Vilpin

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Vilpin (Амлотерон)

10 mg, tablets
Amlodipine
Vilpin and Амлотерон are different 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Vilpin and what is it used for

Vilpin contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Vilpin is indicated for the treatment of high blood pressure (hypertension) or chest pain called angina pectoris and its rare form called vasospastic angina (Prinzmetal's angina).
In patients with high blood pressure, the medicine widens the blood vessels, making it easier for blood to flow.
In patients with coronary heart disease, Vilpin makes it easier for blood to reach the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. The medicine does not provide immediate relief from angina attacks.

2. Important information before taking Vilpin

When not to take Vilpin

• If the patient is allergic (hypersensitive) to amlodipine, other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
• If the patient has significantly low blood pressure (hypotension).
• If the patient has narrowing of the aortic valve or cardiogenic shock (a condition in which the heart is unable to supply blood to meet the body's needs).
• If the patient has heart failure after a heart attack.

Warnings and precautions

Before starting to take Vilpin, you should discuss it with your doctor or pharmacist.
You should inform your doctor if you have or have had any of the following conditions:

• recently had a heart attack,
• heart failure,
• significantly increased blood pressure (hypertensive crisis),
• liver disease,
• need to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of the medicine in children under 6 years of age. Vilpin can 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, you should consult a doctor.

Vilpin and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Vilpin may affect other medicines or other medicines may affect Vilpin:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infection),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort,
• verapamil, diltiazem (medicines used for heart conditions),
• dantrolene (used in severe body temperature disorders),
• simvastatin (a medicine that lowers cholesterol levels),
• tacrolimus (used to control the immune system's response, allowing the body to accept a transplanted organ).

Vilpin may lower blood pressure more if you are taking other anti-hypertensive medicines.

Vilpin with food and drink

You should not consume grapefruit juice or grapefruits while taking Vilpin, as they may cause an increase in the level of the active substance amlodipine in the blood, which may lead to an unexpected increase in the blood pressure-lowering effect of Vilpin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking the medicine.
Pregnancy
There is no data on the safety of using amlodipine during pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a child, you should consult a doctor before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. The effect of amlodipine on infants is unknown. If you are breastfeeding or plan to breastfeed, you should consult a doctor before taking this medicine.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Vilpin may affect your ability to drive or use machines. If you experience nausea, dizziness, fatigue, or headache, you should not drive or use machines; you should contact your doctor immediately.

Vilpin contains sodium

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

3. How to take Vilpin

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Vilpin is available in 5 mg and 10 mg doses.
The usual starting dose of Vilpin is 5 mg once a day. Your doctor may increase the dose to 10 mg once a day.
The medicine can be taken with or without food and drinks. You should take the medicine every day at the same time, preferably in the morning, with a glass of water. You should not take Vilpin with grapefruit juice.
If your doctor has prescribed half a tablet, you should not use any devices to divide the tablet. You should follow the instructions below to split the tablet:

• place the tablet with the embossing facing up on a flat, hard surface (e.g., a table or countertop).
• break the tablet by pressing it with your index fingers on both hands along the break line (drawing 1 and
• 2)

Scheme 1: instructions for simple splitting of the Vilpin tablet in half

Use in children and adolescents

In children and adolescents (6-17 years old), the usual starting dose is 2.5 mg per day.
The maximum recommended dose is 5 mg per day.
It is essential to take the tablets continuously. You should not wait until all the tablets have been used before visiting your doctor.

Overdose of Vilpin

Taking too many tablets may cause a drop in blood pressure (even a significant drop). You may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. If you experience a significant drop in blood pressure, you may go into shock, the symptoms of which include: cool and moist skin, and even loss of consciousness. If you have taken too many Vilpin tablets, you should seek medical help immediately.
Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema).

Missed dose of Vilpin

You should stay calm. If you forget to take a tablet, you should skip it. You should take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping Vilpin treatment

Your doctor will inform you how long you should take the medicine. If you stop taking the medicine before your doctor advises you to, your condition may worsen.
If you have any further doubts about taking this medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following very rare, serious side effects after taking the medicine, you should immediatelycontact your doctor.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat, causing severe difficulty in breathing.
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense itching, blisters, and peeling of the skin, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, arrhythmias.
• Pancreatitis, which can cause severe abdominal pain radiating to the back with very poor general condition. The following frequent side effects have been reported. If any of the side effects are troublesome for you or last more than a week, you should contact your doctor.

Frequent side effects:occurring in 1 to 10 out of 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of the heartbeat), sudden reddening (especially of the face)
• Abdominal pain, nausea
• Swelling of the ankles, fatigue

Other reported side effects are listed below. If any of the side effects worsen or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Uncommon side effects:occurring in 1 to 10 out of 1000 patients

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disorders, fainting, weakness
• Numbness or tingling of the limbs, lack of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing and (or) runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Changes in bowel movements, diarrhea, constipation, indigestion, dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, changes in skin color
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Weakness, pain, poor general condition
• Pain in the joints or muscles, muscle cramps, back pain
• Weight gain or loss

Rare side effects:occurring in 1 to 10 out of 10,000 patients

• Disorientation

Very rare side effects:occurring less often than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count, which may lead to bruising or easy bleeding
• High blood sugar levels (hyperglycemia)
• Nerve disorders that can cause weakness, numbness, or tingling
• Cough
• Gingival swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, found in blood tests
• Increased muscle tension
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremors, and (or) difficulty walking

Frequency not known:(frequency cannot be estimated from the available data)

• Tremors, stiffness of posture, mask-like face, slow movements, and dragging of the feet while walking, unsteady gait
• Toxic epidermal necrolysis (multiforme erythema, blistering exfoliative)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 the medicine.

5. How to store Vilpin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vilpin contains

• The active substance of the medicine is amlodipine. Each tablet contains 10 mg of amlodipine in the form of amlodipine besylate.
• Other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), magnesium stearate.

What Vilpin looks like and what the packaging contains

White, round tablets. One side of the tablet is slightly concave, with the embossing "A10" and a dividing line, the other side of the tablet is slightly convex and smooth. The tablet can be divided into equal doses.
The medicine is available in PVC/PVDC/Aluminum blisters containing 10 tablets. The cardboard box contains 3 blisters (30 tablets).
To obtain more detailed information about the medicine, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, Netherlands
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Czech Industries s.r.o., Ostravská 29, č.p. 305, 747 70 Opava – Komárov, Czech Republic
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20080100

Parallel import authorization number: 141/23

Date of approval of the leaflet: 14.07.2023

[Information about the trademark]