Amlator

Package leaflet: Information for the patient

Amlator, 10 mg + 5 mg, film-coated tablets
Amlator, 10 mg + 10 mg, film-coated tablets
Amlator, 20 mg + 10 mg, film-coated tablets
Atorvastatinum + Amlodipinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Amlator is and what it is used for
2. What you need to know 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 Amlator is and what it is used for

Amlator is a fixed combination medicine containing two active substances: atorvastatin and amlodipine.
Atorvastatin belongs to a group of medicines called statins, which are lipid-regulating agents (fats).
Amlodipine belongs to a group of medicines known as calcium channel blockers, which have a vasodilatory effect on blood vessels.

Amlator is indicated as a replacement therapy in patients whose condition is adequately controlled with concomitant administration of amlodipine and atorvastatin at the same doses as those contained in the fixed-dose combination. Amlator is used in the treatment of hypertension in adult patients (with or without chronic stable angina pectoris or Prinzmetal's angina), who also have one of the following conditions:

• elevated cholesterol levels (so-called primary hypercholesterolemia) or elevated cholesterol and triglyceride levels (so-called mixed or combined hyperlipidemia),
• genetically elevated cholesterol levels (so-called homozygous familial hypercholesterolemia),
• prevention of cardiovascular events in adult patients at high risk of experiencing a first cardiovascular event, together with measures aimed at reducing other risk factors.

Amlator is not intended for initiating treatment. When starting Amlator, treatment with the individual components (medicines containing amlodipine and atorvastatin) should be discontinued.
During treatment, a standard low-cholesterol diet should be maintained.
Your doctor may decide to prescribe Amlator if it is considered appropriate to use both active substances together, or if you have previously been treated with medicines containing these active substances.

2. Important information before using Amlator

When not to use Amlator

• if the patient is allergic to amlodipine, atorvastatin, or if the patient is allergic to the group of medicines known as calcium channel blockers, or to any other drugs similar to atorvastatin used to reduce lipid (fat) 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 valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart does not deliver enough blood to the body),
• if the patient has heart failure following a heart attack,
• if the patient has or has had liver disease,
• if the patient has abnormal liver function test results of unknown cause,
• in women of childbearing potential who are not using effective contraceptive methods,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting Amlator, discuss this with your doctor or pharmacist if:

• the patient has heart failure,
• the patient has recently had a heart attack,
• the patient has acute high blood pressure (hypertensive crisis),
• the patient has previously had a stroke with bleeding into the brain or if small fluid-filled spaces in the brain due to a previous stroke have been diagnosed,
• in case of kidney problems,
• in case of hypothyroidism (underactive thyroid),
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or if such problems occurred in family members,
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4),
• if the patient has previously experienced muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has previously had liver disease,
• in patients over 70 years of age,
• if the patient is taking or has taken within the last 7 days orally or by injection a medicine containing fusidic acid (a medicine used for bacterial infections). Taking fusidic acid together with Amlator may lead to severe muscle damage (rhabdomyolysis).

Consult your doctor or pharmacist before using Amlator

• if the patient has severe respiratory insufficiency.

In patients with any of the above conditions, the doctor will order a blood test before starting Amlator and possibly during treatment to monitor the risk of muscle-related adverse reactions. The risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 "Amlator with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medicines may be required to diagnose and treat this condition.
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 fat levels, overweight, and high blood pressure may be at risk of developing diabetes.

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

Amlator with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may alter the effect of Amlator, and Amlator may affect the action of other medicines. Such interactions may reduce the effectiveness of one or both medicines. This may increase the risk of occurrence or worsening of adverse reactions, including a serious muscle disease called rhabdomyolysis, described in section 4.

• Some antibiotics or antifungal medicines, e.g.: erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.

• Other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine, simvastatin.

• Some calcium channel blockers used for angina or high blood pressure, e.g. diltiazem; medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone.

• Medicines modifying the immune system, e.g. cyclosporine.

• Letermovir, a medicine used to prevent cytomegalovirus infection,

• Medicines used in the treatment of HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, nelfinavir, combination therapy tipranavir/ritonavir, etc.

• Some medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and combination medicines 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 anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium).

• Daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

• Dantrolene (an intravenous infusion used in severe disturbances of body temperature).

• Tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify immune system function).

• Over-the-counter medicines: St. John’s wort (Hypericum perforatum) preparations.

