Vilpin

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Vilpin (Amloteron), 10 mg, tablets
Amlodipine
Vilpin and Amloteron are different trade names of the same medicinal product written in Polish and Bulgarian.
Please read the entire leaflet carefully before use, 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, please 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 another person, even if their symptoms 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:

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 amlodipine as the active substance, 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 less common 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, increasing oxygen supply, thereby preventing chest pain.
This 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, skin redness, 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 sufficient 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, consult 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,
• need for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of Vilpin 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 a doctor.

Vilpin with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Vilpin may affect the action of other medicines, or other medicines may affect the action of Vilpin:

• ketoconazole, itraconazole (antifungal agents),
• 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 in heart diseases),
• dantrolene (used intravenously in severe disturbances of body temperature),
• simvastatin (a medicine that lowers cholesterol levels),
• tacrolimus (used to suppress immune system reactions, allowing acceptance of transplanted organs).

Vilpin may lower blood pressure to a greater extent if the patient is taking other antihypertensive medicines.

Taking Vilpin with food and drink
Do not consume grapefruit juice or grapefruits while taking Vilpin, as they may increase the blood concentration of the active substance—amlodipine—potentially leading 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 become pregnant, she should consult her doctor or pharmacist before using Vilpin.

Pregnancy
There are no adequate data on the safety of amlodipine use during pregnancy.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, 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.
Always consult a doctor or pharmacist before using any medicine.

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 a doctor immediately.

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

3. How to take Vilpin

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Vilpin is available in the following doses: 5 mg, 10 mg.
The usual starting dose of Vilpin is 5 mg once daily. Your doctor may increase the dose to
10 mg once daily.
Vilpin can be taken independently of meals and beverages. 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 advised taking half a tablet, do not use any devices designed for tablet splitting.
Please refer to the instructions below on how to correctly break the tablet in half:

• 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 with both index fingers along the break line (Figure 1).

Figure 1: Instruction for simple method of breaking Vilpin tablets in half.
Use in children and adolescents
In children and adolescents (aged 6–17 years), the usual recommended starting dose is 2.5 mg
per day. The maximum recommended dose is 5 mg per day.
A 2.5 mg dose can be achieved using the 5 mg Vilpin tablet.
It is important to take the tablets continuously. Do not wait until all tablets are used up before
visiting your doctor.
Taking more than the recommended dose of Vilpin
Taking too many tablets may cause a drop in blood pressure (even a very significant drop).
Symptoms may include dizziness, a feeling of "emptiness" in the head, fainting, or weakness.
If blood pressure drops significantly, shock may occur, with symptoms such as cold and
clammy skin, or even loss of consciousness. If an overdose of Vilpin is taken, seek medical
help immediately.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur
even 24–48 hours after taking the medicine.
Missing a dose of Vilpin
Stay calm. If a patient forgets to take a tablet, skip the missed 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
Vilpin before your doctor advises, your condition may return.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following very rare, serious adverse effects occur after taking the medicine, contact a 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 skin all over the body, intense itching, blisters, peeling and swelling of the skin, 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 effects have been reported. If any of these adverse effects are troublesome for the patient or persist for more than one week, contact a doctor.
Common adverse effects: occurring in 1 to 10 out of 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), sudden flushing (especially of the face)
• Abdominal pain, nausea
• Ankle swelling, fatigue

Other reported adverse 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 adverse effects: 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 runny nose 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
• Urinary 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
• Weight gain or weight loss

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

• Disorientation

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

• Decreased white blood cell count, decreased platelet count, which may lead to bruising or easy bleeding
• Excess glucose in the blood (hyperglycaemia)
• Nerve disorders causing 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 rigidity, tremor, and/or difficulty moving

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

• Tremor, postural instability, facial masking, slowed movements, shuffling gait with dragging of the feet, unsteady gait
• Toxic epidermal necrolysis (erythema multiforme with blistering and peeling)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse 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 adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vilpin
Keep the medicine out of 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 stated month.
Medicines should not be disposed of via the sewage system 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 pack and other information

What Vilpin contains

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

What the medicine looks like and contents of the pack
Vilpin 10 mg are white, round tablets. One side of the tablet is slightly concave, with the imprint
"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/Al blisters containing 10 tablets. Each cardboard box contains 3 blisters (30 tablets).
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the 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:
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 Authorisation Number in Bulgaria, the country of export: 20080100
Parallel Import Authorisation Number: 239/22