Vilpin

Patient Information Leaflet

Caution! Please keep this leaflet. The packaging information is in a foreign language.
Vilpin (Amloteron)
10 mg, tablets
Amlodipinum
Vilpin and Amloteron are different trade names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

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 pack 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 channel blockers.
Vilpin is indicated for the treatment of high blood pressure (hypertension) or chest pain known as angina pectoris, including its rare form called vasospastic angina (Prinzmetal's angina).
In patients with high blood pressure, the medicine relaxes blood vessels, making it easier for blood to flow. In patients with ischemic heart disease, Vilpin improves blood flow to the heart muscle by increasing oxygen supply, thereby preventing chest pain. The medicine does not provide immediate relief from angina pain.

2. Important information before using Vilpin

When not to use 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 significant low blood pressure (hypotension).
• If the patient has aortic valve stenosis or cardiogenic shock (a condition in which the heart is unable to deliver enough blood to meet the body's needs).
• If the patient has heart failure following a heart attack.

Warnings and precautions
Before starting treatment with Vilpin, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has had any of the following conditions:

• Recent heart attack,
• Heart failure,
• Severe high blood pressure (hypertensive crisis),
• Liver disease,
• Requirement for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of this medicine in children under 6 years of age have not been conducted. Vilpin may be used only for the treatment of hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, please consult your doctor.
Vilpin with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Vilpin may affect other medicines, or other medicines may affect Vilpin:

• ketoconazole, 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 (used intravenously in severe disturbances of body temperature),
• simvastatin (a medicine that lowers cholesterol levels),
• tacrolimus (used to control immune system responses, allowing the body to accept a transplanted organ).

Vilpin may lower blood pressure to a greater extent if the patient is taking other antihypertensive medicines.
Vilpin with food and drink
Do not consume grapefruit juice or grapefruits while taking Vilpin, as they may increase the concentration of the active substance—amlodipine—in the blood, which could lead to an unexpected intensification of Vilpin's blood pressure-lowering effect.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There are no data on the safety of amlodipine use during pregnancy.
If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using 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 the patient is breastfeeding or planning to breastfeed, she should consult her doctor before using this medicine.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Vilpin may affect the ability to drive or operate machinery. If nausea, dizziness, fatigue, or headache occur, the patient should not drive or operate machinery and should contact their doctor immediately.
Vilpin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Vilpin

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Vilpin is available in doses of 5 mg and 10 mg.
The usual starting dose of Vilpin is 5 mg once daily. Your doctor may increase the dose to
10 mg once daily.
This medicine may be taken regardless of meals or drinks. The medicine should be taken daily at the
same time, preferably in the morning, with water. Do not take Vilpin with grapefruit juice.
If your doctor has recommended taking half a tablet, do not use any devices designed for splitting
tablets. Please follow the instructions below showing how to break the tablet:

• Place the tablet with the imprint facing upwards on a flat, hard surface (e.g., on a table or countertop).
• Break the tablet by pressing your index fingers from both hands along the break line (Figure 1 and 2).

Scheme 1: instructions for simple method of breaking Vilpin tablet in half
Use in children and adolescents
In children and adolescents (6–17 years of age), the usual 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 tablets are used before visiting
your doctor.
Taking more Vilpin than prescribed
Taking too many tablets may cause a drop in blood pressure (even a very significant drop).
Dizziness, a sensation of "emptiness" in the head, fainting, or weakness may occur. If a significant
drop in blood pressure occurs, shock may develop, with symptoms such as cold and clammy skin,
and even loss of consciousness. If an overdose of Vilpin is taken, seek immediate medical help.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur
within 24–48 hours after taking the medicine.
Missing a dose of Vilpin
Stay calm. If a patient forgets to take a tablet, skip that dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Vilpin treatment
Your doctor will inform you how long you should continue taking the medicine. If you stop taking
the medicine before your doctor advises, your condition may recur.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following very rare, serious adverse reactions occur after using the medicine, 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 significant breathing difficulties.
• Severe skin reactions, including severe rash, urticaria, redness of the entire body surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
• Heart attack, heart rhythm disorders.
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition.

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome to the patient or persist for more than one week, contact your doctor.

Common adverse reactions: occurring in 1 to 10 out of 100 patients

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

Other reported adverse reactions 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 adverse reactions: occurring in 1 to 10 out of 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting, weakness
• Numbness or tingling of limbs, loss of pain sensation
• Visual disturbances, double vision, tinnitus
• Low blood pressure
• Sneezing and/or nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Changes in bowel habits, diarrhoea, constipation, indigestion, dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or enlargement of breasts in men
• Weakness, pain, malaise
• Joint or muscle pain, muscle cramps, back pain
• Increase or decrease in body weight

Rare adverse reactions: occurring in 1 to 10 out of 10,000 patients

• Disorientation

Very rare adverse reactions: occurring in fewer than 1 out of 10,000 patients

• Decreased number of white blood cells, decreased number of platelets, which may lead to bruising or easy bleeding
• Excessively high blood glucose levels (hyperglycaemia)
• Nerve disorders, which may cause weakness, tingling, or numbness
• Cough
• Gum swelling
• Abdominal bloating (gastritis)
• Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, detected in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Light sensitivity
• Disorders involving stiffness, tremor, and/or difficulty moving

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

• Tremor, postural rigidity, facial masking, slowed movements, shuffling gait, unsteady gait
• Toxic epidermal necrolysis (erythema multiforme with blistering and peeling)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vilpin

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Vilpin contains

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

What Vilpin looks like and contents of the pack
White, round tablets. One side of the tablet is slightly concave, with an embossing of "A10" and a dividing line, the other side is slightly convex and smooth. The tablet can be divided into equal doses.
The medicine is available in PVC/PVDC/Aluminium blisters containing 10 tablets. Each carton box contains 3 blisters (30 tablets).
For more detailed information about the medicine, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, country of export:
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer:
Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Bulgaria, country of export: 20080100
Parallel import authorisation number: 141/23