Amlopin 10 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Amlopin 10 mg (Amlodipin - 1A Pharma 10 mg Tabletten N)
10 mg, tablets
Amlodipinum
Amlopin 10 mg and Amlodipin - 1A Pharma 10 mg Tabletten N are different brand names of the
same medicine
Please read the leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Leaflet contents:

1. What Amlopin 10 mg is and what it is used for
2. Important information before taking Amlopin 10 mg
3. How to take Amlopin 10 mg
4. Possible side effects
5. How to store Amlopin 10 mg
6. Contents of the pack and other information

1. What Amlopin 10 mg is and what it is used for

Amlopin 10 mg belongs to a group of medicines called calcium antagonists.
It is used to treat:

• high blood pressure (hypertension),
• a certain type of chest pain known as angina pectoris, including its rare form, Prinzmetal's angina (variant angina).

In patients with high blood pressure, the medicine reduces the tension in blood vessels, thereby improving blood flow.
In patients with angina, Amlopin 10 mg improves blood supply to the heart muscle and, consequently, oxygen delivery, thus preventing chest pain.
Amlopin 10 mg does not provide immediate relief from angina pain.

2. Important information before using Amlopin 10 mg

When not to use Amlopin 10 mg
if the patient is allergic to amlodipine, to any other calcium antagonist, or to
any of the other ingredients of this medicine (listed in section 6). Symptoms may
include itching, skin redness, or difficulty breathing.
if the patient has very low blood pressure (hypotension).
if the patient has aortic valve stenosis (aortic stenosis) or cardiogenic shock (a condition in
which the heart cannot deliver sufficient blood to the body).
if the patient has heart failure following a recent myocardial infarction.

Warnings and precautions
Before starting treatment, discuss with the doctor or pharmacist if the patient has currently or in the past been diagnosed with:
recent myocardial infarction,
heart failure,
severe high blood pressure (hypertensive crisis),
liver disease,
need for dose adjustment (in elderly patients).

Children and adolescents
The use of Amlopin 10 mg has not been studied in children under 6 years of age. The medicine should be used for the treatment of hypertension only in children and adolescents aged 6 to 17 years (see section 3).
For further information, consult a doctor.

Amlopin 10 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.
Amlopin 10 mg and other medicines may affect each other's actions. These include:
ketoconazole and itraconazole (antifungal medicines);
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV infection);
rifampicin, erythromycin, clarithromycin (antibiotics);
St John's wort (Hypericum perforatum);
verapamil, diltiazem (medicines used for heart conditions);
dantrolene (an intravenous medicine used in severe disturbances of body temperature);
simvastatin (a medicine used to lower elevated cholesterol levels in the blood);
tacrolimus, sirolimus, everolimus and cyclosporine (medicines used to prevent rejection of transplanted organs and in cancer treatment);
temsirolimus (a medicine used in cancer treatment).
Amlopin 10 mg may lower blood pressure more strongly if the patient is already taking other antihypertensive medicines.

Amlopin 10 mg with food and drink
If the patient is taking Amlopin 10 mg, they should not eat grapefruit or drink grapefruit juice. These may increase the blood concentration of the active substance (amlodipine) and, consequently, unpredictably intensify the blood pressure-lowering effect.

Pregnancy and breastfeeding
Pregnancy
The safety of using Amlopin 10 mg in pregnant women has not been established. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. If the patient is breastfeeding or planning to breastfeed, she should inform the doctor before starting treatment with Amlopin 10 mg.

Driving and using machines
Amlopin 10 mg may affect the ability to drive or operate machinery.
If the patient experiences nausea, dizziness, fatigue, or headache, they should not drive or operate machinery. Inform the doctor immediately.

Amlopin 10 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Amlopin 10 mg

This medicine should always be taken exactly as prescribed by the doctor. In case of any doubts, consult
your doctor or pharmacist.
Amlopin 5 mg and Amlopin 10 mg are available on the market.
The usual starting dose of Amlopin 10 mg is 5 mg once daily. Your doctor may
increase the dose to 10 mg once daily.
This medicine can be taken regardless of meals and drinks. It should be taken at the same time each
day, with water. Do not take Amlopin 10 mg with grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day.
It is important to take the tablets continuously. Do not wait until all prescribed tablets are used up before
visiting your doctor.
Tablets may be divided into equal doses.
Taking more Amlopin 10 mg than recommended
Taking too many tablets may cause a significant drop in blood pressure, even to dangerously low levels.
Dizziness, lightheadedness, fainting, or weakness may occur. A marked decrease in blood pressure may lead to shock. The patient's skin may become cold and clammy, and loss of consciousness may occur. If a patient has taken too many tablets of Amlopin 10 mg, seek immediate medical help.
Breathlessness caused by fluid accumulation in the lungs (pulmonary edema) may occur even up to 24–48 hours after taking the medicine.
Missing a dose of Amlopin 10 mg
Stay calm. If the patient forgets to take a tablet, they should skip that dose and take the next dose at the usual time. Never take a double dose to make up for a missed dose.
Stopping Amlopin 10 mg treatment
Your doctor will determine how long you should take this medicine. Stopping treatment earlier than recommended may cause the condition to return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur in the patient after taking the medicine,
seek immediate medical advice:

