor will tell them when it is safe to resume taking Amlator. Taking Amlator with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Amlator and food, drink, and alcohol

To obtain information on the use of Amlator, see section 3. Pay attention to the following products:
Grapefruit juice
Patients taking Amlator should not consume grapefruit juice or grapefruits, as they may increase the level of the active ingredient amlodipine in the blood, which may result in unexpected enhancement of Amlator's blood pressure-lowering effect.
Alcohol
While taking Amlator, excessive alcohol consumption should be avoided.
For more information, see section 2, "Warnings and precautions".

Pregnancy and breastfeeding

Amlator should not be taken if the woman is pregnant or plans to become pregnant.
It has been shown that small amounts of amlodipine pass into breast milk. Amlator should not be taken if the woman is breastfeeding.
Amlator should not be taken during breastfeeding.
The safety of Amlator in pregnancy and breastfeeding has not been established. In pregnancy, during breastfeeding, or if pregnancy is suspected, or if the woman plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines

Taking this medicine usually does not affect the ability to drive or operate machines. If the tablets cause nausea, dizziness, fatigue, or headache and blurred vision, the patient should not drive or operate machines.

Amlator contains sodium carboxymethylcellulose

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means the medicine is "sodium-free".

3. How to take Amlator

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued while taking Amlator.

Adults

The dose of Amlator is determined by the doctor. They will decide whether the patient should take 1 film-coated tablet of Amlator 10 mg + 5 mg, Amlator 10 mg + 10 mg, or Amlator 20 mg + 10 mg once a day.
The maximum daily dose is one film-coated tablet of Amlator 20 mg + 10 mg.
The tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.
The patient should follow the doctor's recommendations regarding diet, especially a low-fat diet, regular physical exercise, and not smoking.
The duration of treatment with Amlator is determined by the doctor.
If the patient feels that the effect of Amlator is too strong or too weak, they should consult their doctor.

Elderly patients

In elderly patients, there is no need to modify the dose.

Use in children and adolescents

Amlator is not recommended for children and adolescents.

Renal impairment

No dose adjustment is necessary in this patient group.

Hepatic impairment

Amlator should be used with caution in this patient group; liver function tests should be performed frequently.

Overdose of Amlator

Taking too many tablets may cause a drop in blood pressure, even to a dangerously low level. Dizziness, lightheadedness, fainting, or weakness may occur. If the drop in blood pressure is severe, shock may occur. The patient's skin may be cool and moist, and loss of consciousness may occur. In case of overdose, the patient should contact the nearest hospital or doctor for advice. The patient should take the remaining tablets, packaging, and labels with them so that the hospital staff knows what medicine was taken.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missed dose of Amlator

If a dose of Amlator is missed, the next dose should be taken at the scheduled time.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Amlator

Treatment with Amlator should not be stopped unless the doctor decides to stop it.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlator can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects or symptoms, they should stop taking the tablets and contact their doctor or go to the nearest hospital emergency department immediately:

Uncommon(may affect up to 1 in 100 people):

• heart rhythm disorders, abnormal heartbeat.

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

• severe allergic reaction causing swelling of the face, tongue, and (or) throat, which can cause severe breathing difficulties.
• severe skin reactions, including severe 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, toxic epidermal necrolysis) or other allergic reactions.
• muscle weakness, tenderness, pain, or muscle rupture, or brownish discoloration of the urine, especially if accompanied by malaise or high fever, which may be caused by muscle breakdown. Muscle breakdown does not always resolve, even after stopping atorvastatin, and can be life-threatening and lead to kidney problems.

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

• heart attack,
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells),
• if the patient experiences unexpected bleeding or bruising, it may indicate liver problems. The patient should contact their doctor as soon as possible.

Other possible side effects of Amlator:
Very common(may affect more than 1 in 10 people):

• edema (swelling).

Common(may affect up to 1 in 10 people):

• drowsiness, headache, dizziness (especially at the beginning of treatment), fatigue, weakness,
• vision disturbances (including double vision),
• inflammation of the nasal mucosa, sore throat, nosebleeds,
• flushing,
• palpitations (awareness of heartbeat),
• shortness of breath,
• abdominal pain, nausea, constipation, bloating, indigestion, diarrhea,
• muscle pain, muscle cramps, swelling of the ankles, back pain, and limb pain,
• allergic reactions,
• increased blood sugar levels (if the patient has diabetes, they should carefully monitor their blood sugar levels),
• increased creatine kinase activity in the blood,
• abnormal liver function test results.

