Vamlox

Leaflet accompanying the packaging: patient information

Wamlox, 5 mg + 320 mg, film-coated tablets

Wamlox, 10 mg + 320 mg, film-coated tablets

Amlodipine + Valsartan

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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1 What is Wamlox and what is it used for

Wamlox is used to treat high blood pressure in patients who are already taking amlodipine and valsartan in the same doses as in the combination product, instead of taking separate medicines.
Wamlox contains two active substances: amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of substances called calcium antagonists. It prevents calcium ions from entering the blood vessel walls, which inhibits the constriction of blood vessels.
• Valsartan belongs to a group of substances called angiotensin II receptor antagonists. Angiotensin II is produced in the human body and causes blood vessels to constrict, increasing blood pressure. Valsartan blocks the action of angiotensin II.

This means that both substances inhibit the constriction of blood vessels. As a result, blood vessels dilate, and blood pressure decreases.

2. Important information before taking Wamlox

When not to take Wamlox

• if you are allergic to amlodipine or other calcium antagonists - you may experience itching, skin redness, or difficulty breathing;
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6) - if you think you may be allergic, tell your doctor before taking Wamlox;
• if you have severe liver or bile duct diseases, such as liver cirrhosis or bile duct obstruction;
• after the third month of pregnancy (you should also avoid taking Wamlox during early pregnancy, see section "Pregnancy");
• if you have significantly low blood pressure (hypotension);
• if you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body's cells);
• if you have heart failure after a heart attack;
• if you have high blood sugar and have type 2 diabetes (also known as non-insulin-dependent diabetes) or have kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above points apply to you, do not take Wamlox and consult your doctor.

Warnings and precautions

Before starting to take Wamlox, discuss it with your doctor:

• if you have gastrointestinal disorders (vomiting, diarrhea);
• if you have liver or kidney disease;
• if you have had a kidney transplant or have narrowing of the renal artery;
• if you have a disease of the adrenal glands called primary hyperaldosteronism;
• if you have had heart failure or have had a heart attack - you should strictly follow your doctor's recommendations regarding the initial dose, and your doctor may also check your kidney function;
• if you have narrowing of the heart valves (aortic stenosis or mitral stenosis) or thickening of the heart muscle (hypertrophic cardiomyopathy with outflow obstruction);
• if you have experienced swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) - if you experience such symptoms, stop taking Wamlox, contact your doctor, and never take Wamlox again;
• if you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Wamlox, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Wamlox on your own.
See also the section "When not to take Wamlox".
If any of the above points apply to you, tell your doctor before taking Wamlox.

Children and adolescents

Wamlox is not recommended for children and adolescents (under 18 years of age).

Wamlox and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Your doctor may recommend changing the dose and/or taking other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines:

• other blood pressure-lowering medicines, so-called ACE inhibitors or aliskiren
• diuretics (also known as water pills, which increase urine production);
• lithium (a medicine used to treat depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that can increase potassium levels;
• certain painkillers, called non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors - your doctor may recommend checking your kidney function;
• antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's wort;
• glyceryl trinitrate and other nitrates or other vasodilators;
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (medicines used to treat heart diseases);
• simvastatin (a medicine used to lower high cholesterol levels in the blood);
• dantrolene (given by infusion in case of severe body temperature disorders);
• medicines used to prevent organ rejection (cyclosporine, tacrolimus);
• sirolimus, temsirolimus, and everolimus (medicines used to suppress the immune system).

Wamlox with food and drink

Patients taking Wamlox should not eat grapefruits or drink grapefruit juice, as both grapefruits and grapefruit juice can lead to increased levels of the active substance amlodipine in the blood, which can cause unpredictable intensification of the effect of Wamlox, consisting of lowering blood pressure.

• This can lead to increased levels of the active substance amlodipine in the blood, which can cause unpredictable intensification of the effect of Wamlox, consisting of lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Wamlox before planned pregnancy or as soon as you know you are pregnant and will recommend another medicine instead of Wamlox. Wamlox should not be taken during early pregnancy (in the first 3 months) and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Wamlox is not recommended during breastfeeding. Your doctor may recommend another treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby. It has been shown that small amounts of amlodipine pass into human milk.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

This medicine may cause dizziness, which can affect your ability to concentrate. Therefore, do not drive, operate machinery, or perform other activities that require concentration until you know how you react to the medicine.

Wamlox contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Wamlox

Take this medicine always as directed by your doctor. If you are unsure, ask your doctor. This will help you get the best results from the treatment and reduce the risk of side effects.
The usual dose of Wamlox is one tablet per day.

• It is recommended to take the medicine every day at the same time.
• Swallow the tablets with a glass of water.
• Wamlox can be taken with or without food. Do not take Wamlox with grapefruit or grapefruit juice.

Depending on your response to the treatment, your doctor may recommend a higher or lower dose of Wamlox.
Do not take a higher dose than recommended.

Taking Wamlox in elderly patients (65 years and older)

When increasing the dose, your doctor will be cautious.