• sudden wheezing, chest tightness, shortness of breath or difficulty breathing;
• swelling of the eyelids, face or lips;
• swelling of the tongue and throat, making breathing significantly difficult;
• severe skin reactions, including intense rash, urticaria, redness of the entire skin surface, severe itching, flu-like symptoms accompanied by blistering, peeling and swelling of the skin, lips, eyes and genital areas (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• myocardial infarction, irregular heartbeat;
• pancreatitis, which may cause severe abdominal and back pain with general malaise;
• hepatitis, which may cause yellowing of the skin and whites of the eyes (jaundice), fever, chills, fatigue, loss of appetite, abdominal pain, malaise, dark urine.

The following very common side effect has been reported. If it is troublesome for the patient or
persists for more than one week, consult a doctor.
Very common: may occur in more than 1 in 10 people
swelling (fluid retention)

The following common side effects have been reported. If any of them are troublesome for
the patient or if they persist for more than one week, consult a doctor.
Common: may occur in less than 1 in 10 people
headache, dizziness, drowsiness (especially at the beginning of treatment)
palpitations (awareness of heartbeat), skin flushing (especially of the face)
difficulty breathing
abdominal pain, nausea
changes in bowel habits, diarrhoea, constipation, indigestion
ankle swelling
feeling of fatigue, weakness
vision disturbances, double vision
muscle cramps

Other reported side effects are listed below. If any of the adverse effects worsen or if any
unlisted side effects occur, inform the doctor or pharmacist.
Uncommon: may occur in less than 1 in 100 people
mood swings, anxiety, depression, insomnia
tremor, taste disturbances, fainting
numbness or tingling of limbs, loss of pain sensation
tinnitus
low blood pressure
sneezing/rhinorrhea due to inflammation of the nasal mucosa (rhinitis)
cough
dry mouth, vomiting
hair loss, excessive sweating, skin itching, rash, appearance of red spots on the skin, skin discoloration
urinary disturbances, increased need to urinate at night, increased frequency of urination
impotence, discomfort or enlargement of breasts in men
chest pain
pain, general malaise
joint or muscle pain, back pain
increase or decrease in body weight
Rare: may occur in less than 1 in 1,000 people
confusion
Very rare: may occur in less than 1 in 10,000 people
decreased white blood cell count, decreased platelet count, which may cause unusual bruising or easy bleeding
high blood sugar levels (hyperglycaemia)
nerve disorders, which may cause weakness, tingling or numbness
gum swelling
abdominal distension (gastritis)
liver function abnormalities, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect results of certain diagnostic tests
increased muscle tension
vasculitis, often with skin rash
increased sensitivity to light
Side effects with unknown frequency: frequency cannot be estimated from the available data
tremor, rigid posture, mask-like face, slowed movements and shuffling gait, unsteady gait.

Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlopin 10 mg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack. The expiry date refers to the last day of the specified month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – Batch number/expiry date: see imprint
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Amlopin 10 mg contains

• The active substance is amlodipine. Each tablet contains 10 mg of amlodipine (as amlodipine besylate).
• The other ingredients are: sodium carboxymethyl starch (type A), calcium hydrogen phosphate, microcrystalline cellulose, and magnesium stearate.

What Amlopin 10 mg looks like and contents of the pack
Amlopin 10 mg
White or almost white, elongated tablet with bevelled edges, scored on one side and marked with “10” on the other side.
The tablets are packed in aluminium/PVC or aluminium/OPA/aluminium/PVC foil blisters placed in a cardboard box.
Pack sizes:
Blisters of 30 and 60 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Germany, the country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany
Manufacturer:
Lek S.A.
16, ul. Podlipie
95-010
Stryków
Poland

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

ROWA Pharmaceuticals Ltd.
Bantry, Co. Cork
Ireland
Sandoz S.R.L.
Str. Livezeni no. 4
540472 Targu-Mures
Romania
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Number of the marketing authorization in Germany, the country of export:
66351.00.00
Number of parallel import authorization: 87/23
This medicinal product is authorized for marketing in the Member States of the European Economic Area under the following names:
Austria Amlodipin Hexal 10 mg – Tabletten
Denmark Amlohexal
Germany Amlodipin HEXAL 10 mg Tabletten
Hungary Amlodipin Sandoz 10 mg tabletta
Ireland Amlode 10 mg tablets
Italy AMLODIPINA HEXAL AG
Poland Amlopin 10 mg