VILPIN 10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Vilpin, 5 mg, tablets
3. Vilpin, 10 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Vilpin and what is it used for
5. Important information before taking Vilpin
   1. When not to take Vilpin
   2. Warnings and precautions
   3. Children and adolescents
   4. Vilpin and other medicines
   5. Vilpin with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Vilpin contains sodium
6. How to take Vilpin
   1. Scheme 1 and 2: instructions for easy breaking of the Vilpin 5 mg and Vilpin 10 mg tablets.
   2. Use in children and adolescents
   3. Overdose of Vilpin
   4. Missed dose of Vilpin
   5. Stopping treatment with Vilpin
7. Possible side effects
   1. Reporting side effects
8. How to store Vilpin
9. Contents of the pack and other information
   1. What Vilpin contains
   2. What Vilpin looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Vilpin, 5 mg, tablets

Vilpin, 10 mg, tablets

Amlodipine

Read the 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any 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, 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 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 supplied, 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 the patient is 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 the patient has very low blood pressure (hypotension).
• If the patient has narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot supply enough blood to the body).
• If the patient has heart failure after a recent 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:

• 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 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). For further information, the patient should consult their doctor.

• 3) For further information, the patient should consult their doctor.

Vilpin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Vilpin may interact with other medicines or other medicines may interact with 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 temperature regulation disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (a medicine that lowers cholesterol levels)
• cyclosporin (an immunosuppressant medicine)

Vilpin may lower blood pressure more when the patient is taking other blood pressure-lowering medicines.

Vilpin with food and drink

Patient taking Vilpin should not consume grapefruit juice or eat grapefruits, as they may increase 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 is no data on the safety of amlodipine during pregnancy.
If the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. The effect of amlodipine on breastfed infants is unknown. If the patient is breastfeeding or plans to breastfeed, she should tell her doctor before taking this medicine.
Before taking any medicine, the patient should consult her doctor or pharmacist.

Driving and using machines

Vilpin may affect the patient's ability to drive or use machines. If the patient experiences 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 essentially '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.
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 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 score line 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 score line (diagram 1 and 2)

Scheme 1 and 2: instructions for easy breaking of the Vilpin 5 mg and Vilpin 10 mg tablets.

Use in children and adolescents

In children and adolescents (6-17 years old), the recommended initial dose is usually 2.5 mg once daily.
The maximum recommended dose is 5 mg once daily.
It is essential to take the tablets continuously. The patient should not wait until all the tablets have been used before visiting their doctor.

Overdose of Vilpin

Taking too many tablets may cause a decrease or even a dangerous decrease in blood pressure. The patient may experience dizziness, a feeling of emptiness in the head, fainting, or weakness. In the event of a significant drop in blood pressure, the patient may experience 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 contact their doctor or go to the emergency department of the nearest hospital 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).

Missed dose of Vilpin

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

Stopping treatment with Vilpin

The doctor will inform the patient how long they should take this medicine. If the patient stops taking the medicine before their doctor advises, their condition may worsen.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vilpin can cause side effects, although not everybody gets them.
The patient should immediatelycontact their doctor if they 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 breathing difficulties
• 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 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 are troublesome or last for more than a week, the patient should contact their 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 are troublesome or last for more than a week, the patient should contact their 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 start of treatment)
• Pounding heart (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 the patient experiences any side effects not listed in this leaflet, they should tell their 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
• Trembling, taste disturbances, fainting
• Numbness or tingling of the limbs, loss 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
• Sexual dysfunction, discomfort or enlargement of the breasts in men
• Pain, poor general condition
• Pain in the joints or muscles, back pain
• Weight increase or decrease

Rare side effects:occur in less than 1 in 1,000 patients but more than 1 in 10,000 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 may 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 tone
• Vasculitis, often with skin rash
• Sensitivity to light
• Disorders including stiffness, trembling, and (or) difficulty moving

Frequency not known:cannot be estimated from the available data

• Trembling, stiff posture, mask-like face, slow movements, and a shuffling, unbalanced gait
• Toxic epidermal necrolysis (multiforme erythema, blistering)

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to store Vilpin

The medicine should be stored out of 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. 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. 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, calcium hydrogen phosphate anhydrous, sodium carboxymethylcellulose (type A), magnesium stearate. Vilpin 10 mg: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, sodium carboxymethylcellulose (type A), magnesium stearate.

What Vilpin looks like and contents of the pack

Vilpin 5 mg is a white, round tablet. One side of the tablet is slightly concave, with the inscription "A5" and a score line, the other side of the tablet is slightly convex and smooth. The tablet can be divided into equal doses.
Vilpin 10 mg is a white, round tablet. One side of the tablet is slightly concave, with the inscription "A10" and a score line, the other side of the tablet 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.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer:

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

Date of last revision of the leaflet: