Package leaflet: Information for the patient

Tenox, 5 mg, tablets
Tenox, 10 mg, tablets
Amlodipine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Tenox is and what it is used for
What you need to know before taking Tenox
How to take Tenox
Possible side effects
How to store Tenox
Contents of the pack and other information

1. What Tenox is and what it is used for

Tenox contains the active substance amlodipine, which belongs to a group of medicines called
calcium channel blockers.
Tenox is indicated for the treatment of high blood pressure (hypertension) or chest pain known as
angina pectoris, including its rare form called Prinzmetal's angina.
In patients with high blood pressure, the medicine dilates blood vessels, allowing blood to flow more easily. In patients with angina, Tenox improves blood flow to the heart muscle, increasing oxygen supply, thereby preventing chest pain. The medicine does not provide immediate relief of angina-related chest pain.

2. Important information before using Tenox

When not to use Tenox

if the patient is allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonist. Symptoms may include itching, skin redness, or difficulty breathing;
if the patient has severe hypotension;
if the patient has left ventricular outflow tract obstruction (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood flow to the body);
if the patient has heart failure following a previous heart attack.

Warnings and precautions
Before starting treatment with Tenox, discuss this with your doctor or pharmacist.
Inform your doctor if the patient currently has or has previously had:

a recent heart attack,
heart failure,
a marked increase in blood pressure (hypertensive crisis),
liver disease,
the need for dose adjustment in elderly patients.

Children and adolescents
Studies on the use of Tenox in children under 6 years of age have not been conducted. Tenox
may be used only for the treatment of hypertension in children and adolescents aged 6 to 17 years
(see section 3).
For further information, please consult your doctor.
Tenox with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Tenox may affect the action of other medicines, or other medicines may affect the action of Tenox:

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

Tenox may cause a greater reduction in blood pressure if the patient is taking other antihypertensive medicines.
Taking Tenox with food and drink
Patients taking Tenox should not consume grapefruit juice or grapefruits, as they may increase the blood concentration of the active substance, amlodipine, which could lead to an unexpected intensification of the blood pressure-lowering effect of Tenox.
Pregnancy and breastfeeding
Pregnancy
There is insufficient data on the safety of amlodipine use during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before using Tenox.
Driving and operating machinery
Tenox may affect the ability to drive or operate machinery. If the medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or operate machinery and should contact their doctor immediately.
Tenox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Tenox

This medicine should always be used exactly as directed by the physician. If in doubt, consult
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.
Tenox may be taken independently of meals and drinks. It is recommended to take the medicine at the
same time each day, swallowing the tablets with water. Do not take Tenox with grapefruit juice.
Use in children and adolescents
In children and adolescents (aged 6–17 years), the usual recommended starting dose is 2.5 mg per
day. The maximum recommended dose is 5 mg per day.
The 2.5 mg strength of Tenox is currently unavailable. A 2.5 mg dose cannot be obtained from the 5 mg
tablets, as these tablets are manufactured in a way that prevents splitting in half.
It is important to use the medicine continuously. Do not wait until all tablets are used up before
visiting your doctor.
Taking more than the recommended dose of Tenox
Taking too many tablets may cause a reduction, or even a dangerous reduction, in blood pressure.
Dizziness, a sensation of "emptiness" in the head, fainting, or weakness may occur. In cases of severe
hypotension, shock may develop. The skin then becomes cold and clammy, and the patient may lose
consciousness. If an overdose of Tenox is taken, seek immediate medical attention by contacting a
doctor or going to the nearest hospital emergency department.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur up to
24–48 hours after taking the medicine.
Missing a dose of Tenox
Remain calm. If a patient forgets to take a tablet, the missed dose should be skipped. Take the next
dose at the usual time. Do not take a double dose to make up for a 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, your condition may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following side effects occur after taking the medicine, contact your doctor immediately:

Sudden wheezing, chest pain, breathlessness, or difficulty breathing;
Swelling of the eyelids, face, or lips;
Swelling of the tongue and throat causing significant breathing difficulties;
Severe skin reactions, including severe rash, urticaria, generalized redness of the skin, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions;
Heart attack, cardiac rhythm disturbances;
Pancreatitis, which may cause acute abdominal pain radiating to the back, accompanied by severe malaise.

The following very common side effects have been reported. If any of these side effects are troublesome for the patient or persist for more than one week, contact your doctor.
Very common side effects (occur in more than 1 in 10 patients):

Swelling around the ankles (edema)

The following common side effects have been reported. If any of these side effects are troublesome for the patient or persist for more than one week, contact your doctor.
Common side effects (occur in less than 1 in 10 patients):

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

Other reported side effects are listed below. If any of these side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon side effects (occur in less than 1 in 100 patients):

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

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
Increased blood glucose levels (hyperglycemia)
Nerve disorders, which may cause weakness, tingling, or numbness
Gum swelling
Abdominal bloating (gastritis)
Liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in blood tests
Increased muscle tone
Vasculitis, often with skin rash
Photophobia (sensitivity to light)

Unknown frequency (cannot be estimated from available data):

Tremor, rigidity, facial masking, slowed movements, shuffling gait, unsteady gait.

Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tenox

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

6. Contents of the packaging and other information

What Tenox contains

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

What Tenox looks like and contents of the pack
White, round, slightly biconvex tablets with bevelled edges and a division line on one side
Packaging: 30 or 90 tablets in blister packs contained in a cardboard box
Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA-POLSKA Sp. z o.o., Równoległa 5, 02-235 Warsaw, Poland
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500