Vilpin

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Vilpin (Amlodipin [besilat] AbZ 10 mg Tabletten)
10 mg, tablets
Amlodipinum
Vilpin and Amlodipin [besilat] AbZ 10 mg Tabletten are different brand names for the same
medicinal product.
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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Vilpin is and what it is used for
2. What you need to know 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 Vilpin is and what it is 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 known as vasospastic angina (Prinzmetal's angina).
In patients with high blood pressure, Vilpin relaxes blood vessels, allowing blood to flow more easily. In patients with ischaemic heart disease, Vilpin improves blood flow to the heart muscle, 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, 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 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,
• 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 your doctor.
Vilpin and 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 Vilpin:

• ketoconazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (so-called 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 the immune system response, allowing acceptance of 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 grapefruit during treatment with Vilpin, as they may increase the blood concentration of the active substance amlodipine, 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 child, she should consult her doctor or pharmacist before using Vilpin.
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 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 using 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. the medicine is considered "sodium-free".

3. How to use Vilpin

This medicine should always be taken 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 and 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 prescribed half a tablet, do not use any devices intended for splitting tablets. Please refer to 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 with both index fingers along the break line (Figures 1 and 2)

Figures 1 and 2: 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
once daily. The maximum recommended dose is 5 mg once daily.
It is important to take the tablets continuously. Do not wait until all tablets are used up before visiting the doctor.
Taking more Vilpin than recommended
Taking too many tablets may cause low blood pressure (even a 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, and even loss of consciousness. If an overdose of Vilpin is taken, seek medical help immediately.
Breathlessness caused by fluid accumulation in the lungs (pulmonary edema) may occur even 24–48 hours after taking the medicine.
Missed 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 take this 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 taking 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 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 symptoms worsen or if any adverse reactions 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
• Vision 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
• 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
• 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
• Excess glucose in the blood (hyperglycaemia)
• Nerve disorders which may cause weakness, tingling, or numbness
• Cough
• Gum swelling
• Abdominal bloating (gastric irritation)
• 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 to provide more information on the safety of this medicine.

5. How to store Vilpin

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging, protected from light and moisture.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the stated month.
Translation of some abbreviations appearing on the blister:
Ch.-B. und verwendbar bis siehe Prägung - Batch number/Expiry date: see embossing (on the edge of the blister).
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 packaging and other information

What Vilpin contains

• The active substance is amlodipine (in the form of amlodipine besylate). Each tablet contains 10 mg of amlodipine (as 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, embossed with "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 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 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German marketing authorisation number, country of export: 66883.00.00
Parallel import authorisation number: 25/24