ALNETA 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Alneta, 5 mg, tablets
3. Alneta, 10 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents:
4. What is Alneta and what is it used for
5. Important information before taking Alneta
   1. When not to take Alneta
   2. Warnings and precautions
   3. Children and adolescents
   4. Alneta and other medicines
   5. Alneta with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Alneta contains sodium
6. How to take Alneta
   1. Use in children and adolescents
   2. Taking a higher dose of Alneta than recommended
   3. Missing a dose of Alneta
   4. Stopping treatment with Alneta
7. Possible side effects
   1. Reporting side effects
8. How to store Alneta
9. Contents of the pack and other information
   1. What Alneta contains
   2. What Alneta looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in EU member states under the following names:

Package Leaflet: Information for the Patient

Alneta, 5 mg, tablets

Alneta, 10 mg, tablets

Amlodipine

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

• Keep this package leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents:

• 1. What is Alneta and what is it used for
• 2. Important information before taking Alneta
• 3. How to take Alneta
• 4. Possible side effects
• 5. How to store Alneta
• 6. Contents of the pack and other information

1. What is Alneta and what is it used for

Alneta contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Alneta is used to treat high blood pressure (hypertension) and chest pain (angina pectoris), a rare form of which is Prinzmetal's angina.
In patients with high blood pressure, the medicine causes the blood vessels to relax, making it easier for the blood to flow through them.
In patients with angina, Alneta improves blood flow to the heart muscle, which in turn receives more oxygen. This helps prevent chest pain. The medicine does not provide immediate relief from chest pain associated with angina.

2. Important information before taking Alneta

When not to take Alneta

• if you are allergic to amlodipine or any other ingredient of this medicine (listed in section 6) or to any other calcium antagonist; the allergy may manifest as itching, redness of the skin, or difficulty breathing;
• if you have very low blood pressure (severe hypotension);
• if you have narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply the body with enough blood);
• if you have heart failure after a recent heart attack.

Warnings and precautions

Before taking Alneta, 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
• Necessity to increase the dose in elderly patients

Children and adolescents

Alneta has not been studied in children under 6 years of age. Alneta can only be used in children and adolescents from 6 to 17 years of age with high blood pressure (see section 3).
To get more information, you should consult your doctor.

Alneta and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Alneta may affect the action of other medicines, and other medicines may change the action of Alneta:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections)
• St. John's Wort
• verapamil, diltiazem (medicines used to treat heart conditions)
• dantrolene (infusion used to treat severe body temperature disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system)
• simvastatin (used to lower cholesterol levels)
• cyclosporin (immunosuppressive medicine).

Alneta lowers blood pressure more when you take other anti-hypertensive medicines.

Alneta with food and drink

While taking Alneta, do not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice may lead to increased levels of the active substance amlodipine in the blood, which may cause unpredictable intensification of Alneta's action to lower blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of amlodipine during pregnancy in humans has not been established. If you are pregnant or planning to become pregnant, consult your doctor before taking Alneta.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking Alneta.

Driving and using machines

Alneta may affect your ability to drive or use machines. If the medicine causes nausea, dizziness, fatigue, or headache, do not drive or use machines and contact your doctor immediately.

Alneta contains sodium

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

3. How to take Alneta

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual initial dose of Alneta is 5 mg once a day. Your doctor may recommend increasing the dose to 10 mg once a day.
The medicine can be taken before or after a meal. Take the medicine every day at the same time, with a glass of water. Do not take Alneta with grapefruit juice.

Use in children and adolescents

For children and adolescents (aged 6 to 17 years) with high blood pressure, the recommended initial dose is 2.5 mg once daily. The maximum recommended daily dose is 5 mg. The tablet can be divided into equal doses.
It is important not to stop taking the tablets. Do not delay your doctor's visit until you have taken all the tablets.

Taking a higher dose of Alneta than recommended

Taking too many tablets may cause your blood pressure to be too low or even dangerously low. You may feel dizzy, lightheaded, faint, or weak. If the blood pressure drop is significant, it may lead to shock. Your skin may become cold and clammy, and you may lose consciousness. If you have taken too many Alneta tablets, contact your doctor immediately.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may occur 24-48 hours after taking the medicine.

Missing a dose of Alneta

There is no need to worry. If you forget to take a tablet, skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Alneta

Your doctor will decide how long you should take the medicine. If you stop taking the medicine earlier than your doctor recommends, 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, Alneta can cause side effects, although not everybody gets them.
If you experience any of the following very rare but serious side effects after taking Alneta, 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 difficulty breathing.
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, or other allergic reactions.

Frequent side effects. If any of the side effects are troublesome for you or last more than a week, you should contact your doctor.

• Fluid retention in the body (edema)

Common: may affect up to 1 in 10 people

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

Other side effects that have been reported are listed below. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting,
• Numbness or tingling of 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 membrane 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, malaise
• Pain in the joints or muscles, back pain
• Weight gain or loss

Rare: may affect up to 1 in 1,000 people

• Disorientation

Very rare: may affect up to 1 in 10,000 people

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

Unknown(frequency cannot be estimated from available data)

• Tremors, stiffness of posture, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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
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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Alneta

Store the blister in the outer packaging to protect from light.
No special temperature storage conditions are required.
Keep out of the reach and sight of children.
Do not use Alneta after the expiry date stated on the packaging after 'EXP'. The expiry date refers to the last day of that month.
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 Alneta contains

• The active substance of Alneta is amlodipine. Alneta, 5 mg, tablets Each tablet contains 5 mg of amlodipine (as amlodipine besylate). Alneta, 10 mg, tablets Each tablet contains 10 mg of amlodipine (as amlodipine besylate).
• The other ingredients are microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate. See section 2 "Alneta contains sodium".

What Alneta looks like and contents of the pack

5 mg:
White, round (8 mm diameter), slightly convex tablets with beveled edges, with a score line on one side.
The tablet can be divided into two equal parts.
10 mg:
White, round (10.5 mm diameter), slightly convex tablets with beveled edges.
Blister pack (OPA/Aluminum/PVC/Aluminum) in a cardboard box.
Pack sizes: 28, 30, 56, 60, 84, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto, Slovenia
To obtain more detailed information on the names of the medicinal products in other EU member states, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500

This medicine is authorized in EU member states under the following names:

Date of last revision of the leaflet:08.09.2022