Taking a higher dose of Wamlox than recommended

If you have taken too many Wamlox tablets or if someone else has taken your tablets by mistake, contact your doctor immediately.
Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Wamlox

If you forget to take your medicine, take it as soon as possible. Take the next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Wamlox treatment

Stopping Wamlox treatment may worsen your condition. Do not stop taking Wamlox unless your doctor tells you to.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Wamlox can cause side effects, although not everybody gets them.
Some side effects may be serious and may require immediate medical attention - a few patients have experienced serious side effects (may occur in less than 1 in 1000 people).
If you experience any of the following symptoms, tell your doctor immediately:

• allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling of fainting, "emptiness" in the head).

Other possible side effects of Wamlox:

Frequent (may occur in less than 1 in 10 people):flu-like symptoms; nasal congestion; sore throat and discomfort when swallowing; headache; swelling of the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and feeling of warmth on the face and (or) neck.
Uncommon (may occur in less than 1 in 100 people):dizziness of central origin; nausea and abdominal pain; dryness of the mucous membranes of the mouth; drowsiness, tingling, or numbness of the hands or feet; vertigo of labyrinthine origin, rapid heart rate, including palpitations; orthostatic hypotension; cough; diarrhea; constipation; skin rash, redness of the skin; swelling of the joints, back pain; joint pain.
Rare (may occur in less than 1 in 1,000 people):feeling of anxiety; ringing in the ears (tinnitus); fainting; excessive urination or feeling of strong urge to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head; excessive sweating; rash all over the body; itching; muscle cramps.
If any of these symptoms worsen, tell your doctor.
Side effects reported after taking amlodipine or valsartan alone, which have not been observed after taking Wamlox or have been observed more frequently after taking Wamlox:

Amlodipine

If you experience any of the following very rare, serious side effects after taking the medicine, contact your doctor immediately:

• sudden onset of 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, redness of the skin all over the body, severe itching, blistering, and peeling of the skin, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, arrhythmias;
• pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition.

The following side effects have been reported. If any of the side effects are troublesome for you or last more than a week, contact your doctor.
Frequent (may occur in less than 1 in 10 people):dizziness, drowsiness; palpitations (feeling of heartbeats); sudden redness of the skin, especially of the face and neck; swelling of the ankles (edema); abdominal pain, nausea.
Uncommon (may occur in less than 1 in 100 people):mood changes, anxiety, depression, insomnia, tremors, taste disturbances, fainting, loss of sensation; vision disturbances, impaired vision, tinnitus; low blood pressure; sneezing/ runny nose caused by nasal inflammation (rhinitis); indigestion, vomiting; hair loss, increased sweating, itching of the skin, skin discoloration; urinary disturbances, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of the breasts in men, pain, malaise, muscle pain, muscle cramps; weight gain or weight loss.
Rare (may occur in less than 1 in 1,000 people):disorientation.
Very rare (may occur in less than 1 in 10,000 people):decreased white blood cell count, decreased platelet count, which can lead to unusual bruising and bleeding; increased blood glucose levels (hyperglycemia); gum swelling, abdominal bloating (gastritis); liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in the results of some tests; increased muscle tone; vasculitis, often with skin rash, hypersensitivity to light.
Unknown (frequency cannot be estimated from the available data):tremors, stiffness, mask-like face, slow movements, and dragging of the feet while walking, unsteady gait.

Valsartan

Very rare (may occur in less than 1 in 10,000 people):Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
Unknown (frequency cannot be estimated from the available data):decreased red blood cell count, fever, sore throat, or mouth ulcers caused by infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; kidney function disorders and kidney failure; swelling, mainly of the face and throat; muscle pain; rash, purple-red spots; fever; itching; allergic reactions; blistering of the skin (a symptom of a disease called pemphigus).
If you experience any of these symptoms, tell your doctor immediately.

Reporting side effects

If you experience any side effects, including those 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
Phone: +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 to gather more information on the safety of this medicine.

5. How to store Wamlox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Wamlox contains

• The active substances of Wamlox are amlodipine (as amlodipine besylate) and valsartan. Wamlox, 5 mg + 320 mg, film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 320 mg of valsartan. Wamlox, 10 mg + 320 mg, film-coated tablets Each tablet contains 10 mg of amlodipine (as amlodipine besylate) and 320 mg of valsartan.
• The other ingredients are:
• in the tablet core: microcrystalline cellulose (type 200); magnesium stearate, croscarmellose sodium, povidone K25, sodium lauryl sulfate, mannitol, and anhydrous colloidal silica,
• in the coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, iron oxide yellow (E 172), and iron oxide red (E 172) - only in 5 mg + 320 mg tablets. See section 2 "Wamlox contains sodium".

What Wamlox looks like and contents of the pack

Wamlox, 5 mg + 320 mg, film-coated tablets (tablets)
Brown, biconvex, film-coated tablets in the shape of a capsule (tablet dimensions: 16 mm x 8.5 mm, thickness: 5.5 mm - 7.5 mm).
Wamlox, 10 mg + 320 mg, film-coated tablets (tablets)
Brown-yellow, biconvex, film-coated tablets in the shape of a capsule, with possible darker spots (tablet dimensions: 16 mm x 8.5 mm, thickness: 5.8 mm – 7.8 mm).
Wamlox is available in cardboard boxes containing:

• 28 film-coated tablets in blisters.

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
Krka-farma d.o.o., V. Holjevca 20/E, 10 450 Jastrebarsko, Croatia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Date of last revision of the leaflet:19.03.2025