Amlopin 5 mg

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Amlopin 5 mg(Амлопин 5 mg)
5 mg,tablets
Amlodipine
Amlopin 5 mg and Амлопин 5 mg are the same trade names for the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Amlopin 5 mg and what is it used for
• 2. Important information before taking Amlopin 5 mg
• 3. How to take Amlopin 5 mg
• 4. Possible side effects
• 5. How to store Amlopin 5 mg
• 6. Contents of the packaging and other information

1. What is Amlopin 5 mg and what is it used for

Amlopin 5 mg belongs to a group of medicines called calcium channel blockers.
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 5 mg improves the supply of blood to the heart muscle and, through it, oxygen, thus preventing the occurrence of chest pain. Amlopin 5 mg does not provide immediate relief from angina pain.

2. Important information before taking Amlopin 5 mg

When not to take Amlopin 5 mg

• if the patient is allergic to amlodipine, to any other calcium channel blocker, 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 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 currently 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 5 mg 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 5 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Amlopin 5 mg and other medicines may interact with each other. These medicines include:

• ketokonazole and itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used to treat heart conditions);
• dantrolene (a medicine used to treat severe body temperature disorders);
• simvastatin (a medicine used to lower high cholesterol levels in the blood);
• tacrolimus, cyclosporin (medicines used to control the immune system response, allowing the body to accept a transplanted organ).

Amlopin 5 mg may lower blood pressure more strongly if the patient is already taking other anti-hypertensive medicines.

Amlopin 5 mg with food and drink

If the patient is taking Amlopin 5 mg, 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 5 mg 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 5 mg.

Driving and using machines

Amlopin 5 mg may affect the patient's ability to drive or use machines. If the patient feels nauseous, dizzy, tired, or has a headache, they should not drive or use machines. They should immediately tell their doctor.

Amlopin 5 mg contains sodium

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

3. How to take Amlopin 5 mg

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Amlopin 5 mg and Amlopin 10 mg are available on the market.
The usual initial 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 drink. It should be taken at the same time every day, with a glass of water. The patient should not take Amlopin 5 mg with grapefruit juice.

Use in children and adolescents

For children and adolescents (from 6 to 17 years old), the recommended initial dose is 2.5 mg once a day.
The maximum recommended dose is 5 mg once a day.
It is important to take the tablets continuously. The patient should not wait until all the prescribed tablets have been taken before visiting their doctor.
The tablets can be divided into equal doses.

Taking more than the recommended dose of Amlopin 5 mg

Taking too many tablets may cause a significant decrease in blood pressure, even to dangerously low levels. The patient may feel dizzy, faint, or weak. 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 tablets of Amlopin 5 mg, they should immediately seek medical help.

Missing a dose of Amlopin 5 mg

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 5 mg

The doctor will decide how long the patient should take Amlopin 5 mg. Stopping treatment earlier than recommended may cause the illness to recur.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlopin 5 mg 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 pain, 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, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which can cause severe abdominal and back pain with very poor general condition.

The following very common side effecthas been reported. If it is troublesome for the patient or persists 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 persist for more than a week, they should contact their doctor.
Common: may affect up to 1 in 10 people

• headaches, dizziness, drowsiness (especially at the start of treatment)
• palpitations (feeling of heartbeat), skin redness (especially of the face)
• 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
• tremors, taste disturbances, fainting
• numbness or tingling of the limbs, lack of pain sensation
• ringing in the ears
• low blood pressure
• coughing/sneezing due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth, vomiting
• hair loss, increased sweating, itching, 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
• pain, general poor condition
• 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

• decreased white blood cell count, decreased platelet count, which may cause unusual bruising or bleeding
• high blood sugar levels (hyperglycemia)
• nerve disorders, which may cause weakness, numbness, or tingling
• gum swelling
• abdominal bloating (gastritis)
• liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may 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

• tremors, stiff posture, mask-like face, slow movements, and shuffling 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 or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Amlopin 5 mg

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature below 30°C. Store in the original packaging 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 they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Amlopin 5 mg contains

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

What Amlopin 5 mg looks like and what the packaging contains

White or almost white, oblong tablet with beveled edges, with a score line on one side and the marking "5" on the other side.
Packaging contains 30 and 60 tablets.
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Sandoz d.d. Verovškova 57, 1000 Ljubljana, Slovenia

Manufacturer:

LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland
LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland
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., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Bulgaria, the country of export:20090067

Parallel import authorization number: 128/22 Date of leaflet approval: 11.03.2022

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