TENOX 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tenox, 5 mg, tablets
3. Tenox, 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 of the Leaflet
4. What is Tenox and what is it used for
5. Important information before taking Tenox
   1. When not to take Tenox
   2. Warnings and precautions
   3. Children and adolescents
   4. Tenox and other medicines
   5. Taking Tenox with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Tenox contains sodium
6. How to take Tenox
   1. Use in children and adolescents
   2. Taking a higher dose of Tenox than recommended
   3. Missing a dose of Tenox
   4. Stopping treatment with Tenox
7. Possible side effects
   1. Reporting side effects
8. How to store Tenox
9. Contents of the pack and other information
   1. What Tenox contains
   2. What Tenox looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Tenox, 5 mg, tablets

Tenox, 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Tenox and what is it used for

Tenox contains the active substance amlodipine, which belongs to a group of medicines called calcium antagonists.
Tenox is used to treat high blood pressure (hypertension) or chest pain called angina pectoris and its rare form called Prinzmetal's angina.
In patients with high blood pressure, the medicine widens the blood vessels so that blood can flow more easily. In patients with angina, Tenox improves blood flow to the heart muscle, increasing the supply of oxygen, which helps prevent chest pain. The medicine does not provide immediate relief from chest pain caused by angina.

2. Important information before taking Tenox

When not to take Tenox

Warnings and precautions

Before taking Tenox, discuss it with your doctor or pharmacist.
Tell your doctor if you have or have had:

• a recent heart attack,
• heart failure,
• a significant increase in blood pressure (hypertensive crisis),
• liver disease,
• a need to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of Tenox in children under 6 years of age. Tenox can only be used to treat high blood pressure in children and adolescents from 6 to 17 years old (see section 3).
To obtain further information, consult your doctor.

Tenox and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tenox may interact with other medicines or other medicines may interact with Tenox:

• ketokonazole, itraconazole (antifungal medicines),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• St. John's Wort (Hypericum perforatum),
• verapamil, diltiazem (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).

Tenox may enhance the blood pressure-lowering effect of other medicines, which can lead to an excessive drop in blood pressure.

Taking Tenox with food and drink

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

Pregnancy and breastfeeding

Pregnancy
There is no data on the safety of amlodipine during pregnancy. If you are pregnant, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, tell your doctor before taking Tenox.

Driving and using machines

Tenox may affect your ability to drive or operate machinery. If the medicine causes nausea, dizziness, fatigue, or headache, do not drive or operate machinery; contact your doctor immediately.

Tenox contains sodium

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

3. How to take Tenox

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose of Tenox is 5 mg once daily. The dose may be increased to 10 mg once daily.
The medicine can be taken with or without food and drink. It is recommended to take the medicine at the same time every day, with a glass of water. Do not take Tenox with grapefruit juice.

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.
Tenox 2.5 mg is not currently available. A dose of 2.5 mg cannot be obtained with Tenox 5 mg tablets, as they are designed to prevent division into halves.
It is essential to take the medicine continuously. Do not wait until you have used up all the tablets before visiting your doctor.

Taking a higher dose of Tenox than recommended

Taking too many tablets may cause a significant or dangerous drop in blood pressure. You may experience dizziness, a feeling of emptiness in the head, fainting, or weakness. In the event of a severe drop in blood pressure, shock may occur. The skin becomes cool and moist, and you may lose consciousness. If you have taken too many Tenox tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.
Up to 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Tenox

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

Stopping treatment with Tenox

Your doctor will inform you about the duration of treatment. If you stop taking the medicine before your doctor advises 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, Tenox can cause side effects, although not everybody gets them.
If you experience any of the following side effects, 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 severe difficulty breathing;
• severe skin reactions, including intense rash, hives, skin redness, severe 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 commonside effects have been reported. If any of these side effects bother you or last more than a week, contact your doctor.
Very common side effects (occurring in more than 1 in 10 patients):

• Swelling of the ankles (edema)

The following commonside effects have been reported. If any of these side effects bother you or last more than a week, contact your doctor.
Common side effects (occurring in less than 1 in 10 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

Other side effects that have been reported are listed below. If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Uncommon side effects(occurring in less than 1 in 100 patients):

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Numbness or tingling of 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, 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
• Joint or muscle pain, back pain
• Weight gain or loss

Rare side effects(occurring in less than 1 in 1,000 patients):

• Disorientation

Very rare side effects(occurring 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
• Increased blood glucose levels (hyperglycemia)
• Nerve disorders that can cause weakness, numbness, or tingling
• Gingival swelling
• Abdominal bloating (gastritis)
• Abnormal liver function, liver inflammation, jaundice, increased liver enzyme activity in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Photosensitivity

Unknown(frequency cannot be estimated from available data)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, 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:
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, you can help provide more information on the safety of this medicine.

5. How to store Tenox

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date
refers to the last day of the month stated.

6. Contents of the pack and other information

What Tenox contains

• -The active substance of Tenox is amlodipine. Each tablet contains 5 mg or 10 mg of amlodipine as amlodipine maleate.
• The other ingredients are: microcrystalline cellulose, pregelatinized starch, sodium carboxymethylcellulose, anhydrous colloidal silica, magnesium stearate. See section 2 "Tenox contains sodium".

What Tenox looks like and contents of the pack

White, round, slightly convex tablets with a score line on one side
Packaging:30 or 90 tablets in blisters in a cardboard box

Marketing authorization holder:

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

Manufacturer:

KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500

Date of last revision of the leaflet: