Amlopin 5 mg

1. What is Amlopin and what is it used for

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

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

In patients with high blood pressure, the medicine reduces the tension of blood vessels, making it easier for blood to flow.
In patients with angina pectoris, Amlopin improves the supply of blood to the heart muscle and, through it, oxygen, thus preventing the occurrence of chest pain. Amlopin does not provide immediate relief from angina pain.

2. Important information before taking Amlopin

When not to take Amlopin

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). The symptoms may be: itching, skin redness, or difficulty breathing.
if the patient has very low blood pressure (hypotension).
if the patient has a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body).
if the patient has heart failure after a heart attack.

Warnings and precautions

Before starting treatment, the patient should discuss it with their doctor or pharmacist if they have or have had:
a recent heart attack,
heart failure,
a significant increase in blood pressure (hypertensive crisis),
liver disease,
a need to increase the dose (in elderly patients).

Children and adolescents

The use of Amlopin in children under 6 years of age has not been studied. The medicine should only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To obtain further information, the patient should consult their doctor.

Amlopin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those that are available without a prescription.
Amlopin and other medicines may interact with each other. These medicines include:
ketokonazole and itraconazole (antifungal medicines);
ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV infection);
rifampicin, erythromycin, clarithromycin (antibiotics);
St. John's Wort (Hypericum perforatum);
verapamil, diltiazem (medicines used to treat heart diseases);
dantrolene (a medicine used in infusion to treat severe body temperature disorders);
simvastatin (a medicine used to lower high cholesterol levels in the blood);
tacrolimus, sirolimus, everolimus, and cyclosporin (medicines used to prevent organ rejection and to treat cancer)
temsirolimus (a medicine used to treat cancer).
Amlopin may reduce blood pressure more strongly if the patient is already taking other antihypertensive medicines.

Amlopin with food and drink

If the patient is taking Amlopin, they should not eat grapefruits or drink grapefruit juice.
They may cause an increase in the level of the active substance of the medicine (amlodipine) in the blood and, as a result, an unpredictable increase in the blood pressure-lowering effect.

Pregnancy and breastfeeding

Pregnancy
The safety of using Amlopin in pregnant women has not been established. If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before starting to take Amlopin.

Driving and using machines

Amlopin may affect the patient's ability to drive or operate machines. If the patient feels nauseous, dizzy, tired, or has a headache, they should not drive or operate machines. They should immediately tell their doctor.

Amlopin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Amlopin

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The usual starting dose of Amlopin is 5 mg once a day. The doctor may increase the dose to 10 mg once a day.
The medicine can be taken with or without food and drinks. It should be taken at the same time every day, with a glass of water. The patient should not take Amlopin with grapefruit juice.

Use in children and adolescents

For children and adolescents (from 6 to 17 years old), 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. The patient should not wait for a visit to the doctor until all prescribed tablets have been taken.
The tablets can be divided into equal doses.

Taking a higher dose of Amlopin than recommended

Taking too many tablets may cause a significant decrease in blood pressure, even to dangerously low values. The patient may experience dizziness, fainting, or weakness. A significant decrease in blood pressure may cause shock. The patient's skin may be cool and moist, and they may lose consciousness. If the patient has taken too many Amlopin tablets, they should immediately seek medical help.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Amlopin

The patient should stay calm. If they forget to take a tablet, they should skip it and take the next dose at the right time. They should never take a double dose to make up for a missed dose.

Stopping treatment with Amlopin

The doctor will decide how long the patient should take this medicine. Stopping treatment earlier than recommended may cause the disease to recur.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlopin can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects after taking the medicine, they should immediately contact their doctor:

• sudden wheezing, chest tightness, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, which can make breathing difficult;
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, flu-like symptoms accompanied by the formation of blisters, peeling, and swelling of the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which can cause severe abdominal and back pain with a very bad feeling;
• liver inflammation, which can cause yellowing of the skin and the whites of the eyes (jaundice), fever, chills, fatigue, loss of appetite, abdominal pain, bad feeling, dark urine.

