Vilpin

Package Leaflet: Information for the Patient

Vilpin, 5 mg, Tablets

Vilpin, 10 mg, Tablets

Amlodipine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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, known as angina pectoris, and its rare form known as Prinzmetal's angina (vasospastic angina).
In patients with high blood pressure, this medicine widens the blood vessels, making it easier for the blood to flow.
In patients with coronary heart disease, Vilpin makes it easier for the blood to reach the heart muscle, increasing the amount of oxygen delivered, which in turn prevents chest pain.
This medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Vilpin

When not to take Vilpin

• If you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine listed in section 6, or to any other calcium antagonist. Symptoms may include itching, redness of the skin, or difficulty breathing.
• If you have very low blood pressure (hypotension).
• If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to deliver enough blood to the body).
• If you have heart failure after a recent heart attack.

Warnings and precautions

Before taking Vilpin, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had any of the following conditions:

• recent heart attack
• heart failure
• significant increase in 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 this medicine 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). For further information, consult your doctor.

• 3) To obtain further information, consult your doctor.

Vilpin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Vilpin may affect other medicines or other medicines may affect Vilpin:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (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)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporin (an immunosuppressive medicine)

Vilpin may lower blood pressure more when you are taking other blood pressure-lowering medicines.

Vilpin with food and drink

Patients taking Vilpin should not consume grapefruit juice or grapefruit, as they may cause an increase in the levels of the active substance amlodipine in the blood, which may lead to an unexpected increase in the effect of Vilpin, lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
There are no data on the safety of amlodipine in pregnancy.
If you are pregnant, think you may be pregnant, or plan to have a baby, consult your 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 you are breastfeeding or plan to breastfeed, tell your doctor before taking this medicine.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Vilpin may affect your ability to drive or use machines. If you experience nausea, dizziness, fatigue, or headache, do not drive or use machines; contact your doctor immediately.

Vilpin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Vilpin

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended initial dose of Vilpin is 5 mg once daily. The dose may be increased to 10 mg once daily.
This medicine can be taken with or without food and drinks. It is recommended to take this medicine at the same time every day, preferably in the morning, with a glass of water. Do not take Vilpin with grapefruit juice.
If your doctor has prescribed half a tablet, do not use any devices to split the tablet. Follow the instructions below to split the tablet:

• place the tablet with the score line facing up on a flat, hard surface (e.g., a table or countertop).
• break the tablet by pressing it with your index fingers on both hands along the score line (diagram 1 and 2)

Scheme 1 and 2: instructions for easily breaking the Vilpin 5 mg and Vilpin 10 mg tablets in half.

Use in children and adolescents

In children and adolescents (aged 6-17), the recommended initial dose is usually 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 you have taken all the tablets before visiting your doctor.

Overdose of Vilpin

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. You may experience dizziness, a feeling of emptiness in the head, fainting, or weakness. In the case of a significant decrease in blood pressure, shock may occur, with symptoms including cool and moist skin, and even loss of consciousness. If you have taken too many Vilpin tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missed dose of Vilpin

Stay calm. If you forget to take a tablet, skip it. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Vilpin

Your doctor will tell you how long to take this medicine. If you stop taking the medicine before your doctor tells you to, your condition may worsen.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vilpin can cause side effects, although not everybody gets them.
You should immediatelycontact your doctor if you experience any of the following side effects after taking the medicine.

• 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 in breathing
• Severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and skin swelling, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, irregular heartbeat
• Pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition

The following very common side effectshave been reported. If any of these side effects bother you or last more than a week, you should contact your doctor.
Very common side effects:occur in at least 1 in 10 patients

• Swelling (fluid retention)

The following common side effectshave been reported. If any of these side effects bother you or last more than a week, you should contact your doctor.
Common side effects:occur in less than 1 in 10 patients but more than 1 in 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), flushing
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other reported side effects are listed below. If any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Uncommon side effects:occur in less than 1 in 100 patients but more than 1 in 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of the limbs, lack of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing and (or) runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Impotence, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Pain in the joints or muscles, back pain
• Weight gain or loss

Rare side effects:occur in less than 1 in 1,000 patients

• Disorientation

Very rare side effects:occur in less than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and easier bleeding
• High blood sugar levels (hyperglycemia)
• Nerve disorders that can cause muscle weakness, numbness, or tingling
• Gum swelling, gum bleeding
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in blood tests
• Increased muscle tension
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, tremor, and (or) difficulty in movement

Frequency not known:cannot be estimated from the available data

• Tremor, stiffness, mask-like face, slow movements, and a shuffling, unsteady gait
• Toxic epidermal necrolysis (multiforme erosive blistering)

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vilpin

Keep the medicine out of the sight and reach of children.
Vilpin, 5 mg: Store in a temperature below 25°C, in the original packaging.
Vilpin, 10 mg: Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton after the words: "Expiry date" or "EXP". The expiry date refers to the last day of the month.
The batch number on the packaging is stated after the words: "Batch number" or "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vilpin contains

• The active substance of Vilpin is amlodipine. Each Vilpin 5 mg tablet contains 5 mg of amlodipine in the form of amlodipine benzenesulfonate. Each Vilpin 10 mg tablet contains 10 mg of amlodipine in the form of amlodipine benzenesulfonate.
• The other ingredients are: Vilpin, 5 mg: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), magnesium stearate. Vilpin, 10 mg: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium carboxymethylcellulose (type A), magnesium stearate.

What Vilpin looks like and contents of the pack

Vilpin, 5 mg, are white, round tablets. One side of the tablet is slightly concave, with the inscription "A5" and a score line, the other side is slightly convex and smooth. The tablet can be divided into equal doses.
Vilpin, 10 mg, are white, round tablets. One side of the tablet is slightly concave, with the inscription "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, each containing 10 tablets. The carton contains 3 blisters (30 tablets).

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
phone: (22) 345 93 00

Manufacturer:

Teva Operations Poland Sp. z o.o.
Mogilska 80;
31-546 Krakow
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary

Date of last revision of the leaflet: