WAMLOX 10 mg/160 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Wamlox, 5 mg + 80 mg, film-coated tablets
3. Wamlox, 5 mg + 160 mg, film-coated tablets
4. Wamlox, 10 mg + 160 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
   3. 1 What is Wamlox and what is it used for
5. Important information before taking Wamlox
   1. When not to take Wamlox
   2. If any of the above points apply to you, do not take Wamlox and consult your doctor.
   3. Warnings and precautions
   4. If any of the above points apply to you, tell your doctor before taking Wamlox.
   5. Children and adolescents
   6. Wamlox and other medicines
   7. Wamlox with food and drink
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Wamlox contains sodium
6. How to take Wamlox
   1. Taking Wamlox in elderly patients (65 years of age and older)
   2. Taking a higher dose of Wamlox than recommended
   3. Missing a dose of Wamlox
   4. Stopping Wamlox treatment
7. Possible side effects
   1. Some side effects may be serious and may require immediate medical attention:
   2. If you experience any of the following symptoms, tell your doctor immediately:
   3. Other possible side effects of Wamlox:
   4. If any of these symptoms worsen, tell your doctor.
   5. Side effects reported with amlodipine or valsartan alone, which were not observed with Wamlox or were observed more frequently with Wamlox:
   6. If you experience any of the following very rare, serious side effects after taking the medicine, contact your doctor immediately:
   7. Reporting side effects
8. How to store Wamlox
9. Contents of the pack and other information
   1. What Wamlox contains
   2. What Wamlox looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer:
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Wamlox, 5 mg + 80 mg, film-coated tablets

Wamlox, 5 mg + 160 mg, film-coated tablets

Wamlox, 10 mg + 160 mg, film-coated tablets

Amlodipine and valsartan

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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 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 walls of blood vessels, 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. Wamlox is used to treat high blood pressure in adult patients who are not adequately controlled with amlodipine or valsartan alone.

2. Important information before taking Wamlox

When not to take Wamlox

• after the third month of pregnancy (you should also avoid taking Wamlox during early pregnancy, see "Pregnancy");

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

Warnings and precautions

Before taking Wamlox, discuss with your doctor:

• 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. See also "When not to take Wamlox".

If any of the above points apply to you, tell your doctor before taking Wamlox.

If you experience stomach 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.

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, including ACE inhibitors or aliskiren (see also "When not to take Wamlox" and "Warnings and precautions");
• 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 may 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;
• nitroglycerin 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);
• antibiotics (medicines used to treat bacterial infections), such as rifampicin, erythromycin, clarithromycin, telithromycin;
• verapamil, diltiazem (medicines used to treat heart conditions);
• simvastatin (a medicine used to lower high cholesterol levels in the blood);
• dantrolene (used in severe body temperature disorders);
• medicines used to prevent organ rejection (cyclosporine, tacrolimus).

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 an increase in the level of the active substance amlodipine in the blood, which may cause unpredictable intensification of the effect of Wamlox, resulting in a decrease in blood pressure.

• Amlodipine levels in the blood may increase, leading to an unpredictable intensification of the effect of Wamlox, resulting in a decrease in blood pressure.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will usually recommend stopping Wamlox before planned pregnancy or as soon as pregnancy is detected and will recommend another medicine instead of Wamlox. Wamlox is not recommended 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
It has been shown that small amounts of amlodipine pass into human milk. 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 in the case of a newborn or premature baby.
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 attention until you know how the medicine affects you.

Wamlox contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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 of age and older)

When increasing the dose, your doctor will exercise caution.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

Taking a higher dose of Wamlox than recommended

If you have taken too many Wamlox tablets or if someone else has taken them by mistake, consult your doctor immediately.
Even 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 a dose, take it as soon as possible. Take the next dose at the usual time. However, if it is almost time for the 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 recommends it.
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 everyone gets them.

Some side effects may be serious and may require immediate medical attention:

Severe side effects have been reported in a few patients (may affect less than 1 in 1000 people).

If you experience any of the following symptoms, tell your doctor immediately:

An allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling weak, "empty" head).

Other possible side effects of Wamlox:

Common (may affect less than 1 in 10 people):Flu; 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 affect less than 1 in 100 people):Dizziness; nausea and stomach pain; dry mouth; drowsiness, tingling, or numbness of the hands or feet; vertigo of labyrinthine origin, rapid heartbeat, including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint swelling, back pain; joint pain.
Rare (may affect less than 1 in 1,000 people):Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased 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 with amlodipine or valsartan alone, which were not observed with Wamlox or were observed more frequently with 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 stomach pain radiating to the back, with very poor general condition.

The following side effects have been reported. If any of these side effects bother you or last longer than a week, consult your doctor.
Common (may affect less than 1 in 10 people):dizziness, drowsiness; palpitations (feeling of heartbeat); sudden flushing; swelling of the ankles (edema); stomach pain, nausea.
Uncommon (may affect less than 1 in 100 people):mood changes, anxiety, depression, insomnia, tremors, taste disturbances, fainting, loss of sensation; vision disturbances, worsening of vision, tinnitus; low blood pressure; sneezing/ runny nose due to nasal inflammation (rhinitis); indigestion, vomiting; hair loss, increased sweating, itching of the skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of the breasts in men, pain, poor general condition, muscle pain, muscle cramps; weight gain or weight loss.
Rare (may affect less than 1 in 1,000 people):disorientation.
Very rare (may affect less than 1 in 10,000 people):decreased white blood cell count, decreased platelet count, which can lead to unusual bruising and easier bleeding; increased blood glucose levels (hyperglycemia); gum swelling, abdominal bloating (gastritis); liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, as shown in some test results; increased muscle tension; vasculitis, often with skin rash, hypersensitivity to light.
Unknown (frequency cannot be estimated from available data):tremors, stiffness of posture, mask-like face, slow movements, and shuffling gait.
Valsartan
Very rare (may affect less than 1 in 10,000 people):Angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
Unknown (frequency cannot be estimated from available data):decreased red blood cell count, fever, sore throat, or mouth ulcers due to 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 condition 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 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 Wamlox

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Store in a temperature below 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 and valsartan. Wamlox, 5 mg + 80 mg, film-coated tablet Each tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. Wamlox, 5 mg + 160 mg, film-coated tablet Each tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. Wamlox, 10 mg + 160 mg, film-coated tablet Each tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
• Other ingredients are:
• tablet core: microcrystalline cellulose; magnesium stearate, croscarmellose sodium, povidone K25, sodium lauryl sulfate, mannitol, and anhydrous colloidal silica.
• coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, and iron oxide, yellow (E 172). See section 2: "Wamlox contains sodium".

What Wamlox looks like and contents of the pack

Wamlox, 5 mg + 80 mg, film-coated tablets Dark yellow, round, slightly biconvex film-coated tablets with beveled edges, with possible darker spots (tablet diameter: 8 mm, thickness: 3.0 mm - 4.3 mm).
Wamlox, 5 mg + 160 mg, film-coated tablets Dark yellow, oval, biconvex film-coated tablets, with possible darker spots (tablet dimensions: 13 mm x 8 mm, thickness: 3.8 mm - 5.4 mm).
Wamlox, 10 mg + 160 mg, film-coated tablets Light yellow, dark yellow, oval, biconvex film-coated tablets (tablet dimensions: 13 mm x 8 mm, thickness: 3.8 mm - 5.4 mm).
Cartons containing 10, 14, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets in OPA/Aluminum/PVC/Aluminum blisters.
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 TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA – FARMA d.o.o., V.Holjevca 20/E, 10450 Jastrebarsko, Croatia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:19.03.2025