The following very common side effecthas been reported. If it is troublesome for the patient or lasts for more than a week, they should contact their doctor.
Very common: may affect more than 1 in 10 people
swelling (fluid retention)
The following common side effectshave been reported. If any of them are troublesome for the patient or last for more than a week, they should contact their doctor.
Common: may affect up to 1 in 10 people
headache, dizziness, drowsiness (especially at the beginning of treatment)
palpitations (feeling of heartbeat), skin redness (especially of the face)
breathing difficulties
abdominal pain, nausea
changes in bowel movements, diarrhea, constipation, indigestion
swelling of the ankles
feeling of tiredness, weakness
vision disturbances, double vision
muscle cramps
Other reported side effects are listed below. If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people
mood changes, anxiety, depression, insomnia
tremor, taste disturbances, fainting
numbness or tingling of limbs, lack of pain sensation
ringing in the ears
low blood pressure
rhinitis (runny nose)
cough
dry mouth, vomiting
hair loss, increased sweating, itching, rash, red spots on the skin, skin discoloration
urination disorders, increased need to urinate at night, increased frequency of urination
impotence, feeling of discomfort or breast enlargement in men
chest pain
pain, general bad feeling
joint or muscle pain, back pain
weight increase or decrease
Rare: may affect up to 1 in 1,000 people
confusion
Very rare: may affect up to 1 in 10,000 people
reduced number of white blood cells, reduced number of platelets, which can cause unusual bruising or bleeding easily
high blood sugar levels (hyperglycemia)
nerve disorders, which can cause weakness, numbness, or tingling
gum swelling
abdominal bloating (gastritis)
liver function disorders, yellowing of the skin (jaundice), increased liver enzyme activity, which can affect the results of some diagnostic tests
increased muscle tension
blood vessel inflammation, often with skin rash
increased sensitivity to light
Side effects with unknown frequency:frequency cannot be estimated from the available data
tremor, stiff posture, mask-like face, slow movements, and shuffling gait, unsteady gait.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Amlopin

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton and blister or container after "EXP". The expiry date refers to the last day of the month.
Blister: Store in the original package to protect from light. Do not store above 30°C.
HDPE container: Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Amlopin contains

The active substance of the medicine is amlodipine. Each tablet contains 5 mg or 10 mg of amlodipine (as besylate).
The other ingredients are: sodium carboxymethylcellulose (type A), calcium hydrogen phosphate anhydrous, microcrystalline cellulose, and magnesium stearate.

What Amlopin looks like and contents of the pack

Amlopin 5 mg
White or almost white, oblong tablet with beveled edges, with a score line on one side and the marking "5" on the other side.
Amlopin 10 mg
White or almost white, oblong tablet with beveled edges, with a score line on one side and the marking "10" on the other side.
The tablets are packed in blisters of aluminum/PVC or aluminum/OPA/aluminum/PVC, placed in a carton or packed in an HDPE container with a screw cap (with a tamper-evident seal).
Pack sizes:
Blister (aluminum/PVC or aluminum/OPA/aluminum/PVC): 30, 60, or 98 tablets.
HDPE container: 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek S.A.
ul. Podlipie 16
95-010 Stryków
ROWA PHARMACEUTICALS LTD
Bantry, Co. Cork
Ireland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179, Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
S.C. Sandoz, S.R.L.
Livezeni Street no 7A
540472 Targu Mures, Romania

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Austria
Amlodipin Hexal 5 mg – Tabletten
Amlodipin Hexal 10 mg – Tabletten
Denmark
Amlohexal
Germany
Amlodipin HEXAL 5 mg Tabletten
Amlodipin HEXAL 10 mg Tabletten
Hungary
Amlodipin Sandoz 5 mg tabletta
Amlodipin Sandoz 10 mg tabletta
Ireland
Amlode 5 mg tablets
Amlode 10 mg tablets
Italy
AMLODIPINA HEXAL AG
Poland
Amlopin 5 mg
Amlopin 10 mg

For further information, the patient should contact their local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: +48 22 209 70 00
Date of last revision of the leaflet:07/2022
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