Alneta

Package leaflet: Information for the patient

Alneta, 5 mg, tablets
Alneta, 10 mg, tablets
Amlodipine
Please read the entire 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.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen, or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Alneta is and what it is used for
2. What you need to know 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 Alneta is and what it is used for

Alneta contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Alneta is used to treat high blood pressure (hypertension) and chest pain known as angina, including a less common form called Prinzmetal's angina, also known as variant angina.
In patients with high blood pressure, the medicine causes relaxation of blood vessels, allowing blood to flow more easily. In patients with angina, Alneta improves blood flow to the heart muscle, thereby increasing oxygen supply to the heart. This helps prevent episodes of chest pain. Alneta does not provide immediate relief of chest pain caused by angina.

2. Important information before using Alneta

When not to use Alneta

• if the patient is allergic to amlodipine, to any of the other ingredients of this medicine (listed in section 6) or to any other calcium antagonist; allergy may manifest as itching, redness of the skin or difficulty breathing;
• if severe low blood pressure (severe hypotension) is present;
• if there is aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body);
• if the patient has heart failure following acute myocardial infarction.

Warnings and precautions
Before starting treatment with Alneta, discuss this with your doctor or pharmacist.
Inform your doctor if any of the following conditions are present or have occurred in the past:

• Recent myocardial infarction
• Heart failure
• Marked increase in blood pressure (hypertensive crisis)
• Liver disease
• Need for dose adjustment in elderly patients

Children and adolescents
The use of Alneta has not been studied in children under 6 years of age. Alneta may be used
exclusively in children and adolescents aged 6 to 17 years with arterial hypertension (see section 3).
For further information, consult your doctor.
Alneta and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any
medicines you plan to take.
Alneta may affect the action of other medicines, and other medicines may alter the effect of Alneta:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections)
• St John's wort (Hypericum perforatum)
• verapamil, diltiazem (medicines used for heart conditions)
• dantrolene (an intravenous preparation used in severe disturbances of body temperature)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines that suppress the patient's immune system)
• simvastatin (used to reduce cholesterol levels)
• cyclosporine (an immunosuppressive medicine).

Alneta lowers blood pressure to a greater extent if the patient is taking other antihypertensive medicines.
Alneta with food and drink
During treatment with Alneta, grapefruit juice or grapefruit should not be consumed, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to unpredictable intensification of the blood pressure-lowering effect of Alneta.
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 this medicine.
Pregnancy
The safety of amlodipine use during pregnancy in humans has not been established. In case of suspected or planned pregnancy, consult your doctor before using Alneta.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If breastfeeding or planning to breastfeed, consult your doctor before using Alneta.
Driving and using machines
Alneta may affect the ability to drive or operate machinery. If the medicine causes nausea, dizziness, fatigue or headache, do not drive or operate machinery and contact your doctor immediately.
Alneta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Alneta

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual starting dose of Alneta is 5 mg once daily. Your doctor may recommend increasing the dose to 10 mg once daily.
Alneta can be taken before or after food. The medicine should be taken at the same time each day, swallowed with water. Do not take Alneta with grapefruit juice.

Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the recommended starting dose is 2.5 mg once daily.
The maximum recommended daily dose is 5 mg. The tablet may be divided into equal doses.
It is important not to interrupt treatment. Do not delay your doctor's appointment until all tablets are used up.

Taking more Alneta than prescribed
Taking too many tablets may cause blood pressure to become low or even dangerously low. Symptoms may include dizziness, a feeling of emptiness in the head, fainting, or weakness. If blood pressure drops significantly, shock may occur. The patient's skin may become cold and clammy, and loss of consciousness may occur. If too many Alneta tablets have been taken, seek immediate medical attention.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may occur within 24–48 hours after taking the medicine.

If you miss a dose of Alneta
There is no cause for concern. If a dose is missed, 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 Alneta treatment
Your doctor will determine how long you should take this medicine. If you stop taking Alneta earlier than advised by your doctor, your condition may return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

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,
you should seek immediate medical advice.

• 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 severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

• Heart attack, cardiac arrhythmias.

• 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 if they last longer than one week, you should contact a doctor.
Very common: occurs in more than 1 in 10 patients

• Fluid retention in the body (oedema)

Common: occurs in up to 1 in 10 patients

• 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 rhythm, diarrhoea, constipation, dyspepsia
• Fatigue, weakness
• Ankle swelling
• Visual disturbances, double vision
• Muscle cramps

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: occurs in up to 1 in 100 patients

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of limbs, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing and/or nasal discharge due to inflammation of the nasal lining (rhinitis)
• Cough
• Dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red skin spots, skin discoloration
• Urinary disturbances, nocturia (increased need to urinate at night), increased frequency of urination
• Inability to achieve erection, discomfort or enlargement of breasts in men
• Pain, malaise
• Joint or muscle pain, back pain
• Increase or decrease in body weight

Rare: occurs in up to 1 in 1,000 patients

• Disorientation

Very rare: occurs in up to 1 in 10,000 patients

• Decrease in white blood cell count, decrease in platelet count, which may cause bruising and easy bleeding
• Increased blood glucose levels (hyperglycaemia)
• Nerve disorders, which may cause weakness, tingling or numbness
• Gum swelling
• Abdominal distension (dyspepsia)
• Liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in laboratory tests
• Increased muscle tension
• Vasculitis, often accompanied by skin rash
• Photophobia (sensitivity to light)
• Disorders involving rigidity, tremor and/or movement disorders

Unknown (frequency cannot be estimated from available data)

• Tremor, postural rigidity, facial masking, slowed movements and shuffling gait, unsteady walking.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Alneta

Store the blister in the outer packaging to protect it from light.
No special temperature storage requirements.
Keep out of the reach and sight of children.
Do not use Alneta after the expiry date stated on the packaging following the abbreviation
EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines you no longer require. This will help protect the
environment.

6. Contents of the packaging and other information

What Alneta contains

• The active substance 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).
• Other ingredients are microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl starch (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 in diameter), slightly biconvex tablets with bevelled edges and a central breakline on one side.
The tablet can be divided into two equal parts.
10 mg:
White, round (10.5 mm in diameter), slightly biconvex tablets with bevelled edges.
Aluminium/OPA/PVC/Aluminium blister in a cardboard box.
Pack sizes: 28, 30, 56, 60, 84, 90, 98, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information on product names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw, Poland
Tel. 22 57 37 500
This medicinal product is authorised in the Member States of the European Economic Area
under the following names: