Vilpin

Package Leaflet: Information for the Patient

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

Vilpin (Amlodipine [besylate] AbZ 10 mg Tablets)

10 mg, tablets
Amlodipine
Vilpin and Amlodipine [besylate] AbZ 10 mg Tablets are different trade names for the same medicine.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient 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 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 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 pectoris (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 delivered, 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 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, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor if they 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 Vilpin 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, the patient should consult their doctor.

Vilpin and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take.
Vilpin may interact with other medicines or other medicines may interact with 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 to treat 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 the patient is taking other anti-hypertensive medicines.

Vilpin with food and drink

The patient 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking Vilpin.
Pregnancy
There is no data on the safety of amlodipine in pregnancy.
If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their 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 the patient is breastfeeding or plans to breastfeed, they should consult their doctor before taking this medicine.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Vilpin may affect the patient's ability to drive or use machines. If they experience nausea, dizziness, fatigue, or headache, they should not drive or use machines; they should contact their doctor immediately.

Vilpin contains sodium

The 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 exactly as prescribed by the doctor. In case of doubt, the patient should consult their 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. The doctor may increase the dose to 10 mg once a day.
The medicine can be taken with or without food and drinks. The patient should take the medicine every day at the same time, preferably in the morning, with a glass of water. The patient should not take Vilpin with grapefruit juice.
If the doctor has prescribed half a tablet, the patient should not use any devices to divide the tablet. The patient 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 the index fingers of both hands along the break line (see Figure 1 and
• 2)

Scheme 1 and 2: instructions for easy splitting of the Vilpin tablet

Use in children and adolescents

In children and adolescents (aged 6-17), the usual starting dose is 2.5 mg once a day. The maximum recommended dose is 5 mg once a day.
It is essential to take the tablets continuously. The patient should not wait until they have used all the tablets before visiting their doctor.

Taking more Vilpin than prescribed

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

Missing a dose of Vilpin

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

Stopping Vilpin treatment

The doctor will inform the patient how long they should take the medicine. If the patient stops taking the medicine before their doctor advises, their illness may come back.
If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Vilpin can cause side effects, although not everybody gets them.
If the patient experiences any of the following very rare, severe side effects, they should immediatelycontact their 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 breathing.
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and skin swelling, 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 severe illness.

The following side effects have been reported. If any of these side effects bother the patient or last more than a week, they should contact their doctor.
Common 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 the patient experiences any worsening of side effects or any side effects not listed in this leaflet, they should tell their 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 limbs, lack of pain sensation
• Visual disturbances, double vision, tinnitus
• 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
• Disorders of erection, discomfort or enlargement of the breasts in men
• Weakness, pain, malaise
• 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
• 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, stiffness of posture, mask-like face, slow movements, and shuffling gait
• Toxic epidermal necrolysis (multiforme exfoliative blistering)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Vilpin

The medicine should be stored 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 month stated.

Translation of some abbreviations on the blister pack:

Ch.-B. und verwendbar bis siehe Prägung - Batch number/Expiry date: see embossing (on the edge of the blister pack).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vilpin contains

• The active substance of Vilpin is amlodipine (in the form of amlodipine besylate). Each tablet contains 10 mg of amlodipine (in the form of amlodipine besylate).
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose (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 the inscription "A10" and a break line, the other side of the tablet is slightly convex and smooth. The tablet can be divided into equal doses.
Vilpin is available in PVC/PVDC/Aluminum blisters containing 10 tablets. The carton contains 3 blisters (30 tablets).
To obtain more detailed information about the medicine, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the 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:

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
German authorization number: 66883.00.00

Parallel import authorization number: 25/24

Date of leaflet approval: 18.01.2024

[Information about the trademark]