Vilpin

Leaflet attached to the packaging: patient information

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

Vilpin (Amloterone), 10 mg, tablets

Amlodipine
Vilpin and Amloterone are different trade names for the same drug written in Polish and Bulgarian.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their disease symptoms 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 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 flow to the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain.
The medicine does not provide immediate relief from angina pain.

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, skin redness, 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 deliver blood in the amount needed by the body).
• If the patient has heart failure after a heart attack.

Warnings and precautions

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

• recently had a heart attack,
• heart failure,
• significant increase in 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).
For further information, consult a doctor.

Vilpin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Vilpin may affect other medicines or other medicines may affect Vilpin:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (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, allowing the body to accept a transplanted organ).

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

Taking Vilpin with food and drink

Do 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, consult your doctor or pharmacist before taking the medicine.
Pregnancy
There is no data on the safety of amlodipine during pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a child, consult your 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, consult your doctor before taking this medicine.
Before taking any medicine, consult your 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, do not drive or use machines; consult 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

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Vilpin is available in the following strengths: 5 mg, 10 mg.
The usual starting dose of Vilpin is 5 mg once a day. Your doctor may increase the dose to 10 mg once a day.
You can take the medicine with or without food and drinks. Take the medicine every day at the same time, preferably in the morning, with a glass of water. Do not take Vilpin with grapefruit juice.
If your doctor has told you to take half a tablet, do not use any devices to divide the tablet. 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 (figure 1)

Figure 1: instructions for easily breaking 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 once a day. The maximum recommended dose is 5 mg once a day.
A 2.5 mg dose can be achieved using a 5 mg Vilpin tablet.
It is important to take the tablets continuously. Do not wait until you have used all the tablets before visiting your doctor.

Taking more Vilpin than prescribed

Taking too many tablets may cause a significant drop in blood pressure (even a very 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, seek medical help immediately.
Up to 24-48 hours after taking the medicine, you may experience shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema).

Missing a dose of Vilpin

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

Stopping Vilpin treatment

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

4. Possible side effects

Like all medicines, Vilpin can cause side effects, although not everybody gets them.
If you experience any of the following very rare, serious side effects, contact your doctor immediately.

• 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 breathing.
• Severe skin reactions, including severe rash, hives, redness of the skin, severe itching, blisters, peeling, and skin swelling, 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 health.

The following side effects have been reported. If any of these side effects bother you or last more than a week, consult your doctor.
Common side effects:occur in 1 to 10 out of 100 patients

• Headache, dizziness, drowsiness (especially at the start of treatment)
• Palpitations (awareness of "beating" of the heart), 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 you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.
Uncommon side effects:occur in 1 to 10 out of 1000 patients

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disorders, fainting, weakness
• Numbness or tingling of limbs, lack of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel movements, diarrhea, constipation, indigestion, dry mouth, vomiting
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Sexual disorders, discomfort or enlargement of the breasts in men
• Weakness, pain, poor general health
• Joint or muscle pain, muscle cramps, back pain
• Weight gain or loss

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

• Disorientation

Very rare side effects:occur 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
• Gum swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, 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 moving

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

• Tremors, unsteady posture, mask-like face, slow movements, and shuffling gait
• Toxic epidermal necrolysis (multiforme erythema, peeling blisters)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, 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 Vilpin

Keep the medicine out of the sight and reach of children.
Do not store above 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Vilpin contains

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

What Vilpin looks like and contents of the pack

Vilpin, 10 mg, is a white, round tablet. One side of the tablet is slightly concave, with the embossing "A10" and a break 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/Al blisters containing 10 tablets. The cardboard box contains 3 blisters (30 tablets).
For more detailed information, consult 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:

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
Marketing authorization number in Bulgaria, the country of export:20080100
Parallel import authorization number:239/22

Date of leaflet approval: 24.05.2023

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