• If the patient needs to take oral fusidic acid for the treatment of bacterial infection, Amlator treatment should be temporarily interrupted. Your doctor will advise when it is safe to resume Amlator. Taking Amlator together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Amlator may enhance blood pressure lowering effects if the patient is taking other antihypertensive medicines.

Amlator, food, drink and alcohol
For information on using 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 blood levels of the active ingredient amlodipine, which could result in an unexpected intensification of Amlator’s blood pressure-lowering effect.

Alcohol
While taking Amlator, avoid excessive alcohol consumption.
For further details, see section 2, "Warnings and precautions".

Pregnancy and breastfeeding
Do not use Amlator if you are pregnant or planning to become pregnant.
It has been shown that small amounts of amlodipine pass into human milk. Do not use Amlator if you are of childbearing potential unless you are using effective contraceptive methods.
Amlator should not be used during breastfeeding.
The safety of Amlator during pregnancy and breastfeeding has not been established. During pregnancy, breastfeeding, or if pregnancy is suspected, or if planning pregnancy, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine usually does not affect the ability to drive or operate machinery. However, if the tablets cause nausea, dizziness, fatigue, headache or blurred vision, do not drive or operate machinery.

Amlator contains sodium carboxymethyl starch
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Amlator

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Amlator.
Adults
The dose of Amlator is determined by the doctor. The doctor will decide whether the patient should take one coated tablet of Amlator 10 mg + 5 mg, Amlator 10 mg + 10 mg, or Amlator 20 mg + 10 mg once daily.
The maximum daily dose is one coated tablet of Amlator 20 mg + 10 mg.
Tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is recommended to take the tablet at the same time each day.
You should follow your doctor's dietary recommendations, especially regarding a low-fat diet, engage in regular physical exercise, and avoid smoking.
The duration of treatment with Amlator is determined by the doctor.
If you feel that the effect of Amlator is too strong or too weak, consult your doctor.
Elderly patients
No dose adjustment is required in elderly patients.
Use in children and adolescents
Amlator is not recommended for use in children and adolescents.
Renal impairment
No dosage adjustment is necessary in patients with renal impairment.
Hepatic impairment
Amlator should be used with caution in patients with hepatic impairment; regular monitoring of liver function tests is recommended.
Overdose of Amlator
Taking too many tablets may cause a drop in blood pressure, even to dangerously low levels. Symptoms may include dizziness, lightheadedness, fainting, or a feeling of weakness. If the drop in blood pressure is severe, shock may occur. The patient's skin may become cold and clammy, and loss of consciousness may occur. In case of overdose with Amlator, contact the nearest hospital or doctor immediately for advice. Bring any remaining tablets, the medicine packaging, and labels, so that hospital staff know which medicine has been taken.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur even 24–48 hours after taking the medicine.
Missed dose of Amlator
If a dose of Amlator is missed, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping Amlator
Do not stop taking Amlator unless your doctor decides to discontinue treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions or symptoms, stop taking the tablets immediately and contact a doctor immediately or go to the nearest hospital emergency department:
Uncommon (may occur in fewer than 1 in 100 people):

• Heart rhythm disorders, unusual heartbeat.

Rare (may occur in fewer than 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue and (or) throat, which may cause significant breathing difficulties.
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Muscle weakness, tenderness, pain, muscle rupture or red-brown discoloration of urine, especially accompanied by malaise or high fever, which may be due to muscle breakdown. Muscle breakdown may not always resolve even after discontinuation of atorvastatin and may be life-threatening and lead to kidney problems.

Very rare (may occur in fewer than 1 in 10,000 people):

• Heart attack,
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells),
• If the patient develops unexpected bleeding or bruising, this may indicate liver problems. Contact a doctor as soon as possible.

Other possible adverse reactions of Amlator:
Very common (may occur in more than 1 in 10 people):

• Swelling (edema).

Common (may occur in fewer than 1 in 10 people):

• Drowsiness, headache, dizziness (especially at the beginning of treatment), fatigue, feeling of weakness,
• Vision disorders (including double vision),
• Nasal mucosal inflammation, sore throat, nosebleeds,
• Flushing,
• Palpitations (awareness of heartbeat),
• Shortness of breath,
• Abdominal pain, nausea, constipation, bloating, indigestion, diarrhea,
• Muscle pain, muscle cramps, ankle swelling, joint pain and back pain, limb pain,
• Allergic reactions,
• Increased blood sugar levels (if the patient has diabetes, blood sugar levels should be carefully monitored),
• Increased creatine kinase activity in blood,
• Blood test results indicating abnormal liver function.

