Amlopin 5 mg

Package leaflet: information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Amlopin 5 mg (Amlopin 5 mg)
5 mg, tablets
Amlodipinum
Amlopin 5 mg and Amlopin 5 mg are trade names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms of illness are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Amlopin 5 mg is and what it is 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 pack and other information

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

Amlopin 5 mg belongs to a group of medicines called calcium channel blockers.
It is used in the treatment of:

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

In patients with high blood pressure, the medicine reduces the tension in the blood vessels, thus facilitating blood flow.
In patients with angina pectoris, Amlopin 5 mg improves blood supply to the heart muscle and thereby oxygen delivery, preventing the occurrence of chest pain. Amlopin 5 mg does not provide immediate relief from anginal pain.

2. Important information before using Amlopin 5 mg

When not to use Amlopin 5 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 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 heart attack.

Warnings and precautions
Before starting treatment, discuss with your doctor or pharmacist if the patient currently has or has had in the past:

• a recent heart attack,
• heart failure,
• significantly increased blood pressure (hypertensive crisis),
• liver disease,
• need for dose adjustment (in elderly patients).

Children and adolescents
The use of Amlopin 5 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 your doctor.

Amlopin 5 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription.
Amlopin 5 mg and other medicines may affect each other's actions. These include:

• ketoconazole and itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (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 (a medicine used intravenously in severe disturbances of body temperature);
• simvastatin (a medicine used to lower elevated blood cholesterol levels);
• tacrolimus, cyclosporine (medicines used to control the immune system response, allowing acceptance of transplanted organs).

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

Amlopin 5 mg with food and drink
If the patient is taking Amlopin 5 mg, they should not eat grapefruit or drink grapefruit juice. These may increase the blood concentration of the active substance (amlodipine) and consequently lead to unpredictable intensification of blood pressure-lowering effects.

Pregnancy and breastfeeding
Pregnancy
The safety of using Amlopin 5 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 her doctor or pharmacist before using this medicine.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human breast milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before starting treatment with Amlopin 5 mg.

Driving and operating machinery
Amlopin 5 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 5 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Amlopin 5 mg

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Available on the market are: Amlopin 5 mg and Amlopin 10 mg.
The usual initial dose of Amlopin 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 5 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 than the recommended dose of Amlopin 5 mg
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 drop in blood pressure may lead to shock. The patient's skin may become cold and clammy, and loss of consciousness is possible. If a patient has taken too many Amlopin 5 mg tablets, seek immediate medical help.
Missing a dose of Amlopin 5 mg
Stay calm. If a 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 treatment with Amlopin 5 mg
Your doctor will determine how long you should take Amlopin 5 mg. Stopping treatment earlier than advised may cause the condition to return.
If you have any further doubts regarding 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 pain, 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, hives, redness of the entire skin surface, severe itching, formation of blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which may cause severe abdominal and back pain with a very poor general condition.

The following very common side effect has been reported. If it is troublesome for the patient or
if it persists for more than one week , consult a doctor .
Very common : may affect 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 affect up to 1 in 10 people

• headache, dizziness, drowsiness (especially at the beginning of treatment)
• palpitations (awareness of heartbeat), skin flushing (especially of the face)
• abdominal pain, nausea
• changes in bowel rhythm, diarrhoea, constipation, indigestion
• ankle swelling
• feeling of fatigue, weakness
• visual disturbances, double vision
• muscle cramps.

Other reported side effects are listed below. If any of the adverse effects worsen or if any adverse
effects not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon : may affect up to 1 in 100 people

• mood swings, anxiety, depression, insomnia
• tremor, taste disturbances, fainting
• numbness or tingling of limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth, vomiting
• hair loss, excessive sweating, skin itching, appearance of red skin spots, skin discoloration
• problems with urination, increased need to urinate at night, increased frequency of urination
• impotence, discomfort or enlargement of breasts in men
• pain, general malaise
• joint or muscle pain, back pain
• weight gain or weight loss.

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 may cause unusual bruising or easy bleeding
• high blood sugar levels (hyperglycaemia)
• nerve disorders, which may cause weakness, tingling or numbness
• gum swelling
• abdominal bloating (gastric mucosal inflammation)
• liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect results of certain diagnostic tests
• increased muscle tension
• inflammation of blood vessels, 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 any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of 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.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Amlopin 5 mg

Keep the medicine out of the 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 stated month.
Store below 30°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Amlopin 5 mg contains

• The active substance is amlodipine. Each tablet contains 5 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 5 mg looks like and contents of the pack
White or almost white, elongated tablet with bevelled edges, marked with a dividing line on one side and the imprint "5" on the other side.
Pack sizes contain 30 and 60 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia
Manufacturer:
LEK S.A., Podlipie 16, 95-010 Stryków, Poland
LEK S.A., 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 Târgu-Mureș, Romania
Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Bulgaria, country of export: 20090067
Parallel Import Licence Number: 128/22