Vilpin

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Vilpin (Amlodipine [besilate] AbZ), 10 mg, tablets
Amlodipinum
Vilpin and Amlodipine [besilate] AbZ are different trade names for the same medicine.
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 give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your 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 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 ischaemic heart disease, Vilpin improves blood flow to the heart muscle, increasing the oxygen supply, thereby preventing chest pain.
This medicine does not provide immediate relief of anginal 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 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, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or has previously 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 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 and 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 the action of other medicines, or other medicines may affect the action of 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 reactions, 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.

Taking Vilpin with food and drink
Do not consume grapefruit juice or grapefruit while taking Vilpin, as they may increase the blood concentration of the active substance—amlodipine—resulting in 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 child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are no data available 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.

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 the doctor immediately.

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

3. How to use Vilpin

This medicine should always be used according to the doctor's instructions. If in doubt, 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 daily. Your doctor may increase the dose to 10 mg once daily.
Vilpin can be taken regardless of meals and drinks. The medicine should be taken every day 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 tablet-splitting devices. Please refer to the instructions below showing how to break the tablet:

• Place the tablet with the embossed side facing upwards on a flat, hard surface (e.g. on a table or countertop).
• Break the tablet by pressing down with both index fingers along the break line (Figure 1).

Diagram: instructions for simple method of breaking Vilpin tablet 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 strength Vilpin tablet.
It is important to take the tablets continuously. Do not wait until all tablets are used before visiting your doctor.
Taking more Vilpin than recommended
Taking too many tablets may cause a drop in blood pressure (even a very significant drop). Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. If blood pressure drops significantly, shock may develop, with symptoms such as cold and clammy skin, or even loss of consciousness. If an overdose of Vilpin is taken, seek medical help immediately.
Breathing difficulties 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 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 this medicine. If you stop taking Vilpin before your doctor advises, your condition may return.
If you have any further doubts about using this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following very rare, serious adverse reactions occur after using the medicine, you should 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 causing significant breathing difficulties.
• Severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, cardiac 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, consult a 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
• Ankle swelling, 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 rhythm, diarrhoea, constipation, indigestion, dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin color changes
• Urinary disturbances, 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 white blood cell count, decreased platelet count, which may lead to bruising or easy bleeding
• Excessively high blood glucose levels (hyperglycaemia)
• Nerve disorders causing weakness, tingling or numbness
• Cough
• Gum swelling
• Abdominal bloating (dyspepsia)
• 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
• Photosensitivity
• Movement disorders involving rigidity, 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 walk
• 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 reactions helps provide more information on the safety of this 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.
Translation of some information on the immediate packaging:
Ch.-B. und verwendbar bis: siehe Prägung - Batch number and expiry date: see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 an imprint
"A10" and a score 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. A cardboard carton contains
3 blisters (30 tablets).
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Germany, country of export:
AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company

• Teva Gyógyszergyár Zrt. - Pallagi út 13 4042 Debrecen Hungary

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Germany, country of export: 66883.00.00
Parallel Import Authorisation Number: 113/23