Uncommon (may occur in fewer than 1 in 100 people):

• Nasal mucosal inflammation (coryza/sneezing),
• Cough,
• Loss of appetite (anorexia), increased body weight, decreased body weight, decreased blood sugar levels (if the patient has diabetes, blood sugar levels should still be carefully monitored),
• Mood changes, anxiety, depression, tremor,
• Numbness or tingling in fingers of hands and feet, reduced sensation of pain or touch, altered taste sensation, memory loss,
• Blurred vision,
• Ringing in the ears and (or) in the head,
• Chest pain,
• Heart rhythm disorders, unusual heartbeat,
• Fainting, low blood pressure (hypotension),
• Dry mouth, vomiting, heartburn, abdominal pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas, which may cause abdominal pain),
• Hepatitis,
• Hair loss, red spots on the skin, skin discoloration, rash, rash accompanied by itching, hives, eczema, increased sweating,
• Neck pain, muscle fatigue,
• Urination disorders, increased need to urinate at night, increased frequency of urination,
• Erectile dysfunction (impotence), gynecomastia (discomfort or enlargement of breasts in men),
• Elevated body temperature, malaise, swelling, especially of the ankles (swelling),
• Nightmares, insomnia,
• Presence of white blood cells in urine.

Rare (may occur in fewer than 1 in 1,000 people):

• Decreased number of platelets, which may cause unexpected bleeding or bruising,
• Cholestasis (yellowing of the skin and whites of the eyes),
• Disorientation,
• Peripheral neuropathy (a nervous system disorder which may cause weakness, tingling or numbness),
• Tendon injury,
• Angioedema,
• Rash which may appear on the skin, or mouth ulcers (lichenoid drug reaction),
• Purple skin lesions (symptoms of vasculitis).

Very rare (may occur in fewer than 1 in 10,000 people):

• Decrease in the number of white blood cells in blood,
• Muscle stiffness or tension, disorders involving stiffness and (or) movement problems,
• Heart attack,
• Gingival hyperplasia,
• Allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse,
• Light sensitivity,
• Hearing loss,
• Abdominal bloating (gastritis),
• Liver failure.

Unknown (frequency cannot be estimated from available data):

• Persistent muscle weakness,
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing),
• Ocular myasthenia (a disease causing weakness of eye muscles). Talk to a doctor if the patient experiences weakness of hands or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
• Tremor, rigidity, mask-like facial expression, slowed movements and dragging of legs while walking, unsteady gait.

Possible adverse reactions reported with the use of certain statins (medicines of the same type):

• Sexual disorders,
• Depression,
• Breathing problems, including persistent cough and (or) shortness of breath or fever,
• Diabetes. The likelihood of developing diabetes is higher in people with high blood sugar and fat levels, overweight and high blood pressure. The doctor will monitor the patient's condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Amlator medication

• 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 carton and the blister after "EXP". The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light and moisture.
• No special storage conditions required.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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

Other components are:
Tablet core:
calcium carbonate,
microcrystalline cellulose (type 102),
pregelatinized maize starch,
sodium croscarmellose,
calcium oxide,
sodium carboxymethyl starch (type A),
hydroxypropylcellulose,
polysorbate 80,
colloidal anhydrous silica,
magnesium stearate.

Tablet coating (Opadry II 85F 18422 White):
partially hydrolysed polyvinyl alcohol,
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 with a diameter of approximately 9.0 mm. One side is marked with the engraved code "CE3", the other side is smooth.
Amlator 10 mg + 10 mg, film-coated tablets are white, round, biconvex film-coated tablets with a diameter of approximately 9.0 mm. One side is marked with the engraved code "CE5", the other side is smooth.
Amlator 20 mg + 10 mg, film-coated tablets are white, oblong, biconvex film-coated tablets with dimensions of approximately 15.5 x 8.0 mm. One side is marked with the engraved code "CE6", the other side is smooth.

Packaged in white opaque blisters made of PA/Aluminum/PVC//Aluminum foil, containing 30 or 90 film-coated tablets in a carton box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product and its trade names in other Member States of the European Economic Area, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
(( logo of the Marketing Authorisation Holder ))