Uncommon(may affect up to 1 in 100 people):

• inflammation of the nasal mucosa (cold/ sneezing),
• cough,
• loss of appetite, weight gain, weight loss, decreased blood sugar levels (if the patient has diabetes, they should continue to carefully monitor their blood sugar levels),
• mood changes, anxiety, depression, tremors,
• numbness or tingling in the fingers of the hands and feet, decreased sensation of pain or touch, changes in taste, memory loss,
• blurred vision,
• ringing in the ears and (or) head,
• chest pain,
• heart rhythm disorders, abnormal heartbeat,
• fainting, low blood pressure (hypotension),
• dry mouth, vomiting, heartburn, abdominal pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas, which can cause abdominal pain),
• hepatitis,
• hair loss, red spots on the skin, skin discoloration, rash, itchy rash, hives, urticaria, increased sweating,
• neck pain, muscle fatigue,
• urination disorders, increased need to urinate at night, frequent urination,
• erectile dysfunction (impotence), gynecomastia (discomfort or enlargement of the breasts in men),
• increased body temperature, malaise, swelling, especially of the ankles (edema),
• nightmares, insomnia,
• presence of white blood cells in the urine.

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

• decreased platelet count, which can cause unexpected bleeding or bruising,
• bile duct obstruction (jaundice and yellowing of the eyes),
• disorientation,
• peripheral neuropathy (a nerve disorder that can cause weakness, numbness, or tingling),
• tendon damage,
• angioedema,
• rash that can occur on the skin or ulcers in the mouth (lichenoid drug reaction),
• purple skin discoloration (signs of vasculitis).

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

• decreased white blood cell count,
• stiffness or tension in the muscles, disorders that include stiffness and (or) problems with movement,
• heart attack,
• gingival hyperplasia,
• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse,
• sensitivity to light,
• hearing loss,
• abdominal distension (gastritis),
• liver failure.

Unknown(frequency cannot be estimated from the available data):

• persistent muscle weakness,
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing),
• ocular myasthenia (a disease that causes muscle weakness in the eyes), The patient should talk to their doctor if they experience muscle weakness in the arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
• tremors, rigidity, mask-like facial expression, slow movements, and shuffling gait, unsteady gait.

Possible side effects reported with the use of some statins (medicines of the same type):

• sexual disorders,
• depression,
• breathing problems, including persistent cough and (or) shortness of breath or fever,
• diabetes. The risk of developing diabetes is higher in people with high blood sugar and lipid levels, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Amlator

6. Contents of the pack and other information

What Amlator contains

The active substances of Amlator are atorvastatin and amlodipine.
Amlator, 10 mg + 5 mg, film-coated tablets contain 10 mg of atorvastatin (as atorvastatin with L-lysine) and 5 mg of amlodipine (as amlodipine besylate) in each film-coated tablet.
Amlator, 10 mg + 10 mg, film-coated tablets contain 10 mg of atorvastatin (as atorvastatin with L-lysine) and 10 mg of amlodipine (as amlodipine besylate) in each film-coated tablet.
Amlator, 20 mg + 10 mg, film-coated tablets contain 20 mg of atorvastatin (as atorvastatin with L-lysine) and 10 mg of amlodipine (as amlodipine besylate) in each film-coated tablet.

Other ingredients

Core of the tablet:
calcium carbonate,
microcrystalline cellulose (type 102),
maize starch, pregelatinized,
crosarmellose sodium,
calcium oxide,
sodium carboxymethylcellulose (type A),
hydroxypropylcellulose,
Polysorbate 80,
silica, colloidal, anhydrous,
magnesium stearate.
Coating of the tablet (Opadry II 85F 18422 White):
polyvinyl alcohol, partially hydrolyzed,
titanium dioxide (E171),
macrogol 4000,
talc.

What Amlator looks like and contents of the pack

Amlator, 10 mg + 5 mg, film-coated tablets are white, round, biconvex film-coated tablets, approximately 9.0 mm in diameter. One side has the embossed "CE3", the other side is smooth.
Amlator, 10 mg + 10 mg, film-coated tablets are white, round, biconvex film-coated tablets, approximately 9.0 mm in diameter. One side has the embossed "CE5", the other side is smooth.
Amlator, 20 mg + 10 mg, film-coated tablets are white, oval, biconvex film-coated tablets, approximately 15.5 x 8.0 mm in size. One side has the embossed "CE6", the other side is smooth.
30 and 90 film-coated tablets are packaged in white non-transparent blisters of PA/Aluminum/PVC//Aluminum and in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder:

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21
Hungary

Manufacturer:

Gedeon Richter Romania S.A.
Str. Cuza Vodă Nr. 99-105
540306 Târgu-Mureş
Romania
To obtain more detailed information about the medicine and its names in other EU member states, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: January 2025

(( logo of the marketing authorization holder))